Clinical Practice Guidelines

PHILIPPINE SOCIETY OF
OTO L A RY N G O LO G Y -
H E A D A N D N E C K S U R G E RY

Clinical Practice Guidelines

Acute Otitis Media in Children

Cleft Lip Alveolus and Palate
Allergic Rhinitis in Adults
Acute Bacterial Rhinosinusitis in Adults
Chronic Rhinosinusitis in Adults

Clinical Practice Guidelines

Working Group

Ruzanne M. Caro, MD
Jose M. Acuin, MD
Manuel E. Villegas, Jr, MD
Erasmo Gonzalo D.V. Llanes, MD
Christopher E. Calaquian, MD
Karen June P. Dumlao, MD

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FOREWORD

We take pride in this first of a series of releases of the 2016 PSOHNS clinical practice guidelines. The series includes
TABLE OF CONTENTS updated versions of the guidelines on allergic rhinitis, acute bacterial rhinosinusitis and chronic rhinosinusitis in adults.
Significantly, there are new guidelines that address acute otitis media in children, and cleft lip alveolus and palate. The study
groups representing the relevant ENT subspecialties led in each phase of guideline development as well as collaborated with
experts from other specialties.
Foreword (3)
The previous set of guidelines has been widely used as ‘must reads” of ENT residents in training and as such were
used to evaluate care delivered by residents in training. We hope that the 2016 series will be extensively used to improve
patient outcomes by changing professional practice, shaping ENT care policies and driving new research. For these to happen,
Acute Otitis Media in Children (4) the guidelines have to be widely discussed and adapted to specific clinical settings.
Philippine Academy of Otology, Neurotology and Related Sciences
Guidelines do not implement themselves. Clinical pathways, that is, institution–specific protocols and pre-printed
order sets, based on the strongest guideline recommendations, must be developed by multidisciplinary hospital groups.
Cleft Lip Alveolus and Palate (14) Pathways have been proven to effectively translate guideline recommendations into process and outcome improvements.
Philippine Academy of Facial Plastic We, otolaryngologists, can demonstrate leadership by heading these pathway groups and championing pathway
and Reconstructive Surgery implementation.

Allergic Rhinitis in Adults (27) Guidelines are not cast in stone. They are living, breathing documents which should be critically appraised, just like
Philippine Academy of Rhinology any form of research, for their validity and applicability. They have expiry dates that should trigger automatic re-evaluation
and revision. They are like cars that depreciate once they are released from their makers. Thus, we should be alert to new
evidence that may modify or reverse their recommendations.
Acute Bacterial Rhinosinusitis in Adults (36)
Philippine Academy of Rhinology Guidelines do not dictate care, only guide it. Guidelines should not be used to unreasonably standardize care. As
doctors we are required to bend care to respond to unique patients’ needs, not blindly adhere to guidelines. Rather we
Chronic Rhinosinusitis in Adults (41) can use guidelines during audits and peer reviews to debate, discuss and learn from our colleagues’ care decisions and the
Philippine Academy of Rhinology consequent outcomes of such care. This invites healthy professional competition and benchmarking. Our patients should
ultimately benefit from sensible guideline adoption.

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Table 2. Level of Evidence for Therapeutic Studies hyperemia of the mucoperiosteum. Symptoms will include mild earache,
ear fullness and fever. An erythematous and markedly retracted eardrum
Acute Otitis Media in Children Level Type of evidence is seen upon otoscopy.
Philippine Academy of Otology, Neurotology and Related Sciences 2. Stage of Exudation
1A Systematic review (with homogeneity) of RCTs This stage marks the outpouring of fluid from the dilated permeable
Generoso T. Abes, MD The level of recommendation and evidence for therapeutic studies capillaries. All symptoms are aggravated especially pain and fever. A red
C. Gretchen Navarro-Locsin, MD from the American Society of Plastic Surgeons Evidenced-based Clinical 1B Individual RCT (with narrow confidence intervals) and thickened bulging eardrum with loss of the light reflex is seen on
Alexander C. Cabungcal, MD Practice Guidelines were used in the grading of recommendations for this otoscopy.
Charlotte M. Chiong, MD guideline. 1C All or none study 3. Stage of Suppuration / Perforation
Marieflor Cristy M. Garcia, MD During this stage the eardrum ruptures and there is a lot of discharge
Teresa Luisa I. Gloria-Cruz, MD 2A Systematic review (with homogeneity) of cohort studies seen from the middle ear. Fever and pain are relieved but hearing loss
Norberto V. Martinez, MD seems to have worsened.
Maria Rina T. Reyes-Quintos, MD 2B Individual Cohort study (including low quality RCT, e.g. 4. Stage of Coalescence and Surgical Mastoiditis
Table 1. Levels of Recommendation <80% follow-up)
Joel A. Romualdez, MD This stage is marked by a milder recurrence of pain, mastoid tenderness
Franco Abes, MD and fever. Mastoid tenderness and sagging of the posterosuperior wall
Cristopher Ed Gloria, MD Grade Descriptor Qualifying Implications for 2C “Outcomes” research; Ecological studies are revealed upon further evaluation of the patient.
Emmanuel Dela Cruz, MD Evidence Practice 5. Stage of Complication
Marichu Forence Ciceron, MD 3A Systematic review (with homogeneity) of case-control This stage marks the extension of the infection beyond the middle
Level I evidence or Clinicians should follow studies
Harvey Hndrix Chu, MD a strong recommenda-
ear.
consistent findings
Frederick Fernandez, MD A Strong tion unless a clear and 6. Stage of Resolution
from multiple studies
Ryan Chua, MD recommendation of levels II, III, or IV compelling rationale for
3B Individual Case-control study This stage may occur at any stage of the disease.
Frendi Cristi, MD an alternative approach
Ham Casipit, MD is present 4 Case series (and poor quality cohort and case-control PREVALENCE AND EPIDEMIOLOGY
Giselle Gotamco, MD study AOM can affect any age group, although epidemiologic studies report
Mark Alcid, MD that it is more common among children younger than 3 years of age. Two
Generally, clinicians 5 Expert opinion without explicit critical appraisal or based thirds of these children are expected to have one episode of AOM during
Ace Dela Rosa, MD
Levels II, III, or IV should follow a recom- on physiology bench research or “first principles”
Veronica Mendoza, MD childhood and one third of them will have more than three episodes
evidence and mendation but should
Anli Kael Tan, MD B Recommendation before they reach the age of 2. Thus age is an important factor in the
findings are generally remain alert to new in- From the Centre for Evidence-Based Medicine
consistent formation and sensitive incidence of AOM.
SCOPE OF THE PRACTICE GUIDELINES to patient preferences A wide range of AOM incidence rates can be found in different
These clinical practice guidelines are for the use of the Philippine DEFINITION countries. In the Asia-Pacific region, incidence ranges from 0.69%
Society of Otolaryngology-Head and Neck Surgery. It covers the diagnosis Acute otitis media (AOM) is defined as an acute middle ear among Thai school children aged 7-9 years old to 33% among Australian
and management of acute otitis media in children 2 months to 12 years Clinicians should be inflammation. It is characterized by signs and symptoms of middle ear aboriginal children aged 6 to 30 months. Reports from both Europe and
of age.1,2 flexible in their decision- inflammation with or without the presence of effusion of less than 3 the US, show that 62% of children aged less than one year and 83%of
Levels II, III, or IV making regarding appro- weeks duration4. those up to the age of three have suffered at least one bout of AOM.
C Option evidence, but priate practice, although
OBJECTIVES In the Philippines, a cross sectional survey of children ages 0 – 12 years
findings are they may set bounds
The objectives of the guideline are (1) to emphasize the requisites on alternatives; patient
ETIOLOGY old showed an overall prevalence of AOM at 9.6%, with the 0 to 2 year
inconsistent
for the diagnosis of acute otitis media in children and (2) to describe preference should have AOM can be due to multiple multiple organisms such as viruses and age group having the highest prevalence4. By means of extrapolation
treatment options based on current evidence.3 a substantial influenc- bacteria. The most common cultures AOM bacteria are Streptococcus there were approximately 2,721,676 children that were presumed to
ing role pneumonia, non-typable Hemophilus influenza and Moraxella catarrhalis. have acute otits media (out of 228,427,779 among the 0-14 age group,
LITERATURE SEARCH Among cases of AOM the most commonly isolated bacterial pathogens based on Philippine Health Statistics done in 2005). According to the
The National Guideline Clearing House, Society for Middle Ear Disease are S.pneumonia in 25-50%, H.influenza in 15-30% and M.catarrahlis in 2007 National Statistics Data, around 2% of all antibiotic prescriptions
Organization and Cochrane Ear, Nose and Throat Disorders Group of Clinicians should con- 3-20%. The common AOM viruses in children are respiratory syncytial in the Philippines were for the treatment of AOM. The estimated cost
Level V evidence: sider all options in their virus, rhinovirus, coronavirus, parainfluenza, adenovirus and enterovirus. of antibiotic treatment for AOM among the pediatric population was
the National Institute for Health Research were searched for guidelines
D Option little or no systematic decision making and be There is still controversy whether all these viruses are pathogens that
on acute otitis media. Additional Search Strategy included electronic estimated to be around 5.7 billion Philippine pesos.6
empirical evidence alert to new published
databases (Cochrane Database, Medline, CINAHL, Pubmed Database, cause AOM, but it has been identified that adenovirus poses the greatest
evidence that clarifies
ScienceDirect, DOAJ, Biomed Central), local libraries, including attempts the balance of benefit risk of causing AOM after a bout of upper respiratory tract infectin. Co- RISK FACTORS
of searching for unpublished literature. Electronic database were versus harm; patient infection with a viral cause of AOM has been a suspected reason for Risk factors for AOM are not exactly involved in its pathophysiology,
searched using the keywords otitis media to include acute otitis media preference should have failure of antibiotic therapy4. rather their presence may indicate a higher chance of AOM occurrence.
limited to the English language. The search yielded 19,653 articles. a substantial influenc- These risk factors are divided into non-modifiable host related risk
ing role factors (age, sex, race, genetic predisposition) and environment-related
Forty five articles were chosen for review and were divided as follows: NATURAL HISTORY OF ACUTE OTITIS MEDIA4,5. modifiable risk factors (exposure to smoke, poor socioeconomic status,
Meta-analysis/Systematic Review 10 From the American Society of Plastic Surgeons. Evidence-based congested living conditions, daycare center attendance, previous use of
Randomized Controlled Trial 7 clinical practice guidelines. AOM may be clinically seen in any of the following natural occurring antibiotics, bottle feeding and use of pacifiers)4,5
Descriptive/Cohort 12 stages: In a systematic review of the risk factors associated with AOM among
Clinical Practice Guidelines 16 1. Stage of Hyperemia/ Retraction indigenous people in Australia, it was found that swimming pool use may
This is the onset of disease, which is characterized by a generalized also attribute to AOM occurrence. Additional host-related risk factors

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identified included premature birth, allergies, immunological deficiency, Moderate to Severe symptoms include otalgia on the visual analog
cleft palate defects, craniofacial abnormalities and adenoid hypertrophy. scale with a duration of at least 48 hours and body temperature of marginal benefit with regards to pain relief during the early stages of the
Seasonality as another environmental factor may increase the risk of 39°C or more.9 disease.21 Some experts believe that children aged less than two years
RECOMMENDATIONS FOR THE TREATMENT OF ACUTE
otitis media.7 In contrast to most western countries, the Philippines has and children with bilateral disease or with otorrhea need antimicrobials
OTITIS MEDIA
only two seasons: the rainy season (from June to November) and the dry Figure 1. Visual Analog Scale for their initial AOM treatment.5 The Europeans and the Americans may
season (from December to May) 8. differ in the institution of symptomatic relief as initial treatment for AOM
Visual Analog Scale (VAS) 1. Pain relief is an important part of effective AOM management.
Treatment in order to address otalgia is recommended. but they both agree that antimicrobials should immediately be given to
0 1 2 3 4 5 6 7 8 9 10
RECOMMENDATIONS FOR THE DIAGNOSIS OF ACUTE Worst
Grade B Recommendation Level 3A evidence children of ages less than 6 months, have fever greater than 39°C or have
OTITIS MEDIA
no
pain
Possible
Pain severe otalgia. These three indicators have been associated with a greater
Most of the articles that were reviewed and the consensus taken from likelihood of treatment failure and serious infection.3 On the other hand,
1. Diagnosis of acute otitis media is based mainly on clinical several studies have considered children with an age of less than 2 years
different groups agreed that pain associated with acute illness should be
parameters. A good clinical history and physical examination, 2. Pneumatic otoscopy is recommended as a primary tool in the to be an indication for immediate antibiotic therapy regardless of any
addressed17. Treatment options should be based on the severity of illness
particularly otoscopy and pneumatic otoscopy can obtain criteria that diagnosis of middle ear effusion. other associated risk factor.22,23
with incorporation of the preference of the parent/caregiver and the
will fulfill the clinical diagnosis of acute otitis media4. Grade B Recommendation Level 2B evidence
patient. Consideration of benefits and risks should be done whenever Table 3. Indications for antibacterial treatment versus observation in
Grade B Recommendation Level 3A Evidence possible18. Pain should be addressed during the first 24 hours upon children with uncomplicated AOM24
An important criteria for AOM diagnosis is the presence of middle
diagnosis. Paracetamol (10-15 mg/Kg/dose) and Ibuprofen (5-10mg/Kg/
1.1 Diagnosis of acute otitis media requires ear fluid. In order to identify signs and symptoms of middle ear effusion, Moderate or Severe
dose) are the mainstay of treatment that can provide analgesia for mild Age Mild AOM
1.1.1 History of acute (within 3 weeks) onset and confirmation with the use of pneumatic otoscopy is recommended4. AOM
to moderate pain19.
1.1.2 Signs and symptoms of middle ear Pneumatic otoscopy is 70-90% sensitive and specific for determining the
The use of topical anesthetics is currently not recommended because < 6 months Antibacterial Antibacterial
inflammation and presence of middle ear effusion (MEE) when compared to 60-70% accuracy
there was a paucity of evidence with regards to its benefits among Treatment Treatment
1.1.3 Presence of middle ear effusion with simple otoscopy11. Findings include limited or absent mobility of the
patients who concurrently took oral analgesics when they were compared Antibacterial treatment
tympanic membrane, which is the best predictor of AOM (high sensitivity
to patients who concurrently took placebo medications19. 6 months to 2 years Antibacterial in bilateral AOM
1.2 Any of the following otoscopic findings 95%, high specificity 85%), cloudiness of tympanic membrane with (high
sensitivity 74% and high specificity 97%) and bulging of the tympanic Treatment Observation in unilateral
1.2.1 Limited or absent mobility of the 2. Initial observation is an option among children two years and AOM
tympanic membrane9,4 membrane (low sensitivity 51% and high specificity 97%)12.There can be
older with mild symptoms and among infants 6 to 23 months old with ≥ 2 years Antibacterial
Best predictor of AOM (high sensitivity 95%, difficulty in the assessment of the tympanic membrane of infants and
unilateral mild AOM. Treatment Observation
high specificity 85%)9 young children due to problems with cooperation, the external auditory
Grade B Recommendation Level 2A Evidence
1.2.2 Cloudiness of tympanic membrane9,4 meatus anatomy and the presence of cerumen. In such cases the diagnosis
High sensitivity 74% and high specificity 97%9 of AOM cannot be made certain. The use of pneumatic otoscopy in order
Initial observation for AOM refers to deferment of antibacterial 4. High dose amoxicillin is recommended as the first-line
1.2.3 Bulging of the tympanic membrane9,4 to confirm the restricted mobility of the tympanic membrane can be
treatment for the first 48 to 72 hours while providing symptomatic treatment among most patients with mild AOM.
Low sensitivity 51% and high specificity 97%9 helpful but may also present problems when performed among small
relief.19 Observation must be a joint decision between the clinician and Grade A Strong Recommendation Level 1A Evidence
1.2.4 Markedly retracted tympanic membrane9,4 children13,14.
the parents or caregiver. In such cases, a system for close follow-up and
1.2.5 Distinct erythema of the tympanic membrane4 a means of beginning antibiotics must be in place if symptoms worsen Amoxicllin is recommended as first line therapy based on its favorable
1.2.6 Air-fluid level or air bubbles behind the tympanic 3. Tympanometry is not routinely recommended in the diagnosis
or no improvement is seen within the initial 48 to 72 hours. Safety net pharmacologic profile against drug-resistant pneumococci, its proven
membrane9,4 of AOM.
antibiotic prescriptions (SNAP) can be given at the initial visit with a efficacy, safety profile, narrow spectrum of activity and low cost.9
1.2.7 Perforation with otorrhea9 Grade C Recommendation Level 2B Evidence
specific instruction that it will be used only when the condition of the Amoxicillin (80-90 mg/Kg/day in 2 divided doses) is effective in
child persists or worsens after 48 to 72 hours.20 SNAP prescriptions should inhibiting most non-susceptible strains of pneumococci and to achieve
A good clinical history and otoscopic examination of the tympanic The sensitivity and specificity of tympanometry, using pneumatic
be dated so as to prevent the inappropriate use of antibiotics15. adequate concentration of the drug in the middle ear fluid.9,22 Amoxicillin,
membrane is the key to the correct diagnosis of AOM. otoscopy as a gold standard, has been assessed. The presence of a type
Parents or caregivers should be educated about the self-limiting given in high-doses, is able to maintain a minimal inhibitory concentration
A or normal tympanogram does not completely rule out the presence
nature of most cases of AOM, the importance of pain relief early in the (MIC) of antibiotic in the middle ear, exceeding the MICs of intermediate
of air-fluid levels and effusion in the middle ear. Only when performed
course, and the possible side effects of antibacterials (i.e. hypersensitivity, and high-level penicillin-resistant S. pneumoniae.25,26 In 2014, Philippine
1.3 Any of the following findings together with normal otoscopy can it be predictive of the lack of middle
vomiting, diarrhea and diaper rash) 9. data reported that resistance of Streptococcus pneumonia to Penicillin
1.3.1 Otalgia ear fluid. A type B or flat tympanogram should be confirmed by means
was 7% - 10.3% (n=257; 95% CI: 5.9-13.4) while there was a Penicillin
Older children with AOM usually present with a of repeated measurements and by the correlation of tympanometry with
3. Initial antibiotic therapy should be prescribed among the resistance of 6.6% to 13.4% for Haemophilus influenza.27 Resistance to co-
history of rapid ear pain. Among young preverbal pneumatic otoscopy15.
following: trimoxazole was reported to be between 17% to 23% for Streptococcus
children tugging, rubbing or holding of the ear may A particular disadvantage of tympanometry is that it requires a good
a. Children 6 months and older with severe signs or symptoms pneumonia and 22% to 43% for Haemophilus influenza from 2008 to
suggest otalgia. Excessive crying and changes in the seal of the external auditory canal. A tympanogram cannot be obtained
of unilateral or bilateral disease and, 2014.27
child’s sleep pattern may also suggest otalgia9. in children who often move or cry because an adequate seal cannot be
b. Children less than 2 years old with bilateral disease without
1.3.2 Fever obtained16.
severe signs or symptoms 5. An antibiotic with β-lactamase coverage is recommended as a
Acute occurrence of otalgia, fever and/or otorrhea Grade B Recommendation Level 2A evidence first line treatment for severe AOM or when a child’s symptoms worsen
supports the diagnosis of AOM but is nonspecific as 4. Tympanocentesis is not routinely recommended in the
or fail to respond to initial amoxicillin treatment. (Figure 2)
an entity. In relation to the diagnosis of AOM, it has diagnosis of acute otitis media.
Initial antibiotic therapy is defined as treatment of AOM with Grade B Recommendation Level 2B Evidence
a sensitivity of 54% and a specificity of 82%10. antibiotics prescribed upon diagnosis, which has the intent of starting
Grade C Recommendation Level 2B evidence
antibiotic therapy as soon as possible. A recent systematic review that Severe AOM suggests a more severe disease or the presence of
Mild symptoms include mild otalgia on the visual analog scale with a compared the effectiveness of antibiotic and placebo in the initial resistant strains necessitating Amoxicillin with clavulanic acid (90mg/Kg/
duration of less than 48 hours and body temperature of less than Tympanocentesis is the gold standard for bacteriologic diagnosis but
treatment of uncomplicated AOM showed that antibiotic use provided a day amoxicillin plus 6.4mg/Kg/day of clavulanic acid) as initial therapy.4
39°C.9 it is not usually indicated in the diagnosis of acute otitis media4.

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6. If the patient is allergic to amoxicillin, alternative drugs should In a Cochrane review that compared short and long course antibiotics Table 5. Antibiotic treatment after 48-72h of failure of Initial the effects of widespread implementation of PCV on AOM, the effects
be considered. for AOM, children in the former group had a higher treatment failure rate Antibiotic Treatment9 of other serotypes of PCV on AOM, and the risks of complications that
Grade C Recommendation Level 2B Evidence when they were compared to children who received longer courses of PCV vaccine may impose in the general population. However, the overall
antibiotics (OR: 1.44; 95% CI: 1.21–1.71)18. In another systematic review, First-Line treatment Alternative Treatment reduction of AOM cases that may be brought about by the use of PCV-11
Depending on the type of allergic reaction observed, several it was found that short–course azithromycin (3-5 days), had a low risk of may prove to be more beneficial and cost effective in the future.
antibiotics can be recommended. treatment failure29. Ceftriaxone, 3 days
For time-dependent antibacterial agents such as penicillins (amoxicillin) Amoxicillin-Clavulanate Clindamycin Figure 2. Algorithm for Treatment of AOM in children
Table 4. Alternative drugs to amoxicillin for allergic patients.5 (30-40 mg/Kg/day in 3 divided
and cephalosporins, drug concentrations must be maintained above the (90mg/Kg/day amoxicillin with
Type I Hypersensitivity Reac- Non-Type I Hypersensitivity minimum inhibitory concentration for at least 40% of the dosing interval 6.4 mg/Kg/day clavulanate in 2 doses) w/ or w/o third-generation
cephalosporin
tion* Reaction** in order to maintain its efficacy. The efficacy of these drugs increase divided doses)
along with their concentrations. Therefore the bactericidal activity of Clindamycin
Azithromycin ***Cefdinir these antibacterials are dependent on their length of exposure to the (30-40 mg/Kg/day in 3 divided
(10 mg/Kg/day once daily on (14 mg/Kg/day in 1 or 2 doses) pathogen. This principle may explain a risk of treatment failure when doses) plus third generation
Day1, followed by 5 mg/Kg/day Cefpodoxime amoxicillin is given for a short course29. Ceftriaxone cephalosporin
on day 2-5) (10 mg/Kg/day once daily) (50 mg/Kg IM or IV once a day
Clarithromycin Cefuroxime 8. Clinicians must reassess the patient if the symptoms worsen for 3 days) Tympanocentesis or
(15 mg/Kg/day in 2 divided (30 mg/Kg/day in 2 divided or fail to respond to the initial management options within the first Myringotomy
doses for 10 days) doses) 48-72 hours in order to confirm the diagnosis of AOM, to determine
Erythromycin Cefixime the existence of possible complications and to exclude other causes of
Specialist consultation
(30-50 mg/Kg/day in 3 divided (8mg/Kg/day once a day or in 2 the illness.
doses) divided doses) 8.1. If the patient was initially managed with observation,
Sulfamethoxazole-Trimethoprim management options include the initiation of antibacterial therapy. 9. The use of antihistamine and/or decongestant therapy is not
(6-12 mg/Kg/day trimethoprim 8.2. If the patient was initially managed with an antibacterial agent recommended for the treatment of acute otitis media.
in 2 divided doses) (s), management options include 1) change of the antibacterial agent(s); Grade A Strong Recommendation Level 1B Evidence
or 2) tympanocentesis or myringotomy in addition to modification of
*Type I hypersensitivity is immediate or anaphylactic hypersensitivity. The reaction takes 15-30 the antibacterial therapy. Antihistamine/decongestant therapy is not recommended for the
minutes from the time ofexposure to the antigen. Grade C Recommendation Level 3A Evidence management of AOM. Upon review of the Cochrane database, studies
**Non-Type I hypersensivity is not an immediate reaction and may involve other mechanisms
of allergy. that examined the efficacy of antihistamines or decongestants upon
*** Not available in Philippines (Philippine National Drug Formulary) Within 24 hours of antibiotic therapy, the patient’s condition is identification of acute signs or symptoms of AOM, found no significant
expected to stabilize. Pain relief is a useful indicator of treatment differences between treatment groups. The use of antihistamines and/
Clindamycin (30 mg/Kg/day TID) can be used for patients who are response.4 The time course for clinical response should be within 48-
allergic to penicillin and are penicillin-resistant S pneumonia suspects. A or decongestants did not appear justified in the treatment of AOM and is
72 hours. Criteria for response include the following: 1) defervescence therefore not recommended given their known side effects18. However, it
single dose of parenteral ceftriaxone (50 mg/kg) has been shown to be within 48-72 hours, 2) decrease in irritability and 3) normalization of
equivalent to 10 days of amoxicillin and has been known to be effective was recognized that these agents may be used for concomitant illnesses
sleep/eating patterns. such as allergies.4
for patients who cannot tolerate the oral form of antibiotic treatment4. If AOM is confirmed in a patient initially managed with observation
A five-day single-dose azithromycin regimen was shown to provide but has not been noted to clinically improve, the clinician should begin
clinical results parallel to 10 days worth of amoxicillin-clavulanic acid as 10. Clinicians should recommend pneumococcal conjugate
antibacterial therapy. A patient who was initially given amoxicillin may be vaccine to all children.
well4. Cefixime has excellent activity against β- lactamase–producing H. shifted to high dose amoxicillin with clavulanic acid (90 mg/Kg/day + 6.4
influenzae and M. catarrhalis but has significantly weaker activity against Grade B Recommendation Level 2A Evidence
mg/Kg/day). A 3-day course of once daily dosing of Ceftriaxone (50mg/
S. pneumoniae than amoxicillin. Therefore, cefixime may be a good choice Kg/day IV/IM) may be given to patients with vomiting.3 In a local study,
for AOM unresponsive to agents with high activity against S. pneumoniae, In a recent systematic review on the effects of PCV vaccination in
a single 50 mg/Kg IM dose of Ceftriaxone was shown to be effective for AOM prevention, the use of PCV-7 showed modest beneficial effects
as these cases of AOM are likely attributed to H. influenzae or M. the treatment of uncomplicated AOM and did not show any significant
catarrhalis.28 In severe cases of AOM that do not respond to antibacterial among healthy infants but it was unable to reduce overall AOM episodes.
side-effects.30 Furthermore, the administration of PCV 7 among older children with a
therapy, a referral to a specialist may be warranted for tympanocentesis. Tympanocentesis or myringotomy may provide immediate pain
The tympanocentesis may lead to a definitive identification of the history of AOM had no beneficial effect on preventing future episodes of
relief. The procedure may also establish a microbiological analysis of AOM. On the other hand, the use of PCV-11 showed overall reduction in
involved pathogen and may further provide a better evaluation of the the aspirate in order to isolate the pathogens involved and affirm their
disease3. all causes of AOM32.
antibiotic sensitivities especially among AOM cases that have failed to The incorporation of PCV-7 in routine childhood immunization
respond to various antibiotic regimens9,18,25. Grevers mentioned that programs in the US proved to be cost effective. An Asian study done in
7. Duration of antibiotic treatment should depend on the age of tympanocentesis is only indicated for treatment of complications of
the patient and the severity of the disease. Singapore showed the cost effectiveness of PCV-7 on vaccinated infants
AOM, treatment failures and in conditions wherein imminent tympanic when herd immunity was present. Overall, pneumococcal conjugate
Grade A Strong Recommendation Level 1A Evidence membrane perforations cannot be avoided31. 11. Clinicians may recommend annual influenza vaccine to all
vaccines have proven to be safe and immunogenic among young
children.
Antimicrobial treatment for 10-14 days continues to be the current children4.
Grade C Recommendation Level 2B Evidence
clinical practice for AOM.4 A standard 10-day course is favored over In the Philippines, a cohort study done among children 2 to 6 months
shorter courses in children younger than 2 years. In mild to moderate old showed no difference in the development of AOM in children
Upper respiratory tract infections usually caused by viruses may result
cases, 7 days of antibiotics is preferred for children 2 to 5 years of age and whether they were given PCV or not. However, the relative risk data
in AOM particularly in young children. The administration of influenza
a 5 to 7 day course for children 6 years and older.9 derived from this study showed that the vaccine was beneficial in
vaccine demonstrated efficacy in the prevention of AOM by 30% to 55%.9
preventing AOM33. Further studies are still needed in order to determine

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In another study done among children aged 7-50 months, it was found that respiratory infections during the first year of life. However, further clinical media. Pediatric Emergency medicine practice April 2013 volume 3 number 4.
influenza vaccine had an 83% efficacy rate against influenza-associated trials are still warranted to confirm its direct effects on AOM39. Several 21. Sanders, S. Glasziou, PP. Del Mar C.B., Rovers, MM. Antibiotics for Acute Otitis
Meida in Children. Cochrane Database of Systematic Reviews 2004, Issue 1. Art. No.
AOM and a 36% efficacy against all-cause AOM.34 In the US, Influenza studies have also suggested that probiotics did not prevent episodes of CD000219
vaccine is now recommended for all children 6 months of age and older9. AOM in infants and children.40,41 More studies with bigger populations 22. Bluestone CD, Klein JO. Otitis Media in Infants and Children. 4th ed. Hamilton:
Influenza vaccine has to be encouraged because it may be useful in the and high levels of evidence are still needed in order to arrive at a definite BC Decker Inc, 2007 pp 213-325
prevention of first AOM episodes35. However, a recent Cochrane review conclusion. 23. McWilliams CJ, Goldmann RD. Update on Acute Otitis Media in Children
revealed that the influenza vaccine had no effect on drug prescription younger than 2 years of age. Cam Fam Physician. 2011 Nov; 57(11):1283-5.
24. Thomas JP, Berner R, Zahnert T, Dazert S. Acute Otitis Media—a Structured
rates, the prevention of AOM, as well as the consequences of vaccination BIBILIOGRAPHY Approach Deutsches Ärzteblatt International | Dtsch Arztebl Int 2014; 111(9):
and the socioeconomic impact of the influenza vaccine36. 151−60
1. US Department of Health and Human Services Food and Drug Administration Center 25. High dose amoxicillin: Rationale for use in otitis media treatment failures.
for Devices and Radiological Health. Guidance for Industry and FDA Staff: Pediatric
12. Clinicians should encourage exclusive breastfeeding for at Paediatr Child Health Vol 4 No 5 July/August 1999
Expertise for Advisory Panels. Taken from http://www.fda.gov/RegulatoryInformation/ 26. Rationale behind High-Dose Amoxicillin Therapy for Acute Otitis Media Due
least 6 months Guidances/ucm082185.htm to Penicillin-Nonsusceptible Pneumococci: Support from In Vitro Pharmacodynamic
Grade B Recommendation Level 3A Evidence 2. Knoppert D, Reed M, Benavides S, Totton J, Hoff D, Moffet B, Norris K, Vaillancourt Studies. Antimicrobial Agents and Chemotherapy, Vol. 41 No. 9 Sept. 1997
R, Aucoin R, Worthington M. Paediatric Age Categories to be Used in Differentiating 27. Antimicrobial Resistance Surveillance Reference Laboratory. Antimicrobial
Breast milk contains lactoferrin, secretory IgA and antibodies. It Between Listing on a Model Essential Medicines List for Children: Position Paper. Resistance Surveillance Program 2014 Data Summary Report. Research Institute of
World Health Organization archives.
stimulates the infant’s immune response and interferes with bacterial Tropical Medicine DOH 2014.
3. Philippine Society of Otolaryngology Head and Neck Surgery. Clinical Practice 28. Nelson, M. An update on treatment strategies for Acute Otitis Media. InetCE
attachment to the nasopharynx4. Exclusive breastfeeding for at least Guidelines: Acute Otitis Media in Children. 2006. 221-146-04-057-H01
3 months reduces the incidence of AOM by 13% while 6 months of 4. Abes et. al. Acute Otitis Media: Current Evidenced-Based Recommendations for 29. Gulani A, Sachdev HPS. Effectiveness of shortened course (≤ 3 days) of
exclusive breastfeeding reduced the incidence of AOM to 50%35. None of Primary Care Physicians. Manila Otorhinolaryngological Foundation, Inc, Manila antibiotics for treatment of acute otitis media in children. A systematic review of RCT
the studies that explored the association of AOM in infants with duration 2013. efficacy trials. World Health Organization 2009.
5. Philippine Society of Otolaryngology Head and Neck Surgery. Clinical Practice
of breastfeeding had randomized controlled designs, but when they were 30. Bravo LC AG, Castillo Y, Sunga-Mallorca E, Matsuo JM, Hernandez M. Open-
Guidelines: Acute Otitis Media in Children. 2006. Labeled, Non-Comparative Trial: Single-Dose Intramuscular Ceftriaxone For
taken together the results showed a pattern of protection of exclusive 6. Caro RM lE, Ricalde RR, Sarol JN. Prevalence of Clinically Diagnosed Acute Otitis Media Uncomplicated Acute Otitis Media in Children Philippine Infectious Disease Society
breastfeeding9. The position of a child during breastfeeding may be (AOM) in the Philippines: a National Survey with Developing Country’s Perspective. of the Philippines Journal. 1999;3(1):22-6.
better when compared to a child who is bottlefed in a supine position. Acta Medica Philippina. 2014;48(4):30-4. 31. Grevers G et al. Identification and characterization of the bacterial etiology
The supine position and the negative pressure created in the eustachian 7. Jervis-Bardy J, Carney LS. Otitis Media in Indigenous Australian children: review of of clinically problematic acute otitis media after tympanocentesis or spontaneous
epidemiology and risk factors. The Journal of Laryngology & Otology (2014), 128
tube during bottle-feeding may cause infants to suck excessively which otorrhea in German children. BMC Infectious Diseases 2012
(Suppl. S1), S16–S27. 32. Fortanier AC, Venekamp RP, Boonacker CWB, Hak E, Schilder AGM, Sanders
may in turn lead to episodes of AOM.37 8. Philippine Atmospheric, Geophysical, and Astronomical Services Administration. EAM, Damoiseaux RAMJ. Pneumococcal conjugate vaccines for preventing otitis
http://www.pagasa.dost.gov.ph/index.php/climate-of-the-philippines media. Cochrane Database of Systematic Reviews 2014, Issue 4. Art. No.: CD001480.
13. Clinicians should encourage prevention of AOM by reduction 9. Allan S. Lieberthal, Aaron E. Carroll, Tasnee Chonmaitree, Theodore G. Ganiats, DOI: 10.1002/14651858.CD001480.pub4
of risk factors and education of parents/caregivers Alejandro Hoberman, Mary Anne Jackson, Mark D. Joffe, Donald T. Miller, Richard 33. Chu T, Cachola D, Regal MA, Llamas AC. Pneumococcal Conjugate Vaccine
M. Rosenfeld, Xavier D. Sevilla, Richard H. Schwartz, Pauline A. Thomas and
Grade C Recommendation level 2A evidence (Non-Typeable Haemophilus influenzae (NTHi) Protein D, Diphtheria or Tetanus
DavidE. Tunkel. The Diagnosis and Management of Acute Otitis Media. Pediatrics Toxoid Conjugates) in Prevention of Acute Otitis Media in Children: A Cohort Study.
2013;131;e964 Manuscript Submitted for Publication
Parent’s and caregivers’ awareness of the disease helps prevent AOM. 10. Subcommittee for Clinical Practice Guidelines for Diagnosis and Management 34. Heikkinen T, Ruuskanen O. Inlfuenza vaccination in the prevention of Acute
Knowledge and avoidance of modifiable risk factors may alleviate the of Acute Otitis Media in Children. Clinical Practice Guidelines for Diagnosis and Otitis Media in Children. Am J Dis. Child. 1991 Apr; 145(4):445-8.
burden of AOM.4 In a review of studies on risk factors for recurrent AOM Management of Acute Otitis Media in Children. Auris Nasus Larynx 39 (2012) 1-8 35. Marchisio P, Bellussi L, Di Mauro G, Doria M, Felisati G. Acute otitis media:
11. Heikkinen T, Ruuskanen O. Inlfuenza vaccination in the prevention of Acute
they found out that pacifier use, exposure to cigarette smoke, attendance From diagnosis to prevention. Summary of the Italian guideline. International
Otitis Media in Children. Am J Dis. Child. 1991 Apr; 145(4):445-8. Journal of Pediatric Otorhinolaryngology 74 (2010) 1209–1216. doi:10.1016/j.
at daycare facilities, craniofacial anomalies and less breastfeeding history 12. Allan S. Lieberthal, Aaron E. Carroll, Tasnee Chonmaitree, Theodore G. ijporl.2010.08.016
increased the incidence of AOM recurrence.38 Avoidance of exposure Ganiats, Alejandro Hoberman, Mary Anne Jackson, Mark D. Joffe, Donald T. Miller, 36. Jefferson T, Rivetti A. Vaccines for preventing Influenza in healthy children.
to tobacco smoke may also reduce the incidence of AOM in children18. Richard M. Rosenfeld, Xavier D. Sevilla, Richard H. Schwartz, Pauline A. Thomas and Cochrane Database Systematic Review. 2012 Aug 15;8:CD004879
Careful handwashing and use of alcoholic solutions among school-aged DavidE. Tunkel. The Diagnosis and Management of Acute Otitis Media. Pediatrics 37. Brown CE, Magnuson B. On the physics of the infant feeding bottle and middle
2013;131;e964
children were shown to reduce the incidence of AOM by 27%. On the ear sequela: Ear disease in infants can be associated with bottle-feeding. Int J Pediatr
13. Helenius KK, Laine MK, Tahtinen PA, Lahti E, Ruohola A: Tympa - nometry in Otorhinolaryngol 2000;54:13-20.
other hand, pacifier use has been shown to increase the risk of AOM by discrimination of otoscopic diagnoses in young ambulatory children. Pediatr Infect 38. Lubianca Neto JF, Hemb L, Silva DBE. Systematic literature review of modifiable
30%35. Dis J 2012; 31: 1003–6 28. Klein JO: Otitis media. Clin Infect Dis 1994; 19: 823–33 risk factors for recurrent acute otitis media in childhood. J Pediatr (Rio J) 2006; 82:
14. Laine MK, Tahtinen PA, Helenius KK, Luoto R, Ruohola A: Acoustic reflectometry 87-96.
14. Probiotics are not recommended for the prevention of Acute in discrimination of otoscopic diagnoses in young ambulatory children. Pediatr Infect 39. Rautava, S, Salminen S, Isolauri E. Specific probiotics in reducing the risk of acute
Dis J 2012; 31: 1007–11
Otitis Media in children infections in infancy – a randomised, double-blind, placebo-controlled study British
15. UMHS Guidelines Oversight Team. Guidelines for Clinical Care Ambulatory: Journal of Nutrition (2009), 101, 1722–1726 doi:10.1017/S0007114508116282
Grade C Recommendation level 2B evidence Otitis Media. University of Michigan Health System 2013. 40. Cohen et al. Probiotics and prebiotics in preventing episodes of acute otitis
16. Casey J, Pichichero M. Acute Otitis Media Update 2015. ContemporaryPediatrics. media in high-risk children: a randomized, double-blind, placebo-controlled study.
A randomised, double-blind, placebo-controlled study was conducted com March 2015 Pediatr Infect Dis J. 2013 Aug;32(8):810-4. doi: 10.1097/INF.0b013e31828df4f3
in order to determine whether probiotics (Lactobacillus rhamnosus GG 17. Committee on Psychosocial Aspects of Child and Family Health and Task Force 41. Hatakka et al. Treatment of acute otitis media with probiotics in otitis-prone
on Pain in Infants, Children, and Adolescents , The Assessment and Management of
and Bifidobacterium lactis Bb-12) might be effective in reducing the risk children-a double-blind, placebo-controlled randomised study.Clin Nutr. 2007
Acute Pain in Infants, Children, and Adolescents Pediatrics 2001;108;793 Jun;26(3):314-21. Epub 2007 Mar 13.
of infections in infancy. During the first year of life, nine out of thirty- 18. Olesczuk M, Fernandes R, Thomson D, Shaikh N. The Cochrane Library and acute
two (28 %) infants who received probiotics and twenty-two out of forty otitis media in children: an overview of reviews . EVIDENCE-BASED CHILD HEALTH: A
(55 %) infants who received placebo encountered recurrent respiratory COCHRANE REVIEW JOURNAL Evid.-Based Child Health 7: 393–402 (2012).
infections (RR 0·51 (95 % CI 0·27, 0·95); P1⁄4 0·022). This data suggests 19. Sanders, S. Glasziou, PP. Del Mar C.B., Rovers, MM. Antibiotics for Acute Otitis
Meida in Children. Cochrane Database of Systematic Reviews 2004, Issue 1. Art. No.
that probiotics may offer a safe means of reducing the risk of early acute
CD000219
otitis media and antibiotic use as well as reducing the risk of recurrent 20. Nesbit, C. Powers, M. An evidenced-based approach to managing acute otitis

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UNILATERAL CLEFT LIP ALVEOLUS AND PALATE

Philippine Academy of Facial Plastic and secondary palate (hard and soft palate). Cleft lip can further be described (37%) and cleft lip deformities (21%). Of the patients with isolated
Reconstructive Surgery as unilateral or bilateral, complete or incomplete.2 unilateral cleft lip deformity, 75% were left-sided.7

Jaime Anthony A. Arzadon IV MD source and was modified for this clinical practice guideline. This report Primary surgical procedures are the initial interventions designed to RECOMMENDATIONS ON THE DIAGNOSIS OF
Christopher Malorre E. Calaquian MD will need to be reviewed and modified periodically with new and updated correct the deformities associated with the cleft lip and palate. These CLEFT LIP AND PALATE
Richel L. Cavas, MD knowledge. include: cheiloplasty, alveoloplasty, rhinoplasty, and palatoplasty.
Armando M. Chiong, Jr MD 1. History-taking is essential in the evaluation of patient with
Henry John F. Claravall, MD SCOPE OF THE PRACTICE GUIDELINE Primary rhinoplasty is the initial procedure that is usually done during cleft lip and palate deformity.
Edwin M. Cosalan MD These clinical practice guidelines are for the use of the general the primary cheiloplasty. This involves the release and repositioning Grade D Recommendation Level 5 Evidence
Virgilio R. De Gracia MD otorhinolaryngologists. This covers the diagnosis and management of of the deformed alar cartilage and/or columella. The aims of primary
Rachel T. Mercado-Evasco, MD unilateral cleft lip alveolus and palate deformities of pediatric patients rhinoplasty are to achieve normalization of the nose, i.e., symmetry, by Risk factors for cleft lip and palate include maternal alcohol
Mark Arjan R. Fernandez, MD (18 years and younger). lengthening the cleft side columella, elevating the lower lateral cartilage, consumption, reduced folic acid concentrations, and genetic linkage.
Aileen Delos Santos-Garcia, MD and shortening or lifting the cleft side heminose.2 Based on a study by Bezerra et al., maternal alcohol consumption and
Ramon E. Gonzales, MD OBJECTIVES reduced folic acid concentrations increases the risk for non-syndromic
Kathleen R. Fellizar-Lopez, MD The objectives of the clinical practice guidelines are to (1) aid the Secondary surgical procedures are the follow-up interventions cleft lip and palate.8
Nelson G. Magno, MD general ENT in the diagnosis and classification (2) evaluate presurgical designed to correct the residual deformities associated with the cleft
Dennis Cristobal S. Mangoba, MD diagnostics (3) evaluate surgical options (4) describe the multidisciplinary lip and palate. These include alveolar bone grafting, palate rerepair or 2. An initial Head and Neck examination is essential in the
Homer M. Matias, MD cleft care team in managing patients with unilateral cleft lip alveolar and velopharyngoplasty, definitive rhinoplasty, lip revision and orthognathic evaluation of patient with cleft lip and palate deformity.
Michael Edward A. Navalta, MD palate deformity. surgery.2,3 Grade D Recommendation Level 5 Evidence
Roberto M. Pangan, MD
Eduardo Francisco V. Tanlapco, MD LITERATURE SEARCH Definitive rhinoplasty is a nasal procedure to correct residual nasal The head is inspected for symmetry. The auricle and the external
Raynald Edlin P. Torres, MD The National Library of Medicine’s PubMed database was searched deformity done once approximate facial maturity is achieved.2, 3 ear canal are checked for development and location. A facial analysis
Lyra V. Veloro, MD using keywords cleft lip, cleft palate and management. The search was is helpful to identify abnormalities of facial symmetry and harmony.
Manuel E. Villegas, Jr, MD limited to journals published in English for the last fifteen years, and local PREVALENCE Otologic examination includes pneumatic otoscopy and tuning fork tests.
Cesar V. Villafuerte Jr, MD, MHA accredited ENT institution reports. Cleft lip and palate represents the second most frequently occurring Cleft palate is commonly associated with Eustachian tube dysfunction due
Lei-Joan S. Vital, MD congenital deformity. The incidence of cleft lip and palate varies to an abnormal insertion of the levator and tensor veli palatini muscles in
Vanessa P. Cabaluna, MD A total of 590 journals were initially searched and narrowed to 84 considerably according to race. The incidence among Caucasians is the posterior margin of the hard palate. Anterior and posterior rhinoscopy
Alexander Edward S. Dy, MD journals. Of the 84 researches used in the guideline development, thirty- 1:1000 live births, while American Indians is 3.6:1000 live births. The will identify clefting, septal abnormalities, intranasal masses and
Rodolfo U. Fernandez III, MD three committee reports and protocols from institutions were used as incidence for Asians is slightly higher, Japanese 2.1:1000 live births and choanal atresia. Oral cavity examination will reveal any cleft, dental arch
Emilio Raymund G. Claudio, MD guides for the formulation of the clinical practice guidelines. The articles Chinese, 1.7: 1000 live births.4 abnormalities and tongue anomalies such as bifid tongue, macroglossia,
Loella Joy C. Lustestica, MD were divided accordingly: glossoptosis, or lingual thyroid. In addition, malocclusion, hemifacial
May Cristine L. Obana, MD Meta-analysis 8 Based on an 8-year study done by the Corazon Locsin Montelibano hypertrophy or atrophy, and facial clefting are documented. The upper
Mary Harmony B. Que, MD Randomized control trial 4 Memorial Regional Hospital in 1997, the prevalence of cleft lip with or airway tract is evaluated by assessing the adequacy of phonation, cough,
Non-randomized control study 11 without cleft palate is 2 per 1000 live births. Based on the Philippine Oral and deglutition, and by auscultating and palpating the neck.9
DISCLOSURES Descriptive study 24 Cleft registry in 2008, the incidence is 0.46 per 1000 live birth.
The members of the Philippine Academy of Facial Plastic and Committee report 33 3. The Thallwitz Classification in the diagnosis of CLAP deformities
Reconstructive Surgery did not receive funding for the creation of Four unpublished researches were included due to their relevance According to a census by the Philippine Birth Defects Registry Project is recommended.10 For ICD-10 and PHIC use, the Veau classification is
these guidelines. PAFPRS has no conflicts of interest and has nothing to as they provided local data for the recommendations. All materials were from 1999-2001, cleft lip and palate is the third most common birth recommended.
disclose assessed for relevance and classified according to levels of evidence and defect in the Philippines (first is multiple congenital anomalies, second Grade D Recommendation Level 5 Evidence
grades of recommendations based on guidelines from the Oxford Centre is ankyloglossia). A total of 110 cases of cleft lip and palate were tallied,
INTRODUCTION for Evidence-Based Medicine.1 5.6:10,000 live births.5 Cleft lip and palate patients will be classified according to the Thallwitz
The clinical practice guidelines (CPG) on the unilateral cleft lip nomenclature and ICD-10 system. The institutions using the Thallwitz
alveolus and palate deformity was created by the Philippine Academy The guideline development group was divided into three subgroups to In a census done in Philippine General Hospital from 1996-2000, there are the following: Philippine General Hospital, Manila Doctors Hospital,
of Facial Plastic and Reconstructive Surgery (PAFPRS), a study group of formulate key recommendations on diagnosis and pre-surgery concerns, were 378 cases of bilateral cleft lip (associated cleft palate not specified), Far Eastern University Medical Center, Quezon City General Hospital,
the Philippine Society of Otorhinolaryngology-Head and Neck Surgery, surgical and multidisciplinary management. A series of meetings over 208 cases of cleft lip with palate and 188 cases of cleft lip alone. In 2002, Veteran’s Memorial Hospital, St. Luke’s Medical Center, University of the
Inc. which is composed of general otolaryngologists, facial, plastic and one year were performed for writing, discussion and appraisal of an average of 21 CLAP patients per month was seen at the ORL outpatient East Ramon Magsaysay Memorial Medical Center, Quirino Hospital, and
reconstructive otorhinolaryngology surgeons from different accredited recommendations prior to external review and publication. clinic of the Philippine General Hospital. Four to eight cleft operations East Avenue Medical Center.
ENT training institutions as well as ENT practitioners. The views from per month were performed.6
other specialty groups such as plastic surgeons, pediatricians, dentists DEFINITIONS Based on a study done by the Manila Doctors Hospital Department of The Veau system classifies cleft lip and palate deformities into four
and families of patients were considered and included in the creation of Cleft lip and palate is a congenital anomaly with a wide range of Otorhinolaryngology on their patients with cleft lip and palate from 2004 classes, depending on whether the primary and/or secondary palates are
these guidelines. presenting variety of forms and combinations. It is the failure of fusion to 2014, a demographic profile was developed. A total of 178 patients affected and by laterality.11 This classification system is used by the ICD
of embryonal facial clefts. Cleft lip ranges from notching of the lip to a were seen, with an overall sex ratio of 1.17 male: 1 female. Eighty percent and PHIC. (Table 1)
The current CPG for Cleft Lip and Palate of the University of the complete cleft, involving the floor of the nose. It may be associated with of the cases were unilateral, while 20% were bilateral. Of the patients
Philippines - Philippine General Hospital (PGH) is acknowledged as a a cleft of the primary palate (alveolus/pre-maxilla) and with clefts of the with bilateral clefts, 78% had a combined cleft plate and lip deformity. Of
the patients with unilateral clefts, majority were cleft palate deformities

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3.1 According to a study done by Dhillon in 1988 and Robinson in Grade B Recommendation, Level 2B Evidence
Table 1. Veau system of Figure 1. Thallwitz nomenclature 1992, 92% - 97% of patients with cleft palate develop otitis media with
classification effusion.16,17 In a study done at Manila Doctors Hospital, 100% of patients The use of nasoalveolar molding has proven to be an efficient method
Incomplete cleft, soft palate only with cleft palate have otitis media with effusion on both ears.18 for reducing cleft width and improving nasal shape and symmetry in
Veau Class I (right side) (midline) (left side)
(no unilateral/bilateral designation) 3.2 Based on a study by Handzik-Cuk et al., type B tympanograms unilateral clefts. The immediate success of the therapy facilitates cleft
L-lip A-alveolus H-hard palate S-soft palate H-hard palate
Hard and soft palate, secondary palate only are associated with 21-40-dB hearing loss in patients with cleft lip and surgery immensely. Regardless of the cleft width, preoperative narrowing
Veau Class II A-alveolus L-lip
palate.19 Otitis media with effusion is associated with patients with cleft of the lip and alveolar segments, nasal shaping and columella lengthening
(no unilateral/bilateral designation)
palate due to velopharyngeal insufficiency.19 help to reduce tissue tension and therefore improve surgical outcome by
Veau Class III Complete unilateral cleft including lip
3.3 It is established that pediatric patients with effusion develop minimizing wound healing disturbances and scarring.29
(primary and secondary palates) significant hearing loss that could affect speech and language. These
L = Lip - 1/3 or 2/3 or 3/3
Veau Class IV Complete bilateral cleft children are set to a mild to moderate hearing loss that averages about SURGICAL MANAGEMENT OF THE UNILATERAL CLEFT LIP-ALVEOLUS-
A = Alveolar cleft - 1/3 or 2/3 or 3/3 25 dbHL as a result of the fluid in the middle ear space. Such occurrence PALATE DEFORMITY
The ICD-10 system is an international standard of coding. Various will impair the ability to hear speech, and thereby encode information The aim of cleft surgery is to restore the entire cleft defect to as near
descriptions of cleft deformities and their codes are seen in Table 2. ineffectively and inaccurately, from which language develops. Speech a normal anatomy as possible. It is divided into primary and secondary
H = Hard palate cleft - 1/3 or 2/3 at a conversational level will be difficult for these patients that will lead surgical procedures.
Table 2. ICD-10 system or 3/3 to poor interaction, then subsequent decreased opportunities to learn
language.20 RECOMMENDATIONS FOR PRIMARY SUGICAL PROCEDURES
Cleft hard and soft palate with cleft lip, bilateral Q374 S = Soft palate cleft - 1/3 or 2/3 or 3/3 3.4 An otoacoustic emission test (OAE) or an auditory brainstem
Cleft hard and soft palate with cleft lip, unilateral Q375 response (ABR) test is used as hearing screening in newborn with cleft 1. Cheiloplasty is done as early as three months
Cleft hard palate with cleft lip, bilateral Q370 lip and palate.21 Grade D Recommendation, Level 5 Evidence
Cleft hard palate with cleft lip, unilateral Q371 3.5 A retrospective study of middle ear effusion and treatment
Cleft hard palate with cleft soft palate, bilateral Q354 outcomes with cleft palate patients at the Connecticut Children’s Medical Early cheiloplasty is not done as it has been proven to cause maxillary
Cleft hard palate with cleft soft palate, unilateral Q355 Center from 2005 to 2009 by Szabo, et al. revealed that 82% of cleft palate retrusion and reduced maxillary length.30 Performing the procedure at
Cleft hard palate, bilateral Q350 passed the newborn hearing screening. 98% developed middle ear fluid three months or later allows the child to achieve significant maxillary
Cleft hard palate, unilateral Q351 RECOMMENDATIONS ON DIAGNOSTICS AND requiring at least one set of tubes; while 75% only required 1-2 sets of growth, to allow for more tissue availability for the repair, more time
Cleft lip Q36 PRE-SURGERY tubes before resolving the eustachian tube dysfunction sufficiently that for parent-child bonding, and more time for the parents to gain a better
Cleft lip, bilateral Q360 OME did not reaccumulate.22,23 understanding and acceptance of the child’s congenital deformity.
Cleft lip, medial Q361 1. Early second trimester detection of CLAP deformity through Rotation advancement for both complete and incomplete unilateral cleft
Cleft lip, unilateral Q369 ultrasonography is recommended. lip repair is the most common technique among training institutions
Cleft palate Q35 Grade C Recommendation Level 4 Evidence 4. Pre- and post-operative photodocumentation of patients with previously cited.
Cleft palate with cleft lip Q37 cleft lip and palate deformity may aid the clinician in surgical planning
Cleft palate, medial Q356 The second trimester ultrasound recommended can be done and assessing surgical outcomes. 2. Alveoloplasty (soft tissue only) can be done with primary
Cleft palate, unspecified, bilateral Q358 in conjunction with the ultrasound commonly recommended by Grade C Recommendation, Level 4 Evidence cheiloplasty or until the ideal age for bone grafting is reached
Cleft palate, unspecified, unilateral Q359 obstetricians to screen for congenital anomalies. Early detection of a cleft Grade C recommendation, Level 4 Evidence
Cleft soft palate with cleft lip, bilateral Q372 deformity can prepare the family for future interventions, be it medical, Based on literature, there are no standardized views for pre and
Cleft soft palate with cleft lip, unilateral Q373 surgical, psychological, or economic.12 post-operative photodocumentation of cleft lip and palate patients. Early alveoloplasty is not done as it has been found to result in
Cleft soft palate, bilateral Q352 However, there are some studies who have used frontal and submental reduced maxillary height.31 The procedure is delayed to allow significant
Cleft soft palate, unilateral Q353 2. Folic acid supplementation is recommended prior to photographic views for post-operative assessment of patients.24, 25, 26 maxillary growth and to allow for more tissue availability for the repair.
Cleft uvula Q357 conception. The alveolar bone grafting procedure is postponed until 7 to 9 years old
Grade A Recommendation, Level 1A Evidence 5. Cephalometric radiographs for patients ages 6 and above because it is at this time where the root of the permanent canine has
(start of mixed dentition) and candidates for alveolar bone grafting is formed 1/3 to 2/3, and the crown is still partially covered by bone.32,32,34
Based on the 2010 Cochrane review for periconceptional folic acid recommended. At this age, there is minimal retrusion noted as opposed to it being done
The Thallwitz nomenclature (commonly known as the LAHSHAL) is supplementation for the prevention of cleft deformities, folic acid Grade C Recommendation, Level 4 Evidence earlier.
a descriptive classification since site, size, extent and type of cleft are supplementation is favorable.13,14
considered. Severity of the deformity is objectively documented and the Cephalometric radiographs aid in surgical planning for alveolar bone 3. Primary rhinoplasty can be done with primary cheiloplasty or
recorded findings can easily be stored into a computer for data analysis. grafting especially for patients ages 6 and above who already start to until as early as 14 years old for females and 16 years old for males
Each area is divided into thirds, and cleft defects are graded as to extent have mixed dentition.27 which is the ideal age for definitive rhinoplasty.
of affected areas. Grading is done for both sides as shown in Figure 1. 3. While Otoacoustic Emission (OAE) with or without Auditory Grade B Recommendation, Level 2B Evidence
Brainstem Response (ABR) is already done for newborn hearing 6. Pediatric evaluation and clearance prior to surgical intervention
screening, Tympanometry is recommended to be added for patients to assess for other co-morbid conditions is recommended. Primary rhinoplasty occurs with the initial lip repair as previous
with cleft palate. Grade B Recommendation, Level 2 Evidence beliefs on early nasal surgery interfering with nasal and midface growth
Grade B Recommendation, Level 2B Evidence have been overturned.35,36 The benefit of early intervention allows for an
For any surgical procedure, pre-operative evaluation and clearance is earlier restoration of nasal shape with the potential for more symmetric
Paradise, et al. developed the term “universality of otitis media in recommended.28 nasal growth as well as to spare the child the psychosocial impact of
cleft palate children” after demonstrating that 96% of cleft patients had ridicule and bullying.37, 38 Definitive rhinoplasty is done after facial growth
middle ear effusion hence evaluation of hearing status including newborn 7. Presurgical application of Nasoalveolar Molding (NAM) for is completed, which is around 14 years old in females and 16 years old
hearing screening is necessary.15,17 cleft palate is recommended in males.39,40

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4. Palatoplasty can be done at 12 to 18 months. Table 3. Timing of Primary Surgical Procedures 3. Definitive rhinoplasty can be done as indicated, as early as 14 RECOMMENDATIONS ON A MULTIDISCIPLINARY
Grade C Recommendation Level 4 Evidence years old for females and 16 years old for males. CLEFT CARE TEAM
Grade C Recommendation Level 4 Evidence Cleft patients are best managed in an environment of a
Surgery is ideally based on stage of phonemic Procedures Timing multidisciplinary cleft care team which includes pediatricians, cleft
development or articulation age, and not chronologic age.41 Surgery is Definitive rhinoplasty if indicated is performed after the completion surgeons, otorhinolaryngologists, orthodontics, prosthodontics,
delayed to a time after 12 months so that the repair required to establish Cheiloplasty As early as 3 months of maxillary and nasal growth, which usually occurs at 14-16 years of age nutritionists, clinical otologists and audiologists, speech pathologists,
a competent velopharyngeal sphincter is minimized. Surgery should in women and 16-18 years of age in men. The goals of this surgery are clinical psychologists, and genetic councilors .62 The team should include
be performed by 18 months to minimize development of irreversible Alveoloplasty (soft tissue Can be done with primary final creation of lasting symmetry, achieving definition of the nasal base the family of patients with cleft deformities as well. Institutions with
pathologic compensatory speech patterns.41,42 Although some studies only) cheiloplasty or until the ideal age and tip, relief of nasal obstruction, and management of nasal scarring programs for patients with cleft deformities and their families should strive
have advocated early surgical intervention, there is insufficient evidence for bone grafting is reached and webbing.58 to complete their multidisciplinary teams to ensure the comprehensive
that early palatal closure is superior to surgery performed later. In fact, and holistic care of these patients.
early palatoplasty produces maximal growth inhibition in all dimensions, Primary rhinoplasty Can be done with primary 4. Lip revision can be done as indicated but not earlier than 3
and the surgical region has been shown to grow more slowly than the cheiloplasty or until the ideal age months from previous lip surgery. 1. Pediatricians should be a part of the multidisciplinary CLAP
surrounding tissue, possibly due to the extent of scar contracture.43,44 for definitive rhinoplasty is reached Grade C Recommendation, Level 4 Evidence team from birth to adolescence to oversee their general well-being and
proper growth and development.
5. Ventilation tube insertion can be done as indicated. Palatoplasty 12 to 18 months Traditionally scar revision is performed 6-12 months after repair. Grade D Recommendation, Level 5 Evidence
Grade B Recommendation, Level 2B Evidence However, a repair that is uneven, or is obviously poorly positioned may
Ventilation tube As indicated be revised as early as 3 months after the previous lip surgery. If it is 1.1 Pediatric management begins in the hospital nursery by ruling out
Otitis media with effusion was found in 92-100% of patients with cleft insertion possible to tell early that the scar will not improve with maturation, early possible associated anomalies.63
palate to have otitis media with effusion. 45 revision with realignment may allow it to mature more rapidly.59
1.2 Pediatricians are in a unique position to help prepare children and
Patients with type B tympanogram (less than 0.35 compliance) In a review of 750 patients with unilateral cleft lip, secondary their families for surgery and help the perioperative team optimize care.
are recommended to undergo myringotomy with ventilation tube RECOMMENDATIONS FOR SECONDARY SURGICAL PROCEDURES reconstruction was performed in 35% of patients.60 Communication about conditions related to increased risk in the OR and
insertion. Randomized trials show a mean 62% relative decrease in The secondary surgical procedures aim to improve on the aesthetic aiding the family to advocate for their child in a stressful situation are
effusion prevalence after insertion of ventilation tubes.46 Palatoplasty and other functional problems. 5. Orthognathic surgery can be done as indicated as early as 14- valuable contributions to the preoperative preparation of the pediatric
and ventilation tube insertion solved 48.7% of ears with otitis media 16 years old for females and 16-18 years old for males patient.64
with effusion.47 Palatoplasty and ventilation tube insertion changed the 1. Alveolar bone grafting can be done as indicated at 7 to 9 years Grade B Recommendation Level 2B Evidence
pressure conditions in the middle ear cavity raising the hearing level old in consultation with the Orthodontist. 1.3 Since pediatricians oversee the well-being of the child including
to about 17 decibels in the middle-ear-diseased cleft palate patients. Grade B recommendation, Level 2B evidence Orthognathic surgical correction is planned at skeletal maturity the normal growth and development after surgery, frequent monitoring
Patients who underwent palatoplasty alone did not show changes in usually at 14-16 years of age in women and 16-18 years of age in men, is required for children who may be at risk for growth failure, delayed
middle ear function.48 The advantages of alveolar bone graft in an alveolar cleft have been following orthodontic preparation.61 (Table 4) development, or any other significant problems.64
noted to be the following: (1) assists in the closure of the buccoalveolar
A study done at Manila Doctors Hospital comparing otitis media oronasal fistula, (2) provides bony support for unerupted teeth and teeth 2. Cleft surgeons (Otolaryngologist, Plastic Surgeons, Oral and
Table 4. Timing of Secondary Surgical Procedures
with effusion using tympanometry among patients with cleft palate adjacent to the cleft, (30 forms a continuous alveolar ridge to facilitate maxillofacial surgeons) with explicit documentation of training in cleft
who underwent either palatoplasty with ventilation tube placement orthodontic correction of malocclusion, (4) supports the nasal floor and care should perform cleft lip and palate surgery, scar revisions, and
versus ventilation tube placement alone revealed statistically significant the base of the alae to improve nasal aesthetics. 54 rhinoplasty.
Procedure Timing
improvement in the outcome on repeat tympanometry in terms of Grade D Recommendation, Level 5 Evidence
middle ear condition with palatoplasty and ventilation tube placement Mixed dentition bone grafting does not affect subsequent vertical
and antero-posterior development of the maxilla in complete unilateral Alveolar bone grafting 7 to 9 years in consultation with the
(combined procedure), and likewise with ventilation tube placement Orthodontist 1.1 Explicit documentation here entails “documented evidence of
alone. However, it noted better results are obtained in favor of doing the cleft lip and palate patients during the first postoperative years in several residency training (as an operating surgeon, not as an assistant) in lip,
combined procedure with a statistically significant difference between retrospective cephalometric studies.55 palate and nasal procedures” 62
2. Palate re-repair/velopharyngoplasty can be done as indicated Palate re-repair / ve- As indicated or whenever
the pre- and post-surgery compliance in tympanometry.49 lopharyngoplasty recommended by a speech therapist
Ventilation tubes are known to ventilate the middle ear for an average or whenever recommended by a speech therapist. 3. Orthodontics (dentofacial orthopedics) and dental care should
of 6 to 14 months, which would improve hearing loss to a mean of 6 to Grade B recommendation Level 2B evidence be an integral part in the rehabilitation of the child with cleft lip and
17 dB.50 Definitive rhinoplasty As early as 14 years old for females and palate and can be initiated at any age from birth to adolescence 65, 66
Velopharyngoplasty is an important method for repair of Grade B Recommendation, Level 3 Evidence
velopharyngeal insufficiency in patients with cleft palate. Speech quality 16 years old for males
Recommended follow-up intervals for the evaluation of otitis
media with effusion among patients with cleft palate deformities who is improved but an intensive interdisciplinary cooperation of all specialists 3.1 In dental rehabilitation, the dentist provides oral health information
involved is necessary. 56 Lip revision As indicated but not earlier than 6
underwent palatoplasty and ventilation tube insertion are varied. The months from previous lip surgery and should be able to follow the child with cleft lip and palate since the
American Academy of Pediatrics Section on Otolaryngology has published first months of life until establishment of mixed dentition, craniofacial
guidelines for follow-up at intervals of no longer than 6 months51 (Table A systematic review indicated an increased incidence of velopharyngeal growth and dentition development.65
insufficiency as revealed by higher odds of secondary operations in the Orthognathic surgery As early as 16 years old for females and
3). A follow-up tympanometry was done after 12 months in studies 18 years old for males
previously cited and showed considerable changes in compliance for straight-line intravelar veloplasty repair of unilateral cleft lip-cleft palate
both groups even after extrusion.52,53 when compared to the Furlow z-plasty.57

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3.2 The orthodontist monitors the craniofacial growth and 7. A speech pathologist is recommended for the management of 10. A genetic counselor is recommended to be part of the team 2. A panel of assessors is the best method to adopt in the
development and corrects malocclusions, which are more complex velopharyngeal insufficiency after cleft palate surgery to obtain normal to help the family gain understanding of the predisposing factors and evaluation of outcomes.
compared to patients without clefts 66 articulation. determine risk of recurrence. Grade D Recommendation, Level 5 Evidence
Grade B Recommendation, Level 3B Evidence Grade D Recommendation, Level 5 Evidence Bardach et al. evaluated the treatment outcome in bilateral cleft lip and
4. Prosthodontist should be an essential part in care of the child palate with a multidisciplinary approach. The evaluation was comprised
with alveolar and palate deformity in creating nasoalveolar molding 1.1 Speech therapy can begin as early as 2 weeks following surgery, A comprehensive clinical genetic evaluation is a key component in of a plastic surgeon, an orthodontist, an otolaryngologist, and a speech
devices (NAM). NAMS should be done in infancy to narrow and prevent if the patient feels well and the surgeon agrees.74 the management of cleft lip and palate and should include diagnosis, pathologist. This is the first reported attempt at a multidisciplinary
further widening of the cleft palate. recurrence risk counseling and counseling regarding prognosis. 62, 64,78 evaluation of a center’s treatment management of complete bilateral
Grade B Recommendation, Level 3 Evidence 1.2 Following cleft palate closure, speech is usually evaluated cleft lip and palate with no associated malformations.85
at regular 4-6 month intervals, or as needed, in order to ensure the 11. The family of patients with cleft deformities which may
4.1 Feeding instructions, molding appliance fitting and feeding plate continued development of articulation skills and the use of adequate include parents, guardians and older siblings are recommended to be Professionals and lay people rated nasolabial appearance differently.
modification are done in infancy. A study by Konst showed that children velopharyngeal function. In general, speech therapy is usually initiated part of the multidisciplinary team. Their ratings did not correlate with the results from a self-assessment
treated with intra-oral prosthesis during their first year of life followed a anywhere from 20 months to 2 years of age.74 Grade D Recommendation, Level 5 Evidence questionnaire of patients with UCLP and controls. The current results
more normal path of phonological development between 2 and 3 years suggest that judgement of nasolabial appearance in adults treated for
of age.67 7.3 Children ages 3 through 5 are more receptive to acquiring new The family of patients with cleft deformities as part of the UCLP differs among professionals, laymen, and patients. This should
speech patterns and correcting abnormal speech patterns than older multidisciplinary team should be properly oriented in order to empower be considered in the decision-making process for secondary surgical
4.2 The combined use of palatal obturator and lactation education children. They are in a critical period of brain development, making the them in decision-making and the day-to-day care and long-term treatment of signs of clefts.86
reduced feeding time, increased volume intake and was associated with brain more receptive to learning these skills.74 interventions needed by the patients.79
good growth.68
7.4 When oral-nasal resonance balance and articulation were RECOMMENDATIONS ON OUTCOMES MONITORING 3. Institutional outcomes should be reported as outcomes
5. Breastfeeding is encouraged for patients with cleft lip and combined in each child, those children who achieved both normal oral- Better recommendations can be developed with better evidence researches for the medical community to contribute in improving the
palate nasal resonance balance and normal articulation (per age expectancy) of reported outcomes of care. The following are recommendations on comprehensive multidisciplinary care for patients and families with
Grade A Recommendation, Level 1A Evidence amounted to 88%. 75 outcomes monitoring for Unilateral Cleft Lip Alveolus and Palate care. unilateral cleft lip alveolus and palate care.
Grade D Recommendation, Level 5 Evidence
1.1 Mothers should be counseled about likely breastfeeding 8. Clinical audiologists and otologists are recommended to be 1. Assessment parameters should be standardized for the
success. Where direct breastfeeding is unlikely to be the sole feeding part of the team to determine the hearing status and evaluate of the different stages of unilateral cleft lip alveolus and palate care. A reliable measure of the facial appearance of patients with cleft lip
method, the need for breastmilk feeding should be encouraged, and presence of middle ear diseases among cleft palate patients. Grade D Recommendation, Level 5 Evidence and palate is essential if meaningful research into surgical outcome is to
when appropriate, possible delayed transitioning to breastfeeding should Grade A Recommendation, Level 1B Evidence progress. Assessment of facial appearance should be used in conjunction
be entertained.69 Various instruments are available in literature, however, there is no with assessment of speech, psychosocial adjustment, dental arch
1.1 Otoacoustic Emission (OAE) with or without Auditory Brainstem single instrument available that comprehensively assess perceptions of relationships, and conventional cephalometric analysis. 84,87
6. A nutritionist is recommended to be part of the team for Response (ABR) and Tympanometry can be done for newborns with cleft children with cleft deformities. Suggested parameters like aesthetics and
feeding instructions and support for new parents of babies with cleft palate as previously recommended.76 associated conceptual and perceptual consequences, functional deficits Intercenter and multicenter studies are useful methods for evaluation
lip and palate deformity. in chewing, breathing, and vocal resonance, and treatment benefits is treatment outcomes. The inclusion criteria should be uniform and the
Grade D Recommendation, Level 5 Evidence 1.2 Paradise, et al developed the term “universality of otitis media recommended to be included in a quality of life instrument.80, assessment should be approached from multiple perspectives including
in cleft palate children” after demonstrating that 96% of cleft patients facial appearance, speech, craniofacial morphology and occlusion. 88
6.1 The patient with cleft lip and/or palate deformity is faced had middle ear effusion hence evaluation of hearing status including Evaluating satisfaction must be the fundamental goal in any team
with nutritional problems beginning at birth because of the difficulty newborn hearing screening is necessary. 15,77 with genuine concern for the well-being of people in their care. The RECOMMENDATIONS ON POST-OPERATIVE CARE
in feeding resulting from the altered anatomical structures. Nutritional challenge is to improve these efforts through the development of more The goal of any postoperative plan should be to minimize complications
deficiencies lead to inadequate nourishment and poor weight gain in the 1.3 An otoacoustic emission test (OAE) or an auditory brainstem robust and revealing instruments that can be meaningfully used in the and return the child to normal life as quickly as possible.
young patient that can cause delays in any contemplated surgery for the response (ABR) test is used as hearing screening in newborn with cleft lip future international comparison.81 A study from Manila Doctors Hospital
repair of cleft deformities.70 and palate according to Tropper, et al. 21,77 evaluated the treatment and delivery of services to indigent patients with 1. Minimal hospital stay and early discharge after surgery is
cleft lip and palate deformities. It included a questionnaire to determine recommended.
6.2 Nutritionists provide feeding guidance beginning in the neonatal 9. A clinical psychologist is recommended to be part of the patient and family satisfaction, questionnaire for participant physicians, Grade D Recommendation, Level 5 Evidence
period by giving information concerning the feeding resources available team to work with the child, parents and the family to ensure normal and review of outcomes (e.g. complications symmetry, revisions). 82
for children with clefts, including breastmilk whenever necessary by use functioning by providing intervention on issues such as parental Katzel et al. evaluated practices of American Cleft Palate-Craniofacial
of feeding bottle, cup, spoon or feeder; including the appropriate posture adjustment and cleft child self-esteem. For purposes of documentation and outcome analysis, a standardized Association surgeons and cleft teams in relation to length of hospital stay
during feeding, and pre- and post-feeding oral hygiene.71 Grade C Recommendation, Level 4 Evidence video recording to assess cleft surgery outcomes has been suggested. 83 following cleft repair and postoperative complications. The findings in
this study suggest cleft patients are discharged early, within 1 or 2 days
6.2 Growth parameters are monitored closely during the first week of 9.1 The earliest intervention may help to improve social competence Several inter-center studies have cited and used nasolabial aesthetic postoperatively. Several studies support the safety of this type of early
life and over the long term. 72 and reduce stress beginning in the antenatal or perinatal stages of care outcome evaluation and have been shown to provide a reasonably discharge specifically in non-syndromic patients.89
when working with parents and significant family members. 78 reliable and reproducible rating system. The system allows sensitive
6.3 In a study done at Manila Doctors Hospital to determine rating of the individual feature of the nasolabial complex and appears The financial benefits to patients and the health care system because
the effectiveness of integrating clinical nutrition management with 9.2 Emotional effects and psychological aspects of cleft lip and palate workable in practice.84 of early discharge following cleft palate repair have also been documented
individualized nutrition counseling in the CLAP surgical mission, the deformities and their treatment must be considered. Understanding of in the literature.89
following were the findings: all patients had less than normal BMI pre- the causes of cleft deformities is clouded by myths in the community.
operatively and statistically significant weight gain was seen in patients This causes increased anxiety among the child, parents and the rest of
with individualized nutrition counseling.73 the family.78

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2. Immediate return to breastfeeding after surgery is 21.Tropper, G, Moran, L, Odell, P, Durieux-Smith A. The contribution of brainstem 48.He Y, Xu H, Zhen Q, Liao X, Xu L, Zhen Y. The influence of palatoplasty and tympanotomy 71.Bessell A, Hooper L, Shaw WC, Reilly S, Reid J, Glenny AM. Feeding interventions for
recommended. electric response audiometry (BERA) to the evaluation and management of infants on middle ear function in cleft palate patients. Hua Xi Kou Qiang Yi Xue Za Zhi, 2001 growth and development in infants with cleft lip, cleft palate or cleft lip and palate.
with cleft palate. J Otolaryngol, 1988 Apr;17(2):103-10. Aug;19(4):243-5. Cochrane Database Syst Rev. 2011 Feb 16;(2):CD003315. doi: 10.1002/14651858.
Grade D Recommendation, Level 5 Evidence 22.Szabo C, Langevin K, Schoem S, Mabry K. Treatment of persistent middle ear effusion 49.Mercado, G. Villegas, M. Gloria-Cruz, T. Comparative analysis of otitis media with CD003315.pub3.
in cleft palate patients. Int J Pediatr Otorhinolaryngol. 2010 Aug;74(8):847-7. effusion among cleft palate surgical mission patients ages 0-11 years who underwent 72.Amstalden-Mendes LG, Magna LA, Gil-da-Silva-Lopes VL. Neonatal Care of Infants
Postoperative feeding remains somewhat more controversial as to the 23.Narayanan DS, Pandian SS, Murugesan S, Kumar R. The Incidence of Secretory Otitis palatoplasty with ventilation tube placement versus ventilation tube placement alone with cleft lip and/or Palate: feeding orientation and evolution of weight gain in a
length of time until return to normal diet and type of bottle recommended Media in Cases of Cleft Palate. J Clin Diagn Res. 2013 Jul;7(7):1383–86. using tympanometry from 2008 to 2011. Manila Doctors Hospital. Forthcoming. nonspecialized Brazilian Hospital. Cleft Palate Craniofac J: 2007 May;44(3);329-34.
or use of spoon or syringe feeding. American Cleft Palate-Craniofacial 24.Jenwitheesuk, K. Aesthetic evaluation by laypersons of Noordhoff’s Technique of 50.Mandel EM, Rockette HE, Bluestone CD, Paradise JL, Nozza RJ. Efficacy of myringotomy 73.Evasco R., Villegas M., Effectiveness of Clinical Nutrition Management in the Bridging
unilateral cleft lip cheiloplasty. Thai J Surg 2004;25:63-6. with and without tympanostomy tubes for chronic otitis media with effusion. Pediatr the Gap Surgical Mission of Manila Doctors Hospital from 2011 to 2012. Manila
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veli palatini muscle in the development of cleft palate-associated middle ear 44.Peterson-Falzone SJ. The relationship between timing of cleft palate surgery and Infant Orthopedics: A Randomized Clinical Trial. Cleft Palate Craniofac J. 2003 Sep;124(3):899-906.
problems. Clin Oral Invest. 2016;20:1389–1401. speech outcome: what have we learned, and where do we stand in the 1990s? Semin Jan;40(1):32-9. 90.Eaton AC, Marsh JL, Pilgram TK. Does reduced hospital stay affect morbidity and
18.Clinical Practice Guidelines for Cleft Lip, Alveolus and Palate (CLAP) in children Orthod. 1996 Sep;2(3):185-91. 68.Tumer L, Jacobsen C, Humenkzuk M, Singhal VK, Moore D, Bell H. The effects of mortality rates following cleft lip and palate repair in infancy? Plast Reconstr Surg.
and adults. The Department of Otorhinolaryngology. Manila Doctors Hospital. 45.Ponduri S, Bradley R, Ellis PE, Brookes ST, Sandy JR, Ness AR. The management of lactation education and a prosthetic obturator appliance on feeding efficiency in 1994 Dec;94(7):911–5; discussions 916-8.
2011. otitis media with early routine insertion of Grommets in children with cleft palate – a patients with cleft lip and palate. Cleft Palate Craniofac J. 2001 Sept;38(5):519-24.
19.Handzik-Cuk J, Cuk V, Gluhinic M, Risavi R, Stanjer-Katusic S, et al. systematic review. 2009 Jan. Cleft Palate Craniofac J. 2009 Jan;46(1): 30-38. 69.Reilly S, Reid J, Skeat J, Cahir P, Mei C, Bunik M. ABM Clinical Protocol #18: guidelines
Tympanometric findings in cleft palate patients: influence of age and 46.Kuo CL, Tsao YH, Cheng HM, Lien CF, Hsu CH, Huang CY, et al.. Grommets for otitis for breastfeeding. Breastfeed Med. 2013 Aug;8(4):349-53. Erratum in: Breastfeed
cleft type. J Laryngol Otol 2001 Feb;115(2):91-6. media with effusion in children with cleft palate: a systematic review. Pediatrics. 2014 Med. 2013 Dec;8(6):519.
20.American Academy of Family Physicians, American Academy of Nov;134(5):983-94. Epub 2014 Oct 6. 70.Freitas JA, Garib DG, Oliveira M, Lauris Rde C, Almeida AL, Neves LT, et al.
Otolaryngology-Head and Neck Surgery and American Academy of Pediatrics 47.Civelek B, Celebioglu S, Sagit M, Akin I. Ventilation tubes in secretory otitis Rehabilitative Treatment of Cleft Lip and Palate: Experience of the Hospital for
Subcommittee on Otitis Media With Effusion. Otitis Media with media associated with cleft palate: a retrospective analysis. Turk J. Med Sci. 2007 Rehabilitation of Craniofacial Anomalies/USP (HRAC/USP) – Part 2 Pediatric Dentistry
Effusion. Pediatrics. 2004 May;113 (5);1412-29. Jun;37(4):223-26. and Orthodontics. J Appl Oral Sci. 2012 Mar-Apr;20(2):268-81.

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 Clinical Practice Guidelines Clinical Practice Guidelines

APPROACH TO UNILATERAL CLEFT LIP AND PALATE

ALLERGIC RHINITIS IN ADULTS
Philippine Academy of Rhinology
Antonio H. Chua, MD, FPSOHNS Additionally, older journal articles, unpublished literature and
Anne Marie V. Espiritu, MD, FPSOHNS oral communications were included. A draft of the evidence-based
Rodante A. Roldan, MD, FPSOHNS recommendations (EBR) was collated and presented by the panel to the
January E. Gelera, MD, DPBOHNS general assembly of ORL-HNS specialists.
Benjamin S.A. Campomanes, Jr., MD, FPSOHNS This guideline will undergo review and updating five (5) years after
Cecile B. Duran, MD, FPSOHNS publication, or earlier, depending on the emergence of new information.
Ma. Lourdes B. Enecilla, MD, FPSOHNS
Josefino G. Hernandez, MD, FPSOHNS FUNDING AND DISCLAIMER
Peter I. Jarin, MD, FPSOHNS This development of this guideline was funded exclusively by the
Norman N. Mendoza, MD, FPSOHNS Philippine Society of Otolaryngology-Head and Neck Surgery. The
Niño Bernardo V. Timbungco, MD, FPSOHNS views or interests of the funding body have not influenced the final
Gil M. Vicente, MD, FPSOHNS recommendations.

PURPOSE COMPETING INTERESTS

This clinical practice guideline (CPG) is intended to describe appropriate All authors have stated that they have no competing interests.
care based on the best available scientific evidence and broad consensus
for allergic rhinitis in adults. It aims to reduce inappropriate variations in DEFINITION AND PREVALENCE OF ALLERGIC RHINITIS
clinical practice and to highlight management principles unique to the
specialty of Otorhinolaryngology in the Philippines. Allergic rhinitis (AR) is defined as chronic or recurrent IgE-mediated
inflammation of the nasal mucosa. Primary symptoms include rhinorrhea,
TARGET POPULATION, SETTING AND sneezing, nasal itching, nasal congestion and postnasal drainage. It may
PROVIDERS OF CARE be associated with other symptoms such as frequent throat clearing,
This CPG is for use by the Philippine Society of Otolaryngology-Head eye itching, tearing, eye redness, palatal itching, impaired sense of smell
and Neck Surgery. It covers the diagnosis and management of Allergic (and taste), fatigue, impaired concentration and reduced productivity.(1-3)
Rhinitis (AR) in adults. It can be classified as intermittent or persistent, and as mild or moderate-
severe.(3) Intermittent AR is characterized by symptoms of less than four
OBJECTIVES (4) days a week OR less than four (4) consecutive weeks. Persistent AR
The objectives of this guideline are (1) to provide the requisite criteria has symptoms occurring for more than four (4) days a week AND for
for the diagnosis of allergic rhinitis; (2) to describe the current diagnostic more than four (4) weeks.(3) Using a conservative estimate, AR occurs in
techniques; and (3) to recommend management options relevant to the over 500 million people around the world. Its prevalence is increasing in
local setting. most countries. In the Philippines, prevalence ranges from 18% in urban
areas to 22.1% in rural areas and from 26% in young children to 32% in
METHODOLOGY adolescents (4)

The panel was asked to review the previously published guideline RECOMMENDATIONS ON THE DIAGNOSIS OF ALLERGIC RHINITIS IN
for allergic rhinitis. Data from scientific studies were presented in an ADULTS
analytical framework in the initial panel meeting, and revisions and
recommendations were formulated. In the present document, an 1. The diagnosis of AR is strongly considered in the presence of the
extensive search of MEDLINE, National Library of Medicine’s PubMed following symptoms: nasal itching, sneezing, rhinorrhea, and/or nasal
database, and Agency for Healthcare Research and Quality (AHRQ) congestion or obstruction, triggered by allergen exposure. Symptoms
Evidence Report and Technology Assessment was done using the may be associated with conjunctival redness, itchy and/or teary eyes.
keyword “Allergic rhinitis”, exploded to include definition/classification, Grade A Recommendation, Level 1C Evidence
prevalence/epidemiology, diagnosis, and therapy. The search was limited
to articles involving adult (19 years old and above) humans, and those Gendo et al (2004) showed that eliciting the following points in the
published in English from 2010 to 2015. The search yielded 885 articles medical history would lead to an accurate diagnosis of AR: allergy triggers,
which included the following: presence of nasal symptoms and watery-itchy eyes, positive personal
Meta-analysis/Systematic Reviews: 66 history of atopy, and positive family history of atopy (positive likelihood
Randomized controlled trial: 295 ratios ranging from 2.49 to 6.69).(5) Crobach et al (1998) earlier showed
Consensus report/ CPG: 4 that medical history alone compared favorably to radioallergosorbent
tests (RAST) and skin prick tests (SPT) for allergies to tree pollen, grass
pollen, weed pollen, house dust mite, mold, cat dander, and dog dander.
When only the medical history was used, the diagnostic power of the
logistic regression model was 0.77 to 0.89. (6)

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 Clinical Practice Guidelines Clinical Practice Guidelines

Supportive clinical information that must be sought includes the Sensitivity (SN) of 67%, Specificity (SP) of 63%, Positive predictive value *Local allergic rhinitis (LAR) is a subset of AR wherein patients have Grade B Recommendation, Level 2B Evidence
following: (PPV) of 50%, and a Negative predictive value (NPV) of 80%. This may a clinical history and physical examination findings consistent with AR,
be due to relative subjectivity in evaluating the nasal cavity. However, but have no evidence of systemic atopy (i.e., negative skin prick tests, In the Philippines, Cua-Lim (1994) found that the most common
1.1 The frequency and duration (intermittent or persistent) and combining history with PE increases the diagnostic accuracy to SN=87%, negative serum specific IgE tests). However, on nasal provocation testing aeroallergens were house dust mites (87%), cockroach (41%), mold
severity of symptoms SP=87%, PPV=77%, and NPV=93%.(8) with aeroallergens, patients with LAR show local increased levels of spores (37%), cat dander (36%), kapok (35%), dog dander (32%), grass
1.2 Personal history of other manifestations of atopy specific IgE, tryptase, and eosinophilic cationic protein (ECP). Rondon et pollens (26%), weed pollens (25%), Acacia pollen (2%).(22)
1.3 Family history of atopy 3. Nasal endoscopy is strongly recommended for selected patients. al (2012), found a 28.9% prevalence of LAR in patients with AR. LAR is
1.4 Identification of possible allergens in the environment: home, Grade A Recommendation, Level 1C Evidence treated as AR.(15) In Fullante and Hernandez’ (2005) unpublished observations, they
workplace, school, etc. found that the most common indoor allergens are house dust mite
1.5 Absence of symptoms upon change of environment Nasal endoscopy allows a more thorough visualization of nasal and (69.3%), cockroach (56.8%), and cat hair (8%).(23) In a recent study of
1.6 Result of previous allergy testing (e.g., skin test, serum specific nasopharyngeal structures with a sensitivity of 84% and a specificity of RECOMMENDATIONS ON THE TREATMENT OF ALLERGIC RHINITIS IN children with AR, Santos-Reyes and Gonzalez-Andaya (2014) found that
IgE test, nasal provocation test) 92%. Endoscopy was found to identify more disease than rhinoscopy ADULTS D. farinae (86%), D. pteronyssinus (87%), B. tropicalis (60%), cat pelt
1.7 The effects of previous allergen avoidance measures (85% versus 74%); and a similar picture was seen when combining history (47%), and cockroach (45%) were the most predominant allergens.(24)
1.8 Response to pharmacological treatment and previous with either endoscopy or rhinoscopy. It provides valuable information 1. Patients should be advised to avoid or minimize exposure to Regionally, Andiappan et al (2014) found that Blomia tropicalis (68.9%),
immunotherapy especially in cases with atypical symptoms, complications, treatment allergens. Dermatophagoides pteronyssinus (68.5%), and German cockroach
1.9 A simple Visual Analog Scale (VAS) quantifying the severity of failures, or when other pathology is suspected.(9, 10) 1.1 Highly pollen-allergic individuals should limit exposure to the (14.6%) were the predominant indoor allergens in Singapore.(17) Bunnag
rhinitis symptoms (Figure 1) outdoors when high pollen counts are present. et al (2009) reported that house dust mite (64.7%), cockroach (49.8%),
4. A complete Ear, Nose and Throat (ENT) examination must be Grade B Recommendation, Level 2C and dog (44.2%) were the predominant indoor allergens in Thailand.
Figure 1. Visual Analog Scale (VAS) performed on all patients with AR. (18)
Asha’ari et al (2010) found that house dust mite (80%), cat dander
Grade D Recommendation, Level 5 Evidence Cua-Lim (1978) identified grass pollen as the predominant pollen (37.8%), and Mucor mucedo (20%) were the predominant indoor
Moderate- in the Philippines, followed by Mimosa, Moraceae, Cyperaceae, lower allergens in Malaysia.(25)
Mild 0 to
Performing a complete ENT examination provides information on vascular plants spores, Amaranth, Coconut, Tiliaceae, Pinus, Compositae
the chronicity and severity of the patient’s AR (e.g., high-arched palate, and Alnus.(16) Regionally, Andiappan et al (2014) found that Bermuda Indoor allergen avoidance measures have been shown to reduce
open-mouth posture, Denny-Morgan lines, nasal crease). The presence grass, Common ragweed, and Acacia were the predominant outdoor allergen levels but do not necessarily result in symptom control or
of other associated conditions, such as otitis media with effusion, may allergens in Singapore.(17) Bunnag et al (2009) reported that Bermuda decreased medication use.(1, 19, 26-33)
also be uncovered. grass, para grass, sedge, careless weed were the predominant outdoor
allergens in Thailand.(18) 1.3 Multimodal environmental control strategies are better than
5. Detailed allergic work-up, e.g., skin tests, serum specific IgE tests, any single strategy.
Not Most
or nasal provocation tests, may be performed for the following: Weather factors affect pollen counts in various ways. High humidity, Grade D Recommendation, Level 5 Evidence
The severity of the disease may be evaluated using a visual analog 5.1 Patients with whom a questionable diagnosis exists moisture and barometric pressure cause pollen to rupture into tiny
scale in answer to the question of “how bothersome are your symptoms 5.2 Patients unresponsive or intolerant to pharmacotherapy particles that can be carried and distributed by winds. Pollen counts are Individual allergen avoidance measures have failed to show
of rhinitis”? This can help guide the clinician on the appropriate 5.3 Patients with multiple target organ involvement (i.e., allergic generally highest on sunny, windy days with low humidity.(1, 19-21) consistent decrease in AR symptoms and/or medication use. Combining
management.(7) manifestations in the eyes, nose, throat, skin, lungs, etc.) environmental control strategies may offer more benefit for patients
5.4 Patients for whom immunotherapy is considered Limiting exposure to the outdoors may include exercising indoors, with AR.(1, 2, 19) When the quality of life (QOL) is severely affected due to
5.5 Patients with suspected Local AR (LAR)* keeping doors and windows closed, doing activity after 10 a.m. (when allergen exposure, transfer of residence/work may be considered.
2. Anterior rhinoscopy must be performed to support the diagnosis
Grade A Recommendation, Level 1C Evidence pollen counts are lower), wiping pets that have come in from outside
of AR and other nasal pathology. The following findings may be
with a damp cloth to remove pollen on their coats, and washing and 2. Nasal saline irrigation (NSI) or douching is recommended as an
observed:
Specific IgE testing is indicated to provide evidence of an allergic basis drying clothes indoors to avoid pollen contamination. adjunctive treatment for patients with allergic rhinitis.
2.1 Pale gray, dull red, or red turbinates
for the patient’s symptoms, to confirm or exclude suspected causes of Grade A Recommendation, Level 1A‒ Evidence
2.2 Boggy turbinates
the patient’s symptoms, or to assess sensitivity to specific allergens for 1.2 Indoor allergen avoidance may provide some benefit for patients
2.3 Minimal to profuse, watery to mucoid nasal discharge
avoidance measures and/or allergen immunotherapy.(6, 11, 12) with AR. A meta-analysis done by Hermelingmeier (2012) showed NSI
Grade D Recommendation, Level 5 Evidence
1.2.1 Clinically effective dust mite avoidance includes a combination performed regularly was observed to have a positive effect on all
In general practice, if skin tests are not readily available, serum specific of measures such as humidity control, frequent change of beddings, investigated outcome parameters in adults and children with AR. NSI
Anterior rhinoscopy using a nasal speculum and head mirror/head
IgE tests may be carried out. With the advent of Molecular Allergology, avoidance of carpeting and heavy curtains, avoidance of clothed produced a 27.66% improvement in nasal symptoms, a 62.1% reduction
light, although offering a limited view, remains an appropriate method
the standardization and number of tested allergens is expected to upholstery, dust mite covers for beddings, and the use of tea sprays or in medicine consumption, a 31.19% acceleration of mucociliary clearance
for studying pathologic signs observed in most cases of allergic rhinitis.
increase and skin testing may eventually be replaced by tests such as acaricides. time, and a 27.88% improvement in quality of life.(34)
Moreover, anterior rhinoscopy helps to exclude conditions other than AR
ImmunoCAP Immune Solid-phase Allergy Chip (ISAC).(13, 14) 1.2.2 Reduction of indoor fungal exposure involves removal of
(e.g., nasal polyposis, infectious rhinitis, nasal septal deviation, sinonasal
moisture sources, replacement of contaminated materials, and the use Studies on NSI are heterogeneous as to the type, amount, and timing
tumors and systemic disorders with sinonasal manifestations).(1, 3)
Cost and geographic constraints were considered by the panel as of dilute bleach solutions on nonporous surfaces. of nasal irrigation and the use of different saline solutions. Nevertheless,
important clinical modulating factors in our setting. Benefits of allergy 1.2.3 Removal is the most effective way to manage animal or NSI is well tolerated, inexpensive, easy to use, and there is no evidence
Examination is performed before and after topical decongestion and,
testing include high accuracy and low adverse effects. However, these cockroach sensitivity. showing that regular, daily irrigation adversely affects the patient’s health
when needed, topical anesthesia. Suctioning of excessive secretions is
tests are relatively expensive and may not be readily accessible to many 1.2.4 Pollen movement indoors may be minimized by closure of or causes unexpected side effects.(34)
also performed to optimize visualization.
patients. doors and windows during the relevant time of year, and by active
removal from indoor air through the use of high-efficiency particulate 3. Oral antihistamines are strongly recommended in AR with
The diagnosis of AR based on physical examination (PE) alone is
air filters. intermittent symptoms and short term allergen exposure.
not reliable and consistent. Raza et al (2011) found that PE alone has a

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 Clinical Practice Guidelines Clinical Practice Guidelines

3.1 Oral antihistamines have been found to cause statistically 9.2 Topical decongestants can be considered for short-term or 11.2 It may be used in the following select group of AR patients:
significant improvement of nasal symptoms in patients with allergic Due to scarcity of topical antihistamine in the local setting, the possibly intermittent or episodic therapy of nasal congestion, but - Patients who did not benefit from avoidance therapy and
rhinitis. addition of oral antihistamine in combination with INCS for cases with are inappropriate for long-term daily use because of the risk for the pharmacotherapy
Grade A Recommendation, Level 1A Evidence uncontrolled AR symptoms or in cases of exacerbation is an option. development of rhinitis medicamentosa. - Patients who cannot tolerate or who refuse
Grade B Recommendation, Level 2B pharmacotherapy
Oral antihistamines have a rapid onset of action, once-daily dosing, 6. A short course of oral corticosteroids (5 to 7 days) may be - Patients who are chronically exposed to allergens
maintenance of effectiveness with regular use, and the availability of some recommended in AR with moderate-severe and persistent symptoms Development of rhinitis medicamentosa poses a significant - Patients with rhinitis and symptoms from the lower airways
drugs over the counter without need of a prescription. Some patients who not responsive to INCS. concern for clinicians prescribing topical decongestants. While topical during peak allergen exposure
fail to improve with one agent may respond to an alternative drug in this Grade B Recommendation, Level 2C Evidence decongestants are often given for 3-10 days, there is insufficient literature Grade A Recommendation, Level 1B Evidence
category. Maximum benefit is seen with continuous use, but use on an on the appropriate duration of use.(1-3, 46) Toohill et al (1981) found a 1%
as-needed basis can provide significant symptom relief and is appropriate Short course systemic corticosteroids are often used clinically incidence of rhinitis medicamentosa in his practice.(49) Immunotherapy produces significant improvement of AR symptoms
for some patients, especially those with intermittent symptoms.(1-3, 35) for patients with severe AR but this lacks evidence of superiority to which leads to improvement of quality of life and decreased need for
INCS. A paper by Karaki et al (2013) comparing the use of INCS versus 9.3 Oral and topical decongestants should be used with caution medical therapy. The positive benefit of SIT continues even after
3.2 Second-generation antihistamines are generally preferred over systemic corticosteroid revealed no significant difference making INCS in patients of any age who have a history of cardiac arrhythmia, discontinuation. A study by Jacobson et al (2007) documented that
first-generation antihistamines because the former are associated with sufficient in the treatment of AR.(42) Also, due to known side effects, oral angina pectoris, cerebrovascular disease, hypertension, bladder neck beneficial effects were observed at 10 and 8 years after treatment
less sedation, performance impairment, and anticholinergic effects. corticosteroids are not routinely given hence should not be considered as obstruction, glaucoma or hyperthyroidism. cessation for subcutaneous immunotherapy (SCIT) and sublingual
Grade B Recommendation, Level 2B Evidence first-line treatment of AR patients.(1-3, 42) Grade B Recommendation, Level 2A‒ Evidence immunotherapy (SLIT), respectively.(56)

Histamine in the brain facilitates learning and memory, and regulates 7. Oral anti-leukotriene agents, alone, in combination with Regular use of oral and topical decongestants comes with caution so Additional advantages of SIT are prevention of asthma and reduction
the circadian sleep/wake cycle. First-generation antihistamines, antihistamines, or in combination with INCS, may be recommended in as to avoid adverse effects particularly involving the cardiovascular and of new sensitizations.(1, 2, 52, 56, 57)
which cross the blood-brain barrier, interfere with histamine’s AR especially in the presence of asthma. neurovascular systems. A meta-analysis study by Salerno et al (2005)
functions. Moreover, the long half-lives of drugs (≈24 hours) such Grade A Recommendation, Level 1A Evidence concluded “pseudoephedrine caused a small but significant increase in 11.3 The use of SIT has potential adverse effects. These are classified
as diphenhydramine, chlorpheniramine and hydroxyzine, mean that systolic blood pressure (0.99 mm Hg; 95% CI, 0.08 to 1.90) and heart as local (SCIT: redness and induration at site of injection; SLIT: oral
these effects are still present the following morning leading to daytime Recognizing that as many as 40% of patients with AR have coexisting rate (2.83 beats/min; 95% CI, 2.0 to 3.6) with no effect on diastolic blood itching and discomfort) or systemic reactions (urticaria, gastrointestinal
somnolence, increased traffic accidents, decreased productivity at work asthma, montelukast may be considered when treatment can benefit pressure (0.63 mm Hg, 95% CI, -0.10 to 1.35)”.(50) Decongestants may be upset, wheezing and anaphylaxis). Thus, SIT should not be used in
and reduced children’s learning. Second-generation H1 antihistamines both upper and lower airways.(1-3, 43-45) given as rescue medication to patients with inadequate response to INCS patients with uncontrolled asthma.
are largely devoid of these effects.(1-3, 36) and antihistamines and/or in cases of symptom exacerbation.(1-3, 51) Grade B recommendation, Level 2B Evidence
8. Intranasal cromolyn sodium may be used in AR, especially
4. Intranasal antihistamines are recommended alternative therapy because of its lesser side effects. However, it is less effective than 10. Combination preparations of pharmacotherapeutic agents may A safety data systematic review of SIT by Lin et al (2003) reported
to oral antihistamines in AR with intermittent symptoms and short term corticosteroids, and has not been adequately studied in comparison to be considered for patients suffering from AR with inadequate response rates of local reactions ranging from 0.6% to 58% for SCIT and 0.2% to
exposure to allergens. anti-leukotriene and antihistamine agents. to monotherapy. 97% for SLIT.(1, 53)
Grade A Recommendation, Level 1A Evidence Grade A Recommendation, Level 1B Evidence Grade D Recommendation, Level 5 Evidence
The rate of systemic reactions has been reported to be from 0.6% to
Intranasal antihistamines are efficacious and equal or superior to Cromolyn sodium inhibits the degranulation of sensitized mast cells, Formulations combining two drugs such as oral antihistamine 0.9% and deaths at 1 per 2.5 million (3.4 deaths per year) for SCIT.(58, 59) No
oral second-generation antihistamines. Antihistamines are generally less thereby blocking the release of inflammatory and allergic mediators. It and oral decongestant, oral antihistamine and oral montelukast, oral deaths were recorded for SLIT.(1)
effective than intranasal corticosteroids.(1, 37-39) may be given several hours prior to allergen exposure, thus preventing antihistamine and oral steroid, topical antihistamine and INCS may offer
symptoms of the early phase reaction. However, adherence is poor additional symptom relief for some patients, as well as the convenience Due to possibility of serious adverse effects, it is recommended
5. Intranasal corticosteroids (INCS) for at least one month, is strongly because it should be taken 4 times daily compared to once or twice daily of single intake dosing.(1, 2) that SCIT should not be used in patients with uncontrolled asthma.
recommended in AR with intermittent moderate-severe symptoms, dosing for antihistamines and INCS.(1, 2, 46) Additionally, SCIT should be administered in a clinic where serious
persistent symptoms, and long-term exposure to allergens. Duration of 11. Allergen specific immunotherapy (SIT) is effective for the reactions can be promptly recognized. Patients should also be observed
therapy can be individualized based on patient follow-up findings. Chromones are safe, even for small children and pregnant women, treatment of AR. for 30 minutes after injection.(59)
Grade A Recommendation, Level 1A Evidence however, they are less efficacious compared to antihistamines, and are
not strongly recommended as first line treatment of AR.(1, 2, 46, 47) 11.1 Allergen immunotherapy may prevent the development of new 11.4 Patients must be well-informed of the costs of SIT before
INCS are the most effective medication class in controlling symptoms allergen sensitizations and reduce the risk for the future development initiating it.
of allergic rhinitis.(1, 2, 40) 9. Oral and topical decongestants may be used for patients with of asthma in patients with AR. Grade D recommendation, Level 5 Evidence
prominent nasal obstruction. However, they must be used judiciously Grade A Recommendation, Level 1A Evidence
5.1 Topical antihistamines may be added to INCS for patients with and according to pharmacologic indications. The cost of immunotherapy in the Philippine General Hospital
inadequate control and exacerbation of symptoms. 9.1 Oral decongestants can reduce nasal decongestion but can result SIT represents the only treatment that can alter the natural history Allergy Section is 90-280 pesos for charity patients, and 190-390 pesos
Grade A Recommendation, Level 1B Evidence in side effects such as insomnia, irritability and palpitations. of AR. It restores normal immunity and/or increases tolerance against for private patients per injection of allergens (Espiritu AMV 2015, oral
Grade A Recommendation, Level 1B Evidence allergens resulting in decreased AR symptoms, and long-term allergen- communication, 1st October). In private hospitals (Abong JM 2015, oral
Studies have shown that the combination of INCS and topical specific immune tolerance. Overall, available evidence supports communication, 1st October), rates vary widely. The initial injection is at
antihistamines is more effective than INS and topical antihistamine Oral decongestants have clearly shown improvement of nasal the effectiveness and safety of both subcutaneous and sublingual least 700 pesos and the cost goes up as the concentration of the allergen
monotherapy.(1-3, 41) obstruction and are even more efficacious if given together with INCS. immunotherapy for the treatment of allergic rhinitis.(1, 2, 46, 52-55) in solution increases with subsequent injections. Charity patients spend
(48)
However, due to possible adverse effects of headache, dry mouth, approximately 800-1,600 pesos/month, while private patients may pay
5.2 Oral antihistamines may be considered when topical hypertension, and nervousness, use of decongestants is limited to short upwards of 2,800 pesos/month.(60, 61)
antihistamines are unavailable. course treatment.(1, 2)
Grade D Recommendation, Level 5 Evidence

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 Clinical Practice Guidelines Clinical Practice Guidelines

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Reviews. 2010(7):CD001563. 51.Johnson DA, Hricik JG. The pharmacology of alpha-adrenergic decongestants.
5. Gendo K, Larson EB. Evidence-based diagnostic strategies for evaluating suspected
29.Sever ML, Arbes SJ, Jr., Gore JC, Santangelo RG, Vaughn B, Mitchell H, et al. Cockroach Pharmacotherapy. 1993;13(6 Pt 2):110S-5S; discussion 43S-46S.
allergic rhinitis. Ann Intern Med. 2004;140(4):278-89.
13. A multidisciplinary approach to treatment, including referrals allergen reduction by cockroach control alone in low-income urban homes: a 52.Niggemann B, Jacobsen L, Dreborg S, Ferdousi HA, Halken S, Host A, et al. Five-year
6. Crobach MJ, Hermans J, Kaptein AA, Ridderikhoff J, Petri H, Mulder JD. The
to other specialists, may be necessary for selected patients, especially randomized control trial. J Allergy Clin Immunol. 2007;120(4):849-55. follow-up on the PAT study: specific immunotherapy and long-term prevention of
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30.Arbes SJ, Jr., Sever M, Archer J, Long EH, Gore JC, Schal C, et al. Abatement of asthma in children. Allergy. 2006;61(7):855-9.
those with uncontrolled AR. of radioallergosorbent tests and skin prick tests. Scand J Prim Health Care.
cockroach allergen (Bla g 1) in low-income, urban housing: A randomized controlled 53.Lin SY, Erekosima N, Suarez-Cuervo C, Ramanathan M, Kim JM, Ward D, et al.
Grade D Recommendation, Level 5 Evidence 1998;16(1):30-6.
trial. J Allergy Clin Immunol. 2003;112(2):339-45. Allergen-Specific Immunotherapy for the Treatment of Allergic Rhinoconjunctivitis
7. Bousquet PJ, Combescure C, Neukirch F, Klossek JM, Mechin H, Daures JP, et al. Visual
31.Wood RA, Chapman MD, Adkinson NF, Jr., Eggleston PA. The effect of cat and/or Asthma: Comparative Effectiveness Review [Internet]. Rockville (MD): Agency
analog scales can assess the severity of rhinitis graded according to ARIA guidelines.
Bousquet et al (2010) determined that about 20% of patients being removal on allergen content in household-dust samples. J Allergy Clin Immunol. for Healthcare Research and Quality (US); 2013 Mar. (Comparative Effectiveness
Allergy. 2007;62(4):367-72.
treated for AR had uncontrolled symptoms, and that these patients had 1989;83(4):730-4. Reviews, No. 111.) Available from: http://www.ncbi.nlm.nih.gov/books/NBK133240/
8. Raza SN, Yousuf K, Small P, Frenkiel S. Diagnosing allergic rhinitis: effectiveness of
32.Wood RA, Johnson EF, Van Natta ML, Chen PH, Eggleston PA. A placebo-controlled 54.Lin SY, Erekosima N, Kim JM, Ramanathan M, Suarez-Cuervo C, Chelladurai Y, et al.
a VAS of 5 or more.(62) Hence, Uncontrolled AR is defined as patients the physical examination in comparison to conventional skin testing. Journal of
trial of a HEPA air cleaner in the treatment of cat allergy. Am J Respir Crit Care Med. Sublingual immunotherapy for the treatment of allergic rhinoconjunctivitis and
with AR having persistent symptoms with a severity of VAS > 5, despite Otolaryngology - Head & Neck Surgery = Le Journal D’oto-rhino-laryngologie et de
1998;158(1):115-20. asthma: a systematic review. JAMA. 2013;309(12):1278-88.
pharmacologic treatment and allergen avoidance. Chirurgie Cervico-faciale. 2011;40(5):407-12.
33.Nicholas CE, Wegienka GR, Havstad SL, Zoratti EM, Ownby DR, Johnson CC. Dog 55.Reha CM, Ebru A. Specific immunotherapy is effective in the prevention of new
9. Hughes RG, Jones NS. The role of nasal endoscopy in outpatient management. Clinical
allergen levels in homes with hypoallergenic compared with nonhypoallergenic dogs. sensitivities. Allergol Immunopathol (Madr). 2007;35(2):44-51.
Otolaryngology and Allied Sciences. 1998;23(3):224-6.
Hellings et al (2013) suggested that patients with uncontrolled Am J Rhinol Allergy. 2011;25(4):252-6. 56.Jacobsen L, Niggemann B, Dreborg S, Ferdousi HA, Halken S, Host A, et al. Specific
10.Stankiewicz JA, Chow JM. Nasal endoscopy and the definition and diagnosis of chronic
34.Hermelingmeier KE, Weber RK, Hellmich M, Heubach CP, Mosges R. Nasal irrigation immunotherapy has long-term preventive effect of seasonal and perennial asthma:
AR be investigated for disease-related, diagnosis-related, treatment- rhinosinusitis. Otolaryngology-Head and Neck Surgery. 2002;126(6):623-7.
as an adjunctive treatment in allergic rhinitis: a systematic review and meta-analysis. 10-year follow-up on the PAT study. Allergy. 2007;62(8):943-8.
related, and patient-related factors that may contribute to the persistent 11.VanArsdel PP, Jr., Larson EB. Diagnostic tests for patients with suspected allergic
Am J Rhinol Allergy. 2012;26(5):e119-25. 57.Inal A, Altintas DU, Yilmaz M, Karakoc GB, Kendirli SG, Sertdemir Y. Prevention of
symptoms of AR.(63) Disease-related factors may include allergen load, disease. Utility and limitations. Ann Intern Med. 1989;110(4):304-12.
35.Mosges R, Konig V, Koberlein J. The effectiveness of modern antihistamines for new sensitizations by specific immunotherapy in children with rhinitis and/or asthma
12.Sibbald B, Barnes G, Durham SR. Skin prick testing in general practice: a pilot study.
cigarette smoke, pollutants, occupational factors, hormonal factors, treatment of allergic rhinitis - an IPD meta-analysis of 140,853 patients. Allergol Int. monosensitized to house dust mite. J Investig Allergol Clin Immunol. 2007;17(2):85-
Journal of Advanced Nursing. 1997;26(3):537-42.
genetic factors, and even innate steroid resistance. Diagnosis-related 2013;62(2):215-22. Epub 2013 March 25. 91.
13.Melioli G, Bonifazi F, Bonini S, Maggi E, Mussap M, Passalacqua G, et al. The
36.Church MK, Maurer M, Simons FE, Bindslev-Jensen C, van Cauwenberge P, Bousquet J, 58.Cox LS, Larenas Linnemann D, Nolte H, Weldon D, Finegold I, Nelson HS. Sublingual
factors may include missing the presence of nasal hyperreactivity, septal ImmunoCAP ISAC molecular allergology approach in adult multi-sensitized Italian
et al. Risk of first-generation H(1)-antihistamines: a GA(2)LEN position paper. Allergy. immunotherapy: a comprehensive review. J Allergy Clin Immunol. 2006;117(5):1021-
deviation, nasal valve dysfunction, nasal polyps, adenoidal hypertrophy, patients with respiratory symptoms. Clinical Biochemistry. 2011;44(12):1005-11.
2010;65(4):459-66. 35.
or even a CSF leak. Patient-related factors may include inappropriate 14.Gadisseur R, Chapelle JP, Cavalier E. A new tool in the field of in-vitro diagnosis
37.Katial RK. Intranasal antihistamines in the treatment of allergic rhinitis. Ann Allergy 59.Bernstein DI, Wanner M, Borish L, Liss GM. Twelve-year survey of fatal reactions
of allergy: preliminary results in the comparison of ImmunoCAP(c) 250 with the
use of intranasal sprays and wrong technique and positioning. Patient Asthma Immunol. 2011;106(2 Suppl):S1. Epub 2011/02/10. to allergen injections and skin testing: 1990-2001. J Allergy Clin Immunol.
ImmunoCAP(c) ISAC. Clin Chem Lab Med. 2011;49(2):277-80. Epub 2010 Dec 14.
perceptions about his condition, and expectations with treatment may 38.Kaliner MA, Berger WE, Ratner PH, Siegel CJ. The efficacy of intranasal antihistamines 2004;113(6):1129-36.
15.Rondon C, Campo P, Galindo L, Blanca-Lopez N, Cassinello MS, Rodriguez-
in the treatment of allergic rhinitis. Annals of Allergy, Asthma, & Immunology. 60.Espiritu AMV. Immunotherapy Costs in University of the Philippines-Philippine General
also impact adherence to therapy. Treatment-related factors include Bada JL, et al. Prevalence and clinical relevance of local allergic rhinitis. Allergy.
2011;106(2 Suppl):S6-S11. Hospital Department of Medicine Section of Allergy. 2015 (Oral Communication).
inappropriate route and dose of drug administration, and treatment 2012;67(10):1282-8.
39.Davies RJ, Bagnall AC, McCabe RN, Calderon MA, Wang JH. Antihistamines: topical vs 61.Abong JM. Immunotherapy Costs in Private Hospitals in the Philippines. 2015 (Oral
modality that is inappropriate for the patient’s symptom severity.(63) 16.Cua-Lim F, Payawal PC, Laserna G. Studies on atmospheric pollens in the
oral administration. Clin Exp Allergy. 1996;26 Suppl 3:11-7. Communication).
Philippines. Ann Allergy. 1978;40(2):117-23.
40.Weiner JM, Abramson MJ, Puy RM. Intranasal corticosteroids versus oral H1 receptor 62.Bousquet PJ, Bachert C, Canonica GW, Casale TB, Mullol J, Klossek JM, et al.
17.Andiappan AK, Puan KJ, Lee B, Nardin A, Poidinger M, Connolly J, et al. Allergic
Patients with persistent AR with possible asthma, patients with antagonists in allergic rhinitis: systematic review of randomised controlled trials. Uncontrolled allergic rhinitis during treatment and its impact on quality of life: a
airway diseases in a tropical urban environment are driven by dominant mono-
BMJ. 1998;317(7173):1624-9. cluster randomized trial. J Allergy Clin Immunol. 2010;126(3):666-8 e1-5.
multiple target organ involvement, and those with failure of medical specific sensitization against house dust mites. Allergy. 2014;69(4):501-9.
41.Ratner PH, Hampel F, Van Bavel J, Amar NJ, Daftary P, Wheeler W, et al. Combination 63.Hellings PW, Fokkens WJ, Akdis C, Bachert C, Cingi C, Dietz de Loos D, et al.
treatment will benefit from consultations with other specialties.(1-3) 18.Bunnag C, Jareoncharsri P, Tantilipikorn P, Vichyanond P, Pawankar R. Epidemiology
therapy with azelastine hydrochloride nasal spray and fluticasone propionate nasal Uncontrolled allergic rhinitis and chronic rhinosinusitis: where do we stand today?
and current status of allergic rhinitis and asthma in Thailand -- ARIA Asia-Pacific
spray in the treatment of patients with seasonal allergic rhinitis. Ann Allergy Asthma Allergy. 2013;68(1):1-7. Epub 2012 Oct 1.
Workshop report. Asian Pac J of Allergy Immunol / launched by the Allergy and
14. Although there is no surgical treatment for allergic rhinitis, Immunol. 2008;100(1):74-81. 64.Gunhan K, Unlu H, Yuceturk AV, Songu M. Intranasal steroids or radiofrequency
Immunology Society of Thailand. 2009;27(1):79-86.
surgery may be indicated in the management of comorbid conditions. 42.Karaki M, Akiyama K, Mori N. Efficacy of intranasal steroid spray (mometasone turbinoplasty in persistent allergic rhinitis: effects on quality of life and objective
19.Wallace DV, Dykewicz MS, Bernstein DI, Blessing-Moore J, Cox L, Khan DA, et al. The
furoate) on treatment of patients with seasonal allergic rhinitis: comparison with oral parameters. Eur Arch Otorhinolaryngol. 2011;268(6):845-50. Epub 2010 Dec 28..
Grade C Recommendation, Level 2B Evidence diagnosis and management of rhinitis: an updated practice parameter. J Allergy Clin
corticosteroids. Auris Nasus Larynx. 2013;40(3):277-81. Epub 2012 Nov 3.
Immunol. 2008;122(2 Suppl):S1-84.
43.Esteitie R, deTineo M, Naclerio RM, Baroody FM. Effect of the addition of montelukast
Indications for a surgical intervention include the following:(1, 19) 20.Schappi GF, Taylor PE, Pain MC, Cameron PA, Dent AW, Staff IA, et al. Concentrations of
to fluticasone propionate for the treatment of perennial allergic rhinitis. Ann Allergy
major grass group 5 allergens in pollen grains and atmospheric particles: implications
• Inferior turbinate hypertrophy unresponsive to medications (64) Asthma Immunol. 2010;105(2):155-61. Epub 2010 Jun 19.
for hay fever and allergic asthma sufferers sensitized to grass pollen allergens. Clinical
• Anatomical variations of the septum with functional relevance 44.Pinar E, Eryigit O, Oncel S, Calli C, Yilmaz O, Yuksel H. Efficacy of nasal corticosteroids
and Experimental Allergy. 1999;29(5):633-41.
alone or combined with antihistamines or montelukast in treatment of allergic
• Adenoidal hyperplasia 21.Pehkonen E, Rantio-Lehtimaki A. Variations in airborne pollen antigenic particles
rhinitis. Auris Nasus Larynx. 2008;35(1):61-6. Epub 2007 Sep 7.
• Anatomical variations of the bony pyramid with functional caused by meteorologic factors. Allergy. 1994;49(6):472-7.
45.Rodrigo GJ, Yanez A. The role of antileukotriene therapy in seasonal allergic rhinitis: a
relevance 22.Cua-Lim F. Aeroallergens in the Philippines. Phil J Allergy Immunol. 1994;1:7.
systematic review of randomized trials. Ann Allergy Asthma Immunol. 2006;96(6):779-
23.Fullante P, Hernandez J. Allergic rhinitis: Positive predictive value of clinical diagnosis
• Secondary or independently developing chronic rhinosinusitis and 86.
versus skin testing in the diagnosis of Allergic Rhinitis. Manila:University of the
complications thereof Philippines-Philippine General Hospital. In press 2005.

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DIAGNOSIS AND TREATMENT FLOWCHART FOR ACUTE BACTERIAL RHINOSINUSITIS IN ADULTS

ALLERGIC RHINITIS IN ADULTS Philippine Academy of Rhinology

Benjamin S.A. Campomanes, Jr., MD, FPSOHNS FUNDING AND DISCLAIMER

Cecile B. Duran, MD, FPSOHNS The development of this guideline was funded exclusively by the
Norman N. Mendoza, MD, FPSOHNS Philippine Society of Otolaryngology-Head and Neck Surgery. The
Antonio H. Chua, MD, FPSOHNS views or interests of the funding body have not influenced the final
Ma. Lourdes B. Enecilla, MD, FPSOHNS recommendations.
Anne Marie V. Espiritu, MD, FPSOHNS
January E. Gelera, MD, DPBOHNS COMPETING INTERESTS
Josefino G. Hernandez, MD, FPSOHNS All authors have declared that they have no competing interests.
Peter I. Jarin, MD, FPSOHNS
Rodante A. Roldan, MD, FPSOHNS DEFINITION
Niño Bernardo V. Timbungco, MD, FPSOHNS Rhinosinusitis is a group of disorders characterized by inflammation
Gil M. Vicente, MD, FPSOHNS of the mucosa of the nose and paranasal sinuses. (1) Sinusitis is generally
preceded by rhinitis and rarely occurs without concurrent rhinitis,
PURPOSE therefore, sinusitis is best described as rhinosinusitis. (2)
This clinical practice guideline (CPG) is intended to describe appropriate
care based on the best available scientific evidence and broad consensus Acute rhinosinusitis (ARS) is an inflammatory condition involving
for acute bacterial rhinosinusitis in adults. It aims to reduce inappropriate the paranasal sinuses, as well as the lining of the nasal passages, which
variations in clinical practice and to highlight management principles lasts up to 4 weeks (28 days).(1) In general, a diagnosis of acute bacterial
unique to the specialty of Otorhinolaryngology in the Philippines. rhinosinusitis (ABRS) may be made in adults with symptoms of a viral
upper respiratory infection (URI) that have not improved after 10 days
TARGET POPULATION, SETTING AND or worsen after 5 to 10 days.(2) There may be some or all of the following
PROVIDERS OF CARE symptoms: nasal drainage, nasal congestion, facial pressure/pain,
This CPG is for use by the Philippine Society of Otolaryngology-Head postnasal drainage, hyposmia/anosmia, fever, cough, fatigue, maxillary
and Neck Surgery. It covers the diagnosis and management of Acute dental pain, and ear pressure/fullness.(2) On the other hand, the European
Bacterial Rhinosinusitis (ABRS) in adults. Position Paper on Rhinosinusitis and Nasal Polyps (EPOS) has included all
cases lasting for < 12 weeks with complete resolution of symptoms under
OBJECTIVES acute rhinosinusitis.(3)
The objectives of this guideline are (1) to provide the requisite
criteria for the diagnosis of acute bacterial rhinosinusitis; (2) to describe The most common bacterial species isolated from the maxillary
the current diagnostic techniques; and (3) to recommend management sinuses in adults with ABRS are Streptococcus pneumoniae, Haemophilus
options relevant to the local setting. influenzae and Moraxella catarrhalis.(2) Other streptococcal species,
anaerobic bacteria, and Staphylococcus aureus have also been
METHODOLOGY documented in a smaller percentage of cases.
The panel was asked to review the previously published PSO-HNS
CPG for Acute Bacterial Rhinosinusitis in Adults. Data from scientific PREVALENCE
studies were presented in an analytical framework in the initial panel The prevalence of bacterial infection in patients with diagnosed ARS is
meeting, and revisions and recommendations were formulated. In the not well-defined given the difficulty of distinguishing viral from bacterial
present document, an extensive MEDLINE, National Library of Medicine’s ARS because the clinical features are similar. (2, 4) Predisposing factors for
PubMed database, and Agency for Healthcare Research and Quality rhinosinusitis include allergic rhinitis, non-allergic rhinitis, nasal polyps,
(AHRQ) Evidence Report and Technology Assessment was done using the rhinitis medicamentosa, trauma, dental infections, immunodeficiency,
keyword “acute sinusitis” or “acute rhinosinusitis”, exploded to include or other factors that lead to inflammation of the nose and paranasal
the definition/classification, prevalence/epidemiology, diagnosis, and sinuses. In addition, rhinosinusitis is found more commonly in patients
therapy. The search was limited to articles involving adult (19 years old with tumors, Wegener’s granulomatosis, HIV infection, Kartagener’s
and above) humans, and those published in English from 2006 to 2015. syndrome, immotile cilia syndrome, and cystic fibrosis.(2)
The search yielded 310 articles, which included the following:
Meta-analysis/Systematic Reviews: 27 Presumed bacterial ARS (ABRS) is one of the most common conditions
Randomized controlled trial: 64 encountered by clinicians. Secondary bacterial infection of the paranasal
Consensus report/ CPG: 2 sinuses following an antecedent viral upper respiratory tract infection
Additionally, older relevant literatures were included. A draft of the (URI) is estimated to be 0.5% - 2% of adult cases.(1) The prevalence of a
evidence-based recommendations (EBR) was collated and presented by bacterial infection during ARS is estimated to be 2% - 10%, whereas viral
the panel to the general assembly of ENT-HNS specialists. causes account for 90% - 98%. Several imaging, clinical and laboratory
‡Adapted from Hellings et al (2013) (63) This guideline will undergo review and updating five (5) years after tests have been used to increase the likelihood of a correct diagnosis
publication, or earlier, depending on the availability of new information. of ABRS with endoscopically directed middle meatal cultures (EMMC)

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 Clinical Practice Guidelines Clinical Practice Guidelines

being a viable culture method for determining antimicrobial efficacy and purulent discharge. Additionally, endoscopy-guided retrieval of samples RECOMMENDATIONS ON THE TREATMENT OF ACUTE BACTERIAL line antimicrobial regimen should be started. (7)
bacterial resistance patterns.(5, 6) for microbiological culture may be done. RHINOSINUSITIS
Grade C Recommendation, Level 4 Evidence Second-line treatment options are the following:
RECOMMENDATIONS ON THE DIAGNOSIS OF ACUTE BACTERIAL 1. The primary treatment for Acute Bacterial Rhinosinusitis Amoxicillin-Clavulanic Acid 2g q 12h
RHINOSINUSITIS (ABRS) In a prospective controlled study by Berger and Berger regarding the (ABRS) is empiric antibiotic therapy. Doxycycline 100mg q 12h
use of flexible endoscopy for diagnosis of ABRS, it was shown that using Grade A Recommendation, Level 1A and 2B Evidence Levofloxacin 500mg OD
1. The diagnosis of ABRS is based on the following criteria: clinical criteria alone had moderate predictive value of 66.3%, highlighting Moxifloxacin 400mg OD
● Acute onset of some or all of the following symptoms: nasal the need for objective measures for diagnosis of ABRS.(6)
congestion, purulent nasal discharge (anterior/posterior nasal drip) 3. Failure of second-line antibiotic treatment warrants further
with or without facial pain/pressure, dental pain and ear pressure/ Endoscopically guided cultures of the discharge from the middle 1.1 First-line antimicrobial regimen for ABRS in patients with low- work-up.
fullness, fever, cough, fatigue, hyposmia/anosmia that fail to improve meatus have a sensitivity of 81%, specificity of 91%, positive predictive risk for antimicrobial resistance: Grade B Recommendation, Level 2B Evidence
after 10 days value of 83% and negative predictive value of 89%, with an overall
● Symptoms worsening within 5-10 days after an initial accuracy of 87% compared with direct sinus aspiration.(5) It may be Amoxicillin-Clavulanic Acid 625mg q8h or 1g q12h OR Patients with ABRS with inadequate response to treatment should be
improvement (i.e. double worsening) performed in selected cases: 1] in the establishment of present local Amoxicillin alone at 500mg q8h or 1g q12h worked up for other conditions and possible disease modifiers. (5, 6, 9)
● Symptoms not lasting beyond 4 weeks bacteriology and resistance; 2] in cases where initial antibiotics fail to
Grade D Recommendation, Level 5 Evidence improve patient symptoms; 3] or in patients with immune-compromised Patients at low risk for antimicrobial resistance are those <65 years of Further work-up may include, but not limited to, the following:
status or with severe infection.(5) age, no prior antibiotic use within the past 30 days, no prior hospitalization 3.1 CT of the Paranasal Sinuses
In the first 3 to 4 days of illness, there is difficulty in differentiating in the past 5 days, no co-morbidities and not immunocompromised.(12) 3.2 Sinus or meatal culture
a viral etiology from early-onset bacterial etiology of rhinosinusitis. If 4. Imaging Studies are NOT recommended for the routine 3.3 Immune system studies
symptoms persist for 5 to 10 days, this could represent the beginning diagnosis of ABRS. Amoxicillin may still be used for patients with no history of antibiotic
stages of ABRS. In this time period, a pattern of initial improvement Grade A(-) Recommendation, Level 1A Evidence use in the past 6 weeks and where local resistance patterns support its 4. Watchful waiting is an option in uncomplicated ABRS
followed by worsening characterized by new onset of fever, headache Sinus radiography has moderate sensitivity (76%) and specificity (79%) use. (1, 12) (Temperature <38.3oC, no extra-sinus complications), provided that
or increased nasal discharge may be observed. This pattern of “double compared with sinus puncture in diagnosing ABRS. Sinus involvement is there is good follow-up.
worsening” or “double sickening” is consistent with ABRS. (1, 2, 7) common in documented viral URIs, making it impossible to distinguish 1.2 Seven (7) to ten (10) days is the recommended treatment Grade A Recommendation, Level 1A Evidence
The severity of the disease may be evaluated using a visual analog ABRS from viral ARS based solely on imaging studies. Plain films of the duration for ABRS (7, 12-14)
scale (Figure 1) in answer to the question of “how troublesome are your sinuses are inaccurate in a high percentage of patients.(8) Early-onset viral ARS and ABRS show considerable overlap in
symptoms of rhinosinusitis”? This can help guide the clinician on the 1.3 For Penicillin allergy: inflammatory mechanisms and clinical presentation.(4, 7, 17) Antibiotic
appropriate management. (1) 5. Imaging Studies are reserved for patients with persistent Doxycycline 100mg q12h OR therapy is started if the patient’s condition fails to improve 7 days after
symptoms, recurrent ABRS or complications, and when sinus surgery Levofloxacin 500mg OD OR the diagnosis of ABRS has been made or if symptoms worsen at any time
is contemplated. Moxifloxacin 400mg OD (double-worsening). Complications of ABRS are similar regardless of
Figure 1: Visual Analog Scale (VAS) Grade A(-) Recommendation, Level 1A Evidence initial management. (7, 17)
Respiratory Fluoroquinolones (Levofloxacin, Moxifloxacin) are not
mild 0-3 Moderate 4- Severe 8- When a complication of ABRS or an alternative diagnosis is suspected, first line treatment and should only be used in penicillin-allergic patients. 5. Nasal saline irrigation (NSI) is safe to use and is recommended
imaging studies may be obtained. (8) Complications of ABRS may include (15)
as an adjunctive treatment.
orbital, intracranial, or soft tissue involvement while alternative Grade A Recommendation, Level 1A Evidence
diagnoses include malignancy and other noninfectious causes of facial In recently published international guidelines, macrolides are not
pain. Radiographic imaging may also be obtained when the patient has recommended as first-line therapy in ABRS due to increasing prevalence Hypertonic saline irrigation showed a modest benefit for ARS and
co-morbidities that predispose to complications, including diabetes, an of S. pneumoniae resistance. However, local data on erythromycin for S. may have superior anti-inflammatory effect and better ability to improve
immune-compromised state, or a history of facial trauma or surgery. (7, 9) pneumonia showed <5% resistance for the past decade. (16) Therefore, the mucociliary clearance. (7, 18)
use of macrolides may still be considered.
Not Most CT imaging of the sinuses is appropriate when a complication of ABRS
is suspected based on severe headache, facial swelling, cranial nerve Second-generation cephalosporins are no longer recommended as
2. A thorough physical examination should include inspection, palsies, or forward displacement or bulging of the eye (proptosis). The CT monotherapy due to variable resistance patterns among S. pneumoniae. 6. Intranasal Corticosteroid Sprays (INCS) may be used as
palpation of the maxillary and frontal sinus, as well as anterior and findings that correlate with ABRS include opacification, air-fluid level, and (12)
However, due to absence of local data, the panel still considers this as monotherapy or adjunct therapy to antibiotics in the empiric treatment
posterior rhinoscopy. moderate to severe mucosal thickening. (7, 9, 10) an option in ABRS treatment. of ABRS.
Grade D recommendation, Level 5 Evidence Grade A Recommendation, Level 1A Evidence
Complications of ABRS are best assessed using iodine contrast-
Performing a complete ENT examination provides information on enhanced CT or gadolinium- based Magnetic Resonance Imaging (MRI) to Topical Nasal Steroids can be used alone or in combination with oral
the chronicity and severity of the patient’s ABRS. The presence of other identify extra-sinus extension or involvement. Suspected complications antibiotics for symptomatic relief of ABRS. (7, 19, 20)
associated conditions, such as otitis media with effusion, may also be are the only indication for MRI of the Paranasal sinuses in the setting of
uncovered. Nasal decongestion and suctioning of excess secretions may ABRS. (7, 9, 11) 2. Second-line antimicrobial regimens are considered for A Cochrane review found that INCS increased the rate of symptom
be performed to aid in diagnosis. patients at high risk of antimicrobial resistance and for failure of initial improvement from 66% to 73% after 15-21 days of use.(19, 20)
treatment.
Grade C Recommendation, Level 2B Evidence 7. There is a lack of available RCTs supporting the efficacy
3. Nasal endoscopy is a safe, radiation-free, and relatively and use of topical and oral decongestants, and antihistamines in the
inexpensive office procedure. It may be used to examine the nasal Failure of first-line treatment should be considered in all patients with treatment of ABRS.
cavity and nasopharynx for anatomical abnormalities and the origin of worsening or no improvement of symptoms after 5-7 days and second- Grade D Recommendation, Level 5 Evidence

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 Clinical Practice Guidelines Clinical Practice Guidelines

CHRONIC RHINOSINUSITIS IN ADULTS

Philippine Academy of Rhinology
Symptomatic management should focus on hydration, analgesics, 10.Hoxworth JM, Glastonbury CM. Orbital and intracranial complications of acute Josefino G. Hernandez, MD, FPSOHNS This guideline will undergo review and updating five (5) years after
antipyretics, saline irrigation and INCS. (3, 7) sinusitis. Neuroimaging clinics of North America. 2010;20(4):511-26. Epub 2010 Oct
Peter I. Jarin, MD, FPSOHNS publication, or earlier, depending on the availability of new information.
27.
11.Mafee MF, Tran BH, Chapa AR. Imaging of rhinosinusitis and its complications: plain Ma. Lourdes B. Enecilla, MD, FPSOHNS
8. In the management of patients with ABRS, patient education film, CT, and MRI. Clin Rev Allergy Immunol. 2006;30(3):165-86. Niño Bernardo V. Timbungco, MD, FPSOHNS FUNDING AND DISCLAIMER
is important and should emphasize avoidance of inciting factors like 12.Chow AW, Benninger MS, Brook I, Brozek JL, Goldstein EJ, Hicks LA, et al. IDSA clinical Benjamin S.A. Campomanes, Jr., MD, FPSOHNS The development of this guideline was funded exclusively by the
allergens, environmental irritants or microbes (bacteria, fungi, virus), practice guideline for acute bacterial rhinosinusitis in children and adults. Clin Infect Antonio H. Chua, MD, FPSOHNS Philippine Society of Otolaryngology-Head and Neck Surgery. The
as well as discussing treatment options with emphasis on antibiotic Dis. 2012;54(8):e72-e112. Epub 2012 March 20.
Cecile B. Duran, MD, FPSOHNS views or interests of the funding body have not influenced the final
13.Ahovuo-Saloranta A, Rautakorpi UM, Borisenko OV, Liira H, Williams JW, Jr., Makela
resistance patterns. M. Antibiotics for acute maxillary sinusitis in adults. The Cochrane database of Anne Marie V. Espiritu, MD, FPSOHNS recommendations.
Grade D Recommendation, Level 5 Evidence systematic reviews. 2014;2:CD000243. January E. Gelera, MD, DPBOHNS
14.Lemiengre MB, van Driel ML, Merenstein D, Young J, De Sutter AI. Antibiotics Norman N. Mendoza, MD, FPSOHNS COMPETING INTERESTS
ABRS is frequently initiated by a viral upper respiratory infection. for clinically diagnosed acute rhinosinusitis in adults. The Cochrane database of Rodante A. Roldan, MD, FPSOHNS All authors have stated that they have no competing interests.
The pathophysiology in the development of ABRS involves an interplay systematic reviews. 2012;10:CD006089.
Gil M. Vicente, MD, FPSOHNS
15.Karageorgopoulos DE, Giannopoulou KP, Grammatikos AP, Dimopoulos G, Falagas ME.
between a predisposing condition (allergies, environmental irritants, Fluoroquinolones compared with beta-lactam antibiotics for the treatment of acute DEFINITION AND PREVALENCE
anatomical deformities, and immune deficiency), infection and bacterial sinusitis: a meta-analysis of randomized controlled trials. 2008;178(7):845- PURPOSE Rhinosinusitis is a group of disorders characterized by inflammation
consequent inflammation of the nasal and paranasal sinus mucosa. (4) 54. This clinical practice guideline (CPG) is intended to describe appropriate of the mucosa of the nose and paranasal sinuses.
16.Research Institute for Tropical Medicine. Antimicrobial Resistance Surveillance care based on the best available scientific evidence and broad consensus
Antimicrobial resistance is a global health problem. It causes Program 2014 Data Summary Report. Data Summary Report (Antimicrobial Resistance
for chronic rhinosinusitis in adults. It aims to reduce inappropriate Chronic rhinosinusitis (CRS) is defined as inflammation of the nasal
Surveillance Reference Laboratory, Research Institute for Tropical Medicine -
prolonged illness, which may lead to mortality and risk of spreading the Department of Health). Muntinlupa: Research Institute for Tropical Medicine. 2014. variations in clinical practice and to highlight management principles cavity and paranasal sinuses and/or the underlying bone that has been
disease. It also creates a financial burden to the patient due to increased 17.Falagas ME, Giannopoulou KP, Vardakas KZ, Dimopoulos G, Karageorgopoulos DE. unique to the specialty of Otorhinolaryngology in the Philippines. present for at least 12 weeks. It is primarily an inflammatory disorder
cost and prolonged duration of treatment. On the global economic Comparison of antibiotics with placebo for treatment of acute sinusitis: a meta-analysis due to multiple etiologic factors. There is increasing evidence that
scale, economic losses could be observed due to reduced productivity of randomised controlled trials. The Lancet Infectious diseases. 2008;8(9):543-52. TARGET POPULATION, SETTING AND the recalcitrance and chronicity of this disease is due to a deranged
caused by the illness and higher cost of treatment. Thus, judicious use 18.Wabnitz DA, Wormald PJ. A blinded, randomized, controlled study on the effect of
PROVIDERS OF CARE host immune response against environmental agents. (1) Due to the
buffered 0.9% and 3% sodium chloride intranasal sprays on ciliary beat frequency.
of antibiotics should be practiced and patients should be made aware of The Laryngoscope. 2005;115(5):803-5. This CPG is for use by the Philippine Society of Otolaryngology-Head obstruction of the sinuses secondary to the inflammatory process, there
this by discouraging them from taking antibiotics without the advice of 19.Zalmanovici Trestioreanu A, Yaphe J. Intranasal steroids for acute sinusitis. The and Neck Surgery. It covers the diagnosis and management of Chronic may be occasional acute exacerbations of rhinosinusitis associated
doctors. (21) Cochrane database of syst reviews. 2013;12:CD005149. Rhinosinusitis (CRS) in adults. with infection. However treating the infection, without addressing the
20.Hayward G, Heneghan C, Perera R, Thompson M. Intranasal corticosteroids in underlying inflammatory disorder, will likely lead to increased frequency
management of acute sinusitis: a systematic review and meta-analysis. Annals of
OBJECTIVES of exacerbations. Thus, accurate and comprehensive diagnosis and
family medicine. 2012;10(3):241-9.
BIBILIOGRAPHY 21.World Health Organization. Antimicrobial Resistance Global Report on Surveillance. The objectives of the guideline are (1) to provide the requisite criteria management is essential.
World Health Assembly, World Health Organization, 2014. for the diagnosis of CRS; (2) to describe current diagnostic techniques;
1. Meltzer EO, Hamilos DL, Hadley JA, Lanza DC, Marple BF, Nicklas RA, et al. and (3) to describe treatment options relevant to the local setting. CRS is divided into two subgroups, CRS without nasal polyps (CRS
Rhinosinusitis: establishing definitions for clinical research and patient care. J allergy w/o NP) and CRS with nasal polyps (CRS w/ NP). These have differences
Clin Immunol. 2004;114(6 Suppl):155-212.
METHODOLOGY in etiopathogenesis and response to various treatment modalities.
2. Anon JB, Jacobs MR, Poole MD, Ambrose PG, Benninger MS, Hadley JA, et al.
Antimicrobial treatment guidelines for acute bacterial rhinosinusitis. Otolaryngol The panel was asked to review the previously published PSO-
Head Neck Surg. 2004;130(1 Suppl):1-45. HNS CPG for Chronic Rhinosinusitis in Adults. Data from scientific Nasal Polyps are smooth, semi-translucent, pearly white to pinkish,
3. Fokkens WJ, Lund VI, Mullol J, Bachert C, Alobid I, Baroody Fuad, et al. European studies were presented in an analytical framework in the initial panel pedunculated masses of edematous inflamed mucosa commonly
Position Paper on Rhinosinusitis and Nasal Polyps 2012. Rhinology. 2012; meeting, and revisions and recommendations were formulated. In the originating from the ostiomeatal complex.
50(Supplement 23).
present document, an extensive search of MEDLINE, National Library
4. Smith SS, Ference EH, Evans CT, Tan BK, Kern RC, Chandra RK. The prevalence of
bacterial infection in acute rhinosinusitis: a Systematic review and meta-analysis. The of Medicine’s PubMed database, and Agency for Healthcare Research Surveys conducted in recent years using patient-reported symptoms
Laryngoscope. 2015;125(1):57-69.. and Quality (AHRQ) Evidence Report and Technology Assessment was of CRS lasting >12 weeks revealed a prevalence of 5-13% in the United
5. Benninger MS, Payne SC, Ferguson BJ, Hadley JA, Ahmad N. Endoscopically directed done using the keywords “Chronic sinusitis” or “Chronic rhinosinusitis”, States, Europe and China. (2) However, prevalence of doctor-diagnosed
middle meatal cultures versus maxillary sinus taps in acute bacterial maxillary exploded to include definition, classification, prevalence, epidemiology, CRS is lower with rates of 2-4%. (3)
rhinosinusitis: a meta-analysis. Otolaryngol Head Neck Surg. 2006;134(1):3-9.
diagnosis and therapy.
6. Berger G, Berger RL. The contribution of flexible endoscopy for diagnosis of acute
bacterial rhinosinusitis. Eur Arch Otorhinolaryngol. 2011;268(2):235-40. Epub 2010 RECOMMENDATIONS ON THE DIAGNOSIS OF
July 8. The search was limited to articles involving adult (19 years old and CHRONIC RHINOSINUSITIS (CRS)
7. Rosenfeld RM, Piccirillo JF, Chandrasekhar SS, Brook I, Ashok Kumar K, Kramper M, et above) humans, and those published in English from 2006 to 2015. The
al. Clinical Practice Guideline (Update): Adult Sinusitis. Otolaryngol Head Neck Surg. search yielded 718 articles, which included the following: 1. The diagnosis of CRS is based on the following criteria:
2015; 152(2 Suppl) S1-S39.
Meta-Analysis/ Systematic Reviews: 68 - Presence of two or more of the following symptoms, one of
8. Cornelius RS, Martin J, Wippold FJ, 2nd, Aiken AH, Angtuaco EJ, Berger KL, et al. ACR
appropriateness criteria sinonasal disease. J Am Coll Radiol 2013;10(4):241-6. Epub Randomized controlled trial (RCT): 91 which should be either (a) nasal blockage/obstruction/congestion or (b)
2013 Feb 16 . Consensus report/CPG: 6 nasal discharge (anterior/posterior nasal drip); (c) facial pain/pressure;
9. Setzen G, Ferguson BJ, Han JK, Rhee JS, Cornelius RS, Froum SJ, et al. Clinical consensus and (d) reduction or loss of smell.
statement: appropriate use of computed tomography for paranasal sinus disease. Additionally, older relevant literatures were included. A draft of the - Duration of ≥12 weeks
Otolaryngol Head Neck Surg. 2012;147(5):808-16. Epub 2012 Oct 12.
evidence-based recommendations (EBR) was collated and presented by - AND presence of any of the following objective evidence
the panel to the general assembly of ORL-HNS specialists. of inflammatory disease, (a) mucopurulent discharge primarily from

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the middle meatus; (b) nasal polyps; (c) edema/mucosal obstruction ruling-in CRS and (-) NE afforded an added value of 5-30% for ruling out PNS x-rays are rapid, economical and non-invasive but give limited 2. Nasal saline irrigation (NSI) is recommended for management
primarily in the middle meatus; (d) radiographic imaging showing CRS. The authors concluded that NE should be the first-line confirmatory evaluation of the paranasal sinuses and the lower third of the nasal of CRS w/o NP.
mucosal changes within the ostiomeatal complex and/or sinuses. test for diagnosing CRS. (7) cavity. These have high specificity but 50% sensitivity in diagnosing CRS. Grade A Recommendation, Level 1A Evidence
Grade A Recommendation, Level 1B Evidence The upright Waters view may suggest but cannot rule out the presence
The Endoscopic Appearance Score (8) (Table 1) can be obtained at of sinusitis. (12) It has been reported in a Cochrane meta-analysis and several
The severity of the disease may be evaluated using a visual analog baseline and at regular intervals to monitor response to treatment. systematic reviews that NSI provide symptomatic relief in CRS. (18) (19) (20) (21)
scale (Figure 1) in answer to the question of “how troublesome are your 3. Maxillary aspirate or endoscopic-guided middle meatal swab It has even been shown to be effective as sole treatment in CRS though
symptoms of rhinosinusitis”? This can help guide the clinician on the culture and sensitivity may be done in cases of acute exacerbations of its effect is not as significant as with the use of INCS. (18)
appropriate management. (3) Table 1: Endoscopic Appearance Score (8) CRS.
Grade C Recommendation, Level 2A Evidence High-volume (>100ml) low-pressure saline irrigation is superior to
Figure 1: Visual Analog Scale (VAS) Characteristic Baseline 3mos 6mos 1yr saline spray in improving symptom scores. Similar symptom improvement
Discharge, right (0,1,2) Maxillary aspirate culture and sensitivity is useful for establishing is seen when comparing isotonic vs. hypertonic saline irrigations. (21) (22)
mild 0-3 Moderate Severe Discharge, left (0,1,2) present local bacteriology and resistance, for patients who are
Edema, right (0,1,2) immunocompromised, for those with severe infections, or for research 3. CRS in acute exacerbation should be treated with short-term
Edema, left (0,1,2) purposes. Occasionally, endoscopic-guided middle meatal cultures antibiotics.
Polyp, right (0,1,2,3) may be done as an alternative to maxillary sinus puncture for obtaining Grade B Recommendation, Level 2B Evidence
Polyp, left (0,1,2,3) cultures in patients with CRS (13).
Short-term antibiotic treatment is defined as treatment duration
* Discharge: 0 – no discharge; 1 – clear, thin discharge; 2 – thick, 4. Other tests may be done to further investigate modifying shorter than 4 weeks. Amoxicillin-clavulanic acid, cefuroxime axetil and
purulent discharge factors in the development of CRS as well as to assist in the evaluation ciprofloxacin have been used with CRS in acute exacerbation with good
Edema: 0 – absent; 1 – mild; 2 – severe of obstructive symptoms. clinical response. (3) INCS should be continued while the patient is on
Not Most
Polyp: 0 – absence of polyps Grade C Recommendation, Level 3B Evidence antibiotic therapy.
1 – polyps in the middle meatus only
1.1. A distinction should be made if there is an acute exacerbation 2 – polyps beyond the middle meatus but not blocking Allergy skin testing and determination of serum IgE levels may 4. Long-term, low dose macrolide therapy, lasting >12 weeks, is
of CRS. the nose completely be performed to diagnose allergic rhinitis and atopy. Although the an option in the management of CRS w/o NP especially in those with
Grade B Recommendation, Level 2B Evidence 3 – polyps completely obstructing the nose relationship of allergy to CRS w/ and w/o NP remains controversial and normal or low total serum IgE levels
Acute exacerbation of CRS is diagnosed when there is sudden results of studies are conflicting, determining the presence of this disease Grade B Recommendation, Level IIB Evidence
deterioration of the patient’s condition with either worsening of baseline in the patient may still be helpful in choosing appropriate treatment
symptoms or development of additional symptoms. This is usually 2. Multi-slice high resolution computed tomography scan may options. (14) Numerous open studies and one RCT have reported the efficacy of
associated with bacterial infection. (1) be used to confirm the diagnosis of CRS, especially in patients with a long-term, low dose macrolide as treatment for CRS with a response rate
prolonged or complicated course, failed medical management and/or Tests may be done to determine if the patient has bronchial asthma of 60-80%. Macrolides have been used for airway inflammatory disease
1.2. CRS should be distinguished from Recurrent Acute Bacterial in whom surgery is contemplated. Plain sinus x-rays have a limited role and/or sensitivity to aspirin. The presence of aspirin-exacerbated due to its immunomodulatory activity rather than its antibacterial effect.
Rhinosinusitis in the diagnosis of CRS and is not recommended. respiratory disease such as Samter’s triad (i.e. aspirin sensitivity, asthma Data suggests that CRS patients with normal or low total IgE (<250 U/ml)
Grade B Recommendation, Level 2B Evidence Grade B Recommendation, Level 2C Evidence and nasal polyposis) has been shown to be associated with high recurrence are more likely to respond to macrolide treatment compared to those
Conventional computed tomography (CT) non-contrast scan rate of nasal polyps and 15-20% long-term revision surgery rate. (15) with high serum IgE levels. (3) It has been shown to suppress neutrophilic
Recurrent Acute Bacterial Rhinosinusitis (rABRS) is diagnosed when demonstrates good sensitivity (85%) and above average specificity (59%) inflammation in the airways. (23) Thus, macrolide treatment would
the patient has 4 or more episodes of Acute Bacterial Rhinosinusitis in in diagnosing sinusitis in general. (9) The CT scan can aid in evaluating the Rhinomanometry and rhinometry can be useful in assessing airflow most likely benefit patients with symptoms dominated by neutrophilic
a year without signs or symptoms of rhinosinusitis in between episodes. extent of mucosal disease, patency of the sinus ostia and ostiomeatal and nasal cavity volume. It can be useful for patients complaining of inflammation such as purulent discharge or postnasal drip. (2)
(1)
Though the symptom burden of CRS and rABRS is similar, distinction complex, as well as the presence of anatomic abnormalities or tumors. It is nasal obstruction to assess if it is a result of inflammation or a mechanical
should be made between the two because antibiotic utilization is higher recommended in failed medical therapy, in the presence of complications obstruction. (3) The recommended dosage regimen based on RCTs:
in rABRS (4) (5) (6) or in suspected malignancies. The anatomic detail the CT scan provides is a. Roxithromycin 150mg/day for 12 weeks (24)
also a useful roadmap for the surgeon during surgery. CT scan should be RECOMMENDATIONS ON THE TREATMENT OF CHRONIC b. Clarithromycin 250mg/day for 12 weeks (25) or 500mg/day for 12
1. The clinical diagnosis of CRS should be supported with obtained in all patients who will undergo endoscopic sinus surgery. RHINOSINUSITIS WITHOUT NASAL POLYPS (CRS w/o NP) weeks (21)
objective documentation of sinonasal inflammation through anterior Side-effects of long-term macrolide treatment should be considered
rhinoscopy and/or nasal endoscopy. High-resolution multi-slice CT (MSCT) shows advantage over 1. CRS w/o NP, being an inflammatory disease, should be such as development of antibiotic resistance, GI disorders, cardiac
Grade A Recommendation, Level 1A Evidence conventional CT in demonstrating CRS. Superior image quality is primarily treated with intranasal corticosteroids (INCS) arrhythmia and hepatotoxicity. (2)
obtained from coronal reconstructions from MSCT of the PNS compared Grade A Recommendation, Level 1A Evidence
Anterior rhinoscopy remains the first step in evaluating patients with with coronal reconstructions of single-slice CT (SSCT). There is absence Long-term low-dose macrolide therapy may be given together with
this disease but it is of limited value. Nasal endoscopy (NE) is highly of dental metal artifacts in coronal reconstructions of MSCT thus INCS improved symptom scores with minimal reported adverse INCS especially when there is inadequate response to INCS alone. (21)
recommended for a thorough examination. It provides better illumination conferring superiority over direct coronal images of SSCT. (10) Images in effects in a Cochrane review of RCTs and 5 meta-analyses. (16)
and visualization compared to anterior rhinoscopy. Likewise, it facilitates all three planes (i.e. coronal, axial, sagittal) is recommended. In a study 5. Short-term oral steroids may be used in patients with severe
visualization of the sinus drainage pathways in the middle and superior by Kew et al (2002), it was found that the addition of the parasagittal A systematic review of RCTs done by Snidvongs (2013) on the efficacy disease, alone or in combination with other treatment options
meati as well as the nasopharynx. view improved the surgeon’s understanding of the anatomy of the frontal of INCS concluded that there is enhanced effectiveness of INCS in patients Grade B Recommendation, Level IIB
recess by a mean of 57% on a 10-point visual analogue scale. In fact, with with prior sinus surgery and with direct sinus delivery (i.e. steroid sinus Oral steroids, in combination with antibiotics or INCS, have been shown
In a systematic review by Wuister et al in 2014 comparing the the parasagittal scan, the surgical plan for the patient was altered in more irrigation) (17) to improve symptoms, radiologic findings and nasal endoscopy findings
diagnostic value of nasal endoscopy against CT scan as the gold-standard, than 50% of the patients studied. (11) in patients with CRS w/o NP in several retrospective and prospective
it was found that (+) NE findings afforded an added value of 25-28% for studies. However, there is lack of high quality RCTs to support the use of

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Based on a Cochrane review, the benefits of topical NSI outweigh the increase in the percentage of eosinophils in the sample polyp tissue of Failure of medical management implies that the patient still
oral steroids, whether alone or in combination, for CRS w/o NP. (26)
minor side effects associated with its use. There is evidence that it has patients who had poor response to macrolide therapy. (43) experiences CRS-specific symptoms that negatively affect quality of
beneficial effects when used as a sole treatment modality but it is not life and daily productivity. In mild to moderate persistent disease (i.e.
6. Mucolytics and decongestants have been traditionally used
as effective as INCS in CRS w/ and w/o NP. (18) The beneficial physiologic Some have proposed classifying CRS w/ NP into eosinophilic or non- VAS 0-7 and/or Grade 1-2 nasal polyps), ESS is an option if there is no
in the management of CRS, however there is no evidence supporting
effects of NSI are improvement in ciliary beat activity and mucociliary eosinophilic due to difference in clinical profile and therapeutic response. improvement after 3 months of medical therapy. In severe persistent
their use.
clearance as well as removal of antigens, biofilms and inflammatory Many regional studies suggest that there is increased prevalence of disease (i.e VAS 8-10 or grade 3 nasal polyp), ESS is an option if there is
Grade C and D Recommendation, Level 4 and 5 Evidence respectively
mediators. (2) the non-eosinophilic type of nasal polyposis among Asians. Although no improvement after 1 month of medical therapy. (3) Even with severe
There were no RCTs found on the use of mucolytics and decongestants
at this time there is no single agreed-upon criterion for differentiating disease, giving initial medical treatment will have the added benefit
for the treatment of CRS w/o NP (3)
Studies have shown greater symptom improvement with high-volume eosinophilic vs. non-eosinophilic polyps, a recommendation can be of optimizing conditions for surgery. Surgical treatment temporarily
saline irrigations. Recommended is a volume of 100-240 ml split between made to classify eosinophilic polyps in the presence of >5 eosinophils/ relieves ostiomeatal complex blockage and serves primarily to facilitate
7. Topical antibiotics, oral and topical antifungals and probiotics
two nasal cavities once to three times per day. (21) hpf. This criterion was selected based on the preponderance of evidence the penetration of topical steroid therapy. (37)
are not recommended in the management of CRS
correlating this cut-off to disease severity and clinical outcomes and due
Grade A(-) Recommendation, Level 1A Evidence
3. Short-term oral steroids may be given as an adjunct treatment to its simplicity and practicality. (44) (45) (46) (47) Systematic review and large outcome studies have shown the
Three RCTs using topical antibiotics for CRS showed no added
option for rapid though transient effects on polyp size reduction and safety and efficacy of ESS for CRS w/ NP. However, systematic reviews
benefit compared to saline. Likewise, no RCTs or systematic reviews for
symptom improvement. Due to lack of strong evidence supporting the use of long-term, have shown no significant difference in benefits of medical vs. surgical
oral and topical antifungals and probiotics were found. These are not
Grade A Recommendation, Level 1A Evidence low dose macrolide in CRS w/ NP and the possible side effects of this management in terms of symptom scores and quality of life. (50) Thus,
recommended for the management of CRS w/o NP. (3)
Systematic reviews have shown the short-term benefit of short courses mode of treatment (i.e. antibiotic resistance, GI symptoms), the panel surgery is recommended if there is failure of medical management.
of oral steroids (i.e. 2-4 weeks) with reduction in polyp size and subjective recommends reserving this for patients with poor response to INCS, low
8. Surgical management may be considered if the patient does
improvement in nasal symptom scores and quality of life. (35) Patient’s serum IgE and non-eosinophilic type of nasal polyps. Several studies have shown that ESS is superior to other sinonasal
not improve after 2-3 months of INCS treatment.
response to a course of oral steroids may aid the clinician in deciding procedures (i.e. polypectomy, Caldwell-Luc, radical nasalization and
Grade A Recommendation, Level 1A Evidence
whether to continue with medical treatment or to consider surgery. Suggested dosage regimen of macrolides based on intranasal ethmoidectomy) with greater rates of complete relief of
Short-term treatment courses of systemic steroids combined with long uncontrolled trials(48): symptoms and better overall outcomes in terms of symptom score and
Large prospective studies and case series have shown that endoscopic
term INCS led to satisfactory results in 85% of patients. If more than a. Clarithromycin 400mg/day for at least 12 weeks disease recurrence. However, there are no studies comparing open
sinus surgery (ESS) is effective and safe for the management of patients
three systemic courses of oral steroids proved to be necessary for control b. Roxithromycin 150mg/day for at least 8 weeks sphenoethmoidectomy with ESS for CRS. (3) (51)
with CRS w/o NP who have failed medical treatment. (3) Long-term success
of severe or progressive disease, a surgical option may be proposed. (36)
rates of ESS are high with over 90% symptomatic improvement. Greater
5. Short-term treatment with Doxycycline may be given as a 8. Early postoperative care with use of nasal saline irrigation,
improvement is seen in CRS w/ NP compared to CRS w/o NP. (1)
Suggested dosage regimen of steroids based on RCTs: treatment option in CRS w/ NP debridement and corticosteroid (topical intranasal and/or oral) is
a. Prednisolone 25mg/day for 2 weeks (37) Grade A Recommendation, Level 1B Evidence strongly recommended. Other therapeutic interventions may be
There is paucity of well-designed RCTs comparing medical vs. surgical
b. Prednisone 30mg/day for 4 days then taper by 5mg every 2 days tailored to the patient’s specific needs.
treatment for CRS w/o NP. Based on a Cochrane review, the evidence
for a total of 2 weeks (38) One theory for the development of nasal polyps is the presence of Grade B recommendation, Level 2A Evidence
shows that surgical management is just as effective as prolonged maximal
c. Methylprednisolone 32mg/day for 5 days followed by 16mg/day Staphylococcus superantigens and targeting this mechanism is one way
medical management. Thus, ESS should be reserved for patients who
for 5 days, then 8mg/day for 10 days (39) of treating CRS w/ NP. An RCT by Van Zele (2010) has shown that giving Postoperative use of INCS has been shown to significantly improve
have failed to improve with maximal medical treatment. (27) The reported
d. Methylprednisolone 16mg/day for 7 days (40) Doxycycline at 200mg on the first day followed by 100mg/tab once daily polyp score, patient’s symptom scores and decrease the odds of polyp
incidence of complications from ESS ranges from 0.3 to 22.4%, majority of
for a total of 20 days resulted in moderate though significant decrease in recurrence compared to placebo (52)
which are minor causing minimal patient morbidity. Major complications
Oral steroids may also be given perioperatively to improve surgical nasal polyp size, nasal symptoms and mucosal and systemic markers of
(i.e. CSF leak, orbital hemorrhage) occur in <1% of patients. (1)
outcomes. In a double-blind RCT done by Wright et al (2007), patients inflammation. (39) The study population involved patients with recurrent 9. Measurement of subjective and objective treatment outcomes
treated with 30mg of prednisone 5 days preoperatively and 9 days nasal polyps after surgery for grade 3 polyps. Doxycycline may be given is recommended. Persistence or recurrence of disease will warrant
RECOMMENDATIONS ON THE TREATMENT OF CHRONIC
postoperatively had technically less difficult surgery compared to as an adjunct treatment which may benefit a subset of the population further workups for modifying factors.
RHINOSINUSITIS WITH NASAL POLYPOSIS (CRS w/ NP)
placebo, as reported by the surgeon, and significantly healthier cavities with CRS w/ NP. Grade D recommendation, Level 5 Evidence
1. The management of CRS w/ NP is primarily medical, with INCS
postoperatively. (41)
as the first-line treatment option.
6. Leukotriene receptor antagonists (LTRAs) can be a treatment In a systematic review by Quintanilla-Dieck et al (2012), the most
Grade A Recommendation, Level 1A Evidence
4. Long-term, low-dose macrolide treatment may be given as option especially in those with concomitant allergy. commonly utilized CRS-specific quality-of-life (QOL) instruments were the
an option in CRS w/ NP, especially if there is poor response with INCS. Grade C Recommendation, Level IIB Sinonasal Outcomes Test (SNOT-22), the Rhinosinusitis Disability Index
INCS are indicated for long term treatment of CRS w/ NP. (28) Numerous
Greater response is seen in patients with normal or low serum IgE or (RSDI) and the Chronic Sinusitis Survey (CSS). (53) Persistent or recurrent
systematic reviews support the efficacy of INCS in terms of symptom
non-eosinophilic type of CRS w/ NP. A recent systematic review (2015) showed that LTRAs, specifically disease may indicate the possibility of previously unrecognized modifying
improvement, decrease in polyp size, prevention of polyp recurrence
Grade B Recommendation, Level 2B Evidence Montelukast, may improve symptoms of CRS compared with placebo but factors such as immunodeficiency, AERD, allergy, odontogenic infection,
after surgery, improvement in nasal airflow and olfaction. (3) (29) (30)
there was no difference compared with INCS. Montelukast did not confer laryngopharyngeal reflux, ciliary dysmotility, granulomatous disease and
There are few studies on the effect of long-term low-dose macrolide additional benefit when used as an adjunct to INCS. Some studies have various other systemic diseases with sinonasal manifestations. (1)
Recommended INCS dosage regimens based on RCTs and local
where the population was specifically defined into groups of CRS w/ shown that LTRAs have greater effect in patients with concomitant allergic
availability of the drug:
or w/o NP. These studies showed a moderate effect on polyp size and rhinitis, asthma and aspirin-exacerbated respiratory disease (AERD) but
Fluticasone propionate nasal spray 200mcg BID (31) or 400mcg/BID (32)
patient symptoms. (3) Early studies by Suzuki et al (2000) showed that further studies are needed. (21) (49)
Mometasone furoate nasal spray 200mcg OD (33) or 200mcg BID (34)
response to macrolide therapy was inversely related to serum IgE level
and eosinophil counts in the sinus mucosa. He found no relation between 7. Surgical management is recommended if there is failure of
2. Topical NSI is recommended for symptom relief in CRS w/ NP.
response to macrolide therapy and tissue neutrophilia. (42) This was further medical management.
Grade A Recommendation, Level 1A Evidence
corroborated by Haruna et al (2009) where he found poorer response to Grade A Recommendation, Level 1A Evidence
macrolides in CRS w/ NP. He found that there was statistically significant

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