DURATION OF ORAL ANTIBIOTIC IN THE SETING OF MAXIMAL MEDICAL THERAPY FOR CHRONIC RHINOSINUSITIS. Dr. Ziyad Al-Abduljabbar

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1 DURATION OF ORAL ANTIBIOTIC IN THE SETING OF MAXIMAL MEDICAL THERAPY FOR CHRONIC RHINOSINUSITIS Dr. Ziyad Al-Abduljabbar

2 International Forum of Allergy & Rhinology, Vol. 5, No. 9, September 2015

3 INTRODUCTION Prior to consideration for functional endoscopic sinus surgery (FESS), it is widely accepted that patients with chronic rhinosinusitis (CRS) receive a trial of maximal medical therapy. Maximal medical therapy generally centers on oral antibiotics as the mainstay of treatment, but may also include oral steroids, topical nasal steroids, nasal saline irrigation, and other treatments.

4 However, maximal medical therapy is a broad term with varying definitions that differs significantly between otolaryngologists. Several studies have demonstrated the clinical efficacy of varying forms of maximal medical therapy. Lal et al. found that a minimum 4-week treatment with oral antibiotics, oral steroids, topical nasal steroids, topical nasal decongestant rotation, and saline nasal douching was found to be successful in 51% of patients, with a partial benefit occurring in an additional 18% of patients. Subramaniam et al. found that 36 of 40 patients experienced statistically significant symptomatic and/or radiographic improvement of disease after 1 month of antibiotics, a short course of oral steroids, and adjunctive therapy including nasal irrigations and steroids.

5 The typical duration of therapy has steadily increased over the years from 10 days to 21 to 28 days The use of such prolonged courses of antibiotics raises concerns for several negative outcomes including development of antibiotic resistant bacteria, liver function disruption, gastrointestinal side effects, Clostridium difficile colitis, allergic reactions, and significant added healthcare costs

6 Yet, if these longer courses of antibiotics are able to mitigate the disease process to a greater degree than shorter courses, they may serve as a useful therapeutic option in routine clinical practice

7 OBJECTIVE The objectives of this study was to provide high-level and comprehensive evidence evaluating the duration of antibiotics as part of maximal medical therapy for CRS with and without nasal polyposis

8 METHODS This study was a prospective, randomized cohort study evaluating 3 weeks vs 6 weeks of oral antibiotic treatment Population: Patients >18 years Satisfying diagnostic criteria for CRS as defined by EPOS12 No treatment with oral steroids or oral antibiotics in the prior 2 months. All Subjects received (CT) scan at time of enrollment demonstrating sinus disease Pregnant Ladies were excluded

9 INTERVENTION Patients were randomly enrolled into 3-week or 6-week treatment cohorts CRSwNP were prescribed Doxycycline 100 mg orally taken twice a day, an oral steroid taper was also prescribed CRSsNP were prescribed Azithromycin 250 mg orally taken once daily

10 All patients underwent flexible fiber optic or rigid nasopharyngoscopy. If there was purulence evident in the nasal cavity that could be cultured, patients underwent culture and antibiotics were adjusted based on antibiotic susceptibility as indicated. All patients were also provided topical nasal steroid sprays and isotonic saline nasal rinses

11 Patients were administered the Rhinosinusitis Disability Index (RSDI) and Chronic Sinusitis Survey (CSS) at their initial clinical visits. A fine-cut pretreatment sinus CT scans were obtained and scored using the Lund- Mackay (LM) grading system At the time of the follow-up visit, the RSDI and CSS questionnaires were administered again and patients also received posttreatment sinus CT scans that were again scored using the LM grading rubric

12 Assess for treatment compliance: Patients were given an exit survey at their follow-up visit At the mid-point in the protocol, patients received phone calls to determine treatment compliance and inquire about possible side effects Primary outcome was failure of maximal medical therapy with subsequent surgical recommendation

13 40 patients were enrolled in this study: 21 subjects in the 3-week cohort 19 subjects in the 6-week cohort, with 100% clinical follow-up achieved in this final cohort of 40 patients

14 RESULTS Primary outcomes: There was no statistically significant difference found between the 2 treatment cohorts In the 3-week treatment cohort, 71% of subjects were deemed as having failed medical management and were recommended to undergo surgical intervention In the 6-week treatment cohort, 68% of subjects were also defined as having failed maximal medical therapy and received recommendations to undergo

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16 Regarding subjective quality of life measures, including the CSS and RSDI surveys no statistically significant differences were seen in overall quality of life score changes between the 2 treatment cohorts Even when stratifying patients based on polyp status, no significant difference in RSDI and CSS scores was observed between the 2 treatment arms

17 The mean difference between LM scores of pretherapy and posttherapy sinus CT scans revealed no significant difference between the 3-week and 6-week treatment cohorts Stratification based on polyp status also yielded no statistically significant difference in the mean change in LM scores

18 DISSCUSSION Comparing 2 discrete durations of antibiotic treatment in the setting of maximal medical therapy, data suggest that there were no statistically significant differences between 3 and 6 weeks of antibiotic therapy across all of our primary and secondary study outcomes including subjective quality of life measures, objective radiographic sinus CT scoring,

19 Based on these data, longer durations of antibiotic treatment in CRS patients with and without nasal polyposis may have no significant clinical effect in achieving a favorable response to medical therapy Prolonged exposure to antibiotics may not be recommended because of the potential for increased antibiotic resistance and substantial GI side effects associated with chronic use

20 Notably, in the CRS cohort with nasal polyps across both treatment arms, there was, on average, a worsening in quality of life scores based on the CSS measure and no improvement in average overall RSDI scores in the 6-week treatment arm Though a small sample of 14 patients in the cohort of patients with nasal polyps may limit the generalizability of these data,

21 The radiographic sinus CT imaging resulted in no statistically significant difference between our treatment arms

22 CONCLUSION Little difference in clinical outcome between 3 weeks vs 6 weeks of antibiotic treatment for CRS as part of maximal medical therapy. No significant differences in quality of life or sinus CT imaging between these cohorts was seen. Although healthcare insurance providers are often required more than 4 weeks to prove medical therapy failure, increased duration of antibiotic treatment theoretically increases risk from side effects and absolutely creates higher healthcare costs. Inquiry into clinically significant change or obtaining higher clinical numbers for improved statistical power should be investigated in future research endeavors

23 THANK YOU