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International consensus statement on rhinosinusitis

caution when prescribing these medications for this indi cation given the associated side effects. In the above studies the most common of these included gastrointestinal com plaints, genitourinary infections, cutaneous rashes, and Clostridium difficile colitis (see Table II-1). The toll on patients and the cost on the healthcare system associated with these adverse events is significant. A review by Poet ker and Smith found that medication errors were a com mon cause of medical litigation with antibiotics as the main source. 1106 In sum, the dearth of rigorous clinical studies and a focus on AECRS in most studies precludes the ability to make recommendations regarding the use of non-macrolide antibiotic for 3 weeks or less in CRSsNP.

IX.D.4 Management of CRSsNP: Antibiotics IX.D.4.a. Antibiotics for CRSsNP: Oral Non-Macrolide Antibiotics for < 3Weeks ICAR-RS-2016 found minimal evidence in this area and made no recommendations. For treatment of CRS with antibiotics for less than 3 weeks, the majority of the liter ature is focused on the treatment of AECRS. Despite the high utilization of this class of pharmacotherapy in CRS there is a surprising paucity of published evidence. High quality prospective studies are lacking, but ICAR-RS-2016 evaluated several studies that addressed the short-term treatment of CRS with non-macrolide antibiotics. Gehanno et al. observed 198 patients with diagnosis of CRS treated with ofloxacin for 12 days; however, these patients were not characterized by nasal polyposis. 1100 The study achieved a 93.7% improvement rate without any mea surable objective outcome. There were a total of 4 double blind randomized trials comparing 2 individual antibiotic regimens head-to-head without the inclusion of a placebo arm. 1101–1104 Clinical resolution of RS was the main end point in each study, and in none were there significant differences between treatment arms. None of these stud ies differentiated between CRSsNP or CRSwNP, and some treatment groups included AECRS and ABRS patients. Therefore, none of these studies was included in consid eration of this updated EBRR. Since ICAR-RS-2016 a single Cochrane review was pub lished exploring systemic antibiotic usage in CRS. 1105 The authors found no studies that addressed this particular section’s cohort. A literature search found only 1 new study evaluating the efficacy of non-macrolide antibiotics in CRSsNP with 3 weeks or less duration. Liu et al. evaluated 5 years of patient data to com pare patients with CRSsNP who were treated with 1) non macrolide antibiotics, 2) steroids, or 3) a combination of the2. 1090 Patients were treated with a variety of antibiotics for a range of 10 to 21 days (median 21 days in the antibiotic only group and 14 days in the combination group) and/or a variable steroid regimen. The authors retrospectively evaluated improvement in CT Lund-Mackay score which necessitated that they exclude patients who did not have pre-treatment or post-treatment scans. They found that all groups had significant improvement in Lund-Mackay scores with no significant difference between the groups; the median pre-treatment score was 9 and improved to a median of 6. The authors found no difference in post treatment need for surgery and they did not use a validated method of evaluating symptoms. As of this update there continues to be minimal evi dence on the efficacy of short-term (ie, < 3 weeks) non macrolide antibiotics in CRSsNP. Practitioners should use

Oral Non-Macrolide Antibiotics for < 3Weeks forCRSsNP Aggregate Grade of Evidence: Not applicable (Table IX-29).

IX.D.4.b. Antibiotics for CRSsNP: Oral Non-Macrolide Antibiotics for ≥ 3Weeks There has been no change in the literature on this topic since ICAR-RS-2016. While there is significant research on the role of prolonged treatment with macrolide antibi otics for CRSsNP, there are few studies evaluating non macrolide therapies. Two early studies were observational, utilizing “maximal medical treatments” including antibi otics for 4 weeks in a total of over 240 patients, but neither distinguished outcomes between patients with polyps or without. 1096,1107 These studies were therefore not included in this EBRR. A prospective study by Dubin et al. examined treatment duration with oral antibiotics in CRSsNP patients. 1108 A total of 35 patients with CT scan-confirmed CRSsNP were prescribed culture-directed antibiotics, clindamycin, or amoxicillin/clavulanic acid for a total of 6 weeks. Sequen tial CT scans were obtained at weeks 3 and 6 and compared to their baseline for any improvement using the Lund Mackay (LM) scoring system. Only 45% of the patients (n = 16) completed the full 6 weeks of therapy and obtained the 2 interval CT scans. The authors noted a significant improvement in average CT scores between the baseline scan (LM = 8.9) and the interval scan at week 3 (LM = 4.38). Although there were no significant improvements between week 3 and week 6 (LM = 4.125) the authors noted that a subset of patients (38%) did have a significant improvement in LM scores. The safety profile of the pro longed treatment was good; the only adverse event noted