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International consensus statement on rhinosinusitis

in opacification and or variations of the Lund-Mackay score. 1162,1163,1167–1169 Validated HRQoL scores were used in 6 of the studies; RSOM-31, 1172 Chinese RSOM-31, 1164 Persian RSOM-31, 1170 SNOT-20, 1162,1163 SNAQ-11 1169 and Taiwanese SNOT-22. 1171 There was however little consistency among these studies, and the other studies did not use a validated HRQoL score at all. 1165–1167 The studies also varied in the way the data from these scores were both reported and analyzed with a non-normal distribution in 3 of the 4 studies. Nonetheless in all studies with symptom scores, there were no reported differences between the groups. In 2 studies where only CRSwNP patients were recruited, disease severity was reported as the sum of 5 individual symptom scores. 1167,1172 Ebbens et al. also reported SF-36 scores but without evi dence of any significant differences. 1172 Side effects of treat ment were not fully reported by all studies. Ebbens et al. reported on epistaxis and headache symptoms. 1172 Four other studies reported on local discomfort. 1163,1165,1166,1170 Overall it was noted that there was a lack of standard reporting of outcome measures across the studies in the Cochrane review. In contrast with the 1 oral administration study, the daily doses of topical antifungals used were lower than expected. This may reflect a lack of specific guidance in prescrib ing authorities however, typical rhinology clinical practice dose regimens for amphotericin B would be approximately 20 mg/d. The studies involving Amphotericin B used 10 mg/d or less in 6 out of 10, which may be considered to be half of the "usual" daily dose or less; it ranged from 0.5 mg/d to 20 mg/d and notably with varying concentrations, dosing regimens and delivery methods. In the 1 study using fluconazole, the dose used was 1.2 mg/d, also considered to be low. Nonetheless disease-specific and generic HRQoL and disease severity showed no significant difference between the topical antifungals and placebo/no treatment groups. Endoscopy and CT scores similarly did not show any sig nificant differences. Variable reporting of adverse events left uncertainty about any adverse effects, although the studies suggest that local irritation may be the most common adverse effect associated with topical anti fungals. Other adverse effects included epistaxis and headache; 1162,1163,1166,1167,1172 1 study reported a hypersensi tivity reaction to amphotericin B. 1168 The Cochrane Review concluded that the evidence was of low or very low quality . The risk of bias in the stud ies was low and although they were considered to have been well conducted, only 1 study had more than 80 par ticipants. These studies were generally small. Also, these studies have often sampled mixed CRS populations or failed to define cases of AFRS for exclusion; the con text of AFRS should be considered separately. Although 2

TABLE IX-34 Evidence for CRS management with oral antifungals Study Year LOE Study Design Study Groups Clinical Endpoint Conclusions Kennedy 1160 2005 1 RCT Terbinafine 625 mg/d Placebo Lund-Mackay score QoL scorerating of CRS and response to treatment No benefit of systemic antifungal over placebo