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International consensus statement on rhinosinusitis

IX.D.5 Management of CRS: Antifungals Because of limited data, CRSsNP and CRSwNP are com bined in this analysis and recommendations. At the end of the 1990s, the use of topical antifungals for CRS started to rise in popularity with the publica tion of studies such as those by Ponikau et al. 616 To date this remains a controversial area due to data from stud ies of both topical and systemic antifungal agents that both support and refute their usage in CRS. 1159 A 2018 Cochrane review therefore considered the evidence for both oral and topical antifungals in CRS. 618 The review considered a mixed group of 8 studies with either CRSsNP, CRSwNP, CRS in which NP was not recorded or CRSwNP and CRSsNP in the same study. These 2 sections provide the opportunity to revisit the evidence and consider new additions since 2018. IX.D.5.a. Antifungals for CRS: Oral Antifungals Searches revealed only 1 study for CRS patients with or without polyps when allergic fungal RS was excluded. This study by Kennedy et al. 1160 used an oral antifungal in the form of terbinafine tablets (625 mg/d) for 6 weeks. This study included 53 adult CRS patients in which the phe notype for with or without polyps was not distinguished, were entered into a double blind RCT of terbinafine (n = 25) vs placebo (n = 28). The above dose used in the trial appears to be a high dose in accordance with prescribing guidelines such as the British National Formulary which recommends 250 mg/d. Patients who had undergone ESS within 3 months prior to recruitment, were not included in the study. Outcome measures included percentage change in Lund-Mackay scores (primary) and QoL scores and patient and clinician rating of their CRS and therapeu tic response (secondary). Nine patients failed to complete the study – 4 in the terbinafine and 5 in the placebo group. There was no statistically significant difference observed between active and placebo treatment with respect to QoL (Rhinosinusitis Disability Index), CT scores or patient symptoms, albeit with limited data reported and the data spread indicating very large variations in the results. A key limitation of this study was the use of the CT scan scores as the primary outcome measure as radiological changes cor relate poorly with symptom scores. 1161 Of the participants in the terbinafine group, one had elevated liver enzymes and another experienced gastrointestinal disorders and in the placebo group 3 participants experienced gastrointesti nal side effects. On the basis of the 1 available study, there is no evidence to support the use of systemic antifungal treatment in the routine management of CRSsNP.

Oral Antifungals for CRSsNP Aggregate Grade of Evidence: not applicable (Table IX-34).

IX.D.5.b. Antifungals for CRS: Topical Antifungals Few studies on topical antifungals in CRS separated CRSsNP and CRSwNP. Due to the limitations of the stud ies identified within the Cochrane review, the results here are presented as a summary of all studies for topical antifungals in both CRSsNP and CRSwNP. Some studies defined inclusion as unresponsiveness to previous medical therapy for CRS. 1162,1163 Liang et al. definitively excluded CRSwNP cases 1164 and 1 study did not provide details about whether participants had NPs. 1163 Five studies cited NPs as an inclusion criterion; 1165–1169 the remaining 4 stud ies reported polyps in 20%, 1170 35.6%, 1171 43.8% 1162 , and 81.9% 1172 of participants. Four studies excluded patients withAFRS 1165–1167,1172 and 1 study reported on double den sity signs and positive fungal cultures being present in 29% and 30% of cases, respectively, but did not definitively diag noseAFRS. 1168 The remainder failed to report any evidence for AFRS. One study had aspirin sensitivity present in 77% of participants. 1165 From the 11 studies that investigated the use of topical antifungal agents, amphotericin B was used in 10 studies and fluconazole in only 1 study. The Cochrane review of 2018 summarized the evidence for topical antifungals 618 and there were 3 additional RCTs published after the review that have been included here. 1168,1170,1171 The deliv ery methods varied among the studies with nasal irri gations being most popular, 1164,1168,1170–1172 followed by syringe delivery; 1163,1165,1166 Weschta et al. and Gerlinger et al. used a spray delivery method 1167,1169 and Hashemian et al. formulated the fluconazole as nasal drops. 1162 Inclusion criteria were variable with some studies being mixed and some included participants having had prior ESS. Outcome measures assessed included endoscopic scores, radiological scores, generic and disease specific HRQoL scores, serum IgE levels and side effects. In the study by Zia et al., participants had not undergone any pre vious nasal surgery but underwent ESS and were then ran domized in a 1:2 ratio of amphotericin to placebo due to a lack of funding. 1168 Seven studies reported the results of nasal endoscopy and 4 studies assessed the extent of nasal polyps on a scale of 0 to 4 for each side 1162,1163 or 0 to 3 each side. 1167,1169 Other studies used a generic endoscopic score 1164,1172 and 1 study simply reported on polyp recurrence. 1165 Five stud ies measured CT score either using the percentage change