Objective To determine the efficacy of fibroblast growth factor‐2 (FGF‐2) in treating chronic nonhealing tympanic membrane (TM) perforations. Method Double‐blinded, randomized placebo controlled phase 2 clinical trial for patients with chronic TM perforations of more than 3 months duration with a cross‐over arm. Patients received either FGF‐2 or placebo (sterile water) saturated gelatin sponge in the perforation after rimming the perforation under topical anesthesia. The perforation was then covered with Tisseel fibrin glue. The primary endpoint was complete closure of the TM perforation. Secondary end points included change in hearing and partial TM closure rates. The TM was examined every 3 weeks with otoendoscopy for closure. The treatment was repeated if there was incomplete closure every 3 weeks up to a total of three treatments per arm. Results Seventy four patients were recruited for the study. Fifty seven met eligibility criteria and fifty four completed the study. Ten of 14 perforations closed completely in the placebo group (71.4%) and 23 of 40 perforations closed completely in the FGF‐2 treatment group (57.5%), P value = .36. Pure tone averages and word recognition scores were not statistically significantly different between study groups post‐treatment. After initial complete closure, re‐perforation occurred in seven FGF‐2 treated patients and two placebo patients making the effective final closure rate 40% for FGF and 57% for placebo, respectively. Conclusion No statistically significant difference in tympanic membrane perforation closure rate was found between the FGF‐2 and placebo groups. There were no differences in hearing outcomes between the groups. Level of evidence 1b.

BackgroundPrevious studies have consistently shown that females with chronic rhinosinusitis (CRS) have a greater CRS symptom burden than males with CRS. Our objective was to determine whether differential disease perception could explain this phenomenon.MethodsA total of 500 participants (239 males, 261 females) with CRS were recruited. CRS symptom burden was assessed with the 22‐item Sino‐Nasal Outcome Test (SNOT‐22). General health‐related quality of life was assessed with the visual analog scale of the 5‐dimensional EuroQol questionnaire (EQ‐5D VAS). Participants were asked to rate their CRS symptom control as “Not at all,” “A little,” “Somewhat,” “Very,” and “Completely.” “Not at all,” “A little,” and “Somewhat” controlled symptoms were considered to reflect poorly controlled symptoms.ResultsSNOT‐22 score was significantly more severe (p < 0.001) among females (mean, 44.0; standard deviation [SD], 22.5) than males (mean, 36.3; SD, 20.2). However, there was no significant difference in male‐ vs female‐reported CRS symptom control (p = 0.154). In addition, there was no significant difference (p = 0.109) in EQ‐5D VAS score between males (mean, 70.9; SD, 19.0) and females (mean, 68.4; SD, 19.5). Although a SNOT‐22 score of ≥25 was predictive of poorly controlled symptoms in males (sensitivity, 82.6%; specificity, 62.5%), a SNOT‐22 score of ≥30 was predictive of poorly controlled symptoms in women (sensitivity, 82.4%; specificity, 64.5%).ConclusionFemales with CRS reported more severe SNOT‐22 scores, despite reporting a similar level of symptom control and general health‐related quality of life as men. Women had a higher SNOT‐22 threshold for poorly controlled symptoms. Female CRS patients may have greater perception and tolerance of CRS symptoms without a corresponding significant, disparate downstream impairment.