ABSTRACT

Kingsberg et al. described results from two 24-week Phase III trials of bremelanotide for treating hypoactive sexual desire disorder (HSDD) in women. 72.72% of protocol-listed outcomes were not reported by Kingsberg et al., who provided results of 15 secondary measures which were not listed in the study protocols. None of their efficacy outcomes were reported in line with CONSORT data reporting standards and no secondary outcome had a stated rationale or cited evidence of validity. My meta-analysis of the trials’ data, based on the FDA New Drug Application, found similar results to Kingsberg et al. However, Kingsberg et al. did not report that a) adverse event-induced study discontinuation was substantially higher on bremelanotide: OR = 11.98, 95% CI = 3.74–38.37, NNH: 6 or b) participants preferred placebo, measured by the combination of both 1) completing a clinical trial and 2) electing to participate in the follow-up open-label study (OR = 0.30, 95% CI = .24-.38, NNH: 4). Bremelanotide’s modest benefits on incompletely reported post-hoc measures of questionable validity in combination with participants substantially preferring to take placebo suggest that the drug is generally not useful. Kingsberg et al.’s data reporting and measurement practices were incomplete and lacked transparency.

摘要

金斯伯格等人。描述了布雷默浪丹治疗女性性欲减退症 (HSDD) 的两项为期 24 周的 III 期试验的结果。Kingsberg 等人未报告 72.72% 的方案所列结果，他们提供了研究方案中未列出的 15 项次要措施的结果。他们的疗效结果报告均不符合 CONSORT 数据报告标准，并且次要结果也没有明确的理由或引用的有效性证据。我基于 FDA 新药申请对试验数据的荟萃分析发现了与 Kingsberg 等人相似的结果。然而，金斯伯格等人。未报告 a) 布雷默浪丹不良事件引起的研究中止率明显更高：OR = 11.98，95% CI = 3.74–38.37，NNH：6 或 b) 参与者更喜欢安慰剂，通过 1) 完成临床试验和 2) 选择参与后续开放标签研究的组合来衡量（OR = 0.30，95% CI = .24-.38，NNH：4）。Bremelanotide 对不完整报告的有效性可疑的事后测量的适度益处，加上参与者基本上更喜欢服用安慰剂，表明该药物通常没有用。Kingsberg 等人的数据报告和测量实践不完整且缺乏透明度。