Department of Clinical Medicine, Life, Health and Environmental Sciences, Andrology Unit, University of L'Aquila, L'Aquila, Italy.
Department of Life, Health and Environmental Sciences, Epidemiology Division, University of L'Aquila, L'Aquila, Italy.
Andrology. 2023 Sep;11(6):1067-1076. doi: 10.1111/andr.13373. Epub 2023 Jan 18.
Although selective estrogen receptor modulators have been proposed as a treatment for men with central functional hypogonadism, only a few data have been produced in men with obesity-related functional androgen deficiency.
To determine whether and to what extent selective estrogen receptor modulators are an effective and safe therapy in men with obesity-related functional androgen deficiency.
A thorough search of PubMed, Web of Science, Scopus, and Cochrane Library databases was performed to identify studies comparing testosterone levels before and after treatment. Mean differences with 95% coefficient intervals were combined using random effects models. Funnel plot, Egger's test, and trim-and-fill analysis were used to assess publication bias.
Seven studies met the inclusion criteria providing information on 292 men with obesity-related functional androgen deficiency treated with clomiphene citrate (12.5-50 mg daily) or enclomiphene citrate (12.5-25 mg daily) for 1.5-4 months. The pooled estimates indicated a significant increase in testosterone levels both with clomiphene (mean difference: 11.56 nmol/L; 95% coefficient interval: 9.68, 13.43; I = 69%, p = 0.01) and enclomiphene citrate (mean difference: 7.50 nmol/L; 95% coefficient interval: 6.52, 8.48; I = 4%, p = 0.37). After the exclusion of one study on severely obese men, who exhibited the highest response rate to clomiphene citrate, the heterogeneity disappeared (mean difference: 10.27 nmol/L; 95% coefficient interval: 9.39, 11.16; I = 0%, p = 0.66). No publication bias was revealed by Egger's test and trim-and-fill analysis. No treatment-related unexpected findings regarding safety profile were registered.
Treatment with clomiphene citrate and enclomiphene citrate may be an effective and safe alternative to testosterone replacement therapy in men with obesity-related functional androgen deficiency. Further long-term studies are warranted to define clinical reflections of the selective estrogen receptor modulators-induced increase in testosterone levels and to better clarify the safety profile.
尽管选择性雌激素受体调节剂已被提议作为治疗中枢性功能性性腺功能减退症男性的一种方法，但在肥胖相关功能性雄激素缺乏症男性中，仅有少数数据。
确定选择性雌激素受体调节剂是否以及在何种程度上对肥胖相关功能性雄激素缺乏症男性有效和安全。
对 PubMed、Web of Science、Scopus 和 Cochrane Library 数据库进行了全面检索，以确定比较治疗前后睾酮水平的研究。使用随机效应模型合并具有 95%置信区间的均值差异。使用漏斗图、Egger 检验和修剪填充分析来评估发表偏倚。
有 7 项研究符合纳入标准，提供了 292 名接受枸橼酸氯米酚（每日 12.5-50mg）或环戊氯米酚（每日 12.5-25mg）治疗 1.5-4 个月的肥胖相关功能性雄激素缺乏症男性的信息。汇总估计表明，枸橼酸氯米酚（平均差异：11.56nmol/L；95%置信区间：9.68，13.43；I = 69%，p = 0.01）和环戊氯米酚（平均差异：7.50nmol/L；95%置信区间：6.52，8.48；I = 4%，p = 0.37）均可显著增加睾酮水平。排除了一项关于重度肥胖男性的研究后，该研究对枸橼酸氯米酚的反应率最高，异质性消失（平均差异：10.27nmol/L；95%置信区间：9.39，11.16；I = 0%，p = 0.66）。Egger 检验和修剪填充分析未显示发表偏倚。未发现与安全性相关的治疗相关意外发现。
枸橼酸氯米酚和环戊氯米酚治疗可能是肥胖相关功能性雄激素缺乏症男性替代睾酮替代治疗的有效且安全的选择。需要进一步的长期研究来确定选择性雌激素受体调节剂诱导的睾酮水平升高的临床意义，并更好地阐明安全性概况。
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