Finasteride 5 mg and sexual side effects: How many of these are related to a nocebo phenomenon?
Finasteride 5 mg and sexual side effects: How many of these are related to a nocebo phenomenon?
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DOI：
10.1111/j.1743-6109.2007.00563.x
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发表时间：
2007-11-01
影响因子：
3.5
通讯作者：
Bartoletti, Riccardo
中科院分区：
文献类型：
--
作者：
Mondaini, Nicola;Gontero, Paolo;Bartoletti, Riccardo
介绍。性不良经历，如勃起功能障碍（ED）、性欲减退和射精障碍，是非那雄胺治疗1年后一贯的副作用，最大比例为15%。如果与任何普通临床实践中可能发现的较高百分比相比，这样的数据可能被视为与现实相距甚远。本研究旨在解释文献资料与临床实践资料之间的二分法。120例临床诊断为良性前列腺增生（BPH），性活跃，国际勃起功能指数-勃起功能域(IIEF-EF) >= 25的患者随机接受非那雄胺5mg，作为“治疗BPH有效的X化合物”，为期1年，有（2组）或没有（1组）关于药物性副作用的咨询。用于告知第二组患者的短语是“……它可能会导致勃起功能障碍，性欲下降，射精问题，但这些都是罕见的。”主要结果测量。在6个月和12个月时使用男性性功能4 （MSF-4）问卷和自填问卷对副作用进行估计。107名患者完成了这项研究。与1组（N = 52）相比，2组患者（N = 55）报告了一种或多种性副作用的比例（43.6%比15.3%）（P = 0.03）。1组ED、性欲减退、射精障碍发生率分别为9.6、7.7、5.7%，2组为30.9、23.6、16.3% （P = 0.02、P = 0.04、P = 0.06）。在目前的研究中，与未提供相同信息的患者（1组）相比，盲法给药非那雄胺与告知性副作用的患者（2组）出现性功能障碍的比例明显更高（P = 0.03）。在临床实践中，类似于本研究第2组的情况很可能发生，患者由医生提供建议，并可获得药物信息表。在处理非那雄胺性副作用时，必须考虑到反安慰剂效应的负担（不是药物特定药理作用的直接结果的不良副作用）。
Introduction. Sexual adverse experiences such as erectile dysfunction (ED), loss of libido, and ejaculation disorders have been consistent side effects of finasteride in a maximum percentage of 15% after 1 year of therapy. Such data could be seen as far from reality, if compared to a higher percentage that may be found in any common clinical practice.Aim. This study aims to explain the dichotomy between literature's data and clinical practice data.Methods. One hundred twenty patients with a clinical diagnosis of benign prostatic hyperplasia (BPH), sexually active and with an International Index of Erectile Function-erectile function (IIEF-EF) domain >= 25 were randomized to receive finasteride 5 mg concealed as an "X compound of proven efficacy for the treatment of BPH" for 1 year with (group 2) or without (group 1) counseling on the drug sexual side effect. The phrase used to inform group 2 patients was ". . . it may cause erectile dysfunction, decreased libido, problems of ejaculation but these are uncommon".Main Outcome Measures. The estimation of side effect was conducted at 6 and 12 months using the male sexual function-4 (MSF-4 item) questionnaire and a self-administered questionnaire.Results. One hundred seven patients completed the study. Group 2 patients (N = 55) reported a significant higher proportion of one or more sexual side effects as compared to group 1 (N = 52) (43.6% vs. 15.3%) (P = 0.03). The incidence of ED, decreased libido, and ejaculation disorders were 9.6, 7.7, and 5.7% for group 1, and 30.9, 23.6, and 16.3% for group 2, respectively (P = 0.02, P = 0.04, and P = 0.06).Conclusion. In the current study, blinded administration of finasteride was associated with a significantly higher proportion of sexual dysfunction in patients informed on sexual side effects (group 2) as compared to those in which the same information was omitted (group 1) (P = 0.03). A scenario similar to group 2 of the current study is likely to occur in clinical practice, where the patient is counseled by the physician and has access to the drug information sheet. The burden of this nocebo effect (an adverse side effect that is not a direct result of the specific pharmacological action of the drug) has to be taken into account when managing finasteride sexual side effects.