Mondaini Nicola, Gontero Paolo, Giubilei Gianluca, Lombardi Giuseppe, Cai Tommaso, Gavazzi Andrea, Bartoletti Riccardo
UO Urology, S Maria Annunziata Hospital, University of Florence, Florence, Italy.
J Sex Med. 2007 Nov;4(6):1708-12. doi: 10.1111/j.1743-6109.2007.00563.x. Epub 2007 Jul 26.
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.
This study aims to explain the dichotomy between literature's data and clinical practice data.
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".
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.
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).
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.
性功能不良经历，如勃起功能障碍（ED）、性欲减退和射精障碍，一直是非那雄胺治疗1年后出现的副作用，最高发生率为15%。与在任何普通临床实践中可能发现的更高比例相比，这些数据可能与实际情况相差甚远。
本研究旨在解释文献数据与临床实践数据之间的差异。
120例临床诊断为良性前列腺增生（BPH）、有性活动且国际勃起功能指数-勃起功能（IIEF-EF）领域≥25的患者被随机分为两组，一组（第2组）接受隐匿为“治疗BPH的已证实疗效的X化合物”的5毫克非那雄胺治疗1年，并接受关于药物性副作用的咨询，另一组（第1组）不接受咨询。用于告知第2组患者的表述是“……它可能导致勃起功能障碍、性欲减退、射精问题，但这些情况并不常见”。
在6个月和12个月时使用男性性功能-4（MSF-4项目）问卷和一份自我管理问卷对副作用进行评估。
107例患者完成了研究。与第1组（n = 52）相比，第2组（n = 55）报告一种或多种性副作用的比例显著更高（43.6%对15.3%）（P = 0.03）。第1组勃起功能障碍、性欲减退和射精障碍的发生率分别为9.6%、7.7%和5.7%，第2组分别为30.9%、23.6%和16.3%（P = 0.02、P = 0.04和P = 0.06）。
在本研究中，与未被告知性副作用信息的患者（第1组）相比，被告知性副作用信息的患者（第2组）在接受非那雄胺盲法给药时性功能障碍的比例显著更高（P = 0.03）。在临床实践中可能会出现与本研究第2组类似的情况，即医生向患者提供咨询且患者可获取药物说明书。在处理非那雄胺性副作用时，必须考虑这种安慰剂效应（一种并非药物特定药理作用直接结果的不良副作用）的负担。
