Herder Thalia, Spoelstra Symen K, Niemeijer Anuschka S, Knegtering Hendrikus
Department of Psychiatry, Martini Hospital, Groningen, The Netherlands.
Addiction Care North Netherlands, Groningen, The Netherlands.
PLoS One. 2025 Aug 21;20(8):e0329559. doi: 10.1371/journal.pone.0329559. eCollection 2025.
Sexual dysfunctions are a challenging side effect associated with antipsychotic treatment. This protocol outlines a systematic review and meta-analysis to assess the prevalence of overall sexual dysfunction, as well as the specific phases of sexual function affected by antipsychotic medications. Additionally, the analysis will explore the relationship between prolactin levels and sexual dysfunction.
This protocol has been registered in the database of the International prospective register of systematic reviews (PROSPERO) under the registration number CRD42024573877. We will conduct a systematic search across electronic databases, including PubMed, MEDLINE, PsycINFO, Web of Science, the Cochrane Central Register of Controlled Trials (CENTRAL), Embase, and CINAHL, to identify relevant studies. Studies will be included if they meet predefined inclusion criteria, which include only controlled randomized trials assessing sexual functioning in patients receiving antipsychotic treatment. The antipsychotic medications of interest are amisulpride, aripiprazole, asenapine, brexpiprazole, cariprazine, chlorpromazine, clopenthixol, clozapine, droperidol, flupenthixol, fluphenazine, haloperidol, iloperidone, levomepromazine, loxapine, lurasidone, molindone, olanzapine, paliperidone, penfluridol, perphenazine, perazine, pimozide, prochlorperazine, quetiapine, risperidone, sertindole, sulpiride, thiothixene, thioridazine, trifluoperazine, ziprasidone, zuclopenthixol and zotepine. The primary outcome is the overall prevalence of sexual dysfunction among patients undergoing antipsychotic treatment, while the secondary outcomes include the domains of sexual dysfunction (e.g., desire, arousal, orgasm) and serum prolactin levels. A network meta-analysis (NMA) will be performed using random effects to combine all available evidence for each outcome, aimed to provide a comprehensive ranking of different antipsychotics. NMA will be performed in R within a frequentist paradigm. The Cochrane Risk of Bias tool and RoB 2.0 will be used to assess the risk of bias in studies. We will evaluate the quality of the evidence contributing to network estimates for the primary outcomes using the GRADE framework, and key factors that may affect the observed effects will be analysed for consistency across studies.
性功能障碍是抗精神病药物治疗中一个具有挑战性的副作用。本方案概述了一项系统评价和荟萃分析，以评估总体性功能障碍的患病率，以及受抗精神病药物影响的性功能的具体阶段。此外，该分析将探讨催乳素水平与性功能障碍之间的关系。
本方案已在国际系统评价前瞻性注册数据库（PROSPERO）中注册，注册号为CRD42024573877。我们将在包括PubMed、MEDLINE、PsycINFO、科学网、Cochrane对照试验中心注册库（CENTRAL）、Embase和CINAHL在内的电子数据库中进行系统检索，以识别相关研究。如果研究符合预先定义的纳入标准，将被纳入，这些标准仅包括评估接受抗精神病药物治疗患者性功能的对照随机试验。感兴趣的抗精神病药物有氨磺必利、阿立哌唑、阿塞那平、布瑞哌唑、卡利拉嗪、氯丙嗪、氯哌噻吨、氯氮平、氟哌利多、氟哌噻吨、氟奋乃静、氟哌啶醇、伊潘立酮、左美丙嗪、洛沙平、鲁拉西酮、吗茚酮、奥氮平、帕利哌酮、五氟利多、奋乃静、哌嗪、匹莫齐特、丙氯拉嗪、喹硫平、利培酮、舍吲哚、舒必利、硫利达嗪、三氟拉嗪、齐拉西酮、氯哌噻吨和佐替平。主要结局是接受抗精神病药物治疗患者中性功能障碍的总体患病率，次要结局包括性功能障碍的领域（如性欲、性唤起、性高潮）和血清催乳素水平。将使用随机效应进行网络荟萃分析（NMA），以综合每个结局的所有可用证据，旨在对不同抗精神病药物进行全面排名。NMA将在R中采用频率主义范式进行。将使用Cochrane偏倚风险工具和RoB 2.0来评估研究中的偏倚风险。我们将使用GRADE框架评估对主要结局网络估计有贡献的证据质量，并分析可能影响观察到的效应的关键因素在各研究中的一致性。
