Sarris Jerome, Byrne Gerard, Castle David, Bousman Chad, Oliver Georgina, Cribb Lachlan, Blair-West Scott, Brakoulias Vlasios, Camfield David, Ee Carolyn, Chamoli Suneel, Boschen Mark, Dean Olivia M, Dowling Nathan, Menon Ranjit, Murphy Jenifer, Metri Najwa-Joelle, Nguyen Thomas P, Wong Andrew, Jordan Rebecca, Karamacoska Diana, Rossell Susan L, Berk Michael, Ng Chee H
NICM Health Research Institute, Western Sydney University, Westmead, NSW, Australia; Florey Institute for Neuroscience and Mental Health, Kenneth Myer Building, Royal Parade, Parkville, Melbourne, Victoria, Australia; Professorial Unit, The Melbourne Clinic, Department of Psychiatry, The University of Melbourne, Melbourne, Victoria, Australia.
University of Queensland Centre for Clinical Research, Royal Brisbane & Women's Hospital, Brisbane, Australia; Mental Health Service, Royal Brisbane & Women's Hospital, Brisbane, Australia.
Prog Neuropsychopharmacol Biol Psychiatry. 2022 Jul 13;117:110550. doi: 10.1016/j.pnpbp.2022.110550. Epub 2022 Mar 15.
Preliminary evidence has suggested that adjunctive N-acetylcysteine (NAC), an antioxidant precursor to glutathione, may reduce symptoms of obsessive-compulsive disorder (OCD). We conducted a 20-week, multi-site, randomized controlled trial to investigate the safety and efficacy of the adjunctive use of NAC in OCD.
The study was a phase III, 20-week, double-blind, randomized controlled trial across multiple sites in Australia investigating 2 g to 4 g per day of NAC (titrated according to response) in 98 participants with DSM-5 diagnosed OCD. Data were analysed using linear mixed effects models for the 89 participants who attended at least one follow-up visit.
A modified intention-to-treat analysis of the primary outcome found no evidence that NAC reduced symptoms of OCD measured on the Yale-Brown Obsessive-Compulsive Scale, relative to placebo (mean difference at week 20 = 0.53, 95% compatibility interval = -2.18, 3.23; p = 0.70; favouring placebo). There was also no evidence that NAC, compared to placebo, improved outcomes on the secondary measures including anxiety, depression, quality of life, functioning, or clinician/participant impression. NAC was well-tolerated with only mild gastrointestinal adverse events associated with the treatment.
We found no evidence supporting the efficacy of the adjunctive use of NAC in OCD.
初步证据表明，谷胱甘肽的抗氧化剂前体N-乙酰半胱氨酸（NAC）辅助治疗可能减轻强迫症（OCD）症状。我们开展了一项为期20周的多中心随机对照试验，以研究NAC辅助治疗OCD的安全性和有效性。
该研究为澳大利亚多中心开展的III期、20周、双盲随机对照试验，对98名诊断为DSM-5标准OCD的参与者使用每日2克至4克NAC（根据反应进行滴定）。对至少参加过一次随访的89名参与者的数据采用线性混合效应模型进行分析。
对主要结局的改良意向性分析发现，没有证据表明相对于安慰剂，NAC能减轻耶鲁-布朗强迫症量表所测量的OCD症状（第20周时平均差异=0.53，95%相容性区间=-2.18，3.23；p=0.70；支持安慰剂）。也没有证据表明与安慰剂相比，NAC能改善包括焦虑、抑郁、生活质量、功能或临床医生/参与者印象等次要指标的结局。NAC耐受性良好，仅出现与治疗相关的轻度胃肠道不良事件。
我们没有发现支持NAC辅助治疗OCD有效的证据。
