Alex P. Hood, Chris E. Corlett, Cameron T. Alldredge, Gary R. Elkins
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One pilot study was excluded due to a lack of inter-group comparison.To date, six (four Phase II and two Phase III) randomized, controlled trials of MDMA-AT have been published which met criteria for inclusion in this review. Study design, sponsor, recruitment methods, and participant demographics are similar across trials.Five out of six reviewed studies provide evidence for the apparent safety and efficacy of MDMA-AT. However, the lack of suitable comparison condition, poor blinding, and rigid study design across trials make interpretation of results difficult. In addition, the high costs of MDMA-AT and lack of head-to-head comparisons with validated PTSD therapies cast doubt on its potential promise as a treatment. The role of the sponsoring organization behind all trials may further introduce bias into findings. 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引用次数: 0
摘要
创伤后应激障碍(PTSD)是一种使人衰弱的疾病,影响着相当一部分美国平民、军人和退伍军人。3,4-亚甲二氧基甲基苯丙胺辅助疗法(MDMA-AT)是一种治疗创伤后应激障碍的新型方法,既激起了媒体的热情,也招致了批评。这篇评论性综述分析了亚甲二氧基甲基苯丙胺辅助疗法的各项随机对照试验,并进行了叙述性综述。通过图书馆检索和分析现有文献综述,确定了包含原始研究结果的出版物,这些研究结果来自亚甲二氧基甲基苯丙胺辅助疗法的随机对照试验,并进行了组间统计比较。共找到七篇文章。迄今为止,已发表的六项(四项 II 期和两项 III 期)MDMA-AT 随机对照试验符合本综述的纳入标准。六项综述研究中的五项为亚甲二氧基甲基苯丙胺-AT 的明显安全性和有效性提供了证据。然而,由于缺乏合适的对比条件、盲法不完善以及各试验的研究设计僵化,因此很难对结果做出解释。此外,亚甲二氧基甲基苯丙胺-AT 的高昂成本以及缺乏与有效创伤后应激障碍疗法的正面比较,也使人们对其作为一种治疗方法的潜在前景产生了怀疑。所有试验背后的赞助机构的作用可能会进一步导致研究结果的偏差。尽管迄今为止的研究令人鼓舞,但还没有足够的证据表明亚甲二氧基甲基苯丙胺应被广泛采用,而不是目前有效的创伤后应激障碍治疗方法。
Critical review of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for posttraumatic stress disorder: Unanswered questions and future directions
Post-Traumatic Stress Disorder (PTSD) is a debilitating condition that affects a sizable proportion of U.S. civilians, military personnel, and veterans. 3,4-Methylenedioxymethamphetamine-Assisted Therapy (MDMA-AT) is a novel treatment approach for PTSD that has both stirred media enthusiasm and drawn criticism. This critical review analyzes individual randomized, controlled trials of MDMA-AT and provides a narrative synthesis.A library search and analysis of extant literature reviews was conducted to identify publications containing original research findings with inter-group statistical comparisons from randomized, controlled trials of MDMA-AT. Seven articles were identified. One pilot study was excluded due to a lack of inter-group comparison.To date, six (four Phase II and two Phase III) randomized, controlled trials of MDMA-AT have been published which met criteria for inclusion in this review. Study design, sponsor, recruitment methods, and participant demographics are similar across trials.Five out of six reviewed studies provide evidence for the apparent safety and efficacy of MDMA-AT. However, the lack of suitable comparison condition, poor blinding, and rigid study design across trials make interpretation of results difficult. In addition, the high costs of MDMA-AT and lack of head-to-head comparisons with validated PTSD therapies cast doubt on its potential promise as a treatment. The role of the sponsoring organization behind all trials may further introduce bias into findings. Though research to date is encouraging, there is not yet sufficient evidence to suggest that MDMA-AT should be see widespread adoption over current, validated forms PTSD of treatment.