Ma Hong-Li, Xie Liang-Zhen, Gao Jing-Shu, Cong Jing, Deng Ying-Ying, Ng Ernest H Y, Liu Jian-Ping, Wu Xiao-Ke
Department of Obstetrics and Gynecology, First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, 150040, China.
Department of Obstetrics and Gynecology, The University of Hong Kong, Queen Mary Hospital, Pokfulam, Hong Kong.
Trials. 2018 Nov 1;19(1):601. doi: 10.1186/s13063-018-2942-7.
Polycystic ovary syndrome (PCOS) is the most common endocrinopathy of reproductive-aged women. Clomiphene is regarded as the first-line medical treatment for ovulation induction in PCOS patients and acupuncture is often used as an alternative and complementary treatment for fertility issues such as those associated with PCOS. The efficacy of acupuncture alone or combined with clomiphene still lacks strong supporting evidence. Factorial 2 × 2 designs can be used for the evaluations of two treatments within a single study, to test the main effects of acupuncture and clomiphene and their interactions.
PCOSAct was designed to test the effect of clomiphene and acupuncture by three two-group comparisons in the original protocol. However, the trial was designed as a standard factorial trial and the factorial analysis approach for analyzing the data that were actually obtained during the trial was found to be more appropriate and more powerful than the three two-group comparisons described in the original protocol, so the statistical analysis approach and different datasets of PCOSAct in the primary publication were accordingly changed.
Although the statistical analysis approach used in the primary publication deviated from the statistical analysis planned in the study protocol, focusing on the main effects of the two interventions and their interactions was a more standard approach to a factorial trial and proved to be more suitable and consistent with the characteristics of the trial data. Statistically, the revision is more powerful and precise and should be more useful to the journal and the readers.
Chinese clinical trial registry, ChiCTR-TRC-12002081 . Registered on 20 March 2012. Clinicaltrials.gov, NCT01573858 . Registered on 4 April 2012.
多囊卵巢综合征（PCOS）是育龄女性中最常见的内分泌疾病。克罗米芬被视为多囊卵巢综合征患者诱导排卵的一线药物治疗，而针灸常被用作治疗与多囊卵巢综合征相关的生育问题的替代和补充疗法。单独使用针灸或与克罗米芬联合使用的疗效仍缺乏有力的支持证据。析因2×2设计可用于在单一研究中评估两种治疗方法，以测试针灸和克罗米芬的主要作用及其相互作用。
PCOSAct最初的方案是通过三组两组比较来测试克罗米芬和针灸的效果。然而，该试验设计为标准析因试验，结果发现，用于分析试验期间实际获得的数据的析因分析方法比原始方案中描述的三组两组比较更合适、更有效，因此，主要出版物中PCOSAct的统计分析方法和不同数据集相应地进行了更改。
尽管主要出版物中使用的统计分析方法与研究方案中计划的统计分析有所偏差，但关注两种干预措施的主要作用及其相互作用是析因试验更标准的方法，并且被证明更适合且与试验数据的特征一致。从统计学角度来看，修订后的方法更有效、更精确，应该对期刊和读者更有用。
中国临床试验注册中心，ChiCTR-TRC-12002081。于2012年3月20日注册。Clinicaltrials.gov，NCT01573858。于2012年4月4日注册。
