Abstract：
Objectives: Prevalence of irregular menstrual cycle ranges from 81.7% to 96.3%. Recent research suggested that homeopathy is one of the most popular choices for women with various gynecological disorders. This trial was aimed at differentiating individualized homeopathic medicinal products (IHMPs) from identical-looking placebos in the treatment of menstrual irregularities in early reproductive women. Design: Double-blind, randomized (1:1), two parallel arms, placebo-controlled trial. Setting: D. N. De Homoeopathic Medical College & Hospital, Kolkata, West Bengal, India. Subjects: Ninety-two females with menstrual irregularities. Interventions: Group verum (n = 46; IHMPs plus concomitant care) versus group control (n = 46; placebos plus concomitant care). Outcome Measures: Primary-The proportion of early reproductive females in whom menstrual irregularities can be corrected for consecutive three cycles; Secondary-Menstrual Distress Questionnaire (MDQ) total score; all of them were measured at baseline and every month, up to 4 months. Results: Intention-to-treat sample (n = 92) was analyzed. Group differences were examined by chi-squared tests with categorical outcomes, two-way repeated measure analysis of variance accounting for the time-effect interactions, and unpaired t-tests comparing the mean estimates obtained individually every month. The level of significance was set at p < 0.05 two-tailed. After 4 months of intervention, the group difference in the primary outcome was nonsignificant statistically-IHMPs: 22/46 v/s placebo: 24/46, chi-square (Yates corrected) = 0.043, p = 0.835. The improvement observed in the MDQ total score (F1,90 = 0.054, p = 0.816) and subscales scores were higher in the IHMPs group than in placebos, however statistically nonsignificant in most of the occasions, except for the behavioral change subscale (F1,90 = 0.029, p < 0.001). Pulsatilla nigricans was the most frequently prescribed medicine. Kent\'s Repertory and Zandvoort\'s Complete Repertory were the most frequently used repertories. No harm or serious adverse events were reported from either group. Conclusions: The analysis failed to demonstrate clearly that IHMPs were effective beyond placebos in all but one of the outcomes. More appropriate outcome measures may be sought for future trials. Clinical Trial Registration Number: CTRI/2022/04/041659.
摘要：
目的：月经周期不规则的患病率为81.7％至96.3％。最近的研究表明，顺势疗法是患有各种妇科疾病的女性最受欢迎的选择之一。该试验旨在将个性化顺势疗法药物（IHMPs）与外观相同的安慰剂区分开来，以治疗早期生殖女性的月经不调。设计：双盲，随机化（1：1），两个平行的臂,安慰剂对照试验。设置：D.N.De同势医学院和医院，加尔各答,西孟加拉邦,印度。受试者：92名女性月经不调。干预措施：第一组（n=46；IHMPs加伴随护理）与对照组（n=46；安慰剂加伴随护理）。结果测量：主要-可以连续三个周期纠正月经不调的早期生殖女性比例；次要-月经困扰问卷（MDQ）总分；所有这些都在基线和每月进行测量，长达4个月。结果:分析了意向治疗样本(n=92)。通过具有分类结果的卡方检验检查了群体差异，考虑时间效应相互作用的双向重复测量方差分析，和非配对t检验，比较每月单独获得的平均估计值。显著性水平设定为p<0.05双尾。经过4个月的干预，主要结局的组间差异无统计学意义-IHMPs:22/46v/s安慰剂:24/46,卡方(Yates校正)=0.043,p=0.835.在MDQ总分（F1,90=0.054，p=0.816）和分量表评分中观察到的改善在IHMPs组中高于安慰剂组，然而，在大多数情况下，统计上并不显著，除了行为变化分量表(F1,90=0.029，p<0.001)。白头翁是最常用的处方药。肯特的《剧目》和赞德沃特的《完整剧目》是最常用的剧目。两组均未报告任何伤害或严重不良事件。结论：分析未能清楚地证明IHMPs在除一项结果外的所有结果中均有效。未来的试验可能会寻求更合适的结果指标。临床试验登记号：CTRI/2022/04/041659。
