Ghosh Shubhamoy, Ravindra Rai Khushboo, Modak Amila, Maiti Shukdeb, Nath Arunava, Koley Munmun, Saha Subhranil
Dept. of Pathology & Microbiology, Mahesh Bhattacharyya Homeopathic Medical College and Hospital, Howrah, West Bengal, India.
Dept. of Repertory , Mahesh Bhattacharyya Homeopathic Medical College and Hospital, Howrah, West Bengal, India.
J Complement Integr Med. 2021 Jun 3;20(1):258-267. doi: 10.1515/jcim-2020-0512. eCollection 2023 Mar 1.
Homeopathic treatment is claimed to be beneficial for primary dysmenorrhoea (PD); still, systematic research evidences remain compromised. This study was undertaken to examine the efficacy of individualized homeopathic medicines (IH) against placebo in the treatment of PD.
A double-blind, randomized, placebo-controlled trial was conducted at the gynecology outpatient department of Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, West Bengal, India. Patients were randomized to receive either IH (n=64) or identical-looking placebo (n=64). Primary and secondary outcome measures were 0-10 numeric rating scales (NRS) measuring intensity of pain of dysmenorrhea and verbal multidimensional scoring system (VMSS) respectively; all measured at baseline, and every month, up to 3 months. Group differences and effect sizes (Cohen's ) were calculated on intention-to-treat (ITT) sample.
Groups were comparable at baseline (all p>0.05). Attrition rate was 10.9% (IH: 7, placebo: 7). Differences between groups in both pain NRS and VMSS favoured IH over placebo at all time points (all p<0.001, unpaired -tests and two-ways repeated measures analysis of variance) with medium to large effect sizes. and (n=20 each; 15.6%) were the most frequently prescribed medicines. No harms, serious adverse events and intercurrent illnesses were recorded in either of the groups.
Homeopathic medicines acted significantly better than placebo in the treatment of PD. Independent replication is warranted. Trial registration: CTRI/2018/10/016013.
顺势疗法治疗据称对原发性痛经（PD）有益；然而，系统的研究证据仍存在缺陷。本研究旨在检验个体化顺势疗法药物（IH）在治疗PD方面相对于安慰剂的疗效。
在印度西孟加拉邦马赫什·巴塔查里亚顺势疗法医学院和医院的妇科门诊进行了一项双盲、随机、安慰剂对照试验。患者被随机分为接受IH组（n = 64）或外观相同的安慰剂组（n = 64）。主要和次要结局指标分别为0 - 10数字评分量表（NRS）测量痛经疼痛强度和言语多维评分系统（VMSS）；所有指标均在基线时以及之后每月测量，直至3个月。在意向性治疗（ITT）样本上计算组间差异和效应量（科恩d值）。
两组在基线时具有可比性（所有p>0.05）。脱落率为10.9%（IH组：7例，安慰剂组：7例）。在所有时间点，疼痛NRS和VMSS两组间的差异均显示IH组优于安慰剂组（所有p<0.001，非配对t检验和双向重复测量方差分析），效应量为中到大。和（每组n = 20；15.6%）是最常处方的药物。两组均未记录到有害事件、严重不良事件和并发疾病。
顺势疗法药物在治疗PD方面的效果明显优于安慰剂。有必要进行独立重复试验。试验注册号：CTRI/2018/10/016013。
