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个体化顺势疗法药物治疗肠易激综合征的疗效:一项双盲随机、安慰剂对照试验。

Efficacy of individualized homeopathic medicines in irritable bowel syndrome: A double-blind randomized, placebo-controlled trial.

作者信息

Das Aakash Deep, Ghosh Shubhamoy, Palanisamy Chithra, Guha Nilanjana, Mandal Sanjukta, Maiti Shukdeb, Nath Arunava, Singh Navin Kumar, Koley Munmun, Saha Subhranil

机构信息

Department of Repertory, JIMS Homoeopathic Medical College & Hospital, Shamshabad, Telangana, India; Department of Repertory, Mahesh Bhattacharyya Homoeopathic Medical College & Hospital, Govt. of West Bengal, India.

Department of Pathology & Microbiology, D. N. De Homoeopathic Medical College & Hospital, Govt. of West Bengal, India; Department of Pathology & Microbiology, Mahesh Bhattacharyya Homoeopathic Medical College & Hospital, Govt. of West Bengal, India.

出版信息

Explore (NY). 2023 Jul-Aug;19(4):519-527. doi: 10.1016/j.explore.2022.10.004. Epub 2022 Oct 19.

DOI:10.1016/j.explore.2022.10.004
PMID:36307315
Abstract

CONTEXT

Gastrointestinal ailments are some of the common conditions treated in homeopathy; yet only a few trials have explored the effects of individualized homeopathic medicines (IHMs) for irritable bowel syndrome (IBS).

OBJECTIVE

To explore the efficacy of IHMs in treatment of IBS.

DESIGN

Double-blind, randomized, placebo-controlled trial.

SETTING

Outpatient departments of Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, India.

PATIENTS

Sixty patients suffering from IBS; randomized to receive either IHMs (n = 30) or identical-looking placebo (n = 30).

INTERVENTIONS

IHMs or placebo in the mutual context of concomitant care in terms of dietary advice, yoga, meditation and exercises.

MAIN OUTCOME MEASURES

Primary - IBS quality of life (IBS-QOL) questionnaire; secondary -IBS severity scoring system (IBS-SSS) and EQ-5D-5L scores; all measured at baseline and every month, up to 3 months.

RESULTS

Group differences and effect sizes (Cohen's d) were calculated on intention-to-treat (ITT) sample. Groups were comparable at baseline. Recruitment, retention and attrition rates were 64.5%, 91.7% and 8.3% respectively. Group differences in IBS-QOL total scores, IBS-SSS, EQ-5D-5L scores favored IHMs against placebo overall and at all the time points (all P < 0.001). Pulsatilla nigricans (n = 4, 6.7%) and Thuja occidentalis (n = 4, 6.7%) were the most frequently prescribed medicines. Barring some minor events unrelated to interventions, no harms or serious adverse events were recorded in either of the groups. Thus, IHMs acted significantly better than placebos in the treatment of IBS. Independent replications are warranted. [Trial registration: CTRI/2019/10/021632].

摘要

背景

胃肠道疾病是顺势疗法治疗的常见病症之一;然而,只有少数试验探讨了个体化顺势疗法药物(IHM)对肠易激综合征(IBS)的疗效。

目的

探讨IHM治疗IBS的疗效。

设计

双盲、随机、安慰剂对照试验。

地点

印度马赫什·巴塔查里亚顺势医学院及医院门诊部。

患者

60例IBS患者;随机分为接受IHM组(n = 30)或外观相同的安慰剂组(n = 30)。

干预措施

在饮食建议、瑜伽、冥想和锻炼等伴随护理的共同背景下给予IHM或安慰剂。

主要观察指标

主要指标——IBS生活质量(IBS-QOL)问卷;次要指标——IBS严重程度评分系统(IBS-SSS)和EQ-5D-5L评分;均在基线时及之后每月测量一次,直至3个月。

结果

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。招募率、保留率和损耗率分别为64.5%、91.7%和8.3%。IBS-QOL总分、IBS-SSS、EQ-5D-5L评分的组间差异总体上以及在所有时间点均显示IHM组优于安慰剂组(所有P < 0.001)。白头翁(n = 4,6.7%)和北美崖柏(n = 4,6.7%)是最常开具的药物。除了一些与干预无关的 minor 事件外,两组均未记录到伤害或严重不良事件。因此,IHM在治疗IBS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/2019/10/021632]

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