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个体化顺势疗法药物治疗颈椎病的疗效:一项双盲、随机、安慰剂对照试验

Efficacy of Individualized Homeopathic Medicines in the Treatment of Cervical Spondylosis: A Double-Blind, Randomized, Placebo-Controlled Trial.

作者信息

Tomar Maneela, Bhowmik Nitai Chand, Singh Subhas, Sadhukhan Satarupa, Michael James, Parewa Maneet, Rai Shruti, Gupta Bharti, Vashisht Himani, Misra Pankhuri, Koley Munmun, Saha Subhranil

机构信息

Department of Organon of Medicine and Homeopathic Philosophy, National Institute of Homoeopathy, Ministry of AYUSH, Government of India, Affiliated to the West Bengal University of Health Sciences, Government of West Bengal, Kolkata, India.

National Institute of Homoeopathy, Ministry of AYUSH, Government of Indiae, Affiliated to the West Bengal University of Health Sciences, Government of West Bengal, Kolkata, India.

出版信息

Complement Med Res. 2023;30(1):26-36. doi: 10.1159/000527523. Epub 2022 Oct 14.

Abstract

INTRODUCTION

Cervical spondylosis (CS) is a degenerative condition of the cervical spine, with approximately 80-90% of people suffering from disc degeneration by the age of 50 years. This trial attempts at evaluating the efficacy of individualized homeopathic medicines (IHMs) against placebos in the treatment of CS.

METHODS

A 3-month, double-blind, randomized, placebo-controlled trial was conducted at the Organon of Medicine outpatient department of the National Institute of Homoeopathy, India. Patients were randomized to receive either IHMs (n = 70) or identical-looking placebos (n = 70) in the mutual context of concomitant conservative and standard physiotherapeutic care. Primary outcome measures were 0-10 Numeric Rating Scales (NRSs) for pain, stiffness, numbness, tingling, weakness, and vertigo, and the secondary outcome was the Neck Disability Index (NDI), measured at baseline and every month until 3 months. The intention-to-treat sample was analyzed to detect group differences and effect sizes.

RESULTS

Overall, improvements were clinically significant and higher in the IHM group than the placebo group, but group differences were statistically nonsignificant with small effect sizes (all p > 0.05, two-way repeated measure analysis of variance). After 2 months of time points, improvements observed in the IHM group were significantly higher than placebo on a few occasions (e.g., pain NRS: p < 0.001; stiffness NRS: p = 0.024; weakness NRS: p = 0.003). Sulfur (n = 21; 15%) was the most frequently prescribed medication. No harm, unintended effects, or any serious adverse events were reported from either group.

CONCLUSIONS

An encouraging but nonsignificant direction of effect was elicited favoring IHMs against placebos in the treatment of CS.

摘要

引言

颈椎病(CS)是一种颈椎的退行性疾病,到50岁时约80 - 90%的人会出现椎间盘退变。本试验旨在评估个体化顺势疗法药物(IHMs)与安慰剂相比治疗颈椎病的疗效。

方法

在印度国家顺势疗法研究所医学门诊进行了一项为期3个月的双盲、随机、安慰剂对照试验。患者在接受保守和标准物理治疗的同时,被随机分为接受IHMs(n = 70)或外观相同的安慰剂(n = 70)。主要结局指标为疼痛、僵硬、麻木、刺痛、无力和眩晕的0 - 10数字评分量表(NRS),次要结局为颈部功能障碍指数(NDI),在基线时以及直至3个月每月测量一次。对意向性治疗样本进行分析以检测组间差异和效应量。

结果

总体而言,改善具有临床意义,且IHM组高于安慰剂组,但组间差异无统计学意义,效应量较小(所有p > 0.05,双向重复测量方差分析)。在2个月的时间点后,在一些情况下,IHM组观察到的改善明显高于安慰剂组(例如,疼痛NRS:p < 0.001;僵硬NRS:p = 0.024;无力NRS:p = 0.003)。硫磺(n = 21;15%)是最常处方的药物。两组均未报告有害、意外影响或任何严重不良事件。

结论

在颈椎病治疗中,与安慰剂相比,IHMs显示出令人鼓舞但无统计学意义的疗效趋势。

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