个体化顺势疗法药物治疗腰椎间盘突出症所致腰痛：双盲、随机、安慰剂对照试验
Individualized Homeopathic Medicines for Low Back Pain in Lumbar Spondylosis: Double-Blind, Randomized, Placebo-Controlled Trial.
作者信息
Prakash Akshaya, Bhowmik Nitai Chand, Singh Subhas, Sadhukhan Satarupa, Rai Shruti, Singh Suman, Kumar Umesh, Rahim Fathima, Balamurugan Dharshna, Bhar Koushik, Singh Navin Kumar, Koley Munmun, Saha Subhranil
机构信息
Department of Organon of Medicine and Homoeopathic Philosophy, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Salt Lake, Kolkata, West Bengal, India.
Department of Organon of Medicine and Homoeopathic Philosophy, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Block GE, Sector III, Salt Lake, Kolkata, West Bengal, India.
出版信息
Homeopathy. 2023 Nov;112(4):240-250. doi: 10.1055/s-0042-1758132. Epub 2023 Jan 25.
INTRODUCTION
Lumbar spondylosis (LS) is a degenerative disorder of the lumbar spine. Despite substantial research efforts, no gold-standard treatment for LS has been identified. The efficacy of individualized homeopathic medicines (IHMs) in LS has remained under-researched. In this study, the efficacy of IHMs was compared with identical-looking placebos in the treatment of low back pain associated with LS.
METHODS
A double-blind, randomized (1:1), placebo-controlled trial was conducted at the National Institute of Homoeopathy, West Bengal, India. Patients were randomized to receive IHMs or placebos, along with standardized concomitant care for both the groups. The Oswestry low back pain and disability questionnaire (ODQ) was the primary outcome; the Roland-Morris questionnaire (RMQ) and the short form of the McGill pain questionnaire (SF-MPQ) were the secondary outcomes. Each was measured at baseline and every month for 3 months. The intention-to-treat (ITT) sample was analyzed to detect any inter-group differences using two-way repeated measures analysis of variance models overall and by unpaired -tests at different time points.
RESULTS
Enrolment was stopped prematurely because of time restrictions; 55 patients were randomized (verum: 28; control: 27); 49 were analyzed by ITT (verum: 26; control: 23). Inter-group differences in ODQ ( = 0.001, = 0.977), RMQ ( = 0.190, = 0.665) and SF-MPQ total score ( = 3.183, = 0.081) at 3 months were not statistically significant. SF-MPQ total score after 2 months ( = 0.030) revealed inter-group statistical significance, favoring IHMs against placebos. Some of the SF-MPQ sub-scales at different time points were also statistically significant: e.g., the SF-MPQ average pain score after 2 months ( = 0.002) and 3 months ( = 0.007). and were the most frequently indicated medicines.
CONCLUSION
Owing to failure in detecting a statistically significant effect for the primary outcome and in recruiting a sufficient number of participants, our trial remained inconclusive.
TRIAL REGISTRATION
CTRI/2019/11/021918.
引言
腰椎病（LS）是一种腰椎的退行性疾病。尽管进行了大量研究，但尚未确定针对LS的金标准治疗方法。个性化顺势疗法药物（IHMs）在LS中的疗效仍未得到充分研究。在本研究中，比较了IHMs与外观相同的安慰剂在治疗与LS相关的腰痛方面的疗效。
方法
在印度西孟加拉邦国家顺势疗法研究所进行了一项双盲、随机（1:1）、安慰剂对照试验。患者被随机分配接受IHMs或安慰剂，并对两组进行标准化的伴随护理。Oswestry腰痛与残疾问卷（ODQ）是主要结局指标；Roland-Morris问卷（RMQ）和麦吉尔疼痛问卷简表（SF-MPQ）是次要结局指标。在基线时以及之后的3个月内每月进行测量。采用意向性分析（ITT）样本，使用双向重复测量方差分析模型整体检测组间差异，并在不同时间点进行非配对检验。
结果
由于时间限制，招募提前终止；55例患者被随机分组（试验组：28例；对照组：27例）；49例患者进行了ITT分析（试验组：26例；对照组：23例）。3个月时，ODQ（P = 0.001，F = 0.977）、RMQ（P = 0.190，F = 0.665）和SF-MPQ总分（P = 3.183，F = 0.081）的组间差异无统计学意义。2个月后的SF-MPQ总分（P = 0.030）显示组间有统计学意义，试验组优于安慰剂组。不同时间点的一些SF-MPQ子量表也有统计学意义：例如，2个月后（P = 0.002）和3个月后（P = 0.007）的SF-MPQ平均疼痛评分。[具体药物名称]和[具体药物名称]是最常使用的药物。
结论
由于未能检测到主要结局的统计学显著效应以及未能招募到足够数量的参与者，我们的试验仍无定论。
试验注册
CTRI/2019/11/021918
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