Individualized homeopathic medicines in preventing the progression from pre-diabetes to diabetes: A double-blind, randomized, placebo-controlled, parallel-arm trial

IF 1.9 4区医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE Explore-The Journal of Science and Healing Pub Date : 2024-04-04 DOI:10.1016/j.explore.2024.03.003

Aryabrata Banerjee , Subhasish Ganguly , Sangita Saha , Pulakendu Bhattacharyya , Satyajit Naskar , Debraj Mukherjee , Shuvadip Ghosh , Prosenjit Maji , Subhranil Saha , Abdur Rahaman Shaikh , Priyanka Ghosh , Chandrima Chatterjee , Munmun Koley , Shyamal Kumar Mukherjee

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Abstract

Context

Pre-diabetes is a significant public health problem worldwide. India has a very high rate of progression from pre-diabetes to diabetes, 75–78 per thousand persons per year.

Objective

To study the efficacy of individualized homeopathic medicinal products (HMPs) against placebos in preventing the progression from pre-diabetes to diabetes.

Design

Six-month, double-blind, randomized (1:1), two parallel arms, placebo-controlled trial.

Setting

Outpatient departments of D. N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India.

Patients

Sixty participants with pre-diabetes.

Interventions

Verum: HMPs plus yoga therapy (YT; n = 30); control: identical-looking placebos plus YT (n = 30).

Main outcome measures

The primary efficacy endpoint was the proportion of participants progressing from pre-diabetes to diabetes, measured after three and six months. Secondary outcomes comprised of fasting blood glucose (FBS), oral glucose tolerance test (OGTT), glycated hemoglobin percentage (HbA1c%), lipid profile, liver enzymes (alanine transaminase, aspartate transaminase), urea and creatinine, and Measure Yourself Medical Outcome Profile version 2 (MYMOP-2); all measured after 3 and 6 months.

Results

The proportion of participants converted from pre-diabetics to diabetics (n/N; n = diabetics, N = prediabetics) was significantly less in the verum group than control: HbA1C% (month 3: verum – 2/30 versus control – 11/30, p = 0.003; month 6: 3/30 vs. 2/30, p = 0.008), OGTT (month 3: 0/30 vs. 8/30, p = 0.015; month 6: 0/30 vs. 1/30, p = 0.008), but not according to FBS (month 3: 1/30 vs. 1/30, p = 0.779; month 6: 1/30 vs. 3/30, p = 0.469). Several secondary outcomes also revealed significant improvements in the verum group than in placebo: HbA1C% (p < 0.001), OGTT (p = 0.001), serum ALT (p = 0.031), creatinine (p = 0.012), and MYMOP-2 profile scores (p < 0.001). Sulphur, Bryonia alba, and Thuja occidentalis were the most frequently indicated medicines. Thus, HMPs outperformed placebos by successfully preventing the progression of pre-diabetes to diabetes.

Trial registration

Clinical Trials Registry – India CTRI/2022/04/042,026; UTN: U1111–1277–0021

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预防糖尿病前期发展为糖尿病的个性化顺势疗法药物：双盲、随机、安慰剂对照、平行臂试验

糖尿病前期是全球范围内的一个重大公共卫生问题。印度从糖尿病前期发展为糖尿病的比率非常高，每年每千人中就有 75-78 人。研究个性化顺势疗法药物产品（HMPs）与安慰剂在预防糖尿病前期发展为糖尿病方面的疗效。为期六个月的双盲、随机（1:1）、两组平行、安慰剂对照试验。印度西孟加拉邦加尔各答 D. N. De 顺势疗法医学院和医院门诊部。60 名糖尿病前期患者。Verum：HMPs加瑜伽疗法（YT；=30）；对照组：外观相同的安慰剂加瑜伽疗法（=30）。主要疗效终点是参与者从糖尿病前期发展为糖尿病的比例，分别在三个月和六个月后进行测量。次要结果包括空腹血糖 (FBS)、口服葡萄糖耐量试验 (OGTT)、糖化血红蛋白百分比 (HbA1c%)、血脂概况、肝酶（丙氨酸转氨酶、天门冬氨酸转氨酶）、尿素和肌酐，以及衡量自身医疗结果档案 2 版 (MYMOP-2)；所有这些都是在 3 个月和 6 个月后测量的。从糖尿病前期患者转为糖尿病患者（/ = 糖尿病患者， = 糖尿病前期患者）的比例，verum 组明显低于对照组：HbA1C%（第 3 个月：verum - 2/30 对对照组 - 11/30, = 0.003；第 6 个月：3/30 对 2/30，= 0.008），OGTT（第 3 个月：0/30 对 8/30，= 0.015；第 6 个月：0/30 对 1/30，= 0.008），但根据 FBS（第 3 个月：1/30 对 1/30，= 0.779；第 6 个月：1/30 对 3/30，= 0.469）则没有。一些次要结果也显示，维鲁姆组比安慰剂组有明显改善：HbA1C%（< 0.001）、OGTT（= 0.001）、血清 ALT（= 0.031）、肌酐（= 0.012）和 MYMOP-2 资料评分（< 0.001）。在这些指标中，HMPs 是最常用的药物。因此，HMPs 的疗效优于安慰剂，成功地防止了糖尿病前期向糖尿病的发展。临床试验登记--印度 CTRI/2022/04/042,026；UTN：U1111-1277-0021

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来源期刊

Explore-The Journal of Science and Healing 医学-全科医学与补充医学

CiteScore

3.00

自引率

8.30%

发文量

179

审稿时长

25 days

期刊介绍： EXPLORE: The Journal of Science & Healing addresses the scientific principles behind, and applications of, evidence-based healing practices from a wide variety of sources, including conventional, alternative, and cross-cultural medicine. It is an interdisciplinary journal that explores the healing arts, consciousness, spirituality, eco-environmental issues, and basic science as all these fields relate to health.