背景:糖尿病前期是全球范围内的重大公共卫生问题。印度从糖尿病前期发展到糖尿病的速度非常快,每年每千人75-78人。
目的:研究针对安慰剂的个体化顺势疗法药物(HMPs)预防糖尿病前期发展为糖尿病的疗效。
方法:六个月,双盲,随机化(1:1),两个平行的臂,安慰剂对照试验。
方法:D.N.De同势医学院和医院的门诊部,加尔各答,西孟加拉邦,印度。
方法:60名糖尿病前期患者。
方法:Verum:HMPs加瑜伽疗法(YT;n=30);对照:外观相同的安慰剂加YT(n=30)。
方法:主要疗效终点是参与者从糖尿病前期进展为糖尿病的比例,三个月和六个月后测量。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%),血脂谱,肝酶(丙氨酸转氨酶,天冬氨酸转氨酶),尿素和肌酐,并测量自己的医疗结果简介2版(MYMOP-2);所有测量均在3个月和6个月后进行。
结果:从糖尿病前期转变为糖尿病患者的参与者比例(n/N;n=糖尿病患者,N=糖尿病前期)在Verum组中明显低于对照组:HbA1C%(第3个月:Verum-2/30与对照组-11/30,p=0.003;第6个月:3/30与2/30,p=0.008),OGTT(月3:0/30vs.8/30,p=0.015;第6个月:0/30vs.1/30,p=0.008),但根据FBS(月3:1/30vs.1/30,p=0.779;第6个月:1/30vs.3/30,p=0.469)。几个次要结果也显示,与安慰剂组相比,verum组有显著改善:HbA1C%(p<0.001),OGTT(p=0.001),血清ALT(p=0.031),肌酐(p=0.012),和MYMOP-2概况评分(p<0.001)。硫磺,白兰地,和冬青是最常用的药物。因此,HMP通过成功预防糖尿病前期发展为糖尿病而优于安慰剂。
背景:临床试验注册-印度CTRI/2022/04/042,026;UTN:U1111-1277-0021。
BACKGROUND: 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.
METHODS: Six-month, double-blind, randomized (1:1), two parallel arms, placebo-controlled trial.
METHODS: Outpatient departments of D. N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India.
METHODS: Sixty participants with pre-diabetes.
METHODS: Verum: HMPs plus yoga therapy (YT; n = 30); control: identical-looking placebos plus YT (n = 30).
METHODS: 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.
BACKGROUND: Clinical Trials Registry - India CTRI/2022/04/042,026; UTN: U1111-1277-0021.