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. To study the efficacy of individualized homeopathic medicinal products (HMPs) against placebos in preventing the progression from pre-diabetes to diabetes. Six-month, double-blind, randomized (1:1), two parallel arms, placebo-controlled trial. Outpatient departments of D. N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India. Sixty participants with pre-diabetes. Verum: HMPs plus yoga therapy (YT; = 30); control: identical-looking placebos plus YT ( = 30). 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. The proportion of participants converted from pre-diabetics to diabetics (/ = diabetics, = prediabetics) was significantly less in the verum group than control: HbA1C% (month 3: verum – 2/30 versus control – 11/30, = 0.003; month 6: 3/30 vs. 2/30, = 0.008), OGTT (month 3: 0/30 vs. 8/30, = 0.015; month 6: 0/30 vs. 1/30, = 0.008), but not according to FBS (month 3: 1/30 vs. 1/30, = 0.779; month 6: 1/30 vs. 3/30, = 0.469). Several secondary outcomes also revealed significant improvements in the verum group than in placebo: HbA1C% ( < 0.001), OGTT ( = 0.001), serum ALT ( = 0.031), creatinine ( = 0.012), and MYMOP-2 profile scores ( < 0.001). , and were the most frequently indicated medicines. Thus, HMPs outperformed placebos by successfully preventing the progression of pre-diabetes to diabetes. Clinical Trials Registry – India CTRI/2022/04/042,026; UTN: U1111–1277–0021

中文翻译：

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个体化顺势疗法药物预防糖尿病前期进展为糖尿病：一项双盲、随机、安慰剂对照、平行臂试验

糖尿病前期是世界范围内的一个重大公共卫生问题。印度从糖尿病前期进展为糖尿病的比率非常高，每年每千人中有 75-78 人患有糖尿病。研究个体化顺势疗法药品 (HMP) 相对于安慰剂在预防糖尿病前期进展为糖尿病方面的功效。为期六个月、双盲、随机 (1:1)、两个平行臂、安慰剂对照试验。印度西孟加拉邦加尔各答 DN De 同种疗法医学院和医院门诊部。六十名患有糖尿病前期的参与者。 Verum：HMP 加上瑜伽疗法（YT；= 30）；对照：外观相同的安慰剂加 YT (= 30)。主要疗效终点是三个月和六个月后测量的从糖尿病前期进展为糖尿病的参与者比例。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、肝酶（丙氨酸转氨酶、天冬氨酸转氨酶）、尿素和肌酐以及自我测量医疗结果概况版本 2（MYMOP-2）；均在 3 个月和 6 个月后测量。 Verum 组中从糖尿病前期患者转变为糖尿病患者（/ = 糖尿病患者，= 糖尿病前期患者）的参与者比例显着低于对照组：HbA1C%（第 3 个月：verum – 2/30 对比对照组 – 11/30，= 0.003；第 6 个月：3/30 与 2/30，= 0.008），OGTT（第 3 个月：0/30 与 8/30，= 0.015；第 6 个月：0/30 与 1/30，= 0.008），但是不根据 FBS（第 3 个月：1/30 与 1/30，= 0.779；第 6 个月：1/30 与 3/30，= 0.469）。几个次要结果还显示，Verum 组比安慰剂组有显着改善：HbA1C% ( < 0.001)、OGTT ( = 0.001)、血清 ALT ( = 0.031)、肌酐 ( = 0.012) 和 MYMOP-2 评分 ( < 0.001) ）。 ，并且是最常用的药物。因此，HMP 成功预防糖尿病前期进展为糖尿病，其效果优于安慰剂。临床试验注册中心 – 印度 CTRI/2022/04/042,026； UTN：U1111–1277–0021