A double-blind, randomized, placebo-controlled study assessing polarity-analysis-guided individualized homeopathic therapy for chronic primary heel pain in adults.

This double-blind, randomized, placebo-controlled trial (n=74, 2:1 allocation) evaluated polarity analysis-guided individualized homeopathic medicines (IHMs) versus placebo over 3 months in adults with chronic primary heel pain, using Foot Function Index (FFI) total score as primary outcome and MYMOP-2 as secondary, revealing monotonic FFI improvement in IHMs versus flat placebo trajectories (FDA divergence by week 3; p<0.001), placebo ending 29.9 points higher (GEE; p<0.001), 100% Bayesian superiority probability (slope difference 16.06), 100% responder rates (MCID ≥7; OR=741, NNT=1.1; AUC difference -96.7; p<0.001), robust across subgroups/sensitivity analyses via MLMM/GEE, confirming PA-guided IHMs as safe, rapidly effective therapy warranting larger confirmatory trials.

本项双盲、随机安慰剂对照试验（样本量n=74，分配比例2:1）针对慢性原发性足跟痛成人患者开展了为期3个月的随访研究，对比极性分析指导的个体化顺势疗法药物（individualized homeopathic medicines, IHMs）与安慰剂的治疗效果。该试验以足部功能指数（Foot Function Index, FFI）总分为主要结局指标，以MYMOP-2量表为次要结局指标。结果显示，IHMs组患者的FFI评分呈单调改善趋势，而安慰剂组评分轨迹趋于平缓；经功能数据分析（Functional Data Analysis, FDA）显示，两组于第3周出现组间差异（p<0.001），试验结束时安慰剂组FFI总分较IHMs组高29.9分（广义估计方程（Generalized Estimating Equations, GEE）分析，p<0.001）；贝叶斯优效概率达100%（斜率差值为16.06）；IHMs组应答率达100%（最小临床重要差异（Minimal Clinically Important Difference, MCID）≥7；比值比（Odds Ratio, OR）=741，需治疗人数（Number Needed to Treat, NNT）=1.1；曲线下面积（Area Under the Curve, AUC）差值为-96.7，p<0.001）。上述结果在亚组分析与敏感性分析中均保持稳健，经多层线性混合模型（Multilevel Linear Mixed Models, MLMM）与GEE验证，证实极性分析指导的IHMs是一种安全、快速起效的治疗方案，有待开展更大规模的确证性试验进一步验证。