Add-on Bach flower remedies to individualized homeopathic medicines in mild to moderate depression: An open, randomized factorial pilot trial

This pilot randomized controlled trial assessed Bach flower remedies (BFR), individualized homeopathic medicines (IHMs), and their combination against placebo in 100 adults with mild-to-moderate depression over three months, using Hamilton Depression Rating Scale (HDRS) as primary outcome and Beck Depression Inventory (BDI) as secondary, revealing significant symptom reductions in active arms (HDRS mean differences vs. placebo: IHMs -7.12, combined -6.54, BFR -5.14; all p<0.001) with 88-92% responder rates (NNT 1.1), rapid onset (40% in IHMs/combined by month 1), 100% Bayesian superiority probability, and 36.8% IHMs effect mediated via somatic relief, confirmed robust across subgroups via GEE, mixed models, and sensitivity analyses, with only seven mild transient adverse events and no serious issues, supporting these safe complementary therapies as promising adjuncts warranting larger blinded confirmatory trials.

本先导性随机对照试验针对100名轻中度抑郁症成人患者开展了为期3个月的研究，评估巴德花疗法（Bach flower remedies, BFR）、个体化顺势疗法药物（individualized homeopathic medicines, IHMs）以及二者联合疗法与安慰剂的疗效差异。试验以汉密尔顿抑郁量表（Hamilton Depression Rating Scale, HDRS）作为主要结局指标，贝克抑郁量表（Beck Depression Inventory, BDI）作为次要结局指标。结果显示，各干预组的抑郁症状均出现显著改善：与安慰剂组相比，IHMs组、联合疗法组、BFR组的汉密尔顿抑郁量表均数差分别为-7.12、-6.54、-5.14（所有p<0.001）；各组应答率达88%~92%，需治疗人数（Number Needed to Treat, NNT）为1.1；干预起效迅速，第1个月时IHMs组与联合疗法组即有40%的患者实现应答；贝叶斯优势概率为100%，且IHMs组36.8%的疗效通过躯体症状缓解实现介导。上述结果经广义估计方程（Generalized Estimating Equations, GEE）、混合效应模型及敏感性分析验证，在各亚组中均表现稳健。本试验仅发生7例轻度一过性不良事件，未出现严重不良事件，证实上述安全的补充疗法是颇具前景的辅助治疗手段，值得开展更大规模的盲法确证试验。