Development of a Prognostic Factor Prediction Model in Patients with Musculoskeletal Pain Treated with Homeopathy: An Individual Patient Data Meta-Analysis of Three Randomized Clinical Trials

Abstract

&lt;b&gt;&lt;i&gt;Background:&lt;/i&gt;&lt;/b&gt; Prognostic factor research methodology has not yet been applied to randomized clinical trial data of homeopathic medicines. &lt;b&gt;&lt;i&gt;Objectives:&lt;/i&gt;&lt;/b&gt; To investigate the principle of individualization in homeopathy by developing a prognostic factor prediction model. &lt;b&gt;&lt;i&gt;Method:&lt;/i&gt;&lt;/b&gt; A pooled, in­dividual patient data meta-analysis of 3 randomized trials ­investigating the efficacy of a homeopathic gel (Spiroflor SRL®) containing &lt;i&gt;Rhus toxicodendron&lt;/i&gt; as a key ingredient in osteoarthritis of the knee and acute low back pain. The prognostic value of a predefined set of 5 typical &lt;i&gt;R. toxicodendron&lt;/i&gt; symptoms was investigated by assessing treatment-by-symptom interactions on pain as an outcome measure in a regression model. &lt;b&gt;&lt;i&gt;Results:&lt;/i&gt;&lt;/b&gt; The pooled dataset consisted of 284 patients in the Spiroflor SRL group and 275 patients in the control group. Adjusted for pain at baseline, a statistically significant effect modification for the symptoms “numbness or tingling of the affected part” (+2.0 mm VAS; &lt;i&gt;p&lt;/i&gt; = 0.02), “amelioration by movement” (–5.6 mm VAS; &lt;i&gt;p&lt;/i&gt; = 0.01), and “amelioration of pain by local heat” (+7.0 mm VAS; &lt;i&gt;p&lt;/i&gt; = 0.02) was found. &lt;b&gt;&lt;i&gt;Conclusions:&lt;/i&gt;&lt;/b&gt; Investigating aspects of treatment individualization in homeopathy using randomized trial data and standard meta-analytical techniques is possible. The symptom amelioration by local heat is of possible value as a homeopathic symptom (prognostic factor) predicting an increased likelihood of pain relief following treatment with the homeopathic product. </jats:p