Supplementary Material for: Efficacy of individualized homeopathic medicines in treatment of cervical spondylosis: Double-blind, randomized, placebo-controlled trial

Introduction: Cervical spondylosis (CS) is a degenerative condition of the cervical spine, with approximately 80-90% of people suffering from disc degeneration by the age of 50 years. This trial attempts at evaluating the efficacy of individualized homeopathic medicines (IHMs) against placebos in the treatment of CS. Methods: A 3-months, double-blind, randomized, placebo-controlled trial was conducted at the Organon of Medicine outpatient department of the National Institute of Homoeopathy, India. Patients were randomized to receive either IHMs (n=70) or identical-looking placebos (n=70) in the mutual context of concomitant conservative and standard physiotherapeutic care. Primary outcome measures were 0-10 Numeric Rating Scales (NRSs) for pain, stiffness, numbness, tingling, weakness, and vertigo, and the secondary outcome was Neck Disability Index (NDI); measured at baseline and every month, until 3 months. The intention-to-treat sample was analyzed to detect group differences and effect sizes. Results: Overall, improvements were clinically significant and higher in the IHMs group than placebo, but group differences were statistically non-significant with small effect sizes (all P>0.05, two-way repeated measure analysis of variance). After 2 months of time points, improvements observed in the IHMs group were significantly higher than placebo on a few occasions (e.g., pain NRS: P<0.001; stiffness NRS: P=0.024; weakness NRS: P=0.003). Sulfur (n=21; 15%) was the most frequently prescribed medication. No harm, unintended effects, or any serious adverse events were reported from either group. Conclusions: An encouraging, but non-significant direction of effect was elicited favoring IHMs against placebos in the treatment of CS. Trial registration: CTRI/2018/10/016156; UTN: U1111-1221-8064