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