Individualized Homeopathic Medicines as Adjunctive Treatment of Pediatric Epilepsy: A Double-Blind, Randomized, Placebo-Controlled Trial.

INTRODUCTION: Epilepsy, one of the most common neurological diseases, contributes to 0.5% of the total disease burden. The burden is highest in sub-Saharan Africa, central Asia, central and Andean Latin America, and south-east Asia. Asian countries report an overall prevalence of 6/1,000 and that in India of 5.59/1,000. We examined whether individualized homeopathic medicines (IHMs) can produce a significantly different effect from placebos in treatment of pediatric epilepsy in the context of ongoing standard care (SC) using anti-epileptic drugs (AEDs). METHODS: The study was a 6-month, double-blind, randomized, placebo-controlled trial (n = 60) conducted at the pediatric outpatient department of a homeopathic hospital in West Bengal, India. Patients were randomized to receive either IHMs plus SC (n = 30) or identical-looking placebos plus SC (n = 30). The primary outcome measure was the Hague Seizure Severity Scale (HASS); secondary outcomes were the Quality of Life in Childhood Epilepsy (QOLCE-16) and the Pediatric Quality of Life inventory (PedsQL) questionnaires; all were measured at baseline and after the 3rd and 6th month of intervention. The intention-to-treat sample was analyzed to detect group differences and effect sizes. RESULTS: Recruitment and retention rates were 65.2% and 91.7% respectively. Although improvements were greater in the IHMs group than with placebos, with small to medium effect sizes, the inter-group differences were statistically non-significant - for HASS (F 1, 58 = 0.000, p = 1.000, two-way repeated measures analysis of variance), QOLCE-16 (F 1, 58 = 1.428, p = 0.237), PedsQL (2-4 years) (F 1, 8 = 0.685, p = 0.432) and PedsQL (5-18 years) (F 1, 47 = 0.000, p = 0.995). Calcarea carbonica, Ignatia amara, Natrum muriaticum and Phosphorus were the most frequently prescribed medicines. No serious adverse events were reported from either of the two groups. CONCLUSION: Improvements in the outcome measures were statistically non-significantly greater in the IHMs group than in the placebos group, with small effect sizes. A different trial design and prescribing approach might work better in future trials. TRIAL REGISTRATION: CTRI/2018/10/016027.

Efficacy of Individualized Homeopathic Medicines in the Treatment of Cervical Spondylosis: A 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-month, 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 the 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 IHM group than the placebo group, but group differences were statistically nonsignificant 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 IHM 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 nonsignificant direction of effect was elicited favoring IHMs against placebos in the treatment of CS.

Efficacy of Individualized Homeopathic Medicines in Treatment of Acne Vulgaris: A Double-Blind, Randomized, Placebo-Controlled Trial.

BACKGROUND: Acne is estimated to affect 9.4% of the global population, making it the 8th most prevalent disease worldwide. Acne vulgaris (AV) is among the diseases that directly affect quality of life. This trial evaluated the efficacy of individualized homeopathic medicines (IHM) against placebo in AV. METHODS: In this double-blind, randomized, placebo-controlled trial conducted at the National Institute of Homoeopathy, India, 126 patients suffering from AV were randomized in a 1:1 ratio to receive either IHM (verum) in centesimal potencies or identical-looking placebo (control). The primary outcome measure was the Global Acne Grading System score; secondary outcomes were the Cardiff Acne Disability Index and Dermatology Life Quality Index questionnaires - all measured at baseline and 3 months after the intervention. Group differences and effect sizes (Cohen's d) were calculated on the intention-to-treat sample. RESULTS: Overall, improvements were greater in the IHM group than placebo, with small to medium effect sizes after 3 months of intervention; however, the inter-group differences were statistically non-significant. Sulphur (17.5%), Natrum muriaticum (15.1%), Calcarea phosphorica (14.3%), Pulsatilla nigricans (10.3%), and Antimonium crudum (7.1%) were the most frequently prescribed medicines; Pulsatilla nigricans, Tuberculinum bovinum and Natrum muriaticum were the most effective of those used. No harms, unintended effects, homeopathic aggravations or any serious adverse events were reported from either group. CONCLUSION: There was non-significant direction of effect favoring homeopathy against placebo in the treatment of AV. TRIAL REGISTRATION: CTRI/2018/11/016248; UTN: U1111-1221-8164.