A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy of Individualized Homeopathic Medicines in Pre-diabetes.

BACKGROUND: Pre-diabetes (PD) contributes importantly to the disease burden worldwide and is a precursor to stroke, cardiovascular diseases, as well as type-2 diabetes mellitus. OBJECTIVE: In this project, the efficacy of individualized homeopathic medicines (IHMs) was explored against placebos in the treatment of PD. METHODS: A 6-month, double-blind, randomized, placebo-controlled trial was conducted at the outpatient departments of a homeopathic medical college and hospital in India. Sixty participants with PD were randomized to receive either IHMs (n = 30) or identical-looking placebos (n = 30). Concomitant care measures were advised to both groups of participants in terms of dietary advice, yoga, meditation and exercise. The primary outcome measures were fasting blood sugar (FBS) and the oral glucose tolerance test (OGTT); the secondary outcome was the Diabetes Symptom Checklist-Revised (DSC-R) score. All the outcomes were measured at baseline and after 3 and 6 months of treatment. Inter-group differences and effect sizes (Cohen's d) were calculated using two-way repeated measures analysis of variance models after adjusting baseline differences using analysis of co-variance on the intention-to-treat data. RESULTS: Between-group differences for FBS were statistically significant, favoring IHMs against placebos (F 1,58 = 7.798, p = 0.007), but not for OGTT (F 1,58 = 1.691, p = 0.199). The secondary outcome, DSC-R total score, favoring IHMs significantly compared with placebos (F 1,58 = 15.752, p < 0.001). Calcarea Carbonicum, Thuja occidentalis and Sulphur were the most frequently prescribed medicines. No harm or serious adverse events were recorded from either of the participant groups. CONCLUSION: IHMs produced significantly better results than placebos in FBS and in DSC-R scores but not in OGTT. Independent replications with larger sample sizes are warranted to substantiate the findings. TRIAL REGISTRATION: CTRI/2019/10/021711.

Double-Blind, Randomized, Placebo-Controlled Trial of Individualized Homeopathic Medicines in Atopic Dermatitis in Adults: A Replication Trial with 6 Months' Follow-up.

BACKGROUND: Atopic dermatitis (AD) is a chronic relapsing and remitting inflammatory skin disease that can have a significant impact on quality of life. During the last four decades, a rising trend in AD has been observed in India. Homeopathic medicines are claimed to be beneficial in AD; however, convincing research evidence has been lacking. We compared the efficacy of individualized homeopathic medicines (IHMs) against placebos in the treatment of AD. METHODS: In this double-blind, randomized, placebo-controlled trial of 6 months' duration (n = 60), adult patients were randomized to receive either IHMs (n = 30) or identical-looking placebos (n = 30). All participants received concomitant conventional care, which included the application of olive oil and maintaining local hygiene. The primary outcome measure was disease severity using the Patient-Oriented Scoring of Atopic Dermatitis (PO-SCORAD) scale; secondary outcomes were the Atopic Dermatitis Burden Scale for Adults (ADBSA) and Dermatological Life Quality Index (DLQI) - all were measured at baseline and every month, up to 6 months. Group differences were calculated on the intention-to-treat sample. RESULTS: After 6 months of intervention, inter-group differences became statistically significant on PO-SCORAD, the primary outcome (-18.1; 95% confidence interval, -24.0 to -12.2), favoring IHMs against placebos (F 1, 52 = 14.735; p <0.001; two-way repeated measures analysis of variance). Inter-group differences for the secondary outcomes favored homeopathy, but were overall statistically non-significant (ADBSA: F 1, 52 = 0.019; p = 0.891; DLQI: F 1, 52 = 0.692; p = 0.409). CONCLUSION: IHMs performed significantly better than placebos in reducing the severity of AD in adults, though the medicines had no overall significant impact on AD burden or DLQI.

Efficacy of individualized homeopathic medicines in irritable bowel syndrome: A double-blind randomized, placebo-controlled trial.

CONTEXT: Gastrointestinal ailments are some of the common conditions treated in homeopathy; yet only a few trials have explored the effects of individualized homeopathic medicines (IHMs) for irritable bowel syndrome (IBS). OBJECTIVE: To explore the efficacy of IHMs in treatment of IBS. DESIGN: Double-blind, randomized, placebo-controlled trial. SETTING: Outpatient departments of Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, India. PATIENTS: Sixty patients suffering from IBS; randomized to receive either IHMs (n = 30) or identical-looking placebo (n = 30). INTERVENTIONS: IHMs or placebo in the mutual context of concomitant care in terms of dietary advice, yoga, meditation and exercises. MAIN OUTCOME MEASURES: Primary - IBS quality of life (IBS-QOL) questionnaire; secondary -IBS severity scoring system (IBS-SSS) and EQ-5D-5L scores; all measured at baseline and every month, up to 3 months. RESULTS: Group differences and effect sizes (Cohen's d) were calculated on intention-to-treat (ITT) sample. Groups were comparable at baseline. Recruitment, retention and attrition rates were 64.5%, 91.7% and 8.3% respectively. Group differences in IBS-QOL total scores, IBS-SSS, EQ-5D-5L scores favored IHMs against placebo overall and at all the time points (all P < 0.001). Pulsatilla nigricans (n = 4, 6.7%) and Thuja occidentalis (n = 4, 6.7%) were the most frequently prescribed medicines. Barring some minor events unrelated to interventions, no harms or serious adverse events were recorded in either of the groups. Thus, IHMs acted significantly better than placebos in the treatment of IBS. Independent replications are warranted. [Trial registration: CTRI/2019/10/021632].

Efficacy of Individualized Homeopathic Medicines in the Treatment of Menopausal Syndrome: Double-Blind, Randomized, Placebo-Controlled Trial.

Objectives: Menopausal symptoms are systemic symptoms that are associated with estrogen deficiency after menopause. Although widely practiced, homeopathy remains under-researched in menopausal syndrome in terms of quality evidence, especially in randomized trials. The efficacy of individualized homeopathic medicines (IHMs) was evaluated in this trial against placebos in the treatment of the menopausal syndrome. Design: Double-blind, randomized (1:1), two parallel arms, placebo-controlled trial. Setting: Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Howrah, West Bengal, India. Subjects: Sixty women with menopausal syndrome. Interventions: Group 1 (n = 30; IHMs plus concomitant care; verum) versus group 2 (n = 30; placebos plus concomitant care; control). Outcome measures: Primary-the Greene climacteric scale (GCS) total score and menopause rating scale (MRS) total score, and secondary-the Utian quality of life (UQOL) total score; all of them were measured at baseline and every month up to 3 months. Results: Intention-to-treat sample (n = 60) was analyzed. Group differences were examined by two-way (split-half) repeated-measure analysis of variance, primarily taking into account all the estimates measured at monthly intervals, and secondarily, by unpaired t tests comparing the estimates obtained individually every month. The level of significance was set at p < 0.025 two-tailed. Between-group differences were nonsignificant statistically-GCS total score (F1, 58 = 1.372, p = 0.246), MRS total score (F1, 58 = 0.720, p = 0.4), and UQOL total scores (F1, 58 = 2.903, p = 0.094). Some of the subscales preferred IHMs significantly against placebos-for example, MRS somatic subscale (F1, 56 = 0.466, p < 0.001), UQOL occupational subscale (F1, 58 = 4.865, p = 0.031), and UQOL health subscale (F1, 58 = 4.971, p = 0.030). Sulfur and Sepia succus were the most frequently prescribed medicines. No harm or serious adverse events were reported from either group. Conclusions: Although the primary analysis failed to demonstrate clearly that the treatment was effective beyond placebo, some significant benefits of IHMs over placebo could still be detected in some of the subscales in the secondary analysis. Clinical trial registration number: CTRI/2019/10/021634.