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.

Individualized Homeopathic Medicines for Low Back Pain in Lumbar Spondylosis: Double-Blind, Randomized, Placebo-Controlled Trial.

INTRODUCTION: Lumbar spondylosis (LS) is a degenerative disorder of the lumbar spine. Despite substantial research efforts, no gold-standard treatment for LS has been identified. The efficacy of individualized homeopathic medicines (IHMs) in LS has remained under-researched. In this study, the efficacy of IHMs was compared with identical-looking placebos in the treatment of low back pain associated with LS. METHODS: A double-blind, randomized (1:1), placebo-controlled trial was conducted at the National Institute of Homoeopathy, West Bengal, India. Patients were randomized to receive IHMs or placebos, along with standardized concomitant care for both the groups. The Oswestry low back pain and disability questionnaire (ODQ) was the primary outcome; the Roland-Morris questionnaire (RMQ) and the short form of the McGill pain questionnaire (SF-MPQ) were the secondary outcomes. Each was measured at baseline and every month for 3 months. The intention-to-treat (ITT) sample was analyzed to detect any inter-group differences using two-way repeated measures analysis of variance models overall and by unpaired t-tests at different time points. RESULTS: Enrolment was stopped prematurely because of time restrictions; 55 patients were randomized (verum: 28; control: 27); 49 were analyzed by ITT (verum: 26; control: 23). Inter-group differences in ODQ (F 1, 47 = 0.001, p = 0.977), RMQ (F 1, 47 = 0.190, p = 0.665) and SF-MPQ total score (F 1, 47 = 3.183, p = 0.081) at 3 months were not statistically significant. SF-MPQ total score after 2 months (p = 0.030) revealed inter-group statistical significance, favoring IHMs against placebos. Some of the SF-MPQ sub-scales at different time points were also statistically significant: e.g., the SF-MPQ average pain score after 2 months (p = 0.002) and 3 months (p = 0.007). Rhus toxicodendron, Sulphur and Pulsatilla nigricans were the most frequently indicated medicines. CONCLUSION: Owing to failure in detecting a statistically significant effect for the primary outcome and in recruiting a sufficient number of participants, our trial remained inconclusive. TRIAL REGISTRATION: CTRI/2019/11/021918.

Efficacy of Individualized Homeopathic Medicines in Plantar Fasciitis: Double-blind, Randomized, Placebo-Controlled Clinical Trial.

INTRODUCTION: Plantar fasciitis (PF) is a chronic degenerative condition causing marked thickening and fibrosis of the plantar fascia, and collagen necrosis, chondroid metaplasia and calcification. There is little convincing evidence in support of various approaches, including homeopathy, for treating PF. This study was undertaken to examine the efficacy of individualized homeopathic medicines (IHMs) compared with placebo in the treatment of PF. METHODS: A double-blind, randomized, placebo-controlled trial was conducted at the outpatient departments of Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, West Bengal, India. Patients were randomized to receive either IHMs or identical-looking placebo in the mutual context of conservative non-medicinal management. The Foot Function Index (FFI) questionnaire, as an outcome measure, was administered at baseline, and every month, up to 3 months. Group differences (unpaired t-tests) and effect sizes (Cohen's d) were calculated on an intention-to-treat sample. The sample was analyzed statistically after adjusting for baseline differences. RESULTS: The target sample size was 128; however, only 75 could be enrolled (IHMs: 37; Placebo: 38). Attrition rate was 9.3% (IHMs: 4, Placebo: 3). Differences between groups in total FFI% score favored IHMs against placebo at all the time points, with large effect sizes: month 1 (mean difference, -10.0; 95% confidence interval [CI], -15.7 to -4.2; p = 0.001; d = 0.8); month 2 (mean difference, -14.3; 95% CI, -20.4 to -8.2; p <0.001; d = 1.1); and month 3 (mean difference, -23.3; 95% CI, -30.5 to -16.2; p <0.001; d = 1.5). Similar significant results were also observed on three FFI sub-scales (pain%, disability%, and activity limitation%). Natrum muriaticum (n = 14; 18.7%) and Rhus toxicodendron and Ruta graveolens (n = 11 each; 14.7%) were the most frequently prescribed medicines. No harms, serious adverse events, or intercurrent illnesses were recorded in either of the groups. CONCLUSION: IHMs acted significantly better than placebo in the treatment of PF; however, the trial being underpowered, the results should be interpreted as preliminary only. Independent replications are warranted. TRIAL REGISTRATION: CTRI/2018/10/016014.

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.

Individualized Homeopathic Medicines in Chronic Rhinosinusitis: Randomized, Double-Blind, Placebo-Controlled Trial.

BACKGROUND: Chronic rhinosinusitis (CRS) is a common disorder, with up to an estimated 134 million Indian sufferers, and having significant impact on quality of life (QOL) and health costs. Despite the evidence favoring homeopathy in CRS being inadequate, it is highly popular. This trial attempts to study the efficacy of individualized homeopathy (IH) medicines in comparison with placebo in patients with CRS. METHODS: A double-blind, randomized (1:1), placebo-controlled, preliminary trial (n = 62) was conducted at the National Institute of Homoeopathy, West Bengal, India. Primary outcome measure was the sino-nasal outcome test-20 (SNOT-20) questionnaire; secondary outcomes were the EQ-5D-5L questionnaire and EQ-5D-5L visual analog scale scores, and five numeric rating scales (0-10) assessing intensity of sneezing, rhinorrhea, post-nasal drip, facial pain/pressure, and disturbance in sense of smell, all measured at baseline and after the 2nd and 4th months of intervention. Group differences and effect sizes (Cohen's d) were calculated on the intention-to-treat sample. RESULTS: Groups were comparable at baseline. Attrition rate was 6.5% (IH: 1, Placebo: 3). Although improvements in both primary and secondary outcome measures were higher in the IH group than placebo, with small to medium effect sizes, the group differences were statistically non-significant (all p > 0.05, unpaired t-tests). Calcarea carbonica, Lycopodium clavatum, Sulphur, Natrum muriaticum and Pulsatilla nigricans were the most frequently prescribed medicines. No harmful or unintended effects, homeopathic aggravations or any serious adverse events were reported from either group. CONCLUSION: There was a small but non-significant direction of effect favoring homeopathy, which ultimately renders the trial as inconclusive. Rigorous trials and independent replications are recommended to arrive at a confirmatory conclusion. [Trial registration: CTRI/2018/03/012557; UTN: U1111-1210-7201].

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.

Individualized Homeopathic Medicines in Treatment of Vitiligo: Double-Blind, Randomized, Placebo-Controlled Pilot Trial.

Objective: The feasibility of a definitive trial was tested to evaluate individualized homeopathic medicines (IHMs) for the treatment of vitiligo. Design: This was a double-blind randomized (1:1) placebo-controlled pilot trial conducted at the National Institute Homeopathy, India. Sixty patients with vitiligo were included in the study. Interventions: IHMs and identical-looking placebos at 50-millesimal (LM) potencies. Outcome measures: Feasibility issues and scores from the Vitiligo Area Scoring Index (VASI), Vitiligo-specific Quality-of-life instrument (VitiQoL), and Dermatology Life Quality Index (DLQI) were measured at baseline and after 3 and 6 months. Results: The recruitment and retention rates were satisfactory. Mean reductions in the outcome measures were higher in the IHM group than placebo. Conclusions: Definitive efficacy trials are warranted. Clinical Trials Registry-India: CTRI/2018/10/016160; secondary identifier UTN: U1111-1221-7704.

Efficacy of Individualized Homeopathic Medicines in the Treatment of Atopic Dermatitis in Adults: A Double-Blind, Randomized, Placebo-Controlled, Preliminary Trial.

INTRODUCTION: Individualized homeopathy (IH) in atopic dermatitis (AD) remained under-researched. OBJECTIVE: We aimed at evaluating efficacy of IH in AD. METHODS: A double-blind, randomized, placebo-controlled, short-term, preliminary trial was conducted in an Indian homeopathy hospital. Patients were randomized to either IH (n = 30) or identical-looking placebo (n = 30) using computerized randomization and allocation. Outcomes were patient-oriented scoring of AD (PO-SCORAD; primary end point), Dermatological Life Quality Index (DLQI) score, and AD burden score for adults (ADBSA; secondary end points), measured monthly for 3 months. An intention-to-treat sample was analyzed after adjusting baseline differences. RESULTS: On PO-SCORAD, improvement was higher in IH against placebo, but nonsignificant statistically (pmonth 1 = 0.433, pmonth 2 = 0.442, pmonth 3 = 0.229). Secondary outcomes were also nonsignificant - both DLQI and ADBSA (p > 0.05). Four adverse events (diarrhea, injury, common cold) were recorded. CONCLUSIONS: There was a small, but nonsignificant direction of effect towards homeopathy, which renders the trial inconclusive. A properly powered robust trial is indicated.

Efficacy of individualized homeopathic medicines in intervening with the progression of pre-hypertension to hypertension: A double-blind, randomized, placebo-controlled trial.

CONTEXT: Pre-hypertension remains a significant public health challenge and appropriate intervention is required to stop its progression to hypertension and/or cardiovascular diseases. OBJECTIVE: To study the effects of individualized homeopathic medicines (IH) against placebo in intervening with the progression of pre-hypertension to hypertension. DESIGN: Double-blind, randomized, two parallel arms, placebo-controlled trial. SETTING: Outpatient departments of D. N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India. PATIENTS: Ninety-two patients suffering from pre-hypertension; randomized to receive either IH (n = 46) or identical-looking placebo (n = 46). INTERVENTIONS: IH or placebo in the mutual context of lifestyle modification (LSM) advices including dietary approaches to stop hypertension (DASH) and brisk exercises. MAIN OUTCOME MEASURES: Primary - systolic and diastolic blood pressure (SBP and DBP); secondary - Measure Yourself Medical Outcome Profile version 2.0 (MYMOP-2) scores; all measured at baseline, and every month, up to 3 months. RESULTS: After 3 months of intervention, the number of patients having progression from pre-hypertension to hypertension between groups were similar without any significant differences in between (all P>0.05). Reduction in BP and MYMOP-2 scores were non-significantly higher (all P>0.05) in the IH group than placebo with small effect sizes. Lycopodium clavatum, Thuja occidentalis and Natrum muriaticum were the most frequently prescribed medicines. No harms or serious adverse events were reported from either group. Thus, there was a small, but non-significant direction of effect favoring homeopathy, which ultimately rendered the trial as inconclusive. [Trial registration: CTRI/2018/10/016,026; UTN: U1111-1221-8251].

Individualized Homeopathic Medicines in Stage I Essential Hypertension: A Double-Blind, Randomized, Placebo-Controlled Pilot Trial.

Objective: The present study assessed the feasibility of a definitive placebo-controlled trial for evaluating individualized homeopathy (IH) in stage I hypertension (HTN). Design: Double-blind, randomized (IH: 34, placebo: 34), placebo-controlled, parallel arms, pilot trial. Settings/Location: National Institute of Homoeopathy, India. Subjects: Patients suffering from stage I HTN. Interventions: IH and identical-looking placebo. Outcome measures: Feasibility issues, blood pressure (BP) and Measure Yourself Medical Outcome Profile-2 (MYMOP-2) were assessed for 6 months. Results: The recruitment and retention rates were 44.4% and 85.3%, respectively. Group differences were seemingly higher in the IH group than in the placebo group. Conclusions: Despite challenges in recruitment, an adequately powered efficacy trial appears feasible in the future.

Individualized Homeopathic Medicines in the Treatment of Generalized Anxiety Disorder: A Double-Blind, Randomized, Placebo-Controlled, Pilot Trial.

INTRODUCTION: Evidence favoring homeopathy in generalized anxiety disorder (GAD) remains scarce. The objective of this pilot trial was to test feasibility of a definitive trial in future. We also experimented whether individualized homeopathic medicines (IH) plus psychological counseling (PC) can produce significantly different effects beyond placebo plus PC in the treatment of GAD. METHODS: A double-blind, randomized, placebo-controlled, parallel arm, pilot trial was conducted on 62 GAD patients at the National Institute of Homoeopathy, India. GAD-7 questionnaire and Hamilton Anxiety Scale (HAM-A) were used as the primary and secondary outcomes, respectively, measured at baseline and 3 months. Patients received either IH plus PC (n = 31) or identical-looking placebo plus PC (n = 31). Intention-to-treat sample was analyzed to detect group differences using unpaired t tests. RESULTS: Recruitment and retention rates were 56 and 90%, respectively. Mean age was 31.5 years; 56.5% were male. GAD-7 reductions were non-significantly higher in IH than placebo (p = 0.122). Group differences on HAM-A favored IH significantly (p = 0.018). Effect sizes were small to medium. Calcarea carbonica was the most frequently indicated medicine. No serious adverse events happened. CONCLUSIONS: A small but positive direction of anxiolytic effect was observed favoring homeopathy over placebo. A definitive trial appeared feasible in future.

Efficacy of individualized homeopathic treatment of insomnia: Double-blind, randomized, placebo-controlled clinical trial.

BACKGROUND: Insomnia is the most common sleep-related complaint associated with impaired day-time functioning, reduced quality of life, increased morbidity and substantial societal cost. We evaluated whether individualized homeopathy (IH) could produce significant effect beyond placebo in treatment of insomnia. METHODS: In this double-blind, randomized, placebo-controlled, two parallel arms trial, 60 patients were randomized to receive either IH/verum or control/placebo (1:1). Patient-administered sleep diary (6 items; 1: latency to fall asleep, 2: minutes awake in middle of night, 3: minutes awake too early, 4: hours spent in bed, 5: total sleep time in hours, and 6: sleep efficiency) and Insomnia Severity Index (ISI) were taken as the primary and secondary outcomes respectively, measured at baseline, and after 3 months. RESULTS: Five patients dropped out (verum: 2, control: 3). Intention to treat sample (n = 60) was analyzed. Trial arms were comparable at baseline. In the verum group, except sleep diary item 3 (P = 0.371), rest of the outcomes improved significantly (all P < 0.01). In the control group, there were significant improvements in diary item 6 and ISI score (P < 0.01) and just significant improvement in item 5 (P = 0.018). Group differences were significant for items 4, 5 and 6 (P < 0.01) and just significant (P = 0.014) for ISI score with moderate to large effect sizes; but non-significant (P > 0.01) for rest of the outcomes. CONCLUSION: IH seemed to produce significantly better effect than placebo. Rigorous trials and independent replications are warranted.