Individualized homeopathic medicines in preventing the progression from pre-diabetes to diabetes: A double-blind, randomized, placebo-controlled, parallel-arm trial.

CONTEXT: Pre-diabetes is a significant public health problem worldwide. India has a very high rate of progression from pre-diabetes to diabetes, 75-78 per thousand persons per year. OBJECTIVE: To study the efficacy of individualized homeopathic medicinal products (HMPs) against placebos in preventing the progression from pre-diabetes to diabetes. DESIGN: Six-month, double-blind, randomized (1:1), two parallel arms, placebo-controlled trial. SETTING: Outpatient departments of D. N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India. PATIENTS: Sixty participants with pre-diabetes. INTERVENTIONS: Verum: HMPs plus yoga therapy (YT; n = 30); control: identical-looking placebos plus YT (n = 30). MAIN OUTCOME MEASURES: The primary efficacy endpoint was the proportion of participants progressing from pre-diabetes to diabetes, measured after three and six months. Secondary outcomes comprised of fasting blood glucose (FBS), oral glucose tolerance test (OGTT), glycated hemoglobin percentage (HbA1c%), lipid profile, liver enzymes (alanine transaminase, aspartate transaminase), urea and creatinine, and Measure Yourself Medical Outcome Profile version 2 (MYMOP-2); all measured after 3 and 6 months. RESULTS: The proportion of participants converted from pre-diabetics to diabetics (n/N; n = diabetics, N = prediabetics) was significantly less in the verum group than control: HbA1C% (month 3: verum - 2/30 versus control - 11/30, p = 0.003; month 6: 3/30 vs. 2/30, p = 0.008), OGTT (month 3: 0/30 vs. 8/30, p = 0.015; month 6: 0/30 vs. 1/30, p = 0.008), but not according to FBS (month 3: 1/30 vs. 1/30, p = 0.779; month 6: 1/30 vs. 3/30, p = 0.469). Several secondary outcomes also revealed significant improvements in the verum group than in placebo: HbA1C% (p < 0.001), OGTT (p = 0.001), serum ALT (p = 0.031), creatinine (p = 0.012), and MYMOP-2 profile scores (p < 0.001). Sulphur, Bryonia alba, and Thuja occidentalis were the most frequently indicated medicines. Thus, HMPs outperformed placebos by successfully preventing the progression of pre-diabetes to diabetes. TRIAL REGISTRATION: Clinical Trials Registry - India CTRI/2022/04/042,026; UTN: U1111-1277-0021.

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

Objectives: Sciatica is a debilitating condition that causes pain in its distribution or in the lumbosacral nerve root that is connected to it. Although there are claims that homeopathy can reduce sciatica pain, systematic scientific proof is currently lacking. The objective of the trial was to determine whether individualized homeopathic medicines (IHMs) were as effective as identical-looking placebos in treating sciatica pain. Design: This is a double-blind, randomized (1:1), two parallel arms, placebo-controlled trial. Setting: The study was conducted at Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Howrah, West Bengal, India. Subjects: Sixty participants with sciatica pain were included in this study. Interventions: Verum (n = 30; IHMs plus concomitant care) versus control (n = 30; placebos plus concomitant care). Outcome measures: Primary-Sciatica Bothersome Index (SBI) and Sciatica Frequency Index (SFI) scores and secondary-Roland Morris Pain and Disability Questionnaire (RMPDQ), Short Form McGill Pain Questionnaire (SF-MPQ), and Oswestry Low Back Pain Questionnaire (OLBPQ) scores: 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 accounting for between groups and time interactions, and additionally, by unpaired t tests comparing the estimates obtained individually every month. The level of significance was set at p < 0.025 and <0.05 two tailed for the primary and secondary outcomes, respectively. Group differences could not achieve significance in SBI (p = 0.044), SFI (p = 0.080), and RMPDQ scores (p = 0.134), but were significant for SF-MPQ (p = 0.007) and OLBPQ (p = 0.036). Gnaphalium polycephalum (n = 6; 10%) was the most frequently prescribed medicine. No harm, serious adverse events, or intercurrent illnesses were recorded in either of the groups. Conclusions: The primary outcome failed to demonstrate evidently that homeopathy was effective beyond placebo, and the trial remained inconclusive. Independent replications are warranted to confirm the findings. Clinical Trial Registration Number: CTRI/2020/10/028617.

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

Objectives: To investigate the efficacy and safety of individualized homeopathic medicines (IHMs) in treating hemorrhoids compared with placebo. Design: This is a double-blind, randomized (1:1), two parallel arms, placebo-controlled trial. Setting: The trial was conducted at the surgery outpatient department of the State National Homoeopathic Medical College and Hospital, Lucknow, Uttar Pradesh, India. Subjects: Patients were 140 women and men, aged between 18 and 65 years, with a diagnosis of primary hemorrhoids grades I-III for at least 3 months. Excluded were the patients with grade IV hemorrhoids, anal fissure, and fistula, hypertrophic anal papillae, inflammatory bowel disease, coagulation disorders, rectal malignancies, obstructed portal circulation, patients requiring immediate surgical intervention, and vulnerable samples. Interventions: Patients were randomized to Group 1 (n = 70; IHMs plus concomitant care; verum) and Group 2 (n = 70; placebos plus concomitant care; control). Outcome measures: Primary-the anorectal symptom severity and quality-of-life (ARSSQoL) questionnaire, and secondary-the EuroQol 5-dimensions 5-levels (EQ-5D-5L) questionnaire and EQ visual analogue scale (VAS); all of them were measured at baseline, and every month, up to 3 months. Results: Out of the 140 randomized patients, 122 were protocol compliant. Intention-to-treat sample (n = 140) was analyzed. The level of significance was set at p < 0.05 two tailed. Statistically significant between-group differences were elicited in the ARSSQoL total (Mann-Whitney U [MWU]: 1227.0, p < 0.001) and EQ-5D-5L VAS (MWU: 1228.0, p = 0.001) favoring homeopathy against placebos. Sulfur was the most frequently prescribed medicine. No harm or serious adverse events were reported from either of the groups. Conclusions: IHMs demonstrated superior results over placebo in the short-term treatment of hemorrhoids of grades I-III. The findings are promising, but need to be substantiated by further phase 3 trials. Clinical Trial Registration Number: CTRI/2020/03/024342.

Individualized Homeopathic Medicines in the Treatment of Post-COVID-19 Fatigue in Adults: Single-Blind, Randomized, Placebo-Controlled Trial.

INTRODUCTION: The coronavirus disease 2019 (COVID-19) is leading to unknown and unusual health conditions that are challenging to manage. Post-COVID-19 fatigue is one of those challenges, becoming increasingly common as the pandemic evolves, as it impairs the quality of life of an individual. This trial attempts to identify the preliminary evidence of the efficacy of individualized homeopathic medicines (IHMs) against placebos in the treatment of post-COVID-19 fatigue in adults. METHODS: A 3-month, single-blind, randomized, placebo-controlled, parallel-arm trial was conducted at the outpatient department of The Calcutta Homoeopathic Medical College and Hospital, India. Sixty participants were randomized in a 1:1 ratio to receive either IHMs (n = 30) or identical-looking placebos (n = 30). The primary and secondary outcome measures were the Fatigue Assessment Scale (FAS) and Outcome in Relation to Impact on Daily Living (ORIDL), respectively, measured every month, for up to 3 months. Comparative analysis was carried out on the intention-to-treat sample to detect group differences. RESULTS: Group differences in both the primary (FAS total: F1, 58 = 14.356, p < 0.001) and secondary outcomes (ORIDL: F1, 58 = 210.986, p < 0.001) after 3 months favored IHMs against placebos. Lycopodium clavatum (11.7%), sulfur (11.7%), Arsenicum album (10%), and Thuja occidentalis (10%) were the most frequently indicated medicines. No harm, unintended effects, homeopathic aggravations, or any serious adverse events were reported from either of the groups. CONCLUSION: IHMs produced significantly better effects than placebos in the treatment of post-COVID-19 fatigue in adults. Definitive robust trials may be undertaken to confirm the findings.Die Coronainfektion (COVID-19) zieht unbekannte und ungewöhnliche gesundheitliche Probleme nach sich, deren Management oft eine Herausforderung darstellt. Das gilt unter anderem für Ermüdung nach einer COVID-19-Erkrankung, die mit zunehmender Dauer der Pandemie immer häufiger auftritt und die Lebensqualität der Betroffenen beeinträchtigt. In dieser Studie wird versucht, vorläufige Belege für die Wirksamkeit individualisierter homöopathischer Mittel (IHM) im Vergleich zu Placebo zur Behandlung von Ermüdung nach COVID-19 bei Erwachsenen zu identifizieren.Eine einfach verblindete, randomisierte, placebokontrollierte Parallelgruppenstudie von 3 Monaten Dauer wurde im ambulanten Bereich des Calcutta Homoeopathic Medical College and Hospital in Indien durchgeführt. 60 Teilnehmer erhielten nach Randomisierung im Verhältnis 1:1 entweder IHM (n = 30) oder identisch aussehendes Placebo (n = 30). Die primäre und die sekundäre Zielgröße waren die Fatigue Assessment Scale (FAS) und das Outcome in Relation to Impact on Daily Living (ORIDL) für bis zu 3 Monate, jeweils monatlich gemessen. Vergleichende Analysen wurden an der Intent-to-treat-Population durchgeführt, um Unterschiede zwischen den Gruppen zu erkennen.Gruppenunterschiede bei der primären (FAS gesamt: F1, 58 = 14,356; p < 0.001) sowie der sekundären Zielgröße (ORIDL: F1, 58 = 210,986; p < 0.001) nach 3 Monaten sprachen für die IHM gegenüber Placebo. Lycopodium clavatum (11.7%), sulfur (11.7%), Arsenicum album (10%) und Thuja occidentalis (10%) waren die am häufigsten indizierten Mittel. In beiden Gruppen wurden keine Schädigungen, unbeabsichtigten Wirkungen, homöopathischen Verschlechterungen oder jegliche schwerwiegenden unerwünschten Ereignisse beobachtet.Die IHM erzielten signifikant bessere Effekte als Placebo in der Behandlung von Post-COVID-Ermüdung bei Erwachsenen. Definitive, belastbare Studien können eingeleitet werden, um diese Befunde zu bestätigen.

Individualized Homeopathic Medicines in the Treatment of Knee Osteoarthritis: Double-Blind, Randomized, Placebo-Controlled Feasibility Trial.

INTRODUCTION: This study aimed at examining the feasibility issues of comparing individualized homeopathic medicines (IHMs) with identical-looking placebos for treating knee osteoarthritis (OA). METHODS: Forty eligible patients participated in this double-blind, randomized (1:1), placebo-controlled feasibility trial in the outpatient clinics of a homeopathic hospital in West Bengal, India. Either IHMs or identical-looking placebos were administered, along with mutually agreed-upon concomitant care guidelines. The Knee Injury and Osteoarthritis Outcome Score (KOOS) was the primary outcome measure, and derived Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores from KOOS, EQ-5D-5L questionnaire, and Visual Analog Scale (VAS) were the secondary outcomes; all measured at baseline and after 2 months. Group differences and effect sizes (Cohen's d) were estimated using an intention-to-treat approach. p-Values less than 0.05 (two-tailed) were considered statistically significant. RESULTS: Enrolment/screening and trial retention rates were 43% and 85% respectively. Recruitment was difficult owing to the coronavirus disease 2019 (COVID-19) lockdown. Group differences were statistically significant, favoring IHMs against placebos in all the KOOS sub-scales: symptoms (p < 0.001), pain (p = 0.002), activities of daily living (p < 0.001), sports or recreation (p = 0.016), and quality of life (p = 0.002). Derived WOMAC scores from KOOS favored IHMs against placebos: stiffness (p < 0.001) and pain (p < 0.001). The EQ-5D-5L questionnaire score (p < 0.001) and EQ-5D-5L VAS scores (p < 0.001) also yielded significant results, favoring IHMs over placebos. All the effect sizes ranged from moderate to large. Sulphur was the most frequently prescribed homeopathic medication. Neither group reported any harm or serious adverse events. CONCLUSION: Although recruitment was sub-optimal due to prevailing COVID-19 conditions during the trial, the action of IHMs was found to be superior to that of placebos in the treatment of knee OA. Larger and more definitive studies, with independent replications, are required to substantiate the findings. TRIAL REGISTRATION: CTRI/2021/02/031453.

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 in FBS were statistically significant, favored 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.

Individualized Homeopathic Medicines in the Treatment of Psoriasis Vulgaris: Double-Blind, Randomized, Placebo-Controlled Trial.

INTRODUCTION: Psoriasis is a chronic inflammatory skin disorder, affecting the trunk and extensor surfaces of the limbs and scalp predominantly. Worldwide prevalence ranges between 0.1 and 11.4%, and in India between 0.4 and 2.8%; this creates a serious health burden. Psoriasis remains a frequently encountered condition in homeopathy practice, but there is a dearth of conclusive efficacy data supporting its use. METHODS: This 6-month, double-blind, randomized trial was conducted on 51 patients suffering from psoriasis at the National Institute of Homoeopathy, India. Patients were randomized to receive either individualized homeopathic medicines (IHMs; n = 25) in LM potencies or identical-looking placebos (n = 26). Psoriasis area and severity index (PASI; primary), psoriasis disability index (PDI), and dermatological life quality index (DLQI; secondary) were measured at baseline and every 2 months, up to 6 months. The intention-to-treat sample was analyzed using a two-way repeated measure analysis of variance. RESULTS: Although intragroup changes were significant in both groups in the outcome measures, improvements were significantly higher in the IHMs group than in placebos in PASI scores after 6 months of intervention (F1, 49 = 10.448, p = 0.002). DLQI daily activity subscale scores also yielded similar significant results favoring IHMs against placebos after 6 months (F1, 49 = 5.480, p = 0.023). Improvement in PDI total (F1, 49 = 0.063, p = 0.803), DLQI total (F1, 49 = 1.371, p = 0.247), and all remaining subscales were higher in the IHMs group than placebos after 6 months, but nonsignificant statistically. Calcarea carbonica, Mercurius solubilis, Arsenicum album, and Petroleum were the most frequently prescribed medicines. CONCLUSIONS: IHMs exhibited better results than placebos in the treatment of psoriasis. Further research is warranted.Psoriasis ist eine chronisch entzündliche Hauterkrankung, die vor allem den Körperstamm und die Streckseiten der Extremitäten sowie die Kopfhaut betrifft. Die weltweite Prävalenz liegt zwischen 0,1 und 11,4% und in Indien zwischen 0,4 und 2,8%, was sie zu einer erheblichen Belastung für das Gesundheitssystem macht. In der homöopathischen Praxis ist die Psoriasis nach wie vor häufig anzutreffen, doch mangelt es an schlüssigen Wirksamkeitsdaten, die deren Anwendung stützen.Diese sechsmonatige, doppelblinde, randomisierte Studie wurde mit 51 Psoriasis-Patienten am National Institute of Homoeopathy in Indien durchgeführt. Die Patienten erhielten randomisiert entweder individualisierte homöopathische Arzneimittel (individualized homeopathic medicines, IHMs; n = 25) in LM-Potenzen oder identisch aussehende Placebos (n = 26). Der Psoriasis Area and Severity Index (PASI; primär), der Psoriasis Disability Index (PDI) und der Dermatological Life Quality Index (DLQI; sekundär) wurden bei Baseline und anschließend alle zwei Monate für bis zu sechs Monate gemessen. Die Analyse der Intention-to-Treat-Stichprobe erfolgte mittels zweifaktorieller Varianzanalyse mit wiederholten Messungen.Zwar waren in beiden Gruppen die gruppeninternen Veränderungen bei den Zielkriterien signifikant, doch fielen die Verbesserungen der PASI-Werte nach der sechsmonatigen Intervention in der IHM-Gruppe signifikant höher aus als in der Placebogruppe (F1, 49 = 10,448, p = 0,002), und die Werte der DLQI-Subskala für die tägliche Aktivität zeigten nach 6 Monaten ähnliche signifikante Ergebnisse zugunsten der IHMs gegenüber Placebo (F1, 49 = 5,480, p = 0,023). Die Verbesserungen beim PDI-Gesamt-Score (F1, 49 = 0,063, p = 0,803), beim DLQI-Gesamt-Score (F1, 49 = 1,371, p = 0,247) und bei den anderen Subskalen waren nach 6 Monaten in der IHM-Gruppe höher als in der Placebo-Gruppe, erreichten jedoch keine statistische Signifikanz. Calcarea carbonica, Mercurius solubilis, Arsenicum album und Petroleum waren die am häufigsten verordneten Arzneimittel.Die IHMs zeigten in der Behandlung der Psoriasis bessere Ergebnisse als Placebo. Weitere Untersuchungen sind erforderlich.

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.

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.

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 treatment of post-stroke hemiparesis: A randomized trial.

BACKGROUND: Hemiparesis is a serious motor impairment following stroke and affecting around 65% of stroke patients. This trial attempts to study the efficacy of individualized homeopathic medicines (IHMs) in comparison with identical-looking placebos in treatment of post-stroke hemiparesis (PSH) in the mutual context of standard physiotherapy (SP). METHODS: A 3-months, open-label, randomized, placebo-controlled trial (n = 60) was conducted at the Organon of Medicine outpatient departments of National Institute of Homoeopathy, West Bengal, India. Patients were randomized to receive IHMs plus SP (n = 30) or identical-looking placebos plus SP (n = 30). Primary outcome measure was Medical Research Council (MRC) muscle strength grading scale; secondary outcomes were Stroke Impact Scale (SIS) version 2.0, Modified Ashworth Scale (MAS), and stroke recovery 0-100 visual analogue scale (VAS) scores; all measured at baseline and 3 months after intervention. Group differences and effect sizes (Cohen's d) were calculated on intention-to-treat sample. RESULTS: Although overall improvements were higher in the IHMs group than placebos with small to medium effect sizes, the group differences were statistically non-significant (all P>0.05, unpaired t-tests). Improvement in SIS physical problems was significantly higher in IHMs than placebos (mean difference 2.0, 95% confidence interval 0.3 to 3.8, P = 0.025, unpaired t-test). Causticum, Lachesis mutus, and Nux vomica were the most frequently prescribed medicines. No harms, 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 against placebos in treatment of post-stroke hemiparesis. TRIAL REGISTRATION: CTRI/2018/10/016196; UTN: U1111-1221-7664.

Individualized Homeopathic Medicines in Treatment of Hyperuricemia: Evaluation by Double-Blind, Randomized, Placebo-Controlled Trial.

INTRODUCTION: Hyperuricemia (HU) is a major health issue in India and across the globe. It increases the disease burden and hampers quality of life. This study was aimed at exploring the effects of individualized homeopathic medicines (IHMs) against placebo in the treatment of HU. METHODS: This double-blind, randomized, placebo-controlled trial was conducted on 60 patients suffering from HU in the outpatient department of D. N. De Homoeopathic Medical College and Hospital, Kolkata. Each patient received either IHMs or identical-looking placebos, along with advice on dietary modifications irrespective of codes. Serum uric acid (SUA) level was the primary outcome measure; the HU quality of life questionnaire (HUQLQ) and the Measure Yourself Medical Outcome Profile version 2 (MYMOP-2) were the secondary outcomes; all measured at baseline, and every month, up to 3 months. Group differences were examined by two-way (split-half) repeated-measures analysis of variance after adjusting for baseline differences. Significance level was set at p ≤0.05, two-tailed. RESULTS: The intention-to-treat sample (n = 58) was analyzed. Between-group differences in SUA levels (F 1, 56 = 13.833, p <0.001), HUQLQ scores (F 1, 56 = 32.982, p <0.001) and MYMOP-2 profile scores (F 1, 56 = 23.873, p <0.001) were statistically significant, favoring IHMs against placebos, with medium to large effect sizes. Calcarea carbonica and Pulsatilla nigricans were the most frequently prescribed medicines. No serious adverse events were reported from either of the groups. CONCLUSION: IHMs showed significantly better results than placebos in reducing SUA levels and improving quality of life in patients suffering from HU. TRIAL REGISTRATION: CTRI/2019/10/021503; UTN: U1111-1241-1431.

Individualized Homeopathic Medicines in the Treatment of Tinea Corporis: Double-Blind, Randomized, Placebo-Controlled Trial.

INTRODUCTION: Tinea corporis (TC; ringworm or dermatophytosis) is a superficial skin infection caused by Microsporum, Epidermophyton and Trichophyton genera of dermatophytes. We compared the effects of individualized homeopathic medicines (IHMs) in fifty-millesimal (LM) potencies against placebo in TC. METHODS: A double-blind, randomized, placebo-controlled, two parallel arms trial was conducted on 62 individuals suffering from TC at the National Institute of Homoeopathy, India. Participants were randomized in a 1:1 ratio to receive either IHMs in LM potencies or identical-looking placebos for a period of 3 months. The primary outcome measure was the number of participants showing complete disappearance of skin lesions after 3 months. Secondary outcomes were a numeric rating scale (NRS) measuring intensity of itching and the Skindex-29 questionnaire (overall, and three sub-scales - degree of symptoms, psychological functioning, emotional status). All were assessed at baseline and every month, up to 3 months. The intention-to-treat sample was analyzed to detect inter-group differences using two-way repeated measures analysis of variance after adjusting for baseline differences. RESULTS: The primary outcome revealed no improvement in either of the groups (χ 2 = 0.012, p = 0.999). Inter-group differences in some of the secondary outcomes favored IHMs against placebo - itching NRS (mean group difference after 3 months: -0.7 (95% confidence interval [CI], -1.1 to -0.4; p = 0.001); Skindex-29 overall (mean group difference after 3 months: 3.2 [95% CI, -0.6 to 7.0; p = 0.009]); Skindex-29 degree of symptoms (mean group difference after 3 months: 0.9 [95% CI, -0.2 to 1.9; p = 0.007]); and Skindex-29 psychological functioning (mean group difference after 3 months: 1.7 [95% CI, 0-3.4; p = 0.002]). CONCLUSION: Results were negative on the primary outcome; however, secondary outcomes included some statistically significant results favoring IHMs against placebo after 3 months. TRIAL REGISTRATION: CTRI/2019/11/021999; UTN: U1111-1242-0070.

Efficacy of individualized homeopathic medicines in primary dysmenorrhea: a double-blind, randomized, placebo-controlled, clinical trial.

OBJECTIVES: Homeopathic treatment is claimed to be beneficial for primary dysmenorrhoea (PD); still, systematic research evidences remain compromised. This study was undertaken to examine the efficacy of individualized homeopathic medicines (IH) against placebo in the treatment of PD. METHODS: A double-blind, randomized, placebo-controlled trial was conducted at the gynecology outpatient department of Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, West Bengal, India. Patients were randomized to receive either IH (n=64) or identical-looking placebo (n=64). Primary and secondary outcome measures were 0-10 numeric rating scales (NRS) measuring intensity of pain of dysmenorrhea and verbal multidimensional scoring system (VMSS) respectively; all measured at baseline, and every month, up to 3 months. Group differences and effect sizes (Cohen's d) were calculated on intention-to-treat (ITT) sample. RESULTS: Groups were comparable at baseline (all p>0.05). Attrition rate was 10.9% (IH: 7, placebo: 7). Differences between groups in both pain NRS and VMSS favoured IH over placebo at all time points (all p<0.001, unpaired t-tests and two-ways repeated measures analysis of variance) with medium to large effect sizes. Natrum muriaticum and Pulsatilla nigricans (n=20 each; 15.6%) were the most frequently prescribed medicines. No harms, serious adverse events and intercurrent illnesses were recorded in either of the groups. CONCLUSIONS: Homeopathic medicines acted significantly better than placebo in the treatment of PD. Independent replication is warranted. Trial registration: CTRI/2018/10/016013.

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 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 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.

Plant Extracts as Add-On Therapeutics in Homeopathy: An Open-Label, Randomized Trial Using Mother Tinctures in Prediabetes.

Objectives: Prediabetes is a major public health concern. Different plant extracts are used in homeopathy as mother tinctures (MTs) for the treatment of prediabetes as an adjunct to individualized homeopathic medicines (IHMs); however, their effectiveness remains under-researched. Design: Open-label, randomized (1:1), active-controlled, pragmatic, exploratory trial. Setting: Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Howrah, West Bengal, India. Subjects: Eighty-nine patients with prediabetes. Interventions: Group 1 (n = 45; IHMs plus any one of the following MTs: Cephalandra indica, Gymnema sylvestre, and Syzygium jambolanum; experimental/verum) versus Group 2 (n = 44; IHMs only; control). Outcome measures: Blood parameters, including-the fasting blood sugar (FBS) level, blood sugar level 2 h after ingestion of 75 g of glucose (oral glucose tolerance test [OGTT] result), and glycosylated hemoglobin percentage (HbA1c%), and symptoms, including the Diabetes Symptom Checklist-Revised (DSC-R) score; all of them were measured at baseline and after 3 and 6 months. Results: Although recruitment of 140 patients was initially planned, the target sample size could not be achieved because of coronavirus disease pandemic-related restrictions. Only 89 patients could be enrolled, and the trial had to be terminated prematurely owing to the time constraints of the project. The data of 82 patients (Group 1, n = 40; Group 2, n = 42) were analyzed using a modified intention-to-treat approach. Improvements in all outcomes were greater in Group 1 than in Group 2, but without a significant difference: FBS level (F1, 80 = 4.095, p = 0.046), OGTT result (F1, 80 = 2.399, p = 0.125), HbA1c% (F1, 80 = 1.612, p = 0.208), and DSC-R score (F1, 80 = 0.023, p = 0.880). Conclusions: A promising but nonsignificant trend favored the combination of MTs and IHMs compared with IHMs alone among the patients with prediabetes, especially in FBS. Therefore, further studies are required. Clinical Trial Registration Number: CTRI/2018/08/015319; secondary identifier (UTN): U1111-1218-6016.

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.