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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.
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Homeopatia , Materia Medica , Tinha , Humanos , Homeopatia/métodos , Método Duplo-Cego , Tinha/tratamento farmacológico , Materia Medica/uso terapêutico , Prurido/tratamento farmacológico , Resultado do TratamentoRESUMO
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.
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Epilepsia , Homeopatia , Materia Medica , Humanos , Criança , Qualidade de Vida , Materia Medica/uso terapêutico , Método Duplo-Cego , Epilepsia/tratamento farmacológico , Epilepsia/etiologia , Resultado do TratamentoRESUMO
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.
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Homeopatia , Psoríase , Humanos , Psoríase/tratamento farmacológico , Método Duplo-Cego , ÍndiaRESUMO
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.
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Materia Medica , Vitiligo , Método Duplo-Cego , Humanos , Materia Medica/uso terapêutico , Projetos Piloto , Resultado do Tratamento , Vitiligo/tratamento farmacológicoRESUMO
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.