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.

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.

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 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.

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.