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.

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.

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.

A Randomized, Double-Blind, Placebo-Controlled, Pilot Trial of Individualized Homeopathic Medicines for Cutaneous Warts.

BACKGROUND: Though frequently used in practice, research studies have shown inconclusive benefits of homeopathy in the treatment of warts. We aimed to assess the feasibility of a future definitive trial, with preliminary assessment of differences between effects of individualized homeopathic (IH) medicines and placebos in treatment of cutaneous warts. METHODS: A double-blind, randomized, placebo-controlled trial (n = 60) was conducted at the dermatology outpatient department of D.N. De Homoeopathic Medical College and Hospital, West Bengal. Patients were randomized to receive either IH (n = 30) or identical-looking placebo (n = 30). Primary outcome measures were numbers and sizes of the warts; secondary outcome was the Dermatology Life Quality Index (DLQI) questionnaire measured at baseline, and every month up to 3 months. Group differences and effect sizes were calculated on the intention-to-treat sample. RESULTS: Attrition rate was 11.6% (IH, 3; placebo, 4). Intra-group changes were significantly greater (all p < 0.05, Friedman tests) in IH than placebo. Inter-group differences were statistically non-significant (all p > 0.05, Mann-Whitney U tests) with small effect sizes-both in the primary outcomes (number of warts after 3 months: IH median [inter-quartile range; IQR] 1 [1, 3] vs. placebo 1 [1, 2]; p = 0.741; size of warts after 3 months: IH 5.6 mm [2.6, 40.2] vs. placebo 6.3 [0.8, 16.7]; p = 0.515) and in the secondary outcomes (DLQI total after 3 months: IH 4.5 [2, 6.2] vs. placebo 4.5 [2.5, 8]; p = 0.935). Thuja occidentalis (28.3%), Natrum muriaticum (10%) and Sulphur (8.3%) were the most frequently prescribed medicines. No harms, homeopathic aggravations, or serious adverse events were reported. CONCLUSION: As regards efficacy, the preliminary study was inconclusive, with a statistically non-significant direction of effect favoring homeopathy. The trial succeeded in showing that an adequately powered definitive trial is both feasible and warranted. TRIAL REGISTRATION: CTRI/2019/10/021659; UTN: U1111-1241-7340.

Patients' preference for integrating homeopathy (PPIH) within the standard therapy settings in West Bengal, India: The part 1 (PPIH-1) study.

There is lack of studies assessing the preference of Indian patients for integration of homeopathy into standard therapy settings. The objectives of this study were to examine the knowledge, attitudes, and practice of homeopathy among Indian patients already availing homeopathy treatment and its integration into mainstream healthcare. A cross-sectional survey was conducted among adult patients attending the out-patients of the four government homeopathic hospitals in West Bengal, India. A self-administered 24-items questionnaire in local vernacular Bengali was developed and administered to the patients. A total of 1352 patients' responses were included in the current analysis. 40% patients thought that homeopathic medicines can be used along with standard therapy. 32.5% thought that homeopathic medicines might cause side effects, while only 13.3% believed that those might interact with other medications. Patients' knowledge ranged between 25.1 and 76.5% regarding regulations of practicing and safety of homeopathic medicine in India and abroad; while positive attitude towards the same ranged between 25.4 and 88.5%. 88.6% of the patients had favorable attitude toward integrated services. 68.2% of the patients used homeopathic medicines in any acute or chronic illness for themselves and 76.6% for their children. Preference for integrated services was significantly associated with better knowledge (P = 0.002), positive attitudes toward safety and regulations (P < 0.0001), and integration (P < 0.0001), but not with the level of practice (P = 0.515). A favorable attitude toward integrating homeopathy into conventional healthcare settings was obtained among the patients attending the homeopathic hospitals in West Bengal, India.

Obstetrics and gynecology outpatient scenario of an Indian homeopathic hospital: A prospective, research-targeted study.

The authors aimed to document prescriptions and clinical outcomes in routine homeopathic practice to short list promising areas of targeted research and efficacy trials of homeopathy in obstetrics and gynecology (O&G). Three homeopathic physicians participated in methodical data collection over a 3-month period in the O&G outpatient setting of The Calcutta Homeopathic Medical College and Hospital, West Bengal, India. A specifically designed Excel spreadsheet was used to record data on consecutive appointments, including date, patient identity, socioeconomic status, place of abode, religion, medical condition/complaint, whether chronic/acute, new/follow-up case, patient-assessed outcome (7-point Likert scale: -3 to +3), prescribed homeopathic medication, and whether other medication/s was being taken for the condition. These spreadsheets were submitted monthly for data synthesis and analysis. Data on 878 appointments (429 patients) were collected, of which 61% were positive, 20.8% negative, and 18.2% showed no change. Chronic conditions (93.2%) were chiefly encountered. A total of 434 medical conditions and 52 varieties were reported overall. The most frequently treated conditions were leucorrhea (20.5%), irregular menses (13.3%), dysmenorrhea (10%), menorrhagia (7.5%), and hypomenorrhea (6.3%). Strongly positive outcomes (+3/+2) were mostly recorded in oligomenorrhea (41.7%), leucorrhea (34.1%), polycystic ovary (33.3%), dysmenorrhea (28%), and irregular menses (22.2%). Individualized prescriptions predominated (95.6%). A total of 122 different medicines were prescribed in decimal (2.9%), centesimal (87.9%), and 50 millesimal potencies (4.9%). Mother tinctures and placebo were prescribed in 3.4% and 30.4% instances, respectively. Several instances of medicine-condition pairings were detected. This systematic recording cataloged the frequency and success rate of treating O&G conditions using homeopathy.

Medicine prescription practices of homeopathic undergraduate students in West Bengal, India.

OBJECTIVE: To our knowledge, prescription of homeopathic medicines by homeopathic undergraduate students has not been studied before though it may possess serious implications. We aimed to determine the practice and attitudes of prescription by homeopathic undergraduate students. METHODS: A cross-sectional study was carried out involving all the students from four government homeopathic schools of West Bengal, India. Ethical requirements were ensured and data were collected using self-administered questionnaires. Chi-square tests and logistic univariate regression analyses were performed to identify associations and differences. RESULTS: A total of 328 forms were completed. Of these, 264 (80.5%) homeopathic undergraduate students admitted of prescribing medicines independently and most (40.5%) said that they did this 2-3 times a year. The most common reasons for this were 'urgency of the problem' (35.2%), 'previous experience with same kind of illness' (31.8%), and 'the problem too trivial to go to a doctor' (25.8%). About 63.4% of the students thought that it was alright to independently diagnose an illness while 51.2% thought that it was alright for them to prescribe medicines to others. Common conditions encountered were fever, indigestion, and injury. Students who prescribed medicines were more likely to belong to Calcutta Homeopathic Medical College and Hospital (odds ratio = 5.8; 95% confidence interval 2.247-14.972). Prescription by students gradually increased with academic years of homeopathic schools. Many students thought it was alright for students to diagnose and treat illnesses. CONCLUSION: Prescription of medicines by homeopathic undergraduate students is quite rampant and corrective measures are warranted.

Medicine prescription practices of homeopathic undergraduate students in West Bengal, India / 中西医结合学报

To our knowledge, prescription of homeopathic medicines by homeopathic undergraduate students has not been studied before though it may possess serious implications. We aimed to determine the practice and attitudes of prescription by homeopathic undergraduate students.

A survey exploring research perception of homeopathic undergraduate students in West Bengal, India

Background: Prioritizing undergraduate research is emphasized to develop critical analytical skills and thinking, independent writing, future clinical practice, enhanced employability, and improved research productivity. Despite far reaching consequences, research perception of homeopathic undergraduate students has barely been investigated to date. Poor participation of homeopathic undergraduates in research is reflected by a single MEDLINE indexed publication with adequate students’ contribution in the last decade. We aimed to assess their knowledge and attitude towards research and to identify barriers towards successful conduct of research. Methods: Institutional cross-sectional survey was carried out during August-September, 2013 in the four Government undergraduate homeopathic schools in West Bengal, India involving 902 participants. A semi-structured questionnaire was developed for the purpose depending on earlier studies on medical undergraduates. 364 completed responses were analyzed in the end. Results: Study sample mostly spanned 18-25 years of age group (94%), belonged to urban families (44.8%), with no gender differences (almost 1:1) and no physicians in family (73.1%). Maximum complete responses were obtained from 3rd year students (61.5%) and students of Calcutta Homeopathic Medical College and Hospital (51.2%). In spite of willingness to participate and keeping a positive attitude towards research, current involvement, training, knowledge and awareness remained quite unsatisfactory. Lack of infrastructure was identified as the chief barrier towards research. Conclusion: Undergraduates had a positive attitude towards homeopathic research, but need a realistic understanding of the research process. Opportunities for research skill development are underdeveloped.

Introdução: Estimular a pesquisa no nível de graduação é considerado um recurso importante para o desenvolvimento da capacidade de análise e pensamento críticos, redação independente, prática clínica futura, melhorar as possibilidades de inserção no mercado de trabalho e a produtividade em pesquisa. Apesar dessas consequências de amplo alcance, a percepção sobre pesquisa de estudantes de graduação em homeopatia tem sido raramente investigada. A escassa participação em pesquisas de estudantes de graduação em homeopatia é evidenciado pelo achado de um único trabalho indexado em MedLine com expressiva participação de estudantes nos últimos 10 anos. O nosso objetivo consistiu em avaliar o conhecimento e atitude em relação à pesquisa e identificar as barreiras que impedem o sucesso na realização de pesquisas. Métodos: Um estudo transversal foi realizado entre agosto e setembro de 2013 nas quatro faculdades públicas de homeopatia na Bengala Ocidental, Índia, com um total de 902 participantes. Um questionário semiestruturado foi desenvolvido especificamente para este estudo baseado nos resultados de estudos anteriores realizados com estudantes de medicina. Um total de 364 questionários completos foi incluído na análise. Resultados: A maioria dos participantes tinha entre 18 e 25 anos de idade (94%), residia em áreas urbanas (44.8%) e não incluía médicos na família (73,1%). A amostra apresentou homogeneidade em relação ao sexo (quase 1:1). O maior número de questionários completos correspondeu a estudantes do 3o ano (61,5%) e da Faculdade e Hospital Homeopático de Calcutá (51,2%) [...] Conclusão: Os estudantes manifestaram atitude positiva em relação à pesquisa em homeopatia, porém precisam adquirir uma compreensão mais realista do processo de pesquisa. As oportunidades para desenvolvimento de competências de pesquisa são muito escassas.

Understanding of biostatistics among the homeopathic fresh graduates and post-graduate trainees in West Bengal, India

Background: A basic understanding of biostatistics is essential, both for designing quality research and evaluating medical literature. We evaluated the understanding of biostatistics and interpretation of research results among homeopathic fresh graduates’ (House Staffs; HSs) and postgraduate trainees’ (PGTs) in West Bengal, India. Methods: A cross-sectional survey of homeopathic HSs and PGTs in the four government homeopathic schools in West Bengal, India, using a pre-tested, valid and reliable biostatistics multiple choice knowledge, confidence and attitude test questionnaire. Results: Internal consistency of the used questionnaires was acceptable (Cronbach’s á = 0.611 – 0.672). Response rate was only 55.6%. Research journal reading habit was seriously lacking. No one had ever taken any research courses or possessed any advanced degrees or diplomas. The overall mean% correct on statistical knowledge was very poor, 1.0% (95% CI 0.1 – 1.9%) vs. 10.0% (95% CI 8.6 – 11.6%) for HSs and PGTs (P < 0.0001). Comparatively, higher knowledge scores were found in respondents from Mahesh Bhattacharyya Homeopathic Medical College and Hospital (P = 0.003). No one could interpret an unadjusted odds ratio, Kaplan-Meier analysis results, and determine strength of evidence for risk factors. Percentages of correct answers for all other knowledge-based questions ranged between only 2.7 – 9.5%. Respondents’ self-assessed confidence in ability to understand biostatistics ranged between 41 – 60%. Positive attitude towards biostatistics was elicited in 16 – 63% respondents. Conclusions: The respondents seriously lacked knowledge in biostatistics needed to interpret research results. Training programs needs to undergo massive and immediate transformation to include more effective biostatistics training in curricula to encourage meaningful research.

A survey exploring research perception of homeopathic undergraduate students in West Bengal, India

Background: Prioritizing undergraduate research is emphasized to develop critical analytical skills and thinking, independent writing, future clinical practice, enhanced employability, and improved research productivity. Despite far reaching consequences, research perception of homeopathic undergraduate students has barely been investigated to date. Poor participation of homeopathic undergraduates in research is reflected by a single MEDLINE indexed publication with adequate students’ contribution in the last decade. We aimed to assess their knowledge and attitude towards research and to identify barriers towards successful conduct of research. Methods: Institutional cross-sectional survey was carried out during August-September, 2013 in the four Government undergraduate homeopathic schools in West Bengal, India involving 902 participants. A semi-structured questionnaire was developed for the purpose depending on earlier studies on medical undergraduates. 364 completed responses were analyzed in the end. Results: Study sample mostly spanned 18-25 years of age group (94%), belonged to urban families (44.8%), with no gender differences (almost 1:1) and no physicians in family (73.1%). Maximum complete responses were obtained from 3rd year students (61.5%) and students of Calcutta Homeopathic Medical College and Hospital (51.2%). In spite of willingness to participate and keeping a positive attitude towards research, current involvement, training, knowledge and awareness remained quite unsatisfactory. Lack of infrastructure was identified as the chief barrier towards research. Conclusion: Undergraduates had a positive attitude towards homeopathic research, but need a realistic understanding of the research process. Opportunities for research skill development are underdeveloped. (AU)

Introdução: Estimular a pesquisa no nível de graduação é considerado um recurso importante para o desenvolvimento da capacidade de análise e pensamento críticos, redação independente, prática clínica futura, melhorar as possibilidades de inserção no mercado de trabalho e a produtividade em pesquisa. Apesar dessas consequências de amplo alcance, a percepção sobre pesquisa de estudantes de graduação em homeopatia tem sido raramente investigada. A escassa participação em pesquisas de estudantes de graduação em homeopatia é evidenciado pelo achado de um único trabalho indexado em MedLine com expressiva participação de estudantes nos últimos 10 anos. O nosso objetivo consistiu em avaliar o conhecimento e atitude em relação à pesquisa e identificar as barreiras que impedem o sucesso na realização de pesquisas. Métodos: Um estudo transversal foi realizado entre agosto e setembro de 2013 nas quatro faculdades públicas de homeopatia na Bengala Ocidental, Índia, com um total de 902 participantes. Um questionário semiestruturado foi desenvolvido especificamente para este estudo baseado nos resultados de estudos anteriores realizados com estudantes de medicina. Um total de 364 questionários completos foi incluído na análise. Resultados: A maioria dos participantes tinha entre 18 e 25 anos de idade (94%), residia em áreas urbanas (44.8%) e não incluía médicos na família (73,1%). A amostra apresentou homogeneidade em relação ao sexo (quase 1:1). O maior número de questionários completos correspondeu a estudantes do 3o ano (61,5%) e da Faculdade e Hospital Homeopático de Calcutá (51,2%) [...] Conclusão: Os estudantes manifestaram atitude positiva em relação à pesquisa em homeopatia, porém precisam adquirir uma compreensão mais realista do processo de pesquisa. As oportunidades para desenvolvimento de competências de pesquisa são muito escassas. (AU)

Understanding of biostatistics among the homeopathic fresh graduates and post-graduate trainees in West Bengal, India

Background: A basic understanding of biostatistics is essential, both for designing quality research and evaluating medical literature. We evaluated the understanding of biostatistics and interpretation of research results among homeopathic fresh graduates’ (House Staffs; HSs) and postgraduate trainees’ (PGTs) in West Bengal, India. Methods: A cross-sectional survey of homeopathic HSs and PGTs in the four government homeopathic schools in West Bengal, India, using a pre-tested, valid and reliable biostatistics multiple choice knowledge, confidence and attitude test questionnaire. Results: Internal consistency of the used questionnaires was acceptable (Cronbach’s á = 0.611 – 0.672). Response rate was only 55.6%. Research journal reading habit was seriously lacking. No one had ever taken any research courses or possessed any advanced degrees or diplomas. The overall mean% correct on statistical knowledge was very poor, 1.0% (95% CI 0.1 – 1.9%) vs. 10.0% (95% CI 8.6 – 11.6%) for HSs and PGTs (P < 0.0001). Comparatively, higher knowledge scores were found in respondents from Mahesh Bhattacharyya Homeopathic Medical College and Hospital (P = 0.003). No one could interpret an unadjusted odds ratio, Kaplan-Meier analysis results, and determine strength of evidence for risk factors. Percentages of correct answers for all other knowledge-based questions ranged between only 2.7 – 9.5%. Respondents’ self-assessed confidence in ability to understand biostatistics ranged between 41 – 60%. Positive attitude towards biostatistics was elicited in 16 – 63% respondents. Conclusions: The respondents seriously lacked knowledge in biostatistics needed to interpret research results. Training programs needs to undergo massive and immediate transformation to include more effective biostatistics training in curricula to encourage meaningful research.(AU)