Individualized Homeopathic Medicines in the Management of Symptomatic Adenotonsillar Hypertrophy in Children: A Prospective Observational Study.

BACKGROUND: Globally, adenotonsillar hypertrophy (ATH) is one of the most prevalent upper respiratory tract disorders of children, with associated troublesome symptoms such as sleep apnea and cognitive disturbances. In this study, we evaluated the potential role of individualized homeopathic medicines in the management of symptomatic ATH in children. METHODS: A multicenter prospective observational study was conducted at five institutes under the Central Council for Research in Homoeopathy, India. Primary and secondary outcomes (symptom score for adenoids, other symptoms of ATH, Mallampati score, tonsillar size, Sleep-Related Breathing Disorder of the Paediatric Sleep Questionnaire [SRBD-PSQ]) were assessed through standardized questionnaires at baseline and at 3, 6, 9 and 12 months. Radiological investigations for assessing the adenoid/nasopharyngeal (A/N) ratio were carried out at baseline, 6 and 12 months. All analyses were carried out using an intention-to-treat approach. RESULTS: A total of 340 children were screened and 202 children suffering from ATH were enrolled and followed up monthly for 12 months. Each patient received individualized homeopathic treatment based on the totality of symptoms. Statistically significant reductions in adenoid symptom score, Mallampati score (including tonsillar size), SRBD-PSQ sleep quality assessment and A/N ratio were found over time up to 12 months (p < 0.001). Homeopathic medicines frequently indicated were Calcarea carbonicum, Phosphorus, Silicea, Sulphur, Calcarea phosphoricum, Pulsatilla, Lycopodium and Tuberculinum. No serious adverse events were recorded during the study period. CONCLUSION: This study suggests that homeopathic medicines may play a beneficial role in the management of symptomatic ATH in children. Well-designed comparative trials are warranted.

Prevalence and correlates of multimorbidity among patients attending AYUSH primary care settings in Delhi-National Capital Region, India.

INTRODUCTION: India has a multifaceted healthcare system and recognizes complementary and alternative systems of medicine (AYUSH) that cater to the healthcare needs of people. Multimorbidity requires frequent visits to physicians and long-term use of medications, due to which people tend to prefer AYUSH systems as they provide holistic patient-centered treatment. Hence, we aimed to estimate the prevalence of multimorbidity and assess its correlates among patients attending AYUSH primary care clinics in Delhi. METHODS: A cross-sectional study was conducted among 943 patients aged ≥ 18 years attending various AYUSH primary care clinics in Delhi from September 2021 to February 2022, employing a stratified random sampling technique. Descriptive statistics such as frequency and proportion were used to report the prevalence of multimorbidity (two or more chronic conditions in an individual out of the 33 conditions listed as per the Multimorbidity Assessment Questionnaire for Primary Care). A multivariable logistic regression assessed the association between various socio-demographic characteristics and multimorbidity, presented as an adjusted odds ratio (AOR) with a 95% confidence interval (CI). RESULTS: The prevalence of diabetes (14.7%) was found to be the highest (out of all included chronic conditions) among the patients attending various AYUSH primary care settings. The overall prevalence of multimorbidity was observed to be around 39.4%. We observed a higher likelihood of having multimorbidity among participants aged ≥ 70 years [AOR: 9.19 (95% CI: 3.75-22.54)], females [AOR: 1.57 (95% CI: 1.04-2.37)], and middle class [AOR: 2.23 (95% CI: 1.45-3.43)]. CONCLUSION: Multimorbidity was evidently prevalent across AYUSH primary care settings, which cannot be overlooked. The results suggest behavioral change communication may be aimed at older individuals, females, and the middle class.

Practice, prescription habits, experience and perception of Indian homeopathic practitioners in treatment of diabetes mellitus: An online observational study.

BACKGROUND: Studies have shown homoeopathy to effectively control blood sugar levels and improve quality of life (QOL), though a standard treatment protocol is required. OBJECTIVE: This study intended to assess the homoeopathic practice, prescription habits, experience, and perception of Indian Homeopathic Practitioners (HPs) in treating DM. METHODOLOGY: A web-based cross-sectional with a snowball sampling method was conducted between 30th July 2021 and 18th August 2021. A questionnaire to record clinical attributes of Indian HPs in the management of DM was formed after the consensus of the subject experts and pilot testing for feasibility. RESULTS: Participants were 513 HPs with mean age [Standard Deviation (SD)] of 40.44 years (11.16) and a mean duration of the homoeopathic medical practice of 14.67 years [95% Confidence Interval (CI) = 13.71-15.63]. The majority of HPs made classical homoeopathic prescription (201, 39.2%) though the success in the management of DM was better among HPs who prescribed more than one potentized medicine [vs classical prescription, Odds Ratio (OR) = 2.34, p = 0.032]. As perceived by the HPs, homoeopathic treatment resulted in a major improvement in QOL of the diabetic patients (418, 81.5%) with very few adverse effect (100, 19.5%). The blood sugar level was controlled better when homoeopathy was given alongside conventional medicine (348, 67.8%). CONCLUSION: The clinical experience of HPs in this study has shown that homoeopathic treatment can benefit DM patients in preventing complications and improving QOL. It further reported that homoeopathy can be an important adjuvant to conventional treatment in managing DM.

Impact of COVID-19 Pandemic on Patients with Non-Communicable Disease: An Observational Cross-Sectional Study at AYUSH Set-Ups of Krishna and Darjeeling District, India.

OBJECTIVE: The objective of this study was to determine the impact of COVID-19 in patients suffering from NCDs in terms of their knowledge, awareness, perception about COVID-19, use of AYUSH immune boosters (AIB), and management of chronic condition during the pandemic. METHOD: During the unlock down period (October 2020), a cross-sectional study was conducted in the Krishna and Darjeeling district of Andhra Pradesh and West Bengal, India. 499 individuals suffering from at least one chronic disease were interviewed using a structured questionnaire. Logistic regression was applied to investigate the relationship of socio-demographic characteristics, AIB, and morbidity with pandemic-related care challenges. Principal component analysis was applied to minimize the dimensionality of factors related to COVID care challenges. RESULTS: 499 individuals were surveyed. 91% identified at least three correct COVID appropriate behaviours. 92.2% considered the coronavirus to be a potential threat (mean ± SD: 5.8 ± 2.6). 44.7% and 55.3% lived with one and 2 or more chronic conditions, respectively. Hypertension alone (27.4%) and diabetes with hypertension (33%) were leading presentations. Out of 499, participants, 88.8% had at least one form of AIB. 52% took Ars. alb. with other AIB and 40% took Ars. alb. alone. Only 9 participants were infected with COVID-19. CONCLUSION: In the interest of a densely populated country like India, the inclusion of simple and safe AYUSH measures is realistic, ethical, and cost-effective. AYUSH interventions as COVID-19 prophylactic and treatment as well as integrative care of chronic illnesses such as NCDs are suggested.

Multimorbidity in a 35-Year-Old Female Patient Treated with Homeopathy: A Case Report.

BACKGROUND: Multimorbidity, a prevailing trend in the primary care population of all ages, is a challenge for health care systems that are largely configured for single disease management. Homeopathy has shown competence in the management of chronic diseases, whether they occur as a single ailment or as a multimorbidity. CASE HISTORY: A 35-year-old female patient presenting with hemorrhoids, low back pain, hypothyroidism, fibroadenosis breasts (bilateral), and fibroid uterus was given homeopathic treatment for 33 months at Nandigama AYUSH Lifestyle Disorders Clinic, Andhra Pradesh. She was prescribed the homeopathic medicines Lachesis mutus and Thyroidinum at different time intervals based on the totality of symptoms. RESULTS: Following treatment, a reduction in the size of the uterine fibroid and complete regression of breast lumps in ultrasonography were noted. The modified Naranjo criteria total score was 10 out of 13. Further, significant improvement in symptoms and laboratory parameters, such as triiodothyronine (T3), tetra-iodothyronine (T4), and thyroid-stimulating hormone (TSH), indicated that a well-chosen homeopathic medicine may be beneficial in managing multimorbidity. CONCLUSION: This case study reveals a positive role of homeopathic treatment in multimorbidity. More case studies and well-designed controlled research should be used to further investigate homeopathic intervention in multimorbidity.

Comparative Effectiveness of Pre-Identified Homeopathic Medicines in Asymptomatic COVID-19 Individuals Receiving Standard Care-An Open-Label, Randomized, Controlled Exploratory Trial.

BACKGROUND: Asymptomatic COVID-19 subjects can transmit the infection for as many as 14 days and are regarded as a significant factor in the rapid spread of the COVID-19 pandemic. This exploratory study aimed to determine any additional benefits of selected homeopathic medicines compared with placebo in asymptomatic COVID-19 individuals receiving standard care. METHODS: This open-label, randomized, placebo-controlled, exploratory trial was undertaken at a COVID Care Centre (CCC) in Madhya Pradesh, India. Patients (n = 200, 18-65 years, both sexes) having a positive RT-PCR and asymptomatic during admission were enrolled. They were randomly assigned to one of four groups (each n = 50): Arsenicum album 30C (Ars. alb.), Camphora 1M (Camph.), Bryonia alba 30C (Bry. alb.) and placebo (Pl.). All the patients were given standard care. The primary outcome was the number of patients becoming RT-PCR negative for SARS-CoV-2 at days 5, 10 and 15. RESULTS: In total, 200 asymptomatic COVID-19 patients were enrolled. One hundred and seventy-seven patients became RT-PCR negative by day 15; 88%, 80%, 98% and 88% from Ars. alb., Camph., Bry. alb. and Pl. respectively. A Chi-square test of association for the total patients who became RT-PCR negative for SARS-Cov-2 in each group showed a marginal statistical significance (Chi-square: 8.1, p = 0.04). A two-proportion Z-test comparing each pre-identified homeopathic medicine with placebo showed marginal statistical significance (p = 0.05) for Bry alb. only. Median time in days to RT-PCR negative (Kaplan Meier analysis) was 10 days in each of the groups. CONCLUSION: There was some evidence that, compared with Ars alb., Camph. or Pl., Bry. alb. was associated with an increased number of patients who became RT-PCR negative for COVID-19 by day 15. The possible effect exerted needs to be investigated in additional research.

Clinical Repurposing of Medicines is Intrinsic to Homeopathy: Research Initiatives on COVID-19 in India.

As at mid-October 2020, the coronavirus disease 2019 (COVID-19) pandemic has been continuing on the rise across the globe, including in India. Historically, homeopathy has been used in a number of epidemics/pandemics. The development of homeopathic medicines is approached uniquely through "drug provings" and clinical verification; these two intrinsic processes establish the background for the application of homeopathic medicines, regardless of nosological diagnosis. This article reflects research initiatives on COVID-19 in India and identifies studies listed in the Clinical Trial Registry-India database. We identified 29 studies being undertaken in different settings, including those in conventional medicine: 20 randomized controlled trials (RCTs) and 9 observational studies. Fifteen studies are aimed at prophylaxis and 14 are aimed at treatment. Amongst the treatment studies, 11 are focused on efficacy or comparative effectiveness. The findings might provide evidence for clinically repurposing some of homeopathy's medicines, an approach that is intrinsic to the therapy, enabling their use in COVID-19 as an adjuvant or stand-alone to help reduce costs and improve patient recovery.

Recommendations for Designing, Conducting and Reporting Observational Studies in Homeopathy.

BACKGROUND: Randomized placebo-controlled trials are considered to be the gold standard in clinical research and have the highest importance in the hierarchical system of evidence-based medicine. However, from the viewpoint of decision makers, due to lower external validity, practical results of efficacy research are often not in line with the huge investments made over decades. METHOD: We conducted a narrative review. With a special focus on homeopathy, we give an overview on cohort, comparative cohort, case-control and cross-sectional study designs and explain guidelines and tools that help to improve the quality of observational studies, such as the STROBE Statement, RECORD, GRACE and ENCePP Guide. RESULTS: Within the conventional medical research field, two types of arguments have been employed in favor of observational studies. First, observational studies allow for a more generalizable and robust estimation of effects in clinical practice, and if cohorts are large enough, there is no over-estimation of effect sizes, as is often feared. We argue that observational research is needed to balance the current over-emphasis on internal validity at the expense of external validity. Thus, observational research can be considered an important research tool to describe "real-world" care settings and can assist with the design and inform the results of randomised controlled trails. CONCLUSIONS: We present recommendations for designing, conducting and reporting observational studies in homeopathy and provide recommendations to complement the STROBE Statement for homeopathic observational studies.

Efectos del tratamiento homeopático individualizado en la hipertensión esencial de estadio I: ensayo aleatorizado, simple ciego, controlado con placebo / Effects of Homeopathic Treatment Individualized in Hypertension Stage I Essential: Randomized Trial, Single Blind, Placebo controlled

Fundamentos: la hipertensión arterial es el cuarto principal factor de riesgo de muerte e incapacidad, así como el responsable de más de 1.6 millones de fallecimientos en la India. Los informes de casos clínicos, los estudios observacionales y los ECA evidencian los efectos de los medicamentos homeopáticos en la hipertensión. Objetivos: los resultados de este estudio se añaden a la evidencia de la eficacia del uso de los medicamentos homeopáticos individualizados en la hipertensión de estadio I. Materiales y métodos: Se ha realizado un ensayo aleatorizado, simple ciego y controlado por placebo entre octubre de 2013 y marzo de 2018. El parámetro primario fue evaluar los cambios en la presión sistólica (PS) y la presión diastólica (PD) mensualmente durante tres meses. 217 pacientes de los 2,127 pacientes examinados cumplieron los criterios de selección y fueron aleatorizados para recibir un medicamento en potencias Q (o potencias LM) más indicaciones para la modificación del estilo de vida (MEV) (116 pacientes) o bien placebo + MEV (101 pacientes). La modificación del estilo de vida incluyó actividad física y dieta como parte de la pauta terapéutica. El análisis fue de intención de tratamiento. Resultados: Las mediciones ANOVA repetidas entre los grupos mostraron una diferencia estadística significativa (Lambda de Wilks 0.85, F=12.12, dF=213, P=0.0001) tanto en la PS como en la PD a favor de la Homeopatía individualizada. La prueba t independiente post hoc mostró una reducción media significativa de la PS [diferencia media 7.12 mmHg, IC del 95%; CI 4.72 a 9.53, P=0.0001] y un descenso medio de la PD [diferencia media 5.76 mmHg, IC del 95%: 4.18 a 7.23, P=0.0001] a favor del grupo con Homeopatía más MEV. Los medicamentos más utilizados fueron: Sulphur (n=24), Natrium muriaticum (n=21), Lycopodium (n=16), Nux vomica (n=12) y Phosphorus (n=10). Conclusiones: Se ha constatado que la Homeopatía individualizada junto con la MEV fue más eficaz que el placebo junto con la MEV en los pacientes que sufren hipertensión en estadio I. Se precisan más ensayos en un marco estricto. (AU)

Background: Hypertension (HTN) is a leading risk factor for death and disability and responsible for over 1.6 million deaths in India. Clinical case reports, observational studies and randomised controlled trials show the effects of homoeopathic medicine in HTN. Objectives: The results of this study will add to the evidence of effectiveness of individualised homoeopathic medicine in Stage I HTN. Methods: A single-blind, randomised, placebocontrolled trial was undertaken from October 2013 to March 2018. The primary outcome measure was to evaluate the change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) every month for 3 months. Of 2,127 patients screened, 217 patients who fitted the inclusion criteria were randomised to receive either homoeopathic Q potencies (or LM potencies) plus lifestyle modification (LSM)=116 or placebo + LSM=101. LSM included physical activity and diet as part of the treatment regimen. Analysis was by intention to treat. Results: Repeated-measure ANOVA between the groups showed statistically significant difference (Wilk lambda 0.85, F=12.12, df=213, P=0.0001), in both SBP and DBP favouring Individualised Homoeopathy (IH) along with LSM. Post hoc independent t-test showed a significant mean reduction in SBP (mean difference 7.12 mmHg, 95% confidence interval [CI] 4.72-9.53, P=0.0001) and DBP (mean difference 5.76 mmHg, 95% CI: 4.18-7.23, P=0.0001) favouring Homoeopathy plus LSM group. Sulphur (n=24), Natrum muriaticum (n=21), Lycopodium (n=16), Nux vomica (n=12) and Phosphorus (n=10) were the most useful medicines. Conclusion: IH in LM potency along with LSM was found effective over placebo along with LSM in the patients suffering from Stage I HTN. Further trials in rigorous setting are warranted. (AU)

Effectiveness of Homeopathic Medicines as Add-on to Institutional Management Protocol for Acute Encephalitis Syndrome in Children: An Open-Label Randomized Placebo-Controlled Trial.

BACKGROUND: Acute encephalitis syndrome (AES) is endemic to certain parts of India, with limited treatment options. In our initial exploratory comparative observational study of 151 patients with AES, there was significantly reduced mortality with adjunctive homeopathy compared to institutional management protocol (IMP). The present randomized placebo-controlled trial brings more statistical rigor to this research program. METHODS: This study was conducted at a pediatric unit from 2013 to 2015. Children aged > 6 months and ≤ 18 years and receiving IMP were randomized to receive adjunctive homeopathy (n = 325) or placebo as control (n = 323). The primary effectiveness analysis was based on Glasgow Outcome Scale (GOS). Morbidity was assessed using the Liverpool Outcome Score for Assessing Children at Follow-up. Analysis was by intention to treat. RESULTS: A total of 612 children were analyzed (Homeopathy [H] = 304; Control [C] = 308). The primary outcome, GOS, differed significantly between H and C groups. There was 14.8% death/neuro-vegetative state in the H group compared to 29.8% in the C group. Relative risk was 0.49 (95% confidence interval [CI]: 0.36 to 0.68), with absolute risk reduction of 15.0% (95% CI: 8.6 to 21.6%). Number needed to treat to prevent one additional death/neuro-vegetative state was 6.6 (95% CI: 4.6 to 11.6). Proportional-odds analysis also revealed a greater effect in the H group: odds ratio, 0.40 (95% CI: 0.27 to 0.60). The most frequently used medicines were Belladonna (n = 116), Stramonium (n = 33), Arsenicum album (n = 25), Sulfur (n = 18), Opium (n = 17), and Nux vomica (n = 10). CONCLUSION: Adjunctive homeopathic medicines may improve clinical outcomes associated with AES. Further randomized and controlled studies, using double-blinded trial design, are recommended to discover if the current findings may be corroborated.

A prospective multi-centric open clinical trial of homeopathy in diabetic distal symmetric polyneuropathy.

OBJECTIVES: To evaluate homeopathic treatment in the management of diabetic distal symmetric polyneuropathy. METHODS: A prospective multi-centric clinical observational study was carried out from October 2005 to September 2009 by Central Council for Research in Homeopathy (CCRH) (India) at its five institutes/units. Patients suffering from diabetes mellitus (DM) and presenting with symptoms of diabetic polyneuropathy (DPN) were screened, investigated and were enrolled in the study after fulfilling the inclusion and exclusion criteria. Patients were evaluated by the diabetic distal symmetric polyneuropathy symptom score (DDSPSS) developed by the Council. A total of 15 homeopathic medicines were identified after repertorizing the nosological symptoms and signs of the disease. The appropriate constitutional medicine was selected and prescribed in 30, 200 and 1 M potency on an individualized basis. Patients were followed up regularly for 12 months. RESULTS: Out of 336 patients (167 males and 169 females) enrolled in the study, 247 patients (123 males and 124 females) were analyzed. All patients who attended at least three follow-up appointments and baseline curve conduction studies were included in the analysis.). A statistically significant improvement in DDSPSS total score (p = 0.0001) was found at 12 months from baseline. Most objective measures did not show significant improvement. Lycopodium clavatum (n = 132), Phosphorus (n = 27) and Sulphur (n = 26) were the medicines most frequently prescribed. Adverse event of hypoglycaemia was observed in one patient only. CONCLUSION: This study suggests homeopathic medicines may be effective in managing the symptoms of DPN patients. Further studies should be controlled and include the quality of life (QOL) assessment.