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.

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.

Counting Polar Symptoms: How to Represent Results?

BACKGROUND: Polar symptoms (PS)-symptoms with opposite values-are frequently used in homeopathy, but have many misleading entries in the repertory. This is caused by using absolute occurrence of symptoms, causing the same medicine to appear in both (opposite) symptom rubrics, and by lack of comparison with other medicines. Some PS, like 'aversion/desire for sweets' have a frequency distribution that is not evenly distributed around the neutral value: a desire for sweets is much more common than aversion. A desire for sweets is an indication for a specific medicine only if this desire occurs more frequently in this specific medicine population than in the remainder of the population. We need to find the best way to represent this difference. METHODS: A multi-centre, explorative, prospective, observational study was conducted by nine centres of the Central Council for Research in Homoeopathy. Two-hundred and sixteen patients were enrolled with chronic cough lasting more than 8 weeks, and received usual homeopathic care. During intake, 30 general PS, 27 polar cough symptoms and 3 non-polar cough symptoms were checked. Different ways of representing results were explored, including two quantities borrowed from mechanics: Centre of Mass (CoM) and Leverage. RESULTS: At the fourth follow-up, three medicines with more than 10 cases with good results were identified: 20 Phosphorus, 19 Pulsatilla and 13 Sulphur. The mean value of the frequency distribution of some symptoms in the whole sample was considerably different from the neutral value. Comparing a medicine population with the remainder of the respective population can give results that differ from polarity analysis. For some symptoms, the 'distance' (Leverage) between the CoMs of the medicine population and the remainder of the population was clearer than the likelihood ratio (LR). CONCLUSION: If the LR value is not clear about the prognostic value in PS, notions from mechanics such as CoM and Leverage can clarify how to interpret a polar symptom.

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.

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.

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.

Homeopathy in chronic sinusitis: a prospective multi-centric observational study.

OBJECTIVE: The primary objective was to ascertain the therapeutic usefulness of homeopathic medicine in the management of chronic sinusitis (CS). MATERIALS AND METHODS: Multicentre observational study at Institutes and Units of the Central Council for Research in Homoeopathy, India. Symptoms were assessed using the chronic sinusitis assessment score (CSAS). 17 pre-defined homeopathic medicines were shortlisted for prescription on the basis of repertorisation for the pathological symptoms of CS. Regimes and adjustment of regimes in the event of a change of symptoms were pre-defined. The follow-up period was for 6 months. Statistical analysis was done using SPSS version 16. RESULTS: 628 patients suffering from CS confirmed on X-ray were enrolled from eight Institutes and Units of the Central Council for Research in Homoeopathy. All 550 patients with at least one follow-up assessment were analyzed. There was a statistically significant reduction in CSAS (P = 0.0001, Friedman test) after 3 and 6 months of treatment. Radiological appearances also improved. A total of 13 out of 17 pre-defined medicines were prescribed in 550 patients, Sil. (55.2% of 210), Calc. (62.5% of 98), Lyc. (69% of 55), Phos. (66.7% of 45) and Kali iod. (65% of 40) were found to be most useful having marked improvement. 4/17 medicines were never prescribed. No complications were observed during treatment. CONCLUSION: Homeopathic treatment may be effective for CS patients. Controlled trials are required for further validation.

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)

A multi-centric open clinical trial to evaluate the usefulness of 13 predefined homeopathic medicines in the management of acute rhinitis in children

Aims: The study aimed to evaluate the effect of a group of homeopathic medicines in children with acute rhinitis. Materials and methods: In this multi-centric open clinical trial, a total of 784 children (408 males; 384 females) aged 6 months to 15 years, presenting symptoms of acute rhinitis were enrolled from 7 Institutes/ Units under the Central Council for Research in Homeopathy (India). Symptoms were assessed using an acute rhinitis symptom score (ARSS). A total of 13 homeopathic medicines were shortlisted after repertorizing the nosological symptoms of acute rhinitis in children and the results were analyzed. The medicines were prescribed in dilution 6c (10-12) and doses were repeated from few minutes to few hours as per the need of the case. Appearance of any change (improvement or worsening) was followed by placebo / change in dilution or change in medicine according to the response of the patient. The follow up period was up to the 7th day of illness. Results: Out of 784 children enrolled, 638 children were followed up and analyzed. A significant change in the score from the baseline (p<0.05) was observed. Twelve medicines were found to be useful in 638 children suffering from acute rhinitis and among them Nux-v (n=109), Merc (n=106) and Bell (n=88) were the most useful. No complications were observed during the treatment. Adverse events in the form of hyperpyrexia were observed in 2 children only. Conclusion: This study indicates the usefulness of homeopathic medicines in the management of acute rhinitis of children; controlled studies are needed to investigate their efficacy and effectiveness.

Objetivos; este estudo objetivou avaliar o efeito de um grupo de medicamentos em crianças com rinite aguda. Materiais e métodos: neste estudo multicêntrico aberto, foram recrutadas 784 crianças (408 masculinas; 384 femininas) com idade entre 6 meses e 15 anos apresentando sintomas de rinite aguda e que consultaram 7 institutos/centros sob o Conselho Central de Pesquisa em Homeopatia (Índia). Os sintomas foram avaliados através de um escore para sintomas de rinite aguda (ARSS). Um total de 13 medicamentos homeopáticos foi estabelecido após repertorização dos sintomas nosológicos da rinite aguda em crianças e os resultados foram analisados. Os medicamentos foram prescritos na diluição 6cH (10-12) e as doses foram repetidas de minutos a horas segundo a necessidade em cada caso. O aparecimento de qualquer mudança (melhora ou piora) foi seguido pela prescrição de placebo ou mudança da diluição ou do medicamento, de acordo com a resposta do paciente. O período de acompanhamento foi até o 7º dia da doença. Resultados: dentre as 784 crianças recrutadas, 638 foram acompanhadas e analisadas. Houve mudança significativa no escore (p<0,05) por comparação ao ingresso. Doze medicamentos foram úteis em 638 crianças com rinite aguda, entre eles Nux-v (n=109), Merc (n=106) e Bell (n=88) foram os mais úteis. Não foram observadas complicações durante o tratamento. Efeitos adversos sob a forma de hiperpirexia foram observados somente em 2 crianças. Conclusão: este estudo indica a utilidade dos medicamentos homeopáticos no manejo da rinite aguda em crianças; são necessários estudos controlados para determinar sua eficácia e efetividade.

Objetivos: este estudio buscó evaluar el efecto de un grupo de medicamentos homeopáticos en niños portadores de rinitis aguda. Materiales y métodos: en este estudio multicéntrico abierto fueron reclutados 784 niños (408 niños; 384 niñas) de edad entre 6 meses y 15 años que consultaron con síntomas de rinitis aguda en 7 institutos/centros dependientes del Consejo Central de Investigación en Homeopatía (India). Los síntomas fueron evaluados mediante un score para síntomas de rinitis aguda (ARSS). Fueron listados 13 medicamentos homeopáticos después de repertorización y análisis de los síntomas de rinitis aguda en niños. Los medicamentos fueron prescritos en la dilución 6cH (10~12) y las dosis fueron repetidas desde minutos a horas según la necesidad en cada caso. La aparición de todo cambio (mejoría o empeoramiento) fue seguida de prescripción de placebo/cambio de la dilución o del medicamento según la respuesta del paciente. Los pacientes fueron acompañados hasta el 7º día de tratamiento. Resultados: De 784 niños reclutados, 638 fueron acompañados y analizados. Fue observado cambio significativo en el score (p<0,05). Doce medicamentos se mostraron útiles en 638 niños portadores de rinitis aguda; entre ellos, Nux-v (n=108), Merc (n=106) y Bell (n=88) fueron los más útiles.