Management of early years of simple and mucopurulent chronic bronchitis with pre-defined Homoeopathic medicines ­ a Prospective Observational Study with 2-Years Follow-Up

Background Simple and mucopurulent chronic bronchitis (SMCB) is characterized by recurrent mucoid or mucopurulent expectoration in absence of localized suppurative disease. This observational open label study was undertaken to evaluate the effects of homeopathic medicine in SMCB. Methods 1902 patients were screened from 07 centres out of which 1305 were excluded. 597 patients were enrolled as per the inclusion and exclusion criteria. A total of 14 pre-defined homeopathic medicines were shortlisted for prescription after repertorizing the pathological symptoms of SMCB. Outcomes were assessed through chronic bronchitis symptom scale (CBSS) and FEV1/ FVC ratio with spirometry for over a period of two years. Appearance of any change (relief/ worse)/ status quo was immediately followed by placebo/ change in dilution/ change in remedy. Statistical analysis was done using SPSS version 20. Results: 532 patients were analyzed based on the intention to treat principle using last observation carry forward method. Mean CBS score reduced from 29.86±4.5 at baseline to 12.33±7.6 at completion of 2 years. Repeated measures ANOVA, at time points 0 (baseline), 3, 6, 9, 12 ,15, 18, 21 and 24 months, showed significant reduction in CBS scores [Wilk's Lambda 0.104, F=564, df 524; p=00001]. The FEV1 and FEV1/FVC was maintained within normal limits. 86% prescriptions included Lycopodium, Arsenicum album, Pulsatilla, Phosphorus, Stannum metallicum, Calcarea carbonica, Silicea, Bryonia alba. Conclusion: The result suggests effectiveness of homeopathic treatment in early years of SCMB patients. Controlled trials are warranted. (AU)

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.

A multi-centric open clinical trial to evaluate the usefulness of 13 predefined homeopathic medicines in the management of acute rhinitis in children / Estudo multicêntrico aberto para avaliação da utilidade de 13 medicamentos homeopáticos predefinidos no manejo da rinite aguda em crianças / Estudio multicéntrico abierto para evaluar la utilidad de 13 medicamentos homeopáticos pre definidos en el manejo de la rinitis aguda en niños

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.(AU)

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.(AU)

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.(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.