Association between Usage of Prophylactic AYUSH Medicines and Disease Severity in COVID-19 Patients: A Retrospective Cohort Study.

BACKGROUND: Prior vaccination is often studied for its impact on individuals' post-infection prognosis. Ayurveda, Yoga, Unani, Siddha and Homeopathy (AYUSH) medicines, advised by the Government of India as prophylaxis during the first wave of the coronavirus disease 2019 (COVID-19) pandemic, were consumed by the masses in 2020. A study was therefore undertaken to observe any association between the prior usage of AYUSH prophylactic medicines and post-infection severity as reported by recovered COVID-19 individuals. METHODS: This was a retrospective, multi-centre, cohort study conducted in 21 cities of India from 5th August to 30th November 2020. Data from recovered COVID-19 patients, of either sex or any age, captured information about AYUSH prophylactic medicines intake prior to infection, disease severity, symptomatology, duration of complaints, etc. The study participants were grouped into AYUSH intake and non-intake. Primary composite outcome was the disease clinical course. Secondary clinical outcomes were the rate of and time to clinical recovery. RESULTS: Data of 5,023 persons were analysed. Ayurveda or homeopathic prophylactic medicines were consumed by more than half of the study participants: that is, 56.85% (n = 1,556) and 56.81% (n = 1,555) respectively. The overall adjusted protective effect (PE) of AYUSH prophylactic intake against moderate/severe forms of COVID-19 disease was 56.7% (95% confidence interval [CI], 48.7 to 63.50; p < 0.001). Adjusted PE for homeopathy and Siddha was 52.9% (95% CI, 42.30 to 61.50; p < 0.001) and 59.8% (95% CI, 37.80 to 74.10; p < 0.001), respectively. A statistically significant association was found between AYUSH prophylactic medicine intake and clinical recovery more frequently by the 3rd day of illness (χ2 = 9.01; p = 0.002). Time to resolution of symptoms in the AYUSH intake group was on average 0.3 days earlier than in the non-intake group (p = 0.002). CONCLUSION: AYUSH prophylactics were associated with statistically significant levels of protection against COVID-19 disease severity. Amongst these, previous intake of homeopathy or Siddha medicines was associated with some protection against moderate/severe illness and with a somewhat quicker clinical recovery. Prospective studies with experimental research design are needed to validate the findings of this study. STUDY REGISTRATION: Clinical Trials Registry-India (CTRI/2020/08/027000).

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.