The use of homeopathy to prevent symptoms of human flu and acute respiratory infections: a double-blind, randomized, placebo-controlled clinical trial with 600 children from Brazilian Public Health Service

In Brazil, homeopathy was implemented in the Public Health Service through the National Policy on Complementary and Integrative Practices of the Health Ministry, published in 2006. Homeopathy appears as a very interesting therapy to be used in the Public Health Services since its medicines are compounded at a very low cost. Considering this interesting scenario to develop research in the Public Health, the Family Health Program (FHP) in Petropolis and the Faculty of Pharmacy at UFRJ started a partnership with the Roberto Costa Institute. A homeopathy clinical trial, employing a control protocol (double-blind, randomized, placebo-controlled), was developed as a result of this partnership starting in April 2009 and ending in April 2010. This clinical trial, approved by the Ethics Committee at UFRJ, number 194/08, aimed to evaluate the efficacy of two types of biotherapics to prevent symptoms of both flu and acute respiratory infections, compared to placebo (ethanol 30%). The biotherapics tested were ARI (Acute Respiratory Infection) and InfluBio. ARI is a homeopathic complex containing three different microorganisms related to respiratory infection while InfluBio is a biotherapic compounded from infectious influenza A virus. Before the development of this clinical trial, ARI had been used routinely in FHP, in Petropolis, to prevent acute respiratory infections in patients. The qualitative results obtained from this application suggested that this medicine has a prophylactic potential in the treatment of respiratory diseases. Additionally, we evaluated the antiviral activity of InfluBio using in vitro methodology and the promising results obtained motivated our group to test it in a clinical trial. With this aim, 600 children, from 1 to 5 years of age, were selected by physicians in 21 units of FHP, following the inclusion/exclusion criteria. For 1 month (April 2009), the children received daily, in a blind manner, the test solutions (placebo, ARI, InfluBio) in the posology of 1 drop per year of age. After 30 days, the use of these solutions was interrupted, and the health agents monitored the children for the subsequent twelve months, registering, in a specific questionnaire, symptoms of flu and acute respiratory infections. The respiratory symptoms that were to be reported were: runny nose, fever, prostration, myalgia, cough and headache. In the occurrence of one or more of these symptoms, the health agents evaluated the necessity of intervention by the physician. Of the 600 children, 450 completed the planned monitoring. The main reasons why 150 quit the treatment were change of address and parents’ abandonment. Additionally, no death was recorded and all the children presented good clinical evolution. In the case of the children who received placebo, the frequency of episodes diagnosed as acute respiratory infection/flu was three times higher when compared to those that received the ARI and InfluBio samples, considering the superior limit of the interquartile interval. Moreover, children treated with these biotherapics did not present any or presented only a single episode of ARI/Flu. These results showed that both biotherapics tested were statistically higher (p