Revisão sistemática de ensaios patogenéticos homeopáticos

• Autor(a) principal: Oliveira, Flávio José Dantas de [UNIFESP]
• Data de Publicação: 2006
• Tipo de documento: Tese
• Idioma: por
• Título da fonte: Repositório Institucional da UNIFESP
• Texto Completo: http://repositorio.unifesp.br/handle/11600/10064
• topic: Homeopatia; Ensaios patogenéticos homeopáticos; Medicina Baseada em Evidências; Revisão

Every homeopathic prescription must compare symptoms in the patient with symptoms produced in healthy volunteers after being exposed to substances in material doses or to homeopathic medicines administered during Homeopathic Pathogenetic Trials (HPTs). These are clinical trials designed to assess the effects of potentially toxic or pathogenetic substances, diluted and serially agitated according to homoeopathic pharmacopeias, in non-patient volunteers in good and relatively stable health conditions. They aim to generate valid and reliable information concerning all kinds of change in human beings after using a homeopathic medicine. Their methodology was first proposed by Hahnemann, which defined several guidelines to better control of the trials and validity of outcomes, although recently there were detected some flaws that could lead to an overestimation of the incidence of pathogenetic effects. In order to assess methods and outcomes of HPTs, a criterion-based systematic review of HPTs was done in trials published in six languages (English, German, Spanish, French, Portuguese and Dutch) from 1945 to 1995. The literature was comprehensively searched in databases, hand searching of journals and expert knowledge of reviewers, all with experience in conducting pathogenetic or clinical research. Only published reports of HPTs were included. Information was independently extracted by two reviewers by using a specially developed form with 87 items. Information on medicines, volunteers, ethics, sample, randomization, masking, experimental control, presentation of data, safety, interpretation of results, number of claimed findings and global methodological judgement were collected Methodological quality of published HPTs were assessed by a specially designed index, ranging from 4 to 16. 156 HPTs on 143 medicines, involving 2,815 volunteers, produced 20,538 pathogenetic effects. There was a large variation in methods and results. The number of published HPTs increased along the decades, but this was not followed by improvements in methodological quality. Most studies were of poor quality and showed flawed designs, mainly absence of proper randomization, blinding, placebo control and criteria for analysis of outcomes. Mean methodological score was 5,6 . Incidence of pathogenetic effects was noticed in 98% of publications and about 84% of volunteers receiving active treatment developed at least one symptom. More symptoms were reported from HPTs of poor quality than from better ones. Most investigators were homoeopathic physicians and a large proportion of volunteers was represented by students of homeopathy. Sample size (median 15, range 1-103) and trial duration (mean 34 days) were very variable. On average each volunteer contributed with 7,3 pathogenetic effects. Use of placebo control was variable, overall in 56% of trials volunteers took placebo, placebo symptoms were often not used as comparators, some investigators progressively abandoned the use of placebo. The quality of reports was in general poor, and much important information for analysis and reproducibility was not available. Validity and reliability of information gathered from HPT are fundamental for the success of homeopathic practice and clinical research. Due to major omissions and outstanding methodological problems it is not possible to draw definitive conclusions on whether homoeopathic medicines in high dilutions can provoke effects in healthy volunteers. There is an urgent need to develop and test sound methodological designs for HPTs and to properly describe their results, together with a critical analysis of outcomes informed in past publications.