Therapeutic encounter: evaluation of an integral approach in patients with functional dyspepsia, randomized controlled clinical trial

INTRODUCTION: This study aims to evaluate, in patients with functional dyspepsia, a type of medical care that has the support of a larger epistemological basis (therapeutic encounter) compared with standard medical care grounded in the biomedical model (medical consultation). It begins with a discussion where theories and definitions on the topic "epistemological pluralism" are described. The author believes that this is the foundation capable of providing the necessary support for the critical exercise of professional activity in a more humane and humanistic basis, and for a health research capable of the integration of multiple areas of knowledge. Then he describes the steps that transform "consultation" in "therapeutic encounters." According to the author, this transformation enables the rescue of the characteristics of the art of medicine. Art in the sense of artisanal (the "tailor made") instead of biomedicine that is technical (in the sense of systematic, generalized). METHODS: This was a randomized, placebo-controlled clinical trial, registered in ClinicalTrials.gov., held from November 2007 to February 2012. 131 patients with functional dyspepsia were recruited from 753 volunteers belonging to the Gastroenterology outpatient clinic of Faculdade de Medicina do ABC. These patients were divided into two groups A and B, where group A (n = 63) was treated with traditional medical consultations and group B (n = 68) with therapeutic encounters. These two groups were divided into 4 subgroups A1, A2, B1 and B2, where the subgroups A1 (n = 31) and B1 (n = 34) received omeprazole, A2 (n = 32) and B2 (n = 34) received placebo. All patients answered the Questionnaire Symptoms of Functional Dyspepsia (QSFD) at study entry. Those patients who completed treatment answered the QSFD again in the end (six months after the onset). The outcome variable was defined as a reduction of 50% and more on the score obtained between the first and second application of QSFD. RESULTS: 1) There were no differences between the groups and subgroups with respect to the number of patients, according to the distribution by gender, age and frequency of use of rescue medication. 2) Among the 131 patients in the study 74 (56.5%) completed treatment and 57 (43.5%) dropped out before completion. There is no significant difference between groups A (n = 30) and B (n = 44) as the proportion of patients who completed their treatment (p = 0.076). 3) In subgroups B1 and B2, 79.5% and 80% of patients, respectively, achieved a reduction of 50% and more in the score QSFD, against only 22.2% and 41.7% of patients in subgroups A1 and A2. The difference between the groups is significant (p <0.001). CONCLUSIONS: In this study the "therapeutic encounter" was (2.65 times) more effective than “traditional medical consultation". Technical excellence is fundamental to good medical practice, but it is more effective when combined with art.