Ensaios clínicos de fase II para avaliação da eficácia de um fitoterápico composto (Schinus terebinthifolius raddi; plectranthus amboinicus Lour e Eucalyptus globulus Labill) no tratamento das dispepsias

Abstract

The phytotherapeutic agent prepared with the medicinal plants Schinus terebinthifolius Plectranthus amboinicus and Eucaliptus globulus is a herbal medicine produced in Paraiba and selied through all the northeastern states of Brazil by more than a century, being employed in several indications for external and internal use. Pre-clinical and clinical toxicological studies camed out with healthy volunteers by investigators from the Laboratório de Tecnologia Farmacêutica, have proved its safety use in the recognized doses. The aim of this study was to carry out phase II clinical trial in order to test the phytotherapeutic agent efficacy in the treatment of dyspepsia. Clinical trial and laboratonal analyses were carried out in the Hospital Universitário Lauro Wanderley /UFPB in fourteen men and sixteen women, ages varying from 21 to 55 years presenting dyspeptic symptoms, any abnormality in the esofagogastroduodenal mucosa detected by an initial endoscopy and no abnormalities in clinical, laboratorial or electrocardiographic exams. The volunteers were submitted to endoscopy and biopsies from antral mucosa in order to perform urease test and hystopathological examination, hematologic blood biochemical exams and electrocardiogram before and after the treatment The phytoterapeutic agent was given in a single dose of 30 miday for 4 weeks. for patients with gastritis, the dose was increased to 45 mi/day for 6 weeks for patients with peptic ulcer or oesofagitis. Proper formulary and questionnaire of symptoms were elaborated in order to register cinical evolution and symptoms follow up accompaniment in 3 different times of evaluation: the initial appointment, 10 days after treatment and the final appointment after complete treatment. Besides dyspepsis, the volunteers were diagnosed with different pathologies, and gastritis non erosive was the predominant endoscopic diagnostic Gastritis non-erosive was present in 50% of male and 56% of female volunteers. Helicobacter pylon was present on antral gastric mucosa in 71,4% of the male and 62.3% of feminine volunteers. All volunteers refereed Improvement of dyspeptic symptoms, with a reduction of about 80% of the intensity of the symptoms related to the initial appointment, in both genders None refereed any adverse reaction with the use of the phytotherapeutic agent Endoscopic alterations have shown improvement only in women. The phytotherapeutic did not alter tests for detection of Helicobacter pylori when it was present in the initial test and caused no clinical, electrocardiographic or laboratorial alteration in volunteers relating to the initial exams. It's possible to conclude that: 1) The phytotherapeutical studied presented efficacy for the treatment of symptoms in organic and functional dyspepsia, 2) Its use is safe in dyspeptic patients and 3) It may be useful in the symptomatological therapy of dyspepsia, with some advantages over inhibitors of the acid secretion, in patients in expectation for the endoscopic examination with investigation for Helicobacter pylori infection because of its low cost, and it didn't interfered with the diagnostic test for the microorganism.