Toxicology and safety of the tincture of Operculina alata in patients with functional constipation

The tincture of Operculina alata, popularly known as "tincture of jalapa", is used in Northeast Brazil to treat constipation and encephalic vascular accident, but it has not yet been adequately tested for safety and efficacy. The aim of this study was to evaluate the toxicology and safety of the tincture of O. alata in patients with functional constipation. This was a double-blind, randomized, placebo-controlled clinical trial. The study consisted of three phases: pre-treatment, treatment and post-treatment, each phase with duration of seven days. Arterial pressure, heart rate, body weight, adverse events, hematological, metabolic, liver and kidney functions were monitored. Forty patients were randomized to receive tincture of O. alata and 43 patients to receive placebo. There were statistical differences in the clinical aspects between groups, but these changes were not considered clinically significant. Adverse events were considered not serious and of mild intensity, especially dizziness, headache, abdominal pain and nausea. This clinical trial confirmed the safety of the tincture of O. alata in the pharmaceutical form and dosage tested, allowing the product to be safely used in a larger population for the assessment of its clinical efficacy. A tintura de Operculina alata, popularmente conhecida como "tintura de jalapa", é usada no Nordeste do Brasil para tratar constipa o intestinal e acidente vascular encefálico, mas sua eficácia e seguran a ainda n o foram confirmadas. O objetivo deste estudo foi avaliar a toxicologia e seguran a da tintura de O. alata em pacientes com constipa o intestinal funcional. Este foi um ensaio clínico duplo-cego, randomizado e controlado por placebo. O estudo consistiu de três fases: pré-tratamento, tratamento e pós-tratamento, cada fase com dura o de sete dias. Foram monitorizados a press o arterial, frequência cardíaca, peso corporal, eventos adversos e fun es hematológica, metabólica, hepática e renal. Quarenta pacientes foram randomizados para receber tintura de O. alata e 43 pacientes para receber placebo. Houve diferen as estatísticas nos aspectos clínicos entre os grupos, contudo, estas mudan as n o foram consideradas clinicamente significativas. Eventos adversos foram considerados n o sérios e de leve intensidade, especialmente, cefaléia, tontura, dor abdominal e náusea. Este ensaio clínico confirmou a seguran a da tintura de O. alata na forma farmacêutica e dosagem testada, permitindo que o produto seja testado em popula o maior para determinar sua eficácia clínica.