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

Abstract

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. Uniterms:Operculina alata/pharmacognosy. Operculina alata/tincture/toxicological evaluation. Operculina alata/tincture/safety. Tincture of Jalapa see Operculina alata/tincture.A tintura de Operculina alata, popularmente conhecida como "tintura de jalapa", é usada no Nordeste do Brasil para tratar constipação intestinal e acidente vascular encefálico, mas sua eficácia e segurança ainda não foram confirmadas. O objetivo deste estudo foi avaliar a toxicologia e segurança da tintura de O. alata em pacientes com constipação 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 duração de sete dias. Foram monitorizados a pressão arterial, frequência cardíaca, peso corporal, eventos adversos e funções hematológica, metabólica, hepática e renal. Quarenta pacientes foram randomizados para receber tintura de O. alata e 43 pacientes para receber placebo. Houve diferenças estatísticas nos aspectos clínicos entre os grupos, contudo, estas mudanças não foram consideradas clinicamente significativas. Eventos adversos foram considerados não sérios e de leve intensidade, especialmente, cefaléia, tontura, dor abdominal e náusea. Este ensaio clínico confirmou a segurança da tintura de O. alata na forma farmacêutica e dosagem testada, permitindo que o produto seja testado em população maior para determinar sua eficácia clínica. Unitermos:Operculina alata/farmacognosia. Operculina alata/tintura/avaliação toxicológica. Operculina alata/tintura/segurança. Tintura de Jalapa see Operculina alata/tintura.

Glycosidic Acid Content from the Roots of Operculina hamiltonii (Brazilian Jalap) and Some of Their Phytopharmaceuticals with Purgative Activity

“…S16). Preclinical studies confirmed its laxative action in mice (Michelin and Salgado 2004;Gonçalves et al 2007) and the lack of toxicity in patients (Cunha et al 2011;Santos et al 2012).…”

Toxicological Evaluation of Methanolic Extract of Vetiveria Zizanioides Roots in Male and Female

“…The general public is largely unaware that adverse effects can be associated with the use of herbal drugs resulting from overdosing, contaminated formulations to the inherent toxicity of the herbs of choice (Hazel et al, 1999). The safe use of herbal drugs requires knowledge of their chemical properties and possible adverse effects (Santos et al, 2012). However, it should be a cardinal requirement to find the toxic effects of some of the major substances present in the plants when considering for public health protection because it can be hazardous and results to adverse effects on human being (Asante-Duah et al, 2003;Bellini et al, 2008).…”

“…Despite knowledge of biological activities of V. zizanioides roots, toxicological studies are not reported so far. With the continuous increase in the use of herbal medicines worldwide, the safety and quality of herbal medicines have become a major concern (Santos et al, 2012). Hence, preclinical acute and sub-acute toxicological evaluations using Organisation for Economic Cooperation and Development (OECD) guidelines need to be undertaken to establish safety profiles of drugs of herbal origin (Jadeja et al, 2011;OECD.…”

“…2001;Joshi et al2007). Plant materials are used throughout the world as home remedies or raw materials for the pharmaceutical industry and represent a substantial proportion of the global drug market (Santos et al, 2012). The present study therefore aims to investigate the acute and sub-acute oral toxicity of MEVZ in animal models.…”