Diabetic gastroparesis: Therapeutic options

Gastroparesis is a condition characterized by delayed gastric emptying and the most common known underlying cause is diabetes mellitus. Symptoms include nausea, vomiting, abdominal fullness, and early satiety, which impact to varying degrees on the patient’s quality of life. Symptoms and deficits do not necessarily relate to each other, hence despite significant abnormalities in gastric emptying, some individuals have only minimal symptoms and, conversely, severe symptoms do not always relate to measures of gastric emptying. Prokinetic agents such as metoclopramide, domperidone, and erythromycin enhance gastric motility and have remained the mainstay of treatment for several decades, despite unwanted side effects and numerous drug interactions. Mechanical therapies such as endoscopic pyloric botulinum toxin injection, gastric electrical stimulation, and gastrostomy or jejunostomy are used in intractable diabetic gastroparesis (DG), refractory to prokinetic therapies. Mitemcinal and TZP-101 are novel investigational motilin receptor and ghrelin agonists, respectively, and show promise in the treatment of DG. The aim of this review is to provide an update on prokinetic and mechanical therapies in the treatment of DG

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 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