Abstract
BackgroundUlcer remains a health challenge worldwide with antibiotics and proton pump inhibitors as major management therapy. The study investigated the acute, sub-chronic toxicity and gastrointestinal protective activity of a polyherbal formulation (Mystomate4®) used locally in Nigeria.MethodsOral LD50 and the sub-chronic toxicity test were determined in mice and rats. Mice were grouped into 8 groups of 8 mice each. They were dosed a graded concentration of the formulation (1.28, 2.56; 5.12; 10.24; 20.48; 40.96; 81.92; 163.84 g/kg body weight). The graded dose used was arrived at after an initial pilot study. Thereafter doses were chosen around the dose obtained from the pilot study. Animal were dosed orally and observed for sign of toxicity and number of death recorded after 24 h. The sub-chronic toxicity study was carried out for 3 months in rats at a dose of 2.5 and 5.0 g/kg body weight arrived at by titrating down the LD50 value after which some vital tissues were harvested and assessed for toxicity using relevant biomarkers. Anti-ulcer activity was evaluated in rats using ethanol, indomethacin and pylorus ligation induced ulcer models. Data were analysed with Graph Pad Prism version 5.0 using appropriate statistical method and significant level placed at p ≤ 0.05.ResultsThe acute toxicity study showed an LD50 result of 22,837.21 g/kg. The sub-chronic toxicity study resulted in a significant reduction in body weight due to significant decrease (p ≤ 0.05) in feed consumption. Biochemical analyses of the blood samples showed a significant increase (p ≤ 0.05) in creatinine and albumin level in the 2.5 mg/kg female group. ALT was significantly increased in all the treated rats except in 2 mg/kg female rats. Alkaline phosphatase significantly increased in high dosed male (HM) group while blood urea:creatinine ratio was significantly lowered in all the treated groups. There was a significant increase in serum TGL in all rats while LDL was significantly increased and decreased in HM and high dosed female (HF) respectively.ConclusionMystomate4® showed significant protection against ethanol and indomethacin-induced ulcer models but did not modify the gastric parameters in pylorus ligation-induced ulcer model. The polyherbal formulation is nontoxic with promising potentials for treating experimental peptic ulcer.
Highlights
Ulcer remains a health challenge worldwide with antibiotics and proton pump inhibitors as major management therapy
The true prevalence of peptic ulcer in Nigeria is unknown, report showed that peptic ulcer disease is very common in Africa with an estimated prevalent rate of 70 to 90% especially among young adults contrary to what was obtainable in Europe where prevalence is higher among adults above 40 years of age [2,3,4,5]
Acute oral toxicity study of Mystomate4® Highest number of deaths was recorded at very high doses
Summary
Ulcer remains a health challenge worldwide with antibiotics and proton pump inhibitors as major management therapy. The prevalence has been attributed to the changing prevalence of Helicobacter pylori (H. pylori) infection, the increasing use of non-steroidal anti-inflammatory drugs, and the aging population [1,2,3]. Peptic ulcer was reported as one of the world’s major gastrointestinal disorders. Treatment includes the use of antibiotics, antiacids and discontinuation of the ue of non steroidal anti inflammatory drugs (NSAIDs) which could provoke its development. Disease causing microbes are fast developing resistance to the lines of antibiotics commonly prscribed [6], and the quest for new and more effective drugs for use. Many medicinal plants and other naturally products are continuously been screened for their potential in developing new and more effective drugs. There is the need to evaluate these products for possible toxic effect on the body systems when consumed by man or his animals
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
