Self-reported adverse drug effects and associated factors among H. pylori infected patients on standard triple therapy: Prospective follow up study

Abstract

BackgroundOne of the most common reasons for poor medication adherence and associated treatment failure of triple therapy is adverse drug effect (ADEs) of medications.ObjectiveAssessment of ADEs and associated factors during H. pylori eradication therapy.MethodConsented H. pylori positive adult outpatients on standard triple therapy (proton pump inhibitor, amoxicillin and clarithromycin) were involved in this facility based follow up study from May 2016 to April 2018 at Bahir Dar city in Ethiopia. Pre-developed questionnaire and formats were used to collect sociodemographic, medical information, and patient practice data before, during, and after therapy. Bivariate and backward stepwise multivariate logistic regression was used to analyze data. P-value < 0.05 at 95%CI was considered as significant.ResultA total of 421 patients were involved in the study. Almost 80% of the patients were urban residents. Mean (±SD) age and body weight of patients were 30.63 (± 10.74) years and 56.79 (± 10.17) kg, respectively. ADE was reported from 26.1% of the patients and of all the reported ADEs, more than 85% was manifested with gastrointestinal symptoms which include gastrointestinal discomfort(39.1%), nausea (13.6%), constipation(12.7%), diarrhea(12.9%) and anorexia(10%). Determinants of self-reported ADEs among patients in the present study were body mass index above 25 (AOR: 2.55; 95%CI (1.21–5.38), p = 0.014), duration of acid-pepsin disorder more than 3weeks (AOR: 3.57; 95%CI (1.63–7.81), p = 0.001), pain feeling during long interval between meals (AOR: 2.14; 95%CI (1.19–3.84), p = 0.011), and residence in urban area (AOR: 1.95; 95% CI (1.04–3.67), p = 0.038).ConclusionSignificant proportion of patients reported ADEs which commonly manifested with gastrointestinal symptoms. Consideration of patients’ body mass index, duration of the disorder, period of the day when patients feel pain, and patients’ area of residence could help to reduce ADEs experienced during H. pylori eradication therapy.

The onset of ulcerative colitis upon Helicobacter pylori eradication in a 72-year-old woman: report of a rare case with a 3-year follow-up

“…Unfortunately, our patient suffered from ADRs and the therapy had to be stopped after 7 days. Eradication therapy ADRs are relatively common and expected [ 23 ], so a second eradication attempt was planned 2 months later after penicillin allergy and H. pylori antibiotic sensitivity testing to plan the optimal treatment strategy [ 24 ]. Unfortunately, bloody diarrhea developed on the 5th day, and colonoscopy revealed pancolitis that was initially considered either antibiotic-associated or hemorrhagic.…”

Complete symptom resolution as predictor of Helicobacter pylori eradication and factors affecting symptom resolution: Prospective follow up study

“…This practice has been described to have more clinical importance in developing countries where testing of H. pylori after eradication therapy is infeasible due to several reasons mainly patients economic status. Although this study was part of our previous studies done to assess eradication rate and self-reported adverse drug effects, it was completely different in its objective, method and data analysis, following which the findings and associated implications were different [27,28].…”

The Role of Probiotics in the Eradication of Helicobacter pylori and Overall Impact on Management of Peptic Ulcer: A Study Involving Patients Undergoing Triple Therapy in Bangladesh

“…Diarrhea, constipation, nausea, vomiting, epigastric pain, flatulence, metallic taste, and pain in the abdomen, especially in the epigastric region, are frequently occurring adverse drug reactions (ADRs) following SST therapy to combat H. pylori infection [86,87]. Another study revealed that over 26% of the research participants had experienced ADRs [88]. Among them, 85% had gastrointestinal issues, such as gastrointestinal distress, nausea, uncomfortable or infrequent bowel movements (typically less than three times per week), loose motions, stomach upset, an eating disorder frequently accompanied by unrestrained body weight loss, and headache [88,89].…”

“…Another study revealed that over 26% of the research participants had experienced ADRs [88]. Among them, 85% had gastrointestinal issues, such as gastrointestinal distress, nausea, uncomfortable or infrequent bowel movements (typically less than three times per week), loose motions, stomach upset, an eating disorder frequently accompanied by unrestrained body weight loss, and headache [88,89]. Another study revealed that over 45% of participants encountered principally gastrointestinal ADRs [90].…”