Engidaworku, EphremGebeyehu, Endalew2022-06-082023-11-062022-06-082023-11-062021-09http://etd.aau.edu.et/handle/123456789/31969Background: Helicobacter pylori eradication based on standard triple therapy (STT) has been accepted to curb risks associated with H. pylori infection, commonly chronic gastritis and peptic ulcer disease. However, rate of eradication of H. pylori with triple therapy has been claimed to be below the recommended level due to several factors such as adverse drug effects (ADEs) and its determinants. ADEs during triple therapy may initiate poor medication adherence, which in turn reduces rate of eradication and associated patient outcomes. Evaluation of symptom resolution after H. pylori eradication therapy is the most common clinical practice in Ethiopia. As a result, studies that aimed at assessment of the rate of H. pylori eradication with STT, incidence of ADEs, status of symptom resolution after therapy and predictors for each of these consequences can have paramount importance in improving eradication therapy based on triple therapy regimen. Methods: STT based on a proton pump inhibitor, amoxicillin and clarithromycin was given to consented H. pylori positive adult outpatients in this facility based follow up study from May 2016 to April 2018 at Bahir Dar city in Ethiopia. Pre-developed structured questionnaire as used to collect anthropometric, sociodemographic and clinical data before and after eradication therapy. Eradication was confirmed with H. pylori monoclonal stool antigen test conducted after the end of 4–6 weeks of standard triple therapy. Data was analyzed by using descriptive statistics, chi-square test, bivariate and backward LR multivariate logistic regression. Significance was considered when p-value is less than 0.05 at 95%CI.Results: A total of 421 patients who completed follow up were involved in this study. The overall H. pylori eradication rate was 90.02% (379/421). Self-reported ADE was the only factor associated with H. pylori eradication rate with adjusted odds ratio of 2.92 (95%CI; 1.52-5.59, p < 0.001). Nearly a quarter (26.1%) of the patients reported ADEs and of all the reported ADEs, more than 85% were revealed as gastrointestinal symptoms, including gastrointestinal discomfort (39.1%), nausea (13.6%), diarrhea (12.9%), constipation (12.7%), and anorexia (10%). Predictors of self-reported ADEs were failure of eradication therapy (AOR: 12.64; 95% CI [3.29 - 48.53], p=0.001), body mass index above 25 (AOR: 2.82; 95%CI [1.26 - 6.31], p = 0.011), pain feeling during long interval between meals (AOR: 2.18; 95%CI [1.20 - 3.98], p = 0.011), failure to achieve complete symptom resolution (AOR: 5-19; 95%CI [1.46 - 18.50], p =0.011) and duration of acid-pepsin disorder more than 3weeks (AOR: 3.67; 95%CI [1.62 - 8.29], p = 0.002). Patients who achieved complete symptom resolution were 84.3%, which was lower than the overall H. pylori eradication rate of 90.02%. Positive predictive value and negative predictive value of complete symptom resolution after H. pylori eradication therapy was 98.9% (351/355) and 57.6%(38/66), respectively. Being non-user of traditional homemade supplements prepared from Fenugreek and/or Flaxseed (AOR: 2.14 95%CI [1.25 - 3.65], p = 0.005) was the only factor associated with complete symptom resolution. Conclusions: Modification or replacement of the STT observed in different healthcare institutions are not evidence-based since eradication of H. pylori with STT is still within the recommended level for clinical practice. Self-reported ADEs manifested with gastrointestinal symptoms are common during STT. Self-reported ADEs affect H. pylori eradication therapy. Body mass index, time duration of acid-pepsin disorder, pain feeling period in a day, eradication status and symptom resolution are determinants of self-reported ADEs. Success of H. pylori eradication is predictable with complete symptom resolution. Use of traditional food supplements prepared from Fenugreek and/or Flaxseed during eradication therapy affects status of symptom resolution. Key words: H. pylori eradication rate, Adverse drug effects, Predictive values, Complete symptom resolution, Associated factorsen-USH. pylori eradication rate, Adverse drug effects, Predictive values, Complete symptom resolution, Associated factorsThesis