Background & Aims We compared a high‐dose dual therapy (HDDT) with rabeprazole and amoxicillin and compared it with a standard triple therapy (STT) with rabeprazole, amoxicillin, and clarithromycin for 2 weeks for H pylori eradication in treatment naïve patients. Methods H pylori‐positive patients were randomly assigned to either a rabeparzole (Pariet) 20 mg b.i.d., amoxicillin (Ospamox) 1 g b.i.d. and clarithromycin (Klacid) 500 mg b.i.d. for 14 days or rabeprazole (Pariet) 20 mg q.i.d., amoxicillin (Ospamox) 1 g q.i.d. also for 14 days. Eradication was tested for by the C13‐UBT at least 4 weeks after the completion of therapy. Results H pylori was eradicated in 86.2% of patients (81/94) (95% CI: 77.8‐91.7) in the STT group compared with 92.8% (90/97) (95% CI: 85.9‐96.5) in the HDDT group on ITT analysis. On PP analysis, H pylori was eradicated in 91.0% of patients (81/89) (95% CI: 83.3‐95.4) in the STT group compared with 93.8% (90/96) (95% CI: 87.0‐97.1) in the HDDT group. Side effects were few although many patients in the STT arm complained of bitter taste. The HDDT arm was well tolerated by patients. Conclusions The HDDT gave a high eradication rate comparable to the STT for 2 weeks and was a well‐tolerated regimen for H pylori eradication.
Objective: Helicobacter pylori (H. pylori) treatment failures are difficult to treat. In this study we aimed to test the efficacy of two high-dose dual therapy regimens with or without bismuth for 2 weeks as a rescue therapy for patients with previous H. pylori treatment failure. Methods: H. pylori-positive patients were randomly assigned to either dexlansoprazole 60 mg twice a day and amoxicillin 1 g 4 times a day without (highdose dual therapy [HDDT]) or with colloidal bismuth subcitrate 240 mg twice a day (HDDT-Bi) for 14 days. Eradication of H. pylori was tested using the 13 C-urea breath test at least 4 weeks (HDDT) or 8 weeks (HDDT-Bi) after the completion of therapy. Results: H. pylori was eradicated in 84.6% (33/39) of patients (95% confidence interval [CI]: 70.3-92.8%) in the HDDT group, compared with 80.5% (33/41) (95% CI: 66.0-89.8%) in the HDDT-Bi group on an intention-to-treat (ITT) analysis, and in 89.2% (33/37) (95% CI: 75.3-95.7%) in the HDDT group compared with 82.5% (33/40) (95% CI: 68.1-91.3%) in the HDDT-Bi group on a perprotocol (PP) analysis. There was no significant difference in the eradication rates in both groups on ITT and PP analysis. Both treatment regimens were well tolerated. Conclusions: Adding bismuth to HDDT did not increase H. pylori eradication rates after treatment failure. HDDT and HDDT-Bi achieved a satisfactory eradication rate of more than 80% as rescue therapies. Both treatment regimens were well tolerated by patients and compliance with treatment was good.
Background Inflammatory bowel disease is an uncommon disease in developing nations whereby patient’s knowledge on the disease may be limited. The CCKNOW questionnaire, a widely known questionnaire to assess patient’s knowledge on the disease, may be too complex to comprehend for patients in developing countries. The aim of this study is to develop a new tool known as AIBDKQ questionnaire to evaluate the local inflammatory bowel disease patient’s knowledge. Methods This was a prospective study carried out in four phases. In phase 1, three gastroenterologists with expertise in IBD generated a total of 21 questions related to the general knowledge of the disease in the English language. Phase 2 involved content and face validity whereby the questions were further validated by other gastroenterologists. In phase 3, the validated questions were translated into three languages namely Malay, Mandarin and Tamil which are commonly used in Malaysia. In phase 4 (statistical validity), administration of the questionnaires to patients and hospital staff were conducted to assess the construct validity, discriminative ability, predictive validity and reliability of the questionnaires. Results A total of 21 questions were generated initially. Further evaluation indicated that 20 items had adequate kappa and content validity index for relevance (CVI: 0.714 to 1, Kapp: 0.645 to 1) and clarity (CVI: 0.714 to 1, Kapp: 0.645 to 1). The questionnaires in four languages were administered to 213 patients to assess the construct validity. Six items were removed (three for low communality, one for small loading factors, two for cross loading), resulting in 16 final questions. Assessment with 34 hospital staff involving nurses, doctors and clerks showed significant differences in knowledge between the groups (F = 14.007, p < 0.001) and were able to discriminate doctors from nurses and clerks. Another group of 18 hospital staff administered with AIBDKQ and CCKNOW questionnaires showed a Pearson’s correlation coefficient of 0.8 indicating strong correlation and concurrent predictive validity between the two questionnaires. Final assessment with 38 patients for reliability assessment revealed high intraclass correlation of the questionnaire among the four languages. Conclusions The AIBDKQ has an excellent discriminant ability and internal consistency with a strong correlation when compared to the standard CCKNOW questionnaire.
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