Medical Inspection – Health Blog

A total of 103 patients were initially enrolled in the study. Of these, 51 were in the omeprazole once daily arm and 52 were allocated to the omeprazole twice daily arm. Three patients were lost to follow-up immediately after the first visit and were excluded because it was not known whether any medi­cations had been taken. Two of these were from the omeprazole once daily arm and one was from the omeprazole twice daily arm. Thus, the total ITT population was 49 in the omeprazole once daily arm and 51 in the omeprazole twice daily arm. Demographic data were similar in both ITT groups (Table 1). Patient diagnoses were not significantly different by %² (P=0.23), and sex distribution was the same (P=0.43).

Three patients in the omeprazole once daily arm took all their medications but did not have a final assessment and were excluded from the APT analysis but included in the ITT analysis. Reasons for drop out were that one patient was too busy and refused any final assessment, one moved away and the last was unreachable despite many attempts. Two patients in the omeprazole once daily arm took only half of their metronidazole pills by error. Because they were non- compliant, they were excluded from PP analysis, but a final assessment was available in both. H pylori was eradicated in one and persisted in the other. The patient in whom H pylori persisted was the only patient in this arm who had also re­ceived previous treatment and had received omeprazole and clarithromycin dual therapy.

TABLE 1 Demographics of patients treated for seven days with clarithromycin and metronidazole plus either omeprazole once daily (O1CM) or omeprazole twice daily (O2CM)

Three patients in the omeprazole twice daily group who took their medications were excluded from APT analysis be­cause final assessment was not done. One woman developed obstructive jaundice shortly after she completed her pills and pancreatic cancer was subsequently diagnosed. Another pa­tient developed diabetic foot ulcers and was admitted to a hospital in another city; he was treated with confounding antibiotics and developed Clostridium difficile diarrhea that required treatment with metronidazole. The last patient felt well and refused further assessment. Three patients were ex­cluded from PP analysis – one for noncompliance because only half the prescribed metronidazole was taken by error, and the other two for protocol violations. One had a con­founding, 10-day course of penicillin for a salivary gland in­fection prescribed by a family practitioner, and the other had persistent symptoms and was given another 10-day course of omeprazole, clarithromycin and metronidazole by the family practitioner.

TABLE 2 Eradication efficacy of seven days’ treatment with clarithromycin and metronidazole plus either omeprazole once daily (O1CM) or omeprazole twice daily (O2CM)

Two patients in the omeprazole twice daily arm had been treated previously, both with omeprazole, clarithromycin and amoxicillin triple therapy. One had successful H pylori eradication, while H pylori persisted in the other patient who also took only half the metronidazole dose by error. Eradication rates: Whether omeprazole was given once or twice daily in combination with clarithromycin and metronidazole for one week, the eradication efficacy was no different between treatments (Table 2). Side effects and safety: Side effects were reported spontane­ously and not elicited through a structured questionnaire. The frequency and type of side effects did not vary between treatments (Table 3). At least one side effect was reported by the majority (65% to 69%) of patients. The most commonly reported side effects were loose stools and taste disturbance, but these were minor and did not prevent completion of med­ications. Overall, compliance with medications was excel­lent, with 94% of patients able to complete 100% of their pills (Table 1).Only one of 100patients (1%) stopped taking medications due to drug side effects. This patient had to stop taking the metronidazole due to excessive perspiring after completing 88% of the metronidazole. Laboratory parame­ters assessed did not change significantly with drug therapy (data not shown).
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TABLE 3 Side effects of seven days’ treatment with clarithromycin and metronidazole plus either omeprazole once daily (O1CM) or omeprazole twice daily (O2CM) (intent-to-treat population)

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