ABSTRACT
BACKGROUND: Acid suppressants such as H2 blockers and proton pump inhibitors are often used for the treatment of non-ulcer dyspepsia, also known as functional dyspepsia. This study evaluated the efficacy of different doses of lansoprazole for the treatment of non-ulcer dyspepsia.
POPULATION STUDIED: The patients in this study (335 women and 118 men) were all Chinese, aged 18 to 80 years, and had been referred to an endoscopy unit. All patients had a normal upper gastrointestinal endoscopy and had had functional dyspepsia for at least 12 weeks during the previous 12 months. Functional dyspepsia was defined as persistent pain or discomfort in the upper abdomen with no evidence of organic disease, irritable bowel syndrome, or chronic severe constipation. Patients were excluded if they had classical acid regurgitation as their only symptom, or had used any acid suppressants, nonsteroidal anti-inflammatory drugs, or antibiotics in the previous 4 weeks. To be eligible for the study they had to have moderate symptoms defined by a dyspepsia score in the preceding 2 weeks.
STUDY DESIGN AND VALIDITY: This randomized controlled trial was triple blinded (the managing physicians, patients, and investigators were all blinded). The 453 patients were randomized to receive placebo or lansoprazole 15 or 30 mg daily for 4 weeks. Patient compliance was satisfactory and checked by pill counting.
OUTCOMES MEASURED: The outcomes assessed were dyspepsia and quality-of-life scores, and complete relief of symptoms. The dyspepsia score was calculated from a questionnaire that comprised 12 questions relating to dyspepsia, each of which was graded on a 5-point Likert scale. The quality-of-life score was assessed from the Short Form (SF-36) Health Survey, which contains 11 items related to general well-being.
RESULTS: Significant improvement in the dyspepsia scores at 4 weeks was noted in each of the 3 groups. The changes in dyspepsia score from baseline to the 4-week visit were similar between lansoprazole 30 mg and placebo, and lansoprazole 15 mg and placebo (approximate change from 22 at baseline to 18.7 out of a possible 60 points at 4 weeks). The changes in mean quality-of-life score from baseline to the score at 4 weeks were also similar for both doses of lansoprazole and placebo (approximate change from 60 to 64.8 out of a possible score of 100 at 4 weeks). No difference was noted in the proportion of patients with complete symptom relief between the lansoprazole groups (23%) and the placebo group (30%). Even when the results were analyzed in groups according to the severity of the dyspepsia, there was still no difference in complete relief of symptoms between the 3 groups.
Patients with functional dyspepsia, which involves no organic disease and no reflux, do not benefit from lansoprazole, a proton pump inhibitor. Any improvement seen is probably related to a placebo effect. Prescribing proton pump inhibitors for these patients just for their placebo effect is going to further raise health care costs. Antacids and H2 blockers are less expensive alternatives.