THE AMBULATORY pH STUDY IS NORMAL, BUT THE PATIENT IS NOT—THE IMPORTANCE OF THE SYMPTOMS INDEX

ABSTRACTThe authors conducted a double blind, crossover, placebo controlled trial of Omeprazole 20 mg twice daily versus placebo in patients with heartburn and regurgitation with normal esophagoscopy and esophageal acid exposure during ambulatory pH monitoring of less than 5% of the total monitoring time who had at least one symptom episode during the pH monitoring period. The authors calculated a symptom index using previously described cutoff of 50% as indicating positive or negative (1). Each crossover period was 4 wk and the trial was done in a randomized, double blind fashion. Patients completed the SF-36 Quality of Life questionnaire (a well-validated instrument that gives a score for each of eight quality of life parameters) at the start of the trial and at 4 and 8 wk. Heartburn and regurgitation were graded on a scale of 0–3 from absent to severe. Patients were also evaluated for other upper gastrointestinal symptoms, including epigastric discomfort, postprandial fullness, early satiety, anorexia, nausea, belching, vomiting, pain on swallowing, nocturnal cough, and nocturnal wheeze. Subjects were asked at 4 and 8 wk whether they were the same, better, or worse compared to the previous 4 wk and given a score of 0, +1, and −1, respectively. Alginate tablets were allowed, and the number used was recorded on a diary card. Patients also recorded symptom frequency on a daily diary card. Statistical comparisons were by paired sign tests, except for the Quality of Life tests which were done by paired t-tests.Over a 1-yr period, 44 of 244 patients (18%) were found to have an acid-sensitive esophagus. Nineteen were recruited for the study. Fifteen were excluded because of distance from the study sight, and the remaining 10 were excluded for reasons not revealed. Thirteen had positive symptom index and six negative. Six were men, 13 women, mean age was 41.7 yr. Two patients dropped out because of severe symptoms or unacceptable side effects. These two were regarded as treatment failures and included in the final analysis.Twelve of the 18 patients had a better overall improvement of symptoms with Omeprazole 20 mg bid compared to placebo (p < .01). Only one patient was worse on Omeprazole compared to placebo with five reporting no difference. Quality of Life scores showed improvement in parameters of bodily pain and vitality on Omeprazole compared to placebo with no difference in the other six scores (physical function, general health, emotional role, physical role, social function, mental health). Ten of 12 (83%) with a positive symptom index reported a better overall level of improvement with Omeprazole compared to placebo (p < .02). In the patients with a negative symptom index, there was no significant difference compared to the two groups. Heartburn and regurgitation decreased in the positive symptom index group (p < .01) on Omeprazole as did the average number of days per week when alginate tablets were needed. The average number of days per week with symptoms was 4.75 on Omeprazole and 5.8 on placebo (p < .01). Alginate tablets were used an average of 3 days per week in Omeprazole and 5.21 in the placebo group (p < .01). The other upper gastrointestinal symptoms showed no significant difference between the two treatment groups. It is of interest that Quality of Life scores improved significantly from baseline in vitality, social function, physical role, emotional role, and bodily pain on Omeprazole, but not on placebo.