Factors affecting dose selection and outcome of cisapride treatment for dyspepsia in primary care. The Austro-Cis Study Group.

BACKGROUND

Little is known about the prescribing habits and impact of life style or disease factors on the outcome of cisapride treatment for dyspepsia in primary care.

METHOD

In this large-scale open, multi-centre study in Austria, primary care physicians were asked to prescribe cisapride according to the current prescribing guidelines (standard dose, 5 mg t.d.s.; in case of severe symptoms, 10 mg t.d.s.). Symptom severity was rated by the physicians, after 4 weeks of treatment and after another 4 weeks of follow-up without medication. The global therapeutic result was given by both the physicians and patients.

RESULTS

Among the 3912 recruited patients, 60.0% received cisapride 5 mg t.d.s. and 38.5% received 10 mg t.d.s. The dose selection by the physicians was not only influenced by severity of the symptoms (significantly more patients with severe symptoms receiving the higher dosage when compared to those with milder symptoms (P < 0.001), but also other factors were associated with prescription of the higher dose: including heavy smoking, longer pre-existence of complaints and failing previous treatment. After 4 weeks of treatment, the dyspeptic symptoms improved in about 80% of patients, in both dosage groups. Four weeks after discontinuation of medication, 21% of patients still further improved, while 10% relapsed. The overall therapeutic outcome defined as the percentage of patients with good or excellent results was comparable in both dosage groups and appeared independent of the patient's characteristics, life style or disease factors. However, when only the proportion of "excellent' responders was analysed, this rate significantly decreased the longer the duration of symptoms, the heavier the smoking and with failing previous therapy. This effect was particularly seen with the patients' ratings.

CONCLUSIONS

Although the open-study design does not allow evaluation of the contribution of placebo-effect and calls for cautious interpretation, the data suggest that the use of flexible cisapride doses for management of dyspepsia in primary care results in a good acute and medium-term outcome, with apparently little dependence on life style and disease factors, at least when assessed by physicians.