Effect of domperidone on the health-related quality of life of patients with symptoms of diabetic gastroparesis.

OBJECTIVE: To describe the health-related quality of life (HRQOL) of patients with insulin-treated diabetes and symptoms of diabetic gastroparesis and to assess the impact of domperidone on HRQOL in these patients. RESEARCH DESIGN AND METHODS: This two-phase multicenter study was part of a safety and efficacy investigation. Phase I involved 4-week single-blind treatment with domperidone 20 mg q.i.d. (n=269). Patients demonstrating significant symptomatic improvement (n=208) continued to phase 11, a 4-week, double-blind, parallel-group study with patients receiving placebo (n=103) or domperidone (n=105). Patients completed the Medical Outcomes Study Short-Form-36 Health Survey at selection and at the end of each phase. Physical component summary (PCS) and mental component summary (MCS) scores served as primary parameters, and the eight subscales were secondary parameters. RESULTS: HRQOL scores of subjects enrolled in the trial were significantly lower than norms from the general population and people with diabetes (P < 0.001). Subjects experiencing symptomatic improvement after 4 weeks of single-blind treatment demonstrated significant improvement in all HRQOL parameters (P < 0.001); PCS, MCS, and six subscale scores of nonresponders did not change. Between-group change score differences were significant for PCS, MCS, and seven subscales (P < 0.05 to P < 0.001). During phase II, the domperidone group maintained their HRQOL; the placebo group showed a significant decline in PCS and four subscales (P < 0.05). The between-group difference in the PCS score change was statistically significant (-1.77 vs. 0.65, P=0.05). CONCLUSIONS: Results suggest that patients with symptoms of diabetic gastroparesis experience notable HRQOL impairment and that symptomatic relief with domperidone is accompanied by improvements in HRQOL that can be sustained over 4 weeks of treatment.

Symptoms associated with gastroesophageal reflux disease: development of a questionnaire for use in clinical trials.

UNLABELLED: Many persons who suffer from GERD report additional symptoms, e.g., chest pain, dyspepsia, dysphagia, that are often not measured in clinical trials even though they may be distressing to the GERD sufferer. The primary goal of this study was to develop and assess the psychometric characteristics of a new GERD symptom scale measuring frequency, severity, and distress. The GERD Symptom Assessment Scale (GSAS) was administered to a sample of 169 GERD sufferers at baseline and two weeks. Internal consistency, construct validity, and test-retest reliability were assessed. Responsiveness was evaluated using clinical trial data assessing drug efficacy. RESULTS: Internal consistency was >0.80 for the symptom severity and distress scales. All three scales showed stability over two weeks (ICC >0.70). Both validity hypotheses were supported. Comparison of effect sizes showed the GSAS is sensitive to changes in severity of symptoms. In conclusion, the GSAS is a reliable, valid, and responsive measure of GERD symptoms.