Is gastric electrical stimulation superior to standard pharmacologic therapy in improving GI symptoms, healthcare resources, and long-term health care benefits?

CONTEXT: Severe upper gastrointestinal (GI) motor disorders, including gastroparesis (GP), can consume significant health care resources. Many patients are refractory to traditional drug therapy. OBJECTIVE: To compare symptoms, healthcare resource utilization and costs in two groups of patients with the symptoms of GP: those treated via gastric electrical stimulation (GES) and those treated with traditional pharmacological agents in an intensive outpatient program (MED). DESIGN: A long-term comparison of patients with devices (n = 9) vs intensive medical therapy (n = 9). SETTING AND PATIENTS: A total of 18 eligible patients with the symptoms of GP reported for 1-year baseline and long-term treatment for 3 years. INTERVENTIONS: Patients with the symptoms of GP were treated by a GES or intensive medical therapy (MED). MAIN OUTCOME MEASURES: GP Symptoms, healthcare resource utilization using investigator-derived independent outcome measure score (IDIOMS) and total hospital (inpatient and outpatient) billing costs. RESULTS: Gastrointestinal symptoms were significantly different from baseline (F = 3.03, P < 0.017) with GP patients treated via GES showing more sustained improvement over 36 months than those treated via MED. Healthcare resource usage, measured via the IDIOMS, significantly improved at 12, 24 and 36 month follow-up for GES patients (F = 10.49, P < 0.001), compared with patients receiving medical therapy, who demonstrated further deterioration. GP patients treated via GES also proved superior to medical therapy at 24 and 36 months with regard to decreased costs (F = 4.85, P < 0.001). Within group comparisons indicated significantly reduced hospital days for both patient groups; however, no statistical differences were noted between groups in terms of hospital days. Three of nine patients in the MED group died primarily from i.v. access related problems; none of the GES patients died. CONCLUSION: We conclude that GES is more effective in improving long-term GI symptoms and costs, and decreasing use of healthcare resources than intensive medical therapy, in this sample of patients with the symptoms of GP followed for 3 years. Certain patients with GP form a high-risk group in terms of costs, quality of life, morbidity and mortality.

Effect of cisapride therapy for severe dyspepsia on gastrointestinal symptoms and quality of life.

Quality of life measures have received little attention in evaluation of therapy for dyspepsia. To examine the effect of cisapride on gastrointestinal symptoms and quality of life measures, we studied eight patients with chronic, severe dyspepsia, before and after therapy with cisapride (20 mg three times daily) for 12 months. Gastrointestinal (GI) Total Symptom Score (TSS), Overall Patient Assessment (OPA), and quality of life by both trait (Minnesota Multiphasic Personality Inventory (MMPI)) and physical function (Sickness Impact Profile (SIP)) were measured at base line and at month 12 of cisapride therapy. Results showed significant improvement in TSS, OPA, and the MMPI Depression and Anxiety scales (all, p < 0.05). Improvement in the SIP physical dimension score approached significance (p = 0.065). We conclude that, in this group of patients with severe dyspepsia, both GI symptoms and quality of life measures improved with 12 months of cisapride therapy. These quality of life measures may prove useful in evaluating the efficacy of drug treatment for dyspepsia.

Symptom improvement from prokinetic therapy corresponds to improved quality of life in patients with severe dyspepsia.

Prokinetic therapy has been shown to improve patients' symptoms associated with gastrointestinal motility disorders and quality of life. This study investigated the correlation between clinical improvement and quality of life after 12 months of treatment with cisapride or domperidone in patients with severe dyspepsia. Psychological and quality-of-life measures were assessed at baseline and after 12 months of therapy using three patient-administered, standardized questionnaires: the Minnesota Multiphasic Personality Inventory, the Millon Behavioral Health Inventory, and the Sickness Impact Profile. Changes in clinical symptoms were correlated with changes in these measures. Twenty-seven patients with symptoms of severe dyspepsia were treated with cisapride or domperidone (60-80 mg/day) for 12 months. Symptoms and quality-of-life measures were improved at the end of therapy. There were significant correlations between improvement in clinical symptoms and improvement in quality of life parameters. Patients with more marked symptom improvement had more significant improvements in quality of life measures. We conclude that prokinetic therapy improved symptoms and quality of life. Standardized questionnaires can be used to quantify response to prokinetic therapy and to individualize treatment regimens for patients with dyspepsia who have specific psychologic or behavioral characteristics.

Predominant symptoms in irritable bowel syndrome correlate with specific autonomic nervous system abnormalities.

BACKGROUND/AIMS: Irritable bowel syndrome may be influenced by the autonomic nervous system. Abnormalities in autonomic function, colon transit time, and psychological profiles in 21 patients were assessed. METHODS: Using modified Manning criteria for irritable bowel syndrome, patients were classified as constipation-predominant or diarrhea-predominant. Autonomic function was determined by one vagal cholinergic and two sympathetic adrenergic measures. Colon transit was assessed by radiopaque markers, and psychological profiles were determined by three inventories. RESULTS: Autonomic function tests showed that diarrhea-predominant subgroup values for one sympathetic adrenergic measure (postural adjustment ratio) were significantly different from controls (P < 0.01). Constipation-predominant subgroup values were significantly lower for the vagal cholinergic measure R-R interval (P < 0.05). Colon transit measures differed by subgroup in left, right, rectosigmoid, and total colon transit times. Both subgroups differed significantly from controls on psychological measures; the constipation subgroup showed more psychological distress. CONCLUSIONS: Irritable bowel syndrome specific-symptom subgroups had different patterns of autonomic functioning, colonic transit, and psychological measures. The constipation subgroup is associated with a cholinergic abnormality and the diarrhea-predominant subgroup with an adrenergic abnormality. These findings suggest specific associations between the autonomic nervous system, predominant physical symptoms, colon transit time, and psychological factors in patients with irritable bowel syndrome.