Functional dyspepsia, delayed gastric emptying and impaired quality of life

Nicholas J Talley ^1*, G. Richard Locke III ¹, Brian Lahr ¹, Alan R. Zinsmeister ¹, Gervais Tougas ², Gregory Ligozio ³, Mikhail A. Rojavin ³ and Jan Tack ⁴

¹ Mayo Clinic, United States
² Novartis Pharmaceuticals Corporation, Canada
³ Novartis Pharmaceuticals Corporation, United States
⁴ University Hospitals Leuven, Belgium

^* To whom correspondence should be addressed. E-mail: talley.nicholas{at}mayo.edu.

Accepted 8 November 2005

Abstract

Background: It remains controversial whether delayed gastric emptying in functional dyspepsia (FD) is associated with a specific symptom pattern, and it is unknown if gastric emptying in FD is a driver of impaired health related quality of life (HRQOL). We aimed to evaluate the relationship between FD symptoms, gastric emptying (GE) and HRQOL.

Methods: U.S. patients (n=864, mean age 44 years (range 18-82), 74% female) with FD as defined by Rome II criteria were enrolled into one of four clinical trials. All patients had a baseline scintigraphic assessment of gastric emptying of an egg substitute meal, and the trials were stratified on this assessment. Delayed gastric emptying was defined as having at least 6.3% residual volume at 4 hours. 290 (34%) had delayed gastric emptying. HRQOL was assessed by the SF 36 and Nepean Dyspepsia Index (NDI).

Results: Postprandial fullness was independently associated with delayed gastric emptying but the association was weak (OR=1.98, 95% CI=[1.02, 3.86], p=0.04). No independent association was seen with epigastric pain, early satiety, nausea or bloating. The mean SF 36 physical composite score (PCS) was 42.3 (95% CI 41.6, 43.0) and the mean SF 36 mental composite score (MCS) was 46.8 (95% CI 46.0, 47.5); both mean scores were significantly lower than age- and sex-adjusted national norms of 50 (p<.0001). Female gender, increasing age, and higher symptom scores for fullness, epigastric pain and nausea were each independently associated with decreased PCS scores (all p<0.05). Higher baseline nausea symptom score, lower gastric emptying rates at 1 hour, and lower body mass index were associated with decreased MCS (all p<0.05). Female gender, epigastric pain and nausea, but not gastric emptying, were associated with an impaired score on the NDI. However, the magnitude of the significant associations were all small.

Conclusions: In patients with FD selected for a clinical trial program, gastric emptying did not usefully stratify them symptomatically. The quality of life of patients with FD enrolled in this clinical trial program was significantly impaired, but this was not explained by delayed gastric emptying.

Keywords: early satiety, functional dyspepsia, gastric emptying, quality of life

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