Table 2.
Characteristics of randomised controlled trials of management strategies for uninvestigated dyspepsia
| Study | Country, setting, and duration of follow-up | Characteristics of included participants | No of participants in each trial arm and management strategies used |
|---|---|---|---|
| Bytzer 199413 | Denmark, primary care, 12 months | 414 participants ≥18 years, mean age 44 years, 238 (57.5%) female | 208 participants prompt endoscopy with medical treatment according to endoscopic findings; 206 participants empirical acid suppression using ranitidine 150 mg twice daily for four weeks |
| Heaney 199948 | Northern Ireland, secondary care,* 12 months | 104 participants ≥18-45 years, mean age 32 years, 45 (43.3%) female, 104 (100%) Helicobacter pylori positive | 52 participants prompt endoscopy with medical treatment according to endoscopic findings; 52 participants “test and treat” by carbon 13 urea breath test, with those testing positive receiving eradication treatment with one week of omeprazole 20 mg twice daily, clarithromycin 250 mg twice daily, and tinidazole 500 mg twice daily |
| Delaney 200015 | England, primary care, 18 months | 442 participants ≥50 years, mean age 65 years, 222 (50.7%) female | 256 participants prompt endoscopy with medical treatment according to endoscopic findings; 186 participants symptom based management according to the primary care physician’s preferred strategy |
| Lassen 200049 | Denmark, secondary care,* 12 months | 500 participants ≥18 years, mean age 46 years, 270 (54.0%) female, 141 (28.2%) H pylori positive | 250 participants prompt endoscopy with medical treatment according to endoscopic findings; 250 participants “test and treat” by carbon 13 urea breath test, with those testing positive receiving eradication treatment with two weeks of lansoprazole 30 mg twice daily, metronidazole 500 mg three times daily, and amoxicillin 1 g twice daily; those testing negative received reassurance and lifestyle advice |
| Delaney 200116 | England, primary care, 18 months | 478 participants ≥18-49 years, mean age 37 years, 204 (42.9%) female, 112 (40.3%) of 278 in “test and scope” arm H pylori positive | 285 participants “test and scope” by serology, with endoscopy for H pylori positive participants and medical treatment according to endoscopic findings; those testing negative received empirical acid suppression; 193 participants symptom based management according to the primary care physician’s preferred strategy |
| Lewin van den Broek 200154 | The Netherlands, primary care, 12 months | 265 participants ≥18 years, mean age 43.5 years, 113 (45.9%) of 246 with data female | 86 participants prompt endoscopy with medical treatment according to endoscopic findings; 89 participants empirical acid suppression using omeprazole 20 mg once daily for up to eight weeks; 90 participants symptom based management according to national primary care guidelines |
| McColl 200217 | Scotland, secondary care,* 12 months | 708 participants ≥18-55 years, mean age 36 years, 331 (46.8%) female, 352 (49.7%) H pylori positive | 352 participants prompt endoscopy; also tested for H pylori by carbon 14 urea breath test, with those testing positive receiving eradication treatment as described below; 356 participants “test and treat” by carbon 14 urea breath test, with those testing positive receiving eradication treatment with one week of omeprazole 20 mg twice daily, clarithromycin 250 mg three times daily, and amoxicillin 500 mg or metronidazole 400 mg three times daily; those testing negative received reassurance |
| Arents 200350 | The Netherlands, primary care, 12 months | 270 participants ≥18 years, mean age 44 years, 141 (52.2%) female, 102 (37.8%) H pylori positive | 129 participants prompt endoscopy with medical treatment according to endoscopic findings; also tested for H pylori by serology, with those testing positive receiving eradication treatment, as described below; 141 participants “test and treat” by serology, with those testing positive receiving eradication treatment with one week of lansoprazole 30 mg twice daily, amoxicillin 1 g twice daily, and metronidazole or clarithromycin 500 mg twice daily; those testing negative received cisapride 20 mg twice daily for four weeks |
| Manes 200352 | Italy, secondary care,* 12 months | 219 participants ≥18-45 years, mean age 38.5 years, 99 (45.2%) female, 67 (60.9%) of 110 in “test and treat” arm H pylori positive | 110 participants “test and treat” by carbon 13 urea breath test, with those testing positive receiving eradication treatment with one week of omeprazole 20 mg twice daily, clarithromycin 500 mg twice daily, and tinidazole 500 mg twice daily; those testing negative received omeprazole 20 mg once daily for four week; 109 participants empirical acid suppression using omeprazole 20 mg once daily for four weeks |
| Jarbol 200645 | Denmark, primary care, 12 months | 472 participants ≥18 years, mean age 45.4 years, 272 (57.6%) female, 60 (24.0%) of 250 in “test and treat” arm H pylori positive | 250 participants “test and treat” by carbon 13 urea breath test, with those testing positive receiving eradication treatment with one week of esomeprazole 20 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily; those testing negative received no treatment; 222 participants empirical acid suppression using esomeprazole 20 mg twice daily for one week |
| Kjeldsen 200753 | Denmark, primary care, 12 months | 368 participants ≥18 years, mean age 48 years, 202 (54.9%) female | 184 participants prompt endoscopy with medical treatment according to endoscopic findings; 184 participants empirical acid suppression using omeprazole 40 mg once daily for two weeks |
| Delaney 200814 | England, primary care, 12 months | 699 participants ≥18-65 years, mean age 41 years, 355 (50.8%) female, 100 (29.2%) of 343 in “test and treat” arm H pylori positive | 343 participants “test and treat” by carbon 13 urea breath test, with those testing positive receiving eradication treatment with one week of omeprazole 20 mg once daily, clarithromycin 250 mg twice daily, and metronidazole 400 mg twice daily; those testing negative received omeprazole 20 mg once daily for four weeks; 356 participants empirical acid suppression using omeprazole 20 mg once daily for four weeks |
| Mahadeva 200851 | Malaysia, secondary care,* 12 months | 432 participants ≥18-45 years, mean age 30.5 years, 234 (54.2%) female, 141 (32.6%) H pylori positive | 210 participants prompt endoscopy with medical treatment according to endoscopic findings; also tested for H pylori by rapid urease test, with those testing positive receiving eradication treatment, as described below; 222 participants “test and treat” by carbon 13 urea breath test, with those testing positive receiving eradication treatment with one week of pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily; those testing negative received reassurance and symptom based treatment |
| Duggan 200918 | England, primary care, 12 months | 762 participants ≥18-70 years, mean age 42 years, 351 (46.1%) female, 277 (36.4%) H pylori positive | 187 participants prompt endoscopy with medical treatment according to endoscopic findings; 199 participants “test and scope” by serology, with endoscopy for H pylori positive participants and medical treatment according to endoscopic findings; those testing negative received lansoprazole 30 mg once daily for four weeks; 198 participants “test and treat” by serology, with those testing positive receiving eradication treatment with one week of omeprazole 20 mg twice daily, clarithromycin 250 mg twice daily, and metronidazole 400 mg twice daily; those testing negative received lansoprazole 30 mg once daily for four weeks; 178 participants empirical acid suppression using lansoprazole 30 mg once daily for four weeks |
| Myres (unpublished)† | Wales, primary care, 12 months | 61 participants ≥18-45 years, mean age 34 years, 33 (54.1%) female, 61 (100%) H pylori positive | 28 participants prompt endoscopy with medical treatment according to endoscopic findings; 33 participants “test and treat” by serology, with those testing positive receiving eradication treatment according to the primary care physician’s preferred strategy for treatment of H pylori |
*
Participants recruited in secondary care at first referral from primary care.
†
Data available in Ford 2005.19