Empirical eradication therapy was better than endoscopy-based management for Helicobacter pylori infection and dyspepsiaPDF
ACP J Club. 2000 Mar-Apr;132:46. doi:10.7326/ACPJC-2000-132-2-046
Heaney A, Collins JS, Watson RG, et al. A prospective randomised trial of a “test and treat” policy versus endoscopy based management in young Helicobacter pylori positive patients with ulcer-like dyspepsia, referred to a hospital clinic. Gut. 1999;45:186-90. [PubMed ID: 10403729]
In younger patients with Helicobacter pylori infection and dyspepsia, is empirical eradication therapy better than an endoscopy-based management strategy for reducing dyspepsia and improving quality of life?
Randomized (unclear allocation concealment*), unblinded,* controlled trial with 12-month follow-up.
Gastroenterology clinics of 2 hospitals in Belfast, Northern Ireland, United Kingdom.
104 patients who had ulcer-like dyspepsia and were ≤ 45 years of age (mean age 32 y, 57% men). Exclusion criteria were weight loss, dysphagia, symptoms of gastroesophageal reflux disease, history of gastrointestinal bleeding, regular use of nonsteroidal antiinflammatory drugs, gallstone symptoms, pregnancy, and H. pylori eradication treatment in the previous 2 weeks. Follow-up was 96%.
After stratification for sex and tobacco and alcohol use, patients were allocated to empirical eradication therapy (n = 52) or esophagogastroduodenoscopy (EGD) (n = 52). In the EGD group, eradication therapy was given according to type of diagnosis. Empirical eradication therapy consisted of 1-week triple therapy: omeprazole, 20 mg twice daily; clarithromycin, 250 mg twice daily; and tinidazole, 500 mg twice daily.
Main outcome measures
Dyspepsia symptoms (Glasgow dyspepsia severity score) and quality of life (Short Form-36 health survey).
At 12 months, dyspepsia symptom scores (P < 0.05) and quality-of-life scores for physical function (P < 0.05) were better in the empirical eradication group than in the EGD group (Table).
In younger patients with Helicobacter pylori infection and dyspepsia, empirical eradication therapy for 1 week was better than an endoscopy-based management strategy for reducing dyspeptic symptoms and improving physical function.
Source of funding: Not stated.
For correspondence: Dr. A. Heaney, Royal Victoria Hospital, Belfast BT12 6BA, Northern Ireland, UK.
Table. Empirical eradication therapy (EE) vs esophagogastroduodenoscopy (EGD) for Helicobacter pylori infection and dyspepsia
|Outcomes at 12 mo||Scale||Mean scores|
|Dyspepsia symptoms||Glasgow dyspepsia severity score||3.37||5.08|
|Quality of life—physical function||Short Form-36 health survey||91.88||81.96|
Several working groups have recommended a strategy of testing and treating H. pylori infection in younger patients who have dyspepsia without alarm symptoms (1, 2). The study by Heaney and colleagues provides more empirical support for testing and treating than for endoscopy. Both strategies were safe, but 43% of patients were symptom free and 76% did not require antisecretory therapy at 12 months in the test-and-treat arm compared with 30% and 63%, respectively, in the EGD group. Although these results can be best applied to secondary care, a recent study in primary care adds further support for the generalizability of the findings (3).
Why was empirical therapy superior to endoscopy in these patients? This finding probably does not reflect a substantial effect of eradication therapy on patients with nonulcer dyspepsia (4). Whether lack of blinding biased the outcome is uncertain. Notably, a high background rate of peptic ulcer existed in the evaluated patients (47% in the endoscopy group). It is conceivable that eradication therapy would be more successful in patients with a high background rate of peptic ulcer because patients in the EDG group with healed ulcers would have been misdiagnosed as having non-ulcer dyspepsia and would not have been offered eradication therapy. Reassurance was not evaluated in this study. Others have observed that reassurance is greater in patients receiving endoscopy (5), but symptom improvement is likely to parallel satisfaction scores.
On the basis of available data, the standard of care for young, healthy persons with dyspepsia should be testing and treating. Long-term outcome data are still required, however, to better understand the effect of this strategy in practice.
Nicholas J. Talley, MD, PhD
University of Sydney
Sydney, New South Wales, Australia
1. Talley NJ, Silverstein MD, Agréus L, et al. AGA technical review: evaluation of dyspepsia. American Gastroenterological Association. Gastroenterology. 1998;114:582-95. [PubMed ID: 9496950]
2. Talley NJ, Axon A, Bytzer P, et al. Management of uninvestigated and functional dyspepsia: a Working Party report for the World Congresses of Gastroenterology 1998. Aliment Pharmacol Ther. 1999;13:1135-48. [PubMed ID: 10468695]
3. Jones R, Tait C, Sladen G, Weston-Baker J. A trial of a test-and-treat strategy for Helicobacter pylori positive dyspeptic patients in general practice. Int J Clin Pract. 1999;53:413-6. [PubMed ID: 10622066]
4. Talley NJ, Vakil N, Ballard ED 2nd, Fennerty MB. Absence of benefit of eradicating Helicobacter pylori in patients with nonulcer dyspepsia. N Engl J Med. 1999;341:1106-11. [PubMed ID: 10511608]
5. Bytzer P, Hansen JM, Schaffalitzky de Muckadell OB. Empirical H2-blocker therapy or prompt endoscopy in management of dyspepsia. Lancet. 1994;343:811-6. [PubMed ID: 7980747]