Current issues of ACP Journal Club are published in Annals of Internal Medicine


Therapeutics

Helicobacter pylori eradication improved dyspepsia symptoms

PDF

ACP J Club. 2002 Jan-Feb;136:17. doi:10.7326/ACPJC-2003-138-1-017

Related Content in this Issue
• Companion Abstract and Commentary: Noninvasive Helicobacter pylori testing was as effective as endoscopy for managing dyspepsia


Source Citation

Chiba N, Veldhuyzen van Zanten SJ, Sinclair P, et al. Treating Helicobacter pylori infection in primary care patients with uninvestigated dyspepsia: the Canadian adult dyspepsia empiric treatment—Helicobacter pylori positive (CADET-Hp) randomised controlled trial. BMJ. 2002;324:1012-6. [PubMed ID: 11976244]


Abstract

Question

In patients with dyspepsia and a positive test result for Helicobacter pylori, is an H. pylori eradication strategy more effective than placebo for improving dyspepsia symptoms?

Design

Randomized {allocation concealed*}†, blinded (clinicians, patients, data collectors, outcome assessors, {data analysts and manuscript writers}†),* placebo-controlled trial with 1-year follow-up.

Setting

36 family practices in Canada.

Patients

294 patients (mean age 49 y, 50% men) who were ≥ 18 years of age and had uninvestigated symptoms of dyspepsia for ≥ 3 months. Dyspepsia was defined as a complex of epigastric pain including heartburn, acid regurgitation, excessive burping or belching, increased abdominal bloating, nausea, abnormal or slow digestion, or early satiety. All patients had to have positive test results for H. pylori on the Helisal rapid blood test and the 13C urea breath test. Exclusion criteria included gastroesophageal reflux disease, upper gastrointestinal investigation in the previous 6 months or ≥ 2 times in the past 10 years, eradication therapy for H. pylori in the past 6 months, previous gastric surgery, ulcer disease or endoscopic esophagitis, and the irritable bowel syndrome. Follow-up was 87%.

Intervention

Patients were allocated to omeprazole, 20 mg; metronidazole, 500 mg; and clarithromycin, 250 mg (eradication) (n = 145), or omeprazole, 20 mg, and placebo metronidazole and placebo clarithromycin (placebo) (n = 149) twice daily for 7 days.

Main outcome measures

Global overall severity of dyspepsia symptoms assessed with a 7-point scale (1 = no problem, 7 = very severe problems). Treatment success was a score of 1 or 2. Secondary outcomes were proportion of asymptomatic patients and treatment success according to H. pylori status.

Main results

Analysis was by intention to treat, and an analysis of all evaluable patients was also done (n = 267). Patients in the eradication group had greater treatment response than did those in the placebo group (Table). More patients in the eradication group were completely asymptomatic (Table). Treatment was more successful in patients in whom H. pylori was eradicated than in those it was not (54% vs 39%, P = 0.02). Eradication treatment reduced societal costs, but the difference was not statistically significant (Cdn $53, 95% CI −86 to 180).

Conclusion

In patients with dyspepsia and a positive test result for Helicobacter pylori, an H. pylori eradication strategy was more effective than placebo for improving dyspepsia symptoms.

*See Glossary.

†Information provided by author.

Source of funding: Astra-Zeneca Canada Inc.

For correspondence: Dr. N. Chiba, Surrey GI Clinic/Research, Guelph, Ontario, Canada. E-mail chiban@on.aibn.com.


Table. Helicobacter pylori eradication vs placebo for uninvestigated dyspepsia at 1 year‡

Outcomes Eradication Placebo RBI (95% CI) NNT (CI)
Treatment success 50% 36% 37% (5 to 80) 7 (4 to 63)
Completely asymptomatic 28% 15% 92% (21 to 205) 8 (5 to 24)

‡Abbreviations defined in Glossary; RBI, NNT, and CI calculated from data in article.


Commentary

Patients with dyspeptic symptoms should be managed with 2 goals in mind: early detection of malignant disease and cost-effective relief of symptoms. Patients < 55 years of age without “alarm features” (e.g., weight loss, dysphagia, and anemia) are at very low risk for malignancy and do not require endoscopic investigation. The question of management then turns on the relative costs and effectiveness of endoscopy, noninvasive tests, and eradication of H. pylori and empiric acid suppression (1).

The trials by McColl and Chiba and their colleagues provide important information for physicians managing patients presenting with uninvestigated dyspepsia. The study by McColl and colleagues adds to 2 previous studies (2, 3) that confirm the cost-effectiveness of a secondary care–based H. pylori test-and-treat service compared with endoscopy-based management. All 3 trials of test-and-treat compared with endoscopy-based management showed equivalent effectiveness, but costs were reduced because fewer patients had endoscopy. The trial by McColl and colleagues showed a rate of endoscopy in the year of follow-up in the test-and-treat group of only 8%, whereas Heaney (2) and Lassen (3) showed rates nearer 30%. Patients positive for H. pylori in both groups of the trial by McColl and colleagues received eradication therapy. Thus, any differences caused by the eradication therapy itself were abolished. The trial can therefore be considered to address the question, “Is the cost of endoscopy warranted by the effect on symptoms, quality of life, and patient satisfaction of having the investigation?” The answer is “no.”

The trial by Chiba and colleagues (CADET-Hp) takes the McColl and colleagues’ trial 2 steps further. First, patient recruitment and the intervention took place in a primary care setting. Second, test-and-treat was compared with acid suppression alone. In contrast to the trial by McColl and colleagues, CADET-Hp was designed to examine the effect of eradication therapy on dyspeptic symptoms and found a substantial improvement in the proportion of patients with dyspeptic symptoms at the end of the trial. However, the difference in costs was small and not statistically significant.

The reason for the difference in effects and costs between CADET-Hp and McColl and colleagues lies in the use of eradication therapy for H. pylori. In CADET-Hp, the control-group patients did not receive eradication therapy and were therefore at risk for recurrent peptic ulcers that had healed initially with omeprazole. Furthermore, patients with nonulcer dyspepsia may also benefit from H. pylori eradication. A Cochrane review of 9 placebo-controlled trials of H. pylori eradication therapy in patients without peptic ulcers or esophagitis at endoscopy found a number needed to treat of 15 (4).

The CADET-Hp trial does not show conclusively that H. pylori test-and-treat is more cost-effective in primary care than omeprazole alone, because it was only done in H. pylori–positive patients. The cost-effectiveness of this strategy needs to be tested by randomizing patients with dyspepsia, both positive and negative for H. pylori, before noninvasive testing for H. pylori to determine the effect of the management strategy on the whole group. It does, however, lend more support to the eradication of H. pylori in all patients known to be infected.

Brendan Delaney, MD, FRCP, MRCGP
University of Birmingham
Birmingham, England, UK


References

1. Delaney BC, Innes MA, Deeks J, et al. Initial management strategies for dyspepsia. Cochrane Database Syst Rev. 2001;(3):CD001961. [PubMed ID: 11687004]

2. 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]

3. Lassen AT, Pedersen FM, Bytzer P, Schaffalitzky de Muckadell OB.Helicobacter pylori test-and-eradicate versus prompt endoscopy for management of dyspeptic patients: a randomised trial. Lancet. 2000;356:455-60. [PubMed ID: 10981888]

4. Moayyedi P, Soo S, Deeks J, et al. Eradication of Helicobacter pylori for non-ulcer dyspepsia. Cochrane Database Syst Rev. 2001;(1):CD002096. [PubMed ID: 11279751]