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Heartburn treatment in primary care: randomised, double blind study for 8 weeks.
BMJ. 1999 Aug 28; 319(7209):550-3.BMJ

Abstract

OBJECTIVE

To compare the effects and tolerability of omeprazole and cisapride with that of placebo for control of heartburn in primary care patients.

DESIGN

Randomised, double blind, placebo controlled study.

SETTING

65 primary care practices in Norway.

PARTICIPANTS

483 untreated patients with complaints of heartburn >/=3 days a week, with at most grade 1 reflux oesophagitis.

INTERVENTIONS

Omeprazole 20 mg once daily, cisapride 20 mg twice daily, or placebo for 8 weeks.

MAIN OUTCOME MEASURES

Adequate control of heartburn, defined as </=1 day of the past 7 days with no more than mild heartburn, after 4 weeks of treatment.

RESULTS

In the all patients treated analysis, adequate control of heartburn was achieved in 71% of patients taking omeprazole, 22% taking cisapride, and 18% taking placebo after 4 weeks of treatment (omeprazole v cisapride and placebo, P<0.0001; cisapride v placebo, non-significant). Results were comparable in patients with or without reflux oesophagitis. In patients treated with omeprazole only, symptom control was achieved significantly more often in patients positive for Helicobacter pylori. Antacid use was 2-3 times greater in patients taking cisapride or placebo than in those taking omeprazole. Relief of non-reflux symptoms did not significantly differ between the three groups. Significantly more patients taking cisapride reported adverse events than those taking omeprazole or placebo.

CONCLUSIONS

Omeprazole 20 mg once daily was highly effective in relieving heartburn whereas cisapride 20 mg twice daily was not significantly more effective than placebo.

Links

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    ncbi.nlm.nih.gov
    bmj.com
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    Authors+Show Affiliations

    Hatlebakk JG
    Department of Medicine, Haukeland Sykehus, University of Bergen, N-5021 Bergen, Norway.
    Hyggen A
    No affiliation info available
    Madsen PH
    No affiliation info available
    Walle PO
    No affiliation info available
    Schulz T
    No affiliation info available
    Mowinckel P
    No affiliation info available
    Bernklev T
    No affiliation info available
    Berstad A
    No affiliation info available

    MeSH

    Anti-Ulcer AgentsCisaprideDouble-Blind MethodFemaleHeartburnHumansMaleMiddle AgedNorwayOmeprazolePrimary Health CareTreatment Outcome

    Pub Type(s)

    Clinical Trial
    Journal Article
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    10463897

    Citation

    Hatlebakk, J G., et al. "Heartburn Treatment in Primary Care: Randomised, Double Blind Study for 8 Weeks." BMJ (Clinical Research Ed.), vol. 319, no. 7209, 1999, pp. 550-3.
    Hatlebakk JG, Hyggen A, Madsen PH, et al. Heartburn treatment in primary care: randomised, double blind study for 8 weeks. BMJ. 1999;319(7209):550-3.
    Hatlebakk, J. G., Hyggen, A., Madsen, P. H., Walle, P. O., Schulz, T., Mowinckel, P., Bernklev, T., & Berstad, A. (1999). Heartburn treatment in primary care: randomised, double blind study for 8 weeks. BMJ (Clinical Research Ed.), 319(7209), 550-3.
    Hatlebakk JG, et al. Heartburn Treatment in Primary Care: Randomised, Double Blind Study for 8 Weeks. BMJ. 1999 Aug 28;319(7209):550-3. PubMed PMID: 10463897.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Heartburn treatment in primary care: randomised, double blind study for 8 weeks. AU - Hatlebakk,J G, AU - Hyggen,A, AU - Madsen,P H, AU - Walle,P O, AU - Schulz,T, AU - Mowinckel,P, AU - Bernklev,T, AU - Berstad,A, PY - 1999/8/27/pubmed PY - 1999/8/27/medline PY - 1999/8/27/entrez SP - 550 EP - 3 JF - BMJ (Clinical research ed.) JO - BMJ VL - 319 IS - 7209 N2 - OBJECTIVE: To compare the effects and tolerability of omeprazole and cisapride with that of placebo for control of heartburn in primary care patients. DESIGN: Randomised, double blind, placebo controlled study. SETTING: 65 primary care practices in Norway. PARTICIPANTS: 483 untreated patients with complaints of heartburn >/=3 days a week, with at most grade 1 reflux oesophagitis. INTERVENTIONS: Omeprazole 20 mg once daily, cisapride 20 mg twice daily, or placebo for 8 weeks. MAIN OUTCOME MEASURES: Adequate control of heartburn, defined as </=1 day of the past 7 days with no more than mild heartburn, after 4 weeks of treatment. RESULTS: In the all patients treated analysis, adequate control of heartburn was achieved in 71% of patients taking omeprazole, 22% taking cisapride, and 18% taking placebo after 4 weeks of treatment (omeprazole v cisapride and placebo, P<0.0001; cisapride v placebo, non-significant). Results were comparable in patients with or without reflux oesophagitis. In patients treated with omeprazole only, symptom control was achieved significantly more often in patients positive for Helicobacter pylori. Antacid use was 2-3 times greater in patients taking cisapride or placebo than in those taking omeprazole. Relief of non-reflux symptoms did not significantly differ between the three groups. Significantly more patients taking cisapride reported adverse events than those taking omeprazole or placebo. CONCLUSIONS: Omeprazole 20 mg once daily was highly effective in relieving heartburn whereas cisapride 20 mg twice daily was not significantly more effective than placebo. SN - 0959-8138 UR - https://www.unboundmedicine.com/medline/citation/10463897/Heartburn_treatment_in_primary_care:_randomised_double_blind_study_for_8_weeks_ L2 - http://www.bmj.com/cgi/pmidlookup?view=long&amp;pmid=10463897 DB - PRIME DP - Unbound Medicine ER -
    Grapherence [↓20 ↑18]

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