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Maintenance therapy with cisapride after healing of erosive oesophagitis: a double-blind placebo-controlled trial.

Abstract

BACKGROUND

There are few data on the role of prokinetic agents as maintenance therapy in moderately severe reflux oesophagitis despite the high relapse rate of this condition after healing.

AIMS

To determine whether cisapride is more effective than placebo as maintenance therapy after healing of moderate erosive oesophagitis in two respects: first, in preventing symptomatic relapse and preserving quality of life; and, second, in improving oesophageal motor function.

PATIENTS

Forty-two patients whose grade II-III oesophagitis had been healed with omeprazole were randomized to receive either cisapride 20 mg nocte or placebo for 6 months. Oesophageal pH monitoring and manometry were performed before starting maintenance therapy and after 4 weeks, and symptomatic status and quality of life were assessed at weeks 0, 4, 13 and 26.

RESULTS

After 4 weeks of maintenance therapy, lower oesophageal sphincter pressure improved in the cisapride group (16.4-21.9 mmHg, P = 0.01) but not in the placebo group (25.5-22.7 mmHg, P = 0.2). Oesophageal pH monitoring showed no significant changes in either group. Sixteen (76%) cisapride patients and 12 (57%) placebo patients withdrew within 4 weeks owing to symptomatic relapse (P = 0.2). After 26 weeks, 21 (100%) cisapride and 17 (81%) placebo patients had relapsed (log-rank analysis of survival time P = 0.07). Quality of life parameters deteriorated in both treatment groups to a similar degree.

CONCLUSION

Maintenance therapy with cisapride 20 mg nocte improves the lower oesophageal sphincter pressure in patients whose oesophagitis has been healed with omeprazole. However, cisapride is no better than placebo in preventing symptomatic relapse or deterioration in quality of life.

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  • Authors+Show Affiliations

    ,

    Department of Medicine, Queen's University of Belfast, UK.

    , , ,

    Source

    MeSH

    Adult
    Anti-Ulcer Agents
    Cisapride
    Double-Blind Method
    Esophagitis, Peptic
    Female
    Humans
    Hydrogen-Ion Concentration
    Male
    Middle Aged
    Piperidines
    Quality of Life
    Treatment Outcome

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    9218071

    Citation

    McDougall, N I., et al. "Maintenance Therapy With Cisapride After Healing of Erosive Oesophagitis: a Double-blind Placebo-controlled Trial." Alimentary Pharmacology & Therapeutics, vol. 11, no. 3, 1997, pp. 487-95.
    McDougall NI, Watson RG, Collins JS, et al. Maintenance therapy with cisapride after healing of erosive oesophagitis: a double-blind placebo-controlled trial. Aliment Pharmacol Ther. 1997;11(3):487-95.
    McDougall, N. I., Watson, R. G., Collins, J. S., McFarland, R. J., & Love, A. H. (1997). Maintenance therapy with cisapride after healing of erosive oesophagitis: a double-blind placebo-controlled trial. Alimentary Pharmacology & Therapeutics, 11(3), pp. 487-95.
    McDougall NI, et al. Maintenance Therapy With Cisapride After Healing of Erosive Oesophagitis: a Double-blind Placebo-controlled Trial. Aliment Pharmacol Ther. 1997;11(3):487-95. PubMed PMID: 9218071.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Maintenance therapy with cisapride after healing of erosive oesophagitis: a double-blind placebo-controlled trial. AU - McDougall,N I, AU - Watson,R G, AU - Collins,J S, AU - McFarland,R J, AU - Love,A H, PY - 1997/6/1/pubmed PY - 1997/6/1/medline PY - 1997/6/1/entrez SP - 487 EP - 95 JF - Alimentary pharmacology & therapeutics JO - Aliment. Pharmacol. Ther. VL - 11 IS - 3 N2 - BACKGROUND: There are few data on the role of prokinetic agents as maintenance therapy in moderately severe reflux oesophagitis despite the high relapse rate of this condition after healing. AIMS: To determine whether cisapride is more effective than placebo as maintenance therapy after healing of moderate erosive oesophagitis in two respects: first, in preventing symptomatic relapse and preserving quality of life; and, second, in improving oesophageal motor function. PATIENTS: Forty-two patients whose grade II-III oesophagitis had been healed with omeprazole were randomized to receive either cisapride 20 mg nocte or placebo for 6 months. Oesophageal pH monitoring and manometry were performed before starting maintenance therapy and after 4 weeks, and symptomatic status and quality of life were assessed at weeks 0, 4, 13 and 26. RESULTS: After 4 weeks of maintenance therapy, lower oesophageal sphincter pressure improved in the cisapride group (16.4-21.9 mmHg, P = 0.01) but not in the placebo group (25.5-22.7 mmHg, P = 0.2). Oesophageal pH monitoring showed no significant changes in either group. Sixteen (76%) cisapride patients and 12 (57%) placebo patients withdrew within 4 weeks owing to symptomatic relapse (P = 0.2). After 26 weeks, 21 (100%) cisapride and 17 (81%) placebo patients had relapsed (log-rank analysis of survival time P = 0.07). Quality of life parameters deteriorated in both treatment groups to a similar degree. CONCLUSION: Maintenance therapy with cisapride 20 mg nocte improves the lower oesophageal sphincter pressure in patients whose oesophagitis has been healed with omeprazole. However, cisapride is no better than placebo in preventing symptomatic relapse or deterioration in quality of life. SN - 0269-2813 UR - https://www.unboundmedicine.com/medline/citation/9218071/Maintenance_therapy_with_cisapride_after_healing_of_erosive_oesophagitis:_a_double_blind_placebo_controlled_trial_ L2 - https://onlinelibrary.wiley.com/resolve/openurl?genre=article&sid=nlm:pubmed&issn=0269-2813&date=1997&volume=11&issue=3&spage=487 DB - PRIME DP - Unbound Medicine ER -