Randomised controlled trial of Helicobacter pylori eradication in patients on non-steroidal anti-inflammatory drugs: HELP NSAIDs study. Helicobacter Eradication for Lesion Prevention.

Background: The effect of Helicobacter pylori in patients receiving non-steroidal anti-inflammatory drugs (NSAIDs) is unclear. We investigated the effects of H. pylori eradication in patients with current or previous peptic ulceration, dyspepsia, or both who continued to use NSAIDs.Methods: 285 pati...

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Publicado en:Lancet Vol. 352; no. 9133; pp. 1016 - 1022
Autores principales: Hawkey CJ, Tulassay Z, Szczepanski L, van Rensburg CJ, Filipowicz-Sosnowska A, Lanas A, Wason CM, Peacock RA, Gillon KRW, Hawkey, C J, Tulassay, Z, Szczepanski, L, van Rensburg, C J, Filipowicz-Sosnowska, A, Lanas, A, Wason, C M, Peacock, R A, Gillon, K R
Formato: research tables/charts randomized controlled trial Journal Article
Publicado: Lancet 9/26/1998
Acceso en línea:Ver este registro en EBSCOhost
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      dt: 9/26/1998
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      pub: Lancet
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        10.1016/s0140-6736(98)04206-8
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        atl: Randomised controlled trial of Helicobacter pylori eradication in patients on non-steroidal anti-inflammatory drugs: HELP NSAIDs study. Helicobacter Eradication for Lesion Prevention.
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        au:
          Hawkey CJ
          Tulassay Z
          Szczepanski L
          van Rensburg CJ
          Filipowicz-Sosnowska A
          Lanas A
          Wason CM
          Peacock RA
          Gillon KRW
          Hawkey, C J
          Tulassay, Z
          Szczepanski, L
          van Rensburg, C J
          Filipowicz-Sosnowska, A
          Lanas, A
          Wason, C M
          Peacock, R A
          Gillon, K R
        affil: Division of Gastroenterology, University Hospital, Nottingham, UK
      sug:
        subj:
          Helicobacter Infections Drug Therapy
          Antiinflammatory Agents, Non-Steroidal Therapeutic Use
          Helicobacter Pylori
          Peptic Ulcer Microbiology
          Dyspepsia Microbiology
          Peptic Ulcer Drug Therapy
          Antiinflammatory Agents, Non-Steroidal Adverse Effects
          Peptic Ulcer Complications
          Treatment Outcomes
          Control Group
          Adult
          Middle Age
          Aged, 80 and Over
          Aged
          Recurrence
          Data Analysis, Statistical
          Antibiotics Therapeutic Use
          Clinical Trials
          Risk Factors
          Human
          Adult: 19-44 years
          Middle Aged: 45-64 years
          Aged, 80 & over
          Aged: 65+ years
      ab: Background: The effect of Helicobacter pylori in patients receiving non-steroidal anti-inflammatory drugs (NSAIDs) is unclear. We investigated the effects of H. pylori eradication in patients with current or previous peptic ulceration, dyspepsia, or both who continued to use NSAIDs.Methods: 285 patients were randomly assigned omeprazole 20 mg, amoxycillin 1000 mg, and clarithromycin 500 mg, twice daily (n=142, H. pylori eradication treatment), or omeprazole with placebo antibiotics (n=143, controls) for 1 week. All patients received omeprazole 20 mg once daily for 3 weeks until endoscopy, and, if the ulcer was not healed, 40 mg once daily until repeat endoscopy at 8 weeks. Ulcer-free patients with mild dyspepsia continued NSAIDs but not antiulcer treatment. We investigated ulcers with endoscopy at 1, 3, and 6 months and with carbon-13-labelled urea breath test at 3 months.Findings: The estimated probability of being ulcer-free at 6 months was 0.56 (95% CI 0.47-0.65) on eradication treatment and 0.53 (0.44-0.62) on on control treatment (p=0.80). Time to treatment failure did not differ between groups for ulcers or dyspepsia alone, per-protocol analysis, or final H. pylori status. 66% (58-74) of the eradication group compared with 14% (8-20) of the control group had a final negative H. pylori result (p<0.001). Fewer baseline gastric ulcers healed among eradication-treatment patients than among controls (72 vs 100% at 8 weeks, p=0.006).Interpretation: H. pylori eradication in long-term users of NSAIDs with past or current peptic ulcer or troublesome dyspepsia led to impaired healing of gastric ulcers and did not affect the rate of peptic ulcers or dyspepsia over 6 months.
      pubtype: Academic Journal
      doctype:
        research
        tables/charts
        randomized controlled trial
        Journal Article
      ougenre: Article
    language: English
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