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Effect of lansoprazole on the epigastric symptoms of functional dyspepsia (ELF study): A multicentre, prospective, randomized, double-blind, placebo-controlled clinical trial.

United European gastroenterology journal · 2013 · Benefit · Moderate evidence

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BenefitModerate evidencePaper 3070

At week 4, overall dyspeptic symptom relief was higher with lansoprazole 15 mg once daily (30.4%) than placebo (6.7%) (p=0.045). Epigastric pain (p=0.045) and epigastric burning (p=0.03) improved significantly versus placebo, while postprandial fullness (p=0.…

Study snapshot

PublicationUnited European gastroenterology journal · 2013
Study typerandomized_trial
Reported directionBenefit
Evidence ratingModerate

Abstract

BACKGROUND: Since the publication of the Rome III criteria for functional dyspepsia (FD), the evidence about the efficacy of half-dose of proton pump inhibitors for dyspepsia symptoms have been limited. OBJECTIVE: To examine the efficacy of lansoprazole for functional dyspepsia (FD) diagnosed with the Rome III criteria by the multicentre, double-blind, randomized, placebo-controlled study in Japan. METHODS: A total of 54 FD participants were randomized to lansoprazole 15 mg once daily or placebo for a 4-week double-blind treatment period. The primary efficacy endpoint was an overall dyspeptic symptom relief rate evaluated by 5-point Likert scale scores. The alteration of dyspeptic symptom scores during the study period was also assessed. RESULTS: At week 4, the overall dyspeptic symptom relief rates were higher in the lansoprazole group (30.4%) than in the placebo group (6.7%) (p = 0.045). The scores for epigastric pain (p = 0.045) and epigastric burning (p = 0.03) were significantly improved in the lansoprazole group compared to the placebo group, whereas the improvement of the scores for postprandial fullness (p = 0.81) and early satiation (p = 0.33) was not different between lansoprazole and placebo groups. CONCLUSIONS: Lansoprazole 15 mg ameliorates dyspeptic symptoms, particularly the epigastric pain syndrome-related symptoms of FD.

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AI evidence extraction

Structured fields below were generated from the paper’s abstract and metadata to make the evidence easier to inspect. Automated extraction may be incomplete or incorrect; verify important details against the original paper.

Study typerandomized_trial
Effect directionbenefit
PopulationParticipants with functional dyspepsia (FD) diagnosed with the Rome III criteria in Japan
Sample size54
Exposure4-week double-blind treatment period
Evidence strengthModerateConfidence: 74% · Peer reviewed: yes

Main findings

At week 4, overall dyspeptic symptom relief was higher with lansoprazole 15 mg once daily (30.4%) than placebo (6.7%) (p=0.045). Epigastric pain (p=0.045) and epigastric burning (p=0.03) improved significantly versus placebo, while postprandial fullness (p=0.81) and early satiation (p=0.33) did not differ between groups.

Outcomes measured

  • Overall dyspeptic symptom relief rate (5-point Likert scale)
  • Epigastric pain score
  • Epigastric burning score
  • Postprandial fullness score
  • Early satiation score

Limitations

  • Small sample size (n=54)
  • Short treatment duration (4 weeks)
View raw extracted JSON
{
  "study_type": "randomized_trial",
  "exposure": {
    "band": null,
    "source": null,
    "frequency_mhz": null,
    "sar_wkg": null,
    "duration": "4-week double-blind treatment period"
  },
  "population": "Participants with functional dyspepsia (FD) diagnosed with the Rome III criteria in Japan",
  "sample_size": 54,
  "outcomes": [
    "Overall dyspeptic symptom relief rate (5-point Likert scale)",
    "Epigastric pain score",
    "Epigastric burning score",
    "Postprandial fullness score",
    "Early satiation score"
  ],
  "main_findings": "At week 4, overall dyspeptic symptom relief was higher with lansoprazole 15 mg once daily (30.4%) than placebo (6.7%) (p=0.045). Epigastric pain (p=0.045) and epigastric burning (p=0.03) improved significantly versus placebo, while postprandial fullness (p=0.81) and early satiation (p=0.33) did not differ between groups.",
  "effect_direction": "benefit",
  "limitations": [
    "Small sample size (n=54)",
    "Short treatment duration (4 weeks)"
  ],
  "evidence_strength": "moderate",
  "confidence": 0.74,
  "peer_reviewed_likely": "yes",
  "keywords": [
    "functional dyspepsia",
    "Rome III criteria",
    "lansoprazole",
    "proton pump inhibitor",
    "randomized",
    "double-blind",
    "placebo-controlled",
    "epigastric pain syndrome"
  ],
  "suggested_hubs": []
}
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AI-extracted fields are generated from the abstract and metadata and may be incomplete or incorrect. This material is for informational purposes and is not medical advice.

Identifiers and source

DOI: 10.1177/2050640613510904
PubMed: 24917996

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