Melatonin for Gerd
Verdict: Published with Warning
Across 5 PubMed studies, the evidence for Melatonin in Gerd grades Tier B — preliminary evidence. Effective, but with safety or population caveats.
B 🟡 B Preliminary Evidence Published with Warning
Why this grade7-layer evidence engine
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Scoring transparency
All scores computed by a 7-layer evidence engine — fully auditableRaw score 0.63
D
C
B
A
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← counter-evidence / ineffectiveeffective / strong evidence →
Final grade
B · Published with Warning
Confidence
85%
Highly consistent evidence
Evidence level
E2
Multiple high-quality MAs (≥2 independent, consistent)
▸View the full decision path (audit trail)
- compute_raw_score — 加權公式: L2×0.30 + L3×0.25 + L5×0.25 + L11×0.10 + L1×0.10 = 0.625
- tier_from_score — 依分數區間映射至 tier letter
- apply_hec_rules — 無高階證據可裁決
- tier_strict_requirement_check — Tier 條件達標，未降階
- detect_disputes — 偵測到 0 個 hard + 0 個 soft dispute
- decide_status — 依 tier + dispute 結果決定 status
PubMed studies (5)L2 · primary research & systematic reviews
Regression of gastroesophageal reflux disease symptoms using dietary supplementation with melatonin, vitamins and aminoacids: comparison with omeprazole
Finding: 100% (176/176) of the melatonin-supplement group reported complete symptom regression at 40 days vs 65.7% (115/175) on omeprazole (P<0.05), but the 'supplement' was melatonin combined with vitamins and amino acids and the 100% response is implausibly perfect.
View on PubMed Is the Addition of Sublingual Melatonin to Omeprazole Superior to Omeprazole Alone in the Management of Gastroesophageal Reflux Disease Symptoms: A Clinical Trial
Finding: Adding sublingual melatonin 3 mg/day to omeprazole lowered FSSG more than omeprazole+placebo (10.02+/-2.43 vs 14.97+/-3.28; P=.0001), with greater reductions in heartburn (P=.04) and epigastric pain (P=.03).
View on PubMed The potential therapeutic effect of melatonin in Gastro-Esophageal Reflux Disease
Finding: Melatonin alone improved symptoms but omeprazole alone was more effective than melatonin alone, with the melatonin+omeprazole combination giving the best response; no effect sizes or p-values were reported in this 9-per-arm study.
View on PubMed Bidirectional correlation between gastroesophageal reflux disease and sleep problems: a systematic review and meta-analysis
Finding: Pooling 22 studies, insomnia (OR=2.02, 95% CI 1.64-2.49), sleep disturbance (OR=1.98, 95% CI 1.58-2.50) and short sleep (OR=2.66, 95% CI 2.02-3.15) were associated with higher GERD risk and vice versa (all p<0.001); this only provides an indirect mechanistic rationale for melatonin, not direct treatment evidence.
View on PubMed Melatonin for the treatment of gastroesophageal reflux disease; protocol for a systematic review and meta-analysis
Finding: This is a registered systematic-review/meta-analysis PROTOCOL with no pooled results reported, and as of June 2026 no completed full meta-analysis from this protocol has been published, underscoring the absence of high-tier synthesized evidence.
View on PubMed Regulatory & authoritative positionsL4/L5 · FDA / EMA / NIH ODS / Cochrane / Mayo …
L4a US FDA
Cautious
no basis to conclude that melatonin is GRAS source↗
L4b EU EFSA
Supportive
melatonin and reduction of sleep onset latency source↗
L4c UK NHS
Cautious
Melatonin is available on prescription only. source↗
L4d TW TFDA / 衛福部
Against
褪黑激素產品屬藥品列管 source↗
L4e WHO
Not addressed
altered melatonin excretion source↗
L5a NIH Office of Dietary Supplements
Cautious
short-term use of melatonin supplements appears to be safe source↗
L5e Specialty Society (condition-mapped)
Neutral
The ACG patient page on GERD does not mention melatonin or any dietary supplements. The only remedies discussed are prescription medications, over-the-counter drugs (antacids, H2 blockers, PPIs), lifestyle modifications, and surgery. Similarly, the AGA clinical guideline on management of GERD contains 23 evidence-based recommendations focused on lifestyle modifications, antisecretory drugs (PPI… source↗