Melatonin for Tinnitus
Verdict: Disputed
Across 5 PubMed studies, the evidence for Melatonin in Tinnitus grades Tier C — weak evidence. High-quality studies disagree — the evidence is genuinely mixed.
C 🟠 C Weak Evidence Disputed
Why this grade7-layer evidence engine
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Scoring transparency
All scores computed by a 7-layer evidence engine — fully auditableRaw score 0.43
D
C
B
A
S
← counter-evidence / ineffectiveeffective / strong evidence →
Final grade
C · Disputed
Confidence
81%
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 = 0.429
- 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 1 個 hard + 0 個 soft dispute
- decide_status — 依 tier + dispute 結果決定 status
PubMed studies (5)L2 · primary research & systematic reviews
Efficacy of pharmacologic treatment in tinnitus patients without specific or treatable origin: A network meta-analysis of randomised controlled trials
Finding: Melatonin monotherapy did NOT significantly improve tinnitus severity or quality of life vs placebo; it improved response rate (SUCRA rank 3rd) but the top-ranked arm was intratympanic dexamethasone PLUS melatonin, while oral amitriptyline ranked best for severity.
View on PubMed Melatonin: can it stop the ringing?
Finding: Melatonin produced a significantly greater decrease in tinnitus matching and self-rated tinnitus scores than placebo (p<0.05) and improved sleep quality, in a double-blind placebo-controlled crossover trial.
View on PubMed Comparison of Melatonin and Sertraline Therapies on Tinnitus: A Randomized Clinical Trial
Finding: Both arms improved; melatonin reduced THI from 45.0 to 30.3 (within-group p=0.02) and was described as more effective than sertraline (44.9 to 37.0), but there was no placebo control so the placebo-subtracted effect is unknown.
View on PubMed Intratympanic dexamethasone plus melatonin versus melatonin only in the treatment of unilateral acute idiopathic tinnitus
Finding: Adding intratympanic dexamethasone to melatonin produced significantly better improvement and cure rates than melatonin alone (between-group difference 'highly significant'), indicating melatonin monotherapy is the weaker arm.
View on PubMed Clinical pharmacology of melatonin in the treatment of tinnitus: a review
Finding: Concluded that confirmation of melatonin's clinical effectiveness for tinnitus 'cannot be given in the light of the biases observed,' though melatonin 'seems to improve sleep disturbance linked to tinnitus.'
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↗
L5d Harvard Health
Against
Not recommended: prescription medications such as antidepressants, tranquilizers, antiseizure drugs, or steroid injections; dietary supplements such as Ginkgo biloba, melatonin, or zinc. source↗
L5e Specialty Society (condition-mapped)
Against
Clinicians should not recommend Ginkgo biloba, melatonin, zinc, or other dietary supplements for treating patients with persistent, bothersome tinnitus. Recommendation against based on RCTs and Systematic Reviews with methodological concerns, with a preponderance of benefit over harm. source↗