High-dose melatonin (30 mg/day) is safe and feasible but does not accelerate early biochemical or radiographic bone healing after tibial fracture fixation within 49 days
In a prospective controlled study, 25 adults with closed tibial shaft fractures received either 30 mg/day melatonin for 49 days post-surgery or standard care. Both groups showed significant increases in ALP and RUST scores over time, but no significant between-group differences were found for ALP (p=0.324) or RUST (p=0.261). The intervention was well tolerated with high adherence (91.7%) and no serious adverse events.
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High-dose melatonin (30 mg/day) is safe and feasible but does not accelerate early biochemical or radiographic bone healing after tibial fracture fixation within 49 days The current body of evidence comprises 1 study. EvidenceHub rates the overall confidence at 38/100 (low).
The Claim
High-dose melatonin (30 mg/day) is safe and feasible but does not accelerate early biochemical or radiographic bone healing after tibial fracture fixation within 49 days
This conclusion is most relevant to: Adults aged 18-60 years with closed tibial shaft fractures (AO/OTA 42-A/B/C).
What the Research Shows
The conclusion draws on 1 linked study. Highlights from the cited literature:
- ▸High-dose melatonin for early tibial fracture healing: A prospective study of safety, feasibility, and preliminary biological effects. (Injury, 2026) —
How It Works
The proposed biological pathway:
- ▸Melatonin has antioxidant and osteogenic properties in preclinical models
- ▸Administered nightly at pharmacological dose to enhance bone healing
- ▸Measured ALP and RUST as markers of bone formation and radiographic union
- ▸No significant acceleration of healing observed within 49 days
Who Might Benefit
Evidence fit by population:
- ▸Adults aged 18-60 years with closed tibial shaft fractures (AO/OTA 42-A/B/C)
Recommended Dose
30 mg/day
Limitations & Caveats
Important context when interpreting this evidence:
- ▸Small sample size (n=25) and non-randomized sequential allocation
- ▸Short follow-up (49 days) may not capture full healing trajectory
- ▸Lack of blinding and placebo control
- ▸Single-center design limits generalizability
Frequently Asked Questions
What dose of melatonin was used in this study?▼
30 mg per day, administered orally at night for 49 days.
Did melatonin improve bone healing in tibial fractures?▼
No, the study found no significant difference in ALP or RUST scores between melatonin and control groups at 49 days.
Was high-dose melatonin safe in this patient population?▼
Yes, it was well tolerated with high adherence (91.7%) and only one report of mild daytime sleepiness; no serious adverse events occurred.
What were the main limitations of this study?▼
Small sample size, non-randomized design, short follow-up, and lack of blinding/placebo control.
References
- 1.Ninomiya AF, Bertolucci V, Nonose N, Messias LO, Beck WR, Pejon TMM, de Almeida Guerreiro F, Domingues VM, de Godoy Baruel GJ, da Silva LFM, Scariot PPM, Messias LHD. “High-dose melatonin for early tibial fracture healing: A prospective study of safety, feasibility, and preliminary biological effects..” Injury, 2026. PMID: 42617392 DOI: 10.1016/j.injury.2026.113548