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. 2016 Nov 18;2016(11):CD002779. doi: 10.1002/14651858.CD002779.pub3

NCT02580734.

Methods Placebo‐controlled, triple‐blinded cross‐over RCT
Participants 20 BMS patients
 Mean age: Unknown until published (eligible age range 18 to 90)
Sex: Distribution unknown until published
Inclusion/exclusion and diagnostic criteria appropriate
Interventions Intervention category: Dietary supplements
Group 1: (n = 20) Melatonin 12 mg daily (3 mg capsules taken 4 times p/day)
Group 2: (n = 20) Placebo (capsules taken 4 times p/day)
Duration: 5 months (2 months, followed by 1 month washout, and then final 2 months)
Outcomes
  • Pain intensity at 2 months (assessed by VAS, verbal intensity score and numerical rating scale)

  • QoL (assessed by SF‐36 (36‐Item Short Form Health Survey))

  • QoL surrogate: Anxiety (assessed by Hamilton Anxiety Rating Scale (HAM‐A))

  • Adverse effects


Outcomes not of interest to this review
  • Sleep (assessed by Epworth Sleepiness Scale (ESS) and sleep scale from the Medical Outcomes Study (MOS))

  • Serum melatonin levels (measured by blood sample)

Source of funding Unknown until published
Notes Study currently unpublished
Contact: Andrea Sardella (andrea.sardella@unimi.it)