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. 2023 May 10;2023(5):CD014682. doi: 10.1002/14651858.CD014682.pub2

Hannonen 1998.

Study characteristics
Methods Design: parallel
Duration: 12 weeks
Assessment: baseline and post‐intervention
Country: Finland
Participants Pain condition: fibromyalgia
Population: women with fibromyalgia
Minimum pain intensity: ≥ 4 on 0‐10 VAS
Inclusion criteria
  • Women aged 18‐65

  • Fulfilling ACR criteria for fibromyalgia

  • ≥ 4 out of 0‐10 for pain, general health, sleep, and fatigue


Exclusion criteria
  • Severe physical health problems, major depression, psychosis, obsessive compulsive disorder


Total participants randomised: 130
Age in years (mean): 48.7
Gender: 130/130 were female
Pain duration in years (mean): 8.2
Interventions Placebo
  • n = 45

  • Inert

  • Double‐dummy design


Moclobemide 450‐600 mg
  • n = 43

  • Reversible MAOI

  • Flexible dose dependent upon efficacy

  • Double‐dummy design


Amitriptyline 25‐37.5 mg
  • n = 42

  • TCA

  • Flexible dose dependent upon efficacy

  • Double‐dummy design

Outcomes Pain intensity
Sleep
Mood
Physical function
AEs
Withdrawal
Missing data methods States ITT but no methods reported
Funding source Partly supported by pharmaceutical: "The financial support by Roche Oy, Finland, is gratefully acknowledged."
Conflicts of interest NR
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomisation methods NR
Allocation concealment (selection bias) Low risk The randomisation was organised centrally with sequentially numbered envelopes consisting of blocks of 6
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blinded, study drugs were identical, double‐dummy design
Blinding of outcome assessment (detection bias)
All outcomes Low risk Self‐reported outcomes by blinded participants
Incomplete outcome data (attrition bias)
All outcomes Unclear risk States ITT but no methods reported
Attrition
Total: 38/130 (29.2%)
Moclobemide 450‐600 mg: 13/43 (30.2%)
Amitriptyline 25‐37.5 mg: 10/42 (23.8%)
Placebo: 15/45 (33.3%)
Selective reporting (reporting bias) Unclear risk No protocol or trial registration found
Other bias Low risk No other sources of bias identified