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

Loldrup 1989.

Study characteristics
Methods Design: parallel
Duration: 6 weeks
Assessment: baseline and post‐intervention
Country: Denmark
Participants Pain condition: idiopathic pain syndromes: (a) tension headache, (b) burning mouth syndrome (oral dysaesthesia), (c) abdominal pain (gastroscopy negative for ulcer), and (d) low back pain
Population: people with idiopathic pain syndromes
Minimum pain intensity: no
Inclusion criteria
  • Pain from 1 of the 4 conditions listed above


Exclusion criteria
  • Physical health comorbidies

  • Excluded severe psychiatric conditions but included depression and anxiety


Total participants randomised: 253
Age in years (median, range): 51.0 (17‐80)
Gender: 185/253 were female
Pain duration in years (median, range): 60.0 (6‐636)
Interventions Placebo
  • n = 87

  • Inert


Clomipramine 75‐150 mg
  • n = 84

  • Fixed dose of either 75 mg or 150 mg dependent upon side effects

  • Mean dose: 125 mg/day


Mianserin 30‐60 mg
  • n = 82

  • Fixed dose of either 30 mg or 60 mg dependent upon side effects

  • Mean dose: 45 mg/day

Outcomes Substantial pain
Withdrawal
Missing data methods Completer analysis only
Funding source Non‐pharmaceutical: "This study was financially supported by: Danish Medical Research Council, Danish Medical Research Council‐Region‐III, Kleins legat, Geerd Jorgensens fond, Lundbeck Fonden, Mimi and Victor Larsens Fond, Danish Dental Association (FUT‐foundation), Bryde Nielsen Fond, P. Carl Petersens Fond, Ciba Geigy A/S, and Organon."
Conflicts of interest "Per Bech has occasionally over the past 3 years until August 2008 received funding from and been speaker or member of advisory boards for pharmaceutical companies with an interest in drug treatment of affective disorders (Astra‐Zeneca, Lilly, H. Lundbeck A/S, Lundbeck Foundation, Organon). All other authors declare that they have no conflicts of interests."
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Participants were randomised by use of random numbers
Allocation concealment (selection bias) Unclear risk Allocation procedure not specified
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind, identical study drugs and dosing
Blinding of outcome assessment (detection bias)
All outcomes Low risk Self‐reported outcomes from blinded participants
Incomplete outcome data (attrition bias)
All outcomes High risk Completer analysis only
Attrition
Total: 75/253 (29.6%)
Placebo: 15/87 (17.2%)
Clomipramine 75‐100 mg: 28/84 (33.3%)
Mianserin 30‐60 mg: 28/82 (34.2%)
Selective reporting (reporting bias) Unclear risk No protocol or trial registration found
Other bias Low risk No other sources of bias were identified.