Loldrup 1989.
Study characteristics | ||
Methods | Design: parallel Duration: 6 weeks Assessment: baseline and post‐intervention Country: Denmark |
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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
Exclusion criteria
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) |
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Interventions | Placebo
Clomipramine 75‐150 mg
Mianserin 30‐60 mg
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Outcomes | Substantial pain Withdrawal |
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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. |