Otto 2008.
Study characteristics | ||
Methods | Design: cross‐over Duration: 5 weeks Assessment: baseline and post‐intervention Country: Denmark |
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Participants | Pain condition: polyneuropathy Population: adults aged 20‐80 with chronic polyneuropathy Minimum pain intensity: ≥ 4 on 0‐10 scale Inclusion criteria
Exclusion criteria
Total participants randomised: 48 Age in years (median, range): 62 (37–74) Gender: 12/48 were female Pain duration in months (median, range): 48 (8–180) |
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Interventions | Placebo
Escitalopram 20 mg
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Outcomes | Pain intensity Sleep Mood AEs Withdrawal |
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Missing data methods | ITT with LOCF | |
Funding source | Partly pharmaceutical: Odense University Hospital The work behind this study was supported by unrestricted grants from H. Lundbeck A/S and Gruenenthal GmbH and a grant from the Danish Clinical Intervention Research Academy. | |
Conflicts of interest | This was an investigator‐initiated study and neither company was responsible for the creation of the study protocol, the data analysis, data interpretation, or writing of the manuscript. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Assignment to treatment sequence was random via a computer‐generated randomisation code with a block size of 4. |
Allocation concealment (selection bias) | Low risk | The randomisation plan was generated by a person in the hospital pharmacy at Odense University Hospital who was not involved in the conduct of the trial. The study drugs were packed in boxes marked with randomisation number and treatment period by the hospital pharmacy. Patients were enrolled by the investigators and, after the baseline period, numbered consecutively by the investigators and treated with the study drugs with the corresponding randomisation number. Sealed opaque envelopes with the treatment sequence for each patient for emergency situations were present at the study sites. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind, identical study drugs with matched 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 | ITT with LOCF Attrition Total: 10/41 (24.4%) Placebo: 4/41 (9.8%) Escitalopram 20 mg: 6/41 (14.6%) |
Selective reporting (reporting bias) | High risk | Some outcomes mentioned prospectively on clinicaltrials.gov NR e.g. different subtypes of pain and quality of life |
Other bias | Low risk | No other sources of bias were identified |