Katz 2005.
Study characteristics | ||
Methods | Design: cross‐over Duration: 7 weeks Assessment: baseline and post‐intervention Country: USA |
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Participants | Pain condition: low back pain Population: adults with chronic low back pain Minimum pain intensity: no Inclusion criteria
Exclusion criteria
Total participants randomised: 54 Age in years (mean, SD): 50.6 (10.7) Gender: 26/54 were female Pain duration in years (mean, SD): NR |
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Interventions | Placebo
Bupropion 300 mg
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Outcomes | Pain intensity SAEs Withdrawal |
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Missing data methods | ITT with LOCF | |
Funding source | Partly funded by pharmaceutical: "Supported in part by an investigator‐initiated research grant from GlaxoSmithKline" | |
Conflicts of interest | Supported in part by an investigator‐initiated research grant from GlaxoSmithKline to R.H.D., who has also received research support, consulting fees, or lecture honoraria in the past year from Abbott Laboratories, Eli Lilly & Co., Endo Pharmaceuticals, EpiCept Corporation, NeurogesX, Novartis Pharmaceuticals, Organon, Ortho‐McNeil Pharmaceutical, Pfizer, Purdue Pharma, Ranbaxy Corporation, Reliant Pharmaceuticals, Renovis, and UCB Pharma. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were randomised using a computer‐generated list of random numbers. |
Allocation concealment (selection bias) | Unclear risk | Allocation procedures NR |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | States double‐blind and used same dosing for placebo as intervention but no information given regarding other blinding procedures |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Self‐reported outcomes from participants but uncertain of blinding procedures |
Incomplete outcome data (attrition bias) All outcomes | High risk | ITT with LOCF Attrition Total: 14/54 (25.9%) Placebo: 5/54 (9.3%) Bupropion 300 mg: 9/54 (16.7%) |
Selective reporting (reporting bias) | High risk | "Several other health‐related quality‐of‐life measures of physical and emotional functioning were administered, but these data were not analyzed because of the absence of significant beneficial effects on the pain intensity and relief outcome measures." |
Other bias | Unclear risk | Participants tapering off of bupropion reported having AEs from reducing the medication, which could have lasted the washout period, but this is not explored further in the article. |