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. 2012 Jan 18;2012(1):CD008921. doi: 10.1002/14651858.CD008921.pub2

Emery 1986

Methods Double‐blind cross‐over trial
Participants 27 patients with RA
2 male, 25 female
Mean age 59 years, disease 4‐30 years,
51% receiving gold, penicillamine, chloroquine or prednisone, "All were receiving maximal doses of one or more nonsteroidal anti‐inflammatory drugs, but had persistent pain"
Inclusion: not specified
Exclusion: not specified
Sample size calculation: not reported
Interventions Nefopam 60mg tds or placebo for 4 weeks, followed by one week washout then further 4 weeks on the alternative preparation
Outcomes Baseline, 2 weeks and 4 weeks for each cross‐over period
Primary
1) Pain (VAS 100mm)
2) EMS (VAS 100mm)
3) Joint tenderness
4) Grip strength
5) Proximal interphalangeal joint (PIP) size
Notes Conclusion: nefopam was a more effective analgesic than placebo when given as a supplement to anti‐inflammatory drugs
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No information specified
Allocation concealment (selection bias) Unclear risk No information specified
Blinding (performance bias and detection bias) 
 Participant Low risk Quote: "Placebo tablets were identical in appearance"
Comment: it is likely the patients remained blinded
Blinding (performance bias and detection bias) 
 Personnel Unclear risk Quote: "Neither doctor nor patient was aware of the treatment order"
Comment: no information specified
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 5 patients dropped out and were accounted for. They were excluded from the analysis
Selective reporting (reporting bias) Low risk All prespecified outcomes were reported
Compliance? Unclear risk Information not specified
Co‐interventions? Unclear risk Quote: "Patients were asked to discontinue pure analgesics one week prior to the study"
Comment: no further information on co‐interventions during the trial were supplied
Baseline characteristics? Low risk Cross‐over trial.
Quote: "Baseline measurements in the first and second periods were not significantly different for any variable", "Evidence for an order of treatment or carry‐over drug effect was sought by applying the approach described by Hill and Armitage"
Comment: patients underwent a one week washout period and there was no evidence of a carry over effect
intention to treat analysis? High risk Completers only analysis
Drop Outs? Low risk 5/27 (18.5%) patients withdrew due to adverse events
Summary Assessment of Bias? High risk High risk of bias