| Methods | Randomised, double‐blind, multi‐centre parallel group study | |
| Participants | 58 patients with RA 12 male, 46 female Mean age 62.8yrs Inclusion: active RA (ACR criteria), stable NSAIDs or steroids for one month and stable DMARDs for 3 months Exclusion: history of psychiatric disorders or substance misuse, severe cardiovascular, renal or hepatic disorder, or a history of epilepsy Sample size calculation: not reported |
|
| Interventions | Sativex oromucosal spray (2.7 mg Tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD) with each activation (dose)) vs Placebo Single dose nights 1 and 2, increased by one dose every 2 days to a maximum of six doses (according to individual response). Stable dosing was then maintained for a further 3 weeks Dosing was restricted to the evening to minimize possible intoxication‐type reactions |
|
| Outcomes | Baseline, day 14, 28, 49 and 57‐59 Primary: pain on movement (0–10 numerical rating scale (NRS)) Secondary: 1) Pain at rest (0‐10 NRS), Short Form McGill Pain Questionnaire (SF‐MPQ) 2) Sleep quality (0‐10 NRS) 3) Morning stiffness 4) 28‐joint disease activity score (DAS28) |
|
| Notes | Conclusion: statistically significant improvements in pain on movement, pain at rest, quality of sleep, DAS28 and the SF‐MPQ pain at present component were seen following CBM in comparison with placebo. Data was skewed as median differences were reported for most measures. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "randomised treatment allocation using permuted blocks of four" Comment: adequate |
| Allocation concealment (selection bias) | Unclear risk | No information specified |
| Blinding (performance bias and detection bias) Participant | Unclear risk | Quote: "versus placebo" Comment: no further information specified. Sativex has a mint flavour and it is likely the placebo did not replicate this |
| Blinding (performance bias and detection bias) Personnel | Unclear risk | No information specified |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 4 patients withdrew from the study and were accounted for, however it was unclear at what time point they withdrew and how their data were treated Comment: it is likely they were excluded from the analysis |
| Selective reporting (reporting bias) | Low risk | All prespecified outcomes were reported |
| Compliance? | Unclear risk | No information specified |
| Co‐interventions? | Unclear risk | No information specified |
| Baseline characteristics? | Low risk | Quote: "There were no significant differences in demographics between groups" Comment: baseline characteristics were similar |
| intention to treat analysis? | Unclear risk | 4 patients withdrew from the study. It is not clear how their data were dealt with Comment: no information specified |
| Drop Outs? | Low risk | 4/58 (8.3%) patients dropped out, 3 from the placebo group and 1 active treatment |
| Summary Assessment of Bias? | High risk | High risk of bias |
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