| Methods | Randomised, double-blind, placebo-controlled, parallel-group, not enriched. No imputation method mentioned Titration to adequate pain relief, limit of tolerability or 4200 mg daily, then stable dose for remainder of 12-week study |
|
| Participants | Chronic masticatory myalgia (pain classification based on defined criteria) lasting ≥ 6 months, not resulting from trauma or active inflammatory cause. N = 50, mean age 34 years, 100% women. PI at randomisation ≥ 50/100, initial average daily pain score 6. 2/10 | |
| Interventions | Gabapentin 4200 mg daily (max), n = 25 Placebo, n = 25 Stable doses of antidepressants continued Paracetamol (max 4000 mg daily) allowed as rescue medication |
|
| Outcomes | ≥ 30% reduction in pain Adverse events Withdrawals |
|
| Notes | Oxford Quality Score: R = 2, DB = 2, W = 1, Total = 5 Note: withdrawals > 10% |
|
| Risk of bias | ||
| Item | Authors’ judgement | Description |
| Allocation concealment? | Yes | “concealed randomization and the according allocation were implemented by a research assistant” (not involved with patients or investigators) |
| Blinding? All outcomes |
Yes | “identical looking capsules … packaged in identical clear bottles” |
| Incomplete outcome data addressed? Efficacy |
Unclear | Imputation not mentioned |
| Size Efficacy |
Unclear | 50 randomised |
| Study duration Efficacy |
Yes | 12 weeks |
| Outcomes reported | Unclear | Pain reduction of 30% or more |