Methods | Randomised, double-blind, placebo-controlled 3-period cross-over, no enrichment. No imputation method mentioned Titration to target doses or limit of tolerability over 24 days, then stable dose for 1 week, and tapered dose for 1 week (6 weeks in total); 6-day washout and cross-over to next treatment |
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Participants | PDN and PHN. N = 56, median age 64 years, 40% women. Pain ≥ moderate for 6 months, initial mean pain score 5.4/10 | |
Interventions | Gabapentin 3600 mg daily (max) Nortriptyline 100 mg daily (max) Gabapentin plus nortriptyline 3600 mg/100 mg daily (max) Mean (SE) maximum tolerated doses: gabapentin alone 2433 ± 106 mg, nortriptyline alone 62 ± 3.6 mg, gabapentin + nortriptyline 2180 ± 108 + 50 ± 3.5 mg |
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Outcomes | Pain relief (average) Withdrawals Adverse events |
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Notes | Oxford Quality Score: R = 2, DB = 2, W = 1, Total = 5 | |
Risk of bias | ||
Item | Authors’ judgement | Description |
Allocation concealment? | Yes | “concealed allocation” |
Blinding? All outcomes |
Yes | “double dummy” |
Incomplete outcome data addressed? Efficacy |
Unclear | Imputation not mentioned |
Size Efficacy |
No | Reporting on < 50 completing 2 periods |
Study duration Efficacy |
Unclear | 5-week period on treatment |
Outcomes reported | No | No dichotomous data |