Gilron 2009.
Study characteristics | ||
Methods | Design: cross‐over Duration: 6 weeks Assessment: baseline and post‐intervention Country: Canada |
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Participants | Pain condition: neuropathic pain from diabetic peripheral neuropathy or post‐herpetic neuralgia Population: adults with diabetic polyneuropathy or post‐herpetic neuralgia Minimum pain intensity: ≥ 4 on 0‐10 VAS Inclusion criteria
Exclusion criteria
Total participants randomised: 56 Age in years (median, range): diabetic peripheral: 61 (53‐69); post‐herpetic: 68 (65‐73) Gender: 21/56 were female Pain duration in years (median, range): diabetic peripheral: 5.2 (3.4); post‐herpetic: 2.8 (4.3) |
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Interventions | Gabapentin ≤ 3600 mg
Nortriptyline ≤ 100 mg
Nortriptyline ≤ 100 mg and gabapentin ≤ 3600 mg
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Outcomes | Pain intensity Sleep Mood Physical fucntion SAEs Withdrawal |
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Missing data methods | ITT but no method specified | |
Funding source | Non‐pharmaceutical: Canadian Institutes of Health Research (grant numbers MCT‐69422 and MSH‐55041) | |
Conflicts of interest | IG has received honoraria for consulting or being a member of an advisory board, or both for Pfizer. RLH has received research grant support from Pfizer. All other authors declare that they have no conflicts of interest. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were randomised using computer randomisation of the 3 sequences in blocks of 3. |
Allocation concealment (selection bias) | Low risk | A trial pharmacist prepared a concealed allocation schedule, and the pharmacist had no further involvement in the trial. Patients were assigned in turn to the next consecutive number, and the corresponding series of study drugs was dispensed. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind, double‐dummy design |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Self‐reported outcomes from blinded participants |
Incomplete outcome data (attrition bias) All outcomes | High risk | ITT with LOCF, unequal dropout Attrition Total: 11/56 (19.6%) Gabapentin ≤ 3600 mg: 8/56 (14.3%) Nortriptyline ≤ 100 mg: 1/56 (1.8%) Gabapentin ≤ 3600 mg + nortriptyline ≤ 100 mg: 2/56 (3.6%) |
Selective reporting (reporting bias) | Unclear risk | Can't find global pain relief reported in study (was stated in prospective ISRCTN registration). In the protocol, the Profile of Mood State questionnaire was listed as a secondary outcome but it is NR. |
Other bias | Low risk | No other sources of bias identified |