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. 2023 May 10;2023(5):CD014682. doi: 10.1002/14651858.CD014682.pub2

Max 1988.

Study characteristics
Methods Design: cross‐over
Duration: each cross‐over period was 6 weeks
Assessment: baseline and post‐cross‐over period
Country: USA
Participants Pain condition: post‐herpetic neuralgia
Population: adults with post‐herpetic neuralgia
Minimum pain intensity: no
Inclusion criteria
  • Daily pain, persisting at least 3 months after a segmental herpes zoster eruption


Exclusion criteria
  • Another type of pain as severe

  • Depression


Total participants randomised: 58
Age in years (median, range): 72 (25‐86)
Gender: 27/58 were female
Pain duration in months (median, range): 19 months (3 months‐25 years)
Interventions Placebo
  • Inert ‐ lactose

  • "Placebo (PLAC) is given only during the first period, because both amitriptyline (AMI) and lorazepam (LOR) have prominent side effects. We predicted that patients given placebo following one of those drugs would immediately recognize this inert treatment. The design permitted a comparison of AMI, LOR, and PLAC during the first treatment period."


Amitriptyline 12.5‐150 mg
  • TCA

  • Forced titration to maximum tolerable dose in first 3 weeks, then held at that dose for final 3 weeks


Lorazepam 0.5‐6 mg
  • Benzodiazepine

  • Forced titration to maximum tolerable dose in first 3 weeks, then held at that dose for final 3 weeks

Outcomes AEs
Missing data methods Unclear
Funding source Non‐pharmaceutical: from the Neurobiology and Anaesthesiology Branch, National Institute of Dental Research (Drs Max, Gracely, Smoller, and Dubner). and the Nursing Department, Clinical Center (Ma. Schnfer and Me. Culnane), National Institutes of Health, Bethesda, MD
Conflicts of interest NR
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomisation methods not specified
Allocation concealment (selection bias) Unclear risk Allocation procedures not specified
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Says double‐blind but no information about this was given
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Self‐reported outcomes from participants, but unsure of blinding procedures
Incomplete outcome data (attrition bias)
All outcomes Unclear risk No information regarding missing data reported. 41 completed both of the treatment periods for their group, but authors report data on 58
Selective reporting (reporting bias) Unclear risk No protocol or trial registration found
Other bias Low risk No other sources of bias identified