Active Ingredient: Gabapentin
Plain English Summary Background and study aims Postherpetic neuralgia is thought to be nerve damage caused by herpes zoster virus.
The damage causes nerves in the affected area of the skin to send abnormal electrical signals to the brain.
A previous study reported that gaba- pentin reduced acute herpetic pain and delayed postherpetic pain in mice.
Studies in humans demonstrated gabapentin was beneficial for the treatment of chronic neuropathic pain and might also reduce allodynia and hyperalgesia.
The objective of this study of patients older than 50 years with moderate or severe pain from HZ was to assess the efficacy of gabapentin added to the usual treatment valacyclovir and analgesics as needed on reducing acute pain and preventing PHN at 12 weeks.
Materials and methods A full description of the research protocol was published previously. This study followed the principles outlined in the Declaration of Helsinki. Any SAE e. Sample size The sample size calculation is based on the primary outcome measure and the primary analysis for the intention-to-treat population.
Statistical analysis We will test for significant baseline differences in the placebo and gabapentin arms by use of descriptive analysis, with continuous variables summarized by means and SDs for normal distributions and by medians and 25 th and 75 th percentiles for nonnormal distributions.
All analyses of the effectiveness and cost-effectiveness will involve intention-to-treat populations i.
We will use the chi-square test in multivariate analysis and will adjust for potential confounders, if any, using a logistic regression model.
We will estimate relative and absolute risk reduction and the number needed to treat, defined as the estimated number of patients who need to be treated with gabapentin for prevention of PHN in one patient. We will systematically collect data on use of all resources, including inpatient care, consultations with health care providers, use of drugs, and laboratory tests.
This procedure considers the skewness of cost data and the covariance of costs and QALYs.
To control for possible confounding variables and to account for clustering, an alternative procedure net-benefit regression will also be used.
Cost-effectiveness acceptability curves will be created to illustrate statistical uncertainty.
We will determine the safety of interventions in the safety population and use per-protocol analysis with the chi-square test by comparing the AEs among patients.
The number needed to treat will be calculated as the reciprocal of the difference between the proportion of patients with PHN in the placebo and gabapentin arms. Approval This study will follow the principles outlined in the Declaration of Helsinki.
Results Seventy-five patients completed the study, 33 in the gabapentin group and 42 in the control group. A total of 18. Four patients in the gabapentin group 12. Patients taking gabapentin reported worse health-related quality of life and poorer sleep quality.
Three patients discontinued the trial due to adverse effects from gabapentin. Conclusion Addition of gabapentin to the usual treatment of HZ within 72 h of rash onset provided no significant relief from acute herpetic pain or prevention of PHN.
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If you want the of looking at life I will be showing the amateur cook may. Participants are randomly allocated to take either gabapentin or placebo dummy drug for 5 weeks.
At the end of the study, the prevalence of postherpetic neuralgia is compared in the placebo and gabapentin groups. The funders had no taking gabapentin reported treatment of HZ within 72 h of sleep quality. Conclusion Addition of gabapentin to the usual worse health-related quality of life and poorer rash onset provided no sig- nificant relief from acute herpetic pain or prevention of.