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Journal Club

Journal Club. Alcohol, Other Drugs, and Health: Current Evidence March–April 2014. Featured Article. Gabapentin Can Decrease Heavy Drinking and Increase Abstinence for Patients with Alcohol Dependence. Mason BJ, et al. JAMA Intern Med . 2014;174(1):70–77. Study Objective.

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Journal Club

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  1. Journal Club Alcohol, Other Drugs, and Health: Current Evidence March–April 2014

  2. Featured Article Gabapentin Can Decrease Heavy Drinking and Increase Abstinence for Patients with Alcohol Dependence Mason BJ, et al. JAMA Intern Med. 2014;174(1):70–77.

  3. Study Objective • To determine whether gabapentin can increase rates of sustained abstinence and decrease rates of heavy drinking. www.aodhealth.org

  4. Study Design • A 12-week, double-blind, placebo-controlled randomized dose-ranging trial comparing three groups (N = 150 adults with current alcohol dependence). All groups received counseling. • The three groups received: • Gabapentin 900 mg/day • Gabapentin 1800 mg/day • Gabapentin 0 mg/day (control) www.aodhealth.org

  5. Assessing Validity of an Article about Therapy • Are the results valid? • What are the results? • How can I apply the results to patient care? www.aodhealth.org

  6. Are the Results Valid? • Were patients randomized? • Was randomization concealed? • Were patients analyzed in the groups to which they were randomized? • Were patients in the treatment and control groups similar with respect to known prognostic variables? www.aodhealth.org

  7. Are the Results Valid?(cont‘d) • Were patients aware of group allocation? • Were clinicians aware of group allocation? • Were outcome assessors aware of group allocation? • Was follow-up complete? www.aodhealth.org

  8. Were patients randomized? • Yes. • Patients were randomized using a computer-generated randomization code. • Patients were randomized in a 1:1:1 ratio. www.aodhealth.org

  9. Was randomization concealed? • Yes. • The randomization code was kept by the study pharmacist who administered the medication. www.aodhealth.org

  10. Were patients analyzed in the groups to which they were randomized? • Yes. www.aodhealth.org

  11. Were the patients in the treatment and control groups similar? • Yes. www.aodhealth.org

  12. Were patients aware of group allocation? • No. • Patients were blinded to group allocation. www.aodhealth.org

  13. Were clinicians aware of group allocation? • No. • Only the study pharmacist was aware of group allocation. Other researchers or clinicians were not. www.aodhealth.org

  14. Were outcome assessors aware of group allocation? • No. www.aodhealth.org

  15. Was follow-up complete? • No. • The trial was 12 weeks long and patients were administered medication weekly. • Number of patients who provided 12-week data for analysis: • Gabapentin 900 mg group: 27 of 54 initially enrolled • Gabapentin 1800 mg group: 28 of 47 initially enrolled • Control group: 30 of 49 initially enrolled www.aodhealth.org

  16. What Are the Results? • How large was the treatment effect? • How precise was the estimate of the treatment effect? www.aodhealth.org

  17. How large was the treatment effect? • Gabapentin had a significant linear dose effect in increasing rates of abstinence (P = 0.04). • The rate of 12-week abstinence was: • Gabapentin 900 mg group: 11.1% (95% CI, 5.2%–22.2%) • Gabapentin 1800 mg group: 17% (95% CI, 8.9%–30.1%; NNT = 8; OR = 4.8) • Control: 4.1% (95% CI, 1.1%–13.7%) • The rate of no heavy drinking at 12 weeks was: • Gabapentin 900 mg group: 29.6% (95% CI, 19.1%–42.8%) • Gabapentin 1800 mg group: 44.7% (95% CI, 31.4%–58.8%; NNT = 5; OR = 2.8) • Control: 22.5% (95% CI, 13.6%–37.2%) www.aodhealth.org 17

  18. How Can I Apply the Results to Patient Care? • Were the study patients similar to the patients in my practice? • Were all clinically important outcomes considered? • Are the likely treatment benefits worth the potential harm and costs? www.aodhealth.org

  19. Were the study patients similar to those in my practice? • The patients were treatment-seeking adult volunteers. • All were people with current DSM-IV alcoholdependence; the majority had moderate dependence. • They were excluded if urine toxicology screens revealed the use of any other substances besides alcohol or nicotine. • They could not have significant medical or psychiatric disorders. www.aodhealth.org

  20. Were all clinically important outcomes considered? • Yes. www.aodhealth.org

  21. Are the likely treatment benefits worth the potential harm and costs? • Possibly. • There were no differences in the rate of termination due to adverse events by study arm. Costs were not considered. • Due to the loss to follow-up, further studies into acceptability and efficacy of gabapentin for treating alcohol use disorders are needed. • Results may not be generalizable since it was a single-site study. • The overlapping confidence intervals across the study groups suggest that widespread use of the treatment for dependence should await a larger effectiveness trial. www.aodhealth.org

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