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Journal Club

This study evaluates the efficacy and validity of topiramate for reducing drinking in patients with alcohol dependence. The results show a significant reduction in drinking days and liver enzymes in the topiramate group compared to placebo.

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Journal Club

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  1. Journal Club Alcohol, Other Drugs, and Health: Current Evidence January–March 2008 www.aodhealth.org

  2. Featured Article Topiramate for treating alcohol dependence: a randomized controlled trial Johnson BA, et al. JAMA. 2007;298(14):1641–1651. www.aodhealth.org

  3. Study Objective • To determine topiramate’s efficacy for reducing drinking www.aodhealth.org

  4. Study Design • Researchers randomized 371 patients with dependence from 17 sites across the U.S. to receive for 14 weeks of… • topiramate (up to 300 mg per day) or • placebo • Only subjects without comorbid conditions (e.g., other substance use, depression) who wanted to quit or reduce drinking were eligible to enroll. • All subjects received weekly, manual-guided adherence enhancement counseling. 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.) • 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. • The patients were randomized to either topiramate or to placebo. www.aodhealth.org

  9. Was randomization concealed? • Yes. • Randomization was concealed. www.aodhealth.org

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

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

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

  13. Were clinicians aware of group allocation? • No. • Clinicians were unaware of group allocation. www.aodhealth.org

  14. Were outcome assessors aware of group allocation? • The authors did not state whether or not assessors were aware of group allocation. www.aodhealth.org

  15. Was follow-up complete? • 67 patients randomized to topiramate did not complete the trial. • 41 patients randomized to placebo did not complete the trial. 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? In analyses that considered all dropouts as having relapsed to baseline measures, topiramate recipients had a… • greater reduction in the percentage of drinking days (from a mean of 82% to 44% compared with 82% to 52% for placebo recipients), • greater reduction in liver enzymes, • greater increase in abstinent days (from a mean of 10% to 38% compared with 9% to 29% for placebo recipients). www.aodhealth.org

  18. How large was the treatment effect? (cont.) • In analyses that considered dropouts as missing rather than as relapses,… • the differences between the topiramate and placebo groups were even greater. • With both analytic approaches, topiramate recipients achieved ≥28 days of both continuous abstinence and continuous nonheavy drinking faster than placebo recipients did. www.aodhealth.org

  19. How precise was the estimate of the treatment effect? • In analyses that considered all dropouts as having relapsed to baseline measures, • the mean difference in percentage of heavy drinking days was 8.44% (95% CI, 3.07%–13.80%). www.aodhealth.org

  20. 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

  21. Were the study patients similar to those in my practice? • Patients were seeking treatment and recruited by newspaper, radio, and television advertisements. • The majority of patients were in their late 40’s, male, white, and had no history of inpatient alcohol treatment. www.aodhealth.org

  22. Were all clinically important outcomes considered? • The primary outcome was the percentage of heavy drinking days. • Secondary outcome measures included percentage of days abstinent, drinks per drinking day, and gamma-glutamyltransferase. • These are all standard drinking outcomes in clinical trials. www.aodhealth.org

  23. Are the likely treatment benefits worth the potential harm and costs? • There was no assessment of cost. • The attrition rates due to adverse events were 18.6% (34 of 183) for the topiramate group and 4.3% (8 of 188) for the placebo group (P< 0.001). • Adverse events that were significantly more common in the topiramate group included… • paresthesia, taste perversion, anorexia, difficulty with concentration and attention, nervousness, dizziness, and pruritus. www.aodhealth.org

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