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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

Journal Club

Alcohol, Other Drugs, and Health: Current Evidence

March–April 2014


Featured article

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

Study Objective

  • To determine whether gabapentin can increase rates of sustained abstinence and decrease rates of heavy drinking.

www.aodhealth.org


Study design

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


Assessing validity of an article about therapy

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


Are the results valid

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


Are the results valid cont d

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


Were patients randomized

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


Was randomization concealed

Was randomization concealed?

  • Yes.

    • The randomization code was kept by the study pharmacist who administered the medication.

www.aodhealth.org


Were patients analyzed in the groups to which they were randomized

Were patients analyzed in the groups to which they were randomized?

  • Yes.

www.aodhealth.org


Were the patients in the treatment and control groups similar

Were the patients in the treatment and control groups similar?

  • Yes.

www.aodhealth.org


Were patients aware of group allocation

Were patients aware of group allocation?

  • No.

    • Patients were blinded to group allocation.

www.aodhealth.org


Were clinicians aware of group allocation

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


Were outcome assessors aware of group allocation

Were outcome assessors aware of group allocation?

  • No.

www.aodhealth.org


Was follow up complete

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


What are the results

What Are the Results?

  • How large was the treatment effect?

  • How precise was the estimate of the treatment effect?

www.aodhealth.org


How large was the treatment effect

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


How can i apply the results to patient care

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


Were the study patients similar to those in my practice

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


Were all clinically important outcomes considered

Were all clinically important outcomes considered?

  • Yes.

www.aodhealth.org


Are the likely treatment benefits worth the potential harm and costs

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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