Table 37Summary of findings and strength of evidence for efficacy of FDA-approved medications for alcohol dependence

MedicationOutcomeN Studies; N SubjectsaResults Effect Size (95% CI)bNNTcStrength of Evidence
ACAReturn to any drinking16; 4,847RD: -0.09 (-0.14 to -0.04)12Moderate
Return to heavy drinking7; 2,496RD: -0.01 (-0.04 to 0.03)NAModerate
% DDs13; 4,485WMD: -8.8 (-12.8 to -4.8)NAModerate
% HDDs1; 100WMD: -2.6 (-11.4 to 6.2)NAInsufficient
Drinks per DD1; 116WMD: 0.4 (-1.8 to 2.6)NAInsufficient
Accidents or injuries0;d 0NANAInsufficient
QoL or function1; 612NSDNAInsufficient
Mortality8; 2,6777 events (ACA) vs. 6 events (placebo)NAInsufficient
DISReturn to any drinking2; 492RD: -0.04 (-0.11 to 0.03)eNALow
Return to heavy drinking0; 0NANAInsufficient
% DDs2; 290NSDfNAInsufficient
% HDDs0; 0NANAInsufficient
Drinks per DD0; 0NANAInsufficient
Accidents or injuries0; 0NANAInsufficient
QoL or function0; 0NANAInsufficient
Mortality0; 0NANAInsufficient
NTX 50 mg oralReturn to any drinking16; 2,347RD: -0.05 (-0.10 to -0.00)20Moderate
Return to heavy drinking19; 2,875RD: -0.09 (-0.13 to -0.04)12Moderate
% DDs15; 1,992WMD: -5.4 (-7.5 to -3.2)NAModerate
% HDDs6; 521WMD: -4.1 (-7.6 to -0.61)NAModerate
Drinks per DD9; 1,018WMD: -0.49 (-0.92 to -0.06)NALow
NTX 100 mg oralReturn to any drinking3; 946RD: -0.03 (-0.08 to 0.02)NALow
Return to heavy drinking2; 858RD: -0.05 (-0.11 to 0.01)NALow
% DDs2; 858WMD: -0.9 (-4.2 to 2.5)NALow
% HDDs2; 423WMD: -3.1 (-5.8 to -0.3)NALow
Drinks per DD1; 240WMD: 1.9 (-1.5 to 5.2)NAInsufficient
NTX injectionReturn to any drinking2; 939RD: -0.04 (-0.10 to 0.03)NALow
Return to heavy drinking2; 615RD: -0.01 (-0.14 to 0.13)NALow
% DDs1; 315WMD: -8.6 (-16.0 to -1.2)NAInsufficient
% HDDs2g; 926WMD: -4.6 (-8.5 to -0.56)NALow
Drinks per DD0; 0NANAInsufficient
NTX (any dose)Accidents or injuries0; 0NANAInsufficient
QoL or function4; 1,513Some conflicting resultshNAInsufficient
Mortality6; 1,7381 event (NTX) vs. 2 events (placebo)NAInsufficient

ACA = acamprosate; CI = confidence interval; DD, drinking day; DIS = disulfiram; FDA = U.S. Food and Drug Administration; HDD, heavy drinking day; N = number; NA = not applicable; NNT = number needed to treat; NSD = no statistically significant difference; NTX = naltrexone; QoL, quality of life; RD = risk difference; vs. = versus; WMD = weighted mean difference.

a

Includes only studies rated as low or medium risk of bias included in the main analyses; these numbers do not include studies rated as high or unclear risk of bias that were included in sensitivity analyses.

b

Negative effect sizes favor intervention over placebo/control.

c

NA entry for numbers needed to treat (NNT) indicates that the risk difference (95% CI) was not statistically significant, so we did not calculate a NNT, or that the effect measure was not one that allows direct calculation of NNT (e.g., WMD).

d

One study rated as unclear risk of bias reported that one patient in the placebo group died by “accident.” No other details on the cause or nature of the accident were provided.78 That study also reported 1 injury in the acamprosate group and 2 in the placebo group. Another study, rated high risk of bias, reported a traffic accident in the acamprosate group.184

e

From meta-analysis of disulfiram 250 mg versus control (disulfiram 1 mg).92,93 Meta-analysis including studies rated as high risk of bias also found no significant difference (RD, -0.00; 95% CI, -0.10 to 0.09). Similarly, our meta-analysis found no statistically significant difference between disulfiram 250 mg per day and riboflavin (i.e., no disulfiram) (RD, -0.04; 95% CI, -0.11 to 0.03).

f

One study (N=128) reported similar percentages and no significant difference;93 the other reported that disulfiram was favored among the subset of subjects (N=162 of 605 subjects) who drank and had a complete set of assessment interviews, but it did not report this outcome for the full randomized sample.92 Overall, evidence was insufficient due to imprecision, inconsistency, and indirectness.

g

Contains data from personal communication (B. Silverman, November 14, 2013).

h

Unable to pool data. Two studies found no significant difference between naltrexone- and placebo-treated subjects.102,193 One study reported that patients receiving injectable naltrexone 380 mg per month had greater improvement on the mental health summary score than those receiving placebo at 24 weeks (8.2 versus 6.2, p=0.044).131 One study measured alcohol-related consequences (with the DrInC) and reported that more subjects who received placebo (N=34) had at least 1 alcohol-related consequence than those who received naltrexone (N=34): 76 percent versus 45 percent, p=0.02.42

From: Discussion

Cover of Pharmacotherapy for Adults With Alcohol-Use Disorders in Outpatient Settings
Pharmacotherapy for Adults With Alcohol-Use Disorders in Outpatient Settings [Internet].
Comparative Effectiveness Reviews, No. 134.
Jonas DE, Amick HR, Feltner C, et al.

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.