Abstract
Summarizing the relative effects of different treatments for alcohol use disorders is challenging because there is no standard treatment against which experimental treatments can be contrasted and comparisons to no-treatment control groups are rare. As alternative reference points, we examined outcomes and improvement for untreated participants (i.e., those in wait-list, no-treatment, and placebo conditions) in randomized trials of alcohol treatment over the last three decades. At followup, the average abstinence rate was 21% (n = 17 studies) and the mean level of alcohol consumption was 31 drinks per week (n = 29 studies). The reduction in drinking from baseline was .19 of a SD unit, or a 14% decrease from a baseline mean of 37 drinks per week (n = 17 studies). These values provide approximations of success and improvement that an active treatment for alcohol use disorders should surpass to be considered more beneficial than no treatment.
Keywords
1. Introduction
Although evidence supports the benefits of an array of treatments for alcohol use disorders (
Finney & Monahan, 1996
, McCrady & Langenbucher, 1996
, Miller et al., 1995
, - Miller W.R.
- Brown J.M.
- Simpson T.L.
- Handmaker N.S.
- Bien T.H.
- Luckie L.F.
- Montgomery H.A.
- Hester R.K.
- Tonigan J.S.
What works? A methodological analysis of the alcohol treatment outcome literature.
in: Hester R.K. Miller W.R. Handbook of alcoholism treatment approaches: effective alternatives. 2nd ed. Allyn Bacon,
Boston1995: 12-44
Miller et al., 1998
), their relative performance remains poorly understood. Summarizing the comparative effects of different treatments for alcohol use disorders is challenging for two reasons. First, because interventions are typically evaluated against other treatment modalities that vary in strength, different types of treatments have not been tested on a “level playing field,” making results difficult to interpret (Finney, 2000
). Second, other than investigations of pharmacologic treatments, comparisons to no-treatment control groups are infrequent (Floyd et al., 1996
, Swearingen et al., in press
). One potential way of dealing with the variety of reference treatments is to group studies that include the same treatment or control conditions (Finney & Monahan, 1996
). However, our attempt to find frequently-compared pairs of treatment and/or control conditions among 404 multiple-group studies of treatment for alcohol use disorders indicated that this was not a viable option for more than a few specific treatment modalities (e.g., brief interventions, anti-craving medications, anti-anxiety medications, and relapse prevention).In the absence of helpful comparative information, an alternative benchmark against which to measure treatment success is the outcome of individuals in untreated (i.e., wait list, no-treatment, placebo-only) conditions. Here, we focus on two commonly assessed and complementary drinking-related outcomes, abstinence rate and level of alcohol consumption, to characterize the typical level of followup functioning for untreated individuals. The abstinence rate indicates the proportion of those with drinking problems initially who no longer drink at followup. Level of alcohol consumption is a more sensitive continuous index of the quantity of alcohol that, on average, all individuals are drinking. Changes in consumption from baseline to followup were coded to determine to what extent excessive drinking improves or deteriorates over time without active intervention.
2. Materials and methods
We calculated the average abstinence rate and level of alcohol consumption at the final followup point for individuals in treatment trials randomly assigned to four types of untreated conditions: (1) no treatment (e.g., wait list, assessment only); (2) placebo (e.g., pharmacologically inert pills, sham acupuncture); (3) no treatment following a brief period of detoxification; and (4) placebo following a brief period of detoxification. We examined the no-treatment and placebo conditions separately because of the differing demand effects (expectations, reactions) that might flow from the fact that those in no-treatment groups understand that they are receiving no active treatment, whereas those in placebo groups believe that they may be receiving an effective therapeutic agent (
Klein, 1997
). We separated conditions that included detoxification from those that did not, to distinguish any potential, but likely minimal, salutary effects of detoxification (Klein, D. F. (1997, September 22). Control groups in pharmacotherapy and psychotherapy evaluations. Treatment, 1, (Article 1), Retrieved from the World Wide Web: http://journals.apa.org/treatment/vol1/97_a1.html.
Foster et al., 2000
).Abstinence rate was defined as the proportion of study participants followed that were considered “abstinent” by investigators, regardless of whether any drinking (or “slips”) was allowed. Level of alcohol consumption was defined as alcohol intake over a given period of time. A common way of expressing alcohol intake is in terms of the number of standard drinks or standard ethanol content units consumed per week. Thus, when investigators assessed levels of drinking over different periods of time, such as days or months, we converted this value to number of standard drinks per week. When alcohol intake was measured in units other than standard drinks, such as ounces of ethanol, or in terms of the amount of different types of alcoholic beverages, we used the common approximations of 0.5 ounces, 15 ml, or 10–15 g of absolute alcohol, or 10 ounces of beer, 4 ounces of (12.5%) wine, or 1.25 ounces of 80 proof liquor to estimate the number of standard drinks (
Hester & Delaney, 1997
, Miller et al., 1991
, Scott & Anderson, 1990
, WHO Brief Intervention Study Group, 1996
).Finally, when mean and SD were presented for both baseline and outcome levels of drinking, we calculated effect sizes for the change in alcohol consumption. We used a computer software package (D-STAT;
Johnson, 1989
) to calculate within-group, pre-post effect sizes (d) for each study, to aggregate effect sizes across studies, and to test the individual effect sizes for heterogeneity and the aggregate effect size for significance.We drew on a database of 701 studies investigating treatment for alcohol use disorders spanning the years 1970 to 1998 (
Moyer et al., 2001
). The database contains studies that: (1) focused on an intervention for alcohol use disorders; (2) enrolled participants 18 years or older; (3) had at least five participants in each treatment condition; (4) assessed at least one drinking-related outcome; and (5) were published in the English language. Although studies including untreated control conditions are rare, we were readily able to locate such investigations because the 404 multiple-group projects in the database had been coded with respect to, among other variables, whether or not the study design involved a no-treatment or a minimal-treatment control condition. The studies thus identified were then examined to ascertain true no-treatment conditions, which were organized into the categories listed above.3. Results
We located 17 trials with no-treatment conditions that assessed abstinence rates at followup (
Harris & Miller, 1990
, Miller et al., 1993
, Borg, 1983
, Bullock et al., 1989
, Fine et al., 1979
, Gallimberti et al., 1992
, Malcolm et al., 1992
, Malec et al., 1996
, Ogborne & Wilmot, 1979
, Padjen et al., 1995
, Powell et al., 1985
, Regester, 1971
, Senft & Polen, 1997
, Wilson et al., 1980
, Wadstein et al., 1978
, Whitworth et al., 1996
, WHO Brief Intervention Study Group, 1996
), 29 that assessed alcohol consumption at followup (Alden, 1988
, Anderson & Scott, 1992
, Bruno, 1989
, Dimeff, 1997
, Fine et al., 1979
, Gallimberti et al., 1992
, Harris & Miller, 1990
, Heather et al., 1987
, Heather et al., 1996
, Hester & Delaney, 1997
, Kivlahan et al., 1990
, Maheswaran et al., 1992
, Malec et al., 1996
, Malec et al., 1996
, Malcolm et al., 1992
, Marlatt et al., 1998
, Mason et al., 1994
, Naranjo et al., 1995
, Miller et al., 1993
, Naranjo et al., 1990
, Padjen et al., 1995
, Pond et al., 1981
, Regester, 1971
, Richmond et al., 1995
, Rohsenow et al., 1985
, Scott & Anderson, 1990
, Senft & Polen, 1997
, Tomson et al., 1998
, WHO Brief Intervention Study Group, 1996
) (10 of which were included in the 17 that assessed abstinence rates), and 17 that assessed alcohol consumption at both intake and followup (Alden, 1988
, Anderson & Scott, 1992
, Dimeff, 1997
, Fine et al., 1979
, Fleming et al., 1997
, Gallimberti et al., 1992
, Heather et al., 1987
, Heather et al., 1996
, Kivlahan et al., 1990
, Maheswaran et al., 1992
, Marlatt et al., 1998
, Miller et al., 1993
, Naranjo et al., 1990
, Naranjo et al., 1995
, Richmond et al., 1995
, Scott & Anderson, 1990
). Table 1 summarizes the characteristics of these studies with respect to participants' severity of alcohol use disorders, the timing of the final followup assessment, and the stringency of the definition of abstinence used in terms of whether or not drinking (or “slips”) was allowed. Overall, although each of the three subsets of studies included both more and less severely affected samples, the majority of trials that assessed abstinence rates had samples of higher severity whereas the majority of trials assessing alcohol consumption and changes in alcohol consumption had samples of lower severity. The typical final followup point was less than a year and most of the studies assessing abstinence used definitions that did not allow any drinking “slips.”Table 1Characteristics of randomized trials of alcohol treatment with untreated participants
| Abstinence rates N = 17 | Alcohol consumption N = 29 | Change in alcohol consumption N = 17 | |
|---|---|---|---|
| Problem severity of sample a Lower severity samples were those obtained in studies that explicitly recruited “non-alcoholic,” “problem,” “heavy,” or “at-risk” drinkers, and excluded those with alcohol dependence or abuse, or alcohol consumption above certain levels. Higher severity samples were those obtained in studies that included “alcoholic” participants, or those meeting diagnostic criteria for alcohol dependence or abuse, and/or did not exclude those with alcohol consumption above certain levels. | |||
| Lower | 4 | 20 | 17 |
| Higher | 13 | 9 | 2 |
| Length of follow-up | |||
| Less than 12 months | 13 | 21 | 11 |
| 12 months or more | 4 | 8 | 6 |
| Definition of abstinence | |||
| No drinking permitted | 15 | — | — |
| Some drinking permitted | 2 | — | — |
a Lower severity samples were those obtained in studies that explicitly recruited “non-alcoholic,” “problem,” “heavy,” or “at-risk” drinkers, and excluded those with alcohol dependence or abuse, or alcohol consumption above certain levels. Higher severity samples were those obtained in studies that included “alcoholic” participants, or those meeting diagnostic criteria for alcohol dependence or abuse, and/or did not exclude those with alcohol consumption above certain levels.
Of the 17 studies that assessed abstinence rates at followup, 8 had a no-treatment–only condition, 4 had a placebo-only condition, 1 had a detoxification-plus-no-treatment condition, and 4 had a detoxification-plus-placebo condition. The mean abstinence rates ranged from 14% to 71% for the different types of untreated conditions, with an average of 21% overall (see Table 2). Although not all reports mentioned monitoring additional unplanned treatment received during the treatment or followup periods, five of them indicated that some participants in all conditions were exposed to some kind of potentially therapeutic agent or contact (e.g., rehospitalization for detoxification, psychotropic medications, Alcoholics Anonymous) apart from the conditions under study. The average abstinence rate for the remaining 12 no-treatment conditions was 22%.
Table 2Average abstinence rates at final follow-up point (%)
| n (studies) | Mean | Median | Minimum | Maximum | |
|---|---|---|---|---|---|
| Type of untreated condition | |||||
| No treatment | 8 | 14 | 1 | 0 | 73 |
| Placebo | 4 | 18 | 16 | 6 | 35 |
| Detoxification plus no treatment | 1 | 71 | — | — | — |
| Detoxification plus placebo | 4 | 35 | 27 | 5 | 80 |
| Overall | 17 | 21 | 17 | 0 | 80 |
| Overall (no unplanned treatment) | 12 | 22 | 12 | 0 | 80 |
Six of the 17 studies provided corroboration of self-reported drinking behavior. The abstinence rates were not significantly different for the studies that provided such confirmation (M = 29%, SD = 38%) than for those that did not (M = 16%, SD = 13%, t = 0.81, ns). The number of participants in individual studies ranged from 5 to 486 (M = 75). The average abstinence rate weighted by sample size was 21% (SD = 28%), identical to the unweighted value.
Of the 29 trials that assessed level of alcohol consumption, 20 had a no-treatment-only condition, 8 had a placebo-only condition, and 1 had a detoxification-plus-placebo condition. Mean alcohol consumption ranged from 8 to 40 drinks per week for the different types of untreated condition, with an average of 31 drinks per week overall (see Table 3). The average level of consumption at followup for the 23 studies where no unplanned treatment was reported was 33 drinks per week.
Table 3Average alcohol consumption at final follow-up point (drinks/week)
| n (studies) | Mean | Median | Minimum | Maximum | |
|---|---|---|---|---|---|
| Type of untreated condition | |||||
| No treatment | 20 | 28 | 28 | 8 | 74 |
| Placebo | 8 | 40 | 44 | 9 | 72 |
| Detoxification plus placebo | 1 | 8 | — | — | — |
| Overall | 29 | 31 | 29 | 8 | 74 |
| Overall (no unplanned treatment) | 23 | 33 | 34 | 8 | 72 |
Eleven of the 29 studies provided corroboration of self-reported drinking behavior. The number of standard drinks per week was significantly lower for the studies that provided such confirmation (M = 21.65, SD = 10.99) than for those that did not (M = 36.82, SD = 21.07, t = 2.5, p < .05). The number of participants in individual studies ranged from 5 to 486 (M = 64). The mean number of standard drinks per week weighted by sample size was 23.20 (SD = 12.55).
The aggregate effect for the studies presenting intake and followup alcohol consumption was a significant decrease of .19 of a SD unit (p < .001). The reduction in consumption was 5 drinks per week from a baseline of 37 drinks per week, a 14% decrease. There was no significant heterogeneity among the effect sizes (Q = 8.8, ns), precluding examination of study-level moderators of changes in drinking levels.
4. Discussion
Overall, an average of 21% of individuals in untreated conditions in the treatment efficacy studies we examined were abstinent at followup and the average alcohol intake was 31 drinks per week. Although definitions of problem, excessive, or hazardous drinking vary by investigation, nation, and/or culture, and are often specified differently by gender, in most studies the definition involved a minimum of 20 to 35 drinks per week (e.g.,
Heather et al., 1996
, Tomson et al., 1998
). Thus, in studies that assessed abstinence, about a fifth of untreated individuals were abstinent at followup, whereas in studies that assessed alcohol consumption, average levels of drinking were still in a range considered harmful by some investigators, despite a small (Cohen, 1988
) significant decline from baseline levels.These estimates can help to put findings regarding outcomes following treatment into perspective. For instance,
Miller et al., 2001
, combined the results of seven diverse multisite trials conducted in the United States with individuals with a broad range of problem severity and other personal characteristics. Despite the complexities related to different samples and treatment methods, they sought to provide an indication how people fare, on average, after treatment for alcohol use disorders. They found that, at 12-month followups, the average abstinence rate was 24% and the average level of alcohol consumption was 7 drinks per week. Although this abstinence rate was only slightly higher than our estimate of 21% for persons in non-treated conditions, the level of alcohol consumption, likely a more sensitive indicator, is considerably lower for these treated individuals. Monahan & Finney, 1996
found a higher average abstinence rate of 43% at the first followup point of three months or longer for 150 active treatment conditions drawn from 100 alcohol treatment outcome studies published between 1980 and 1992. Taken together, the outcomes found in the current review for untreated participants and the outcomes in the reports of Miller et al. and Monahan and Finney for individuals in active treatments provide informative rough parameters with which to compare specific program or study outcomes. As Miller and colleagues point out, such estimates should not be interpreted as representing the outcomes of any and all programs, but serve as helpful averages with which to compare specific outcomes. It should be noted, however, that the group of studies on which we based our estimates of abstinence typically included samples of higher severity, whereas the group of studies on which we based our estimates of alcohol consumption typically included samples of lower severity.Between-category statistical analyses were not appropriate because the number of studies examined is small and the means for each type of untreated condition (e.g., placebo vs. no treatment) come from different studies (see
Hrobjartsson & Gotzsche, 2001
, for a review of the outcomes of placebo and no-treatment conditions compared within the same trials of treatments for several types of clinical condition). However, by inspection, as might be expected, placebo-only conditions had higher mean abstinence rates than no-treatment–only conditions, and both types of conditions that included detoxification had higher abstinence rates than no-treatment–only and placebo-only conditions. Yet, placebo conditions also had higher levels of drinking than no-treatment conditions.We can only speculate regarding the mechanisms that might have led to small proportions of untreated participants being abstinent at followup and for there to be a reduction in drinking from baseline to followup. Several factors, such as regression toward the mean, life changes, the passage of time, the benefits of simply seeking help or participating in a research study, anticipation of receiving active treatment for those in wait-list conditions, or placebo effects for those in placebo conditions, could have affected outcomes (
Bowen & Twemlow, 1980
, Kirsch & Sapirstein, 1998
). Reviews of research on pharmacological treatment of depression (Kirsch, I., & Sapirstein, G. (1998, June 26). Listening to Prozac but hearing placebo: A meta-analysis of antidepressant medication. Prevention and Treatment, 1, (Article 0002a), Retrieved from the World Wide Web: http://journals.apa.org/prevention/volume1/pre0010002a.htm.
Kirsch & Sapirstein, 1998
) and child psychotherapy (Kirsch, I., & Sapirstein, G. (1998, June 26). Listening to Prozac but hearing placebo: A meta-analysis of antidepressant medication. Prevention and Treatment, 1, (Article 0002a), Retrieved from the World Wide Web: http://journals.apa.org/prevention/volume1/pre0010002a.htm.
Weiss & Weisz, 1990
) have noted improvement over time in no-treatment and placebo conditions, providing evidence that these factors have some effect.A recent review found only limited differences in the outcomes of placebo and no-treatment conditions administered within the same studies, indicating, somewhat surprisingly, that placebo effects may not be much more powerful than effects that operate for those in no-treatment conditions (
Hrobjartsson & Gotzsche, 2001
; see also Bailar, 2001
). However, placebo effects in alcohol treatment and other drug trials may be reduced by the fact that participants may often suspect correctly that they are receiving a placebo. In one of the studies examined here, 41% of participants and (79% of the research assistants conducting assessments) correctly identified their treatment group (Malec et al., 1996
). Although 41% is below chance (50%), indicating that the blind for participants was successful, it suggests that a considerable proportion of placebo participants suspect correctly that they are not receiving active treatment. Such beliefs may affect trial and treatment adherence. In another trial examined here, those receiving placebo were significantly less likely to remain in an 8-week treatment trial (Bruno, 1989
).Because our findings are based on a small proportion of alcohol treatment studies, their generalizability is difficult to gauge. Participants in the studies reviewed encompassed individuals at risk for alcohol-problems, problem drinkers (who were recruited through health clinics or through the media, rather than presenting for treatment), persons diagnosed with alcohol dependence or abuse (some who were recruited when they were treated for other medical problems and some who were recruited when they sought help at alcohol treatment centers), and individuals with chronic, recidivist alcohol problems. Thus, those included had a range of problem severity and varied in terms of whether or not they were actively seeking treatment (see
Krupnick et al., 1986
).The definitions of abstinence used were fairly stringent, with all but one of the 17 studies coding only those with no drinking “slips” as abstinent. The date of first publication spanned a wide interval of time, from 1971 to 1998. These observations suggest that the estimates obtained are applicable to a wide range of individuals with alcohol problems in studies with stringent definitions of outcome conducted over a broad period of time. It is also true, however, that the individual estimates of outcome for each study varied widely.
A limitation of this investigation is that it considers only two of a much larger number of possible outcomes for those with problem drinking. Changes in abstinence rates and levels of alcohol consumption are just a few aspects of the potential relevant changes in functioning that can occur, both in drinking patterns and in nondrinking outcomes (
Miller et al., 2001
). Abstinence is not a goal of all treatments for alcohol use disorders, or a necessary condition of recovery for all individuals with alcohol problems (Sobell & Sobell, 1995
). In addition, abstinence is a somewhat insensitive measure of success. However, the fact that improvements were seen in untreated conditions even with this crude index makes the findings more compelling. Unfortuantately, the small number of investigations included precluded helpful statistical comparisons of conceptually distinct types of untreated conditions. Finally, the level of success estimated here is probably not relevant to estimates of the percentage of persons becoming abstinent through “natural recovery,” as all individuals considered here had joined randomized trials, and so may differ from individuals who stop drinking on their own or through self-help (Schwartz et al., 1997
).In sum, at followup 21% of untreated participants with alcohol use disorders in randomized trials were abstinent and the average level of alcohol consumption was 31 drinks per week. From baseline, alcohol consumption decreased .19 of a SD unit, or 14%. Thus, a small minority of untreated individuals was no longer drinking, and levels of alcohol consumption showed a significant trend toward reduced drinking. However, levels of consumption were still at levels considered problematic by some investigators. These values provide helpful reference points regarding the approximate average level of success that can be expected without active treatment, and thus, the level which an active treatment should surpass to be considered incrementally beneficial.
Acknowledgements
This work was supported by National Institute on Alcohol Abuse and Alcoholism grant AA08689, the VA Quality Enhancement Research Initiative, and the VA Mental Health Strategic Healthcare Group. The views expressed in this article are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs. We are grateful to Keith Humphreys, Rudolf Moos, and Craig Rosen for helpful comments on an earlier version of this manuscript. A portion of this work was presented at the Society of Behavioral Medicine's Annual Meeting and Scientific Sessions, Washington, DC, April, 2002.
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Article info
Publication history
Accepted:
May 13,
2002
Received in revised form:
April 19,
2002
Received:
December 12,
2001
Identification
Copyright
© 2002 Elsevier Science Inc. Published by Elsevier Inc. All rights reserved.
