Drug and Alcohol Depadence,

Elsevier Scientific Publishers

169

30 (1992) 169- 173

Ireland Ltd.

Acupuncture fails to improve treatment outcome in alcoholics T.M. Worner, Alcoholism Services

B. Zeller, H. Schwarz, F. Zwas, and D. Lyon

and the Departments

of Medicine

and Psychiatry,

The Long Island College Hospital, Brooklyn, NY 10201

(USA)

(Accepted January 21st, 1992) Fifty-six alcoholics (49 male, 7 female) of lower socioeconomic class attending an outpatient treatment program in Brooklyn, New York were prospectively randomized to one of three treatment groups: point-specific acupuncture, sham transdermal stimulation or standard care (control). One third of the subjects reported a history of drug use in addition to alcohol. Results in this small sample showed no significant differences in attendance at Alcoholics Anonymous meetings, number of outpatients sessions attended, number of weeks in either the study or in the outpatient program, number of persons completing treatment or in the number of relapses. It is therefore concluded that in this small racially mixed sample of urban outpatient alcoholics, fixed point-specific standardized acupuncture did not improve outcome. We caution against the routine use of this treatment until more randomized controlled trials demonstrate a beneficial effect. Key words: alcoholism; acupuncture;

alcoholism treatment

Introduction Acupuncture, an ancient Chinese medical treatment can be traced back almost 5000 years. According to legend, acupuncture was discovered when soldiers, wounded superficially by arrows during battle, experienced relief from certain ailments. Ancient physicians, based on these observations, inserted bone or stone needles into patients with similar problems. Treatment for chemical dependency has recently been closely scrutinized, with alternative therapies being proposed. Although acupuncture has been claimed to be an effective treatment especially for opiate and ‘crack’ addicts, no controlled studies of treatment effectiveness have been published to date. The first controlled study of acupuncture for the treatment of alcoholism was done in a highly selected recidivist alcoholic population (Bullock et al., 1987). The treated subjects reported lower levels of alcohol consumption and had fewer admissions to the detoxification unit compared with the control group. In a follow-up study 03768716/92/$05.00 0 1992 Elsevier Scientific Publishers Printed and Published in Ireland

(Bullock et al., 1989), those subjects given pointspecific acupuncture were more likely to complete treatment than those subjects given nonspecific acupuncture treatment. We undertook the following study to evaluate the efficacy of acupuncture in another treatment population. Methods Patient population Male and female subjects, minimum age of 18 years, enrolling in the comprehensive outpatient alcoholism treatment program were recruited for study participation. Only those subjects who had been drinking within 10 days of enrollment were accepted. Subjects with a positive breath alcohol were referred for inpatient detoxification prior to enrollment. Subjects were excluded if they resided in a halfway house, if they refused randomization, or if they were taking disulfiram. Recruitment was a major problem, with approximately five refusals for each patient Ireland Ltd.

170

accepted into the study. Of those subjects refusing, 30% were not interested in acupuncture as a therapeutic modality, feared complications of the procedure or were not interested in participating in this study. Seventy percent of those persons screened did not meet entry criteria. Study design After signing informed consent, using random numbers, subjects were assigned to one of three treatment groups: (1) point specific acupuncture, (2) sham transdermal stimulation and (3) control. Group 1 received fixed-point standardized acupuncture treatment (bilateral body points: liver 3, stomach 36, triple heater 5, large intestine 4; midline point; govenor vessel 20; bilateral ear points: Shen Men and Lung) 3 times per week for 30 min per session. Acupuncture was performed by a licensed acupuncturist and continued for 3 months. During the sessions, persons were seated in a comfortable chair in a large, open room, with quiet background music. Interaction of the acupuncturist with patients was limited to the time required for placement of the needles. Group conversation occurred during the acupuncture sessions. In addition to acupuncture therapy, subjects received standard care, as outlined below for the control group. Group 2 subjects were told that this treatment was a method of ‘needleless’ acupuncture called ‘transdermal stimulation’. These subjects had electrocardiogram pads taped to both forearms and to one lower leg, with the leads attached to an oscilloscope monitor. The monitor was visible to the subject during the session. Sessions occurred 3 times per week for 30 min per session. Treatment continued for 3 months. During the sessions, persons were seated in a comfortable chair in a large, open room, with quiet background music. Interaction with the sham therapist was limited to the time for placement of the electrocardiogram leads. Group conversation occurred during the sham sessions. In addition to sham therapy, subjects received standard care, as outlined below for the control group. Group 3 was the control or standard care group. Subjects attended individual counseling

sessions once per week, education/group therapy sessions three times per week, Alcoholics Anonymous meetings twice per week, and taskoriented group activities twice weekly. The study continued for 3 months. In addition, lunch was available on the days of clinic visits. Breath alcohol analysis was performed twice weekly, or more often, if drinking was suspected. Following termination of the study at 3 months, subjects were monitored for attendance in the comprehensive outpatient program. Statistical analysis Analysis of variance (ANOVA) and lifetable analyses were performed where appropriate, with the significance level for probability of the null hypothesis set to 0.05. Statistical work was performed by an NCSS 5.02 program run on an IBM-PC protocol 3863 computer was 2 megabytes RAM. Results As shown in Table I, groups were comparable in age, marital status and educational level. The study population was predominantly male, with only 7 women being treated. Only 8 of the study subjects had income sources other than welfare.

Table I. Demographic characteristics ment groups at the time of enrollment

of the three treatinto the study.

Group

Acupuncture

Transcutaneous

Control

n=

19

21

16

20 1

13 3

42.4 f 2.2

38.9 f 2.0

NS

10.1 + 0.8

10.1 * 0.8

NS

15 4 1

8 5 0

NS

1 0

2 1

Sex Male 16 Female 3 Age (years)* 41.9 f 2.3 Education (years)* 9.8 f 0.7 Source of income Welfare 11 None 5 Salary 2 Social security 1 Disability 0 ‘(a? + S.E.M.).

P

171

As shown in Table II, there were no significant differences in the age at which subjects first consumed alcoholic beverages nor in the self-reported quantity of alcohol consumed on a daily basis. Likewise, there was also no difference in the number of prior detoxification or in-patient rehabilitation admissions between the groups. Not shown, approximately one-third of the subjects used drugs other than alcohol, with cocaine, cannabis and heroin being the most frequently abused. As shown in Table III, there was no significant difference in attendance at Alcoholic Anonymous meetings in subjects randomized to either the acupuncture or sham group when compared with a group receiving traditional care. Nor was there any difference in attendance at the outpatient program either during the 3 months of the study or in the 3 months following completion of the study. This is further illustrated (Fig. 1) in a survival graph analysis of the 3-month study period. Similar results (not shown) were obtained when the data was analyzed for the 3 months following completion of the study. Likewise, as shown in Table IV, neither acupuncture nor the sham procedure increased the number of subjects who completed treatment. There was also no difference among the groups in the relapse rate, which was defined as return to any alcohol consumption. Neither was there any difference in the number of subjects who were admitted for inpatient detoxificaion.

Table III. Comparison of attendance at AA and the outpatient unit by treatment randomization. Mean

AA attendance Control

S.E.

0.333 0.158 0.471

0.118 0.105 0.111

4.5 3.714 5.0

0.760 0.664 0.698

1.875

0.777

Transcutaneous Acupuncture No. sessions, month 3 Control

1.65 2.579

0.695 0.713

1.25

Transcutaneous Acupuncture No. weeks in study Control

1.05 2.167

0.663 0.593 0.625

Transcutaneous Acupuncture No. sessions, month 1 Control Transcutaneous Acupuncture No. sessions, month 2 Control

Transcutaneous Acupuncture No. Weeks in program Control Transcutaneous Acupuncture

4.562 5.6 5.842

1.076 0.962 0.987

9.312 10.5 11.444

2.456 2.197 2.316

SURVIVAL:

WEEKS

IN

Fratio

F

2.11

0.1329

0.91

0.4087

0.47

0.6307

0.93

0.4023

0.42

0.6565

0.20

0.8196

Prob

STUDY

1.

Table II. Comparison of age of first drink, self-reported daily alcohol consumption, the number of admissions for detoxification and inpatient rehabilitation between the three groups (z + S.E.M.). Group

Acupuncture

Age first 14.8 f ETOH (years)

Transcutaneus 1.1

15.5 f

Control

1.0

17.1 f

P

1.2

NS

Daily 267.6 * 36.6 254.1 + 33.5 239.2 + 39.1 NS intake (g/day) No. detox 2.1 f 0.7 1.3 f 0.7 3.1 f 0.8 NS No. rehab 0.6 f 0.3 0.2 f 0.3 0.6 + 0.3 NS

Suru

iv 01

Time

Fig. 1. Survival analysis curve by treatment randomization based on weeks of participation in the study. There is no difference in outcome.

172 Table IV. Comparison of the number of subjects completing treatment and the number of subjects who either relapsed or required an inpatient detoxification, by treatment randomization.

No. Completing treatment No. Detox/relapse

Acupuncture

Transcutaneous

Control

P

1 8

2 11

0 9

NS NS

Discussion Almost 1.5 million persons received alcoholism treatment in the fiscal year 1987. There have been no significant differences in treatment outcome in those studies comparing inpatient, outpatient, partial hospitalization or day hospital treatment, nor has there been significant impact on treatment outcome based on duration of treatment (Seventh Special Report to Congress, 1990). It is also generally recognized that these studies have been complicated by numerous factors, such as patient population and outcome parameters. Although gaining wide acceptance by the treatment community, only recently has acupuncture been subjected to controlled clinical trials. In acupuncture theory, energy (Chi) from oxygen and food flows through the organs and body where it is transformed and distributed. The acupuncturist assesses (through symptoms, physical examination and pulse diagnosis) the homeostasis of this energy and intervenes with treatment if it is out of balance. Although it is recognized that the acupuncturist is trained to analyze the energy balance of the patient at a point in time and then to devise a course of treatment to correct that balance, this study was controlled and therefore, did not allow for that individualizationof care, which, in other circumstances, may be modified by the acupuncturist from one session to the next. Another possible limitation of this study is the lack of blinding by the acupuncturist. The intent of blinding is to eliminate both negative and positive prejudices in outcome (Colton, 1974).

Although blinding can ensure that pharmacologic treatments are unbiased, non-pharmacologic therapies can be only single blind, since the therapist is aware of the treatment being rendered. In order to minimize possible bias on the part of the therapist, external reviewers are utilized to evaluate the results of therapy (Fuller, 1990). Although double-blind trials are theoretically ideal, pragmatic problems do also occur. For example, ‘blind’ evaluators frequently have vision or are able to correctly predict in the majority of cases the nature of treatment being administered (Ney, 1989). With the above limitations in mind, our data in an urban, primarily male racially-mixed population indicate that there is no significant difference in treatment outcome between a fixed point-specific standardized acupuncture group, a sham-treated group (placebo acupuncture) or a control standard care group, whether assessed by number of sessions in the treatment program, number of weeks of study participiation, AA attendance, number of persons completing treatment or number of persons relapsing. These results suggest that the beneficial effects reported for acupuncture may be a placebo phenomenon, since the sham-treated patients did as well as the point-specific group. These results are at variance with those reported by Bullock et al. (1987) who randomized an indigent midwestern alcoholic population, residing at a Mission Lodge to a point-specific treatment versus a control (non-specific point) group. Treatment duration was 78 days. Unlike our subjects, only 15% of their subjects reported use of drugs other than alcohol. In that pilot study, there was a significant difference between the number of re-admissions for detoxification between the treatment and control groups. Of note, as the authors of that study discuss, only 2 of the original 22 subjects randomized to the control group were used for statistical analysis in the third phase of treatment. In a follow-up study, using the same treatment randomization, similar results were observed in 80 subjects. Similarly to our data, only 1 of the 40 persons randomized to the control group completed

173

treatment. By contrast, only 1 of our subjects randomized to the point-specific group and 2 of those persons randomized to the transcutaneous group completed treatment, as compared with the rather remarkable 52% completion rate observed by Bullock et al. (1987). Our results are more consistent with recently reported outcome data (Drummond et al., 1990). In their sample of 40 problem drinkers randomized to generalist versus specialist intervention, less than 15% of subjects reported total abstinence at 6 months follow up. The search for safe, alternative, non-chemical treatments for alcoholism continues. In view of the lack of significantly improved outcome in the fixed point-specific standardized acupuncture treatment group and the reported toxicities (Fairley, 1974; Shiraishi et al., 1979; Jeffreys et al., 1983), we caution against the routine use of this treatment until more randomized control trials demonstrate a beneficial effect.

References Bullock, M.L., Umen, A.J., Culliton, P.D. and Olander, R.T. (1987) Acupuncture treatment of alcoholic recidivism: a pilot study. Alcoholism: Clin. Exp. Res. 11, 292-295. Bullock, M.K., Culliton, P.D. and Olander, R.T. (1989) Controlled trial of acupuncture for severe recidivist alcoholism. Lancet i, 1435 - 1439. Colton, T. (1974) Clinical trials. In: Statistics in Medicine, pp. 262-264. Little, Brown and Company, Boston. Drummond, D.C., Thorn, B., Brown, C., Edwards, G. and Mullan, M.J. (1990) Specialist versus general practitioner treatment of problem drinkers. Lancet 336, 915-918. Fairley, G.H. (1974) Repeated acupunctures and serum hepatitis. Br. Med. J. 3, 466. Fuller, R.K. (1990) Controlled clinical trials. Alcohol Hlth. Res. World 14, 239 - 244. Jeffreys, D.B., Smith, S., Brennand-Roper, D.A. and Curry, P.V.L. (1983) Acupuncture needles as a cause of bacterial endocarditis. Br. Med. J. 287, 326-327. Ney, P.G. (1989) Double-blinding in clinical trials. Can. Med. Assoc. J. 140, 15. Shiraishi, S., Goto, I., Kuroiwa, Y., Nishio, S. and Kinoshita, K. (1979) Spinal cord injury as a complication of an acupuncture. Neurology 29, 1188 - 1190. Treatment. (1990) In Seventh Special Report to the U.S. Congress on Alcohol 261- 262.

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Acupuncture fails to improve treatment outcome in alcoholics.

Fifty-six alcoholics (49 male, 7 female) of lower socioeconomic class attending an outpatient treatment program in Brooklyn, New York were prospective...
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