THE LANCET, JUNE 24, 1989, p1435-1438

Milton L. Bullock¹, Patricia D. Culliton¹, Robert T. Olander³

In a placebo-controlled study, 80 severe recidivist alcoholics received acupuncture either at points specific for the treatment of substance abuse (treatment group) or at nonspecific points (control group). 21 of 40 patients in the treatment group completed the programme compared with 1 of 40 controls. Significant treatment effects persisted at the end of the six-month follow-up: by comparison with treatment patients more control patients expressed a moderate to strong need for alcohol, and had more than twice the number of both drinking episodes and admissions to a detoxification centre.

For centuries, acupuncture has been used in Far Eastern countries for various human ailments. Only lately, however, has acupuncture been used to treat addictive disorders. Chinese textbooks on acupuncture, do not refer to addictive drugs or to the treatment of addictive disorders, but the suggestion that acupuncture can be effective in the treatment of alcoholism, has led to its use with alcoholics and drug-addicts. Controlled studies of the efficacy of acupuncture in alcoholism have not been reported.

In a pilot study, we evaluated the efficacy of acupuncture therapy in recidivist alcoholic subjects: patients receiving acupuncture at points that were specific for substance abuse were more likely to complete the course of therapy than patients receiving acupuncture at nonspecific (placebo) points. Moreover, "treated" patients had substantially fewer drinking episodes and fewer admissions to a detoxification centre. However, we did not know whether these beneficial effects recorded during therapy would persist during a follew-up period when no scheduled therapy was given. We have now tested the null hypothesis that such beneficial effects during acupuncture therapy would not persist for six months.

Between December 1986, and October 1987, patients eligible for this study were indentified by the chronic case management division of the Hennepin County Detoxifixation Center, an 88-bed etablishment in central Minneapolis where severe "skid-row" alcoholics may recieve care for up to 72 h without charge. At the time of this study, treatment was based on the "medical" model of detoxification; Medications were given to ease functional complaints and to control early signs of alcohol withdrawal. Nursing staff were present at all times and rounds were made daily by a resident in internal medicine from the Hennepin County Medical Center (HCMC), which provides medical backup for the detoxification centre. Alcoholic patients are assigned to the appropirate levet of care by the nursing staff acccording to protocols drawn up by the staff and medical director at the detoxcification centre. Patients may be referred to the HCMC emergency room at any time for evaluation or admission. The detoxification centre admits over 14.000 patiens a year, 91% are male.

Patients were selected for this study by the nurse and personnel of the detoxification centre. Every patient was considered as a possible study candidate. The following criteria were established for entry to the study. Age over 18 years, ten or more total admissions to the detoxification centre or five admissions in the most recent calendar year; previous inpatient or outpatient treatment failure (ie, patient left the programme); and no full-time employment (according to history) for at least the previous six months. Patients were cxcluded if they had previously received acupuncture therapy, or if they were pregnant. The first 80 patients who satisfied these criteria and who gave informed consent were, after a standard 3-5-day detoxification, admitted to the study and transferred to Mission Lodge – a long-term chemical dependency treatment centre in Plymouth, Minnesota, 11 miles from the detoxification centre. Each Monday morning after arrival, Mission Lodge personnel escorted patients to the treatment ledger. Patients were then assigned by pairs either to treatment grop or to control group by alternate selection. Neither Mission Lodge personnel nor the acupuncturists had any knowledge of the patient´s dermographic profile obtained during intake, and Mission Lodge personnel were never aware of patient´s treatment group status.

This was a blinded study. The acupuncturists knew which patients were receiving true acupuncture treatments, whereas the patients, the Mission Lodge personnel, and the follow-up cordinator did not. All study patients were housed and received their acupuncture therapy at Misson Lodge. Individual counselling and group therapy were not provided as part of the study; but all resistents at Mission Lodge must attend Alcoholics Anonymous meetings twice a week and are discharged if they do not. Study patients were free to come and go, and transportation to and from Minneapolis was available at no charge. The drinking of alcohol after study entry was not regarded as grounds for dismissal from the study.

The treatment period was divided into three phases; in phase I, patients received one acupuncture treatment a day from Monday to Friday for two weeks; in phase II, one treatments was given every Monday, Wednesday and Friday for four weeks; and in phase III, acupuncture was given on Mondays and Thursdays for two weeks. Patients were then discharged from Mission Ladge and were asked to return after one, three and six months to complete a follow-up summary sheet. This consisted of six multiple-choice and check-off questions that were designed to assess the subject´s need for alcohol, ability to stay sober, and ability to undertake productive initiatives during the study period. Subjects answered the same six questions at each of the three follow-up interviews. All follow-up sessions were conducted by the study coordinator, who was blinded to the subject´s treatment-group. Furthermore, his interaction with the subjects was limited to evaluating their reading ability (all could read) and collecting the completed questionnaires. When subjects did not return for a scheduled follow-up visit, the study coordinator organised searches in local bars, free food centres, treatment programmes, and hospitals, and questioned other street alcoholics. Also during follow-up subjects could ask for additional acupuncture treatments.

TABLE I - DEMOGRAPHIC CHARACTERISTICS

Patients who completed the entire study received $100 – ic, $10 if they completed they completed the intake process, $15 for each of the three successfully completed treatment phases, and $15 for each completed scheduled follow-up interview.

Traditional Chinese acupuncture was used: acupuncture points are electrically discrete ic, their location can be confirmed by an ammeter.

Standardised acupuncture treatments were given by two experienced acupuncturists. Patients in the treatment group received acupuncture treatment at ear points now regarded by Wen, and the Lincoln Hospital group (New York) as specific for chermical dependency after nearly 15 years of clinical experience. Three ear pionts (Shen Men, lun, and sympathetic points) were used in all treatment patients. Control patients were treated at ear points not specific for chemical dependency but close enough (≤ 5 mm) to the specific points that treatment and control patients could mingle in the same room and yet not notice any defferences in treatment. A single specific hand point, LI4 Hoku, was also used in treatment patients for anxiety, while control patients received a nonspecific hand point. At each patient´s first treatment session, the site of all points was confirmed by a Royer-Anderson' neurometer (Cadre Corporation, San mateo, California); specific points gave a reading of ≥ 50 цA, whereas nonspecific points always registered zero.

Acupuncture treatment were given in a group setting with treatment and control patients seated site-by site in cornfortable chairs in a large open room. After the site was clensed with an alcohol swab, fresh needles were inserted to a subcutaneous depth of about 0-5 mm. All ear and hand points were placed bilaterally. The treatments were given without manual or electrical stimulation and lasted about 30 min. Interaction between the acupuncturists and the patients was limited to the time required for needle placement and casual group (never individual) conversation. The acupuncturists were not involved in the assignment of patients to treatment or control grups, data collection, or evaluation of outcome measures.

TABLE II - ALCOHOL/DUG ABUSE AND TREATMENT HISTORY
BEFORE STUDY ENTRY

* 2 yr before study entry
AA = Alcoholics Anonymous

Analysis was done according to initial treatment assignment. Categorical variables were evaluated by ג analyses and Fischer´s exact test was carried out if cell sizes were less than 10. A p value of less than 0-05 was regarded as statistically significant for the comparison between the treatment and control groups. Continuous data were analysed by Student´s t test. When the variances in the tow groups differed significantly, the t test. When the variances in the two groups differed significantly, the t test for unequal variance was done.

TABLE III - COMPLETION RATES FOR EACH TREATMENT PHASE

* p<0·001 for the difference between the completion rate for each phase./P>  

TABLE IV - ASSESSMENT OF NEED FOR ALCOHOL DURING EACH FOLLOW-UP INTERVAL

* p<0-05
† p<0-01

A Power analysis was performed with the estimates fror our earlier work. We estimated that the acupuncture group would have at least 20% more responders in terms of the endpoints of decreased desire for alcohol, decreased number of detoxification centre admissions, and self-reported drinking episodes. We also assumed that the loss to follow-up rate could be as high as 50% in each group. We calculated that, to have a 0-90 power and a type I error of p < 0-05, we would need 20 subjects in each group at the end of the six months of follow-up. Thus, to allow for a 50% loss to follow-up, the size of each group was set at 40.

RESULTS

The mean age of the patients was 42·2 years (range 23-71); 75 (93·8%) were men. The patients were predominantly white (61·3%); Native Americans were the second largest group (27·5%). 92·5% of the patients were single, separated, or divorced, and hardly had a family or support network at the time of study entry. Educational levels of patients in the treatment and control groups were comparable. All patients had been unemployed at the time of study enrolment (mean 26·8 months). 50 patients received welfare assistance (mean duration 11·4 months). There were no significant differences in demographic characteristics between the treatment and control gruops.

All study patients said that alcohol was their primary drug of abuse at the time of entry to the study, although 24 (30·0%) reported past episodic use of other drugs such as sedatives, opioids, stimulants, tranquillisers, or Cocaine. However, there was no differences in drug use before enrolment between the two groups. Patients who were daily or binge drinkers were equally distributed in the two groups. 40% of all patients had begun to abuse alcohol by the age of 15; the mean years of alcohol abuse were 23 for the treatment group and 21 for the control group. All patients had numerous previous admissions to alcohol treatment programmes, but there was no significant difference in treatment history between the two groups.

The completion rate for each phase of the treatment was significantly higer for patients in the treatment group. Only 3 (7·5%) treatment patients terminated therapy during phase I, compared with 19 (47·5%) control patients (p < 0 001), and a striking attrition of control patients continued during phases II and III. Only (2·5%) control patient completed all three phases of treatment compared with 21 (52·5%) of the treatment patients (p < 0·001).

TABLE V - SELF REPORTED DRINKING EPISODES DURING EACH FOLLOW-UP INTERVAL

* Total = 308 for treatment group and 704 for control group.
† No of patients available for interview during each follow-up interval. Some patients refused to answer questions about no of drinking episodes.
‡ p < 0-001.
§ p < 0-01.

During the six-month follow-up, interview data were obtained from 61 (77·5%) patients. Although some patients did no return for their second and third interviews, the third interview was completed by 27 (68%) and 23 (58%) of the treatment and control patients, respectively.

At each of the follow-up intervals, more control patients than treatment patients expressed a moderate to strong need for alcohol. furthermore, treatment patients did not have an increased need for alcohol as the follow-up period progressed. Aslo, 12 patients in the treatment group asked for and received additional acupuncture therapy during the follow-up period, whereas only 1 control patiens did so (p < 0 001). Most of these patients asked for additional treatments (mean3·7, range 1-7) to help maintain their sobriety usually during a single follow-up interval; 3 patients requested treatment during two consecutive follow-up intervals. 9 of the 12 treatment patients that had requested additional therapy completed all three treatment phases, but 10 had had drinking episodes and had been admitted to the detoxification centre. The impact of this additional therapy on the patient´s course is therefore difficult to assess.

The following indicators, because of their possible relevance to treatment efficacy, were recorded during the follow-up period; episodes of drinking, as reported by the patient (an episode was defined as the consumption of at least three drinks); admissions to the detoxification centre; and hospital admissions and emergency room visits. Control patients reported more than twice the number of drinking episodes than treatment patients. furthermore, 39 control patients and all treatment patients who did not complete all three phases of treatment reported drinking episodes during the six-month follw-up. By contrast, 6 (28·6%) of the 21 patients in the treatment group who completed all three treatment phases claimed that they had not taken any alcohol, and none of these were admitted to the detoxification centre during this period. 4 treatment patients who completed the treatment protocol reported only on drinking episode and on follow-up had been admitted to the detoxification centre only once. It is also noteworthy that during all three follow-up intervals treatment patients were more likely to report abstinence than controls.

TABLE VI - SELF-REPORTED ABSTINENCE VESUS CONTINUED DRINKING DURING EACH FOLLOW-UP INTEVAL

* p<0-01
† p<0-05

TABLE VII - ADMISSIONS TO THE DETOXIFICATION CENTRE DURING EACH FOLLOW-UP INTERVAL

* Total = 75 for treatment group and 186 for control group
† p<0-01
‡ p<0-05

There was a pronounced difference between treatment and control patients in the number of admissions to the detoxification centre. At all three follow-up intervals, the number of control patients admitted to the detoxification centre was more than twice that of treatment patients: 15 of the 21 patients who had been admitted five times or more were from the control group; 5 of the 6 treatment patients with this many admissions did not complete all three phases of treatment. The 7 patients who had been admitted ten or more times to the centre during the six-month period were from the control group; no treatment patient was admitted to the detoxification centre this often. Hospital admissions and emergency room visits were few during follow-up and were not significantly different for treatment and control patients.

Other possible indicators of treatment efficacy were also monitored. 30 (75%) treatment patients compared with 19 (48%) control patiens undertook productive initiatives such as applying for employment, enrolling in classes, or reconciling with a spouse or family. It was impossible, however, to determine how sustained these efforts were.

DISCUSSION

Our findings show that acupuncture can be effective for treatment of severe recidivist alcoholics. Some of the limitations noted in our pilot study must again be mentioned. For example, although more patients in the treatment group that in the control group completed each treatment phase, there was a high drop-out rate among control patients, despite the promise of incentive payment. We believe, however, that our analysis is valid since, as in our pilot study, patients who terminated the treatment part of the study did not differ in their baseline demographic characteristics; and despite the reduced power to detect group differences, statistically significant results were obtained during phase III when the smallest number of patients was available for study. Also, we realise that the use of a breath analyser to monitor drinking episodes would have been desirable: drinking episodes during the follow-up period were, of necessity, self-reported. The validity of such welf-reporting in alcohol studies remains controversiel. However, the ratio of drinking episodes reported by control compared with treatment patients (> 2/1) is comparable with the ratio of admissions to the detoxification centre in the two study groups. Could the acupuncturists have inadvertently conveyed to the patients whether treatment was correct or incorrect? We believe that this is unlikely because acupuncturists were asked not to converse individually to the patients and because treated and control patients were seated side-by-side when receiving acupuncture. Although we did not ask patients if they knew which treatment group they had been assigned to, several volunteered accurate opinions.

This study may have relevance for various aspects of alcoholism therapy. First, increased use af acupuncture therapy not only may be an effective adjunct to therapy in current programmes for patients with persistent craving for alcohol, but also may allow treatment to be extended to a large group of recidivist alcoholics for whom current therapies are not effective. Second, the high retention rate observed in the treatment periods of both the present and the pilot studies was especially encouraging, since additional time in therapy and from other forms of intervention. Third, acupuncture is highly cost-effective: overhead costs are low, equipment needs are negligible, therapy is easily given on an outpatient basis, and numerous patients can be treated simultaneously by one acupuncturist supported by a small ancillary staff. Also, increased use of acupuncture therapy may eventually lead to a decrease in the number of inpatient admissions to expensive treatment centres. For example, the total cost for admissions to the detoxification centre (average stay 30 h) for control patients over the six-month follow-up period was $20 424 higher than that of treatment patients.

Alcoholism is a major health problem in American society, it is also the most expensive with an annual estimated cost of 117 thousand million dollars. Psychosocial treatment with minumum participation of the physician community is the standard of care for alcoholic patients. However, the efficacy of psychosocial alcohol therapy, has been questioned. The drop out rate in all programmes is high, probably over 50%. Clearly, therefore alternative treatments must be investigated and developed to increase the percentage of severe alcoholics who can be successfully treated. We believe that our results are encouraging enough for other research groups to validate the efficacy of acupuncture in the treatment of various subsets of the alcoholic population.