Finnish Experiences with Carbamazepine (Tegretol ) in the Treatment of Acute Withdrawal Symptoms in Alcoholics

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1 J Int Med Res (1979) 7, 168 Finnish Experiences with Carbamazepine (Tegretol ) in the Treatment of Acute Withdrawal Symptoms in Alcoholics Matti SillaDpiiii, MD, Turku University Central Hospital, Turku, Finland TorbjorD SODek, MSei, CIBA -GEIGY, Medical Department, Helsinki, Finland The drinking problem in Finnish society is far from uncommon and has worsened with an increase in economic welfare. Measures have, therefore, been tried in the struggle against the different consequences of alcohol misuse. Efforts are being made all over the world to find an effective drug for the treatment of the alcohol withdrawal syndrome. During the last few years we have performed a series of clinical trials to study the use of carbamazepine (CBZ) in the alcohol withdrawal syndrome. In a multicentre trial (Bjorkqvist et al1976) 105 male out-patients, aged years, who had voluntarily sought treatment for alcohol withdrawal symptoms at five Finnish A-clinics or alcoholism treatment centres were entered into the study. They had been taking alcohol for at least three last days prior to entry and were not misusers of drugs or chronic narcotics, neither had they heart, liver or renal insufficiency. They were not taking antihypertensive treatment or any other preparations acting on the CNS. The patients were randomly allocated to two treatments, CBZ and placebo, a doubleblind technique being employed. The patients Requests for reprints should be addressed to: Torbj6rn Sonck, MSci, elba-geigy Medical Department, PL 11, SF Helsinki 52, Finland. visited the clinic four times over the course of seven successive days. The treatment schedule was as follows: on Days 1-2, four tablets of CBZ 200 mg or placebo; on Days 3-4, three tablets; on Days 5-6, two tablets; and on Day 7, one tablet. Additionally, the patients received oral vitamins of the B-group and for Nights 1-2 a hypnotic (dichloralphenazone) on request. There were altogether thirty-six drop-outs, mostly due to resumed drinking or, alternatively, of unknown cause. Thus, the CBZ and placebo groups consisted of those who completed the whole trial. They were sixty-nine in total. Fifty-one of them were sober and eighteen had taken some alcohol when coming to the clinic. None were clearly drunk. The mean decline ofsymptoms are shown in Figure 1. The scores of most of the symptoms declined faster in the CBZ than in the placebo group. Significant differences between the two groups with respect to sleep disturbances seem especially important as the temporary suppression of the sleep disturbances by ethanol is often the main reason for continued drinking. The scores of the symptoms are summed up in Figure 2 (except dizziness, which occurred as a side-effect, and except for aggressions and hallucinations, which occurred in only a few patients). The Mann-Whitney V-test revealed /79/ $02 00 Cambridge Medical Publications Limited

2 M Sillanpdd and T Sonck that there was a significantly faster decrease in scores in the CBZ than in the placebo group (p < 0 01). Table 1 shows the patients' estimated ability to work during the treatment. Here again, the ability to work improved significantly faster in the CBZ group than in the placebo group (p < 0 01). In the CBZ group, side-effects occurred in eleven out of thirty-four patients (Table 2) and in the placebo group in three out of thirty-five patients, respectively. It would appear obvious that the side-effects of CBZ could have been substantially reduced if smaller doses of CBZ had been administered at the beginning of the treatment. No apparent interaction could be found between CBZ and alcohol, not even in the 169 patients who were intoxicated at the time of commencement of the treatment. In another trial, the efficacy and tolerability of CBZ and clomethiazole, a widely used drug in this indication, were compared using a double-blind technique in sixty-eight in-patients Sonck, Malinen & Janne 1975, Ritola 1975). Six of the patients started to drink again during the course of the study, leaving thirty-three in the CBZ group and twenty-nine in the clomethiazole group completing the trial. The groups were homogeneous with regard to mean age, body-weight, duration of the most recent drinking period, degree of alcoholism and degree of alcohol intoxication on admission. Figure 3 shows the occurrence and decline of the main target symptoms of withdrawal as 100 I CARBA- MAZEPINE- 0 PLACEBO- 80 ~ ~ 60 0 z 0 lj.j ::::> -J 40 «> lj.j :r: f- l.j ~ DAY Fig 1 The decline of withdrawal symptoms from visit to visit

3 170 The Journal ofinternationalmedicalresearch i 'l I ANDRE XIA DAY VOMITING AND GASTROINTES- NAUSE A TlNAl SYMPTOMS c '" '"E 1.5 :1.0 cr o ur./) 0.5 CARBA- I MAZ~PINE O PLACEBO DIFFCULTIES IN FALLING ASLEEP Fig 2 The development 0/ the mean total score 0/ all symptoms ~ zlj.j ~c, u. o LJ.J o ~100 Z LJ.J U ex: ~ carbamazepine clomethiazole carbamazepine clomethiazole CARDIOVASCULAR SYMF TOMS GASTROINTESTINAL SYMPTOMS omild symptom I moderate symptom severe symptom DAY carbamazepine c1omethiazole ANXIETY o DAY carbamazepine clomethiazole DEPRESSION Fig 3 Occurrence ofmain target symptomsofwithdrawalon differentdays ofthe treatment

4 M Sillanpdd and T Sonck 171 GENERAL EVALUATION OF THE TREATMENT DOCTOR CARBAMAZEPINE DCLOMETHIAZOLE (j).- c Q.) ;11)1' "- ",. 5 NURSE co 21 Q :~~:I Q.) aaa 1: E :::J PATIENT z Very good Good Moderate Fig 4 General evaluation of treatment results by the doctor, the nurse and the patient 00 Very poor Thbkl Patients' estimated ability to work with respect to the withdrawal treatment Thbk2 Reported side-ettects Carbamazepinegroup Placebo group Able Notable Able Notable Day to work to work to work to work } 20. * "Difference between carbamazepine and placebo groups X 2 = 5 75, P < 0 01 Carbamazepine Placebo Symptom n =34 n =35 Loss of activity 1 1 Dizziness 6 Thirst 1 Stammering 1 Staggering 1 Nausea 2 Headache 1 Smarting eyes 1 Palpitation 1 Tiredness 1 (discontinued) Total number of patients reporting side-effects 11 3

5 172 Table 3 Treatment, days Patients Day n =342 Discontinued Drop-outs 1 3 (0 9%) (3 5%) (13 2%) (31 9%) (26 0%) (14 3%) 7 24 (7 0%) (0 6%) (2 6%) 1 Missing data 4 Table 4 Patients' ability to work Before After treatment treatment (n = 342) (n =342) Able to work 24 (7 0%) 288 (84 2%) Not able to work 318 (93 0%) 53 (15 5%) Missing data 1 (0 3%) The Journal ofinternational Medical Research evaluated by the nurse. There is no significant difference between the two groups as to the speed of disappearance of symptoms. The symptoms decreased swiftly in all patients with the possible exception of depression which was still present in about 60% of the patients at the end of the trial. The overall evaluation of the therapy by the patient himself, nurse and doctor showed that no significant difference existed between the two treatment groups. Approximately 70% of the patients experienced good or very good results (Figure 4). In the CBZ group, six patients reported untoward side-effects: three reported drowsiness, two fatigue and one headache. In the clomethiazole group three patients reported drowsiness, dryness of the mouth and dizziness, respectively. No interaction between the trial preparations and alcohol was observed. To gain more experience of the practical use and tolerability of CBZ in the withdrawal syndrome we designed a large-scale open trial. This trial was carried out in 390 out-patients who had voluntarily sought treatment at fifteen alcoholism treatment centres in different parts of the country. Almost 90% of the patients Table 5 Reported side-effects Number of Symptom patients Discontinued Dizziness 19 4 Fatigue 8 1 Drowsiness 5 I Drowsiness + dizziness 5 1 Dizziness + nausea 3 2 Nausea 2 Smarting eyes 2 1 Dizziness + headache 1 Nausea + vomiting 1 1 Headache 1 Headache + gastro-intestinal symptoms 1 Itching 1 Itching of the palm 1 Memory disturbances I Sweating + insomnia 1 Urticaria ac. 1 Convulsions 1 1 Number of patients reporting side-effects (3%)

6 M Sillanpdd and T Sonck completed the treatment (Table 3). Of the total number of patients entered into the study, 50% of them were sober on admission and 50% were more or less intoxicated. The mean dose was three tablets a day and in most centres this was constant throughout the treatment period. The duration of the CBZ treatment was 4-5 days on average in nearly 60% of the patients (range 1-9 days). At the end of the treatment, most of the patients were able to work (Table 4). The reported untoward sideeffects and discontinuation of the treatment are shown in Table 5. Only 3% of the patients had to discontinue the treatment on account of side-effects. We conclude, therefore, that CBZ is an alternative treatment in the ambulatory treatment of alcohol withdrawal symptoms particularly because: 1. It has no interaction with alcohol. 2. Its metabolization in the liver of alcoholics is not affected. 3. It has no dependence-inducing properties. 4. It seems to decrease the target of alcohol withdrawal symptoms and to speed up the return of ability to work The mechanism of action still remains to be determined. Whether the anti-convulsive properties of CBZ are also involved in this process is not known but a decreased threshold for convulsions associated with the withdrawal syndrome offers at least one sound reason for a consideration of its use. REFERENCES Bjiirkqvist S-E, Isohanni M, MiikeliiR & Malinen L (1976) Ambulant treatment of alcohol withdrawal symptoms with carbamazepine: A formal multicentre double-blind comparison with placebo. Acta Psychiatrica Scandinavica 53, 333 Pynniinen S, Bjiirkqvist S-E & Pekkarinen A (1978) The pharmacokinetics of carbamazepine in alcoholics. In: Advances in Epileptology Ed by H Meinardi and A J Rowan. p 285. Swets & Zeitlinger, Amsterdam Ritola E (1975) Klometiatsolin (Heminevrin ) ja Itarbamatsepiinin (Tegretol ) kaksoissokkovertailu katkaisuhoidossa. In: Alkoholistien katkaisuhoito. Ed by U G Ahlfors and J Janne, p 51, GEIGY, Helsinki Sonek T, Malinen L & Jiinne J (1975) Carbamazepine in the treatment of the acute withdrawal syndrome in alcoholics: Methodological aspects. In: Rationality ofdrug Development. Excerpta Medica International Congress Series No 383, p 251, Excerpta Medica, Amsterdam

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