Treatment of Acute Alcohol Withdrawal Syndrome with Carbamazepine: A Double-Blind Comparison with Tiapride

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1 J Int Med Res (1982) 10, 160 Treatment of Acute Alcohol Withdrawal Syndrome with Carbamazepine: A Double-Blind Comparison with Tiapride R Agricola, MD, M Mazzarino, MD and R Urani, MD, Casa di Cura Villa Cristina, Torino (Director: A Agricola), Italy V Gal1o, MD and E Grossi, MD, CIBA-GEIGYMedical Department, Origgio, Italy A double-blind, randomized trial is described which was designed to compare the clinical effect of 600 mg daily of carbamazepine (Tegretol's) and of tiapride (Serepriles) in hospitalized patients with pre-delirium tremens. Physicians' assessment ofpatients' progress was made following 2, 4 and 7 days oftreatment. Ofthe sixty patients admitted to the study.five dropped out for various reasons, leaving fifty-five patients who completed the study. Both drugs were effective in the treatment of alcohol withdrawal symptoms; no significant difference was found between the two treatments with respect to total symptoms' score and visual analogue scale assessment. Carbamazepine gave faster relief of symptoms and demonstrated a preferential action on symptoms like fear and hallucinations. No case of delirium tremens was observed in those patients who completed the trial. Introduction It is generally believed that the alcohol withdrawal syndrome results from a widespread hyperexcitability of the central nervous system which can also precipitate epileptic seizures (Brunef 1966, Hubach 1963, Seevers & Deneau 1963). On this concept is based the rationale for the experimental use of anti-epileptic agents in the treatment of alcohol withdrawal symptoms. In some European countries Please send correspondence to: R Agricola, Villa Cristina, 10040Savonera Torino, Italy. carbamazepine is currently used as the primary drug for detoxication of alcoholics. This compound appears to have gained acceptance on the basis of clinical experience (Wibur & Kulik 1981) although there have been few controlled trials. Considering the lack of clinical experience in Italy with the drug for this indication, it seemed interesting to compare the effects of carbamazepine with those of tiapride, a drug which in some clinical trials (Pignol & Casanova 1979, Freour 1979, Cadet et at 1979, Bonnaffoux, Coffinet & Laporte 1981) and in the everyday experience of the authors, had proved to be highly effective in hospitalized patients with a severe alcohol withdrawal syndrome /82/ $02.00 Cambridge Medical Publications Limited

2 R Agricola et al Materials and Methods A double-blind study on carbamazepine (Tegretol'") versus tiapride (Sereprilev) was carried out in sixty alcoholic hospitalized patients with a severe withdrawal syndrome preceeding delirium tremens. Patients with severe heart, liver or kidney diseases and patients who used psychotropic drugs, other than the agents being tested, were excluded from the study. Patients who were addicted or were chronic abusers of other drugs were also excluded. The patients were randomly allocated to two treatment groups: Carbamazepine (CBZ), 200 mg t.i.d. (thirty patients) or Tiapride 200 mg t.i.d, (thirty patients). The experimental design was double-blind. Drugs were administered for 7 days. In order to maintain the double-blind conditions, the drugs were prepared in identical cachets. Evaluation Criteria (a) Withdrawal symptoms The patients were observed on Days 0, 2, 4, 7 with respect to cardiovascular and gastrointestinal symptoms, sleep disturbances, anxiety, aggression, depression, fear, psychotic symptoms and certain neurologic symptoms (tremor, vertigo, restlessness, headache). Symptoms were scored on a 3-point scale as follows: 0 = no symptoms; 1 = moderate symptoms; 2 = severe symptoms. (b) Overall evaluation An overall evaluation of the clinical condition was made at each visit according to a 100 mm visual analogue scale (where 100 = worst clinical condition, and 0 = best clinical condition). (c) Final assessment of therapeutic effectiveness A general evaluation of treatment efficacy was made both by the doctor and the patient on Day 7, according to a 4-point scale (I = no efficacy; 4 excellent efficacy). The following laboratory tests were carried out on Day 0 and on Day 7: SGPT, SGOT, blood glucose. 161 The blood pressure and the heart rate were recorded at each visit. Patients Description Sixty patients (fifty-three males, seven females) aged years (mean 44 28) were enrolled. There were five drop-outs, three in the CBZ group and two in the tiapride group; the two patients on tiapride treatment dropped out because of insufficient therapeutic effect, while the three on CBZ refused to continue. Baseline characteristics of the patients enrolled are shown in Table 1. The two groups were comparable with respect to age, diagnosis, psychiatric history, baseline symptoms, degree of alcoholism, duration of alcohol abuse, systolic and diastolic blood pressure (SBP, DBP), heart rate, SGOT, SGPT and blood glucose value. Results Withdrawal symptoms The mean decline of symptoms which occurred during treatment with the two drugs is shown in Figure 1. Based on the initial score at Day 0, before treatment was started, a reduction of the symptoms' score was observed in both treatment groups (comparison between visits irrespective of treatments: p < 0 01), without a significant difference between the two groups (comparison between treatments irrespective of time: F = 0 60 N.S.). Interaction between treatment and time was statistically significant (F = 7 96; p < 0 01). In fact on Day 2 a significantly higher reduction in the symptoms' score for the CBZ group was observed (p < 0 01). At the end of treatment, both groups of patients showed excellent improvement in all symptoms studied, except for vertigo and disorders of consciousness for CBZ treatment and hallucinations, fear and disorders of consciousness for tiapride treatment (see Table 2). No significant differences between the two treatments were observed with respect to the degree of improvement in all symptoms but anxiety, which was shown to be more improved in the CBZ treatment group. The proportion of patients in whom anxiety improved after treatment was 96 2% for CBZ and 71 4% for tiapride, (p < 0 05; x 2 test).

3 162 The Journal ofinternational Medical Research Table 1 Baseline characteristics of the patients Patients Carbamazepine! Tiapride I Completed the study I Drop-outs 3 2 All patients Mean value S.D. Mean value S.D. F Age ( 83 N.S. Abuse of alcohol (years) N.S. Daily alcohol consumption (ml/wine) N.S. (ml/spirits) N.S. Symptoms score Day N.S. Global evaluation (rnrn) N.S. S B P(mm Hg) N.S. DB P(mm Hg) N.S. Heart rate (beats/min) N.S. S GOT (LV.!I) N.S. S G P T (LV.!I) N.S. Blood glucose (mg/ioo ml) N.S. 100 I CARBAMA- ZEPINE GROUP 0 > 80 «0 TIAPRIDE GROUP 0 z a w :J 60 J «>z «w 40 ::ie w J: l- LL a 20 ;fl o DAY Fig I Fall of withdrawal symptoms in the two treatment groups (The mean S.D. are IIOt reported ill the figure; however none ofthem exceeded 200,1, ofthe relative mean)

4 R Agricola et al Table 2 Symptoms improvement: Day of the study on which the proportion of patients improved achieved significance level (p < 0 05) Symptoms CBZ Tiapride Headache 7 7 Tremor 4 4 Sweating 4 4 Vertigo Never 4 Palpitation 2 4 Anorexia 4 4 Vomiting 2 2 Nausea 4 4 Gastro-intestinal discomfort 7 4 Sleeping disturbances 4 4 Frequent awakenings 2 4 Nightmares 2 7 Restlessness 4 4 Depression 7 7 Fear 4 Never Anxiety 4 4 Agressi veness 4 2 Hallucinations 4 Never Disorders of consciousness Never Never Table 3 shows the mean overall evaluation of severity of the patients' condition at different visits. A significant reduction of the overall evaluation/score was observed in both treatment groups (p < 0 01) without a significant difference between the two groups (comparison between treatment irrespective of time: F = 0 27 N.S.). Bloodpressure and heart rate A parallel reduction of mean systolic and diastolic blood pressure (SBP, DBP) and heart rate was seen in both groups. 163 No significant difference was found between the two groups (see Table 4). Laboratory examinations There were no significant modifications in the SGOT, SGPT, and blood glucose values at Day 7 compared with the basal values. Tolerability The two drugs were generally well tolerated. Two patients in the tiapride group and one patient in the CBZ group reported heartburn 2-3 days after the commencement of the trial which disappeared promptly after symptomatic treatment. Discussion It is generally believed that the alcohol withdrawal syndrome and delirium tremens may be related to disturbances in the electrical brain pattern which result for example in a lowering of the convulsion threshold (Hubach 1963). Thus anti-epileptic agents and drugs which depress the CNS have been used in the past in the treatment of alcohol withdrawal symptoms to reduce psychotic symptoms, induce sleep and prohibit seizures. However, most of the drugs experimented with for this indication have proved to have many unwanted effects that make their use difficult and often unsuitable. Barbiturates, for example, have a cross-tolerance with alcohol, possible risk of addiction (Smith 1968), and can cause paradoxical excitement (Fagan 1971). Paraldehyde and chloral hydrate are highly irritant and may cause toxic hepatitis, particularly in the case of alcohol liver damage (Goodman & Gilman 1970, Greenblatt & Greenblatt 1972); phentoin, relatively free of Table 3 Patients' 100 mm line score reduction at different visits Carbamazepine Tiapride Day 01 observation Mean S.D. Mean S.D. T N.S {j 55 N.S N.S {j 66 N.S.

5 164 The Journal ofinternationalmedicalresearch c. Ė <; a:: c.ẹ..d ='. ėq, e :0. ] c. ] :s or! 1:: ::c N '" '<I" 00 rji :i Z - r- r oo C? C?C? o 00 v vv E; SS 00 '<1" V) V) 00 Vi-.:;t - N '" '" 000 '" '" - '" o. N -N o N N'" -- N o r- - - side-effects in short-term treatment, is only moderately effective against withdrawal symptoms (Sampliner & Iber 1974) and must be combined with other drugs (for example chlordiazepoxide); benzodiazepine and clometiazol are quite effective for alcohol withdrawal symptoms but carry certain risks with regard to addiction and abuse. Valproic acid is a safe drug that has been shown to have some therapeutic potential in 'open' trials (Bonfiglio, Falli & Pacini 1977, Bocci & Beretta 1976). Further clinical investigation is needed under stricter conditions to confirm the effectiveness of valproic acid (Wilbur & Kulik 1981). In several controlled clinical trials, carbamazepine has been shown to be a highly effective treatment for the alcohol withdrawal syndrome because of its rapid effect, lack of addiction and abuse, mild adverse effects, and non-interactions with alcohol (Sillanpaa & Sonck 1979, Carlsson & Pettersson 1972, Sillanpaa, Bj6rkqvist & Alihanka 1980, Bj6rkqvist et a11976, Sonk, Malinen & Janne 1975). The data of the present study confirm previous results and indicate that both carbamazepine and tiapride (a drug which in open studies has been shown to be highly effective) have similar effects on the alcohol withdrawal syndrome. However, the two drugs were shown to be differently effective on individual symptoms. Symptoms like frequent awakenings, nightmares and palpitations decreased faster in the CBZ group, while aggressiveness and gastro-intestinal discomfort decreased faster in the tiapride group. In addition, CBZ was shown to develop a preferential action on fear and hallucinations while tiapride induced better control on vertigo. Both patients and physicians considered the two treatments successful on the whole, perhaps carbamazepine might be considered better because of its faster and preferential action on symptoms like fear and hallucinations which constitute, perhaps, the most distressing part of pre-delirium tremens. With regard to seizures, none of the patients who concluded the treatment had any such incidents during the hospitalization and trial period. The percentage of drop-outs was very low

6 R Agricola et al and almost equal in both treatment groups with CBZ and tiapride. Side-effects were very mild and infrequent in both groups. We might conclude that either drug provides a good alternative in the therapeutic approach to the alcoholic in-patient with severe withdrawal syndrome. REFERENCES Bjorkqvist S E, Isohanni M, Miikelii R & Malinen L (1976) Ambulant treatment of alcohol withdrawal symptoms with carbamazepine: a formal multicentre, double-blind comparison with placebo. Acta Psychiatrica Scandinavica 53, 333 Bocci U & Beretta G (1976) Experience with sodium dipropylacetate in alcoholics and cases of drug addiction. Lavoro Neuropsichiatrico 58, 51 Bonfiglio C, Falli S & Pacini A (1977) The use of sodium dipropylacetate to prevent and treat alcoholic delirium tremens. Minerva Medica 63, 4233 BonnatToux D, Coffinet Ph & Laporte P (1981) Surveillance de 1'alcoolique en post-cure. Bilan comparatif avec deux ans de recu!. A propos de deux cent observations. Semaine des Htipitaux. Paris 57, 916 BrunefF (1966) Anhebung der krampfschwelle als therapeutisches Prinzip bei der Behaudlung von Alkohol-Delirien. Nervenart 37, 415 Cadet M, Dollols B, Bernard J F & Abibol A (1979) La prevention du syndrome de serrage. Semaine des Hiipitaux. Paris 55, 891 Carlsson C & Pettersson L (1972) Dysphoric symptoms in chronic alcoholics and the effect of carbamazepine (Tegretol). International Journal ofclinical Pharmacology 5, 4, 403 Fagan P (1971) Management of acute alcoholism. Journal ofthe Medical Society ofnew Jersey 68, 915 Freour P (1979) La lutte contre l'alcoolisme et ses consequences 165 en pratique medicale courante. Semaine des Hopitaux. Paris 55, 757 Goodman L S & Gilman A (1970) The pharmacological basis of therapeutics. London. Collier-MacMillan Ltd Greenblatt D J & Greenblatt N (1972) Which drug for alcohol withdrawal? Journal of Clinical Pharmacology 12,429 Hubach C (1963) Veriinderungen der KrampFerregbarkeit under Einwirkung von Medikamenten Und Wiihrend der Entziehung. Fortschritte der Neurologie und Psychiatrie 31,177 Pignol F & Casanova P (1979) Nouvel apport therapeutique au cours des manifestations cliniques de l'ethylisme. Semaine des Hopitaux. Paris 55, 655 Sampliner R & Iber F L (1974) Diphenylhydantoin control of alcohol withdrawal seizures: Results of a controlled study. Journal of the American Medical Association 230, 1430 Seevers N H & Deneau G A (1963) Physiological aspects of tolerance and physical dependance In: Root W S and Hofmann F G (Eds): Physiological pharmacology. Vol I Academic Press, New York, p 565 Sillanpiiii M, Bjorkqvist S E & Alihanka J (1980) In: Epilepsy Updated: causes and treatment. Robb P (Ed). Treatment of convulsion and other alcohol withdrawal symptoms. Year Book Medical Publishers Chicago-London Sillanpiiii M & Sonck T (1979) Finnish experiences with carbamazepine (Tegretol) in the treatment of acute withdrawal symptoms in alcoholics. Journal of International Medical Research 7, 168 Smith J (1968) Medical management of acute alcoholic intoxication. General Practitioner 38, 89 Sonck T, Malinen L & Jiinne J (1975) Carbamazepine in the treatment of acute withdrawal syndrome in alcoholics: Methodological aspects in rationality of drug development. Amsterdam: Excerpta Medica Int. Congr. Ser. M. 383, 251 Wilbur R & Kulik F A (1981) Anticonvulsivant drugs in alcohol withdrawal: use of phentoin, primidone, carbarnazepine, valproic acid, and the sedative anticonvulsivants. American Journal Hospital Pharmacy 38, 1138

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