Gamma-hydroxybutyrate (GHB) for treatment of alcohol withdrawal and prevention of relapses (Review)

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1 Gamma-hydroxybutyrate (GHB) for treatment of alcohol withdrawal and prevention of relapses (Review) Leone MA, Vigna-Taglianti F, Avanzi G, Brambilla R, Faggiano F This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2010, Issue 2

2 T A B L E O F C O N T E N T S HEADER ABSTRACT PLAIN LANGUAGE SUMMARY SUMMARY OF FINDINGS FOR THE MAIN COMPARISON BACKGROUND OBJECTIVES METHODS Figure Figure RESULTS Figure ADDITIONAL SUMMARY OF FINDINGS DISCUSSION AUTHORS CONCLUSIONS ACKNOWLEDGEMENTS REFERENCES CHARACTERISTICS OF STUDIES DATA AND ANALYSES Analysis 1.1. Comparison 1 GHB 50mg vs placebo: withdrawal syndrome, Outcome 1 drop-outs Analysis 1.2. Comparison 1 GHB 50mg vs placebo: withdrawal syndrome, Outcome 2 withdrawal score Analysis 1.3. Comparison 1 GHB 50mg vs placebo: withdrawal syndrome, Outcome 3 side-effects Analysis 2.1. Comparison 2 GHB 50mg vs diazepam: withdrawal syndrome, Outcome 1 drop-outs Analysis 2.2. Comparison 2 GHB 50mg vs diazepam: withdrawal syndrome, Outcome 2 CIWA-Ar score Analysis 2.3. Comparison 2 GHB 50mg vs diazepam: withdrawal syndrome, Outcome 3 CIWA-Ar subscore: tremor. 69 Analysis 2.4. Comparison 2 GHB 50mg vs diazepam: withdrawal syndrome, Outcome 4 CIWA-Ar subscore: paroxysmal sweats Analysis 2.5. Comparison 2 GHB 50mg vs diazepam: withdrawal syndrome, Outcome 5 CIWA-Ar subscore: anxiety. 72 Analysis 2.6. Comparison 2 GHB 50mg vs diazepam: withdrawal syndrome, Outcome 6 CIWA-Ar subscore: agitation. 73 Analysis 2.7. Comparison 2 GHB 50mg vs diazepam: withdrawal syndrome, Outcome 7 STAI-y1 score Analysis 2.8. Comparison 2 GHB 50mg vs diazepam: withdrawal syndrome, Outcome 8 SDS Zung test score Analysis 2.9. Comparison 2 GHB 50mg vs diazepam: withdrawal syndrome, Outcome 9 side-effects Analysis 3.1. Comparison 3 GHB 50mg vs clomethiazole: withdrawal syndrome, Outcome 1 drop-outs Analysis 3.2. Comparison 3 GHB 50mg vs clomethiazole: withdrawal syndrome, Outcome 2 4 points withdrawal scale. 78 Analysis 3.3. Comparison 3 GHB 50mg vs clomethiazole: withdrawal syndrome, Outcome 3 CIWA-Ar score Analysis 3.4. Comparison 3 GHB 50mg vs clomethiazole: withdrawal syndrome, Outcome 4 CIWA-Ar subscore: tremor. 80 Analysis 3.5. Comparison 3 GHB 50mg vs clomethiazole: withdrawal syndrome, Outcome 5 CIWA-Ar subscore: hyperhydrosis Analysis 3.6. Comparison 3 GHB 50mg vs clomethiazole: withdrawal syndrome, Outcome 6 CIWA-Ar subscore: anxiety. 82 Analysis 3.7. Comparison 3 GHB 50mg vs clomethiazole: withdrawal syndrome, Outcome 7 side-effects Analysis 4.1. Comparison 4 GHB 100mg vs clomethiazole: withdrawal syndrome, Outcome 1 drop-outs Analysis 4.2. Comparison 4 GHB 100mg vs clomethiazole: withdrawal syndrome, Outcome 2 CIWA-Ar score Analysis 4.3. Comparison 4 GHB 100mg vs clomethiazole: withdrawal syndrome, Outcome 3 CIWA-Ar subscore: tremor Analysis 4.4. Comparison 4 GHB 100mg vs clomethiazole: withdrawal syndrome, Outcome 4 CIWA-Ar subscore: hyperhydrosis Analysis 4.5. Comparison 4 GHB 100mg vs clomethiazole: withdrawal syndrome, Outcome 5 CIWA-Ar subscore: anxiety Analysis 4.6. Comparison 4 GHB 100mg vs clomethiazole: withdrawal syndrome, Outcome 6 side-effects Analysis 5.1. Comparison 5 GHB 50mg vs GHB 100mg: withdrawal syndrome, Outcome 1 drop-outs Analysis 5.2. Comparison 5 GHB 50mg vs GHB 100mg: withdrawal syndrome, Outcome 2 CIWA-Ar score Analysis 5.3. Comparison 5 GHB 50mg vs GHB 100mg: withdrawal syndrome, Outcome 3 CIWA-Ar subscore: tremor. 90 i

3 Analysis 5.4. Comparison 5 GHB 50mg vs GHB 100mg: withdrawal syndrome, Outcome 4 CIWA-Ar subscore: hyperhydrosis Analysis 5.5. Comparison 5 GHB 50mg vs GHB 100mg: withdrawal syndrome, Outcome 5 CIWA-Ar subscore: anxiety. 92 Analysis 5.6. Comparison 5 GHB 50mg vs GHB 100mg: withdrawal syndrome, Outcome 6 side-effects Analysis 6.1. Comparison 6 GHB 50mg vs placebo: maintaining abstinence, Outcome 1 drop-outs Analysis 6.2. Comparison 6 GHB 50mg vs placebo: maintaining abstinence, Outcome 2 average stay in program (weeks). 95 Analysis 6.3. Comparison 6 GHB 50mg vs placebo: maintaining abstinence, Outcome 3 abstinence Analysis 6.4. Comparison 6 GHB 50mg vs placebo: maintaining abstinence, Outcome 4 controlled drinking Analysis 6.5. Comparison 6 GHB 50mg vs placebo: maintaining abstinence, Outcome 5 relapse to heavy drinking.. 98 Analysis 6.6. Comparison 6 GHB 50mg vs placebo: maintaining abstinence, Outcome 6 number of daily drinks Analysis 6.7. Comparison 6 GHB 50mg vs placebo: maintaining abstinence, Outcome 7 craving score Analysis 6.8. Comparison 6 GHB 50mg vs placebo: maintaining abstinence, Outcome 8 side-effects Analysis 7.1. Comparison 7 GHB 50mg vs NTX: maintaining abstinence, Outcome 1 drop-outs Analysis 7.2. Comparison 7 GHB 50mg vs NTX: maintaining abstinence, Outcome 2 abstinence Analysis 7.3. Comparison 7 GHB 50mg vs NTX: maintaining abstinence, Outcome 3 relapses to heavy drinking Analysis 7.4. Comparison 7 GHB 50mg vs NTX: maintaining abstinence, Outcome 4 number of daily drinks Analysis 7.5. Comparison 7 GHB 50mg vs NTX: maintaining abstinence, Outcome 5 controlled drinking Analysis 7.6. Comparison 7 GHB 50mg vs NTX: maintaining abstinence, Outcome 6 Alcohol Craving Scale Analysis 7.7. Comparison 7 GHB 50mg vs NTX: maintaining abstinence, Outcome 7 side-effects Analysis 8.1. Comparison 8 GHB 50mg vs disulfiram: maintaining abstinence, Outcome 1 drop-outs Analysis 8.2. Comparison 8 GHB 50mg vs disulfiram: maintaining abstinence, Outcome 2 abstinence Analysis 8.3. Comparison 8 GHB 50mg vs disulfiram: maintaining abstinence, Outcome 3 relapses to heavy drinking. 109 Analysis 8.4. Comparison 8 GHB 50mg vs disulfiram: maintaining abstinence, Outcome 4 number of daily drinks Analysis 8.5. Comparison 8 GHB 50mg vs disulfiram: maintaining abstinence, Outcome 5 controlled drinking Analysis 8.6. Comparison 8 GHB 50mg vs disulfiram: maintaining abstinence, Outcome 6 Alcohol Craving Scale Analysis 8.7. Comparison 8 GHB 50mg vs disulfiram: maintaining abstinence, Outcome 7 side-effects Analysis 9.1. Comparison 9 GHB 50mg + NTX vs NTX: maintaining abstinence, Outcome 1 drop-outs Analysis 9.2. Comparison 9 GHB 50mg + NTX vs NTX: maintaining abstinence, Outcome 2 abstinence Analysis 9.3. Comparison 9 GHB 50mg + NTX vs NTX: maintaining abstinence, Outcome 3 relapses to heavy drinking Analysis 9.4. Comparison 9 GHB 50mg + NTX vs NTX: maintaining abstinence, Outcome 4 side effects Analysis Comparison 10 GHB 50mg + disulfiram vs disulfiram + placebo: maintaining abstinence, Outcome 1 dropouts Analysis Comparison 11 GHB 75mg + escitalopram vs escitalopram: maintaining abstinence, Outcome 1 abstinence Analysis Comparison 12 GHB 75mg + escitalopram vs NTX + escitalopram: maintaining abstinence, Outcome 1 abstinence Analysis Comparison 13 GHB 75mg + NTX + Escitalopram vs escitalopram: maintaining abstinence, Outcome 1 abstinence ADDITIONAL TABLES APPENDICES WHAT S NEW HISTORY CONTRIBUTIONS OF AUTHORS DECLARATIONS OF INTEREST SOURCES OF SUPPORT DIFFERENCES BETWEEN PROTOCOL AND REVIEW INDEX TERMS ii

4 [Intervention Review] Gamma-hydroxybutyrate (GHB) for treatment of alcohol withdrawal and prevention of relapses Maurizio A Leone 2, Federica Vigna-Taglianti 1, GianCarlo Avanzi 3, Romeo Brambilla 4, Fabrizio Faggiano 1 1 Department of Clinical and Experimental Medicine, University of Piemonte Orientale A. Avogadro, Novara, Italy. 2 SCDU Neurologia, Aziena Ospedaliero-Universitaria Maggiore della Carità, Novara, Italy. 3 Department of Medical Sciences, University of Piemonte Orientale A. Avogadro, Novara, Italy. 4 School of Public Health, University of Turin, Turin, Italy Contact address: Federica Vigna-Taglianti, Department of Clinical and Experimental Medicine, University of Piemonte Orientale A. Avogadro, via Solaroli 17, Novara, 28100, Italy. Editorial group: Cochrane Drugs and Alcohol Group. Publication status and date: Edited (no change to conclusions), published in Issue 4, Review content assessed as up-to-date: 17 February Citation: Leone MA, Vigna-Taglianti F, Avanzi G, Brambilla R, Faggiano F. Gamma-hydroxybutyrate (GHB) for treatment of alcohol withdrawal and prevention of relapses. Cochrane Database of Systematic Reviews 2010, Issue 2. Art. No.: CD DOI: / CD pub2. Background A B S T R A C T Chronic excessive alcohol consumption may lead to dependence, and to alcohol withdrawal syndrome (AWS) in case of abrupt drinking cessation. Gamma-hydroxybutyric acid (GHB) can prevent and suppress withdrawal symptoms, and improve the mediumterm abstinence rate. However, clear estimates of its beneficial and harmful effects have not been yet established. Objectives To evaluate the efficacy and safety of GHB for the treatment of AWS and the prevention of relapse. Search methods We searched the Cochrane Drugs and Alcohol Group s Register of Trials (October 2008), PubMed, EMBASE, CINAHL (January 2005 to October 2008), EconLIT (1969 to February 2008), and reference lists of retrieved articles. Selection criteria Randomized controlled trials (RCT) and Controlled Prospective Studies (CPS) evaluating the efficacy and the safety of GHB versus placebo or other pharmacological treatments. Data collection and analysis Three authors independently extracted data and assessed the methodological quality of the studies. Main results Thirteen RCTs were included, 11 of which had been conducted in Italy. For alcohol withdrawal syndrome, comparing GHB 50mg versus placebo, results from 1 study (23 participants) favour GHB for withdrawal symptoms: MD (95% CI to -8.29), but tolerated side effects were more frequent in the GHB group: RR 16.2 (95% CI 1.04 to 254.9; based on 7 of 11 patients in the GHB group developing transitory vertigo compared to none in the placebo 1

5 group). In the comparison of GHB 50mg versus Clomethiazole, results from 1 study (21 participants) favour GHB for withdrawal symptoms: MD (95% CI to -1.71). For GHB 100mg versus Clomethiazole, results from 1 study (98 participants) favour Clomethiazole for side effects: RR 1.84 (95% CI 1.19 to 2.85). At mid-term, comparing GHB 50mg/day with placebo, 1 study (71 participants, 3 months follow-up) favour GHB for abstinence rate (RR 5.35, 95% CI 1.28 to 22.4), controlled drinking (RR 2.13, 95% CI 1.07 to 5.54), relapses (RR 0.36, 95% CI 0.21 to 0.63), and number of daily drinks (MD -4.60, 95% CI to -3.02). On abstinence, GHB performed better than Naltrexone (NTX) (2 studies, 64 participants) (RR 2.59, 95% CI 1.35 to 4.98 at 3 months) and than Disulfiram (1 study, 59 participants) (RR 1.66, 95% CI 0.99 to 2.80 at 12 months, slightly significant). The combination of GHB and NTX was better than NTX for abstinence (RR 12.3, 95% CI 1.79 to 83.9 at 3 months; 1 study, 35 participants). The combination of NTX, GHB and Escitalopram was better than Escitalopram alone for abstinence (RR % CI 1.03 to 3.94 at 3 months; RR 4.58, 95% CI 1.28 to 16.5 at 6 months; 1 study, 23 participants). For Alcohol Craving Scale, results favour GHB over placebo (MD -4.50, 95% CI to at 3 months; 1 study, 71 participants) and over Disulfiram at 12 months (MD -1.40, 95% CI to -0.94, from 1 study with 41 participants). All other comparisons and outcomes did not show significant differences. Authors conclusions There is insufficient randomised evidence to be confident of a difference between GHB and placebo, or to determine reliably if GHB is more or less effective than other drugs for the treatment of alcohol withdrawl or the prevention of relapses. The small amount of randomised evidence available suggests that GHB 50mg may be more effective than placebo in the treatment of AWS, and in preventing relapses and craving in previously detoxified alcoholics during the first 3 months of follow-up. This review does not provide evidence in favour or against GHB compared to benzodiazepines and Clomethiazole for treatment of AWS; but, again based on a small amount of randomised evidence, GHB appears better than NTX and Disulfiram in maintaining abstinence and preventing craving in the medium term (3 to 12 months). The review does not provide evidence of a difference in side effects between GHB and benzodiazepines, NTX or Disulfiram. These findings should be considered alongside concerns that have been raised about GHB regarding the risk of developing addiction, and the misuse or abuse of the drug, suggesting to use GHB only under strict medical surveillance. P L A I N L A N G U A G E S U M M A R Y Gamma-hydroxybutyrate for treating symptoms associated with alcohol withdrawal and preventing relapses for people who are dependent on alcohol Excessive long term alcohol consumption can lead to dependence on alcohol. This means that when a person stops drinking suddenly he or she experiences withdrawal symptoms. The main goals for clinical management of alcohol withdrawal are to minimize the severity of symptoms and facilitate entry into a treatment program, so that the person can achieve and maintain abstinence from alcohol. Symptoms of withdrawal range from tremor, nausea, anxiety, restlessness and insomnia to more severe effects such as seizures, hallucinations, agitation and delirium. Progression to coma and cardiac arrest is possible. Medications that are intended to help people who are dependent on alcohol to withdraw from it include benzodiazepines, anticonvulsants and gamma-hydroxybutyrate (GHB). GHB was first available as a health food and body-building supplement, but reports of adverse events led to its withdrawal for that purpose. Thirteen randomised controlled trials involving 648 participants were included in this review. Eleven of these were conducted in Italy. However, there is not enough reliable evidence from the research that has been done to date to be confident of a difference between GHB and placebo, or to determine reliably if GHB is more or less effective than other drugs for the treatment of alcohol withdrawl or the prevention of relapses. Six trials with a total of 286 participants evaluated the effectiveness of GHB in reducing withdrawal syndrome. These compared the drug with a variety of other interventions, making it impossible to use them all in a single analysis. One study suggests that GHB might reduce withdrawal symptoms more than a placebo, but this is based on a very small number of patients. No strong differences were observed between GHB and benzodiazepines or Clomethiazole. In the other comparisons, the differences were not statistically significant. Seven trials involving 362 participants tested the use of GHB to treat alcohol dependence or prevent relapses if a person was already detoxified (mid-term outcomes). These included several different comparisons, so each analysis was able to include only one or two trials; and the trials were generally small (range 17 to 98 participants). GHB did appear to be better than Naltrexone and Disulfiram 2

6 in maintaining abstinence and preventing craving, based on two trials and one trial respectively for these comparisons. The most consistently reported side effect of GHB was dizziness and vertigo, with this being more common at higher doses. The findings of this review should be considered alongside concerns that have been raised about GHB regarding the risk of developing addiction, and the misuse or abuse of the drug, suggesting to use GHB only under strict medical surveillance. 3

7 S U M M A R Y O F F I N D I N G S F O R T H E M A I N C O M P A R I S O N [Explanation] GHB 50mg compared to placebo for alcohol withdrawal Patient or population: patients with alcohol withdrawal Settings: Intervention: GHB 50mg Comparison: placebo Outcomes Illustrative comparative risks*(95% CI) Relative effect (95% CI) withdrawal score - 7 hours side-effects - tolerated side-effects Assumed risk placebo Mediumriskpopulation 3 1per1000 Corresponding risk GHB 50mg The mean withdrawal score-7hoursintheintervention groups was 12.1 lower (14.65 to 9.55 lower) 16per1000 (1to255) RR16.25 (1.04 to ) No of Participants (studies) 23 (1) 23 (1) Quality of the evidence (GRADE) verylow 1,2 low 1,2 Comments *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention(and its 95% CI). CI: Confidence interval; RR: Risk ratio; GRADE Working Group grades of evidance High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Lowquality:Furtherresearchisverylikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandislikelytochangetheestimate. Very low quality: We are very uncertain about the estimate. 4

8 1 verylowsamplesize 2 evidenceavailableonlyfrom1study 3 mediumriskincontrolpopulationestimatedas1per1000 xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 5

9 B A C K G R O U N D Description of the condition Chronic excessive alcohol consumption may lead to dependence, and hence to the alcohol withdrawal syndrome (AWS) in the event of abrupt reduction or cessation of drinking. AWS is a life-threatening condition. Its severity ranges from a moderate form characterized by tremor, nausea, anxiety, restlessness, insomnia to a more severe form with seizures, hallucinations, agitation and delirium. Progression to coma, cardiac arrest and death is also possible (Pieninkeroinen 1992; Morton 1994; Schuckit 1995). All the signs and symptoms of AWS arise from alcohol-induced adaptations in the central nervous system (CNS). Alcohol usually acts in the brain like a depressant drug. During prolonged intoxication, the CNS adapts to these effects and alcohol tolerance ensues. The amount of GABA receptors decreases, whereas the amount of NMDA receptors increases (Tan 1997). The main goals of the clinical management of AWS are to minimize the severity of symptoms, prevent its more severe manifestations (such as seizure and delirium) and facilitate entry into a treatment program to achieve and maintain abstinence from alcohol (O Connor 1998). Withdrawal from alcohol may require pharmacological management, depending on the amount of drinking, the presence of symptoms, and the setting of detoxification (SIGN 2003). Approximately, three-quarters of patients can be detoxified successfully as out-patients without medication (SIGN 2003), but more intensive support is generally required for patients at risk or already presenting symptoms of withdrawal, for whom in-patient detoxification is recommended. Different classes of drugs have been used to prevent and treat AWS. These include benzodiazepines, neuroleptics, antiepileptics and others (Hillbom 2003). How the intervention might work GHB was used in Europe for decades without reports of severe side effects and incidents of abuse. When it became widely available in the US, as a health food and body-building supplement during the 1980s, reports of adverse events increased to the point that the Food and Drug Administration (FDA 2006) ordered its removal from the market in 1990.These adverse effects ranged from mild hypothermia, dizziness, nausea, vomiting, weakness, loss of peripheral vision, confusion, agitation, hallucination, decreased respiratory effort, unconsciousness and coma.some deaths have been reported in relation to GHB ingestion, usually when mixed with other drugs (Nicholson 2001; Caldicott 2004). One death has been ascribed to GHB alone (CDC 1997). Why it is important to do this review Clear estimates of the beneficial and harmful effects of GHB, and the balance between these, have not been yet established. O B J E C T I V E S To evaluate the efficacy and safety of GHB for the treatment of AWS and the prevention of relapse, and more specifically: to compare the efficacy of GHB with placebo or other drugs; to identify the most effective GHB dosage and schedules; to estimate the frequency of side effects. Description of the intervention Gamma-hydroxybutyric acid (GHB) is a short-chain fatty acid, a metabolite of gamma-amino-butyric acid (GABA). Its neuropharmacological and neurophysiological effects (Gessa 2000) include the modulation of some neurotransmitters such as dopamine, serotonin, acetylcholine and opioids. Similarity of the effects of GHB and alcohol on the CNS was first described in the 1970s and subsequently confirmed (Frau 1995; Colombo 1995; Colombo 1998; Agabio 1998). Its alcohol-mimicking effects represent a rationale for using GHB in alcohol addiction treatment and in craving (Gallimberti 1989; Gallimberti 1992) and clinical trials (Di Bello 1995; Ceccanti 1996; Addolorato 1998; Nimmerrichter 2002) have shown that GHB can prevent and suppress withdrawal symptoms, and improve abstinence rate in the medium term. M E T H O D S Criteria for considering studies for this review Types of studies Randomized controlled trials (RCT), controlled clinical trials (CCT), and controlled prospective studies (CPS) evaluating the efficacy and the safety of GHB in treating AWS and preventing mid-term relapses, in comparison with placebo or other pharmacological treatments. 6

10 Types of participants Alcohol dependent patients diagnosed in accordance with appropriate standardized criteria (e.g., criteria of Diagnostic and Statistical Manual of Mental Disorders (DSM IV-R 1994) or equivalent) or as defined by the authors of the original research, who are receiving therapy to prevent or to treat AWS. All patients are eligible, regardless of age, gender, outpatient or inpatient setting, and history of previous detoxification treatments. Types of interventions Secondary outcomes: Severity of single symptoms and signs, measured with either qualitative or quantitative scales, including: Tremor; Anxiety; Agitation; Depression; Paroxysmal sweat; Hyperhydrosis. Side effects Experimental intervention: Gamma-hydroxybutyric acid (GHB) at any dosage. Dosage classification is intended as mg/kg/day. Mid-term outcomes: Mid-term outcomes were those evaluated after the first month of administration of GHB for preventing relapses. Control intervention: Placebo, any other pharmacological treatment. Comparisons that are expected: GHB vs. placebo for the treatment of AWS; GHB vs. placebo for the prevention of mid-term relapses; GHB vs. other drugs for the treatment of AWS; GHB vs. other drugs for the prevention of mid-term relapses; GHB combined with other drugs vs. placebo for the treatment of AWS; GHB combined with other drugs vs. placebo for the prevention of mid-term relapses; GHB combined with other drugs vs. other drugs for the treatment of AWS; GHB combined with other drugs vs. other drugs for the prevention of mid-term relapses. Types of outcome measures Outcomes were categorized as measures of global severity, severity of single symptoms and signs, and other short-term and mid-term efficacy outcomes. Short-term outcomes: Short-term outcomes were those evaluated in the first month of administration of GHB for treating AWS. Primary outcome: Global severity of overall alcohol withdrawal syndrome as measured using a prespecified scale, including Clinical Institute Withdrawal Assessment for Alcohol [CIWA-Ar], and others. Primary outcomes: Drop-out rate; Abstinence rate; Relapse to heavy drinking; Craving, as measured in prespecified scales (including Alcohol Craving scale, LCCR-1, and others). Secondary outcomes: Length of stay in treatment; Controlled drinking; Number of daily drinks; Number of heavy drinking days; Side effects. Relapse to heavy drinking is defined as 5 or more drinks on one occasion for men and 4 or more drinks on one occasion for women (WHO 2004). Controlled drinking is defined as drinking less than 40g alcohol per day for men and less than 20g per day for women (WHO 2004). Search methods for identification of studies Electronic searches The following electronic databases were searched: MEDLINE (1950 to September 2008); EMBASE (1988 to September 2008); PsycInfo (1967 to September 2008); CINAHL - Cumulative Index to Nursing and Allied Health Literature (1982 to September 2008); The Cochrane Library (update September 2008). 7

11 We used a search strategy based on MEDLINE but revised appropriately for each database to take account of differences in controlled vocabulary and syntax rules. No language, publication or time restrictions were applied. Details of the search strategies can be found in Appendix 1, Appendix 2, Appendix 3 and Appendix 4. Searching other resources Editorials, reviews, commentaries, letters to the editor were included in the set. Review articles, as well included and excluded studies cited in the review were checked to identify other relevant studies. Relevant editorials, commentaries, and letters were reviewed to identify useful articles. The authors of all included and excluded studies (n=29) were contacted to identify other potentially relevant studies. Seven authors sent published references or papers. Three pharmaceutical companies distribute GHB: 1. Laboratorio Farmaceutico C.T. S.r.l., Sanremo, Italy; 2. Jazz Pharmaceuticals, Palo Alto, California, USA; and 3. UCB Pharma Ltd, Brussels (Belgium). Only Laboratorio Farmaceutico C.T. supplies GHB for the treatment of alcohol withdrawal and dependence. The other two companies supply GHB for the treatment of narcolepsy. We contacted all three companies to obtain published and unpublished trials. Laboratorio Farmaceutico C.T. provided information on two ongoing trials. Data collection and analysis Selection of studies Two authors (FVT and RB) checked the abstracts for relevance. Three authors (FVT, MAL and RB) blindly reviewed whole reports and assessed trials for inclusion, abstracted the outcome data and evaluated the quality of the trials. Disagreements were resolved by discussion with a fourth author (FF). Data extraction and management The following information were extracted: Total number of patients allocated to each treatment group; Demographic characteristics; Setting (out- or in-patients); Whether medication was started immediately after the onset of withdrawal or not; Factors related to the alcohol withdrawal episode (severity of symptoms, time since the last drink); Risk factors (previous detoxification or withdrawal episodes, years of alcohol use, mixed abuse of drugs); Dose and duration of GHB therapy; Dose and duration of other therapies; Adverse effects; Deaths. We s four authors of included studies to ask for data or supplementary information. All four replied and one provided the requested data, which was used in our analysis. Assessment of risk of bias in included studies The risk of bias assessment for RCTs, CCTs and CPSs in this review was performed using the criteria recommended by the Cochrane Handbook (Higgins 2008) and by completing the risk of bias tables in RevMan 5 software. This is achieved by answering a pre-specified question about the adequacy of the study in relation to the relevant item, such that a judgement of Yes indicates low risk of bias, No indicates high risk of bias, and Unclear indicates unclear or unknown risk of bias. To make these judgments, we used the criteria indicated by the Handbook adapted to the addiction field. In particular, the following criteria were used to evaluate risk of bias: 1. Sequence generation (avoidance of selection bias); 2. Allocation concealment (avoidance of selection bias); 3. Completeness of outcome data (avoidance of attrition bias); 4. Selective reporting (avoidance of reporting bias); 5. Other possible bias, such as similarity of patients in the groups (avoidance of selection bias); 6. Blinding of patients, providers and assessors of subjective outcomes (avoidance of performance bias and detection bias). Inclusion of all patients in the analysis and drop out rate were used to evaluate completeness of outcome data. A mention of the study protocol in the paper was used to evaluate the possibility of selective reporting. Similarity of patients in the groups at the starting of the trial and methods used to increase the strength of the statistical analysis were used to check for other possible biases. Blinding was considered separately for patients, providers and assessors of subjective outcomes. These were considered the most important potential biases for our review, because objective outcomes were limited to retention in treatment. Two review authors independently assessed the internal validity of the included studies. Any disagreement between the review authors was resolved by discussion, including input from a third independent reviewer if required. Our assessment of risk of bias was not blinded to the authors, institution or journal of the original research. There were too few studies in the meta-analyses to support sensitivity analysis. This will be done in the future updates of the review, if possible. Results of our risk of bias evaluation are shown in the Risk of bias tables and figures (Figure 1; Figure 2). 8

12 Figure 1. Methodological quality graph: review authors judgements about each methodological quality item presented as percentages across all included studies. 9

13 Figure 2. Methodological quality summary: review authors judgements about each methodological quality item for each included study. 10

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