Likhitsathian 2013.
| Methods | Randomised placebo‐controlled double‐blind study | |
| Participants | 106 participants; mean age 41.5 years; 100% male; 8.5 years of education on average; 29.3 years on average the age of alcoholism onset; 15.4 mean drinks per day; CIWA‐Ar score 1.2 on average (Sullivan 1989) Inclusion criteria: between 18 and 60 years old; fulfilling DSM‐IV (APA 1994) diagnostic criteria for alcohol dependence using MINI (Sheehan 1998); > one week of ≥ 35 standard drinks in men or ≥ 28 standard drinks in women, during four‐week period before admission; Alcohol Use Disorders Identification Test (AUDIT) score of eight or higher (Bohn 1995 a); mild or no alcohol withdrawal; likely to be discharged within 14 days; body mass index ≥ 18 kg/m2; intention to decrease or stop drinking (Sullivan 1989) Exclusion criteria: previous or current cognitive disorder, schizophrenia and other psychotic disorders, bipolar disorder or antisocial personality disorder; other substance dependence, except nicotine and caffeine dependence; treated with antipsychotics, mood stabilisers, anticonvulsants, opioid analgesics, systemic steroids, carbonic anhydrase inhibitors, hydrochlorothiazide, metformin, pioglitazone or disulfiram; risk of suicide; physical illness, including narrow‐angle glaucoma, renal impairment, urinary stone and epilepsy; unstable medical conditions; pregnancy and breast‐feeding; receiving medication for 14 days or longer while inpatient |
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| Interventions | (1) Topiramate, 53 participants; (2) placebo, 53 participants Drug dose: topiramate up to 300 mg/d During residential phase, participants were involved in one or two sessions of individual motivational enhancement therapy (MET), individual counseling for alcohol and drug use, group therapy and family counseling. After discharge, participants received two or three sessions of individual MET Setting: inpatient up to 14 days, then outpatient Duration: 12 weeks. Country of origin: Thailand |
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| Outcomes | Primary outcomes: heavy drinking days (numbers of days on which men consumed ≥ five standard drinks per day or women consumed ≥ four standard drinks per day divided by the number of study days) and time to first day of heavy drinking. Drinking characteristics were assessed using timeline follow‐back (Sobell 1992) Secondary outcomes: participants with heavy‐drinking relapses; drinking days; drinks per day; drinks per drinking day; alcohol craving, assessed by an 11‐point Likert‐type questionnaire; plasma gamma glutamyltransferase (GGT); HRQoL measured using the Medical Outcomes Study Short Form 36‐item questionnaire (SF‐36), Thai version (Kongsakon 2000); side effects measured by a six‐point Likert‐type questionnaire (Johnson 2007) |
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| Notes | Participants were enrolled at the end of a two‐ to four‐week residential treatment programme | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation balanced using permuted blocks of six. Random allocation sequences generated by computer |
| Allocation concealment (selection bias) | Low risk | Topiramate and matching placebo capsules provided by Department of Pharmaceutical Sciences. A random number indicating intervention or control treatment kept in an opaque and sealed envelope. Envelope opened after baseline assessment of each participant had been completed |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Data analysed by intention‐to‐treat. Methods applied to account for missing data |
| Blinding of participants and personnel (performance bias) all outcomes | Low risk | Topiramate supplied in over‐encapsulated tablets with identical matching placebos. Participants and care providers blinded to assigned treatment |
| Blinding of outcome assessment (detection bias) subjective | Low risk | Topiramate supplied in over‐encapsulated tablets with identical matching placebos. Outcome assessors blinded to treatment assignment |
| Blinding of outcome assessment (detection bias) objective | Low risk | Topiramate supplied in over‐encapsulated tablets with identical matching placebos. Outcome assessors blinded to treatment assignment |