METHODS: 126 detoxified heroin-dependent patients, from an outpatient research clinic and detoxification programme in Malaysia, were randomly assigned by a computer-generated randomisation sequence to 24 weeks of manual-guided drug counselling and maintenance with naltrexone (n=43), buprenorphine (n=44), or placebo (n=39). Medications were administered on a double-blind and double-dummy basis. Primary outcomes, assessed by urine testing three times per week, were days to first heroin use, days to heroin relapse (three consecutive opioid-positive urine tests), maximum consecutive days of heroin abstinence, and reductions in HIV risk behaviours over 6 months. The study was terminated after 22 months of enrolment because buprenorphine was shown to have greater efficacy in an interim safety analysis. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00383045.
FINDINGS: We observed consistent, linear contrasts in days to first heroin use (p=0.0009), days to heroin relapse (p=0.009), and maximum consecutive days abstinent (p=0.0007), with all results best for buprenorphine and worst for placebo. Buprenorphine was associated with greater time to first heroin use than were naltrexone (hazard ratio 1.87 [95% CI 1.21-2.88]) or placebo (2.02 [1.29-3.16]). With buprenorphine, we also recorded significantly greater time to heroin relapse (2.17 [1.38-3.42]), and maximum consecutive days abstinent than with placebo (mean days 59 [95% CI 43-76] vs 24 [13-35]; p=0.003); however, for these outcomes, differences between buprenorphine and naltrexone were not significant. Differences between naltrexone and placebo were not significant for any outcomes. HIV risk behaviours were significantly reduced from baseline across all three treatments (p=0.003), but the reductions did not differ significantly between the three groups.
INTERPRETATION: Our findings lend support to the widespread dissemination of maintenance treatment with buprenorphine as an effective public-health approach to reduce problems associated with heroin dependence.
DESIGN: We estimated the cost-effectiveness ratios of three treatments for heroin dependence. We used a microcosting methodology to determine fixed, variable, and societal costs of each intervention. Cost data were collected from investigators, staff, and project records on the number and type of resources used and unit costs; societal costs for participants' time were estimated using Malaysia's minimum wage. Costs were estimated from a provider and societal perspective and reported in 2004 US dollars.
SETTING: Muar, Malaysia.
PARTICIPANTS: 126 patients enrolled in a randomized, double-blind, placebo-controlled clinical trial in Malaysia (2003-2005) receiving counseling and buprenorphine, naltrexone, or placebo for treatment of heroin dependence.
MEASUREMENTS: Primary outcome measures included days in treatment, maximum consecutive days of heroin abstinence, days to first heroin use, and days to heroin relapse. Secondary outcome measures included treatment retention, injection drug use, illicit opiate use, AIDS Risk Inventory total score, and drug risk and sex risk subscores.
FINDINGS: Buprenorphine was more effective and more costly than naltrexone for all primary and most secondary outcomes. Incremental cost-effectiveness ratios were below $50 for primary outcomes, mostly below $350 for secondary outcomes. Naltrexone was dominated by placebo for all secondary outcomes at almost all endpoints. Incremental treatment costs were driven mainly by medication costs, especially the price of buprenorphine.
CONCLUSIONS: Buprenorphine appears to be a cost-effective alternative to naltrexone that might enhance economic productivity and reduce drug use over a longer term.
METHODS: In this case-control observational study, 32 adults with post-TBI olfactory dysfunction (cases) were matched with 32 TBI patients with intact olfactory function (controls). All subjects self-rated their olfactory function using the Visual Analogue Scale (VAS). Cases also underwent objective olfactory function assessment with the Sniffin' Sticks test, which generated a Threshold, Discrimination, and Identification (TDI) score. QoL was assessed with the Questionnaire for Olfactory Disorders (QOD). Factors evaluated included age, gender, smoking, TBI severity and duration, lesion localisation, and Disability Rating Scale (DRS) score.
RESULTS: Cases had a higher mean QOD score than controls at 26.31 ± 14.37 and 9.44 ± 8.30, respectively (F = 16.426, p
METHODS: This was a retrospective cross-sectional study conducted on specialist medical reports written from 2009 to 2019, involving patients who survived after TBI from RTA. The functional outcome was assessed using the Glasgow Outcome Scale-Extended (GOSE). Factors associated with good outcome were analysed via logistic regression analysis. Multivariate logistic regression analysis was used to derive the best fitting Prediction Model and split-sample cross-validation was performed to develop a prediction model.
RESULTS: A total of 1939 reports were evaluated. The mean age of the study participants was 32.4 ± 13.7 years. Most patients were male, less than 40, and with average post RTA of two years. Good outcome (GOSE score 7 & 8) was reported in 30.3% of the patients. Factors significantly affecting functional outcome include age, gender, ethnicity, marital status, education level, severity of brain injury, neurosurgical intervention, ICU admission, presence of inpatient complications, cognitive impairment, post-traumatic headache, post traumatic seizures, presence of significant behavioural issue; and residence post discharge (p<0.05). After adjusting for confounding factors, prediction model identified age less than 40, mild TBI, absence of post traumatic seizure, absence of behaviour issue, absence of cognitive impairment and independent living post TBI as significant predictors of good functional outcome post trauma. Discrimination of the model was acceptable (C-statistic, 0.67; p<0.001, 95% CI: 0.62-0.73).
CONCLUSION: Good functional outcome following TBI due to RTA in this study population is comparable to other low to middle income countries but lower than high income countries. Factors influencing outcome such as seizure, cognitive and behavioural issues, and independent living post injury should be addressed early to achieve favourable long-term outcomes.