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Concerns regarding the external validity of phase-III trials are common to many medical disciplines, with relevant discrepancies found between experimental and clinical samples in some diseases such as hypertension. The aim of this study was to compare the samples included in the pivotal, phase-III clinical trials of nalmefene with that of a recently conducted phase-IV trial. Baseline characteristics of the studies were compared through univariate analysis. Significant differences were found in the percentage of low-risk drinkers included. Differences were also found in the prescription and intake pattern of nalmefene, as well as in the rate of psychiatric and addictive comorbidities, which were much higher in the phase-IV study. These data suggest that in the field of alcohol use disorders there are also relevant differences between experimental and clinical samples, a fact that reinforces the need for phase-III trials to be balanced with observational, phase-IV trials.

Background: The Multidimensional Alcohol Craving Scale (MACS) and Single Photon Emission Computerized Tomography (SPECT) with (123)I-iodobenzamide ((123)I-IBZM) can be useful tools for assessing relapse risk in early recovery from alcohol-dependency. The aim of this study was to assess possible relationships between MACS score, (123)I-IBZM binding and time to first heavy drinking day (TFHD) after detoxification treatment., Methods: Nineteen alcohol-dependent in-patients were evaluated by MACS scale and an 123I-IBZM-SPECT, performed following alcohol detoxification treatment. At discharge, participants were advised to take naltrexone 50 mg/day for relapse prevention. TFHD was assessed over a 12-week follow up., Results: The MACS score at the beginning of the detoxification process and naltrexone treatment after detoxification were independent predictive factors for TFHD., Conclusions: The MACS scale is a better predictor of TFHD than IBZM binding. It is simple, non-invasive and inexpensive and appears to be a useful instrument both for clinical practice and for research.

Unlabelled: Introduction Recent pharmacotherapy findings from new alcohol reduction programmes could change the paradigm of alcohol-dependence treatment., Material and Method: This study reviews the neurobiological background and pharmacotherapy of alcohol-dependence disorder, focusing on opioid receptor antagonists, abstinence-oriented treatment and moderation-oriented treatment., Results: 1. Alcohol-dependence treatment programs show only low to moderate efficacy. 2. Patients usually show low motivation to sustain abstinence but high motivation to reduce alcohol use. 3. A treatment program based on continued reduction of drinking and associated with intermittent treatment with naltrexone can be useful for low-severity alcohol-dependent patients., Discussion: Although high severity alcohol-dependent patients should stop drinking alcohol, low severity patients may have the option of reducing their alcohol consumption if they take an opioid antagonist medication every day that they decide to drink alcohol. In the short term, the continuing drinking-reduction programmes may reduce the number of drinks per drinking day and in the long term, they may progressively decrease the obsession for drinking, alcohol seeking behavior, and related medical, behavioral and social disorders. To change the paradigm in the treatment of alcohol-dependence disorder there is a need for further randomized controlled trials in order to assess their efficacy and tolerability.

Several observational follow-up studies about cardiovascular health have found an overlap between moderate drinking and lower mortality from coronary heart disease and other causes. However, such studies have serious methodological limitations. Most non-drinkers were in fact ex-drinkers, that is, people who had had to stop drinking for health reasons. Other variables that may play a decisive role in cardiovascular risk, such as tobacco smoking, exercise and body mass index, were not evaluated, and changes in drinking habits were not assessed periodically. Due to the methodological limitations of these studies, the findings suggest a statistical association but not a causality relationship between moderate alcohol consumption and lower risk of mortality. Furthermore, numerous studies have shown that excessive drinking can cause not only cardiovascular diseases--such as hypertension, arrhythmias, dilated cardiomyopathy and stroke--but also other medical and psychiatric disorders. Alcohol clearly has addictive properties that can contribute to the development of heavy drinking in some people, leading to alcohol-related physical and mental disorders. The public health message should emphasize the potential risk of heavy drinking rather than promote the possible benefits of moderate consumption. A simplistic message that alcohol is good for cardiovascular health may be prejudicial when stated outside the context of the possible adverse consequences of heavy drinking.