To compare Russian evidence and practice in addiction medicines with international standards.
METHODS: Situation and literature analysis.
RESULTS: The analysis shows that in the wording of recommendations on the use of medicines, some were subject of serious methodological errors. For some drugs globally there is high quality evidence supporting effects of certain drugs globally, but this is not recognized in Russia. As a result, Russian standards of clinical care for the treatment of dependency syndrome are radically different to the standards of
therapy, presented in the WHO recommendations. This is due both to the disregard of the meta-analyses presented in the Cochrane reviews and also to the specific bioethical preferences in
drug treatment in Russia.It is known that there is no convincing data on the effectiveness and safety of
antipsychotics in the treatment of
alcohol dependence syndrome [3]. 13 randomized trials with a double blind placebo-controlled design involving 1593 patients assessing effects of
amisulpride,
aripiprazole, flupentixolum dekonoat,
olanzapine,
quetiapine,
tiapride showed that
antipsychotics do not result in abstinence, do not reduce abuse and do not stop craving in alcoholic patients: "
Antipsychotics should not be used in patients with a primary diagnosis of dependence. Appointment of
antipsychotics for the treatment of
substance abuse disorders are contraindicated, since not only does it not improve the condition of patients, but it can even worsen the course of the disease, leading to a reduction in the duration and quality of the remission, and is fraught with serious side effects that threaten the health of patients."SSRI
antidepressants indirectly improve the results of treatment of comorbid
alcoholism in depressed patients, without affecting
alcohol dependence per se. Also, there is currently no convincing evidence of the efficacy of
anticonvulsants in the treatment of dependence syndrome, particularly alcohol.Despite the fact that traditional psychotherapeutic interventions remain widespread in practice, and treatment of
alcohol dependence syndrome showed high efficiency, there is no convincing evidence for long-term benefits as opposed to short-term benefits.The Cochrane Review with data based on 146 scientific studies involving 21,404 patients confirmed the effectiveness of
opioid receptor agonists in treatment of
opioid dependence. This
therapy showed a statistically significant reduction in the use of
illegal drugs, HIV transmission and risky sexual behavior, and was significantly more effective compared to the conventional maintenance
therapy with
opioid receptor antagonists. In countries, where law prohibits prescribing and use of
opioid agonists for
opioid dependence treatment, the drugs of choice are antagonists.A meta-analysis of thirteen randomized placebo-controlled trials of oral form of
naltrexone (1158 subjects), did not show any advantages of this type of treatment both for management and prevention of relapse compared with placebo [4]. Special studies also showed no inclination to reduce the use of
opiates in patients receiving
naltrexone [5]. However, studies carried out in Russia, showed the best results for daily intake of
naltrexone after detoxification, which increased the duration of remission [6]. It was noted that the effect is associated with higher levels of adherence and family support in the examined population.An overview based on controlled clinical studies on the use of
antipsychotic drugs (
neuroleptics) in patients dependent on
opioids revealed no evidence of effectiveness of this approach. It was concluded that the use of
antipsychotics is justified only in the presence of co-morbid psychiatric problems in patients [7]. In a recent meta-analytic review on the use of atypical
antipsychotics for off-label indications (off-label), there was a lack of data to support the effectiveness of their use in
substance abuse [8, 9]. The effectiveness of
anticonvulsants in the treatment of
opioid dependence syndrome has not been proven.In connection with the above puzzling fact, for Russian standards of treatment (clinical guidelines) the level of credibility of the effectiveness of
antipsychotics and
antidepressants in treatment of
substance abuse is assessed as A or B. This paradox raises the question of the methodology for determining the level of credibility of evidence. It should be noted that Russian recommendations for inclusion of certain drugs and
therapies are based on sufficient consensus of experts rather than on the results of meta-analyses [2].
CONCLUSIONS: This fact casts doubt on credibility and validity of scientific recommendations. Thus, one may say that Russian addiction medicine is not based on evidence, which is, in our view, erroneous and may impair the quality of care.