BACKGROUND:
For
many years, clinical protocols for treatment of drug abuse patients and
treatment standards in Russian Federation were not grounded on the principles
of evidence-based medicine [1]. Recommendations for use of certain drugs were
not accompanied by any indication of the level of credibility of the evidence
supporting it. The appearance in 2014 of such indications in clinical
recommendations can be considered a significant step forward for the science of
addiction medicine [2].
OBJECTIVE:
To
compare Russian evidence and practice in addiction medicines with international
standards.
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]. Thirteen 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.
