CLINICAL STUDIES
Tabex was clinically tested on a large number of patients. Stoyanov S. and
Yanachkova M. studied 70 volunteers with a long experience in smoking and
found that 57% stopped smoking, in 31.4% the result was partial: reduction
of the cigarettes smoked from 20-30 to 3-4 a day. The results were
negative in about 11% of the patients, which is due to the premature
abandoning of the therapeutic course: before the 3rd day of treatment - a
period of time necessary to saturate the organism with cytisine. In a
second group of 17 smokers with serious psychic diseases (schizophrenia,
epilepsy and reactive psychosis), the administration of Tabex together
with neuroleptics, antidepressants and insulin led 5 patients to stop
smoking and induced significant decrease - in 7. Tabex does not interact
unfavorably with the drugs received by the mentioned groups of patients.
Vlaev S. et al. considers the possibility to control the depressive
symptoms in 5 patients with psychogenic and periodic depression, parallel
with the treatment of the pathologically fixed wish to smoke. Tabex was
applied in gradually increasing doses, the maximum daily dose being 15 mg
(5 tablets 3 times daily). The author has observed a rapid reduction of
the depressive symptoms, the improvement of the patients with reactive
depression being obtained at the end of the first week, in the patients
with periodic depression - by the end of the second week. The improvement
is particularly good with respect to the patients' activity, followed by
the mood and finally by the depressive mental symptoms. As a side effect,
the slight internal tension and a slight decrease of blood pressure are
pointed out. The antidepressive action of the drug is explained with the
increase of the catecholamine level, especially that of adrenaline, which
is reduced in depressive patients. The adrenostimulating effect of Tabex
has been well known for a long time, but its antidepressive activity is
reported by Antonov L. and V. Velkov in an experiment on laboratory rats
(by overcoming Persolt's test of immobility).
Fig. 4 Clinical testing of Tabex in smokers without concomitant bronchitis
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Dynamics of the effect of the treatment with TABEX in the
Friedrichsheim Hospital in Berlin, manifested as decrease of the number of
smokers who have given up smoking
The antidepressant action is confirmed by the exacerbation of the
schizophrenic psychosis in two patients who have received Tabex in a state
of remission. The effect resembles the picture of the application of the
antidepressant psychoforin of schizophrenic patients. These data are
confirmed by Stoyanov and Yanachkova in psychic patients. These authors
pointed out that the simple form of depression is appropriate for Tabex
treatment with very careful increase of the daily doses.
Paun D. and Franze J. from the Friedrichscheim Hospital in Berlin studied
the therapeutic effectiveness of Tabex in 266 smokers, by comparing it to
the effect obtained in 239 patients treated with placebo. The therapeutic
results were followed on the 4th, 8th, 13th and 26th week of Tabex
treatment. The patients with a serious intention to give up smoking have
priority. On the 8th week, 55% of the patients treated with Tabex gave up
smoking, this percentage decreasing to 26% at the end of the 26th week.
However, the recidivists in the main group reduced twice the number of
cigarettes smoked. The authors emphasize the statistically significant
very good effect in the group treated with Tabex, compared to the group
treated with placebo, and conclude that the drug may be successfully used
when the patient has a serious intention to give up smoking, especially
when the concomitant psychotherapeutic means cannot obtain such an effect.
The authors have also treated with Tabex 366 smokers with concomitant
bronchitis and 239 patients treated with placebo. After completin the full
treatment course (maximum duration 4 weeks), 55% of the patients gave up
smoking, while in the group with placebo there was an effect in only 34%.
Out of 230 smokers with chronic bronchitis (Berlin and Potsdam), treated
with Tabex, 85% gave up smoking by the end of the 4th week, after 8 weeks
- 66% and after 23 weeks - 46%. Almost all patients who had given up
smoking manifested subjective improvement of the bronchitic symptoms.
Fig. 5 Clinical testing of Tabex in smokers with chronic bronchitis
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Schmidt F. conducted volume testing of 14 preparations on 1975 smokers
by means of a double-blind placebo-controlled experiment. Tabex was given
to 181 patients. The results obtained show that patients treated with
Tabex have had optimum improvement. 103 patients (157%) gave up smoking,
after 3 months this percentage decreased to 38%. Tabex is followed by the
drugs niperli (54% and 48% respectively), atabaco (54% and 29%
respectively), citotal (50% and 36% respectively), unilobin, potassium
chloride, potassium granulate, potassium citrate, nicobrevin, targophagin,
etc. The volunteers received by mail instructions concerning the mode of
treatment, thus avoiding the influence of the extrapharmacological
factors, hence the results registered by the patients themselves in
inquiry forms are maximally reliable.
On the basis of the multi-center clinical-pharmacological studies, we can
make the following general conclusions concerning the therapeutic
effectiveness of Tabex:
- The drug was tested on 1045 volunteers and compared to 400 patients
treated with placebo and 1500 patients treated with other anti-smoking
drugs. The results obtained show that 55 to 76% of the patients
treated with Tabex gave up smoking. These generalized percentages from
different studies are statistically significant and are higher that
those of the other preparations compared.
- Tabex showed a good effect on the chronic pulmonary diseases
accompanying prolonged smoking, as well as on patients with psychic
diseases of a depressive nature.
- No serious side effects have been noticed by observing the cited
contraindications: severe hypertension and atherosclerosis.
- An improvement of the general state of the patients was observed due
to the discontinuation of the chronic intoxication with nicotine.
- An active approach is necessary in patients who have failed during the first course by repeating the treatment course at intervals of 4-5 months.