Tabex Cytisine 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

Fig. 4 Clinical testing of Tabex in smokers without concomitant bronchitis

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.

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

Fig. 5 Clinical testing of Tabex in smokers with chronic bronchitis

Dynamics of the effect of the treatment with Tabex in a risk group of smokers (with diagnosed chronic bronchitis) in Berlin and Potsdam

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:

  1. 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.
  2. 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.
  3. No serious side effects have been noticed by observing the cited contraindications: severe hypertension and atherosclerosis.
  4. An improvement of the general state of the patients was observed due to the discontinuation of the chronic intoxication with nicotine.
  5. 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.
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