Report about the use of Bioprost by patients with benign prostatic hyperplasia

REPORT

ABOUT THE CLINICAL APPLICATION OF Bioprost® MANUFACTURED BY Intelpharm® WITH PATIENTS HAVING BENIGN PROSTATIC HYPERPLASIA

The Subject of the study is the patients with benign prostatic hyperplasia.

The goal of the present trial is to study the efficacy and safety of Bioprost®, manufactured by ZAO Intelpharm®, in the treatment of benign prostatic hyperplasia, to determine the therapeutic activity, possibility and efficacy of the clinical application of the medicine.

INTRODUCTION

Benign prostatic hyperplasia is a wide-spread disease among men of any age. In 80% of cases benign prostatic hyperplasia is accompanied by non-specific chronic prostatitis, which exacerbates the major disease. Despite the introduction of new medicinal preparations (anti-bacterial medicines, alpha-blockers, 5-alpha-reductase inhibitors , phytopharmaceutical medicines) into clinical practice, the problem of benign prostatic hyperplasia has not been yet solved and remains an urgent task for modern urology. Consequently, along with anti-bacterial medicines, phytopharmaceutical medicines are gaining more and more currency. Clinical trials must be held to assess their efficacy and safety before introduction of these medicines into clinical practice.

The new medicine Bioprost® has the form of rectal suppositories containing 0.5 g of pumpkin seed oil and 0.1 g of thymic acid and up to 2 g of lipophilic base. It is offered for the treatment of non-specific chronic prostatitis, as well as benign prostatic hyperplasia. Bioprost® was developed and manufactured by the Intelpharm® Group of Companies. It meets the medicine requirements (r.003058/01). License No. 64/0363-Л/04 issued on 24.05.2004 by the Ministry of Industrial science and Technologies.

Bioprost® contains pumpkin seed oil, uniquely extracted with the technology which allows retaining the natural complex of biologically active substances (tocopherols, phytosterins, carotenoids, phospholipids, unsaturated fat acids etc.) and a number of active microelements (zinc, copper etc.). The medicine constituents’ efficacy is enhanced by the anti-inflammatory and anti-bacterium activity of thymic acid.

Biologically active constituents of pumpkin seed oil - tocopherols and carotenoids - have an explicit antioxidant effect. Phytosterins have an anti-inflammatory effect while phospholipids help restore the structure and functions of cell membranes of the prostate gland. Unsaturated fat acids participate in the lipidic exchange and pumpkin seed oil corrects proliferation of the prostate gland cells.

The application of the presently manufactured Russian medicine Bioprost® for internal use showed its sufficient efficacy against chronic prostatitis and early stages of benign prostatic hyperplasia. Thymic acid has an explicit anti-inflammatory effect. The rectal method of administration is preferable because it provides delivery of the medicine to blood passing the liver barrier which allows a quick therapeutic effect and excludes inactivation of the medicine by the digestive juice and liver. It leads to a higher concentration of the substance in the secret and tissue of the prostate gland.

THE BODY

25 male participants with benign prostatic hyperplasia took part in the study.

50 packs of Bioprost® were used for the study.

The criteria for the participants were as follows:

• Age from 54 to 69
• Benign prostatic hyperplasia accompanied by non-specific chronic prostatitis in subacute and latent phase.

At this stage of the trials patients having benign prostatic hyperplasia accompanied by non-specific chronic prostatitis in subacute and latent phase were involved. The patients were made aware of the goals of the trials, conditions of the trial, their rights and protection. During the screening of the primary data of the patients, their age, the duration of the disease, previous treatment, the degree of the inflammation, and other factors. As the result of the integrated diagnostics, the patients were interviewed, underwent IPSS, digital rectal examination, prostatic secretion analyses, analysis of the 3d portion of urine, uroflowmetry, USI of the prostate, PSA, general and biochemical blood and urine analyses. The groups were randomized according to the patients’ age and activity of inflammation.

25 male patients with benign prostatic hyperplasia combined with non-specific chronic prostatitis took part in the trial. All the patients were diagnosed with non-specific chronic prostatitis in the subacute and latent phase, confirmed by USI, uroflowmetry, bacteriological analyses, PSA, clinical and laboratory data. The USI diagnosed benign prostatic hyperplasia of 20 to 35 cm3, at the general volume of the prostate of 50 to 72 cm3 as well as the prostate edema with all the patients. It is necessary to note that all the patients took alpha-blockers in therapeutic doses, all of them though had a consequent irritation.

During the second stage all the patients received an integrated treatment which included Bioprost®. The duration of the treatment course was 10 days, 1 suppository 2 times a day rectally. All the patients with the exacerbation of chronic prostatitis, confirmed by clinical and laboratory data, received a course of anti-bacterial therapy with “Doxycycline” of 100 mg 2 times a day.

After the end of the therapy a check examination of the patients took place. The results of the trial showed that before the treatment all the men had complaints typical of patients with benign prostatic hyperplasia combined with non-specific chronic prostatitis: frequent painful urination with a decreased force of the urinary stream, night pollakiuria 2-3 times a night, a sense of incomplete voiding, periodic pains in the perineum. Sponginess of the prostate gland, flattening of the interlobar groove, pain were registered as well as inhomogeneity of structure and edema (registered by USI). The examination of the prostatic secretion showed the decrease of the number of the lecithin grains, and the increase of leucocytes (from 10 to 60 in vision). The bacteriology study of the 3 portion urine showed microflora in the titer of 10000 to 100000 КОЕml with 26 patients with the following kinds of agents: Е. coli, Staph. spp., Staph. epidermidis. All the microorganisms were sensible to “Doxycycline”. The uroflowmetry was registered at the rate of О max 12.3±2.3 mlsec.

The clinical investigation of the general blood and urine analysis no reliable changes were registered. The investigation of biochemical parameters of blood no disorders were registered on the part of the protein, lipidic, or carbohydrate metabolism.

The results showed that 23 patients had lessening of dysuria. The check USI showed positive dynamics, the prostate’s volume decreased, the edema disappeared. The check uroflowmetry showed that the speed of urination increased up to 15,2±1,8 mlsec. The check bacteriological investigation of the prostatic secret after taking “Doxycycline” and Bioprost® showed the absence of the agent with 22 patients.

The digital rectal examination showed the reduction of the edema and absence of pain. The analysis of the prostatic secret after the treatment showed the decrease of leucocytes’ number and the increase of the number of the lecithin grains with 23 patients. 2 patients didn’t have any explicit dynamics.

The safety and tolerance assessment didn’t show a single topical change of the skin or the mucous coating. The medicine proved well-tolerated in all cases. No undesirable consequences took place.

CONCLUSION

As the result of the trial we must note that the use of Bioprost® with patients with benign prostatic hyperplasia combined with non-specific chronic prostatitis is pathogenically reasonable, expedient, safe and effective in the post-surgical period. The results of the treatment were reduction of the inflammatory reaction of the prostatic tissue, improvement of objective and subjective symptoms. The application of the medicine doesn’t cause any undesirable consequences, is well-tolerable, convenient and user-friendly. The medicine can be recommended for patients with benign prostatic hyperplasia combined with non-specific chronic prostatitis.