The preparation, Epilobium Capsules, contains:
1 capsule: Phytosterols, predominantly B sitosterols 10mg.
Extractum Herba Epilobii sicc. 200mg
The preparation contains the active ingredients derived from small flowered types of willow herbs in the form of a siccum extract. This, in turn, contains a generous amount of tannins as well as flavonoids (Kampferol-Quesritin-Myricetin-Glycosides) and tripertone acids. In addition, 10mg per capsule of the purified active ingredient in the sitosterols, mainly beta sitosterol, was derived from plants, and beta sitosterol-B-D-Glocoside (Sitosterolin) was added. Thus, the preparation is a combination of exclusively plant-derived ingredients and comes in the form of a mixture of extract and nearly pure active ingredient.
The sitosterols present in the plant are a mixture of alpha sitosterol, beta sitosterol and sitosterolin. It is primarily the beta sitosterol that has pharmacological/toxicological significance; it is responsible for the effectiveness and clinical relevance of the preparation. Since the seventies, beta sitosterol has been considered a potent candidate for influencing the prostaglandinmetabolism. With respect to this, test have been conducted in the infectios/rheumatic area and, finally, with the benign prostate adenoma. The data provided indications for the following:
-Benign prostate adenoma
While surgery is still the most prevalent therapy for the prostata adenoma, the conservative therapy is increasingly applied in order to prevent needless operations, reduce postoperative complaints and make the patient largely free of complaints. Based on this, the clinical tests under consideration herein result in the indication areas shown. Treatment with preparations containing beta sitosterols was applied to:
-Prostata Adenoma n=19,536
-Adjuvant postoperative therapy n=30
-Combination Prostatitis and adenoma n=1,577
-Urethritis, cystitis, irritable bladder n=30
-Impotentia Coeundi n=110
Out of the total number of these patients, six thousand were tested with the preparation EPILOBIUM CAPSULES. These tests consist of 2 controlled blind studies, 1 controlled open study, and 10 uncontrolled studies. Altogether, these studies extended over a period of 12 to 15 years.
- Regarding Effectiveness: The clinical tests at hand include numerous reports of beneficial results. Average reduction in miction frequency was 20%, while 73% of the patient had fewer dysuric complaints. Due to the therapy, the after-dribbling complaints stopped in as many as 65% of the patients, and there were global improvements in up to 89%. These test results are verified by the function tests in which the uro-flow measurements play a prominent role; in most studies, they reveal an increase in volume/second or a respective decrease in miction time. The improvements of p<0.001 are significant. As for the residual urine measurements, various degrees of improvements were achieved, depending of starting values. Here too the reduction of residual urine was significant in some cases, namely p<0.05.
- Regarding Toleration: The effective ingredient beta sitosterol seems to be highly tolerable. According to the toxicological tests, the LD 50 was found to 3g/kg of body weight. Of the 24,755 patients that were evaluated, only 258 experienced andy side effects; this is equal to 1.04%.
The preparation EPILOBIUM CAPSULES was subjects to a partially controlled blind human study during which its effect and effectiveness were established for the indications: benign prostata adenoma, prostatitis, urethritis and cystitis. The results were documented through progress control, objective and subjective symptoms as well as function tests. These results are verified by the extensive tests with other beta sitosterol containing preparations for the same indications. A total of more than 20,000 patients were treated. Having an LD 50 > 3g/kg of body weight mouse, the preparation is not toxic and has broad therapeutic applications. The suggested dosage of 3×2 capsules initially or 3×1 capsules over an extended period of time is customary and has been tested for similar preparations. A combination of beta sitosterol with other plant-derived, active ingredients rounds out the spectrum of effectiveness. The preparation is perfectly suitable as a meaningful contribution to the therapy for the above indications.