Efficacy and acceptability of tadenan (Pygeum africanum extract) in the treatment of benign prostatic hyperplasia (BPH): a multicentre trial in central Europe.

1998-01-01
Current medical research and opinion 14(3)
- J Breza
- O Dzurny
- A Borowka
- T Hanus
- R Petrik
- G Blane
- H Chadha-Boreham

PubMed: 9787978
DOI: 10.1185/03007999809113352

Study Design

Type: Clinical Trial
Sample size: n = 85
Population: 85 men aged 50-75 years with mild to moderate BPH
Methods: Open three-centre study, 2 weeks washout, 2 months treatment with Pygeum africanum extract 50 mg twice daily, 1 month follow-up
Blinding: Open-label
Duration: 2 months
Funding: Unclear

Pygeum africanum extract is available as Tadenan in many countries, including those in central and eastern Europe, for the treatment of mild to moderate BPH. Its efficacy and acceptability have been demonstrated in numerous open and placebo-controlled studies in large populations. The present open three-centre efficacy and safety study was conducted according to common protocol at urology clinics in the Czech and Slovak Republics and in Poland, in order to confirm the therapeutic profile of Pygeum africanum in conditions of daily practice, using International Prostate Symptom Score (IPSS) and flowmetry assessments. Men aged 50-75 years and in compliance with the selection criteria (including IPSS > or = 12, quality of life (QoL) score > or = 3, and maximum urinary flow < or = 15 ml/s) were first examined then recalled after two weeks during which no treatment was provided (washout and check of stability). If still compliant, they were entered at this point into a two-month period of treatment with Pygeum africanum extract 50 mg twice daily. There followed a further one-month period without treatment, the objective being to evaluate the persistence of any effects observed during the previous two months of Pygeum africanum administration. The primary efficacy parameter investigated was IPSS; the other efficacy parameters were QoL, nocturnal frequency, maximum urinary flow, average urinary flow, post-voiding residual volume and prostatic volume, after one and two months of Pygeum africanum treatment and one month after stopping treatment. A total of 85 patients were evenly distributed between the three centres and completed the entire study. At inclusion their mean IPSS was 16.17, QoL was 3.60 and nocturia was 2.6 times per night. The changes in subjective scores, IPSS and QoL after the two-month treatment period were highly statistically significant with mean improvements of 40% and 31%, respectively. Nocturnal frequency was reduced by 32% and the mean reduction was again highly statistically significant. Mean maximum urinary flow, average urinary flow and urine volume were also statistically significantly improved, but the modest improvement in post-voiding volume did not reach statistical significance. The improvements, which exceeded those observed with placebo in earlier studies, were maintained after one month without treatment indicating an interesting persistence of clinically useful activity. Prostatic volume and quality of sexual life remained unchanged throughout. No treatment-related adverse effects were observed. In conclusion, under conditions of daily practice, Pygeum africanum extract induces significant improvement in IPSS and uroflowmetry parameters. These positive effects are accompanied by a very satisfactory safety profile with the overall result of a substantial improvement in QoL.

Research Insights

Pygeum→Improved Average Urinary Flow
Mean maximum urinary flow, average urinary flow and urine volume were also statistically significantly improved
Effect
Beneficial
Effect size
Moderate
Dose
50 mg twice daily
Pygeum→Improved International Prostate Symptom Score
The improvements, which exceeded those observed with placebo in earlier studies, were maintained after one month without treatment indicating an interesting persistence of clinically useful activity.
Effect
Beneficial
Effect size
Moderate
Dose
50 mg twice daily
Pygeum→Improved Maximum Urinary Flow Rate
Mean maximum urinary flow, average urinary flow and urine volume were also statistically significantly improved
Effect
Beneficial
Effect size
Moderate
Dose
50 mg twice daily
Pygeum→Improved Quality of Life
The changes in subjective scores, IPSS and QoL after the two-month treatment period were highly statistically significant with mean improvements of 40% and 31%, respectively.
Effect
Beneficial
Effect size
Moderate
Dose
50 mg twice daily
Pygeum→Improved Quality of Life Score
The changes in subjective scores, IPSS and QoL after the two-month treatment period were highly statistically significant with mean improvements of 40% and 31%, respectively.
Effect
Beneficial
Effect size
Moderate
Dose
50 mg twice daily
Pygeum→Improved Quality of Sexual Life
Prostatic volume and quality of sexual life remained unchanged throughout.
Effect
Neutral
Effect size
Small
Dose
50 mg twice daily
Pygeum→Improved Urine Volume
Mean maximum urinary flow, average urinary flow and urine volume were also statistically significantly improved
Effect
Beneficial
Effect size
Small
Dose
50 mg twice daily
Pygeum→Reduced Nocturnal Frequency
Nocturnal frequency was reduced by 32% and the mean reduction was again highly statistically significant.
Effect
Beneficial
Effect size
Moderate
Dose
50 mg twice daily
Pygeum→Reduced Post-Voiding Residual Volume
the modest improvement in post-voiding volume did not reach statistical significance
Effect
Neutral
Effect size
Small
Dose
50 mg twice daily
Pygeum→Reduced Prostate Volume
Prostatic volume and quality of sexual life remained unchanged throughout.
Effect
Neutral
Effect size
Small
Dose
50 mg twice daily

Adverse Events Reported

Pygeum→Overall tolerability
No treatment-related adverse effects were observed.
Finding
Reported