Abstract:
A Pilot Study, placebo controlled, double blind randomized Clinical trial was conducted
among patients with symptomatic Benign Prostatic Hyperplasia (BPH) at Muhimbili
National Hospital from April 2006 to January 2007. The aim of the study was to
evaluate the efficacy, and safety of Prunus africana (also known as Pygeum
a,fricanum ) in the treatment of symptomatic Benign Prostatic Hyperplasia. The
main end points were improvement in the IPSS and the quality of life from the
baseline. Patient were divided into two groups in order to compare the drug to a
"placebo". Patients allocation to treatment and placebo were done by permuted blocks
randomization.
A total of 82 patients were emailed and followed for a perioc
patient was followed 4-weekly for a duration of 3 months. Four patients lost to follow
up and were excluded from the study and therefore analysis was done among 78
patients. Among patients who were lost to follow up 3 of them were in the placebo
group. The highest number of the patients 29(37.2 %), were in the mean age 65.5.
In the treatment group, there were 26(65.0%) patients who reported improvement in
IPSS from the baseline and 21(52.5%) patients reported improvement in quality of life.
IPSS from the baseline and 22 (57.9%) patients reported improvement in quality of
life. Among all patients, the proportion of patients who reported improvement in IPSS
in the treatment group was 26(48. I%) as compared to 28 (51 .9%) in the "placebo"
group; The difference was not statistically significant (95% C.I, P=0.47). There were
also no significant difference in proportion of patients with improvement in quality of
life between the treatment group 21(48.8%) as compared to 22 (51.2 % in the
"placebo" group (95% C.I, P=0.66).
No any adverse drug reaction were reported in either group and there were no
deaths reported. There were no significant difference in conversion rate to
surgical intervention in the treatment group 9 (52.9% ) patients as compared to 8
(47.I% ) patients in the placebo group ( 95% C.I, P=I.00). The reasons for
conversion to surgery were due to patients' desire and 7 patients complicated to
acute urinary retention. Among the patients who complicated to urinary retention
4(l0.5%) of them were in the treatment group.
Generally the trend of the results in this initial pilot phase of this study showed
