Biloba Fails Erection Test
June 2, 1998. A double blind study of oral treatment with ginkgo
biloba extract for erectile dysfunction in men with suspected vascular-related
impotence has failed to find any striking benefits.
the start of the trial, 32 men received a standardized diagnostic work-up.
Then they were either given 240 mg of ginkgo biloba extract per day
Twenty-three patients took part in a 24-week
treatment cycle. Nine patients had dropped out. The researchers say:
"In contrast to an uncontrolled pilot study, a placebo-controlled,
double-blind evaluation could not prove any benefit from treatment with
oral Ginkgo biloba extract for patients with erectile dysfunction."
Michael H. Sohn et al: Randomized Placebo-Controlled Study on the
Effects of Oral Treatment with Ginkgo Biloba Extract in Patients with
Uro's Office, MUSE "Disappoints"
June 2, 1998. Published clinical trials of MUSE (Intraurethral
alprostadil) for treating erectile dysfunction (ED) show good results.
But a team of urologists decided to investigate further after seeing
disappointing results in their own clinical practice. They decided to
run their own trial.
OK for "Mild" ED
They recruited 115 male patients, all about
65 years old and all with a regular sexual partner. About half of the
patients were college-educated. On a scale of 1 to 10, they rated their
health at 8.1, but their sexual functioning at 3.5. Most of the men
had either had surgical treatment for prostate cancer or suffered from
The men received in-office treatment with increasing
doses of MUSE. After use, the men gave a self-rating on penile rigidity
from 1 to 5, plus a personal level of comfort rating. The ratings 4
and 5 were considered sufficient for intercourse. The patients also
received blood pressure checks at 15-minute intervals.
Peak rigidity was achieved at 30 minutes with
a score of 2.6 at 250 mcg, 2.4 at 500 mcg, and 2.9 at 1000 mcg. Only
27% of the patients achieved rigidity sufficient for intercourse despite
being challenged to the highest doses.
According to the researchers, discomfort was
maximal at 15 minutes with ratings of 3.5 (250 mcg), 3.7 (500 mcg),
and 4.2 (1000 mcg). Blood pressure decreased significantly at 15 and
30 minutes. Penile pain and burning were the most common adverse events.
At follow-up, according to the researchers only 18.6% of the patients
continued to use the system, while the majority chose alternate treatments.
The investigators concluded: "For a variety
of possible reasons efficacy in a controlled clinical trial has not
translated into clinical usefulness of the MUSE system for the majority
of our patients suffering from ED." Pat F. Fulgham et al, Disappointing
Results with Transurethral Alprostadil in Men with Erectile Dysfunction
(ED) in a Urology Practice Setting
How many physicians will prescribe Vasomax (oral phentolamine) now
that Viagra is widely available? In a recent study, out of 148 patients
who took 40 mg of oral phentolamine, 50 (34%) responded. Out of 145
patients on placebo, 30 (21%) responded.
Wins Over Placebo by 5 to 1
Vasomax, the researchers conclude, is safe and
effective for minimal erectile dysfunction. They also report that ten
percent of those who received the drug experienced side effects including
headache and facial flushing.
Of a total of 3,361 men who had severe erectile dysfunction (ED), 60%
involved males with organic ED, 15% had psychogenic problems, and 25%
had mixed difficulties. These men made up the population of patients
tested in a total of 10 separate studies whose results were then merged
for purposes of "meta-analysis."
The studies were double-blind, placebo-controlled,
fixed dose or flexible dose studies. Over an 8-week period, patients
took sildenafil or placebo, as needed, 1 hour prior to sexual activity.
The frequency of penetration and the frequency of maintained erections
was assessed at baseline and at week 8 using the 15-item self- administered
International Index of Erectile Function.
Responses were from 0 (did not attempt intercourse)
or 1 (almost never/never) to 5 (almost always/always). Severe ED was
defined as a baseline score of 0 or 1.
In this analysis, responders were defined as
patients who had a score greater than 4 or those whose final score increased
by greater than 1. Of 819 men on sildenafil, 377 (46%) had a score greater
than 4 on penetration and 393 (48%) had a score greater than 4 on maintaining
an erection. Placebo responders averaged 8%.
Responders who had a final score increase greater
than 1 averaged from 71% to 73%. According to the investigator, the
results of this meta-analysis of sildenafil at 50 and 100 mg doses show
it is effective in men with severe ED. Meta-Analysis of the Efficacy
of Sildenafil (ViagraTM) in the Treatment of Severe Erectile Dysfunction
August 6, 1998. Page modified December 26, 1998
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