A double-blind crossover trial of methandienone (Dianabol, CIBA) in moderate dosage on highly trained experienced athletes.

A double-blind crossover trial of methandienone (Dianabol, CIBA) in moderate dosage on highly trained experienced athletes.

D. L. Freed and A. J. Banks

Br J Sports Med. 1975 July; 9(2): 78–81.

Orally-active anabolic steroids have been used since the
early 1960's for body-building and athletic purposes; in
particular for weight-lifting and other "heavy" events,
but also for the "explosive" events such as long-jump
and sprint.
Objective evidence of their efficacy and safety is
sparse and contradictory,(Fowler et al., 1965,Johnson
et al., 1969, O'Shea 1971, Casner et al., 1971, Johnson
et al., 1972) and there is a considerable placebo effect,
(Ariel and Saville, 1972). Against this background we
designed a double-blind crossover trial using methandienone
(Dianabol) in doses of 10 mg/day or 25
mg/day, using only highly-trained male athletes as our
subjects. We thus hoped to resolve the controversy in
the literature, and find clear answers to the two crucial
questions:
a) do anabolic steroids benefit athletic performance?
b) what are their side-effects in this situation?

The trial lasted twelve weeks for each man, steroidand placebo being given in random order for six weeks
each. Before the trial began, and at fortnightly intervals
throughout it, the following measurements were made:
1) Strength (measured either as percentage improvement
over pre-trial performance (Fig. 1) or as percentage
improvement over performance at previous
visit (Fig. 2))
2) Body weight
3) Skinfold thickness
4) Blood pressure
5) Cholesterol and alanine transaminase (SGPT)

General health was assessed by clinical interview and
examination and any side-effects were noted. The subjects
pursued their regular training routine throughout.
As each man approached the end of the trial and before
the code was broken, he was challenged to predict the
sequence of placebo and steroid in his case.

Results

Thirteen men took part, of whom only five furnished
complete records for analysis. The remainder
either defaulted from their placebo period or withdrew
during the steroid period because of side-effects.
In spite of this incompleteness, it is possible to
calculate an average percentage improvement for both
placebo and steroid, using the data in Figure 2. There
are eight sets of "placebo" results and ten sets of
"steroid" results. The former show improvements of 0
- 2.3% and the latter show improvements of 0.3 -
13.0%. The difference is significant at the 1% level.
After stopping the steroid, the three men who continued
into their placebo period showed maintained or
even continued improvement.
Body weight rose significantly while on methandienone
(p < 0.001). In contradistinction to strength,
the weight fell rapidly back to pre-trial levels on stopping
the steroid. No change in skinfold thickness was
seen at any time, so it would seem that the increase in
weight is more likely due to water retention than to
increased muscle bulk.
Blood pressure rose slightly while on methandienone
(Fig. 3). The rise is significant for the systolic pressures                                                         at the 5% level, but not the diastolic.
Cholesterol levels showed a slight tendency to rise
throughout the trial period, irrespective of which order
the tablets were given. This is perhaps explicable when
we remember that meat and milk form a large part of
athletes' diets, and no attempt was made to control
recent food intake when the blood samples were taken.

The SGPT level remained as a rule within normal
limits, but in two cases was seen to rise; once to 35
units/mi. (treatment was continued and the SGPT returned
to normal) and once to 75 units/mi (treatment
was stopped, and the level returned to normal).
Other side-effects (Table) included acne, headache,                                                          dizziness and nausea, and one case of greatly raised
blood pressure (150/110) associated with fainting
during lifting. This last occurred in a man who had
shown a gradual tendency to rising blood pressure
while on methandienone (from 125/85 to 130/105),
and after this episode he withdrew from the trial.
All side-effects disappeared within two weeks of
stopping the methandienone; none was seen during
placebo treatment.
All thirteen correctly discerned which tablets contained
steroid and which placebo. None of the effects
of methandienone seen in this trial was dose dependent.

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