M. Legal et al., PHARMATON CAPSULES IN THE TREATMENT OF FUNCTIONAL FATIGUE - A DOUBLE-BLIND-STUDY VERSUS PLACEBO EVALUATED BY A NEW METHODOLOGY, PTR. Phytotherapy research, 10(1), 1996, pp. 49-53
A new method for the evaluation of the complaints reported by patients
suffering from functional fatigue was investigated in the course of a
multicentre, comparative, double-blind, clinical study of Pharmaton C
apsules versus placebo in a total of 232 patients aged between 25 and
60 years. The principle of the study was to allow the patient to choos
e, from a pre-established list of 20 suggestions, the five items that
best described his complaints. An individual Fatigue Score was calcula
ted for each patient on the basis of the sum of the scores given by th
e patient for each of the five items selected (each item was evaluated
according to a 4-point time scale). This score was calculated on day
0 and after 21 and 42 days treatment. The analysis of the Fatigue Scor
es at the end of the study showed a statistically significant differen
ce in favour of the Pharmaton group. The global assessment of the effi
cacy of the treatment (given by the investigators and by the patients)
demonstrated the superior effect of the Pharmaton Capsules, whereas t
he global assessment of the tolerability showed no difference between
the two treatments. Pharmaton Capsules proved their efficacy in improv
ing the various complaints experienced by patients suffering from fati
gue, with tolerability comparable to that of placebo.