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Keywords:

  • functional fatigue;
  • quality of life;
  • new methodology;
  • individual fatigue score;
  • Pharmaton Capsules;
  • double-blind

Abstract

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 capsules 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 choose, from a pre-established list of 20 suggestions, the five items that best described his complaints. An individual Fatigue Score was calculated for each patient on the basis of the sum of the scores given by the 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 Scores at the end of the study showed a statistically significant difference in favour of the Pharmaton group. The global assessment of the efficacy of the treatment (given by the investigators and by the patients) demonstrated the superior effect of the Pharmaton capsules, whereas the global assessment of the tolerability showed no difference between the two treatments.

Pharmaton capsules proved their efficacy in improving the various complaints experienced by patients suffering from fatigue, with tolerability comparable to that of placebo.