Tolerability and efficacy of valerianrlemon ž balm in ... - Nutraxin

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A. Cerny, K. Schmid � Fitoterapia 70 1999 221�228 225
Fig. 1. Rating of tolerability after 30 days of treatment valerian�lemon balm vs. placebo.
overall tolerability as unsatisfactory. There was no statistically significant differ-
Ž .
ence in tolerability between the two treatment groups P � 0.76 .
3.3. Ad�erse e�ents
Twenty-eight Ž 28.6% . volunteers reported adverse events. The proportion of
volunteers reporting adverse events was similar in both treatment groups: 28.8% in
the valerian�lemon balm group and 28.1% in the placebo group. Sleep disturbances
and tiredness were the two most frequent adverse events. Their frequencies
were similar in the two treatment groups valerian�lemon balm vs. placebo Ž12%
vs.
13% . and Ž 11% vs. 13% . , respectively. No severe adverse events were reported
during this study.
3.4. Laboratory tests and physical examination
The mean values of blood pressure, pulse rate, body weight and laboratory test
results at the beginning and the end of the study did not change throughout the
study and there were no statistically significant differences between the two
treatment groups Ž Table 2 . .
3.5. Sleep quality
When questioned during the second visit 33.3% of the volunteers in the
valerian�lemon balm group and 9.4% in the placebo group reported an improvement
in sleep quality Ž P � 0.04. Ž Fig. 2 . . This, however, was not reflected by the
analysis of the results from the visual analogue scale of sleep quality Ž 0�100 mm . .
It revealed only a slight but not statistically significant improvement in sleep
quality in both treatment groups over the 30 days treatment period, valerian�lemon
balm from 74 mm Ž S.D. 23. to 76 mm Ž S.D. 23. and placebo from 77 mm Ž S.D. 19.
to 79 mm Ž S.D. 19 . .