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

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224 ( ) A. Cerny, K. Schmid � Fitoterapia 70 1999 221�228 group was thus 360 mg valerian and 240 mg lemon balm. The treatment duration was 30 days. 2.5. Statistical methods Categorical data were analysed by using the � 2 test, continuous data were analysed by the Student’s t-test. P-values � 0.05 were considered significant. 3. Results 3.1. Subjects and treatment Ninety-eight healthy volunteers Ž 58 women and 40 men. were enrolled in this study Ž Table 1 . . Mean age of the volunteers in the valerian�lemon balm group was 33.4 Ž S.D. 12.5. years, mean age of the volunteers in the placebo group was 34.8 Ž S.D. 11.7. years. By 2:1 randomisation, 66 were allocated to the valerian�lemon balm group, and 32 to the placebo group. All participants were included in the tolerability evaluation: 97% of the valerian�lemon balm group and 94% of the placebo group showed good�acceptable compliance. One volunteer in the placebo group stopped taking the medication early because of nausea and insomnia, which was considered drug-related. Two volunteers in the valerian�lemon balm group discontinued because of lacking efficacy, and nausea and sleep disturbances, respectively. 3.2. Tolerability rating The overall tolerability was rated on a 5-point rating-scale by questioning the volunteers after 30 days of treatment. In general, the preparation was very well tolerated Ž Fig. 1 . : 97.0% of participants in the valerian�lemon balm group and 96.9% of participants in the placebo group reported acceptable to excellent tolerability. Only 3.0% and 3.1%, respectively, of the volunteers considered the Table 1 Synopsis: demographic data Ž Mean, S.D. . Volunteers Valerian� Placebo lemon balm Total 66 32 Females 38 20 Males 28 12 Mean age Ž years. 33.4 Ž 12.5. 34.8 Ž 11.7. Mean weight Ž kg. 66.8 Ž 11.8. 65.6 Ž 9.3. Mean height Ž cm. 173.0 Ž 10.5. 170.8 Ž 9.0.
( ) 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 . .
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Tolerability and efficacy of valerianrlemon ž balm in ... - Nutraxin

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