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Valerian/Lemon Balm Combination Well-Tolerated in Clinical Study

Occasional or chronic insomnia is a widespread problem among Americans and Europeans. The National Institutes of Health estimates that as many as one-third of Americans suffer from some type of sleep disorder. Other estimates hold that up to 18 percent of Germans experience occasional sleep problems, and that at least 7 percent have frequent trouble falling asleep or staying asleep. Sedative herb formulas, including combinations of valerian (Valeriana officinalis L., Valerianaceae) and lemon balm (Melissa officinalis L., Lamiaceae), are widely used and have strong traditional reputations for efficacy and safety. However, few clinical studies have formally investigated their use. With that in mind, a team of Swiss investigators performed a randomized, double blind, placebo controlled clinical study designed to evaluate the effects of a valerian/lemon balm combination in healthy adults (Cerny et al., 1999).

The primary objective of this study was to assess tolerability and incidence of side effects; secondary parameters included assessments of sleep quality and well being. Study participants were 98 healthy volunteers who took either placebo or three tablets of the valerian/lemon balm formula one-half hour before bedtime. The test formula was a Swiss product containing 480 mg valerian dry extract (4.5:1) and 240 mg lemon balm dry extract (5:1) (Songha Night®, Pharmaton Natural Health Products of Bioggio/Lugano, Switzerland).

Presumably because the primary endpoint was safety, the researchers chose to investigate the effects of the formula in healthy adults who did not suffer from insomnia. Overall tolerability was rated as good by 93 percent of those in the valerian/lemon balm group and 91 percent of the placebo group. The incidence of mild adverse events was similar in the two treatment groups (29 percent in the valerian/lemon balm group and 28 percent in the placebo group). The most frequent of these were sleep disturbances and tiredness; no serious side effects were seen. Interestingly, although none of the study participants reported problems with insomnia, there was a much greater improvement in sleep quality in the group taking the herbal combination. Among those taking valerian/lemon balm, 33 percent reported an improvement in sleep quality, as compared with only 9 percent in the placebo group.

The authors noted, "…sleep quality improved significantly in subjects who received valerian/balm, which was surprising as only healthy volunteers not complaining of insomnia participated.…it would be interesting to see how effective this preparation would prove in patients suffering from insomnia, where major improvements may be expected." - Evelyn Leigh, HRF

[Cerny A, Schmid K. Tolerability and efficacy of valerian/lemon balm in healthy volunteers (a double-blind, placebo-controlled, multicentre study). Fitoterapia 1999; 70: 221-228.]

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