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.
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.]