Complementary Therapies in Clinical Practice 19 (2013) 193e196
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Complementary Therapies in Clinical Practice
journal homepage: www.elsevier.com/locate/ctcp
Valerian/lemon balm use for sleep disorders during menopause
S. Taavoni a, b, N. Nazem ekbatani a, *, H. Haghani c
a
Nursing and Midwifery Faculty, Tehran University of Medical Sciences, Tehran 3751847417, Islamic Republic of Iran
Research Institute for Islamic & Complementary Medicine (RICM, TUMS), Tehran, Islamic Republic of Iran
c
Statistics Department, School of Management and Medical Information & Health Sciences, Tehran University of Medical Sciences, Tehran, Islamic Republic
of Iran
b
a b s t r a c t
Keywords:
Menopause
Sleep disorder
Valerian
The onset of Menopause in women is frequently associated with sleep disruption with hot flushes
intensifying problems. Thus the use of supplementary drugs to ameliorate these symptoms is of
significance.
Objectives: The purpose of this research was to determine whether valerian/lemon balm could assist by
enhancing sleep patterns in this client group.
Methods: 100 women aged 50e60 years who complained of sleep disorders were studied. Subjects were
selected randomly in a sampling method utilizing two groups of 50 people (intervention group with
valerian/lemon balm and placebo group). The Pittsburgh Sleep Quality Index (PSQI) was administered
pre and post-intervention.
Results: A significant difference was observed with reduced levels of sleep disorders amongst the
experimental group when compared to the placebo group.
Conclusion: Valerian/lemon balm may assist in reducing symptoms of sleep disorder during the
menopause.
Ó 2013 Elsevier Ltd. All rights reserved.
1. Introduction
For many women, the onset of Menopause and symptoms
associated with hormonal changes and cessation of ovulation can
affect quality of life and perceptions of health and well-being. This
in turn, can impact upon cultural and economic issues [1e4]. As
hormonal changes occur resulting in cessation of ovulation, a range
of symptoms may be experienced over considerable periods of
time. One prevailing issue is associated with sleep disruption. The
symptoms can range from slight discomfort to intensive and
disabling symptoms such as night hot flushes, insomnia and
intermittent sleep [2,5]. This issue has grown due to an aging
population [6,7]. Stacie et al. (2006) suggest symptoms associated
with the menopause is rising and it is estimated that by 2030,
associated menopausal symptoms may affect over a billion women,
increasing annually by approximately 47 million [8,9].
A range of tools have been proffered in order to enhance sleep
patterns in this client group. These include music therapy, healing
touch therapy, pacification, yoga and acupuncture [10]. However,
hormone therapy is commonly prescribed in the first instance [11].
* Corresponding author. Tel.: þ98 9329449056; fax: þ98 2166921228.
E-mail address: neda40012@gmail.com (N. Nazem ekbatani).
1744-3881/$ e see front matter Ó 2013 Elsevier Ltd. All rights reserved.
http://dx.doi.org/10.1016/j.ctcp.2013.07.002
Despite such an approach it has been suggested that many women
do not respond well to hormone therapy [2]. As a result, in the USA,
approximately 1.6 million women have used a supplementary
treatment, such as botanical plants, to reduce sleep problems [7].
Iran is a country offering as wealth of medical plants. At present
it is estimated to have two to three times more medical botanical
resources than Western Europe. Since ancient times, the value and
use of indigenous flora and fauna have been recognized [12]. One of
the oldest recorded plants associated with reducing sleep disorder
is valerian/lemon balm, which has been used for many centuries in
Egypt, Greece, China, and Europe [6,10,13].
Indeed, Donath et al. in Germany observed that valerian causes
improvement in the quality of sleep [14]. However, Balderer et al.
little or no significant differences between valerian consumption
and placebo influencing sleep. Interestingly, to date, there appear
few research studies on the efficiency of these treatments and there
is a need for further research [15]. Some studies, though have
attested to the use of lemon balm improving quality of sleep for
women undergoing the menopause [16]. Additionally, a study utilizing a botanical combination of valerian/lemon balm was
commenced in 2010 [17], whereby women aged between 50e60
years of age, experienced some form of sleep disorder [18]. The
outcome of this study may influence the management of sleep and
sleep patterns in this client group.
194
S. Taavoni et al. / Complementary Therapies in Clinical Practice 19 (2013) 193e196
2. Materials and methods
children, married children, and of individuals in a family). The
Pittsburgh Sleep Quality Index (PSQI) (5) questionnaire was also
completed to measure the status of sleep disorder experienced by
individuals during the previous month. The questionnaire consists
of seven measurements e general descriptions of individual sleep
quality and patterns, delay in sleep onset, sleep duration and
pattern as well as sleep disorders in the form of waking up during
the night, consumption of tranquilizers, and daily performance/
problems experienced as a result of lack of sleep. After final scoring,
an individual with a score of 5 or greater was considered to have a
sleep disorder. The validity and reliability of the PSQI have been
measured in various studies [18].
The PSQI was completed for 250 samples. 100 people with score
5 or greater were included in the study. Samples were randomly
divided into two groups of 50 comprising a test and control group.
Both groups were trained in how to take the capsules. The test
group received two Valerian/Lemon Balm capsules daily containing
160 mg of essence of Valerian officinalis and 80 mg of lemon balm.
The control (standard) group received a placebo capsules containing 50 mg starch to be taken in the same manner as the control
group. The research group was also unaware which capsules was
placebo or Valerian/lemon balm.
The study employed a triple blind approach whereby participants, investigator and statistician were blinded to subjects in the
placebo/experimental groups until data analysis was completed.
During the study, only the pharmacist knew the identity of each
type of capsule.
Consumption of capsules was also monitored each week
through telephone contact with the research units. Participants
who completed the study were offered breast cancer screening free
of charge. Despite the fact that it was known that the medicines do
This study employed clinical random testing compared to a
control group in order to study the effect of a botanical supplement
containing valerian/lemon balm on sleep patterns of menopausal
women between the ages of 50e60 years. The sampling method
consisted of two phases 1) non-random sample selection of centers.
2) Random sample allocation of subjects within each center.
Permission was obtained from selected centers between
September 2011 to March 2012 and patient histories were
undertaken.
Sample volume was estimated with a testing power of 80% and
Type 1 error rate of 5%, using a related formula at the rate of 100
people.
The study was approved by the Ethics Committee of Tehran
University of Medical Science (TUMS).
Individuals meeting the criteria for inclusion and who were
interested in participating in the study were placed on a research
list after obtaining their written agreement. Criteria identified:
minimum of one year from the date of last menstruation after the
start of natural menopause; no reported psychological or physical
disease; lack of drug, tobacco, and alcohol use. Exclusion criteria
included: psychological or physical illness resulting in sleeping
disorders; no previous consumption of valerian/lemon balm in the
previous month. All participants were informed that each participant would be randomly assigned to either the intervention or
control group.
The instruments employed in the research included a demographic data form of 11 questions (age, age of menopause, level
of education, employment status, economic condition, marital
status, age difference between partners, number pregnancies,
Table 1
Demographic characteristics.
Group
Age (y)
Menopause age (y)
Age difference with partner (y)
Marriage status
Number of pregnancies
Family size
Number of children
Number of married children
Education status
Occupation status
Economic status
50e52
53e55
56
40e44
45e49
50
0
1e4
5e9
10e14
Married
Single
1e2
3e5
>6
1e2
3e4
5
0e2
3e4
5e6
0e2
3e4
5
Illiterate
Primary school
Second school
Employed
Housewife
Good
Moderate
Bad
Valerian/lemon balm
Control
Valerian/lemon balm
Control
N
%
N
%
Mean SD
Mean SD
33
5
12
10
22
18
17
16
8
1
42
8
4
24
20
11
31
8
6
32
12
28
17
5
29
15
6
2
48
7
27
16
66
10
24
20
44
36
34
32
16
2
84
16
8/3
50
41/7
22
62
16
12
64
24
56
34
10
58
30
12
4
96
14
54
32
19
13
18
7
23
20
24
8
6
1
39
11
6
31
13
5
27
18
1
39
10
20
26
4
24
21
5
2
48
7
23
20
38
26
36
14
46
40
61/5
20/5
15/4
2/6
78
22
12
62
26
10
54
36
2
78
20
40
52
8
48
42
10
4
96
14
46
40
52/5 7/8
53/7 3/5
47/6 4/1
49/1 3/9
6/4 4/14
4/6 3/7
4/5 2.02
4/9 1.3
3/9 1/6
4/7 1/92
4/4 1/94
4/8 1/3
4/5 2/02
4/9 1/3
S. Taavoni et al. / Complementary Therapies in Clinical Practice 19 (2013) 193e196
Table 2
Frequency of sleep disorder score before intervention in two groups and test results.
Sleep score
5e9
10e14
>15
Mean SD
Analyze (t-Test)
Valerian/lemon balm
Placebo
N
N
%
4. Discussion
%
15
30
14
28
21
42
22
44
14
28
14
28
48/0 98/11
04/4 72/11
Df ¼ 98 F ¼ 18.68 p-value ¼ 0.01
3. Results
The average age of the experimental group was 52/5 7/8 and
53/7 3/5 in the control group with a menopausal onset age of 47/
6 4/1 and 49/1 3/9 respectively. Other features of the sample
descriptions are presented in Table 1.
The scores of menopausal women experiencing sleep disruption
associated with Menopause between the two groups before intervention were compared through independent sample t tests. No
significant difference (Table 2). The two groups were homogenous
from this perspective.
One month following consumption of the botanical supplement,
it was observed that 36% of the experimental group but only 8% of
the placebo group showed an improvement in the quality of their
sleep. Sleep disorder scores were found to have decreased by 5
points. This was determined to be statistically significant
(p ¼ 0.0001, Chi Square test).
Average scores of sleep disorders in the experimental group
prior to intervention was 11/98 0/48 competed to 6/5 0/409
post-intervention which was significant (p ¼ 0.0001, Paired t test).
Average scores pre-intervention in the control group was 11/72 4/
09, and 10/5 2/89 post-intervention representing statistical significance of (p ¼ 0.0001, Paired t test) (Tables 2 and 3).
Due to the potential impact of the placebo on perceptions of
sleep disorder, rates of difference of the effect of Valerian/Lemon
balm compared to the placebo was studied, indicating the a clear
effect of Valerian/Lemon balm on sleep disorder vs. placebo
(p ¼ 0.048, Independent t test). No negative effects were observed
Table 3
Frequency of sleep disorder score after intervention in two groups and test results.
0e4
5e9
10e14
>15
Mean SD
Analyze (t-Test)
during the study from consumption of medicine and after
completion of the study.
Group
not produce any serious side effects, participants were asked to
report any kind of problems to the researcher, and at any time, they
could discontinue consumption of the medicine or leave the study.
No reports of negative consequences were made during the study.
One month post-intervention, the Pittsburgh Sleep Quality Index (PSQI) (questionnaire) was completed by subjects and data
entered and analyzed by computer.
Descriptive and inferential statistics (Paired t test, independent
sample t test, and Chi Square test) were used to analyze data with
the help of 16 SPSS software.
Sleep score
195
This study sought to determine whether a botanical supplement
of valerian/lemon balm could assist in reducing symptoms of sleep
disorders in women undergoing menopause. Muller and Klement
(2006) showed that the consumption of a combination of valerian/
lemon balm is well tolerated [19]. The study reported upon in this
paper, replicated these findings. This may suggest that use of valerian/lemon balm may be better tolerated than many pharmaceutical
tranquilizers currently being prescribed for this client group [20].
In the present study, the consumption of the botanical supplement valerian/lemon balm demonstrated a significant difference
resulting in improved quality of sleep for this client group.
One study suggested that a treatment dose of (400e900) mg of
Valerian is required to reduce sleep disorders [15]. However, in the
present research, a lower dose of Valerian (160) mg in combination
with other medical plants was shown to be effective.
Faraj and Mills (2003) have also suggested that the rate of delay
in sleep onset was significantly reduced amongst consumers of a
botanical supplement. Additionally, significant differences were
observed in sleep duration (p ¼ 0.003). Our study replicates these
findings [21].
One of the limits of this research was being able to control individual’s activities prior to sleep, however participants were
instructed to avoid coffee and alcohol prior sleep.
5. Conclusion
The study demonstrates that Valerian/lemon balm can assist in
promoting sleep and quality of sleep for women experiencing sleep
disruption or symptoms of sleep disorder as they progress through
the Menopause. Furthermore, no adverse effects were reported.
This contrasts with noted side effects frequently associated with
prescribed hypnotics. It is suggested that Valerian/lemon balm
herbal supplements, as described in the study above, may assist in
enhancing sleep and in reducing sleep disorders frequently reported upon by women progressing through the menopauses. It is
recommended that further research in this field be undertaken as
well as investigating potentially other clinical fields where sleep
disruption adversely affects individual’s lives. Further study on
other botanical supplements is also recommended.
Author contributions
S.T. had a role in preparing the protocol of study, monitoring the
study. N. N. had a role in conducting the study and writing the
paper. H.H. had a role in data analyzing of study.
Conflict of interest statement
Not declared.
Acknowledgment
Group
Valerian/lemon balm
Placebo
N
%
N
15
24
11
0
409/0 6/5
Df ¼ 3 F ¼ 2.68
30
48
22
0
5
10
28
56
13
26
4
8
289/2 5/10
p-value ¼ 0.04
%
This article is the outcome of the research project approved by
Tehran University of Medical Science and Health Services under the
Contract No. 11933-28-04-89 dated on 18 January 2011, and hereby,
we would like to thank the concerned university. It is also our
pleasure to acknowledge the efforts made by the Health Network of
Shahr-e Qods for their cooperation with us in collecting samples
and would like to thank all the women who took part in this
research. It is worth mentioning that this project has been
196
S. Taavoni et al. / Complementary Therapies in Clinical Practice 19 (2013) 193e196
registered in The Center for International Registration of Clinical
Trials with Code Number IRCT201106302172N10.
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