Nurs Midwifery Stud. 2015 Jun; 4(2): e27001.
Published online 2015 Jun 27. doi: 10.17795/nmsjournal27001
PMCID: PMC4557408
1Department of Midwifery,
Maternal-Fetal Medicine Research Center, School of Nursing and
Midwifery, Shiraz University of Medical Sciences, Shiraz, IR Iran
2Department of Midwifery, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, IR Iran
3Department
of Midwifery, Community Based Psychiatric Care Research Center, School
of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz,
IR Iran
4Department of Pharmacology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, IR Iran
5Department of Nursing, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, IR Iran
6Department
of Biostatistics, School of Medicine, Infertility Research Center,
Shiraz University of Medical Sciences, Shiraz, IR Iran
Abstract
Background:
Several
studies are conducted on Premenstrual Syndrome (PMS). However, a few
herbal surveys exist on the treatment of PMS in Iran. Due to the
sedative effects of Melissa officinalis (M. officinalis), this question comes to mind that “can it be used in the treatment of PMS symptoms?”
Objectives:
The current study aimed to assess the effect of M. officinalis capsule on the intensity of PMS in high-school girls.
Materials and Methods:
A
double-blind randomized, placebo-controlled trial was performed on 100
high school girls from 2013 to 2014. The intervention group (n = 50)
received 1200 mg of M. officinalis essence daily from the first
to the last day of their menstrual cycle for three consecutive cycles.
The second group (n = 50) received the placebo. The premenstrual
symptoms screening tool was used to assess the intensity of PMS symptoms
in the two groups before and one, two, and three months after the
intervention. The data were analyzed using paired t-test and repeated
measures analysis of variance.
Results:
The
results of repeated measures test revealed a significant reduction (P
< 0.001) in PMS symptoms. Overall, the mean score of PMS intensity in
the intervention group was 42.56 + 15.73 before the intervention and
changed to 32.72 ± 13.24, 30.02 ± 12.08, and 13.90 ± 10.22 at the three
consecutive months after the intervention, respectively (P = 0.001).
Conclusions:
M. officinalis capsules were effective in reduction of the PMS symptoms. Yet, application of this medication requires further investigations.
Keywords: Melissa officinalis, Premenstrual Syndrome, School
1. Background
Premenstrual Syndrome (PMS) is one of the most common disorders among females before menopause (1).
PMS is defined as the periodical recurrence of a set of annoying
physical, psychological, and social symptoms in the luteal phase of
menstrual cycle. Females with severe emotional symptoms are considered
with premenstrual dysphoric disorder (2). Millions of females worldwide experience this disorder in their reproductive ages (3).
The relative prevalence rate of PMS and premenstrual dysphoric disorder
is reported to be between 98.5% and 2.8%, respectively (4). The prevalence of this syndrome varies from 60% to 80% in the Asian countries; 66.6% in Turkey (5), 76% in China (6), and 63.1% in Malaysia (7).
American College of Obstetrics and Gynecology (ACOG) reported the
prevalence of this syndrome 65.5%, with 8.75% of the patients requiring
specialized treatments (8).
In Iran, it is estimated that 98.2% of university female students
experience at least one of the PMS symptoms at age of 18 - 27 years old (9). Sometimes the physical and mental symptoms of PMS are so severe that need to be treated (10, 11).
The
etiology of PMS and dysphoric disorder are unknown, but they are
considered multi-factorial resulting from internal and external factors (12). Biological, physiological, environmental, and social factors are also reported to be involved in the disorder (13).
Although the causes of this disorder are still unknown, research
demonstrated that supportive strategies, such as writing the symptoms
down, might be beneficial in diagnosis and management of the disorder.
Moreover, changing lifestyle (healthy diet, vitamins, mineral
supplements, primrose oil, restricting use of sodium and caffeine,
reduction of stress, and doing sports) (2),
hormone therapy (estrogen, oral contraceptive pills, GnRH analogues,
danazol and progesterone), diuretics, anti-depressants, bromocriptine,
surgery, psychotherapy, and Serotonin Reuptake Inhibitors (SRIS) are
proposed as the first line treatments in this regard (14).
Besides, fluoxetine, paroxetine, and sertralin are reported to be
effective to control the symptoms. However, side effects of
pharmacological treatments are mentioned in some studies (15-19).
In
the past decades, complementary and alternative methods such as
homeopathy and herbal medicine were frequently used in alleviation of
the PMS (11, 20-23) symptoms. A study performed in Iran, investigated the effects of aquatic extract and essence of M. officinalis and reported that this plant has anti-depression and sedative effects (24). Melissa officinalis is a bushy, aromatic plant from the mint family labiatae. Although more than 100 chemical compounds have been identified in M. officinalis,
its main components include citral, linalool, geraniol, β-Caryophyllene
oxide, phenolic acid, tannins, rosmarinic acid and caffeic acid. Melissa officinalis can be effective to improve cognitive function and its effect is similar to that of triazolam (25, 26).
Several
studies are conducted on PMS in Iran. However, most of them focused on
the prevalence of premenstrual symptoms and dysphonic (27), types of symptoms (28), efficacy of stress management or counseling to reduce symptoms (29).
However, less attention is paid to treatment and a few herbal surveys
exist on the treatment of PMS in Iran. Nonetheless, due to the sedative
effects of M. officinalis, this question comes to mind that “can Melissa officinalis be used to treat PMS symptoms?
2. Objectives
The current study aimed to investigate the effect of M. officinalis
capsule, as a substitute for chemical medicines, on the intensity of
menstrual cycles in high-school girl students in Shiraz, Iran.
3. Materials and Methods
The
current double-blind randomized clinical trial was conducted on 100
high school girls during 2013 - 2014. Sample size was calculated based
on the results of a study that used Crocus sativus L. (saffron) to treat PMS (20).
Considering the effect size of 2 (reflecting the difference between the
two groups), Standard Deviation (SD) of 1.3, type I error probability
of 5%, power of 0.9, it was estimated that 42 subjects were needed in
each group. Yet, considering a possible attrition rate of 20%, 50
subjects were recruited in each group.
The study
subjects were selected through random cluster sampling. At first, under
the supervision of the department of education, four girl high schools
(including 800 students) were selected from the four educational
districts of Shiraz, Iran. Then, in each high school, the students with
symptoms of PMS were invited to take part in the study among which,
considering the inclusion criteria, 100 subjects were selected and then
randomly allocated into the intervention (n = 50) and the placebo groups
(n = 50).
The inclusion criteria were willing to
participate in the study, being a high school student, obtaining a score
< 23 from the General Health Questionnaire (GHQ), gaining a score
> 20 from the Premenstrual Syndrome Screening Tool (PSST), not using
vitamin supplements during the study, not having used hormonal drugs
such as oral contraceptive pills at least two months prior to the study,
length of menstrual cycle between 24 and 35 days, not suffering from
other diseases such as thyroid, diabetes and mental disorders. The
exclusion criteria were a decision to withdraw from the study, parents’
request for exclusion of their child from the study, experiencing a
stressful event such as death, marriage, or surgery during the study,
experiencing a change in the intervals of menstrual cycles for less than
24 and more than 35 days, and experiencing changes in the length of
menstrual cycles for less than three and more than seven days.
Melissa officinalis
capsules were made in the pharmacology department in the Shiraz Medical
School under the supervision of a professional counselor. Each capsule
of M. officinalis contained 600 mg of the essence. Moreover, the placebo was prepared from starch in capsules similar to M. officinalis.
To keep the study blind, the drug and placebo were marked with codes 1
and 2 and only the specialized consultant knew about the drugs. The
subjects were not aware of cods.
A self-report
questionnaire was designed consisting of demographic characteristics,
the GHQ-28 questionnaire, and the Premenstrual Syndrome Screening Tool
(PSST). The GHQ-28 was used to screen the subjects’ mental health. The
GHQ-28 consists of four subscales including somatic symptoms (items 1 -
7), anxiety/insomnia (items 8-14), social dysfunction (items 15 - 21)
and severe depression (items 22 - 28). All items are responded on a
4-point Likert scale of none, mild, moderate, and severe which are
scored from zero to three. The score 23 or above was the cut-off point
for probability of having a mental health disorder (30).
Accordingly, girls who obtained scores > 23 were excluded from the
study. The Farsi version of GHQ-28 questionnaire was validated by
Yaghoubi, as cited in Ozgoli et al. and its sensitivity and specificity
were calculated 86.5 and 82, respectively (31).
The
PSST consists of 19 items in three sections. The first and second
sections includes 14 items on physical, and psychological symptoms, and
the third section contains five items that assesse the effects of
symptoms on subject’s life (social symptoms) (32).
All items are responded on a four options Likert scale namely none,
mild, average, and severe, receiving a score from zero to three,
respectively. Thus, the minimum and maximum scores of the questionnaire
are 0 and 57. Scores ranging from 0 - 19, 20 - 38, and 39 - 57
represented mild, average, and severe conditions, respectively. The
subjects who gained scores > 20 were enrolled into the current study.
This scale was validated in Iran. The content validity ratio and
content validity index of this scale were obtained as 0.7, and 0.8,
respectively. Moreover, the reliability of the scale was confirmed by a
Cronbach’s alpha of 0.9 (8).
3.1. The Procedure
Subjects in the intervention group were required to consume 1200 mg M. officinalis
essence daily (two 600 mg capsules) from the first to the last day of
their menstrual cycle for three cycles. In the control group, the
subjects received the placebo in the same way as the intervention group.
The first researcher called the subjects in both groups at least 3 - 4
times to guide them and explain about consumption of the medication. All
subjects in the two groups were required to complete the PSST
questionnaire at the beginning of the study and then in three
consecutive months (three menstrual cycle).
3.2. Ethical Considerations
The
protocol of the study was approved by the Ethics Committee of Shiraz
University of Medical Sciences. Permissions were also received through
the authorities in the schools. Written informed consent letters were
obtained from all the subjects. They were all assured of the
confidentiality of their personal information. In order to prevent any
probable error, the completed questionnaires were encoded by the
researcher’s assistant. Moreover, subjects in the intervention group
were allowed to withdraw from the study at any time.
3.3. Data Analysis
Statistical
analysis was performed using the SPSS ver. 11.5. Paired t-test was used
to compare the changes of PMS scores in each group before and after the
intervention. Moreover, the repeated measures ANOVA was used to compare
the severity of symptoms in the two groups during the four subsequent
measurements.
4. Results
The
mean age of the participants was 16.2 ± 1.06 years in the intervention
group and 16.3 ± 0.66 years in the placebo group. The two groups were
homogeneous with respect to age (P = 0.32), education level (P = 0.83),
and Body Mass Index (BMI) (P = 0.42).
The results of
repeater measures ANOVA showed that the mean (SD) of symptoms in the
intervention group was 42.56 ± 15.73 before, 30.72 ± 13.24 one month
after, 30.2 ± 12.08 two months after, and 13.90 ± 10.22 three months
after the intervention, and the differences were statistically
significant (Table 1).
Comparison of Severity Symptoms of Premenstrual Syndrome in the Study Groups a
The
results of paired t-test showed that the intensity of physical symptoms
significantly decreased in the subjects who consumed the capsules of M. officinalis
(P < 0.001), but no significant difference was observed in the
placebo group in this regard. The results of the paired t-test also
indicated a significant decrease in psychological and social symptoms of
the subjects in the intervention group. However, no significant
difference was found in the control group in this respect (P < 0.001)
(Table 2).
Comparison of Physical, Psychological and Social Symptoms of
Premenstrual Syndrome in the Study Groups Before the Study and at the
End of Third Month a
5. Discussion
The
study results revealed a significant difference between the two groups
regarding the total intensity mean of physical, psychological and social
symptoms of PMS in the first, second and third months after the
intervention. The interaction between time and group was also
statistically significant. Of course, in the control group there was
also a decrease in the severity of symptoms. This finding might be
attributed to the psychological effect of the placebo.
No previous studies were available on the effect of M. officinalis
on the intensity of PMS; however, the effects of other herbal products
were investigated on anxiety, depression, sleep disorder, stress and
other symptoms of PMS (21, 22, 31, 33).
The results of these studies were consistent with those of the present
study. Moreover, Taiwo et al. investigated the effect of M. officinalis on mice and showed the positive psychoactive potentials of this herb (34). Another study indicated the effectiveness of M. officinalis in reduction of restlessness and insomnia in children (35). Another study also reported M. officinalis as a mediator of mood and cognitive function with anxiolytic effects (36). Melissa officinalis leaves have also been shown to have anxiolytic and spasmolytic properties (37).
The results of the above studies are similar to those of the current
study in reducing psychological symptoms and mood changes. PMS is a
multi-factorial disorder with unknown etiology (3). Still no blood or biochemical test is available to diagnose this disorder (38). The main mechanism of PMS is perhaps related to the level of serotonin (39).
Although there is no evidence in favor of hormonal disorders in this
syndrome, since its symptoms can begin at the beginning, middle, or end
of the luteal phase, it might be attributed to the progesterone produced
by ovaries. Overall, GABAergic and serotonergic neurotransmitter
systems and reduction of serotonin are involved in the occurrence of
these symptoms (40, 41). Some studies investigated the effects of herbs such as Crocus sativus (20) and Hypericum perforatum (21)
on the symptoms of PMS and reported that these herbs probably affected
the reduction of PMS symptoms through increasing the level of
circulating serotonin. Some studies also revealed that M. officinalis
can reduce the symptoms of PMS through GABA neurotransmitters
(Gamma-aminobutyric acid, GABAergic system). GABA neurotransmitters have
great inhibitory effects on the central nervous system and are
essential to create balance between nervous stimulation and suppression
in brain’s normal function. It is reported that the brain’s GABA levels
are highly associated with anxiety; in such a way that benzodiazepines
used as sedatives in the past decades imitate GABA. These medications
result in sedative and anxiolytic effects through binding to GABAergic
receptors and changing other neurotransmitters of brain, such as
norepinephrine and serotonin (42, 43).
Review
of the studies performed on treatment of PMS demonstrated that some of
the herbs could, to some extent, decrease the symptoms of this disorder.
However, which herb is more effective, efficient, and cost-effective,
and which mechanisms are involved in the effects yet remains to be
determined. Thus, further studies are recommended to compare other
plants to M. officinalis to confirm the results of the present study and find an answer to the above-mentioned questions.
One
of the limitations of the current study was its small sample size and
its implementation in high school girls. Moreover, the placebo group
also experienced some reductions in their symptoms that might be
attributed to the psychological effects of placebo. A self- report
questionnaire was used to assess the symptoms and this may affect the
students’ responses. Furthermore, the subjects of the present study were
at different stages of puberty and, consequently, did not experience
the changes related to this period similarly. Also, individual
differences in learning ability and interest might have affected the
participation in the adoption of plans. Therefore further studies with
larger sample size, among older females from different levels of the
community, and also studies without a placebo are suggested.
In conclusion, the results of the current study showed that M. officinalis
capsules were effective to reduce the intensity of PMS symptoms. Yet,
this plant is recommended to be compared to other herbal medicines and
its degree of effectiveness should be assessed up to several months
after the intervention.
Acknowledgments
This
article is a part of Mansooreh Dehghani thesis, (thesis number:
92-6805, IRCT: 2014060717998N1). Authors appreciate the support of
Research and Technology Department of Shiraz University of Medical
Sciences, Shiraz, Iran.
Footnotes
Authors’ Contributions:Marzieh
Akbarzadeh and Mansoore Dehghani: manuscript drafting; Marzieh
Akbarzadeh: critical revisions, corresponding author; Zeinab Moshfeghy:
in researching for articles, Pouran Tavakoli: education of psychology
topics; Masoumeh Emamghoreishi: supervision and guidance on doses and
the construction of Melissa officinalis and placebo capsules; Najaf
Zare: data analysis.
Financial Disclosure:There
are no conflicts of interest among the authors of the study. The
current study was financially supported by vice-chancellor of Shiraz
University of Medical Sciences, Shiraz, Iran.
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