Complementary Therapies in Medicine (2014) 22, 601—606

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Effect of Royal Jelly on premenstrual

syndrome among Iranian medical sciences
students: A randomized, triple-blind,
placebo-controlled study
Simin Taavoni a,b,c, Fatemeh Barkhordari b,∗, Ashrafeddin
Goushegir a,c, Hamid Haghani a

a
Iran University of Medical Sciences (IUMS), Tehran, Iran
b
Tehran University of Medical Sciences (TUMS), Tehran, Iran
c
Research Institute for Islamic & Complementary Medicine (RICM, IUMS), Tehran, Iran
Available online 13 May 2014

KEYWORDS Summary
Background: Premenstrual syndrome (PMS) may have negative effects on women’s health and
Royal Jelly;
sometimes need therapeutic non-pharmacological management.
Premenstrual
Objectives: To determine the effect of oral consumption of 1000 mg Royal Jelly capsule on
syndrome (PMS);
premenstrual syndrome.
Premenstrual Profile
Method: This is a randomized, triple-blind, placebo-controlled clinical trial, which was con-
2005
ducted in Tehran University of Medical Sciences female dormitories between December 2011
and October 2012. The study population comprised 110 medical sciences student with PMS,
whom were randomly assigned to an intervention or a control group. Each participant in the
intervention group took one Royal jelly capsule orally per day, starting on the first day of
menstruation and continued the same treatment daily throughout two consecutive menstrual
cycles, while participants in the intervention group took placebo capsules as same method.
The outcome measure in this study was PMS score as obtained through the Premenstrual Profile
2005.
Results: The mean of personal characteristics and baseline level of the premenstrual score
before intervention did not differ between groups. After two consecutive months consumption
of Royal Jelly, PMS score had decreased from 23.17 ± 17.43 to 11.42 ± 14.58 (mean change:
11.75; 95% confidence interval [CI]: 8.31—15.19) and in Placebo, PMS score changed from
21.48 ± 16.39 to 20.27 ± 15.76 (mean change: 1.20; 95% CI: −1.69 to 4.10). Also difference
between mean changes was significant (mean difference: 10.54; 95% CI: 6.10—14.98).

∗
Corresponding author. Tel.: +98 9124103935.
E-mail addresses: staavoni14@yahoo.com (S. Taavoni), barkhordari.f.sh@gmail.com (F. Barkhordari), sidagoush@yahoo.com
(A. Goushegir), haghani511@yahoo.com (H. Haghani).

http://dx.doi.org/10.1016/j.ctim.2014.05.004
0965-2299/© 2014 Published by Elsevier Ltd.
602
Conclusions: The results of the study have demonstrated that 2 months consumption of Royal
Jelly was effective in reducing PMS.
© 2014 Published by Elsevier Ltd.
Introduction
Premenstrual syndrome (PMS), which is a common disorder
among women during their reproductive years are charac-
terized by a range of cyclical physical and psychological
symptoms experienced during the premenstrual period1,2
Such as irritability, tension, fatigue, breast tenderness and
bloating.2 Also PMS could effect on family relationship,
social and work behavior.3
Symptoms and discomfort level vary from one to another,
vary from month to month and there may even be symptom-
free months, also each woman reporting her own unique
syndrome1 and for some women, PMS may last until
the menopause.4 The causes of the PMS have not been
clearly elucidated5 but have been attributed to hormonal
change, neurotransmitters, prostaglandins, diet, drugs, and
lifestyle, so causal treatment is difficult.6 Although surveys
have suggested that between 30% and 80% of women report
PMS,7 in Iranian university students and at least with one
mild to severe PMS, PMS had been reported up to 98.2%.8
Many trials have been carried out to verify the effec-
tiveness of different interventions for the treatment of
PMS. Therapeutic interventions for PMS vary from non-
pharmacological management to psychotropic medications
and hormonal therapy.9 Regarding to variation of beliefs,
there are some interest to use of non-pharmacological
and complementary therapy, whereas others are reluc-
tant to use of them,10 since there has been considerable
public interest in the use of complementary and/or alterna-
tive products11—13 and many reproductive-aged women are
turning to natural alternatives, such as non-pharmacologic
therapies, which may be attempted before prescribing med-
ication include aerobic exercise, nutritional supplements,
dietary adjustments, and psychological therapy.12,13 It is
clear that any healthcare intervention should be safe for
short- and long-term use and free from any side effects14 ;
therefore, nutritional supplement and herbal companies
should guarantee quality of their products.15 Referring to
mentioned it is necessary to pay more attention to honey,
which is well known in many cultures of the world, honey
has long been used as a medicine16,17 and Royal Jelly,
which is one of nutritional supplements18 and a viscous
substance secreted by the hypo pharyngeal and mandibu-
lar glands of worker honey bees as an essential food for
the queen bee larva and the queen herself. Royal Jelly
contains a considerable amount of proteins (12—15%), free
amino acids, lipids (3—7%), sugars (10—12%), and vitamins
of very high biologic value,19,20 and Royal Jelly has been
demonstrated to possess numerous functional properties
such as antibacterial activity, anti-inflammatory activity,
vasodilative and hypotensive activities, disinfectant action,
antioxidant activity, antihypercholesterolemic activity, anti-
tumor activity, and estrogenic activities.18,21—23 Biological
activities of Royal Jelly are mainly attributed to the bioac-
tive fatty acids, proteins and phenolic compounds.23 Royal
S. Taavoni et al.
Jelly is also widely used in commercial medical products,
healthy foods and cosmetics in many count.ries,18,23 with
minimal risk of side effects.24 In two studies mixture of
Royal Jelly, Pollen and Pistil extract had effect on those
suffering from premenstrual syndrome and menopausal
symptoms.24,25 On the other hand another study showed that
Royal Jelly has no beneficial effect on the severity of PMS26
but little effects on human beings have been objectively
shown, also no study published in the field of Royal Jelly
and PMS in Iran. Referring to all mentioned, objective of
this study was to determine the effect of Royal Jelly on PMS
among Iranian University students.
Materials and methods
This study is a randomized, triple-blind, placebo-controlled
trial. All the participants and investigator as well as statis-
tician were blind to the study groups until the analysis was
completed. The objective of study was to determine the
effect of Royal Jelly on PMS of Iranian Medical Sciences Stu-
dents, who live in dorms of Tehran University of Medical
Sciences. Of 289 female students, whom underwent pre-
liminary screening for inclusion in the trial, then 110 were
recruited and finally 92 completed the protocol and were
included in the analysis. The numbers of withdrawals are
shown in Fig. 1, by using flow chart model of CONSORT
2010.27 All the participants were volunteers, received infor-
mation about the objective and method, and then signed in
informed consent. In this study all ethical points had been
considered and approved by the Ethics Committee of Tehran
University of Medical Sciences, also had been registered in
Iranian Registry of Clinical Trial, which is Primary Registry in
the WHO Registry Network set up with the help from the Min-
istry of Health and Medical Education (MOHME) and hosted
by Tehran University of Medical Sciences (TUMS).
The inclusion criteria were as follows: age ‘‘between
18 and 35’’, not suffering from any systemic or genital
diseases, regular menstrual cycles, have not been using anal-
gesics or any kind of medication to overcome symptoms,
diagnosis of PMS according to accepted criteria in the ini-
tial screening questionnaire and daily rating of symptoms
severity using Premenstrual Profile 2005 questionnaire.28
The exclusion criteria were as follows: participation in
other trials, concomitant psychotherapy, pregnancy, drug
dependence, concomitant serious medical condition, and
hypersensitivity to honey.
Two surveys were used in this study. The first was a
demographics collection questionnaire which contained of
personal information (including age, age at menarche, mar-
ital status, and menstrual duration, consumption of caffeine
or junk food, and exercise). The second was the Premen-
strual Profile 2005, the questionnaire which is translated in
Persian and had been used several times in other related
studies in Iran.
Effect of Royal Jelly on premenstrual syndrome among Iranian medical sciences students
Enrollment
Allocated to royal jelly (n=55)
♦ Received allocated intervention (n=55)
♦ Did not receive alloca ted intervention (n=0)
Lost to follow-up (irregular use) (n=2)
Discontinued intervention (Unwillingness)
(n=5)
Analysed (n=48)
♦ Excluded from analysis (n=0)
Figure 1
The Premenstrual Profile 2005 considers three factors,
defined as: negative mood (markedly depressed mood, feel-
ings of hopelessness or self-depreciating thoughts; marked
anxiety, tension, feeling of being ‘‘keyed up’’ or ‘‘on edge’’;
marked affective labiality; persistent and marked anger or
irritability or increased interpersonal conflicts; decreased
interest in usual activities; subjective sense of difficulty in
concentrating; lethargy, easy fatigability, or marked lack of
energy; a subjective change of being over whelmed or out of
control), pain and discomfort (marked change in appetite,
over eating, or specific food cravings; hypersomnia or insom-
nia; other physical symptoms, such as breast tenderness,
headaches, joint or muscle pain, stomach/abdomen pain,
backache), and bloating (breast swelling; a sensation of
‘‘bloating’’; edema; weight gain). The Premenstrual Profile
requires the patient to register daily her overall perception
of the group of symptoms in each one of the three fac-
tors, as well as to indicate if the symptoms are extreme or
bad enough to prevent her from performing her daily tasks.
Symptoms are scored according to the following instruc-
tion: 0 — absent, 1 — noticeable but not disturbing, 2 —
interferes with normal activity, 3 — temporarily incapacitat-
ing. The Premenstrual Profile is meant to gather data over
at least two menstrual cycles plus 1 week so that it will
reflect the subjective changes in the three groups of symp-
toms during two ‘‘premenstrual cycles’’ that is, two entire
luteal phases and their returns to the follicular phase. After
603
Assessed for eligibility (n= 289)
Excluded (n=179)
♦ Not meeting inclusion criteria (n=50)
♦ Declined to participate (n=129)
♦ Other reasons (n=0)
Randomized (n=110)
Allocation
Allocated to placebo (n=55)
♦ Received allocated intervention (n=55)
♦ Did not receive allocated intervention (n=0)
Follow-Up
Lost to follow-up (irregular use) (n=5)
Discontinued intervention (Unwillingness)
(n=6)
Analysis
Analysed (n=44)
♦ Excluded from analysis (n=0)
Flow diagram of participants.
completion of the entire registration period of 2 months and
one week, the average rating per day of both follicular peri-
ods (days 1—13) is compared with the average rating per
day of both luteal periods (days 13 until the end of cycle).
A luteal point’s average that surpasses the follicular point’s
average with 50% of more should be considered an indica-
tion of PMS. The Premenstrual Profile has been provisionally
validated in a mixed nationality sample N = 20.27 In previ-
ous studies, which had done in Iran University of Medical
Sciences its face and content validity had been checked
by expert panel, and for its reliability, coefficient of cor-
relation between respond to questioner during morning and
then to the same questions in afternoon had been checked
(0.85).29,30 Also in our study, validity had been checked in the
same way and reliability of questioner coefficient of correla-
tion in the morning and afternoon had been checked (0.84,
0.86).
The outcome measure of study was premenstrual score
as obtained through the Premenstrual Profile 2005. The pre-
menstrual score is the sum of symptoms’ score recorded by
individuals during 7 days before the first day of each men-
strual cycle. On completion of the study, two premenstrual
scores had been obtained for every participant (once before
intervention and another one after 2 months intervention).
The mean score of every participant over the 2 months base-
line phase before treatment was compared to her mean
scores over the 2 months after the treatment.
604 S. Taavoni et al.

Sample size was calculated based on 80% power and 5%

Table 1 Characteristics of the participants according to
type 1 error, and it was determined that 55 participants
the intervention group.
were needed for each group. All the participants included
in the study met the Premenstrual Profile 2005 criteria for Characteristics Royal Jelly Placebo
premenstrual symptoms. (mean ± SDa ) (mean ± SD)
After 2 months screening, 110 participants with PMS ran-
domly were divided into two groups of receiving Royal Jelly Age (year) 23.34 ± 3.46 22.45 ± 4.37
or placebo. Half of the participants took one Royal Jelly Age at menarche 13.58 ± 1.36 13.29 ± 1.20
capsule orally contain 1000 mg Royal Jelly daily, starting on Caffeine consumption 6.48 ± 13.11 9.55 ± 15.33
the first day of menstruation and continued throughout two (Cup per month)
consecutive menstrual cycles. The other half took the same Junk-food 3.80 ± 4.08 2.66 ± 3.26
order of placebo capsules containing 1000 mg Oral Paraffin consumption (meal
for two consecutive cycles. Random allocation to one of the per month)
two groups was performed in a ratio of 1:1 within balanced Exercise (hour per 3.86 ± 6.45 6.64 ± 7.41
blocks of two. For every two participants, one was allocated month)
to Royal Jelly and other to the placebo group; the sequence Menstrual duration 6.23 ± 1.77 6.65 ± 0.84
varied randomly. Supplement Royal Jelly capsule used in this (day)
study (Capsule label A) was manufactured abroad and regis- a Standard deviation (SD).
tered in Ministry of Health pharmacopeia. The placebo had
the same properties, such as smell, taste, shape and size as
and B, PMS score, between intervention and control group,
in the Royal Jelly supplement (Capsule label B).
had significant difference (p < 0.006) (Table 2), also power
Final participants with PMS, who completed informed
calculation and size effect were 0.66 and 0.42, respectively.
consent form and a demographics questionnaire, had been
No side effect had been seen during intervention.
given two copies of Premenstrual Profile 2005 and asked to
complete one questionnaire every evening on a daily basis.
To reduce bias due to difficulty in remembering, partici- Discussion
pants completed rating from the current day only. If a day
was missed, that questionnaire was left blank and treated Women through premenstrual changes may need to get help
as missing data. Descriptive statistics (including frequency from health care professionals as the symptoms of this
measures of central tendency and variance) and inferential period may have negative effects on their lives. Several
statistics (t-test) were used to analyze the data using SPSS approaches to alleviating the symptoms of premenstrual
version14. disorders are available to women and can be tailored accord-
ing to individual needs and preferences. Recent articles
encourage methods that entail changes to lifestyle and diet
Results and managing PMS without relying on drug therapy. Honey
is one of the remedies that had been used in many cul-
Participant recruitment and data collection were done tures of the world, as a medicine and has been used in
between December 2011 and October 2012. The average of the treatment of fatigue, chest pains, period pains, and
participants’ age was 22.89 ± 3.91 years, average of partici- postnatal disorders. Honey is also used to improve assimila-
pants’ age at menarche was 13.43 ± 1.28 years, and average tion and is well known for its effectiveness in premenstrual
of duration of menstruation period was 6.43 ± 1.3 days. All symptoms.17 In the present study, the effect of Royal Jelly
the participants were single. Regarding to personal charac- (made by worker honey bees), on medical sciences student’s
teristics, there were no significant difference between the PMS was examined. The participants reported a serious level
two groups (Table 1). Also the mean baseline level of the PMS of premenstrual symptoms before the intervention, but par-
score before intervention did not differ between groups. ticipants who consumed one Royal Jelly capsule orally once
In this study, after consumption of Capsule A, which con- daily starting on the first day of menstruation through-
tained Royal Jelly, PMS score decreased from 23.17 ± 17.43 out two consecutive menstrual cycles showed a greater
to 11.42 ± 14.58 (p = 0.000), whereas the score in the reduction in premenstrual score than those in the control
control group, whom received placebo (Capsule B) did group. These findings are similar to earlier studies that
not differ significantly. Regarding to use of independent examined the effect of mixture of Royal Jelly, Pollen and Pis-
sample t-test, after 2 months consumption of Capsules A til extract on those suffering from premenstrual syndrome

Table 2 Impact of Royal Jelly on premenstrual symptoms score.

Group Pre intervention Post intervention Mean change (95% CI) Difference between
(mean ± SD) (mean ± SD) mean changes (95% CI)a

Royal Jelly 23.17 ± 17.43 11.42 ± 14.58 11.75 (8.31—15.19) 10.54 (6.10—14.98)
Placebo 21.48 ± 16.39 20.27 ± 15.76 1.20 (−1.69 to 4.10)
a 95% Confidence interval of the mean; if it excludes the value zero, the difference is statistically significant.
Effect of Royal Jelly on premenstrual syndrome among Iranian medical sciences students
and menopausal symptoms. In a double-blind, placebo-
controlled crossover trial of 32 women, use of the product
of grass Pollen and Royal Jelly for two menstrual cycles
appeared to significantly improve PMS symptoms as com-
pared to use of placebo.24,25 Another trial, which examined
the impact of Royal Jelly on stress induced depression or
anxiety of model mice, showed that Royal Jelly was effective
in ameliorating the stress-inducible symptoms of depression
and anxiety.31 The mechanism of the effect of Royal Jelly
on reduction of premenstrual syndrome, according to the
results of one study, may be due to estrogenic effect of Royal
Jelly. This research found that daily consumption of Tualang
honey for 2 weeks in female adult ovariectomised rats, a
model for menopausal symptoms, provided protective and
beneficial effects. Tualang honey was shown to prevent uter-
ine atrophy, vaginal epithelium atrophy, promote increased
the level of progestogens in menopausal state; however,
the study was performed on animal samples. Clinical tri-
als are required to see if these benefits could be translated
to human.32 On the other hand, another study showed that
Royal Jelly has no beneficial effect on the severity of PMS.26
These differences in results might be due to multi-factorial
nature of PMS and many factors that affect the symptoms
directly or indirectly. Moreover, methodological problems
also might be attributed to the variation in the studies’ find-
ings such as sample size, data gathering techniques, and
different statistical packages for analyzing their data.
It should be mentioned that the present study is limited
by its sample size, and results cannot be generalized to a
wider population. Finally, the study only assessed short-term
effects (for 2 months); long-term effects were not tested in
this study, so these limitations should be considered in fur-
ther study. Within these limitations, the trial methodology
appears to have been reasonably satisfactory, especially for
the triple blinding which is one of the strength points of this
study.
Conclusion
The results of the study have demonstrated that oral con-
sumption of 1000 mg Royal Jelly capsules was effective in
reducing the severity of PMS. In general, evidence on the
effectiveness of Royal Jelly in providing relief to women suf-
fering from PMS is limited. In particular, there is a lack of
studies with an adequate number of participants and study
duration. Further large, good-quality trials are required to
enhance the evidence and enable women to make informed
decisions on their use of natural products. However, the
results are interesting, and it is hoped that they will inspire
researchers to design RCT studies in the mentioned field with
longer period, also comparing the results of this intervention
in multiple intervention study with other nutritional prod-
ucts for finding better and more effective safe intervention
for prevention of PMS and increasing women’s quality of life
during reproductive ages.
Conflict of interest
The authors declare no conflicts of interests.
605
Acknowledgments
This study was part of a M.S. thesis supported by Tehran Uni-
versity of Medical Sciences (Grant No.: 12628-28-03-90), so
we would like to thank Tehran University of Medical Sciences
for the research grant. It should be noted that this trial had
been registered in Iranian Registry of Clinical Trials which
is a Primary Registry in the WHO Registry Network set up
with the help from the Ministry of Health and Medical Edu-
cation (MOHME) and hosted by Tehran University of Medical
Sciences (TUMS) (IRCT ID: 201107192172N12).
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