R E S E A R C H A R T I C L E Open Access
Effect of myrtle fruit syrup on abnormal
uterine bleeding: a randomized double-blind,
placebo-controlled pilot study
Marzieh Qaraaty
1
, Seyed Hamid Kamali
2*
, Fataneh Hashem Dabaghian
3
, Nafiseh Zafarghandi
4*
,
Roshanak Mokaberinejad
5
, Masumeh Mobli
6
, Gholamreza Amin
6
, Mohsen Naseri
1
, Mohammad Kamalinejad
7
,
Mohsen Amin
8
, Azizeh Ghaseminejad
9
, Seyedeh jihan HosseiniKhabiri
10
and Daryush Talei
11
Abstract
Background: Myrtle (Myrtus communis L.) has been used in the Iranian Traditional Medicine as a treatment for
abnormal uterine bleeding-menometrorrhagia. The main aim of this study is to evaluate the effect of myrtle fruit
syrup on abnormal uterine bleeding-menometrorrhagia.
Methods: A randomized, double-blind, placebo-controlled pilot study was conducted on 30 women suffering
from abnormal uterine bleeding-menometrorrhagia. Treatment comprised of giving 15 ml oral myrtle syrup daily
(5 ml three times a day) for 7 days starting from the onset of bleeding. The myrtle syrup along with placebo was
repeated for 3 consecutive menstrual periods. Menstrual duration and number of used pads were recorded by the
Pictorial Blood loss Assessment Chart at the end of each menstrual period. The quality of life was also evaluated
using the menorrhagia questionnaire.
Results: The mean number of bleeding days significantly declined from 10.6 ± 2.7 days to 8.2 ± 1.9 days after
3 months treatment with the syrup (p = 0.01) and consequently the participants in the intervention group used
fewer pads after 3 months (16.4 ± 10.7) compared with the number of pads used at the beginning of the treatment
(22.7 ± 12.0, p = 0.01). Bleeding days and number of pads used by the participants in the placebo group did not
change significantly. Also significant changes of quality of life scores were observed in the intervention group after
3 months compared to the baseline.
Conclusion: Myrtle syrup is introduced as a potential remedy for abnormal uterine bleeding-menometrorrhagia.
Keywords: Abnormal uterine bleeding-menometrorrhagia, Effrat-e-tams, Iranian traditional medicine, Myrtus
communis L, Myrtle, Myrtaceae
Introduction
Abnormal uterine bleeding (AUB) is one of the main rea-
sons of visiting gynecologists [1]. AUB affects up to one-
third of sexually active women [2] and the overall preva-
lence of this abnormality is 11%-13%, reaching 24% at the
age of 36–40 [3]. AUB has a considerable high morbidity
rate among women of childbearing age and imposes major
medical, social and financial burdens on women, their
families and health services [4]. Different types of AUB in-
clude a range of dysfunctional conditions affecting regu-
larity, frequency, duration or volume of menstrual flow
[5,6]. Menorrhagia or hypermenorrhea is defined as men-
strual blood loss of more than 80 ml per cycle or longer
than 7 days or both of them [7], while polymenorrhea is
defined as having menstruations about every 21 days and
occasionally at even shorter intervals causing irregular
ovulation. Metrorrhagia is uterine bleeding at irregular in-
tervals, particularly between the expected menstrual pe-
riods [8]. Abnormal uterine bleeding-Menometrorrhagia
(AUB-MM) is defined as prolonged and excessive uterine
bleeding in irregular intervals [9]. The most common
* Correspondence: kamaliseyyedhamid@yahoo.com;nafis_zafar@ymail.com
2
Department of Traditional Medicine, Faculty of Traditional Medicine, Shahid
Beheshti University of Medical Sciences, Tehran, Iran
4
Department of Gynecology and Obstetrics, Faculty of Medical Sciences,
Shahed University, Tehran, Iran
Full list of author information is available at the end of the article
© 2014 Qaraaty et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative
Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and
reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain
Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article,
unless otherwise stated.
Qaraaty et al. DARU Journal of Pharmaceutical Sciences 2014, 22:45
http://www.darujps.com/content/22/1/45
causes of AUB may be pregnancy, genital tract diseases,
certain medical conditions such as thyroid dysfunctions
and hypothalamic suppressions including stress, weight
loss, excessive exercise, and even coagulopathies [1,10].
AUB treatment includes administration of non-steroidal
anti-inflammatory drugs (NSAIDs), antifibrinolytics such
as tranexamic acid, cyclic oral progestins, oral contra-
ceptives and levonorgestrel-releasing intra-uterine sys-
tem [1,5,11]. Hormone therapies have many side effects
[12] and the common complication of tranexamic acid
is gastrointestinal disturbances [13]. AUB involves two-
thirds of all hysterectomies leading to several complica-
tions [14,15].
Iranian Traditional Medicine (ITM) practitioners such
as Ibn Sina (Avicenna, 980–1037 A.D) believed that the
normal menstruation is a good sign of healthy status of a
woman which results in chastity and modesty [16-18]. In
ITM literature, AUB is described under the title of “Effrat-
e-Tams”or “Kasrat-e-Tams”[7,18]. Menometrorrhagia is
more compatible with Effrat-e-Tams in ITM [17-20].
Based on ITM literature, particularly Avicenna’s book
(Al-Qanun fit-teb or Canon of medicine, 1025 A.D),
myrtle is known as “mourd”or “aass”and
its fruit that called Habbol- aass, is one of the effective
medicinal herbs for decreasing the menstrual bleeding
[18]. Myrtle is a fragrant evergreen shrub belonging to
myrtaceae family, growing wild in Iran [21,22] and the
Mediterranean area. The fruits have sweet-spicy tastes
that are very astringent [23]. Myrtle has been used as anti-
viral, antifungal, antiseptic and antioxidant agent [24,25].
Myrtle berries extract has ulcer-protective properties [26]
and anti-inflammatory effects [27]. The essential oils ob-
tained from leaves, flowers and fruits have been used in
flavor and fragrance industries [28]. Its biological effect in
menstrual disturbances has been described in ITM which
may be novel in modern medicine [18].
There is a lack of detailed trials on the effects of myrtle
syrup on menstruation. The main objective of the present
study was to investigate the effects of myrtle syrup on redu-
cing AUB-MM in a pilot placebo-controlled clinical trial.
Materials and methods
Study design and target group
In this randomized, double-blinded, placebo-controlled
pilot study, 30 patients were randomly assigned into two
groups of placebo (n = 15) and myrtle treatment (n = 15).
Participants were treated with either 15 ml of myrtle fruit
syrup or placebo, 3 times a day for seven days starting
from the onset of bleeding. The treatment was performed
for 3 consecutive menstrual periods. Randomization of
equal number of subjects to placebo or treated group
was achieved using a simple random allocation strategy,
using block randomization method. The participants
were selected according to the defined inclusion criteria:
20 to 55 years old, married women, not disposed toward
hormone therapy, not pregnant, not lactating, normal
gynecological observations, normal pap smear, endo-
metrial thickness less than 12 mm, menstrual period
more than 7 days in duration and/or less than 21 days
fromthestartofoneperioduntilthestartofthenext
menstrual period and/or clot excretion, use of more than
10 sanitary product items in a cycle. Sexually active
women were required to use a suitable non-hormonal
birth control. Initially, 92 patients were interviewed from
which, 35 patients were recruited and randomized in two
groups of placebo and extract treatment. 30 participants
completed the study, 15 in each group (Figure 1). Two
participants in the placebo group discontinued their ther-
apy because of increasing bleeding during first cycle. One
subject in the intervention group did not use the syrup
completely and two persons discontinued the study be-
cause of personal reasons.
Women were excluded from the study if they had a
history of significant medical problems (coagulopathies,
diabetes mellitus, chronic inflammatory disease, thyroid
dysfunctions); had a history of endometrial abnormalities
(such as hyperplasia), cervical carcinoma, uterine or ovary
malignancy; sub-mucosal or intramural fibroids more than
5 cm; needed surgery and emergency procedure because
of increasing bleeding during the study. All of the subjects
were free to withdraw at any time during the course of
study.
Participants were not permitted to use mefenamic acid,
tranexamic acid, any hormonal therapy, herbal medicine
and medicinal herb during the study. Use of acetamino-
phen, oral iron therapy and analgesic opioids was permit-
ted throughout the study.
All participants signed a written informed consent be-
fore recruiting in the study. The Ethics Committee of
Shahed University approved the protocol (approval num-
ber: 41/138342). In addition, the trial was registered in the
Iranian Registry of Clinical Trials under the number IRCT
201109077511 N1.
Plant material
Myrtle dried berries were collected from Manjil on road
to Gilan (North of Iran) in 2011 and its identity was au-
thenticated by Professor Gholamreza Amin. A voucher
specimen of the plant has been deposited in Herbarium
Tehran University of Medical Sciences, Faculty of Phar-
macy under the voucher No 6632-TEH.
Preparation of syrup and placebo
Traditional decoction was prepared as described in
“Qarabadin”(Ghayeni, Qarabadin-e-Salehi, 1765 AD;
Aghili, Qarabadin-e-Kabir, 1781 AD) [29,30] texts be-
longing to ITM pharmaceutical discipline. 63 g of the
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pulverized samples of myrtle fruits were macerated for
24 hours with 200 ml of distilled water, filtered and boiled
for 15 min. 108 g sucrose was added to the extract in
order to prepare the syrup. The medication was supplied
in bottles of 120 ml, containing either drug or placebo.
Placebo was prepared based on pharmacopoeia simple
syrup formula including approved color additives and
looked the same as the myrtle syrup.
Myrtle syrup is standardized based on total phenols
(Folin-Ciocalteau method) and gallic acid (Rhodanine
assay) content. Each 5 ml of syrup contains 0.05 ±
0.03 g dry residue and 41 mg total phenols as gallic
acid equivalents.
The participants were given either 5 ml of prepared
syrup or placebo three times a day, 30 minute after each
meal for seven days starting from the onset of bleeding.
This treatment was repeated for three consecutive men-
struation cycle.
The myrtle syrup and placebo were identical in the
same physical form, packaging and labeling and divided
to groups 1 and 2. Physician prescribed syrups to the pa-
tients according to the label numbers. Physician and
presenter of the myrtle syrup or placebo were blind for
the contents. The pharmacist was the only person who
was aware of the numbers assigned to the myrtle syrup
or placebo.
Bleeding measurements
All the participants were evaluated based on a complete
medical history and gynecological examination. Menstrual
blood loss was assessed with Pictorial Blood loss Assess-
ment Chart (PBAC). The quality of life was evaluated with
Figure 1 Study flow chart.
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menorrhagia questionnaire (MQ-Iranian Version) [31,32]
before treatment and at the end of the study. Certain
blood test including complete blood count (CBC), pro-
thrombin time (PT), partial thromboplastin time (PTT),
follicle-stimulating hormone (FSH), luteinizing hormone
(LH) and thyroid stimulating hormone (TSH) were done
before the study. PT and PTT were done to exclude bleed-
ing disorders. TSH, FSH and LH were done to exclude
thyroid dysfunction and hypothalamic pituitary dysfunc-
tion, respectively. CBC was performed to determine
hemoglobin (Hb) and hematocrit (Hct). Trans-vaginal
ultra sonography was also performed to find out if the
subject had any pelvic pathological disorders and to de-
termine the endometrial thickness. Cervical cytology
(Pap smear) was done to rule out other abnormalities.
Menstrual blood loss and menstrual duration were mea-
sured using PBAC chart during three consecutive treat-
ment cycles and was compared with the ones at the
beginning of the treatment (baseline). The participants
were requested to report the details of their menstrual
cycle i.e., the start date, duration of menstruation, the
number of sanitary pads used (considered as the intensity
of bleeding) and any adverse effects. The information was
recorded at the beginning of the treatment and at the end
of each menstrual cycle. The PBAC chart had a sensitivity
of 80% and specificity of 88% in diagnosing menorrhagia
(as defined in the alkaline hematin method) [33].
Statistical analysis
The primary outcome measures included the duration of
menstrual period, number of pads used during menstru-
ation. The MQ score and the side effects were the sec-
ondary outcome measures.
Normal probability plot was used to test for normality
of data in GraphPad Prism version 5. The data points
appeared linear on the plot and the data were considered
as normal distribution. Repeated-measures ANOVA func-
tion in the program GraphPad Prism version 5 was used
to test for differences of primary outcomes within the
groups. Repeated-measures ANOVA compares the means
of more than two matched groups in a longitudinal
study in which change over time is assessed. Student’st-
test was used to compare the MQ scores before and
after the treatment.
Results
Baseline characteristics
The baseline characteristics of the subjects are described
on Table 1. There were no statistically significant differ-
ences in baseline characteristics between the groups.
Hence, the groups were homogenous with respect to age,
level of education and investigations. Age of the patients
ranged from 20 to 55 years with the mean age 41.2 ±
6.9 years.
Effects of myrtle fruit syrup on duration and intensity of
bleeding
The average number of bleeding days and number of
pads used during the study are summarized on Table 2.
There was not statistically significant difference between
the groups in terms of bleeding days and number of
pads at the beginning of the study.
The number of bleeding days and consequently number
of pads used by the participants significantly decreased in
the intervention group after 3 months (P = 0.01), while
changes of these variables were not significant in the pla-
cebo group.
Significant changes of MQ score was observed in the
intervention group after 3 months compared to the base-
line (P = 0.02).
Discussion
To the best of our knowledge, the present study is the
first randomized placebo-controlled trial on the effects
of myrtle fruit in women with AUB-MM. The results of
this study showed that myrtle syrup had notable advan-
tages over placebo in women with AUB-MM. Also, the
quality of life was significantly improved in the interven-
tion group with minor side effects.
During luteal phase in menstrual cycle, some inflam-
matory processes lead to tissue edema in endometrium
and continue with excessive menstrual bleeding (EMB).
Unusual secretion of local pro-inflammatory cytokines
responsible in the vascular tone has been observed [2,4].
In these women, endometrium synthesizes much more
prostaglandin E
2
(PGE
2
) than it does with vasocon-
strictor PGF
2α
. A noticeable increased PGE
2/
PGF
2α
ratio
happens during luteal phase in women with menstrual
blood loss (>90 ml). Endometrial synthesis of PGs and
signaling in women with profuse menstruation is greater
than women with normal menstrual bleeding [4]. These
inflammatory molecules can be targeted to treat the dis-
turbances in women suffering from AUB.
Myrtle berries aqueous extract contains phenolic-like
tannins (galllic acid derivatives), anthocyanins and flavo-
noids [34]. Tannin-containing medications have been used
traditionally as styptics [35]. Anti-inflammatory activities
of anthocyanins have been proven in some studies [36].
Some studies have demonstrated that flavonoids can
Table 1 Baseline characteristics of study subjects
Parameter Intervention
group
Placebo group P value
Age 41.33 ± 7.228 41.13 ± 6.978 0.5
BMI 28.86 ± 4.68 31.99 ± 6.29 0.2
MQ score 47.8 ± 15.7 41.2 ± 15.3 0.2
Duration of
abnormality (month)
53.93 ± 61.46 72.33 ± 69.92 0.3
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inhibit inflammatory mediators [37]. According to a pre-
liminary study, micronized flavonoids suppressed endo-
metrial prostaglandins and were safe and effective in AUB
[38]. Another phytochemical compound in myrtle that
suppresses prostaglandin E
2
formation efficiently is myrtu-
commulon [39]. Therefore, the presence of the effective
anti-inflammatory components in the myrtle extract can
render the myrtle syrup a potential source to reduce
prostaglandin secretion and to cure AUB subsequently.
Further mechanistic studies are suggested to prove the
anti-inflammatory effects of the components in the
myrtle extract.
This study had some potential limitations which are
usually part of the nature of human studies. Firstly, ITM
has two groups of principal variables: one is part of
human nature, mezaj (temperament), racial/ethnic, sex,
age, season, zone, profession [40], and the second factor
is the composition of the herbal preparations which may
vary based on the geographical habitat of the plant, the
climate, and the time of reaping [41]. These factors have
not been considered in our study.
In the present study, the subjects received syrup only
for three cycles; therefore we cannot comment on any
long-term efficacy of myrtle syrup. Also, the subjects
were not followed up after finishing the study and the
long-lasting effects are not clear to us.
Conclusion
The outcomes of this study showed that myrtle syrup is
an effective drug as a short-term treatment of AUB-
MM. Women in the test group experienced significant
reductions of bleeding duration, as well as a significant
decline of the intensity of bleeding while placebo did not
affect the variables significantly. The quality of life im-
proved among the subjects in the syrup-treated group.
Based on the current novel results, a therapeutic role of
myrtle syrup is suggested for women with AUB-MM,
which is accessible and cost-effective therapy. Larger
and longer randomized trials are being planned in our
research group to confirm the long-term effects of myr-
tle on bleeding reduction in AUB-MM.
Abbreviations
AUB-MM: Abnormal uterine bleeding-menometrorrhagia; CBC: Complete
blood count; EMB: Excessive menstrual bleeding; FSH: Follicle- stimulating
hormone; Hb: Hemoglobin; Hct: Hematocrit; HMB: Heavy menstrual bleeding;
ITM: Iranian traditional medicine; LH: Luteinizing hormone; MQ: Menorrhagia
questionnaire; PG: Prostaglandin; PT: Prothrombin time; PTT: Partial
thomboplastin time; TSH: Thyroid stimulating hormone.
Table 2 The effect of myrtle fruit syrup in bleeding at baseline and post treatment
Variable Group Title Mean(±SD) Mean difference (±SE)
compared with baseline
95% CI* P values**
Menstrual duration (day) Intervention (n = 15) Baseline 10.6(2.7)
After 1
st
cycle 8.8(2.3) 1.7(0.6) −0.3−3.8 0.08
After 2
nd
cycle 8.9(3.8) 1.6(0.9) −1.3−4.7 0.08
After 3
rd
cycle 8.2(1.9) 2.3(0.6) 0.3−4.3 0.01
Placebo (n = 15) Baseline 9.8(3.5)
After 1
st
cycle 8.8(3.2) 1(0.5) −0.7−2.7 0.6
After 2
nd
cycle 8.7(2.6) 1.1(0.6) −0.8−3.1 0.5
After 3
rd
cycle 8.6(3.2) 1.2(0.4) −0.08−2.6 0.5
Number of pads used Intervention (n = 15) Baseline 22.7(12)
After 1
st
cycle 20(14) 2.6(1.6) −2.4−−7.7 0.5
After 2
nd
cycle 21.4(17.9) 1.3(2.7) −7.1−9.7 0.8
After 3
rd
cycle 16.4(10.7) 6.3(1.5) 1.6−11 0.01
Placebo (n = 15) Baseline 15.4(9.8)
After 1
st
cycle 13.9(7.2) 1.5(1.7) −3.7−6.8 0.6
After 2
nd
cycle 11.6(7.8) 3.8(1.5) −0.7−8.4 01
After 3
rd
cycle 15(8.7) 0.4(2) −5.9−6.7 0.9
MQ score Intervention (n = 15) Baseline 47.8(15.7)
After 3 months 39.4(16.7) 8.4(3.7) 0.4-16.4 0.02
Placebo (n = 15) Baseline 41.2(15.3)
After 3 months 39.2(14.5) 2(2.03) −2.3- 6.4 0.7
*One-way analysis of variance (ANOVA) was used to compare the groups before and after each treatment with either placebo or extract. There was statistically
significant difference between groups before and after three rounds of treatment with myrtle syrup, while the difference between groups befor e and after
placebo treatment was not statistically significant.
**P values <0.05 are significant.
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Competing interests
The authors do not have any financial/ commercial competing interest in
the study presented here.
Authors’contributions
MQ has made substantial contribution in designing, acquisition of data, and
drafting the manuscript and has given the final approval of the version to be
published. SHK participated involved in design, and revising, have given the
final approval of the version to be published. FHD analyzed and interpreted
the data. NZ the supervisor of conduction of the study, participated involved
in design, and revising, have given the final approval of the version to be
published. RM participated involved in revising. MM participated involved in
revising. GHA participated in the identification of the plants, plant extraction
and made substantial contributions in the study. MN co- study designer. MK
participated involved in revising. MA participated involved in revising and
analyzing the data of the manuscript. AGH participated involved in
recruitment. SJHK participated involved in randomization procedure.
DT participated involved in revising. All authors read and approved the
final manuscript.
Acknowledgements
The authors thank all the study participants for their participation. The
authors gratefully acknowledge the help of the following individuals: Dr Jale
aliasl Mamaghani for editing the data and revising; Dr Zahra Ghorbanifar for
editing and Dr. Maliheh Tabarrai for revising. This was supported by a
research grant provided by Shahed University.
Author details
1
Traditional Medicine Clinical Trial Research Center, Shahed University,
Tehran, Iran.
2
Department of Traditional Medicine, Faculty of Traditional
Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
3
Research Institute for Islamic and Complementary Medicine, Iran University
of Medical Sciences, Tehran, Iran.
4
Department of Gynecology and Obstetrics,
Faculty of Medical Sciences, Shahed University, Tehran, Iran.
5
Department of
Traditional Medicine, School of Traditional Medicine, Shahid Beheshti
University of Medical Sciences, Tehran, Iran.
6
Department of Traditional
Pharmacy, Faculty of Traditional Medicine, Tehran University of Medical
Sciences, Tehran, Iran.
7
Department of Pharmacognosy, School of Pharmacy
Shahid Beheshti University of Medical Sciences, Tehran, Iran.
8
Department of
Drug and Food control, Faculty of Pharmacy, Tehran University of Medical
Sciences, Tehran, Iran.
9
Department of Gynecology and Obstetrics, Tehran
University of Medical Sciences, Tehran, Iran.
10
Khatam Hospital, Tehran, Iran.
11
Medicinal Plant Research Centre, Shahed University, Tehran, Iran.
Received: 22 December 2013 Accepted: 9 May 2014
Published: 2 June 2014
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doi:10.1186/2008-2231-22-45
Cite this article as: Qaraaty et al.:Effect of myrtle fruit syrup on
abnormal uterine bleeding: a randomized double-blind, placebo-
controlled pilot study. DARU Journal of Pharmaceutical Sciences 2014 22:45.
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