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Effect of myrtle fruit syrup on abnormal uterine bleeding: A randomized double-blind, placebo-controlled pilot study

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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.
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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 3640 [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, 9801037 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-Tamsor Kasrat-e-Tams[7,18]. Menometrorrhagia is
more compatible with Effrat-e-Tams in ITM [17-20].
Based on ITM literature, particularly Avicennas book
(Al-Qanun fit-teb or Canon of medicine, 1025 A.D),
myrtle is known as mourdor aassand
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. Studentst-
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) 0.33.8 0.08
After 2
nd
cycle 8.9(3.8) 1.6(0.9) 1.34.7 0.08
After 3
rd
cycle 8.2(1.9) 2.3(0.6) 0.34.3 0.01
Placebo (n = 15) Baseline 9.8(3.5)
After 1
st
cycle 8.8(3.2) 1(0.5) 0.72.7 0.6
After 2
nd
cycle 8.7(2.6) 1.1(0.6) 0.83.1 0.5
After 3
rd
cycle 8.6(3.2) 1.2(0.4) 0.082.6 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) 7.19.7 0.8
After 3
rd
cycle 16.4(10.7) 6.3(1.5) 1.611 0.01
Placebo (n = 15) Baseline 15.4(9.8)
After 1
st
cycle 13.9(7.2) 1.5(1.7) 3.76.8 0.6
After 2
nd
cycle 11.6(7.8) 3.8(1.5) 0.78.4 01
After 3
rd
cycle 15(8.7) 0.4(2) 5.96.7 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.
Authorscontributions
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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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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... Tese efects may be due to the presence of astringent agents such as tannins and triterpenoids and antioxidant and antiinfammatory compounds that suppress the synthesis of prostaglandins [22]. In addition, it has been shown that myrtle (Myrtus communis L.), which is an evergreen shrub that grows in Iran, has antiseptic, antioxidant, antiinfammatory, ulcer protective, and astringent properties [23]. ...
... Tey concluded that intervention with TA or pomegranate fower in the frst 5 days of the menstrual cycle for three sequential months could equally mitigate the PBAC score. In addition, a trial by Qaraaty et al. [23] indicated that a 15 ml intake of myrtle syrup at the frst 7 days of the cycle for three consecutive menstrual periods declined bleeding compared to a placebo. Te hypothesis was that coadministration of pomegranate fower and myrtle which are components of Golnar product with longer duration can induce more therapeutic efects. ...
... Terefore, it seems that treatment of heavy menstrual bleeding could improve quality of life. Several studies have reported an improvement in quality of life after consumption of Golnar product and its components [18,20,21,23,29]. Other studies also demonstrated that pomegranate peel extract or supplements could improve the quality of life of hemodialysis patients and menopausal women [32,33]. ...
Article
Full-text available
Introduction: Abnormal uterine bleeding (AUB) is a major healthcare problem in females of reproductive age and impacts women's health and quality of life (QoL). This study aimed to test the equivalence of Persian Golnar (PG) and tranexamic acid (TA) for the treatment of excessive menstrual bleeding. Method: A triple-blind randomized equivalence trial with parallel design and block randomization technique was performed. A total of 80 patients with AUB were randomly allocated to receive either PG or TA for three consecutive menstrual cycles. Blood loss was measured by the Pictorial Blood Loss Assessment Chart (PBAC). Hematological evaluations were done before the intervention and after treatment. QoL and premenstrual dysphoric disorder (PMDD) as secondary outcomes were assessed using the menorrhagia questionnaire (MQ) and Premenstrual Symptoms Screening Tool (PSST). Statistical analysis was performed using an independent t-test, paired t-test, χ2 test, Mann-Whitney test, and Wilcoxon signed-rank test. Results: Seventy-six women completed the 12-week follow-up. Both PG and TA groups experienced a significant reduction in blood loss. Furthermore, the serum level of hemoglobin in the PG group enhanced significantly (P < 0.001). QoL and PMDD scores were significantly improved in both groups (P< 0.001). Conclusion: The findings of the current trial supposed that the Golnar product is as effective as tranexamic acid in controlling bleeding and enhancing the quality of life and premenstrual symptoms.
... Its small shrubs normally range in size from 1 to 3 m. Some studies have suggested Myrtle extract as a potential remedy for excessive bleeding (15,16). ...
... In other words, the herbal extract decreased B.T. in the rats treated with the herbal extracts. According to another study, three months of consuming Myrtle extract significantly reduced the number of bleeding days in women with abnormal menorrhagia compared to the control group (15). Also, Pomegranate flower extract could significantly control menstrual bleeding and reduce the volume of bleeding in women, improving relevant clinical indices and their life quality (27). ...
... Myrtle. They found that Myrtle syrup could be used as a potential drug to control excessive uterine bleeding (menorrhagia) (15). The results of these studies on the coagulant effects of Myrtle were consistent with our findings. ...
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Background: Management of bleeding is among the major issues in medicine, particularly during surgery. Objectives: This study investigated the effects of Pomegranate peel and flower, Myrtle, Quercus fruit, and Rhus coriaria L extracts on bleeding control in rats. Methods: In this experimental study, 32 male Wistar rats (weighing 200 - 250 g, 8-10-month-old) with free access to sufficient water and food, were randomly divided into four groups: (a) the topical application of the extracts on tail wounds (bleeding time (B.T.) measurement); (b) intraperitoneal injection of the extracts (measurement of prothrombin time (P.T.) and partial thromboplastin time (PTT) in the blood taken from the heart); (c) control group 1 (B.T. measurement on tail wounds without the topical application of the extracts); and (d) control group 2 (no intraperitoneal injection of the extracts, P.T. and PTT measurement in blood drawn from the heart). The animals in all groups received the same care and were kept under standard laboratory conditions, 12:12 h light/dark cycles, and a temperature of 23 ± 2.0°C. The data were analyzed by the one-way ANOVA and Tukey's post-hoc tests. Results: The mean of B.T. in the control group, 3.57 ± 0.20 s, was significantly higher than that in the intervention group (1.56 ± 0.13 s) (P < 0.001). The mean of P.T. in the control group was not significantly different from that in the intervention group (P = 0.499). The mean of PTT in the control group (18.2 ± 24.82 s) was significantly shorter than that in the intervention group (38.00 ± 14.49 s) (P = 0.006). Conclusions: Considering the acceptable coagulant effects of the extracts of Pomegranate peel & flower, Myrtle, Quercus fruit, and Rhus coriaria L. compared to the control group, it can be concluded that these extracts can be suitable adjuvant drugs for controlling bleeding. Although the coagulant effects of these extracts have been mentioned in many traditional medicine texts, human tests are required to reject or confirm their clinical effects.
... Active derivatives of M. communis L. including myricetin-3-o-galactoside and myricetin-3-o-rhamnoside have anti-genotoxic properties and are involved in apoptosis [35]. Also, in the various laboratory or human models, it has inhibitory effects on prostaglandin E2, in particular, and anti-inflammatory, cytoprotective, and anti-uterine bleeding effects, in general [36,38]. In the animal model, the aqueous and alcoholic extracts of M. communis have anti-nociceptive and anti-inflammatory effects [39]. ...
... In different RCTs performed on M. communis, there is an improvement in the treatment of bacterial vaginosis and remission of stomatitis, as well as the reduction of menstrual bleeding [38,42,43]. In four RCTs, there is a reduction in inflammatory factors due to the pomegranate use [55][56][57][58]. ...
Article
Vaginitis is one of the most common gynecological problems in reproductive age. Because of the limitations of the conventional drugs, identification of new pharmacological interventions for this disease seems to be necessary. The purpose of this article is to review the medicinal herbs mentioned for the treatment of vaginitis by the great Iranian scientist, Avicenna, in his book “the Canon of Medicine” to scientifically demonstrate their effects and their potential to be used as complementary therapies. The medicinal plants listed for vaginitis treatment in “the Canon of Medicine” were extracted. The scientific name and English common name of the given medicinal plants were searched in databases including PubMed, Scopus, and Cochrane Library until December 2017 to obtain any in vitro, animal, and clinical evidence related to vaginitis. Various pharmacological activities, including anti-inflammatory, wound healing, antimicrobial, antifungal, analgesic, and anti-prostaglandin E2, have been demonstrated for medicinal plants emphasized by Avicenna for vaginitis. Randomized controlled trials (RCTs) on Myrtus reported an improvement in the treatment of bacterial vaginosis. Four RCTs on pomegranate indicated a reduction in inflammatory factors in the patients. Medicinal herbs offered in Herbal Medicine are valuable sources for the treatment of various diseases. Effects and pharmacodynamics having been proved by conventional medicine confirm the effectiveness of these herbs. Therefore, these plants can be used in the treatment of vaginitis thanks to further clinical studies. [GMJ.2019;8:e1270]
... and "d" is the accuracy of estimate or how close it is to the true mean (d = 900.40). Given the pioneering nature of this study, the above two data were collected from a previous work including women suffering from abnormal uterine bleeding-menometrorrhagia, conducted by Qaraaty et al., 18 where the mean number of bleeding days was 10.6 AE 2.7 and 8.2 AE 1.9, respectively, before and after the consumption of myrtle syrup. "Zα/2" is the normal deviate for a two-tailed alternative hypothesis at a level of significance (Zα/2 equal to 1.44 at an error rate of 0.20%). ...
... 23 The most interesting effects of sinapic acid are its capacity to influence steroid hormone metabolism and its anti-inflammatory properties. 24 The results of this study were similar to the results of Qaraaty et al. 18 in the management of abnormal uterine bleeding-menometrorrhagia by myrtle fruit syrup. ...
Article
Background : Abnormal uterine bleeding-menometrorrhagia due to uterine myomas is a health problem affecting women’s quality of life and it is considered a frequent cause of emergency visits for women. If first line medication fails to treat symptoms, surgical procedures, such as hysterectomy could be indicated, which could interfere with women's physical, social, emotional, and material quality of life. The purpose of this pilot study was to investigate the effect of a mixture of two medicinal plants, Mentha pulegium L and Artemisia abrotanum L, on 13 women with menometrorrhagia, who were candidates for hysterectomy. Methods: The herbs were taken as a tea infusion by the oral route. A total of 5 g of the dried aerial parts of the mixture were added to 100 ml of boiling water and the tea infusion was taken three times a day starting from the onset of menstruation for three consecutive days, and it was repeated for three consecutive months. Results: The study results showed that 10 out of the 13 women involved avoided the surgical procedures. The mean number of bleeding days declined from 11.50 (±3.77) at baseline to 7.60 (±2.11) ( p=0.01 ). Participants confirmed a change in the bleeding intensity, regularization of their menstrual cycle, and improvement in their quality of life. Conclusions: This preliminary study explores a new approach to treat abnormal uterine bleeding- menometrorrhagia, based on tea infusion consumption of a mixture of two medicinal herbs, and it paves the way for future studies. Trial registration: This study is registered with ClinicalTrials.gov NCT05406960 (07/06/2022).
... The total score and eight health-related dimensions that contribute to the scores were assessed at the baseline and postintervention (TF3). To further categorize the SF-36 dimensions, the physical component summary (PCS) for physical functioning and the mental component summary (MCS) for emotional wellbeing were also assessed in both groups at the baseline and postintervention (Qaraaty et al., 2014). All participants were evaluated at baseline and treatment follow-up (TF3) after menstruation to assess the SF-36 score and hemoglobin levels. ...
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Objective: This study aims to determine the efficacy of the Acacia arabica (Lam.) Willd. and Cinnamomum camphora (L.) J. Presl. vaginal suppository in addressing heavy menstrual bleeding (HMB) and their impact on participants' health-related quality of life (HRQoL) analyzed using machine learning algorithms. Method: A total of 62 participants were enrolled in a double-dummy, single-center study. They were randomly assigned to either the suppository group (SG), receiving a formulation prepared with Acacia arabica gum (Gond Babul) and camphor from Cinnamomum camphora (Kafoor) through two vaginal suppositories (each weighing 3,500 mg) for 7 days at bedtime along with oral placebo capsules, or the tranexamic group (TG), receiving oral tranexamic acid (500 mg) twice a day for 5 days and two placebo vaginal suppositories during menstruation at bedtime for three consecutive menstrual cycles. The primary outcome was the pictorial blood loss assessment chart (PBLAC) for HMB, and secondary outcomes included hemoglobin level and SF-36 HRQoL questionnaire scores. Additionally, machine learning algorithms such as k-nearest neighbor (KNN), AdaBoost (AB), naive Bayes (NB), and random forest (RF) classifiers were employed for analysis. Results: In the SG and TG, the mean PBLAC score decreased from 635.322 ± 504.23 to 67.70 ± 22.37 and 512.93 ± 283.57 to 97.96 ± 39.25, respectively, at post-intervention (TF3), demonstrating a statistically significant difference (p < 0.001). A higher percentage of participants in the SG achieved normal menstrual blood loss compared to the TG (93.5% vs 74.2%). The SG showed a considerable improvement in total SF-36 scores (73.56%) compared to the TG (65.65%), with a statistically significant difference (p < 0.001). Additionally, no serious adverse events were reported in either group. Notably, machine learning algorithms, particularly AB and KNN, demonstrated the highest accuracy within cross-validation models for both primary and secondary outcomes. Conclusion: The A. arabica and C. camphora vaginal suppository is effective, cost-effective, and safe in controlling HMB. This botanical vaginal suppository provides a novel and innovative alternative to traditional interventions, demonstrating promise as an effective management approach for HMB.
... Increasing the quality of life in healthy people (21) and reducing the cost of diseases [22] are the major priorities in PM. Some interesting results of the studies inspired by the opinion of ancient scholars indicate that PM in the feld of gynecology also has the ability to provide efective treatments [23,24]. ...
Article
Full-text available
Introduction: Infertility is an important issue with a high social and psychological burden. From the perspective of Persian Medicine (PM), uterine cold temperament is one of the important causes of female infertility. Aim: The aim of this study was to study the effect of PM or Iranian traditional medicine on improving ovulation and fertility. Methods: From January 2017 to August 2017, sixty infertile women with eugonadotropic ovulation disorder were randomly divided into two groups. Both groups were treated with clomiphene citrate, except that the intervention group also received metabolic Persian diet (MPD). In each cycle, the dominant follicles and endometrium were investigated with ultrasound. At the end of the cycle, beta human chorionic gonadotropin (β-HCG) was evaluated and if positive, another ultrasound was performed two weeks later to confirm early pregnancy. Results: The number of dominant follicles from the first to third cycle increased from 2.15 ± 1.14 to 2.28 ± 0.61 in the intervention group and decreased from 1.86 ± 0.79 to 1.30 ± 0.47 in the control group. The dominant follicle size changed from 16.00 ± 4.08 to 18.78 ± 2.78 and from 15.05 ± 3.11 to 15.80 ± 3.89 in the intervention and control groups, respectively. But endometrial thickness did not change significantly in the intervention group. Pregnancy results based on β-HCG and ultrasound findings were positive in 19 and 16 patients in the intervention group and in 10 and 7 patients in the control group, implying significantly higher numbers in the first group. Conclusion: It seems that MPD may be effective in the success of ovulation induction.
... Traditional Persian Medicine (TPM) with a comprehensive view on etiology, and considering several variables, has been effective in the treatment of diseases. These variables include part of human nature (mizaj), sex, age, racial/ethnic, season, region, profession [25]. TPM provides valuable preparations (phytopharmaceuticals) which are proposed as putative therapeutic medications in numerous health complications [26]. ...
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Vaginal atrophy is one of the most common complaints in postmenopausal women. Symptoms of vaginal atrophy include dryness, itching, bleeding, and dyspareunia. According to Traditional Persian Medicine (TPM), the using of moisturizing plants can treat dry mucous membranes. TPM suggests the use of marshmallow (Alcea angulata) to moisturize dry mucus with its mucilage. The aim of this study was to evaluate the effect of Alcea on the treatment of vaginal atrophy. This double-blind, clinical trial was conducted on 60 postmenopausal women with vaginal atrophy (40 – 65 years of age). The patients were randomly assigned into two groups of treatment and control (n = 30). The treatment group received Alcea vaginal suppository 5% (125 mg), and the control group received placebo. Both groups used suppositories every night for two weeks and every other night for six weeks. Vaginal Maturation Value (VMV), symptoms of vaginal atrophy, and pH were compared before and after the intervention. Data were analyzed using SPSS 16. VMV was increased in the treatment group, from 40.30 ±13.27 to 46.40 ± 11.27, (p ˂ 0.0001) compared to the control group, in which the change of VMV was not significant (p ˂ 0.122). The vaginal pH was significantly decreased in the treatment group, from 6.45 ± 0.92 to 5.52 ± 0.62, (p ˂ 0.0001) compared to the control group, in which the change of pH was not significant (p ˂ 0.257). The symptoms were significantly reduced in the treatment group. It seems that Alcea vaginal suppository can be useful as a natural product to relieve the symptoms of vaginal atrophy.
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Herbal remedies have been utilized for centuries to alleviate menstrual problems, offering a natural alternative to conventional treatments. Menstrual issues encompass a spectrum of symptoms, including pain, irregularity, and mood disturbances, which can significantly impact a person’s quality of life. Herbal remedies offer a comprehensive approach, addressing both physical and emotional aspects of menstruation. One commonly used herb is chasteberry (Vitex agnus-castus), which has been shown to regulate hormonal imbalances and alleviate symptoms of Premenstrual Syndrome (PMS) and irregular cycles. Additionally, ginger (Zingiber officinale) and turmeric (Curcuma longa) possess anti-inflammatory properties, reducing menstrual pain and discomfort. Herbal teas containing ingredients such as chamomile (Matricaria chamomilla) and peppermint (Mentha piperita) can soothe cramps and promote relaxation. Dong Quai (Angelica sinensis) is a traditional Chinese herb known for its ability to regulate menstrual cycles and relieve menstrual pain by promoting blood circulation. Black cohosh (Actaea racemosa) is another herb used to alleviate menopausal symptoms, including hot flashes and mood swings, which may occur during menstruation. The adaptogenic herb ashwagandha (Withania somnifera) can help manage stress and anxiety associated with menstrual problems, supporting overall emotional well-being. Raspberry leaf (Rubus idaeus) is commonly used to tone the uterus and ease heavy menstrual bleeding. Herbal remedies offer a diverse array of options for managing menstrual problems, addressing both physical discomfort and emotional distress. However, it’s essential to consult with a healthcare professional before incorporating herbal remedies into your regimen, especially if you have underlying health conditions or are taking medications, to ensure safety and efficacy. Major Findings: Detailed review showing positive effects of herbs in reducing menstrual problems.
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Herbal combination of Itrifal Saghir (triphala) has been widely used in traditional medicine. And brings health benefits such as antioxidant effect and scavenger of hydroxyl radicals and nitric oxide radicals activity and substantiated in traditional medicine a anti-obesity. In this study we aimed to assess the efficacy of this herbal medicinal on reduction of weight and body mass index (BMI) of simple obese subjects in comparison with placebo. Obese subjects aged between 16 and 60 years were selected for 12-week, double-blind, randomized, placebo-controlled trial using a parallel design. Subjects were randomly assigned to take 5 grams of either the Itrifal Saghir (n = 31) or placebo (n = 31), 2 times daily for 12 weeks. Measures of body weight, BMI, waist circumference (WC), hip circumference (HC), were assessed at baseline and once every four weeks during the 12 week treatment period. The safety was evaluated by means of measuring the liver and kidney function. Homeostasis model of insulin resistance (HOMA-IR) was calculated as [fasting insulin (μU/mL) × fasting glucose (mmol/L)/22.5]. Compared to placebo group, in treatment group the mean difference of effective weight loss was 4.82Kg (CI95% 3.52 - 6.11, ρ < 0.001), the mean of decrease in waist circumference was 4.01 cm (CI 95% 2.13 - 5.90, ρ < 0.001), and the mean decrease in hip circumference was 3. 21 cm (CI 95% 1.96 - 4.45, ρ < 0.001) in treated subjects. No adverse effects or significant changes in liver and kidney function tests were observed in both placebo and treated groups. Itrifal Saghir appears to produce a positive effect on weight loss in obese subjects.
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Amenorrhea is defined as the cessation of menses. Hormone therapy is the most common treatment. Due to the contraindications and side effects of it and the increasing demand for alternative medicine substitutes, Mentha longifolia L. was used in this study. Mentha longifolia L. is a known medication in Iranian traditional medicine to induce menstrual bleeding in women with secondary amenorrhea and oligomenorrhea. A double-blind, randomized, placebo-controlled, multicenter study was conducted in 120 women with secondary amenorrhea and oligomenorrhea. Treatment consisted of sequential oral syrup, 45 ml (15 ml three times a day) for 2 weeks. If the patients did not have menstruation after 2 weeks of taking the medication, we would wait for two more weeks. If the patients had menstruation at each stage of using the drug, we started it one week after the end of menstruation. But if the patients had not menstruate after four weeks (two-week using of drug and waiting for two more weeks), the previous steps were repeated. The drug and placebo were repeated in three cycles of menstruation. Bleeding was documented by the patient on diary cards. The primary outcome variable was the occurrence (yes/no) of bleeding during the first treatment cycle. The secondary efficacy outcome was the regularity of bleeding pattern during the three cycles of the study. The number of women with bleeding during the first cycle were higher in the drug group as in the placebo group (68.3% vs. 13.6%; p < 0.001). The regularity of bleeding throughout the study was markedly better in the drug group compared with those given placebo (33.3% vs. 3.3%; p < 0.001). No notable complication or side effect was reported in relation to Mentha longifolia L. syrup. In conclusion, Mentha longifolia L. syrup is a safe, well-tolerated, and effective choice in inducing bleeding and maintaining regular bleeding in women with secondary amenorrhea and oligomenorrhea.
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Tranexamic acid has proven to be an effective treatment for heavy menstrual bleeding (HMB). It reduces menstrual blood loss (MBL) by 26%-60% and is significantly more effective than placebo, nonsteroidal anti-inflammatory drugs, oral cyclical luteal phase progestins, or oral etamsylate, while the levonorgestrel-releasing intrauterine system reduces MBL more than tranexamic acid. Other treatments used for HMB are oral contraceptives, danazol, and surgical interventions (endometrial ablation and hysterectomy). Medical therapy is usually considered a first-line treatment for idiopathic HMB. Tranexamic acid significantly improves the quality of life of women treated for HMB. The recommended oral dosage is 3.9-4 g/day for 4-5 days starting from the first day of the menstrual cycle. Adverse effects are few and mainly mild. No evidence exists of an increase in the incidence of thrombotic events associated with its use. An active thromboembolic disease is a contraindication. In the US, a history of thrombosis or thromboembolism, or an intrinsic risk for thrombosis or thromboembolism are considered contraindications as well. This review focuses on the efficacy and safety of tranexamic acid in the treatment of idiopathic HMB. We searched for medical literature published in English on tranexamic acid from Ovid Medline, PubMed, and Cinahl. Additional references were identified from the reference lists of articles. Ovid Medline, PubMed, and Cinahl search terms were "tranexamic acid" and "menorrhagia" or "heavy menstrual bleeding." Searches were last updated on March 25, 2012. Studies with women receiving tranexamic acid for HMB were included; randomized controlled studies with a description of appropriate statistical methodology were preferred. Relevant data on the physiology of menstruation and the pharmacodynamics and pharmacokinetics of tranexamic acid are also included.
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AimTo evaluate the efficacy and safety of Safoof Habis in Kasrate Tams (menorrhagia) with validated menstrual pictogram.Materials and methodsA single blind, randomized, standard controlled trial was conducted in the gynaecological outpatient of National Institute of Unani Medicine Hospital. Clinically diagnosed patients (n = 52) were randomized to the test (n = 35) and control (n = 17) groups. In the test group, Safoof Habis (Ingredient are Silicate of alumina and Iron oxide, Hydrated magnesium silicate and Vateria indica L.) 5 g twice daily and in the control group, tranexamic acid 500 mg, thrice daily were administered from day 1 to day 5 of menstrual cycle and Qurs Kushta Faulad, one tablet twice daily was administered in both the groups for three consecutive months. The primary outcome measure was to assess the efficacy and safety of this Unani formulation in menorrhagia with menstrual pictogram. The secondary outcome measures were to assess the effectiveness of test drug formulation on dysmenorrhea and hemoglobin concentration. The results were analyzed by Student's ‘t’ test and Fisher exact test.ResultsThe groups were homogenous in the terms of age, parity, socioeconomic status, marital status and biochemical parameters (P > 0.05). Post treatment when compared to baseline in same group showed significant reduction in menstrual blood loss in both the groups (P < 0.001). The comparison between test and control group showed that both groups were equally effective (P = 0.265). There was improvement in hemoglobin concentration in the test group (P = 0.04) and dysmenorrhea was reduced in both groups (P < 0.001).Conclusion Safoof Habis was found to be effective in reducing menstrual blood loss in menorrhagia.
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Myrtle (Myrtus communis L.) berries extracts were prepared with solvents at different polarity (water, ethanol, and ethyl acetate) and analysed using different in vitro tests in order to evaluate their antioxidant properties. Antiradical and total antioxidant activities were measured with DPPH and FRAP tests, respectively. Their ability to protect biological molecules was assessed using the cholesterol and LDL oxidation assays. In addition, phenolic compounds and unsaturated fatty acids composition was analysed by HPLC–DAD and HPLC–MS/MS. Ethanol and water extracts showed the highest amount of extracted compounds, but the highest antiradical and antioxidant activities were found in ethanol and ethyl acetate extracts. These extracts were also the ones with the highest content of phenolic compounds. In addition, our results showed a highly significant correlation between the amount of total phenols and antiradical (R2 = 0.9993) or antioxidant activities (R2 = 0.9985) in these extracts. HPLC–DAD and HPLC–MS analyses showed significant quantitative and qualitative differences among these three extracts. The ethyl acetate extract had the highest protective effect in assays of thermal (140 �C) cholesterol degradation and Cu2+- mediated LDL oxidation, inhibiting the reduction of polyunsaturated fatty acids and cholesterol, and the increase of their oxidative products. These results suggest that because of these properties, myrtle berries could be used in dietary supplements preparations or as food additives.
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Women today may reasonably anticipate in the order of some 400 menstrual cycles over their reproductive lifespan. The endometrium is thus subject to repeat cycles of shedding and repair and notably healing of the endometrium post menses is "scarless". The local molecular and cellular mechanisms involved in post menstrual resolution of the inflammatory events associated with menstruation and endometrial repair remain to be fully determined. Menstrual complaints are common. It is highly likely that unrestrained local inflammatory events and/ or deficient repair processes within the endometrium contribute to the women's experience of heavy menstrual bleeding (HMB). The management of women with HMB may need to utilize therapeutic approaches that optimize endometrial repair processes, post menses. These approaches may be necessary in addition to current therapies that hitherto have focused on limiting the local inflammation associated with menstruation. Research endeavors thus need to focus upon the molecular and cellular causes of problematic uterine bleeding. Herein the events associated with pre-menstrual progesterone withdrawal, limitation of blood loss, the expression of vasoactive mediators and factors that may modulate vascular morphology are described. Such lines of enquiry and knowledge will be essential if novel targets for treatment of menstrual bleeding complaints, such as HMB, are to be identified.
Article
To estimate the efficacy of a fixed estrogen step-down and progestin step-up 28-day estradiol (E2) valerate and dienogest oral contraceptive regimen in women with heavy menstrual bleeding, prolonged menstrual bleeding, or heavy and prolonged menstrual bleeding without organic pathology. This double-blind, placebo-controlled study randomized women aged 18 years or older with prolonged, frequent, or heavy menstrual bleeding, objectively confirmed during a 90-day run-in phase, to treatment with E2 valerate and dienogest or placebo (2:1) for 196 days. Data from the last 90 days of treatment and the run-in phase were compared. The primary variable was the "complete response" rate (complete resolution of qualifying abnormal menstrual symptoms, including a 50% or greater reduction in pretreatment menstrual blood loss volume in women with heavy menstrual bleeding). Secondary variables included objective changes in menstrual blood loss volume (alkaline hematin methodology) and iron metabolism parameters. Overall, 180 women were needed to provide 90% power. There were no marked differences in the characteristics of E2 valerate and dienogest (n=120) and placebo (n=70) recipients. The proportion of "complete responders" in the evaluable group was significantly higher in E2 valerate and dienogest (35/80; 43.8%) compared with placebo (2/48, 4.2%, P<.001) recipients. The mean [standard deviation] reduction in menstrual blood loss with E2 valerate and dienogest from the run-in phase to the efficacy phase was substantial (-353 mL [309 mL]; mean -64.2%; median -70.6%) and significantly greater than that in placebo recipients (-130 mL [338 mL]; mean -7.8%; median -18.7%; P<.001). Significant improvements in hemoglobin, hematocrit, and ferritin were seen with E2 valerate and dienogest, but not with placebo. Oral E2 valerate and dienogest was highly effective compared with placebo in the treatment of women with heavy menstrual bleeding, prolonged menstrual bleeding, or heavy and prolonged menstrual bleeding without organic pathology. ClinicalTrials.gov, www.clinicaltrials.gov, NCT00293059. I.