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The Effect of Capsella bursa-pastoris Extract on Heavy Menstrual Bleeding and Quality of Life in Patients with Uterine Leiomyoma: A Double-blind Randomized Clinical Trial

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Objectives: Heavy Menstrual Bleeding (HMB) is the most important problems of Uterine Leiomyoma (UL). This study aimed to assess the effect of the extract of the Capsella bursa-pastoris (CBP) on the control of HMB and quality of life in patients with uterine leiomyoma. Design: In a double-blind randomized, clinical trial 54 women with uterine leiomyoma were randomly assigned to the intervention/control groups by block randomization. Setting: Gynecology outpatient clinics. Intervention: The intervention group received 350 mg of alcoholic extract of Capsella bursa-pastoris and the control group received placebo twice daily for three months. Main Outcome Measures: Amount of bleeding by Pictorial blood loss assessment chart (PBAC), quality of life by menstrual quality of life questionnaires (MQ) and bleeding duration by calendar were evaluated. Results: The mean of PBAC decreased from 464.00± 283.61 at baseline to 323.82±207.66 in the intervention group and decreased from 445.92±362.64 to 214.36±137.68 in control group in the third month. The improvement trend was significant in the two groups, but there was no significant difference between groups. The mean of bleeding duration and menstrual quality of life showed improvement in patients of two groups without significant difference between the two groups. Conclusion: Despite the effectiveness of CBP in the intervention group in decreasing of PBAC score and menstrual bleeding duration and improvement of menstrual quality of life in patients who suffered from UL, it did not show a significant effect compared to the control group. Future studies with a larger sample size in one specific type of UL suggested.
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*Corresponding author: E-mail: drfatemehnojavan@yahoo.com;
Journal of Pharmaceutical Research International
31(3): 1-10, 2019; Article no.JPRI.51415
ISSN: 2456-9119
(Past name: British Journal of Pharmaceutical Research, Past ISSN: 2231-2919,
NLM ID: 101631759)
The Effect of Capsella bursa-pastoris Extract on
Heavy Menstrual Bleeding and Quality of Life in
Patients with Uterine Leiomyoma: A Double-blind
Randomized Clinical Trial
Atieh Sadat Danesh
1,2
, Faraz Mojab
3
, Abolfazl Mohammadbeigi
4
,
Soodabeh Bioos
5
, Zahra Siaghati
6
and Fatemeh Nojavan
1,7*
1
Department of Traditional Persian Medicine, School of Medicine, Qom University of Medical
Sciences, Qom, Iran.
2
Student Research Committee, Qom University of Medical Sciences, Qom, Iran.
3
Department of Pharmacognosy, School of Pharmacy, Shahid Beheshti University of Medical
Sciences, Tehran, Iran.
4
Faculty of Health, Qom University of Medical Sciences, Qom, Iran.
5
Department of Traditional Medicine, School of Traditional Medicine, Tehran University of Medical
Sciences, Tehran, Iran.
6
Department of Obstetrics and Gynecology, School of Medicine, Qom University of Medical Sciences,
Qom, Iran.
7
Spiritual Health Committee, Qom University of Medical Sciences, Qom, Iran.
Authors’ contributions
This work was carried out in collaboration among all authors. All authors read and approved the final
manuscript.
Article Information
DOI: 10.9734/JPRI/2019/v31i330303
Editor(s):
(1) Dr. Q. Ping Dou, Professor, Barbara Ann Karmanos Cancer Institute, Departments of Oncology,
Pharmacology and Pathology, School of Medicine, Wayne State University, USA.
Reviewers:
(1) Nain Taara Bukhari, Aga Khan University Hospital, Kenya.
(2)
Ronald Bartzatt, University of Nebraska, USA.
(3)
Afolabi Adeniyi Stephen, Federal Medical Centre, Nigeria.
Complete Peer review History:
http://www.sdiarticle4.com/review-history/51415
Received 25 July 2019
Accepted 28 September 2019
Published 09 November 2019
ABSTRACT
Objectives:
Heavy Menstrual Bleeding (HMB) is the most important problems of Uterine
Leiomyoma (UL). This study aimed to assess the effect of the extract of the Capsella bursa-
pastoris (CBP) on the control of HMB and quality of life in patients with uterine leiomyoma.
Original Research Article
Danesh et al.; JPRI, 31(3): 1-10, 2019; Article no.JPRI.51415
2
Design:
In a double-blind randomized, clinical trial 54 women with uterine leiomyoma were
randomly assigned to the intervention/control groups by block randomization.
Setting: Gynecology outpatient clinics.
Intervention: The intervention group received 350 mg of alcoholic extract of Capsella bursa-
pastoris and the control group received placebo twice daily for three months.
Main Outcome Measures: Amount of bleeding by Pictorial blood loss assessment chart (PBAC),
quality of life by menstrual quality of life questionnaires (MQ) and bleeding duration by calendar
were evaluated.
Results: The mean of PBAC decreased from 464.00± 283.61 at baseline to 323.82±207.66 in the
intervention group and decreased from 445.92±362.64 to 214.36±137.68 in control group in the
third month. The improvement trend was significant in the two groups, but there was no significant
difference between groups. The mean of bleeding duration and menstrual quality of life showed
improvement in patients of two groups without significant difference between the two groups.
Conclusion: Despite the effectiveness of CBP in the intervention group in decreasing of PBAC
score and menstrual bleeding duration and improvement of menstrual quality of life in patients who
suffered from UL, it did not show a significant effect compared to the control group. Future studies
with a larger sample size in one specific type of UL suggested.
Keywords: Capsella bursa-pastoris; leiomyoma; quality of life; uterine; heavy menstrual bleeding.
1. INTRODUCTION
Leiomyoma is smooth muscle tumours that occur
in various parts of the body with soft tissues and
most frequently occur in the uterus. The
estimated prevalence of uterine leiomyoma by
age 50 is nearly 70% -80%
[1-3]. Approximately,
one third to half of the women over 35 have UL
(fibroids) and 25% of women in reproductive age
affected to uterine tumours and was considered
as one of spontaneous abortion causes [4].
According to the reports, UL is responsible for
33% of hysterectomies annually in the United
States
[5]. Prolonged menstruation and irregular
bleeding (spotting) between periods are the
prevalent symptoms of leiomyoma in addition to
Heavy Menstrual Bleeding (HMB) [5,6]. HMB is
the most significant symptom of leiomyoma,
often occurs in one-third of the symptomatic
patients, and generally reflects the need for
treatment [5]. The complication of HMB is
anaemia and as a result, pallor, fatigue,
palpitations, boredom, and depression affected
on individual and social performance and is a
life-threatening problem [5,7]. Moreover, HMB in
patients with uterine leiomyoma is one of the
critical health problems and one of the most
crucial indications of hysterectomy. Several
surgical and non-surgical therapies include
laparotomy, laparoscopy, or hysteroscopy
myomectomy, uterine artery embolization and
medicinal treatments [1,4,8]. Although non-
steroidal anti-inflammatory drugs are more
effective than placebo in functional uterine
bleeding, there is no clinical evidence in favour of
their positive impact on leiomyoma-related
bleeding [4,5]. However, the oral medications
including anti-fibrinolytic drugs (e.g., tranexamic
acid), hormonal contraceptives, GnRH agonists,
selective progesterone receptor modulators,
aromatase inhibitors, and estrogen receptor
antagonists, are effective on leiomyoma-related
bleeding, but have specific complications or
contraindication [6,7,9].
Numerous studies are already underway to
investigate new medications, and a part of these
studies focuses on plants and their extracted
compounds [4,9-16]. Capsella bursa-pastoris (L.)
Medik. (Brassicaceae) commonly known as
‘shepherd’s purse’ is an edible plant with young
leaves and roots that are eaten raw or cooked in
Asian and European countries [17,18]. This plant
is one of the herbs traditionally used to control
different types of bleeding, particularly uterine
bleeding, in many cultures [13,19-23]. CBP was
referred to as "blood plant" in the middle ages
and used to control bleeding anywhere in the
body either orally (extract and decoction) or
topically [24]. The aerial parts of CBP contain
phenolic compounds, amino acids, fatty acids,
organic acids, phytosterols, tyramine, and
choline [25]. The phenolic compounds, including
flavonoids, and alkaloids are responsible for the
anti-inflammatory, analgesic, anti-fever, and anti-
cancer effects in CBP. Todays, CBP known as
an uterotrophic and hemostatic composition
[26,27]. The impact of the alcohol extract of the
CBP on the control of leiomyoma-related uterine
bleeding is not demonstrated, but its anti-
haemorrhage effect showed in several studies
[21,25]. Due to lack of information on the impact
of CBP on controlling the uterine bleeding in UL,
this study aimed to assess the effect of the
Danesh et al.; JPRI, 31(3): 1-10, 2019; Article no.JPRI.51415
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alcohol extract of this functional food on the
control of HMB and quality of life in patients with
uterine leiomyoma.
2. MATERIALS AND METHODS
2.1 Study Design and Participants
This study was a double-blind randomized,
placebo-controlled clinical trial that conducted in
outpatient clinics of Qom University of Medical
Sciences from February 2018 to January 2019. It
was approved by the ethics committee of Qom
University of Medical Science (ethical code:
IR.MUQ.REC.1396.110) and registered at
Iranian registry clinical Trials centre (No
IRCT20161226031582N1).
Inclusion criteria consisted of women within the
age range of 18 to 45 years, menstrual bleeding
with a score more than 100 in Pictorial Blood
Assessment chart (PBAC), uterine leiomyoma
proven by ultrasound, not use of any effective
medication on menstrual bleeding (OCP, ASA,
anti-coagulant), not regular herbal using
during the 2 weeks before the study, no
abnormal pap smear, no pregnancy, no
breastfeeding and absence of systemic disease
(thyroid, hyperprolactinemia, coagulopathy,
hemoglobinopathy). Exclusion criteria were
surgical indications including abnormal bleeding
that led to haemodynamic instability, acute pain,
severe urinary symptoms or hydronephrosis and
Unwillingness to continue treatment.
The minimum sample size for this study
calculated based on the power 80%, confidence
interval 95%, and the acceptable precision.
Based on the results of Naafe et al study, (mean
difference=5.3, SD for each group=6), the
minimum sample size for each group was
estimated as 22 patients [21].
2.2 Randomization
The block random allocation method used to
assign the eligible patients to the study groups.
The size of block considered 4. Therefore, six
quadruple blocks created. Selection of each
block was a crash and done using dice throwing.
Each patient received a code at the beginning of
the study and was placed in either A or B group.
2.3 Preparation of Drug and Placebo
The aerial part of Capsella bursa pastoris (L.)
Medik. was collected from the areas around
Khansar City (Isfahan Province) in June 2017. In
the botanical lab of the School of Pharmacy,
Shahid Beheshti University of Medical Sciences,
Tehran, with herbarium code SBMU-1054 was
identified. According to previous studies, this
plant is safe and LD50 values are more than
3000 mg/kg [28]. For preparing the drug, C.
bursa-pastoris plants were soaked at room
temperature with 96% alcohol for 3 consecutive
nights (X 3) and thus extracted. After evaporation
of alcohol, dry powder of plant prepared and
mixed with starch and packed in capsules of size
0, made by Iran Gelatin capsule company. Each
capsule has 350 mg extract (from 7 gram of
plant) and 150 mg starch. The average
therapeutic dose of CBP for internally use is 10-
15 grams dry plant per day [21,29]. The extract
of CBP was analyzed for the total Phenolic,
flavonoid, and tannin content, respectively by the
Folin–Ciocalteu colorimetric method, aluminium
trichloride method and titrimetric indigosulphonic
acid assay [30-33].
The placebo capsule filled with the 150 mg of
starch. The drug and placebo capsules were
similar in shape and size and were given to
participants twice a day. The prepared capsules
were delivered to the researcher in sealed
packages coded with A and B. The A or B code
for the drug and placebo was randomly selected.
2.4 Measurements
Abnormal uterine bleeding was assessed by
Pictorial blood assessment chart (PBAC). PBAC
is a chart that works by recording a count for
each type of sanitary pad used and its degree of
soaking that depicted in a pictorial table along
with the count and size of blood clots. The scores
of full filled, half-filled, and less than half-filled
sanitary pad are 20, 5 and 1, respectively. In
addition, the score of a small blood clot and large
blood clot are 5 and 1, respectively. Finally, the
scores are summed and one score calculate for
each patient. If the score is more than 100, it
indicates uterine bleeding is more than 80 cc.
The accuracy of this test has been reported
differently in different studies but is still the most
applicable method for measuring the amount of
menstrual blood loss [34]. In addition, the
Persian version of the Menorrhagia
Questionnaire (MQ) was used to assess the
quality of life. The total score of MQ varied from
zero to 100 and a lower score means a better
quality of life. The validity and reliability of this
questionnaire have been confirmed in other
studies in Iran [35,36].
Danesh et al.; JPRI, 31(3): 1-10, 2019; Article no.JPRI.51415
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2.5 Intervention
Before the study, the patient evaluated for
participation in the intervention. First, PBAC chart
was given to them for assessment the amount of
bleeding for baseline. This chart was given to
them three-time else during the study, at first,
second and third month after the intervention.
Before and after of treatment, vaginal and
abdominal ultrasound were performed according
to the patient's condition and the size of the
leiomyoma under the supervision of a specialist
in the infertility centre of Forghani Hospital in
Qom. Before the intervention, pelvic exam also
was performed for the Married participants.
Laboratory tests including TSH, PT, PTT, Hb, Plt
was measured in the laboratory of Forghani
hospital before study to rule out other causes of
bleeding. After delivery of the first PBAC form by
the patient, two capsules were prescribed per
patient code (A or B) daily for three months.
Patients were advised to take capsules at 10 AM
and 5 PM for better absorption with a glass of
water. In this study, that was double-blind, both
patients and researchers were unaware of the
particular drug-assigned to each patient. All
patients in two studied groups were given iron
supplementation, due to ethical considerations.
MQ form completed two times by the patient
once at baseline and again at the end of the
study after the intervention.
2.6 Statistical Analysis
Data included PBAC scores, MQ scores, number
of bleeding days, ultrasound results, laboratory
test results, and other collected data analyzed by
SPSS software (IBM Corp. Released 2013. IBM
SPSS Statistics for Windows, Version 21.0.
Armonk, NY: IBM Corp.). Intention to treatment
method was used for comparing data between
two groups. Normality of data checked by
histogram and Shapiro-wilk test. Descriptive
statistics including mean and percent frequency
was used for descriptive data. Chi-square and t-
test used to compare the studied variables in the
intervention and control groups. Moreover, the
analysis of variance for repeated measures was
used to assess the within and between trend of
bleeding in two groups.
3. RESULTS
3.1 Phytochemical Analysis Results
Total phenolic and flavonoid contents of the CBP
alcoholic extract were 29 mg GAE /g powder and
19.6 mg rutin/g powder, respectively. The
percentage of tannin in terms of Gallic acid in the
CBP plant was 4.57%.
3.2 Clinical Trial Results
140 women with heavy menstrual bleeding and
uterine leiomyoma were evaluated for their
eligibility to study.81 patients did not meet the
inclusion criteria, 4 of them did not accept to
participate and one of them did not follow the
next steps. Finally, 54 eligible patients were
randomized in two groups, intervention (n=27)
and placebo (n=27). In the first month of study,
three patients in intervention group were
excluded because lack of control of heavy
bleeding and one in placebo group was excluded
for unwillingness to continue the intervention. In
the second month, one patient in intervention
group was excluded because of she of
pregnancy. In the third month, one patient in
intervention group was excluded due to failure to
deliver the form of bleeding and one in placebo
group because of consumption of another herbal
medicine with the drug. Finally, the results of the
study were analyzed with 47 subjects, 22
patients in intervention group and 25 ones in
placebo group (Fig. 1). After completing the
study, the nature of the drug samples were
disclosed by the pharmacologist.
The baseline demographic characteristics (Table
1) including age, level of education, marital
status, body mass index, and blood pressure
were analyzed. Two group are homogenous in
BMI 28.4±5.75 vs. 30.74±5.23 (p=0.151), systolic
BP 112.01 ± 12.66 Vs. 118.15 ±15.24 (p= 0.136),
diastolic BP 76.2±8.86 vs. 76.59±10.84 (p=0.41)
and age 41.27±3.15 vs. 40.0±4.70 (p=0.277).
Moreover, two groups were same regarding to
the educational level (p=0.396) and marital
status (p=0.230).
The mean of baseline bleeding based on PBAC
score in intervention and control group was
464.00±283.61 and 445.92±362.64, respectively
and their difference was not statistically
significant (p=0.851). The independent t-test
(Table 2) also did not show significant difference
between two groups one months after treatment
(p=0.160). Nevertheless, a significant difference
showed in PBAC score after second (p=0.017)
and third month (p=0.037) of treatment. The
analysis of variance for repeated measurement
showed that there was a significant decreasing
trend in PBAC score in two groups (p<0.001), but
the improvement trend was not statistically
different between two groups (p=0.115).
Danesh et al.; JPRI, 31(3): 1-10, 2019; Article no.JPRI.51415
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Fig. 1. The CONSORT diagram
Table 1. Comparison the baseline demographic and blood pressure of two studied groups
Characteristic
CBP group (n=22)
Control group (n=25)
P- value
Age 40.0±4.70 41.27±3.15 0.277*
BMI 30.74±5.23 28.4±5.75 0.151*
Systolic BP 118.15±15.24 112.01±12.66 0.136*
Diastolic BP 76.59±10.84 76.2±8.86 0.410*
Marital Status Single 7(28%) 3 (13.6%) 0.230**
Married 18(72%) 19(86.4%)
Education Lower diploma 8(32%) 8(36.4%) 0.396**
Diploma 8(32%) 9(40.9%)
Bachelor and higher 9(36%) 5(22.7%)
*t-test; **Chi square test
Table 2. Comparison of PBAC scores before and after treatment
PBAC score
Control group (n=25)
P value*
Mean
SD
Mean
SD
Baseline 464.00 283.61 445.92 362.64 0.851
After first month 372.64 225.63 261.36 297.29 0.160
After second month 357.59 242.71 215.40 145.10 0.017
After third month 323.82 207.66 214.36 137.68 0.037
P value** <0.001 <0.001
*T-test; ** Analysis of variance for repeated measurement
Danesh et al.; JPRI, 31(3): 1-10, 2019; Article no.JPRI.51415
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Table 3. Comparison of duration of bleeding before and after treatment
Duration of bleeding
CBP (n=22)
Control group (n=25)
P value*
Mean
SD
Mean
SD
Baseline 10.32 5.60 9.80 6.23 0.767
After first month 8.50 2.54 8.32 2.88 0.822
After second month 8.54 3.66 7.00 2.96 0.117
After third month 8.91 2.99 7.80 2.39 0.165
P value** <0.001 0.001
*T-test; ** Analysis of variance for repeated measurement
The independent t-test showed that the mean of
bleeding duration (Table 3) was not statistically
significant between two groups at baseline and
each month during the intervention (p>0.05).
Nevertheless, analysis of variance for repeated
measurement showed that there was a
significant decreasing trend in bleeding duration
in intervention and control groups (p=0.001).
However, there was no significant difference
between two groups (p=0.308).
In the present study, the menstrual quality of life
was same in two groups (55.44±11.96 Vs
47.79±16.81) at baseline (p=0.083) and it is not
different between groups (44.84±16.02 vs.
37.71±18.31) after the intervention (p=0.165).
However, the improvement of quality of life was
observed in two study groups (p<0.001).
In the ultrasound, before and after the study, the
number, size, and type of each leiomyoma were
recorded. The mean number of leiomyoma in the
intervention and control groups was 1.67 ±0.945
and 1.72±0.890, respectively. Based on paired t-
test, there was no significant difference in a
number of leiomyoma between the two groups
before and after the study. T-test also did not
show a significant difference in the size of
leiomyoma between two groups before and after
the study. Moreover, the size of the leiomyoma
did not show any significant change after
treatment and was not significant between the
two groups (p>0.05). The most common typical
types of leiomyoma were intramural, subserosal
and submucosal, respectively.
3.3 Side Effects
There was no significant difference between two
groups regarding to side effects. (p>0.05). In the
intervention group, 18.2% (4 patients), and in the
placebo group 16% (4 patients), were reported
side effects. The complications in the intervention
group including hemorrhoid (9.1%), constipation
(4%), Skin dryness (4%), and pelvic cramps
(4%). The complications in control group
including stomach ache, headache, hair loss,
and acne.
4. DISCUSSION
The current study was the first randomized
clinical trial on the effect of CBP in heavy
menstrual bleeding due to UL. Our results
showed a significant improvement trend in PBAC
score in all studied patients in two groups and
there was no significant difference between
intervention and control groups. However, the
mean of uterine bleeding decreased in the
intervention group from 464.00± 283.61 at
baseline to 323.82±207.66 in the third month
after treatment with CBP. Moreover, the mean of
bleeding decreased from 445.92±362.64 to
214.36±137.68 after follow up in control group.
Other studies showed that the extract of CBP is
an effective drug on control of non-structural
heavy menstrual bleeding and postpartum
haemorrhage [21,22] (1,2). Our results also
showed a decrease in duration of bleeding but
there was not the difference between CBP and
control group. The mean of days with bleeding
decrease from 10.32±5.60 to 8.91±2.99 in
intervention group and decreased from
9.80±6.23 to 7.80±2.39 in control group.
Although CBP has been effective in reducing
bleeding in this study, other studies on the effect
of this plant on unrelated leiomyoma uterine
bleeding have reported better results. The study
was conducted in Iran by Naafe et al., on the
effect of CBP on non-structural uterine bleeding
showed a reduction in the amount of menstrual
bleeding by the hydroalcoholic extract of CBP.
This reduction was more significant in the CBP
group, compared to the control group [21].
Another study was conducted by Ghalandari et
al., demonstrated that the amount of postpartum
bleeding was lower in the CBP and oxytocin
group first, second, and third hours after the
delivery, compared to the oxytocin group [22].
The chemical composition and biological effect of
CBP is responsible for the control of bleeding.
Danesh et al.; JPRI, 31(3): 1-10, 2019; Article no.JPRI.51415
7
Some studies assume that its contractile nature
of CBP is due to the presence of oxytocin-like
polypeptides [37]. CBP is rich in phenolic and
flavonoid compounds that show the antioxidant,
anti-inflammatory and antibacterial effects of this
plant [11,24,25]. In the past, tyramine and
choline were responsible for controlling the
bleeding by the plant. Todays, new researches
have shown that other substances that are not
fully recognized may be responsible for such an
effect [25-38]. Anyway, the contractile and
hemostatic nature of this drug cannot be ignored.
Different response to treatment in this study may
be due to the mechanism of uterine bleeding in
leiomyoma like widening of endometrial veins,
vascular weakness, and abnormal contractions
of the uterus and leiomyoma superficial vascular
bed. Moreover, haemeostatic problems due to
abnormal angiogenesis caused a synergistic
effect on heavy bleeding [1,39].
Due to the inflammatory environment
surrounding leiomyoma, any anti-inflammatory
agent, including flavonoids, can be effective in
controlling the complications of these tumors.
Perhaps the higher amount of this substance in
the plant will be more effective in controlling
inflammation and symptoms in the leiomyoma. A
study conducted by Memarzadeh et al., showed
that Persian Gulnar significantly reduced
leiomyoma related uterine bleeding. In that study,
the flavonoid content of Gulnar was much higher
than the current study. Therefore, Gulnar has
been more effective than CBP in controlling
leiomyoma symptoms [40]. Control of
inflammation is only one of the mechanisms of
control of hemorrhage in patients with
leiomyoma. In herbal studies on control of uterine
bleeding, Tannins have an astringent property
and can cause contraction of uterine vessels that
leads to decreased exudation and blood loss
[32,36,40,41]. Compared to some materials such
as pomegranate peel and oak, tannin content of
CBP is relatively low [30,42,43].
The anatomical position, number and size of the
uterine leiomyomas are effective factors of the
volume of bleeding in patients with UL that
caused excessive uterine bleeding as well as
prolonged menstrual period [1,6,44].
The ultrasound showed both groups were similar
in number and size of the leiomyomas before the
study. The mean number and size of the
leiomyoma did not change significantly after the
study in both groups. Stewart's study, which was
based on the effect of two doses of asoprisnil (10
or 25 mg) on uterine bleeding with leiomyoma,
after 6 months, showed reduction in size of
uterine leiomyoma up to 45% with asoprisnil 10
mg and 54% with asoprisnil 25 mg versus
increase in size of uterine leiomyoma up to 44%
with placebo [7]. Contrary to Stewart's study in
the current study, no increase in leiomyoma size
observed. Short duration of our study or CBP
effect may be responsible for such a result.
The most common typical location of leiomyoma
in our study was intramural, subserosal and
submucous respectively like other studies such
Memarzadeh [40].
Based on the recent studies, UL is a significant
related factor in decreasing the quality of life in
women of reproductive age
1
. Improvement in
mean scores of menstrual quality of life was
same in our and Memarzadeh study. (p<0.001)
[40]. In the study by Naafe, the patient's
satisfaction rate was significantly higher in the
CBP group compare to control group [21]. These
results also point to a better performance of CBP
in reducing non-structural uterine bleeding over
structural causes.
The most side effects in the intervention group
were hemorrhoid, constipation, skin dryness, and
pelvic cramps. This plant is anti-diarrhea in
folklore medicine so constipation was because of
the astringent nature of the plant [24].
Hemorrhoid may be due to constipation. Pelvic
cramps are also due to contractions was created
by the plant [37]. Stomachache, hair loss,
headache, and acne were the most
complications in patients of the intervention
group. These complications seem to be more
due to blood loss.
The present study assessed the extract effect of
CBP on heavy menstrual bleeding and quality of
life in patients suffering from uterine leiomyoma
for the first time in a pilot study.
Mechanisms of bleeding are different in
leiomyoma as structural uterine problems with
nonstructural disorders so more studies must
have conducted to compare the effect of CBP on
bleeding due to structural and nonstructural
uterine disorders. It also recommended studying
the possible effects of starch on uterine bleeding
and leiomyoma.
5. CONCLUSION
The CBP caused an improvement trend in PBAC
score of patients who suffered from UL and
Danesh et al.; JPRI, 31(3): 1-10, 2019; Article no.JPRI.51415
8
decrease the menstrual bleeding duration.
Moreover, the menstrual quality of life showed an
improvement trend. However, there was no
clinically significant difference between
intervention and control groups regarding to
PBAC score, bleeding duration and quality of life.
6. LIMITATION
Small sample size and variety in types of UL
were the limitations of this study. Therefore,
future studies with larger sample size in one
specific type of UL suggested.
CONSENT AND ETHICAL APPROVAL
This study was a double-blind randomized,
placebo-controlled clinical trial that conducted in
outpatient clinics of Qom University of Medical
Sciences from February 2018 to January 2019. It
was approved by the ethics committee of Qom
University of Medical Science (ethical code:
IR.MUQ.REC.1396.110) and registered at
Iranian registry clinical Trials centre (No
IRCT20161226031582N1).
Enrolment of eligible patients was based on
convenience methods after a description of study
purpose to each patient and signing the informed
consent form.
COMPETING INTERESTS
Authors have declared that no competing
interests exist.
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... The fumarates found in shepherd's purse showed a protective effect against autoimmune encephalomyelitis in mice (Al-Snafi, 2015a). C. bursa-pastoris has uterotrophic and hemostatic activities, reducing the heavy menstrual bleeding and duration of bleeding, probably due the presence of oxytocin-like polypeptides and flavonoids with anti-inflammatory potential (Danesh et al., 2019;Istudor, 2005;Stanescu et al., 2014). A quaternary ammonium salt isolated from Bursae pastoris herba may be responsible for some of its activities (EMA/HMPC/262767/2010). ...
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Wider implications of the findings: Daily uninterrupted treatment with asoprisnil was highly effective in controlling menstrual bleeding, improving anemia, reducing fibroid and uterine volume, and increasing HRQL in women with HMB associated with uterine fibroids. However, this treatment led to an increase in endometrial thickness and invasive diagnostic and therapeutic procedures, with potential unknown consequences. Study funding/competing interest(s): This trial was funded by AbbVie Inc. (prior sponsors: TAP Pharmaceutical Products Inc., Abbott Laboratories). E.A. Stewart was a site investigator in the Phase 2 study of asoprisnil and consulted for TAP during the design and conduct of these studies while at Harvard Medical School and Brigham and Women's Hospital. She received support from National Institutes of Health grants HD063312, HS023418 and HD074711 and research funding, paid to Mayo Clinic for patient care costs related to an NIH-funded trial from InSightec Ltd. She consulted for AbbVie, Allergan, Bayer HealthCare AG, Gynesonics, and Welltwigs. She received royalties from UpToDate and the Med Learning Group. M.P. Diamond received research funding for the conduct of the studies paid to the institution and consulted for AbbVie. He is a stockholder and board and director member of Advanced Reproductive Care. He has also received funding for study conduct paid to the institution from Bayer and ObsEva. A.R.W. Williams consulted for TAP and Repros Therapeutics Inc. He has current consultancies with PregLem SA, Gedeon Richter, HRA Pharma and Bayer. B.R. Carr consulted for and received research funding from AbbVie. E.R. Myers consulted for AbbVie, Allergan and Bayer. R.A. Feldman received compensation for serving as a principal investigator and participating in the conduct of the trial. W. Elger was co-inventor of several patents related to asoprisnil. C. Mattia-Goldberg is a former employee of AbbVie and may own AbbVie stock or stock options. B.M. Schwefel and K. Chwalisz are employees of AbbVie and may own AbbVie stock or stock options. Trial registration number: NCT00152269, NCT00160381 (clinicaltrials.gov). Trial registration date: 7 September 2005; 8 September 2005. Date of first patient’s enrolment: 12 September 2002; 6 September 2002.
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The analysis of pomegranate phenolic compounds belonging to different classes in different fruit parts was performed by high-performance liquid chromatography coupled with photodiode array and mass spectrometry detection. Two different separation methods were optimized for the analysis of anthocyanins and hydrolyzable tannins along with phenolic acids and flavonoids. Two C18 columns, core–shell and fully porous particle stationary phases, were used. The parameters for separation of phenolic compounds were optimized considering chromatographic resolution and analysis time. Thirty-five phenolic compounds were found, and 28 of them were tentatively identified as belonging to four different phenolic compound classes; namely, anthocyanins, phenolic acids, hydrolyzable tannins, and flavonoids. Quantitative analysis was performed with a mixture of nine phenolic compounds belonging to phenolic compound classes representative of pomegranate. The method was then fully validated in terms of retention time precision, expressed as the relative standard deviation, limit of detection, limit of quantification, and linearity range. Phenolic compounds were analyzed directly in pomegranate juice, and after solvent extraction with a mixture of water and methanol with a small percentage of acid in peel and pulp samples. The accuracy of the extraction method was also assessed, and satisfactory values were obtained. Finally, the method was used to study identified analytes in pomegranate juice, peel, and pulp of six different Italian varieties and one international variety. Differences in phenolic compound profiles among the different pomegranate parts were observed. Pomegranate peel samples showed a high concentration of phenolic compounds, ellagitannins being the most abundant ones, with respect to pulp and juice samples for each variety. With the same samples, total phenols and antioxidant activity were evaluated through colorimetric assays, and the results were correlated among them.
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Uterine fibroids (leiomyomata) are common uterine neoplasms that are often associated with detrimental symptoms, such as heavy menstrual bleeding, dysmenorrhea, and pressure-related symptoms, which often lead to surgical intervention, including hysterectomy. Although our understanding of the pathophysiology of uterine fibroids, particularly their dependency on progesterone and the role of growth factors, has increased during the past two decades, the medical options currently approved by the United States Food and Drug Administration are limited and are only used for short-term symptom management. A long-term, safe, and effective treatment is not yet available in the United States. However, emerging medical treatments that are currently under clinical development, including progesterone receptor modulators and oral gonadotropin-releasing hormone antagonists, offer hope of new long-term medical therapies for symptomatic uterine fibroids as an alternative to surgery. Herein, we discuss the current and emerging medical therapies for fibroids based on evidence from randomized clinical trials. © 2017 by Thieme Medical Publishers, Inc., 333 Seventh Avenue, New York, NY 10001, USA.