The Effect of Fennel on Pain Quality, Symptoms, and Menstrual Duration in Primary Dysmenorrhea

Abstract

Study Objectives
To assess the effectiveness of fennel on primary dysmenorrhea symptoms and menorrheal duration.

Design
Clinical trial study.

Setting
Islamic Azad University, Toyserkan.

Participants
80 female students were randomly divided in to two groups of intervention (n = 40) and control (n = 40).

Interventions
The intervention group was given one soft capsule Fennel (30 mg) every 4 hours, 3 days before menstruation till the 5th day and continued for 3 months. The control group received no medication.

Main Outcome Measures
The severity of samples pain was graded using a visual analogue scale. 5 standard questionnaires include of Visual analog scale pain (VAS), McGill pain questionnaire, the range of stress about dysmenorrheal (VASA), Perceived stress scale, Well being scale were filled out in intervals of before, during and after fennel capsule uptake. Data were analyzed by SPSS 17 software. P < .05 was considered to be statistically significant.

Results
The mean of nausea intensity and weakness decreased to 1.93, and 2.88 after 3 months, whereas they were 2.37, 6.65 in control group which indicated a significant difference. Reduce the duration of menstrual period, a significant difference was found after two and three months of use. Concern in terms of quality and feelings of well-being after 1 and 3 months, was observed significant difference compared with before using.

Conclusion
Considering the safety of herbal medicines, this drug can use to relieve dysmenorrheal signs and menstrual duration.

Full text

Original Study
The Effect of Fennel on Pain Quality, Symptoms, and Menstrual
Duration in Primary Dysmenorrhea
Zahra Ghodsi MD *, Maryam Asltoghiri MD
Department of Midwifery, Toyserkan Branch, Islamic Azad University, Toyserkan, Iran
abstract
Study Objectives: To assess the effectiveness of fennel on primary dysmenorrhea symptoms and menorrheal duration.
Design: Clinical trial study.
Setting: Islamic Azad University, Toyserkan.
Participants: 80 female students were randomly divided in to two groups of intervention (n 540) and control (n 540).
Interventions: The intervention group was given one soft capsule Fennel (30 mg) every 4 hours, 3 days before menstruation till the 5th day
and continued for 3 months. The control group received no medication.
Main Outcome Measures: The severity of samples pain was graded using a visual analogue scale. 5 standard questionnaires include of Visual
analog scale pain (VAS), McGill pain questionnaire, the range of stress about dysmenorrheal (VASA), Perceived stress scale, Well being scale
were filled out in intervals of before, during and after fennel capsule uptake. Data were analyzed by SPSS 17 software. P!.05 was
considered to be statistically significant.
Results: The mean of nausea intensity and weakness decreased to 1.93, and 2.88 after 3 months, whereas they were 2.37, 6.65 in control
group which indicated a significant difference. Reduce the duration of menstrual period, a significant difference was found after two and
three months of use. Concern in terms of quality and feelings of well-being after 1 and 3 months, was observed significant difference
compared with before using.
Conclusion: Considering the safety of herbal medicines, this drug can use to relieve dysmenorrheal signs and menstrual duration.
Key Words: Fennel soft capsule, Menorrheal duration, Pain quality, Symptoms
Introduction
Dysmenorrhea is one of the most common gynecologic
conditions in women regardless of nationality.
1
Primary
dysmenorrhea often starts shortly before or just after the
onset of the menstrual flow and usually the pain duration is
commonly 48-72 hours.
2
Associated general symptoms,
such as nausea and vomiting (89%), malaise, weakness
(85%), lower backache (60%), diarrhea (60%), and headache
(45%), may be present with primary dysmenorrhea.
2
The
prevalence of dysmenorrhea among youth is about 60%-
96%.
3,4
It occurs only in ovulatory cycles and in women with
high levels or increased sensitivity to prostaglandins.
5,6
High levels of prostaglandin stimulate myometrial con-
tractions, ischemia, and sensitization of pain fibers, which
lead to pelvic pain.
5
Studies have shown that dysmenorrhea is one the most
disruptive factors affecting life quality and social activity of
young women; it makes the person weak and lethargic,
especially if there are symptoms like headaches, weakness,
vomiting, and spasm.
7
Nonsteroidal anti-inflammatory
drugs (NSAID) and oral contraceptive pills, both of which
work by reducing uterine contractions, are the most
common pharmacologic treatments for dysmenorrhea.
8
NSAIDs act by blocking prostaglandin production.
7
The ef-
ficacy of conventional treatments such as nonsteroidals is
considerable; however, the failure rate is still often 20%-
25%.
9,10
Most women do not seek medical treatment
because they believe it would not help to reduce dysmen-
orrhea.
11
In addition, side effects may not be well tolerated
by some women with primary dysmenorrhea.
Many consumers are now seeking alternatives to con-
ventional medicine.
10
Many Americans, nearly 40%, use
health care approaches developed outside of mainstream
Western, or conventional, medicine for specific condi-
tions.
12
Complementary and alternative medicine (CAM),
such as acupuncture, homeopathy, nutritional therapies,
and herbal products with low toxicity, refers to medical
interventions and techniques that are not a part of medical
system.
9
In 51 reports from 49 surveys conducted in 15
countries, prevalence of use of any CAM was 9.8%-76%.
13
Herbal and dietary therapies are more popular comple-
mentary medicines, are suitable for dysmenorrhea, and
are classified in the US as supplements.
11
There are many
studies that show efficacy on primary dysmenorrhea of
herbal therapies such as acupuncture, aromatherapy, and
heat therapy or dietary therapy such as vitamin E.
9,14,15
A
recent study in America showed that the use of vitamin E
taken at 800 IU per day significantly decreases the pain of
primary dysmenorrhea
16
and that it may even be helpful for
decreasing bleeding during menstruation.
17
A recent study
The authors indicate no conflicts of interest.
*Address correspondence to: Zahra Ghodsi, MD, Department of Midwifery, Toy-
serkan Branch, Islamic Azad University, Hayaghooghe Nabi Blvd, Toyserkan, Iran;
Phone: 0098 852 4223288; fax: 0098 852 4225353
E-mail address: Ghodsi2003@yahoo.com (Z. Ghodsi).
1083-3188/$ - see front matter Ó2014 North American Society for Pediatric and Adolescent Gynecology. Published by Elsevier Inc.
http://dx.doi.org/10.1016/j.jpag.2013.12.003

of 120 Iranian students found that treatment of primary
dysmenorrhea with ginger for 5 days has a statistically
significant effect on pain relief.
18
Another studies showed
more efficacy of herbal drugs compared to mefenamic
acid.
18,19
Research has shown that sweet fennel, Foeniculum vul-
gare, can reduce menstrual pains by lowering the level of
prostaglandins in blood circulation.
20,21
Drug information
center recommends the daily uptake of 1 up to 1.5 cup of
fennel powder to reduce dysmenorrhea.
20
Recently, a new
form of sweet fennel in a capsule of 30 mg is prescribed for
pain reduction in case of dysmenorrhea.
21
Information on
the effectiveness of soft capsule of fennel on primary
dysmenorrhea and symptom is limited. The aim of the
present study was to determine the effect of soft fennel
capsules on primary dysmenorrhea.
Subjects and Methods
The research was conducted on 80 female students who
provided informed written consent, from January 12 to
April 12, 2012. First, the ethics confirmation was received
from the Research Ethics Committee of Toyserkan Azad
University. After access to medical students and explaining
the survey, the researcher asked students if they have pre-
menstrual pain, and willingness to participate in research to
be investigated.
All student applicants underwent general physical ex-
aminations for the diagnosis of secondary and primary
dysmenorrhea. Students with primary dysmenorrhea and
pain scoring higher than 3, based on visual analog scales
(VAS) entered the study and were divided randomly into 2
equal groups of intervention (n 540) and control (n 5
40). The inclusion criteria were the willingness to take
part in the study, age range of 18-23, and showing
dysmenorrhea more than 3 based on the score of pain
ruler. The exclusion criteria were mild dysmenorrhea,
student transferring to another university, unwillingness
to attend the research, irregular uptake of capsules; any
similar analgesic drug uptake, the occurrence of unbear-
able side effects, and cases with the following diagnosis:
pelvic inflammatory disease, endometriosis, and any
pelvic tumor.
The intervention group received 30 mg fennel capsules
each 4 hours (8 am to 12 midnight) from about 3 days
before menstruation till end of fifth day for 3 months. There
was no treatment for control group and they did not receive
any placebo. The same questionnaires were given to inter-
vention and control group.
The data sampling tools were a demographic form
including age, menstruation cycle, intensity of dysmenor-
rhea, the level of social activity disturbance, the intake of
painkillers during menstruation and the background of
menstruation, and 5 standard questionnaires as follows:
Visual analog scale pain
McGill pain questionnaire
The range of stress about dysmenorrhea
Perceived stress scale
Well being scale and item
VAS used in first visit to grade pain severity, by marking
on a 10-cm vertical line with a range of 0 (no pain) to 10
(severe pain). Also, VAS was used to measuring 3 symptom
include of nausea and weakness before fennel intake, and
after 1, 2, and 3 months of use in 2 groups. The short-form
McGill pain questionnaire (SF-MPQ) of 15 questions was
used in order to measure pain quality before fennel intake,
and after 1 and 3 months of use. The range of stress or worry
about dysmenorrhea, perceived stress scale comprising 10
questions, and WELL being scale comprising 12 questions
all were used for the other symptoms including levels of
anxiety, stress, and well-being. To determine the validity of
research tools, content validity test and for justifiability of
tools, retests have been applied. Two questionnaires with a
1-week interval were given to 10 similar participants with
case studies to complete. The confidence level of ques-
tionnaire was 94%. SPSS version 17 was used for statistical
analysis.
Results
Two participants of the control group were excluded due
to unwillingness to continue participation in the study, so
the control group consisted of 38. The resulting age aver-
ages in intervention and control groups were 20.8 and 20.5,
respectively. The average age of menstruation initiation
was 13.1 years and the average age for the initiation of
dysmenorrhea were14.7 and 14.4, respectively. No signifi-
cant differences have been observed regarding the vari-
ables. The majority of intervention (67.5%) and control
(60.5%) groups experienced menstruation pain in more half
of the cycles in last year. 57.5% of intervention and 63.2% of
control groups used pain killers for dysmenorrhea pain
during the day before.
No significant difference was observed for nausea be-
tween the 2 groups before intervention and 1 month after
treatment. The averages of nausea points of most students in
both groups were mild. The mean change in nausea score
(from 2 to 3 months of treatment) in the fennel group was
significantly greater than the other group. The level of
weakness was equal in both groups at the beginning of the
experiment. The drug uptake in duration of 1 upto 3 months
decreased weakness point and showed statistical significant
difference after 3 months in both groups (Table 1).
Fig. 1 shows the changes of bleeding duration before and
after drug uptake. The majority of intervention group
menstruation duration decreased from about 7 to 6 days.
However, drug uptake did not have any effect on decrease of
bleeding amount.
Table 2 shows a statistical significant different of worries
points between before and after intervention. The pain
Table 1
Comparison of Nausea and Weakness in the 2 Groups
Variable Time Intervention
(mean SD)
Comparison
(mean SD)
Pvalue
Nausea Before use 2.85 2.98 2.63 2.54 .95
After use 1.93 2.80 2.37 2.55 .03
Weakness Before use 6.65 2.76 6.39 2.71 .68
After use 2.88 2.20 6.39 2.71 .001
Z. Ghodsi, M. Asltoghiri / J Pediatr Adolesc Gynecol 27 (2014) 283e286284

quality of menstruation was severe before capsule uptake in
45% percent of student, was moderate after 1 month uptake
in 42.5%, and was mild after 3 months of uptake in 85% of
them. Drug uptake in 1-3 months changed the points for
good feeling (Table 2).
Discussion
In this study, nausea and weakness by a 3-month uptake
of capsules decreased dramatically in intervention group in
comparison with control group. The average of weakness
points of 42.1% of students in control group was moderate
to severe whereas it was mild in 70% of samples in inter-
vention group. Weakness could be an important factor in
limiting the daily activities that cause a decrease in women
social activities.
22
Weakness plus worries could cause dis-
orders in living quality and absence from work space.
7
Yazdani and colleagues showed that fennel drop was
more effective in decreasing depression, aggressiveness,
and pain stomach and pelvic region.
23
The results of this study showed that the pain quality of
menstruation changed after capsule uptake and that this
decrease in pain was more considerable after months of
uptake. Most cases showed a more improvement in the
second day of menstruation in comparison with the first day.
In addition, after 1, 2 and 3 months use of capsule, pain
significantly decreased. In a study in Iran, uptake of fennel
and its effects on weakness intensity, nausea and vomiting,
reluctance, diarrhea, headache, and unconsciousness did not
have significant difference in treatment group in comparison
with placebo. But, the intensity of symptoms in treatment
group that was graded by pointing system decreased
significantly in comparison with placebo group.
24
In another
study by Nazarpour and Azimi, after 2 periods of treatment
with placebo, mefenamic acid, and fennel showed that by
longer treatment, the difference between averages of pain
intensity became greater.
25
There was a significant decrease in bleeding duration
in fennel treatment group after 1 and 3 months of use. In
a research by Bokaei et al, fennel essence could cause
decrease of bleeding duration in comparison with ibuprofen
group.
26
In another study on groups treated with fennel,
mefenamic acid, and placebo, similar results have been
obtained. In addition, after 2 periods of fennel treatment,
the intensity of symptoms significantly decreased in com-
parison with placebo and in some parts with mefenamic
acid.
25
Conclusion
In general, the results of the present study suggested that
the soft capsule of fennel is a good and effective treatment
for dysmenorrhea and its socio-psychotic problems. This
form of drug was tested for the first time in form of soft
capsule in Iran. It is recommended that healthcare pro-
viders consider it as treatment of primary dysmenorrhea. In
similar studies in other countries, larger groups of popula-
tion are recommended.
Acknowledgment
We would like to thank president and vice-president of
research of Islamic Azad University, Toyserkan Branch, Dr. S.
Jamebozorgi, and Dr. M. Hokmabadi for their cooperation in
this study.
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Table 2
Comparison of Signs before and after Fennel Use in Intervention Group
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Pain quality 30.15 12.85 12.95 5.90 .000
Stress Scale 23.83 5.48 19.38 5.76 .001
Well-being scale 35.6 10.06 21.78 7.81 .001
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