Investigation the effect of oral Aloe Vera gel pills supplementation on the intensity of primary menstrual pain (Dysmenorrhea)

Abstract

Introduction. This study was conducted to evaluate the effects of oral aloe vera gel pills supplementation on the intensity of menstrual pain. A randomized, single-blind clinical experimental plan was conducted amongst 150 single students aged 20 to 26 years who suffered from menstrual pain, at the Islamic Azad University of Medical Sciences from December 24, 2015 to October 22, 2016. The extent of pain was evaluated using the Cox Menstrual Symptom Scale (CMSC).
Material and method. Each participant was randomly assigned to aloe vera gel pill or the anti-PG drug Ibuprofen, ending with 60 participants in each group equally. The first trial group received 10 mg of aloe vera gel orally four times daily until the pain grade reached one or less. The control group received Ibuprofen and three tablets orally three times a day. The participants were permitted to take another drug that they usually took for their pain relief, in addition to the allocated treatment in case of continued pain. At the end of the trial, these participants were excluded in data analysis.
Results and discussions. Changes in the grade and the duration of the pain of participants were compared at the first and second months in both groups. Sample size was computed using α = 5% and absolute error equal to 0.24 for correlation between medication and pain with acceptable absolute precision formula (AAPF). Result of this study showed that the mean age was 22.1±1.4and 20.4±1.2 years in aloe vera gel pills and Ibuprofen groups, respectively. No significant difference was observed for the matched characteristics studied between the treated groups. the mean pain grade amongst aloe vera group was decreased from 2.81±0.65 to 2.02±0.34, while in Ibuprofen group from 2.48 ± 0.4 to 1.32 ± 0.15, respectively, using the described given dose. As result obtained that there was no statistically significant decrease in pain duration for the women who received Ibuprofen compared to those who used aloe vera. Also there was no significant difference in pain grade between the groups at the second month of intervention (p=0.61). Pain duration at the second month of trial was similar between the both groups (p=0.76).
Conclusions. In conclusion we could suggest that aloe vera gel pill as a novel herbal pain killer represents an effective treatment for the menstrual pain with no important side effects, although further clinical trials are recommended to look at the possible side effects in an extended spectrum of subjects.

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Abstract
Introduction. This study was conducted to evaluate the effects of oral aloe vera gel pills supplementation on
the intensity of menstrual pain. A randomized, single-blind clinical experimental plan was conducted
amongst 150 single students aged 20 to 26 years who suffered from menstrual pain, at the Islamic Azad
University of Medical Sciences from December 24, 2015 to October 22, 2016. The extent of pain was
evaluated using the Cox Menstrual Symptom Scale (CMSC).
Material and method. Each participant was randomly assigned to aloe vera gel pill or the anti-PG drug
Ibuprofen, ending with 60 participants in each group equally. The first trial group received 10 mg of aloe
vera gel orally four times daily until the pain grade reached one or less. The control group received
Ibuprofen and three tablets orally three times a day. The participants were permitted to take another drug that
they usually took for their pain relief, in addition to the allocated treatment in case of continued pain. At the
end of the trial, these participants were excluded in data analysis.
Results and discussions. Changes in the grade and the duration of the pain of participants were compared at
the first and second months in both groups. Sample size was computed using α = 5% and absolute error
equal to 0.24 for correlation between medication and pain with acceptable absolute precision formula
(AAPF). Result of this study showed that the mean age was 22.1±1.4and 20.4±1.2 years in aloe vera gel pills
and Ibuprofen groups, respectively. No significant difference was observed for the matched characteristics
studied between the treated groups. the mean pain grade amongst aloe vera group was decreased from
2.81±0.65 to 2.02±0.34, while in Ibuprofen group from 2.48 ± 0.4 to 1.32 ± 0.15, respectively, using the
described given dose. As result obtained that there was no statistically significant decrease in pain duration
for the women who received Ibuprofen compared to those who used aloe vera. Also there was no significant
difference in pain grade between the groups at the second month of intervention (p=0.61). Pain duration at
the second month of trial was similar between the both groups (p=0.76).
Conclusions. In conclusion we could suggest that aloe vera gel pill as a novel herbal pain killer represents an
effective treatment for the menstrual pain with no important side effects, although further clinical trials are
recommended to look at the possible side effects in an extended spectrum of subjects.
Key words: Aloe vera gel, Dysmenorrhea, Menstrual pain, Medicine, Symptoms, Women,
Introduction
Primary dysmenorrhea “Painful Periods” is a very
common problem in young women. It is usually
defined as cramping pain in the lower abdomen
occurring at the onset of menstruation in the absence
of any identifiable pelvic disease. A pain which is of
uterine origin and directly linked to menstruation but
with no visible pelvic pathology is called primary
dysmenorrhea. and is distinguished from secondary
dysmenorrhea, which refers to painful menses
resulting from pelvic pathology such as
endometriosis. It usually presents during
adolescence, within three years of menarche. It is
unusual for symptoms to start within the first six
months after menarche. Affected women and young
girls experience sharp, intermittent spasms of pain,
usually centered in the suprapubic area. Pain may
radiate to the back of the legs or the lower back.
Additionally, systemic symptoms of nausea,
vomiting, diarrhea, fatigue, fever, headache or
lightheadedness are fairly common.
Investigation the effect of oral Aloe Vera gel pills supplementation on the intensity of
primary menstrual pain (Dysmenorrhea)
Samaneh Sardashti 1,2, Tahere Sarboozi Hosein Abadi 1,2, Shoaib Sarboozi Hosein Abadi3,
Rasool Raznahan 1,2*
Corresponding author: Rasool Raznahan, E-mail: rr4239@gmail.com
1- Department of Nursing, School of Nursing and Midwifery, Torbat Heydariyeh University of Medical Sciences,
Torbat Heydariyeh, Iran
2 - Health Sciences Research Center,
Torbat Heydariyeh University of Medical Sciences, Torbat Heydariyeh, Iran.
3 -
Department of Emergency Nursing, School of Nursing and Midwifery, Birjand University of Medical Sciences,
Birjand, Iran
Balneo Research Journal DOI: http://dx.doi.org/10.12680/balneo.2020.326 Vol.11, No.2, May 2020 p: 120–124

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Pain usually develops within hours of the start of
menstruation and peaks as the flow becomes
heaviest during the first day or two of the cycle.
Population surveys suggest a wide variation in
prevalence rate of dysmenorrhea from studies
around the world including Iran reporting a range
between 35% and 75%. To regulate uterine
contractions and uterine tone, many effective drugs
and regimens are described before and various
studies have also been conducted, but a proper
statistical analysis and interpretation are not
available. Use of natural substances with therapeutic
properties is not new but it has been used since
ancient times. Nowadays, a number of drugs
prescribed originate from plants and some natural
precursors (19). Herbal and dietary therapies are
especially suitable for treatment of disorders such as
dysmenorrhoea, as they can be self-administered and
are often easily available from pharmacies. A recent
review of some trials evaluating the efficacy of
herbal and dietary therapies in primary and
secondary dysmenorrhoea showed that vitamin B1
taken daily may be an effective treatment for
dysmenorrhoea. Sun et al., (2009) showed that the
obtained pain scores after the treatment and few
months of post-treatment in herbal group were
significantly lower than those in the control group in
women exposed to the dysmenorrhoe . Aloe Vera is
a plant that belongs to Liliaceae family that grows
easily in hot and arid regions (21). Te existing
mucilage tissue at the center of leaves in this plant
that is also so-called aloe gel is used for various
cosmetics and medical applications. The peripheral
leaf cells in this plant produce bitter and yellow
color latex that is called aloes. It is composed of
anthracene hydroxyl derivatives including aloins A
and B2 and derivatives such as A, B2, and C aloe
resins. The other compounds are sugars such as
glucose, mannose, and cellulose (18). It has various
vitamins consisting of B1, B2, B6, C, E, and folic
acid, and minerals such as calcium, sodium,
magnesium, zinc, copper, and chrome. Aloe vera is
an herbal plant used in a variety of medical
conditions such as wounds healing and decrease
tissue damages and the ancient Egyptians used Aloe
vera for treatment of wounds, burnings, and
infections for the first time. Additionally, the other
nationalities had used this herbal by various
techniques for several purposes. Some researchers
demonstrated that aloe vera is one of the effective
cures for dysmenorrhea as it treats the menstrual
cramps substantially. Some researchers showed that
the Indian aloe is a stimulant of the uterus. Hence it
is given in cases of painful menstruation. It
possesses compound known as aloes which
effectively promotes the sterility and treats disturbed
menstrual activity and pain in women. Due to the
possible side effects of synthetic drugs, there are
many attempts for alternatives traditional or herbal
treatments. Many evidences have reported that
nutrition and metabolism may play an important role
in the cause and treatment of menstrual disorders.
Keeping this in view, this study was carried out to
investigate the effect of different level of oral Aloe
Vera gel supplementation on the intensity of primary
dysmenorrhea in young women and teenage girls
who studied in the Islamic Azad University of
Medical Sciences, Iran.
Materials and Methods
Study Procedures
A randomized, single-blind clinical experimental
plan was conducted amongst 150 single students
aged 20 to 26 years who suffered from menstrual
pain, at the Islamic Azad University of Medical
Sciences from December 24, 2015 to October 22,
2016. Participants who were single, suffered from
menstrual pain, accommodated at the campus of
University of Medical Sciences and had no
pathological disorders were included in this study.
The eligible participants fulfilled the self-completed
questionnaire and the scale form and were visited
physically by a licensed gynecologist before
randomization.
Experimental design
The extent of pain was evaluated using the Cox
Menstrual Symptom Scale1. Each participant was
randomly assigned to aloe vera gel pill or the anti-
PG drug Ibuprofen, ending with 60 participants in
each group equally. The first trial group received 10
mg of aloe vera gel orally four times daily until the
pain grade reached one or less. The control group
received Ibuprofen and three tablets orally three
times a day. The participants were permitted to take
another drug that they usually took for their pain
relief, in addition to the allocated treatment in case
of continued pain. However, at the end of the trial,
1 -(having no pain ≤ 0, for ≥ 0.5 h ≤ 1, for 0.5 – 1 h ≤ 2, for several hours ≤ 3
and several days ≤ 4).

122
these participants were excluded in data analysis.
Changes in the grade and the duration of the pain of
participants were compared at the first and second
months in both groups. A two sectioned
questionnaire was used to collect the data. The first
section included the demographic data, menstrual
history, smoking, diet, exercise and past medical and
reproductive history that was completed before the
intervention of the trial. The second section was
designed to cover the grade and duration of pain and
the accompanying symptoms was completed during
the two months follow up of the study. The primary
outcome was the intensity of menstrual pain, which
was determined using the verbal multidimensional
scoring System described by (1) and it has 4 grade
including grade 0: menstruation is not painful and
daily activity is unaffected, grade 1: Menstruation is
painful but seldom inhibits normal activity,
analgesics are seldom required; mild pain, grade 2:
daily activity is affected, analgesics required and
give sufficient relief so that absence from school is
unusual; moderate pain and grade 3: activity clearly
inhibited, poor effect of analgesics, vegetative
symptoms such as headache, fatigue, vomiting, and
diarrhea.
Statistical analysis
Sample size was computed using α = 5% and
absolute error equal to 0.24 for correlation between
medication and pain with acceptable absolute
precision formula. A p-value of 0.05 was considered
statistically significant. Randomization was
determined on a 1:1 basis using random number
tables. Statistical comparisons were determined
using the Mann-Whitney U test, unpaired t-test, and
within-group comparisons were analyzed by paired t
test or Wilcox on.
Ethical evaluation
Participation in the study was voluntary and the
participants were free to withdraw from the study
whenever they wished. An informed consent was
obtained from all participants before enrolment into
the study.
Results and discussion
As result showed that on table 1, the mean age was
22.1±1.4and 20.4±1.2 years in aloe vera gel pills and
Ibuprofen groups, respectively. No significant
difference was observed for the matched
characteristics studied between the treated groups.
In term of educational field of study, the higher
frequency was seen for the individuals with bachelor
science degree. Level in paramedical science (42 out
of 100 individuals or 42%) compared to the other
groups and in term of educational degree totally.
Moreover, 71 out of 100 had bachelor science
degree in all medical sciences (71.00 %), including
medical students who only were 20 out of 100
(20%). Chemical medication was the most common
method used by the participants in both groups as
the pain relief procedure before interventions
applied by the current clinical trial. The subjects
were followed up at least for two sequential periodic
cycles. The pain grades were similar in both groups
before intervention. About 3 h after the intervention
at the first day of menstruation the mean pain grade
amongst aloe vera group was decreased from
2.81±0.65 to 2.02±0.34, while in Ibuprofen group
from 2.48 ± 0.4 to 1.32 ± 0.15, respectively, using
the described given dose.
The pain grade was 1 and higher before intervention
in both groups, while it reached zero in about 20%
of the individuals of aloe vera group and 17% of
those in Ibuprofen group 6 h after the intervention so
that they did not ask any more interventions (Table
2).
The comparison of the pain duration between the
two groups at the first month of the intervention is
shown in Table 3. There was no statistically
significant decrease in pain duration for the women
who received Ibuprofen compared to those who used
aloe vera. Also there was no significant difference in
pain grade between the groups at the second month
of intervention (p=0.61). Pain duration at the second
month of trial was similar between the both
groups (p=0.76). Furthermore, the duration of
menstrual flow was similar between the two groups
before intervention, while Ibuprofen reduced the
duration of menstruation compared to the aloe vera
at the first and the second month of the intervention.
The present results suggested that the both aloe vera
and Ibuprofen group had equivalently reduced the
grade and the duration of menstrual pain. The effects
of aloe vera as an herbal pain killer can be attributed
to the reduction of PG synthesis by its action as an
antispasmodic and anti-PG. Studies show that β-
adrenoreceptors activation in uterus causes
relaxation (8) and a stimulatory effect of Z.
multiflora Boiss extract has been shown on β2-
adrenoceptors, which is perhaps due to its

123
constituent, carvacrol (Boskabady et al., 2006).
Ozgoli et al., (2009) (13) mentioned that there were
not significant differences between groups in
baseline characteristics, p > 0.05. At the end of
treatment, severity of dysmenorrhea decreased in all
groups and no differences were found between the
groups in severity of dysmenorrhea, pain relief, or
satisfaction with the treatment, p > 0.05. No severe
side effects occurred. Khazaiyan and Navidian
(2012) (12) showed that there was a significant
difference between aloe vera and placebo groups
concerning the intensity of pain, number of
Analgesics and amount of bleeding, but no
significant difference was observed regarding the
side effects.
Conclusion
Management using anti-inflammatory drugs and
analgesics is often an unsatisfactory answer due to
side effects and patient compliance issues. The
results of this study suggested that the aloe vera gel
pill as a novel herbal pain killer represents an
effective treatment for the menstrual pain with no
important side effects, although further clinical trials
are recommended to look at the possible side effects
in an extended spectrum of subjects. The study
showed that herbal pills are effective for relieving
the severity of pain also. Therefore, health-care
providers should consider it as treatment for young
women with primary dysmenorrhoea problem.
Additionally, future studies are recommended to test
the feasibility and effectiveness of this kind of
herbal therapy in large segments of population for
more explanation.
Conflict of interests
There is no known conflict of interests associated
with this paper and there has been no significant
financial support for this work that could have
influenced its outcome.
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Table 1. Comparison of characteristics between experimental groups
Characteristic
Group
n
Mean ± SD
P-Value
Age
Aloe vera gel pill
65
22.1±1.4
n.s
Ibuprofen
42
20.4±1.2
n.s
Age incidence of dysmenorrhea
Aloe vera gel pill
65
15.6±1.7
n.s
Ibuprofen
42
15.1±1.8
n.s
Duration of cycle
Aloe vera gel pill
65
28.2±1.6
n.s
Ibuprofen
42
27.1±1.6
n.s
Duration of menstrual flow
Aloe vera gel pill
65
5.1±1.7
n.s
Ibuprofen
42
4.9±1.5
n.s
Pain duration
Aloe vera gel pill
65
3.5±0.9
n.s
Ibuprofen
42
3.2±0.6
n.s
*SD = Standard deviations; n.s=**no significant.
Table2. Comparison of pain relief between different groups before intervention
Treatments
Aloe Vera gel pill
Ibuprofen
P-Value
n
percentage
n
percentage
0.865
Chemical medicine
40
40.3
31
27.5
Herbal medicine
15
12.5
14
15.4
Others treatments
15
10.4
10
7.5
Total
70
63.2
55
45.4
Table 3. Comparison of pain duration in aloe vera gel and Ibuprofen groups at various time points following
intervention.
Treatments
Aloe vera gel pill
Ibuprofen
Total %
n %
n %
Less than 0.5 h
13
(19)
10
(18.1)
23
(18.5)
0.5 - 1 h
22
(44.5)
17
(49)
39
(46)
Several hours
18
(34)
10
(29)
28
(36)
Total
43
(100)
37
(100)
90
(100)