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Effects of Pomegranate and Spearmint Syrup on Nausea and Vomiting During Pregnancy: A Randomized Controlled Clinical Trial

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Abstract Background: Nausea and vomiting during pregnancy (NVP) affects approximately 50% - 80% of expecting mothers. NVP can impose negative effects on the quality of life; therefore, more attention should be paid to improve patients’ health outcomes. Objectives: The purpose of this trial was to evaluate the efficacy of pomegranate and spearmint syrup on NVP. Methods: In this randomized clinical trial, 74 pregnant women with moderate NVP were divided into 2 groups via block randomization method. A total of 24 and 31 patients were analyzed in the syrup and vitamin B6 groups, respectively. The 24-hour pregnancyunique quantification of emesis (PUQE-24) scale was used to examine the severity of NVP. The intervention included the use of pomegranate syrup (5 cc/TDS) plus vitamin B6 in the syrup group; on the other hand, the control group only received B6 tablets (20 mg/TDS) for 1 week. The subjects were followed-up for 1 week without any interventions. Data were analyzed, using Chi square test for qualitative variables, t test and Mann-Whitney U test for quantitative variables, and Friedman test for repeated measures. Results: There was no significant difference between the groups in terms of demographic and pregnancy characteristics. The mean PUQE-24 score in the syrup group was 9.4 ± 1.8 at baseline, 4.6 ± 1.5 on day 7, and 4.8 ± 2.6 on day 14 (P < 0.001). The mean PUQE-24 score in the control group was 8.5 ± 1.5 at baseline, 6 ± 2.3 on day 7, and 6.2 ± 2.6 on day 14 (P < 0.001). Although a major decline in PUQE-24 scores was observed in both groups, it was more significant in the syrup group (P = 0.001). Also, the PUQE-24 score was significantly lower in the syrup group, compared to the control group on days 7 and 14 (P = 0.02). The visual analog scale scores also showed a greater reduction in the syrup group, compared to the control group (4.7 ± 2.8 vs. 1.6 ± 3; P = 0.001). No significant difference was observed between the groups regarding the duration of nausea, frequency of vomiting, and frequency of retching; also, no complications were reported. Conclusions: The effectiveness of pomegranate and spearmint syrup in reducing NVP was confirmed in the syrup group versus the control group with significant differences. Keywords: Pomegranate, Spearmint, Nausea, Vomiting, Pregnancy, Iranian Traditional Medicine 1. Background The most common, specific, and unpleasant complications among pregnant women include nausea and vomiting during pregnancy (NVP). Approximately 50% - 80% of women experience these complications during pregnancy (1). NVP can impose negative effects on the quality of life; therefore, more attention should be paid to improve patients’ health outcomes (2). Pathophysiology is a combination of genetic, endocrine, gastrointestinal, environmental, and psychosocial factors. Although the exact etiology of NVP remains unknown (3), use of chemical drugs is avoided in early pregnancy as much as possible due to their potential teratogenic effects; therefore, there is an increasing tendency towards alternative therapies (4). Vitamin B6 is prescribed as the first-line agent in the treatment of mild and moderate NVP (5). Effectiveness of vitamin B6 in NVP has been revealed in some previous studies (6). Moreover, today, use of complementary and alternative medicine (CAM) has become more common in different communities. Traditional Persian medicine (TPM), otherwise known as Iranian traditional medicine (ITM), as part of CAM, has proposed various treatments for NVP (7, 8). Use of pomegranate (Punica granatum L.), which belongs to the Lythraceae family, along with spearmint (Mentha spicata L.) from the Lamiaceae family, is one of the proCopyright
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Iran Red Crescent Med J. In Press(In Press):e13542.
Published online 2017 June 7.
doi: 10.5812/ircmj.13542.
Research Article
Effects of Pomegranate and Spearmint Syrup on Nausea and Vomiting
During Pregnancy: A Randomized Controlled Clinical Trial
Shahrbanoo Abdolhosseini,1Fataneh Hashem-Dabaghian,2Roshanak Mokaberinejad,3Omid
Sadeghpour,4and Mitra Mehrabani5,*
1Department of Traditional Medicine, School of Traditional Medicine, Kerman University of Medical Sciences, Kerman, Iran
2Research Institute for Islamic and Complementary Medicine, Iran University of Medical Sciences, Tehran, Iran
3Department of Traditional Medicine, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran
4Research Institute for Islamic and Complementary Medicine, Iran University of Medical Sciences, Tehran, Iran
5Herbal and Traditional Medicines Research Center, Kerman University of Medical Sciences, Kerman, Iran
*Corresponding author: Mitra Mehrabani, Herbal and Traditional Medicines Research Center, Kerman University of Medical Sciences, Kerman, Iran, E-mail:
mmehrabani@hotmail.com
Received 2017 February 01; Revised 2017 March 08; Accepted 2017 April 08.
Abstract
Background: Nausea and vomiting during pregnancy (NVP) affects approximately 50% - 80% of expecting mothers. NVPcan impose
negative effects on the quality of life; therefore, more attention should be paid to improve patients’ health outcomes.
Objectives: The purpose of this trial was to evaluate the efficacy of pomegranate and spearmint syrup on NVP.
Methods: In this randomized clinical trial, 74 pregnant women with moderate NVP were divided into 2 groups via block random-
ization method. A total of 24 and 31 patients were analyzed in the syrup and vitamin B6 groups, respectively. The 24-hour pregnancy-
unique quantification of emesis (PUQE-24) scale was used to examine the severity of NVP. The intervention included the use of
pomegranate syrup (5 cc/TDS) plus vitamin B6 in the syrup group; on the other hand, the control group only received B6 tablets
(20 mg/TDS) for 1 week. The subjects were followed-up for 1 week without any interventions. Data were analyzed, using Chi square
test for qualitative variables, t test and Mann-Whitney U test for quantitative variables, and Friedman test for repeated measures.
Results: There was no significant difference between the groups in terms of demographic and pregnancy characteristics. The mean
PUQE-24 score in the syrup group was 9.4 ±1.8 at baseline, 4.6 ±1.5 on day 7, and 4.8 ±2.6 on day 14 (P < 0.001). The mean PUQE-24
score in the control group was 8.5 ±1.5 at baseline, 6 ±2.3 on day 7, and 6.2 ±2.6 on day 14 (P < 0.001). Although a major decline
in PUQE-24 scores was observed in both groups, it was more significant in the syrup group (P = 0.001). Also, the PUQE-24 score was
significantly lower in the syrup group, compared to the control group on days 7 and 14 (P = 0.02). The visual analog scale scores
also showed a greater reduction in the syrup group, compared to the control group (4.7 ±2.8 vs. 1.6 ±3; P = 0.001). No significant
difference was observed between the groups regarding the duration of nausea, frequency of vomiting, and frequency of retching;
also, no complications were reported.
Conclusions: The effectiveness of pomegranate and spearmint syrup in reducing NVP was confirmed in the syrup group versus the
control group with significant differences.
Keywords: Pomegranate, Spearmint, Nausea, Vomiting, Pregnancy, Iranian Traditional Medicine
1. Background
The most common, specific, and unpleasant complica-
tions among pregnant women include nausea and vomit-
ing during pregnancy (NVP). Approximately 50% - 80% of
women experience these complications during pregnancy
(1). NVP can impose negative effects on the quality of life;
therefore, more attention should be paid to improve pa-
tients’ health outcomes (2).
Pathophysiology is a combination of genetic, en-
docrine, gastrointestinal, environmental, and psychoso-
cial factors. Although the exact etiolog y of NVP remains un-
known (3), use of chemical drugs is avoided in early preg-
nancy as much as possible due to their potential terato-
genic effects; therefore, there is an increasing tendency to-
wards alternative therapies (4).
Vitamin B6 is prescribed as the first-line agent in the
treatment of mild and moderate NVP (5). Effectiveness of
vitamin B6 in NVP has been revealed in some previous stud-
ies (6). Moreover, today, use of complementary and alter-
native medicine (CAM) has become more common in dif-
ferent communities. Traditional Persian medicine (TPM),
otherwise known as Iranian traditional medicine (ITM), as
part of CAM, has proposed various treatments for NVP (7,
8).
Use of pomegranate (Punica granatum L.), which be-
longs to the Lythraceae family, along with spearmint (Men-
tha spicata L.) from the Lamiaceae family, is one of the pro-
Copyright © 2017, Iranian Red Crescent Medical Journal. This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0
International License (http://creativecommons.org/licenses/by-nc/4.0/) which permits copy and redistribute the material just in noncommercial usages, provided the
original work is properly cited.
Uncorrected Proof
Abdolhosseini S et al.
posed ITM treatments for NVP (9). Considering the main
etiology and management of NVP in ITM, pomegranate
juice and spearmint (Anar-Monana syrup in Persian) are as-
sumed to be effective in controlling NVP (10).
Pomegranate, with anti-H. pylori and antiulcer activi-
ties, has been used as a gastric tonic (7,11). The thera-
peutic activities of pomegranate and spearmint have been
recorded in the ITM literature (7,8). Various pharmaco-
logical activities, such as cardiovascular protective activ-
ities, antihypertensive effects (with inhibition of serum
angiotensin-converting enzyme activity), hypoglycemic
effects, and increased high-density lipoprotein (HDL)-
cholesterol level, have been revealed. Moreover, anti-
cancer, antibacterial, anti-H. pylori, antiinflammatory (in
the gastrointestinal tract), and antiulcer effects have been
recently discovered (11-21).
Furthermore, maternal dietary supplementation with
pomegranate juice during pregnancy decreases stimulus-
induced apoptosis, placental oxidative stress, and inci-
dence of placental dysfunction in pregnancy (22). How-
ever, according to our literature search, no studies have
been performed so far on the effects of pomegranate on
NVP.
In this regard, in a double-blind randomized con-
trolled trial (RCT), the participants (n, 60) were routinely
trained to use a bowel of water with 4 drops of pure mint
essential oil (placed on the floor near the bed) for 4 consec-
utive nights before sleeping, while the control group used
4 drops of normal saline. Based on the visual analog scale
(VAS), the mean nausea intensity changed from 4.78 ±1.62
to 3.50 ±1.95 in the mint group and from 4.85 ±1.82 to 4.38
±2.18 in the normal saline group (P = 0.140). Also, the mean
rate of vomiting changed from 3.00 ±2.19 to 2.23 ±1.88 in
the mint group and from 2.52 ±2.4 to 2.55 ±2.55 in the
normal saline group (P = 0.577) (23).
Moreover, a double-blind RCT on the efficacy of M. spi-
cata and M. piperita in the prevention of chemotherapy-
induced nausea and vomiting showed a more significant
reduction in the intensity and number of emetic events in
the first 24 hours in 2 treatment groups receiving M. spi-
cata and M. piperita (P < 0.05), compared to the control
group (24). With this background in mind, the present
study was conducted to assess the efficacy, safety, and tol-
erability of pomegranate and spearmint syrup in the treat-
ment of NVP.
2. Methods
The present study was approved by the ethics com-
mittee of Kerman University of Medical Sciences, Kerman,
Iran (registration number, IR.KMU.REC.1394.232). Consent
forms were obtained from all the participants, and the
trial was registered in the Iranian registry of clinical trials
(IRCT2015022221186N1). This RCT was carried out in prena-
tal clinics of Shahryar district healthcare centers, affiliated
to Iran University of Medical Sciences, Tehran, Iran from
September 15, 2015 to March 19, 2016.
To estimate 1.8 differences in 24-hour pregnancy-
unique quantification of emesis (PUQE-24) scores between
the groups (type I error, 0.05; type II error, 0.2; PUQE-24
score standard deviation, 2.5; and attrition rate, 20%), the
sample size was calculated as 37 patients per group. The ef-
fect size was considered as 0.72, based on the results of our
pilot study. The formula of mean comparison was used to
calculate the sample size.
The inclusion criteria were as follows: 1) being preg-
nant; 2) age range of 18 - 40 years; 3) singleton pregnancy;
4) gestational age of 6 - 16 weeks; 5) moderate NVP (7 - 13
score on the PUQE-24 scale); 6) voluntary participation; 7)
possibility of follow-up; 8) ability to read and write; and 9)
no intake of antinausea drugs within at least 24 hours be-
fore the visit.
On the other hand, the exclusion criteria were as fol-
lows: 1) severe NVP requiring fluid therapy and hospitaliza-
tion; 2) NVP due to secondary causes; 3) presence of preg-
nancy complications such as bleeding; 4) threatened abor-
tion; and 5) history of chronic diseases, drug addiction, al-
coholism, smoking, and drug allergies.
Finally, 74 women were randomized into 2 parallel
groups after obtaining the written consent forms. Vita-
min B6 was used for the control group, while a general
physician administered syrup and vitamin B6 in the syrup
group. Block randomization was used for this parallel-
group RCT; it should be noted that the study was not
blinded. The participants were asked to complete the ques-
tionnaires regarding their demographic and pregnancy
characteristics.
Vitamin B6 tablets (20 mg) were purchased from
Ramopharmin Pharmaceutical Co. (Tehran, Iran). The
syrup was prepared from pomegranate juice (2 kg), which
was concentrated to half and made consistent with 1 kg of
sugar and 0.5 kg of spearmint juice (25). The syrup was pre-
pared at the herbal medicine department of ITM research
institute, Iran University of Medical Sciences. It was pre-
scribed in accordance with the ITM guidelines (5 mL after
meal for 1 week with a frequency of 3 times per day) (9).
The enrolled women were randomly assigned to re-
ceive either 20 mg of vitamin B6 or 5 cc of pomegranate
and spearmint syrup 3 times per day, along with 20 mg of
vitamin B6 for 1 week. The patients were then visited after
1 week of the intervention (day 7) and 1 week following the
end of the intervention (day 14).
The participants were asked to complete the PUQE-24
scale for the assessment of NVP in the past 24 hours. If the
2Iran Red Crescent Med J. In Press(In Press):e13542.
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Abdolhosseini S et al.
subjects’ scores ranged between 7 and 12 (moderate NVP),
they were enrolled in the study. PUQE-24 scale, which is de-
signed to assess NVP within the past 24 hours, is composed
of 3 questions and measures nausea duration, frequency of
vomiting, and frequency of retching in the past 24 hours
using a rating scale.
In the PUQE-24 scale, the range of scores for each ques-
tion is 1 to 5, and the total score ranges from 3 to 15; scores
6, 7-12, and 13 indicate mild, moderate, and severe NVP,
respectively (26). The validity of this questionnaire has
been determined in some previous studies (26-28). In the
present study, the severity of nausea was evaluated by VAS.
VAS consists of a 10-cm line, with 0 representing no symp-
tom(s) and 10 representing the worst symptom(s) (23).
Safety assessments were based on the reports of ad-
verse events and results of routine physical examinations.
Pomegranate syrup was well tolerated by most of the par-
ticipants, and no adverse effects, neither local nor sys-
temic, were reported. Furthermore, no abnormal findings
were observed on physical examination in the follow-ups.
Statistical analyses were carried out, using t test (for
mean age, gestational age, BMI, age at marriage, duration
of marriage, and age at menarche) and Chi square test (for
occupation, educational level, impairment in daily activ-
ities, history of NVP, family history of NVP, wanted preg-
nancy, prepartum nausea, history of psychiatric drug use,
gravidity, history of abortion, anorexia, history of still-
birth, history of mole and EP, multiple birth, medical his-
tory of diseases, and nausea duration). Moreover, Mann-
Whitney U test (for PUQE-24 score and severity of nausea),
Friedman test, and ANCOVA (for PUQE-24 score, severity
of nausea, frequency of vomiting and retching, and nau-
sea duration before, during, and after the intervention)
were performed to determine potentially significant asso-
ciations.
P value 0.05 was considered statistically signifi-
cant. SPSS version 17 was used for statistical analysis. Nor-
mal distribution of variables was assessed by Kolmogorov-
Smirnov test (P > 0.05, normal distribution), while the
nonparametric method (Mann-Whitney U test) was used
for variables without a normal distribution. The results
were obtained via per-protocol analysis.
3. Results
The current study included 100 participants, 26 of
whom were excluded, as they declined to cooperate (n, 20)
or did not meet the inclusion criteria (n, 6). A total of 74
patients with the mean age of 26.6 ±5.7 years (range, 18
- 40 years) were screened and randomly enrolled in the
groups. During the study, some participants left the study
due to unwillingness to continue the interventions; finally,
55 participants completed the study (Figure 1).
The mean PUQE-24 score in patients who left the study
was higher in the syrup group in comparison with the con-
trol group (10.8 ±1 vs. 7.6 ±0.8; P < 0.001). Attrition in the
syrup group occurred after administering only 1 or 2 doses
of syrup or before taking the syrup. Therefore, only pa-
tients who completed the study were included in the anal-
ysis. After eligible subjects were included in the study, per-
protocol analysis was performed.
The results demonstrated homogeneity between the
groups regarding the following variables: maternal age,
gestational age, age at marriage, duration of marriage,
age at menarche, occupational status, education, BMI,
anorexia, impairment in daily activities, history of NVP,
family history of NVP, wanted pregnancy, prepartum nau-
sea, history of psychiatric drug use, history of abortion,
anorexia, history of stillbirth, history of mole and EP, mul-
tiple birth, and medical history of diseases. Also, there was
no significant difference between the groups in terms of
demographic and pregnancy information, except gravid-
ity (Table 1).
3.1. PUQE-24 Scores
The mean ±SD and median (IQR) PUQE-24 scores at
baseline and 7 and 14 days after the intervention are shown
in Table 2. The decline in PUQE-24 scores from baseline to
days 7 and 14 was significant, based on Friedman test re-
sults (P < 0.001). The decline in PUQE-24 scores was 4.7 ±
2 vs. 2.5 ±2.7 in the syrup and control groups on days 0 -
7 (P = 0.005) and 4.5 ±2.8 vs. 2.3 ±2.6 on days 0 - 14 (P =
0.001), respectively. A slight increase was reported in the
PUQE-24 scores on days 7 - 14 in both groups (0.2 ±2.5 vs.
0.16 ±2.0; P = 0.2); however, there was no significant dif-
ference between the 2 groups (Table 3 and Figure 2).
3.2. Duration of Nausea
Duration of nausea was not significantly different be-
tween the groups at baseline (P = 0.8); also, there was no
significant difference on days 7 and 14 (P = 0.3 and P = 0.2,
respectively). Although the duration of nausea decreased
in both groups from baseline to day 7 (P < 0.001), the dif-
ference was not significant between the groups (Figure 3).
3.3. Frequency of Vomiting
The frequency of vomiting was not significantly differ-
ent between the groups at baseline (P = 0.1); similarly,there
was no significant difference on days 7 and 14 (P = 0.1 and
P = 0.4, respectively). Although the frequency of vomiting
in the 2 groups showed no significant difference on days 7
and 14, the decline in the frequency of vomiting on days 0
Iran Red Crescent Med J. In Press(In Press):e13542. 3
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Abdolhosseini S et al.
Assessed for eligibility (n = 100)
Excluded (n = 26)
Not meeting inclusion criteria (n = 20)
Declined to participate (n = 6 )
Analysed (n = 31)
Excluded from analysis (give reasons) (n = 0)
Discontinued intervention (n = 6)
Allocated to intervention (n = 37)
Received allocated intervention (n = 37 )
Discontinued intervention (they were worried
about a new intervention) (n = 13)
Allocated to intervention (n = 37)
Received allocated intervention (n = 37 )
Analysed (n = 24)
Excluded from analysis (give reasons) (n = 0)
Allocation
Analysis
Follow-Up
Randomized (n = 74)
Figure 1. Consolidated Standards of Reporting Trials (CONSORT) flow Diagram
B6 + SYRP
B6
GROUP
PUQE Score
1 2 3
Factor 1
10.00
8.00
6.00
4.00
2.00
0.00
Figure 2. Changes in the Mean PUQE-24 Scores Within 14 days
- 7 and 0 - 14 was significant in the syrup group (P < 0.001)
and insignificant in the control group (P = 0.4 and P = 0.1,
respectively).
B6 + SYRP
B6
GROUP
0 W1 W2
Time
4.00
3.00
2.00
1.00
0.00
Duration of Nausea
Figure 3. Duration of Nausea Within 14 days
3.4. Frequency of Retching
The frequency of retching in the groups was not sig-
nificantly different at baseline (P = 0.6); also, there was no
4Iran Red Crescent Med J. In Press(In Press):e13542.
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Abdolhosseini S et al.
Table1. The Participants’ Demographic and Baseline Characteristicsa
Characteristics Vitamin B6 (N, 31) Syrup + Vitamin B6 (N, 24) P Valueb
Age, y,mean ±SD 27.5 ±5.6 26.1 ±5.7 0.37
BMI, kg/m2, mean ±SD 24.2 ±4.4 25.5 ±3.9 0.23
Anorexia 0.2
Yes 16 (51.6) 16 (66.7)
No 15 (48,4) 8 (33.3)
Age at menarche, y,mean ±SD 13.0 ±1.1 13.4 ±1.3 0.1
Impairment in daily activities 0.3
Yes 21 (67.7) 19 (79.2)
No 10 (32.3) 5 (20.8)
Age at marriage, y,mean ±SD 20.1 ±3.8 19.4±3.4 0.5
Mother’s occupation 0.5
Housewife 29 (96.7) 22(91.7)
Employee 1 (3.3) 2 (8.3)
Education 0.9
Below high-school
diploma
18 (60) 14 (58)
High-school diploma 11 (36.7) 9 (37.5)
Above diploma 1 (3.3) 1 (4.2)
Wantedpregnancy 1.000
Yes 32(86.5) 32(86.5)
No 5 (13.5) 5 (13.5)
Prepartum nausea 0.4
Yes 2(5.4 ) 0 (0)
No 35(94.6 ) 37(100)
Medical history 0.09
Yes 0 (0) 3(12.5)
No 30(96.8) 21 (87.5)
0 1(3.2 )
Gestational age, mean ±SD 9.9 ±2.4 9.8 ±3.1 0.89
History of consumption of
psychiatric drugs
0.4
Yes 0 (0) 1 (4.2)
No 31(100) 23 (95.8)
History of abortion 0.7
Yes 6 (19.6) 3 (12.5)
No 25(80.6) 21 (87.5)
Parity (mean) IQR (min-max) 1 (1 - 2) 0.5 (0 - 1) 0.7
Gravidity (mean) IQR (min-max) 2 (2 - 3) 1.5 (1 - 2) 0.02
History of mole 0.6
Yes 1( 3.2) 0(0)
No 27 (87.1) 22 (91.7)
0 3(9.7) 2 (8.3)
aValuesare expressed as No. (%) unless otherwise indicated.
bt test is used for continuous variables, and Fisher’s exact test is used for discrete variables.
significant difference on days 7 and 14 (P = 0.1 and P = 0.2,
respectively). Although the frequency of retching in the
groups showed no significant difference on days 7 and 14,
the decline in frequency within days 0 - 14 was significant
in both groups (P < 0.001).
3.5. Analysis of the Severity of Nausea with VAS
The severity of nausea is presented in Table 4. At base-
line, the severity of nausea in the syrup group was signifi-
cantly higher than the control group (P = 0.006), whereas
on days 7 and 14, its severity was significantly lower in the
syrup group (P = 0.02 and P = 0.003). Changes in the sever-
ity of nausea from baseline to days 7 and 14 were more sig-
nificant in the syrup group, compared to the control group
(P < 0.001 and P = 0.001, respectively; Table 5). By con-
sidering the baseline severity of nausea as a covariate, AN-
COVA test results showed a significant difference between
the groups in the reduced severity of nausea from baseline
to days 7 and 14 (Figure 4).
B6 + SYRP
B6
GROUP
Time
Baseline
1
2
3
4
5
6
7
8
9
10
11
12
13
14
6.00
5 .00
4 .00
3.00
2.00
1.00
0.00
Severity of Nausea (VAS)
Figure 4. The Severity of Nausea Within 14 Days
4. Discussion
According to the findings of the present study,
pomegranate and spearmint syrup is effective in re-
ducing gestational nausea and vomiting. It could lead to a
decline in the mean scores of PUQE-24 (Tables 2 and 3,Fig-
ure 2) and severity of nausea (Tables 4 and 5,Figure 4). To
the best of our knowledge, this is the first RCT evaluating
the effect of pomegranate on NVP.
The etiology of NVP in ITM is attributed to the effu-
sion and accumulation of inappropriate substances in the
stomach; in fact, stomach weakness is one of the factors in-
volved in its etiology. Treatment of NVP consists of remov-
ing inappropriate substances from the stomach and de-
creasing their production (29). Use of astringent (Ghabiz)
agents, which have the ability to preserve the tonicity of
the stomach, is one of the proposed treatments for stom-
ach weakness (30).
P. granatum (pomegranate) is an example of astrin-
gent agents, repeatedly mentioned in ITM resources for its
effect on the stomach (31). Also, fragmenting (Moghattia),
Iran Red Crescent Med J. In Press(In Press):e13542. 5
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Abdolhosseini S et al.
Table2. Interquartile Range (IQR) and Mean PUQE-24 Scores at Baseline and 7 and 14 Days After the Intervention
Variables Mean ±SD IQR
Vitamin B6 (n, 31) Syrup+ Vitamin B6 (n, 24) P Value Vitamin B6 (n, 31) Syrup+ Vitamin B6 (n, 24)
Baseline 8.5 ±1.5 9.4 ±1.8 0.09 8 (7 - 10) 9 (8 - 11.75)
Day 7 6.0 ±2.3 4.6±1.5 0.02 4 (3 - 6) 6 (4 - 7)
Day 14 6.2 ±2.6 4.8 ±2.6 0.02 3 (3 - 7) 7 (4 - 8)
Table3. Changes in PUQE-24 Scores Within 0 - 7, 0 - 14, and 7 - 14 Days
Variables Days0 - 7 P Value Days 0 - 14 P Value Days 7 - 14 P Value
Syrup + vitamin B6 (n, 24) 4.7 ±2.0
0.005
4.5 ±2.8
0.001
-0.2 ±2.5
0.2
Vitamin B6 (n, 31) 2.5±2.7 2.3 ±2.6 -0.16±2.0
Table4. The Mean Severity of Nausea at Baseline and 7 and 14 Days after the Intervention
Variables Vitamin B6 (n, 31) Syrup + Vitamin B6 (n, 24) P Value
Baseline 4.3 ±1.6 5.9 ±1.8 0.006
Day 7 3.1 ±2.6 1.5 ±1.3 0.02
Day 14 2.6 ±2.3 1.6 ±2.3 0.003
Table5. Changes in the Mean Severity of Nausea Within 0 - 7, 0 - 14, and 7 - 14 Days
Variables Days 0 - 7 PValue Days 0 - 14 PValue Days 7 - 14 P Value
Syrup + vitamin B6 (n, 24) 4.3 ±2.3
< 0.001
4.7 ±2.8
0.001
0.3 ±2.5
0.3
Vitamin B6 (n, 31) 1.2 ±2.9 1.6 ±3.0 0.4 ±2.1
stubbing (Mohallil), and tendering (Mollatif) agents are
necessary for removing soft waste materials around the in-
testinal villi (30) and are found in medicinal plants such as
M. spicata (spearmint) (31).
One of the limitations of this study was the lack of rel-
evant studies in scientific databases. Another limitation
was the higher attrition rate in the syrup group in compar-
ison with the control group, which could produce attrition
bias. Considering the decreasing trend of duration of nau-
sea during the intervention (Figure 3) and lower rates of
vomiting and retching on days 7 and 14 after the interven-
tion in the syrup group, more definitive findings can be ob-
tained through further analysis and use of a larger sample
size.
Application of CAM in Iran has a long history, and mid-
wives and physicians show great interest in this area. Al-
though the therapeutic activity of pomegranate has been
mentioned in the ITM literature (32), the findings of this
trial showed that pomegranate and spearmint syrup, as a
traditional remedy, is effective in reducing NVP (Tables 2 -
5and Figures 2 -4). Despite the side effects of long-term use
of antiemetic drugs, no serious side effects were reported
for the use of pomegranate syrup.
In the present study, pomegranate and spearmint
syrup remained effective for 1 week after drug use. This
finding might be due to the gastric tonic effects of
pomegranate and spearmint, which have been introduced
as a treatment for emesis in ITM texts (32). Pomegranate
seems to be more effective than vitamin B6 in the treat-
ment of NVP, and there were statistical differences be-
tween the treatment groups. Simple preparation, absence
of serious complications, and desirable taste can make
pomegranate an alternative treatment for NVP.
Acknowledgments
The present study was extracted from a PhD thesis of
traditional medicine by Shahrbanoo Abdolhosseini and
was supported by the School of Traditional Medicine, Ker-
man University of Medical Sciences, Kerman, Iran.
Footnote
Conflicts of Interests: We declare no conflicts of interest.
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Uncorrected Proof
... The Personal Information Form and the Turkish version of PUQE-24 were applied by a researcher to 90 pregnant women using the self-report method (Dennis and Faux 1999). Furthermore, the Visual Analog Scale (VAS), used in many studies to evaluate the severity of nausea and vomiting during pregnancy (Vutyavanich et al. 2001;Sripramote and Lekhyananda 2003;Ensiyeh and Sakineh 2009;Ozgoli et al. 2009;Narenji et al. 2012;Pasha et al. 2012;O'Donnell et al. 2016;Abdolhosseini et al. 2017), was used to evaluate concurrent validity. All pregnant women were called by phone one week later for a retest, and it was ensured that they filled in the scale again. ...
... VAS has been used in many studies to evaluate the severity of nausea and vomiting during pregnancy (Vutyavanich et al. 2001;Sripramote and Lekhyananda 2003;Ensiyeh and Sakineh 2009;Ozgoli et al. 2009;Narenji et al. 2012;Pasha et al. 2012;O'Donnell et al. 2016;Abdolhosseini et al. 2017). ...
Article
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The objective of this study is to conduct a reliability and validity study of the Turkish version of the ‘Pregnancy-Unique Quantification of Emesis (PUQE-24)’ in pregnant women. In the Turkish version, Cronbach’s alpha coefficient was 0.75, and the item-total score correlations were between 0.75 and 0.85. In the exploratory factor analysis it was determined that the scale had a single-factor structure explaining 65.968% of the total variance. The factor load values of the scale were found to be between 0.776 and 0.831. The Turkish version of scale was found to be a valid and reliable measurement in pregnant women. • IMPACT STATEMENT • What is already known on this subject? Complaints of nausea and vomiting during pregnancy are common. Therefore, it is important to evaluate nausea and vomiting during pregnancy with a valid and reliable tool. Pregnancy-Unique Quantification of Emesis (PUQE-24) is a reliable tool for assessing the severity of nausea and vomiting symptoms. The original scale was translated into various languages, its validity and reliability were made in some countries and it was used in many studies. • What do the results of this study add? The present study showed that Pregnancy-Unique Quantification of Emesis (PUQE-24) is valid and reliable for Turkish pregnant women. Thus, the scale can be used as a reliable tool in Turkish population. • What are the implications of these findings for clinical practice and/or further research? As a result of this study, Pregnancy-Unique Quantification of Emesis (PUQE-24) can be used as a validated tool for the Turkish population during clinical practice by healthcare professionals and researchers, who are evaluating nausea and vomiting during pregnancy. In future studies, it can be used as an objective assessment tool to determine whether an intervention is needed for nausea and vomiting during pregnancy or to reveal whether the intervention has worked.
... Pomegranate tannins play a protective role against gastric ulcer (24,25). Pomegranate has effectiveness in reducing nausea and vomiting during pregnancy (26). It has anti-H. ...
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Punica granatum L. belongs to the Punicaceae family which is distributed around the world. Different parts of pomegranate like seed, peel, juice, and leaves are rich in potential bioactive compounds. These plants have found application in traditional medicine such as in treatment of gastrointestinal, cardiovascular, and endocrine diseases, among others. The present review aimed to summarize the current research on the traditional and scientific applications of P. granatum with regard to the phytochemical content and clinical applications that may be useful for future drug development. Information about P. granatum was obtained from local classic herbal literature and electronic databases, such as PubMed, Scopus, and ScienceDirect. Several phytochemical constituents including polyphenolics, flavonoids, anthocyanosides, alkaloids, lignans, and triterpenes have been reported from the plant. Randomized clinical trials have provided evidence as to the pharmacological activities of pomegranate in several diseases including diabetes, cardiovascular disease, oral cavity disorders, endocrine disorders, and cancer. The present review has provided an insight into the traditional applications of the plants, and some of them have been validated by scientific evidence, particularly their applications as treatment of cardiovascular and endocrine diseases.
Chapter
One of the most frequently occurring common discomforts of pregnancy is nausea and vomiting of pregnancy (NVP), a very common and difficult discomfort to manage successfully. Multiple etiologies have been implicated in development of this disorder which occurs in over 70% of pregnancies, sometimes persisting throughout gestation. NVP may impact a woman's ability to engage in mutually satisfying partner relationships, achieve success in their work lives, and may negatively affect their ability to care for other children at home. NVP has global significance, as some cultures lack words to relate the concept of the problem, leading to limited understanding and lack of validation from family and community. This may result in diminished social standing and self-esteem. Women experiencing food insecurities may be further impacted. Economic ramifications may result from even milder forms of the problem; more significant symptoms find women seeking care from providers or hospitalization, increasing individual and societal costs. Quality of life may be affected, even with milder symptoms, and may result in decisions to delay or decide against future pregnancies. While there are many treatment options, they vary in efficacy, and acceptability, and there is a dearth of information from clinical trials. Women experiencing NVP desire alleviation of symptoms quickly, and providers often omit some forms of treatment and prescribe pharmaceuticals immediately. A better approach to navigating this common disorder is to provide individual treatment plans based on our patient's unique needs and treatment responses, utilizing available safety and efficacy data.
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Nausea and vomiting are common symptoms experienced by 50– 90% of women’s in early pregnancy. ‘Morning sickness’ is a misnomer frequently used to describe nausea and vomiting in pregnancy (NVP), although the symptoms may persist the whole day and/or night. Pregnant women experience these symptoms mainly in the first trimester between 6 and 12 weeks of gestation, few of them continue till 20 weeks of gestation while in few others it continues throughout the pregnancy. The problem peaks at 9-week gestation, and approximately 60% of NVPs resolve by the end of first trimester. In a very small minority of these patients, the symptoms become severe leading to dehydration, weight loss, excessive vomiting, and mandate hospital admission; this condition is known as Hyperemesis Gravidarum. Fairweather D.V proposed the most widely used definition of Hyperemesis Gravidarum (HG). He defined HG based on the symptoms, vomiting exceeding three times a day with significant ketonurea or weight loss more than or equal to 5% of pre pregnancy weight, electrolytic imbalance or fluid depletion, and onset occurs at 4 to 8 weeks of pregnancy till 14 to 16 weeks. Nausea and vomiting in pregnancy is of multifarious etiology (fluctuating levels of progesterone, estrogens, Thyroid Stimulating Hormone (TSH), slow peristaltic movement of Gastrointestinal (GI) tract); however, the exact mechanism remains still unclear. Given the uncertainty in treatment of NVPs, both patients and healthcare practitioners often fear the use of antiemetic medications in pregnancy due to the potential risk to fetus and mother. The manifestation of nausea and vomiting in pregnancy is different among each woman, so its management should be tailored similarly. An early treatment of nausea and vomiting is important and beneficial since it prevents a more severe form of occurring, or a possible hospitalization, and prevents both emotional and psychological problems. It is very important for the women and the healthcare providers to understand that a safe and effective NVP treatment benefits both fetus and mother, thus all the treatment options should be open and considered. Nonetheless, given the widespread prevalence of nausea and vomiting, its adverse effects and effects on psychological conditions of pregnant women, it is necessary to be treated effectively and safely during embryonic and fetal developmental stages. First trimester exposure is important to be assessed to monitor the teratogenic potential of the drug; however, randomized control trials are rarely conducted for pregnant women for ethical reasons. Whereas the epidemiological studies done are observational and lack population strength to establish safety and risk involved. This review will mainly focus on pharmacological drugs used in treatment of NVP, and explore their safety and efficacy and evidence based practice. There have been many studies examining the safety of drugs used in NVPs and few of them are covered in this review. The dietary, lifestyle modifications, and nonpharmacological approaches are not covered in this section.
Article
Nausea and vomiting of pregnancy affects nearly 75% of pregnant women. The exact cause is unknown. In most cases, it is a mild, self-limited condition that can be controlled with conservative measures and has no adverse fetal sequelae. About 1% of women develop hyperemesis gravidarum, which may result in adverse outcomes for the mother and fetus. Patients with nausea and vomiting of pregnancy should be evaluated for other causes, particularly if symptoms are unremitting or presentation is atypical. Initial treatment is conservative and includes dietary changes, emotional support, and vitamin B6 supplementation. Several safe and effective pharmacologic therapies are available for women who do not improve with initial treatment. Women with hyperemesis gravidarum may require more aggressive interventions, including hospitalization, rehydration therapy, and parenteral nutrition.