The Effect of Black Tea (Camellia sinensis (L) Kuntze) on Pediatrics With Acute Nonbacterial Diarrhea: A Randomized Controlled Trial

Abstract

We aimed to evaluate the antidiarrheal effect of black tea in pediatric patients with acute nonbacterial diarrhea. This single-blind randomized clinical trial study was performed on 2 to 12-year-old patients, with acceptable criteria for acute nonbacterial diarrhea in Shiraz, Iran. In total, 120 patients took part in this study. Blocked randomization method was used to allocate them into 2 groups of intervention (black tea tablet + standard treatment) and control group (standard treatment; 60 patients in each). Frequency of defecation, volume, and consistency of stool were registered on arrival and 24 hours later. We used χ2 test, t test, and Mann-Whitney U test. After a 24-hour follow-up, the proportion of patients with formed stool was higher in the intervention group when compared with the control group (P < .001). There was a significant difference between the mean number of defecations per 24 hours in both groups, after treatment (P < .001). We found a possible antidiarrheal effect of black tea.

Full text

Original Article
The Effect of Black Tea (Camellia
sinensis (L) Kuntze) on Pediatrics
With Acute Nonbacterial Diarrhea:
A Randomized Controlled Trial
Sareh Doustfatemeh, MD
1
, Mohammad Hadi Imanieh, MD
1
,
Abdolali Mohagheghzade, PhD
1
, Mohammad M. Zarshenas, PharmD, PhD
2,3
,
Zahra Torkamani, MD
1
, Gholamhossein Yousefi, MD
1
,
Saman Farahangiz, MD
1
, and Alireza Salehi, MD, MPH, PhD
1
Abstract
We aimed to evaluate the antidiarrheal effect of black tea in pediatric patients with acute nonbacterial diarrhea. This single-blind
randomized clinical trial study was performed on 2 to 12-year-old patients, with acceptable criteria for acute nonbacterial
diarrhea in Shiraz, Iran. In total, 120 patients took part in this study. Blocked randomization method was used to allocate them
into 2 groups of intervention (black tea tablet þstandard treatment) and control group (standard treatment; 60 patients in each).
Frequency of defecation, volume, and consistency of stool were registered on arrival and 24 hours later. We used w
2
test, ttest,
and Mann-Whitney Utest. After a 24-hour follow-up, the proportion of patients with formed stool was higher in the intervention
group when compared with the control group (P< .001). There was a significant difference between the mean number of
defecations per 24 hours in both groups, after treatment (P< .001). We found a possible antidiarrheal effect of black tea.
Keywords
diarrhea, Camellia sinensis, pediatrics, outpatients, tea
Received December 23, 2015. Received revised May 18, 2016. Accepted for publication May 19, 2016.
Diarrhea is among the diseases that are major causes of
mortality of under 5 children around the world, especially
in developing countries, as 2195 children die of diarrhea
every day, which is more than the deaths caused by other
major killers such as AIDS, malaria, and measles.
1
In Iran,
diarrhea is the fifth leading infectious cause of mortality
among children.
2
Despite the application of effective preven-
tion methods such as sanitation and hygiene improvement,
vaccines, oral rehydration therapy, zinc supplement, and
breastfeeding, it still disproportionately affects the children
of poor developing countries, who may have limited access
to these services.
3
Complementary and alternative methods of treatment have
increasingly gained attention in various diseases, including
diarrhea. The effects of various traditional herbal remedies
have been studied on acute diarrhea with some of them show-
ing to be effective.
4
The effects of savory on treatment of diarrhea, regressive
effect of oregano on contractions of ileum and treatment of
diarrhea, antisecretory effect of manna herb, and therapeutic
effect of pennyroyal plant on diarrhea have been reported.
5
Black tea is one of the most consumed beverages in the
world, and especially in Iran.
6
In Iranian traditional medicine,
using black tea has been recommended to treat diarrhea. In this
regard, the famous medical book Makhzan-ul-advia has
pointed to the therapeutic and antidiarrheal effect of black tea.
7
In addition, an Indian herbal medicine book has mentioned the
antidiarrheal effect of black tea.
8
Polyphenolic compounds in black tea undergo enzyme oxi-
dation and convert into pigments called thearubigins and
1
Research Center for Traditional Medicine and History of Medicine, Shiraz
University of Medical Sciences, Shiraz, Iran
2
Medicinal Plants Processing Research Center, Shiraz university of Medical
Sciences, Shiraz, Iran
3
Department of Phytopharmaceuticals (Traditional Pharmacy), School of
Pharmacy, Shiraz university of Medical Sciences, Shiraz, Iran
Corresponding Author:
Alireza Salehi, MD, MPH, PhD, Research Center for Traditional Medicine, and
History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.
Email: salehialireza45@yahoo.com
Journal of Evidence-Based
Complementary & Alternative Medicine
2017, Vol. 22(1) 114-119
ªThe Author(s) 2016
Reprints and permission:
sagepub.com/journalsPermissions.nav
DOI: 10.1177/2156587216654600
journals.sagepub.com/home/cam

theaflavins. The beneficial effects of black tea in the treatment
of peptic ulcer and the impacts of thearubigins pigment in the
treatment of digestive disorders such as inflammatory bowel
disease has been shown in a previous study.
9
Another research
conducted on the effects of black tea extract on bowel move-
ment has shown that this extract can increase or decrease gas-
trointestinal motility in a dose-dependent way; hence, it can be
used to treat gastrointestinal motility disorders such as diarrhea
and constipation.
10,11
It should be noted that all the studies
mentioned above were animal studies, and before we con-
ducted our clinical trial there was no human study about the
antidiarrheal effect of black tea.
It is noteworthy to mention that no significant acute and
subchronic toxicity of Camellia sinensis has been reported in
rats.
12
But, long time consumption of black tea can induce
anorexia and anemia in humans.
13
Regarding the popularity and accessibility of tea beverage
around the world and lack of enough knowledge on its probable
antidiarrheal benefits, we aimed to evaluate the effect of black
tea (Camellia sinensis L Kuntze) on nonbacterial diarrhea
including stool consistency, volume, and frequency of defeca-
tion per 24 hours in pediatrics patients.
Methodology
This was a single-blind clinical trial with parallel design conducted on
pediatric patients aged 2 to 12 years with acute nonbacterial diarrhea
referred to Dastgheib Hospital, Shiraz, in 2011. Ethical consideration
of this study was confirmed by the Ethical Committee of Shiraz Uni-
versity of Medical Sciences (Approval No. 5617-90). This study is
registered in Iranian Registry for Clinical Trials with code number
IRCT201108272434N6.
The eligibility criteria were pediatric patients aged 2 to 12 years,
who have had 3 or more loose stools per 24 hours for less than 14 days,
had been referred to the hospital, and ought to have been managed as
outpatients. According to the primary clinical judgment based on the
patients’ symptoms, the majority of these patients had viral diarrhea.
The exclusion criteria were those with underlying diseases including
diabetes, immunodeficiency, and digestive diseases such as celiac,
lactase deficiency, or malabsorption. Moreover, the patients with
symptoms of severe vomit leading to oral treatment intolerance, fever
>39C, severe abdominal cramps, and bloody diarrhea were excluded.
Needing hospitalization and not being within reaching distance for the
next 24 hours were the other exclusion criteria. A trained research
physician visited the patients for their eligibility to be included in the
study. Written and informed consent from the parents or guardians of
the children was obtained before their enrollment in the study. The
research physician then collected the patient’s information including
demographic data, disease history (duration of diarrhea and symp-
toms), and the characteristics of diarrhea (stool consistency, fre-
quency, and volume) according to a checklist, on entering the trial,
and then allocated the patient blindly to each treatment group.
We used blocked randomization method with blocks of size 4 with
equal number of treatments A and B in each block, in order to have
treatment arms with similar number of patients. Random number gen-
erator was used for generating a sequence of digits; each represented a
block of successive number of 4 patients. A researcher from outside
the hospital and not involved in the process of allocating the patients
did the randomization. The treatment group was written on a card and
sealed in numbered pockets, in order to assure the blinding process.
Accordingly, tablets containing 500 mg of dry black tea were
prepared by pharmacists at the School of Pharmacy, Shiraz University
of Medical Sciences. For tablets to be uniform and compressed as well
as to be dissolved in time in the digestive tract, certain amounts of
permitted additives including binding and disintegrating agents
approved by British Pharmacopoeia, with no reported antidiarrhea
effect, were used in the tablet. In this study, direct compressed tea
tablets were used. The finishing weight of each tablet reached to 750
mg at the end. Beside dry black tea (500 mg of total weight), 3 other
additives, avicel (15%of the black tea weight), magnesium stearate
(5%of the black tea weight), and sodium starch monohydrate (20%of
the black tea weight), were used in the studied tablet.
The 2 groups of treatment were group A (receiving black tea
tablets in addition to the standard therapy) and group B (control;
receiving just the standard treatment). We considered oral rehydration
therapy by oral rehydration supplement and the administration of zinc
syrup supplement (ages 2-6 [2.5 mL/day] and 6-12 [5 mL/day]) as
standard treatment.
14,15
Children aged 2 to 6 years received 1 black tea
tablet, and the older children, aged 6 to 12 years, received 2 black tea
tablets in a single dose in the presence of the researchers. Due to the
difficulty of taking pills in young children, it was dissolved in water to
form a suspension, as the tablet is soluble in water. We considered
using compressed black tea tablets rather than regular steeped black
tea because it was possible to control the consistency and similarity of
dose of the active ingredient. Also, it was easier to assure similar use
by each patient as the method of preparing tea and scaling the required
amount can be different from person to person. Moreover, the con-
centration of steeped tea differs a few times after its preparation and it
was not possible to refresh it for each patient at the hospital.
Another trained research physician who was unaware of the treat-
ment group of each patient performed the follow-up of patients after
24 hours of receiving treatment and recorded the relevant information.
The 2 examiners were trained in the beginning of the study and they
used the same checklist to assure the consistency of data gathering.
Three characteristics of stool—volume (cup per defecation), stool
consistency, and number of defecations per 24 hours reported by
parents of the patients—were used to assess the stool form and were
considered as the outcome measures. The duration of diarrhea was not
an outcome measure, it was only took into account for exclusion of
chronic (more than 14 days) of diarrhea.
The data were analyzed using SPSS software Version 20; w
2
test,
independent and paired ttest, and Mann-Whitney Utest were used for
data analysis, and P< .05 was considered to be statistically significant.
We used per protocol analysis, and only patients who completed the
treatment protocol were included in the statistical analysis.
Results
We assessed 174 patients for eligibility; 28 were excluded
because of not meeting the eligibility criteria and 6 patients
were declined to participate. Finally, 140 patients were selected
to take part in the study. In the follow-up visit 20 patients were
excluded after treatment, because of unavailability and worsen-
ing of their general condition and suspicion to bacterial infec-
tion, which was confirmed by presence of red blood cells and
pus cells in their stool examinations. Sixty patients remained
in each treatment group. Patients’ allocation process is shown
in Figure 1. Mean age +standard deviation of the patients was
Doustfatemeh et al 115

4.35 +2.18 years. Seventy of them were male (58.3%) and 50
(41.7%) were female patients. The majority of the participants
(115; 95.8%) were residences of Shiraz city and only 5 (4.2%)
were from other counties in Fars province. The mean +stan-
dard deviation duration of the participants’ symptoms from the
onset to referral to the hospital was 2.92 +1.57 days. Patients’
demographic information with respect to treatment groups are
shown in Table 1. There was no significant difference between
demographic characteristics of group A (intervention) and
group B (control) patients.
Thirty-two (53.3%) patients from intervention group and 36
patients (60%) from control group had fever of 38C oral tem-
perature. In group A, 29 (48.3%) and 33 (55%) patients, and in
group B, 37 (61.7%) and 43 (71.1%) patients, had complaint of
abdominal pain and vomiting, respectively. In addition, history
of flatulence was noted in 32 (53.3%) patients in group A and in
36 patients (60%) in group B. No patient mentioned dysentery.
There was no significant difference in the symptoms of patients
on entering the hospital in the intervention and control groups.
Patients’ symptoms with regard to intervention and control
groups are shown in Table 2.
None of the patients from both intervention and control
groups reported the history of medication use for their current
situation. Among the patients, 2 cases from the intervention
group and 1 case from the control group had background dis-
eases including glucose-6-phosphate-dehydrogenase
deficiency and anemia. Totally, 9 patients reported a history
of travelling within the last 2 weeks (4 cases from the inter-
vention group and 5 cases from the control group).
Three characteristics of stool, volume (cup per defecation),
stool consistency, and number of defecations per 24 hours, were
used to assess the stool form. Ten (16.7%) patients of the tea
treatment group had loose stool, 27 (45%) had watery stools, and
Table 1. Patients’ Demographic Information With Regard to Treat-
ment Groups A and B.
Parameter Treatment Group
P
Group A Group B
Gender .711
Female, n (%) 24 (40%) 26 (43.3%)
Male, n (%) 36 (60%) 34 (56.7%)
Age, mean +SD
(minimum,
maximum)
4.55 +1.83 (2-10) 4.14 +2.48 (2-12) .298
Living place .648
Shiraz 58 (96.7%) 57 (95%)
Other 2 (3.3%) 3 (5%)
Symptom duration
(days), mean +SD
(minimum,
maximum)
3.08 +1.55 (1-7) 2.76 +1.59 (1-7) .274
Assessed for eligibility
(n=174)
Excluded (n=34)
Not meeting inclusion criteria (n=28)
Declined to participate (n=6)
Analysed (n=60)
Excluded from analysis (5 Loss to follow-up
and 5 develop Bacterial infection regarding
their stool exam) (n=10)
Lost to follow-up (Not being within the reaching
distance for follow-up visit) (n=5)
Treatment group
Allocated to intervention (n=70)
Received allocated intervention (n=70)
Did not receive allocated intervention (n=0)
Lost to follow-up (Not being within the
reaching distance for follow-up visit) (n=8)
Control Group
Allocated to intervention (n=70)
Received allocated intervention (n=70)
Did not receive allocated intervention (n=0)
Analysed (n=60)
Excluded from analysis (8 Loss to follow-up
and 2 develop Bacterial infection regarding their
stool exam) (n=10)
Allocation
Analysis
Follow-Up
Randomized (n=140)
Enrollment
Figure 1. Flow diagram of patients’ allocation process.
116 Journal of Evidence-Based Complementary & Alternative Medicine 22(1)

23 (38.3%) had very watery stools. Eighteen (30%) patients from
the standard treatment group had loose stool, 29 (48.3%)had
watery stools, and 13 (21.7%) had very watery stool. There was
no statistically significant difference in stool form between the 2
treatment groups in the beginning of the study (P¼.07).
In the 24-hour follow-up visit, 19 patients (31.7%)had
formed stool, 39 (65%) had loose stool, and 2 (3.3%)had
watery stool in the intervention group. In addition, 5 (8.3%),
43 (71.7%), and 12 (20%) patients of the control group had
normal, loose, and watery stools, respectively. Significant dif-
ferences between pre- and posttreatment stool consistency were
observed in both groups (P< .001; Figure 2).
Considering the incidence rate of formed stool in the treat-
ment and control groups, 19/60 and 5/60, respectively, the
number needed to treat is calculated, and it is approximately
equal to 4.
At the beginning of the study, 5 (8.3%), 29 (48.3%), and 26
(43.3%) patients of the intervention group (black tea tablet
group) had low (lower than half a cup), medium (half a cup
to one cup), and high stool volume (more than a cup), respec-
tively. In addition, 9 (15%), 41 (68.3%),and10(16.7%)
patients of the control group had low, medium, and high stool
volume, respectively. There was a significant difference
between the stool volume of the intervention (black tea tablet
group) and control groups prior to the treatment (P¼.006). In
the 24-hour follow-up visit, 45 (75%) and 15 (25%) patients of
the intervention group had low and medium stool volume, and
the number of patients with high stool volume decreased to
zero. In addition, from the control group, the stool volume of
39 (65%) patients was low, 20 (33.3%) patients had medium,
and1patient(1.7%) had high stool volume. There was no
statistically significant differences between stool volumes after
24 hours of treatment between the intervention and control
groups (P¼.232).
The mean number of loose/watery defecation per 24 hours
was 5.7 times pretreatment (minimum 3, maximum 10), and 6
times (maximum 10, minimum 3) in patients of the tea and
standard treatment groups, respectively. In the 24-hour
follow-up visit, these values changed to 2.26 (maximum 5,
minimum 1) and 3.45 times (maximum 7, minimum 1) in the
intervention and control groups, respectively. The mean num-
ber of loose/watery defecations was significantly reduced in
both intervention and control groups in pre- and posttreatment
time (P< .001). In addition, the mean number of loose/watery
defecations were significantly lower in the intervention group
than in the control group, after treatment (P< .001).
Discussion
Our study was the first to investigate the antidiarrheal effect of
black tea in pediatric patients. In pharmaceutical evaluation,
tea tablets were gently disintegrated in water and changed the
color of water gradually. It is considerable that the main frac-
tion of tea tablets that could act in this study is tannins. These
components are highly soluble in water and possess astringent
activity. We found that the patients who had used tea tablets in
addition to the standard therapies had better results after 24
hours of follow-up. In the way, the proportion of the patients
whose stool consistency had been transformed from loose or
watery to formed stool was higher in the intervention group
compared to the control group. Moreover, there was a decrease
in defecation frequency and stool volume in the intervention
group. We can see that there was an overall change to better
situation in bowel habit after 24 hours in the intervention group
compared to the control group. Although literature on the effect
of Camellia sinensis (L) Kuntze on acute diarrhea is scarce,
Besra et al showed the antidiarrheal concentration-dependent
effect of black tea on Syrian mice.
10
In addition, comparing the effect of black tea on diarrhea
with that of loperamide and naloxone showed that the effect of
black tea was similar to that of loperamide, and naloxone sig-
nificantly inhibited the prokinetic activity of black tea extract
as well as loperamide.
9,10,16
In addition, it has been reported
that black tea extract had an independent effect on lowering the
diarrhea prevalence in piglets.
17
Table 2. Patients’ Symptoms on Entering the Study With Regard to
Intervention (A) and Control (B) Groups.
Patients’ Symptoms Group A, n (%) Group B, n (%) P
Fever 32 (53.3%) 36 (60%) .58
Abdominal pain 29 (48.3%) 37 (61.7%) .19
Vomiting 33 (55%) 43 (71.7%) .08
Flatulence 23 (38.3%) 31 (51.7%) .19
Rhinorrhea 8 (13.3%) 21 (35%) .1
Figure 2. Comparison between stool form 24 hours after treatment,
in the intervention and control groups.
Doustfatemeh et al 117

There is no human clinical studies indicating the antidiar-
rheal effect of black tea.
We found that from every 3 patients treated by tea tablet
plus standard therapy one proceed to have formed stool. How-
ever, standard treatment in 12 patients will lead to one of them
having formed stool, although it is not clear whether black tea
has synergistic or additive effect if taken simultaneously with
other conventional medications. Increase in peristaltic activity
of gastrointestinal tract and permeability changes in the intest-
inal mucosal membrane to electrolytes and water are seen in
diarrhea conditions. In addition, these events are associated
with prostaglandin release, which is the major cause of arachi-
donic acid–induced diarrhea. It seems that antidiarrheal activ-
ity of black tea may be due to inhibition of prostaglandin
synthesis.
10,16,18
This study had some limitations, the most important of
which was the limited sample. Furthermore, since the present
study was the first clinical trial to study the effect of black tea
on human subjects, we choose just one dose according to indi-
genous medicine books, and no acute complications in patients
occurred. Another limitation was the lack of blinding of the
patients and not using placebo for the control group. Thus,
future studies may be conducted on larger samples and with
different doses and double-blind design, so that results that are
more precise can be achieved regarding the use of these med-
ications. Although there was a minimal difference between the
2 groups according to the sickness of patients at the first point,
it was not statistically significant. Also, the sampling was done
by randomization and this difference may not affect the validity
of the results. Moreover, we have used per protocol analysis in
this study. In per protocol analysis patients who deviated from
the first assignment are excluded. It may lead to the groups of
patients being compared no longer having similar characteris-
tics. The results of this analysis usually provide a lower level of
evidence. On the other hand, it better shows the effects of
treatment when it is taken in an ideal mode. In our study, 10
patients were excluded for the analysis in each group due to
loss to follow-up and developing bacterial diarrhea. As the
excluded number was similar in both groups and there was
no exchange of assigned treatment between them, we have
assumed that per protocol analysis might not have a great
impact on the results of the study.
Conclusion
Given the tendency of people toward traditional medicine and
using herbal remedies, the findings of this study indicate that
the use of the black tea tablet along with conventional drugs
seems to be an effective, inexpensive, and safe treatment for
nonbacterial acute diarrhea management. Further studies are
needed to generalize these results.
Acknowledgment
The authors are thankful to Dr M. R. Dehghani, Dr Golzadeh, and
Research Center for Traditional Medicine and History of Medicine of
Shiraz University of Medical Science for providing necessary facili-
ties for preparation of our article.
Author Contributions
Sareh Doustfatemeh contributed in the data collection, patient alloca-
tion and writing some parts of the article. Mohammad Hadi Imanieh,
Abdolali Mohagheghzade and Gholamhossein Yousefi contributed in
editing and proofing the final manuscript. Zahra Torkamani did parts
of data gathering and final manuscript edit. Saman Farahangiz con-
tributed in method design, data analysis, writing the article, edit, sub-
mission and proof reading of the final manuscript. Alireza Salehi is
the corresponding author suggested the idea, took part in data anlysis,
writing, editing and proofing the final manuscript.
Declaration of Conflicting Interests
The authors declared no potential conflicts of interest with respect to
the research, authorship, and/or publication of this article.
Funding
The authors received no financial support for the research, authorship,
and/or publication of this article.
Ethical Approval
Ethical approval was provided by the Ethical Committee of Shiraz
University of Medical Sciences (Approval No. 5617-90).
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