Material was included 4 parts (personal and social

Material
and method

In
this randomized controlled trial, 74 women were randomly recruited. Data were
collected from selected health care centers affiliated to the Ahvaz Jundishapur
University of medical sciences from April to October, 2017.

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The
protocol of this study was approved by the Ethics Committee of Ahvaz
Jundishapur University of Medical Sciences (Ref No: IR.AJUMS.REC.1395.511).
The protocol was also registered in the Iranian registry for randomized
controlled trials (Ref No: IRCT2016111330874N1).

The
inclusion criteria were as follows:
aged 18-45 years, the existence of one of the signs and symptoms of VVC in the
interview and its observation and confirmation by laboratory tests, having one
husband and, BMI less than 30, nonuse of cream, suppository or vaginal shower
in the last 48 hours, and completing the informed consent. The exclusion
criteria were as follows: pregnancy, breast feeding, menopause, consumption of
oral contraceptive pills, medical disorder, frequent VVC, consumption  of corticosteroids, broad-spectrum antibiotics
in the past two weeks and systemic antifungal medicines in the last four weeks.

 

 2.1. Participants

The
sample size was obtained based on the recovery rate in the previous studies14-16
and the following formula was used for sample size, when P1=0.543   and P2=0.9. Considering the
attrition risk of about 20% during the study and ? = 0.05, the final sample
size was calculated 47 in each group (total 94 women).

= 47

 2.2.
Randomization

Eligible
women were randomly assigned to intervention or control groups using six blocks
by a ratio of 1:1.
Vaginal
cream curcumin was produced in the laboratory of the School of Pharmacy at
Ahvaz Jundishapur University of Medical Sciences and Clotrimazole vaginal cream 1%  made by the Pars Dara Company was prepared
from the pharmacy.

 

2.3.
Measures

A
socio-demographic questionnaire and a checklist were used to collect data. The questionnaire
was included 4 parts (personal and social information, reproductive
information, history of vaginal infections and individual health information).
The individual vaginal hygiene information consisted of using a pad or tampon,
Regular underwear changing, sunlight, drying of underwear, ironing the
underwear, front to back washing and cleaning of the genital area and frequency
of intercourse per week17.

Checklists
for observations and examinations: before and after intervention.

women
who attended the number 1 Eastern health clinic in Ahvaz, Iran, were screened
regarding inclusion criteria. All participants gave their
permission by signing an informed consent form, before entering into the study.

In
the first session, the subjects were placed in lithotomy position, so that
after inserting a clean speculum without lubricant and observing VVC, using 2
sterilized swabs, 2 samples of vaginal discharge from the posterior side of the
vagina were taken. The first swab was spread on a clean slur and was stained in
a warm or blue methylated method. In case of observing other microorganisms in
the spread, the subject was excluded from the study. The second swab was
inoculated onto a chrome agar culture medium. The culture medium was incubated
at 30-35°C for 4-5 days and daily colony count was performed. If the number of
colonies grown was 10 or more in each culture medium, VVC was confirmed. Body mass
index calculated using the formula (kg/m2).

 

2.4.
Preparation of curcumin and clotrimazole vaginal cream

Vaginal
cream curcumin was produced in the laboratory of the School of Pharmacy at
Ahvaz Jundishapur University of Medical Sciences. After purchasing curcumin, a
vaginal plant cream was prepared by importing dissolved curcumin in suitable
carriers (Vaseline, mineral oil, Acetyl Alcohol, Bansyle Alcohol, Monobasic
Sodium Phosphate, and Dibasic Sodium Phosphate). Using the minimum inhibitory
concentration of curcumin on Candida species, 10% concentration was calculated
for the preparation of verminal curcumin creams18. According to a clinical
study, vaginal tablet of curcumin were more similar to the calculated dose for
a longer period than the study period the present was used; the safe
concentration of 10% was approved15. The produced vaginal creams were tested
for stability, uniformity, diffusion, acidity, release rate and standardization
for control and optimization. Finally, curcumin vaginal cream tubes were packed
under clean conditions.

Clotrimazole vaginal cream 1% made by the
Pars Dara Company was provided from the pharmacy.

 

2.5.
Intervention

Women
with a confirmed VVC were recruited for this study. The first researcher (NA)
that was not blind asked participants to take the curcumin vaginal cream, 10%, or  Clotrimazole vaginal cream, 1%  as a full applicator
for one week at bedtime.  Every participant received
a phone call weekly regarding correct consumption of curcumin or clotrimazole vaginal cream.

If
the subjects did not want to continue the study, in the case of emergency use
of antibiotics, or the sensitivity to the drug and forgetting drug use more
than one night, they were excluded from the study. Because of the yellow color
of the curcumin vaginal cream, the individuals in the intervention group
received ten daily sanitary pads, used to prevent the change of the color of
the underwear.

 

 2.6. Outcome measures

The
participants referred again 4-7 days after completion of the one-week course of
treatment to determine the rate of recovery. At the referral visit, 4-7 days
after completion of the treatment course, the post-treatment form was completed
and necessary laboratory and clinical examinations were repeated. The complete
recovery including negative smear and culture, and loss of signs and symptoms,
was measured.

 

 

 

2.7.
Statistics

Continuous
data were screened for normality using Kolmogorov
Smirnov Smirnoff test. The Man Whitney
test was used for the non-parametric quantitative values ??between the two
groups and Kruskal Wallis test within the groups.
Moreover, the qualitative variables were compared between the two groups using
a chi-square test. The significance level was considered p 0.05).  The
two groups did not show any signi?cant differences in childbirth and pregnancy
number, BMI, and contraceptive methods (P>0.05) (Table 1).

As
evident in Table2, although, the frequency of discharge of women in both groups
was signi?cantly decreased after 4-7 days after treatment (from 89.4% to 34% in curcumin group and from 87.2% to 31.9% in
clotrimazole group respectively) (p
0.001).

The
results indicated a significant increase in the frequency of negative cultures
after treatment in 59.6% of the curcumin group vs. 76.6% in the clotrimazole
group (p = 0.002). The difference between the groups, also was signi?cant (p =
0.002). The complete recovery was detected in the 66% of subjects in the curcumin
group vs. in 48.9% subjects in the clotrimazole group. The results showed no
significant differences between groups in complete recovery after intervention (p=0.09)
(Table 3).

Adverse
effect in the curcumin cream was vulvo-vaginal burning sensation seen in
6.4% subjects in curcumin compared to 2.1% in the clotrimazole group. There was
also, a vulvolar itching in 8.5% of subjects compared to 4.3% in the
clotrimazole group and a vulvo-vaginal discomfort in 2.1% of subjects compared
to 4.3% subjects in clotrimazole group. The most frequently observed side
effects in the Curcumin group have been vulvolar itching. However, there was
not any significant difference between two groups with regards to side effects (p=0.3).

 

4.
Discussion

This
study aimed to compare the impact of curcumin with clotrimazole vaginal cream
in the treatment of VVC. The randomization in this study could result in equal
baseline characteristics such as age,
body mass index, childbirth number, pregnancy number and contraceptive method. The
results of this study showed that curcumin can be effective in the treatment of
symptoms of VVC and its complete recovery as well as clotrimazole vaginal cream,
in spite of the negative culture that was more in clotrimazole group. In fact,
the curcumin have similar effects on the improvement of vulvo-vaginal discharge,
itching, burning, erythema and smear results compare to clotrimazole vaginal
cream.

The
possible mechanism of anti-fungal effects of curcumin may due to the fact that Curcumin
significantly inhibits the release of hydrogen ion from fungal cells and decreases
the level of cellular ergosterol, leading to a decrease in the secretion of
proteinase from fungal cells, which ultimately breaks down the membrane,
intracellular fluid leakage and death of fungal cells9,10.

Shabanian
et al.s study indicated that the mean of itching, irritation and a cheesy
discharge in clotrimazole ginger cream users was lower than the control group
after treatment13. Pettil et al. evaluated the effect of curcumin mouthwash
on radiochemical healing induced by oral mucositis in 20 adult cancer patients.
The subjects were randomly divided into an intervention group (mouthwash
containing 0.004% curcumin) and control group (mouthwash clorhexidine 0.2%).
The results showed a significant difference in erythema between the two groups19.
Also the our results indicated that although there was a significant decrease
in stained positive smear in each group, there was no significant difference between
the two groups after the intervention. However, the post-interventional culture
was negative in 76.6% in the control group and 59.6% in the intervention group,
which is in contrast to the almost similar effects on the signs and symptoms of
the disease. There was a significant difference in the negativity of vaginal
cultures after treatment (p=0.002).

Medicinal
methods, including topical treatments with azoles, such as clotrimazole, in
80-90% of cases caused disappearance of symptoms and negative culture. Usual
symptoms disappear within 2-3 days14. In the present study, the combination
of azole (coltrimzole) resulted in the expected negative culture and the same
result; curcumin also caused 59.6% negative cultivation. Although the effect of
curcumin has not been as good as clotrimazole, it can be done by conducting
further investigations as an herbal remedy for complications. The results also
showed no significant differences between the two groups in complete recovery
of VVC after intervention.

The
effects of burning, erythema, itching and vaginal discharge, which are
variables of VVC can have a different effect, which one of them may be
prolonging the course of treatment. Probably, in case of increasing duration of
treatment, we might witness better effects of curcumin in the treatment of VVC,
which itself requires more extensive studies. Our results are consistent with Shabanian
et al and Pettil, et al.13,19. In our study, the negative culture was more in
clotrimazole group.

 

4.1.
Strengths and limitations:

In
this study the impact of curcumin vaginal cream on vulvovaginal candidiasis was
evaluated in Iranian women for the first time in Iran. The limitation of this
study is: we did not follow up women for a longer period and did not measure
the recurrence rate of candidiasis, because of the limited budget to preparing
more curcumin vaginal cream.

 

5.
Conclusion

The
curcumin can be effective in the treatment of symptoms of VVC and its complete
recovery as well as clotrimazole vaginal cream, in spite of the negative
culture that was more in clotrimazole group. However, more studies are
needed in this regard.

 

Funding

Financial
support was provided by the deputy vice-chancellor for research affairs of the
Ahvaz Jundishapur University of Medical Sciences.

 

Declaration of interest statement

The
authors declare that there is no conflict of interests regarding the
publication of this paper.