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BackgroundTheterm “vulvovaginal candidiasis” is defined as the presence of signs andsymptoms of vulvovaginal inflammation in the presence of Candida species in themucous membrane of the lower genitalia. It is considered as one of the most commongynecologic problems in women of reproductive age and the second most commoncause of vaginitis after bacterial vaginosis1.ThoughVVC is the second most common cause of vaginitis, we are now faced with anincrease in the incidence of this disease2.

Narayan Khedkar (2014) reportedthe prevalence of VVC in India 30% as the most common vaginitis3. Brandolt etal. (2014-2013) reported that 13% of the 249 women referring to one of theeducational-treatment centers in Rio Grande, Brazil, had VVC4. Not referring tothe all affected women to the health centers and the arbitrary use ofpharmaceutical compounds of azoles made it difficult to accurately quantify theincidence of candidate vaginitis5.VVCis known as a mental disease. Patients with the symptoms of this problem suchas itching and vaginal discharge have a feeling of dissatisfaction and reducedself-confidence, which leads to reluctance to have sex and reduce sexual satisfactionin any of the couples6.Currently,the most commonly used standard treatment agents are azole antifungalcompounds.

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It is worth mentioning that the widespread use of a drug class aftersome time increases the resistance of that sensitive species to drugs likeketoconazole7. The major concern regarding this disease is the increase in Candidaglabrata colonies instead of Candida Albicans in the vaginal environment, whichcan the reason why many patients complain of non-relief of clinical symptoms ofillness after completing the course of treatment8.Recentstudies show the antifungal effects of curcumin, the effective ingredient foundin the rhizome of turmeric. Curcumin significantly inhibits the release ofhydrogen ion from fungal cells (in the absence or presence of peripheralglucose) and decreases the level of cellular ergosterol, leading to a decreasein the secretion of proteinase from fungal cells, which ultimately breaks downthe membrane, intracellular fluid leakage and death of fungal cells9,10.Karaman et al.(2011) and Dovigo et al.

(2005) suggested that the antifungalactivity of curcumin is effective in improving oral candidiasis in the rats11,12.A pilot study by Petil et al. on 25 chemotherapy patients reported improvementof oral mucositis through mouthwash containing curcumin13.Giventhe antifungal effects of curcumin proven in in-vitro and animal studies  and that no clinical trial studies have beenconducted to evaluate the effect of curcumin on treatment of VVC, this studywas conducted to compare the effect of curcumin-based vaginal cream withclotrimazole vaginal cream in the treatment of VVC.

 2. Materialand methodInthis randomized controlled trial, 74 women were randomly recruited. Data werecollected from selected health care centers affiliated to the Ahvaz JundishapurUniversity of medical sciences from April to October, 2017. Theprotocol of this study was approved by the Ethics Committee of AhvazJundishapur University of Medical Sciences (Ref No: IR.AJUMS.

REC.1395.511).The protocol was also registered in the Iranian registry for randomizedcontrolled trials (Ref No: IRCT2016111330874N1).Theinclusion criteria were as follows:aged 18-45 years, the existence of one of the signs and symptoms of VVC in theinterview and its observation and confirmation by laboratory tests, having onehusband and, BMI less than 30, nonuse of cream, suppository or vaginal showerin the last 48 hours, and completing the informed consent.

The exclusioncriteria were as follows: pregnancy, breast feeding, menopause, consumption oforal contraceptive pills, medical disorder, frequent VVC, consumption  of corticosteroids, broad-spectrum antibioticsin the past two weeks and systemic antifungal medicines in the last four weeks.  2.1. ParticipantsThesample size was obtained based on the recovery rate in the previous studies14-16and the following formula was used for sample size, when P1=0.543   and P2=0.

9. Considering theattrition risk of about 20% during the study and ? = 0.05, the final samplesize was calculated 47 in each group (total 94 women).= 47 2.2.RandomizationEligiblewomen were randomly assigned to intervention or control groups using six blocksby a ratio of 1:1.Vaginalcream curcumin was produced in the laboratory of the School of Pharmacy atAhvaz Jundishapur University of Medical Sciences and Clotrimazole vaginal cream 1%  made by the Pars Dara Company was preparedfrom the pharmacy. 2.

3.MeasuresAsocio-demographic questionnaire and a checklist were used to collect data. The questionnairewas included 4 parts (personal and social information, reproductiveinformation, 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 theunderwear, front to back washing and cleaning of the genital area and frequencyof intercourse per week17.

Checklistsfor observations and examinations: before and after intervention.womenwho attended the number 1 Eastern health clinic in Ahvaz, Iran, were screenedregarding inclusion criteria. All participants gave theirpermission by signing an informed consent form, before entering into the study.Inthe first session, the subjects were placed in lithotomy position, so thatafter inserting a clean speculum without lubricant and observing VVC, using 2sterilized swabs, 2 samples of vaginal discharge from the posterior side of thevagina were taken. The first swab was spread on a clean slur and was stained ina warm or blue methylated method.

In case of observing other microorganisms inthe spread, the subject was excluded from the study. The second swab wasinoculated onto a chrome agar culture medium. The culture medium was incubatedat 30-35°C for 4-5 days and daily colony count was performed. If the number ofcolonies grown was 10 or more in each culture medium, VVC was confirmed. Body massindex calculated using the formula (kg/m2). 2.

4.Preparation of curcumin and clotrimazole vaginal creamVaginalcream curcumin was produced in the laboratory of the School of Pharmacy atAhvaz Jundishapur University of Medical Sciences. After purchasing curcumin, avaginal plant cream was prepared by importing dissolved curcumin in suitablecarriers (Vaseline, mineral oil, Acetyl Alcohol, Bansyle Alcohol, MonobasicSodium Phosphate, and Dibasic Sodium Phosphate). Using the minimum inhibitoryconcentration of curcumin on Candida species, 10% concentration was calculatedfor the preparation of verminal curcumin creams18. According to a clinicalstudy, vaginal tablet of curcumin were more similar to the calculated dose fora longer period than the study period the present was used; the safeconcentration of 10% was approved15.

The produced vaginal creams were testedfor stability, uniformity, diffusion, acidity, release rate and standardizationfor control and optimization. Finally, curcumin vaginal cream tubes were packedunder clean conditions.Clotrimazole vaginal cream 1% made by thePars Dara Company was provided from the pharmacy. 2.5.InterventionWomenwith 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 applicatorfor one week at bedtime.  Every participant receiveda phone call weekly regarding correct consumption of curcumin or clotrimazole vaginal cream. Ifthe subjects did not want to continue the study, in the case of emergency useof antibiotics, or the sensitivity to the drug and forgetting drug use morethan one night, they were excluded from the study. Because of the yellow colorof the curcumin vaginal cream, the individuals in the intervention groupreceived ten daily sanitary pads, used to prevent the change of the color ofthe underwear.  2.6. Outcome measuresTheparticipants referred again 4-7 days after completion of the one-week course oftreatment to determine the rate of recovery. At the referral visit, 4-7 daysafter completion of the treatment course, the post-treatment form was completedand necessary laboratory and clinical examinations were repeated.

The completerecovery including negative smear and culture, and loss of signs and symptoms,was measured.   2.7.

StatisticsContinuousdata were screened for normality using KolmogorovSmirnov Smirnoff test. The Man Whitneytest was used for the non-parametric quantitative values ??between the twogroups and Kruskal Wallis test within the groups.Moreover, the qualitative variables were compared between the two groups usinga chi-square test.

The significance level was considered p < 0.05. ResultsAllparticipants (in the two groups) continued their cooperation to the end of thestudy course (Fig 1).

The mean age of women in the curcumin group was 27.57 ± 4.86and in the Clotrimazolegroup 28.06 ± 2.

35years (p > 0.05).  Thetwo groups did not show any signi?cant differences in childbirth and pregnancynumber, BMI, and contraceptive methods (P>0.05) (Table 1).Asevident in Table2, although, the frequency of discharge of women in both groupswas signi?cantly decreased after 4-7 days after treatment (from 89.4% to 34% in curcumin group and from 87.2% to 31.

9% inclotrimazole group respectively) (p < 0.001), but differences between thegroups was not signi?cant (p =0.82).Thefrequency of vaginal itching, Burning, erythema and vaginal smear results alsoin both groups were signi?cantly decreased after 4-7 days after treatment (p< 0.001), but differences between the groups was not signi?cant (p >0.001).

Theresults indicated a significant increase in the frequency of negative culturesafter treatment in 59.6% of the curcumin group vs. 76.6% in the clotrimazolegroup (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 curcumingroup vs.

in 48.9% subjects in the clotrimazole group. The results showed nosignificant differences between groups in complete recovery after intervention (p=0.09)(Table 3). Adverseeffect in the curcumin cream was vulvo-vaginal burning sensation seen in6.4% subjects in curcumin compared to 2.1% in the clotrimazole group.

There wasalso, a vulvolar itching in 8.5% of subjects compared to 4.3% in theclotrimazole group and a vulvo-vaginal discomfort in 2.1% of subjects comparedto 4.3% subjects in clotrimazole group. The most frequently observed sideeffects in the Curcumin group have been vulvolar itching. However, there wasnot any significant difference between two groups with regards to side effects (p=0.3).

 4.DiscussionThisstudy aimed to compare the impact of curcumin with clotrimazole vaginal creamin the treatment of VVC. The randomization in this study could result in equalbaseline characteristics such as age,body mass index, childbirth number, pregnancy number and contraceptive method.

Theresults of this study showed that curcumin can be effective in the treatment ofsymptoms 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 vaginalcream.Thepossible mechanism of anti-fungal effects of curcumin may due to the fact that Curcuminsignificantly inhibits the release of hydrogen ion from fungal cells and decreasesthe level of cellular ergosterol, leading to a decrease in the secretion ofproteinase from fungal cells, which ultimately breaks down the membrane,intracellular fluid leakage and death of fungal cells9,10. Shabanianet al.s study indicated that the mean of itching, irritation and a cheesydischarge in clotrimazole ginger cream users was lower than the control groupafter treatment13. Pettil et al. evaluated the effect of curcumin mouthwashon radiochemical healing induced by oral mucositis in 20 adult cancer patients.

The subjects were randomly divided into an intervention group (mouthwashcontaining 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 decreasein stained positive smear in each group, there was no significant difference betweenthe two groups after the intervention. However, the post-interventional culturewas 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 ofthe disease. There was a significant difference in the negativity of vaginalcultures after treatment (p=0.002).Medicinalmethods, including topical treatments with azoles, such as clotrimazole, in80-90% of cases caused disappearance of symptoms and negative culture. Usualsymptoms disappear within 2-3 days14.

In the present study, the combinationof azole (coltrimzole) resulted in the expected negative culture and the sameresult; curcumin also caused 59.6% negative cultivation. Although the effect ofcurcumin has not been as good as clotrimazole, it can be done by conductingfurther investigations as an herbal remedy for complications. The results alsoshowed no significant differences between the two groups in complete recoveryof VVC after intervention. Theeffects of burning, erythema, itching and vaginal discharge, which arevariables of VVC can have a different effect, which one of them may beprolonging the course of treatment. Probably, in case of increasing duration oftreatment, we might witness better effects of curcumin in the treatment of VVC,which itself requires more extensive studies. Our results are consistent with Shabanianet al and Pettil, et al.13,19.

In our study, the negative culture was more inclotrimazole group.  4.1.Strengths and limitations: Inthis study the impact of curcumin vaginal cream on vulvovaginal candidiasis wasevaluated in Iranian women for the first time in Iran. The limitation of thisstudy is: we did not follow up women for a longer period and did not measurethe recurrence rate of candidiasis, because of the limited budget to preparingmore curcumin vaginal cream. 5.

ConclusionThecurcumin can be effective in the treatment of symptoms of VVC and its completerecovery as well as clotrimazole vaginal cream, in spite of the negativeculture that was more in clotrimazole group. However, more studies areneeded in this regard. FundingFinancialsupport was provided by the deputy vice-chancellor for research affairs of theAhvaz Jundishapur University of Medical Sciences. Declaration of interest statementTheauthors declare that there is no conflict of interests regarding thepublication of this paper.       

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