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J Clin Exp Dent. 2014;6(5):e535-8.            The therapeutic effects of chamomilla tincture mouthwash on oral aphthae



            disease severity [pain], the patient’s medical history, the   uptake, syndrome-related aphthous lesions, e.g. Behcet,
            frequency of flare-ups, and the patient’s ability to tolera-  Crohn, ulcerative colitis,…, patients whose lesions did
            te the medication (3).                           not regress after one month according to the standards
            For common forms of RAS, standard topical treatment   defined in the literature (6) 50 patients with aphthous
            options that provide symptomatic relief include analge-  lesions were selected and randomly divided into group
            sics, anesthetics, antiseptics, anti-inflammatory agents,   A [n=25], and group B [n=25], using the site “www.re-
            steroids, sucralfate, tetracycline suspension, and silver   searchrandomiser.com”.  Chamomilla  tincture  [Matrica
            nitrate (4).                                     Drop, Barij Esans, Iran] and its placebo, made by Mas-
            Complementary and alternative medicines are frequently   had  herbal  medicine  pharmacological  research  center,
            used in chronic conditions (5). Chamomilla tincture is a   were  used  in  this  study.  Chamomilla  tincture  and  the
            herbal medicine which has many applications. The anti-  placebo were coded as A, and B respectively. Half of the
            inflammatory, anti spasm, anti bacterial, antifungal, and   sample received drop A, and the other half received drop
            analgesic effects of chamomilla tincture have been inves-  B, randomly. The drug and placebo had identical bottles,
            tigated on inflammatory dermal lesions (6). Chamomilla   and the patient, clinician, and statistical expert were not
            mouth rinse is prescribed for aphthous lesions, gingivitis,   aware of the medicine type [triple blind]. The patients
            and laryngitis (7). Faster healing has been observed after   were instructed to apply the drop three times a day [tid],
            administration of chamomilla. The effective ingredients   and ten drops each time. Patients washed their mouth,
            in Chamomilla are essences [azolene, camozolene] and   and then rinsed for three minutes each time, and dischar-
            flavonoids. Camazolene has a dose-dependent antiinfla-  gedthe mouth rinsed refrained from eating for half an
            matory and anti spasm effects, it inhibits leukoterine B4   hour. The patients were clinically examined after 2, 4,
            [LTB4] synthesis, and peroxidation of arachidonic acid in   and 6 days, and then on a weekly basis [if the lesions
            neutrophils. Azolene has analgesic and anti-inflammatory   were still present]. Healing duration, number of lesions
            effects. Flavenoids are also known to have anti-inflamma-  in each visit, size [lesser/greater than 1cm in diameter,
            tory characteristics (6).                        measured by a digital caliper], side effects of the medi-
            There  are  few  randomized clinical trials  on  the  effect   cation [the mucosa was investigated for any signs of side
            of  chamomilla  on  aphthous  lesions.  The  aim  of  this   effected, and the patients were questioned regarding any
            randomized clinical study was to investigate the thera-  burning or irritation symptoms], pain and burning were
            peutic effects of chamomilla tincture mouthwash on oral   recorded using a visual analogue scale. If new aphthous
            aphthae.                                         lesions  developed,  they  were  separately  recorded  and
                                                             followed up until complete healing. The patients were
            Material and Methods                             asked not to use any other medication in the study period
            In this triple-blind [patient, doctor, and statistics expert]   without informing the clinicians.
            randomized clinical study 36 patients, diagnosed with   Normality of data distribution was tested with Smirnov-
            aphthous lesions were selected from the patients atten-  Kolmogrov test. Independent t-test, and Man-Whitney
            ding the department of oral medicine in Mashad faculty   tests were used [when the distribution was normal, and
            of dentistry between the years 2008-2010. All the pa-  not-normal respectively] to compare the test and control
            tients were educated by the clinicians about their condi-  group.  For qualitative [ranking] data Man-Whitney and
            tion and the study, and then signed an informed consent   for qualitative [Nominal] data chi-square was used. P
            approved by the ethical committee of Mashad Universi-  value < 0.05 was considered to be significant.
            tyof medical sciences. A complete patient file was com-
            pleted for each patient, in three parts; 1- demographic   Results
            data [age, sex, educational degree,…], 2- complete me-  Total number of 36 cases fulfilled the study period, 4
            dical history 3- questions about the aphthous lesions [   cases in the case and 10 cases in the control dropped out
            number of lesions, site, size, shape, degree of pain, past   of the study.
            medication]. All  the  patients  had  their  blood  samples   Comparison of mean age using Pearson Chi Square re-
            tested for: CBC, SI, TIBC, FE, Ferritin, and FBS.  vealed that the sample was homogenous regarding age
            Inclusion  Criteria:  confirmed  clinical  diagnosis  of   and  there  was  no  significant  difference  between  the
            aphthous lesions, minimum of 2 weeks past from the last   groups regarding age (Table 1).
            medications for aphthous. Exclusion criteria: Any syste-  The mean number of lesions at the beginning of the study
            mic conditions or medication having interference with   was 2.95 in the case group and 2.67 in the control group,
            chamomilla/placebo  mouth  rinse,  immunosuppressive   Pearson chi square test revealed no significant difference
            medication, patients with anemia, blood dyscrasia, liver   and the groups were homogenous (Table 2).
            diseases, kidney diseases, GI tract disturbances, epilep-  Moreover, Pearson chi square test revealed no signifi-
            sy, psychosis, all of which may develop aphthous-like   cant difference between the groups regarding sex, pain
            lesions,  pregnancy,  lactation,  age<10  years,  warfarin   and burning sensation, and the site of the lesions.


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