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Polycystic ovarian syndrome is the most common cause of infertility and endocrine disorder among women due to anovulation. The aim of the present study is to investigate the effect of chamomile on oligomenorrhea and hirsutism symptoms as well as hormonal parameters among patients suffering from polycystic ovarian syndrome.
The present study is a randomized clinical trial performed on 70 patients with diagnosis of polycystic ovarian syndrome according to Rotterdam criteria referring to the infertility clinic of a university hospital. The patients were randomly assigned into intervention and control groups, with the former receiving two chamomile capsules 500 mg for three months, and the latter receiving two placebo capsules for 3 months. Both groups were evaluated in terms of laboratory parameters (FBS, LDL, and testosterone) on the third day of first and third cycles. The collected data were analyzed by SPSS 20.
overall, the chamomile therapeutic regimen has relatively been able to mitigate the clinical symptoms and testosterone levels in patients suffering from polycystic ovarian syndrome. Use of chamomile plant as a simple, inexpensive, and effective measure can be suggested for improving and treating patients with PCOS after confirmation by further studies.
Keywords: Chamomile, Clinical Symptom, Hormonal Parameters, Polycystic Ovarian SyndromePolycystic ovarian syndrome (PCOS) is one of the most common endocrine disorders in reproductive age women, with 10–15% of women developing it in their lifetime (1). The Rotterdam diagnostic criteria syndrome for PCOS include menstruation disorders (amenorrhea, oligomenorrhea), clinical or biochemical hyperandrogenism. Alternatively, sonography symptoms of PCOS, after ruling out other diseases causing a phenotype similar to PCOS include adrenal congenital hyperplasia, adrenal and ovarian neoplasm, Cushing’s syndrome, hypo or hypergonadotropic disorders, hyperprolactinemia, and thyroid disease (2).
In PCOS, the pituitary gland may secrete high levels of luteinizing hormone, and the ovaries produce high levels of androgens. This impairs the menstruation cycle and can cause infertility, hirsutism, and acne (3). Various factors underlie incidence of PCOS including diet, environmental factors, physical activity, genetic factors, and neuroendocrine factors (4). There are various treatment methods for PCOS such as changing lifestyle (5), weight loss, exercise (6), daily regular jogging, surgery, as well as taking drugs. The treatment methods and drugs include contraceptive drugs, medroxyprogesterone acetate, gonadotropin releasing hormone agonists, glucocorticoids, ketoconazole, spironolactone, cyproterone acetate, flutamide, cimetidine, finasteride, and insulin sensitizers (7).
Herbal plants are one of the selected choices for improving the symptoms of PCOS. Recently, extensive studies have dealt with examining the effect of different types of herbs on PCOS (8–10). Chamomile plant with the scientific name of chamomilla matricaria belongs to the family of chicory, and its extract contains flavonoid and antioxidant compounds including gallic acid, chamazulene, farnesene, matricin, coumarin derivatives, apigenin, and colin, which has anti-inflammatory properties (11). Other properties of chamomile include antidiabetic (12) and menstruation regulating effects (13). Chamomile has shown antidiabetic effects in female rats. Chamomile flowers contain Anthemine oil extract, tannin, phytosterol as well as a bitter compound called Anthemique acid (14).
There are various drugs for treating this disease, with each having their own side effects. Chamomile is an herb with anti-estrogenic and menstruation cycle regulating effects. So far, no study has been performed regarding the effect of chamomile on PCOS. Given the inexpensiveness of this plant and since it grows easily in most parts of Iran and is easily available and eventually does not have the side effects of chemical products, in this research we intended to compare the effect of chamomile against placebo on oligomenorrhea and hirsutism symptoms as well as changes in hormonal parameters including the levels of testosterone hormone and metabolism including glucose and lipid in PCOS
This randomized clinical control trial has been performed on 70 patients with PCOS. It has been approved on 6 November 2017 in the organizational/regional ethics committee of the faculty at Mashhad University of medical sciences with the code of IR.MUMS.fm.REC.1396.444. This study was approved on 16 June 2018 with the code of IRCT20170315033085N3 in clinical trial centers. The sample size in the initial study, since so far no study has used chamomile for treating PCOS, was obtained 31 in each group, with the initial assumption that chamomile may have 20% effect in the intervention group over the control, and while considering α=0.05 and β=0.2 using PASS software. According to possible attrition of 10%, eventually 35 was the final number considered in each group.
The sampling method was available sampling, whereby the studied individuals were chosen from among clients referring to special clinic of educational hospitals of Mashhad in case they fulfilled the inclusion criteria and signed written informed consent form. The inclusion criteria were having PCOS according to the criteria of normal history of maturity, thyroid test within the normal range (0.5–5), having dysmenorrhea, patient age 18–35 years, no recent history of surgery for PCOS and treatment for PCOS, nonuse of sexual steroids (such as contraceptive pills, hormone therapy, androgenic drugs), nonuse of chemical or herbal drugs and no smoking.
Initially, other disorders that would mimic PCOS phenotype including hyperprolactinemia, thyroid functional disorders, Cushing’s syndrome, adrenal congenital hyperplasia, and androgen secreting ovarian tumors were ruled out by a gynecologist. Next, based on Rotterdam criteria, PCOS was diagnosed. Based on this criterion, having at least two out of three criteria (Rotterdam criteria) is essential: 1) anovulation which usually presents as oligomenorrhea, amenorrhea, and polymenorrhea, 2) elevated levels of androgens in the bloodstream, hirsutism and FSH/LH ratio of 2, and 3) polycystic ovaries that would be observed in ultrasonography.
After explaining the study objectives, observing the ethical considerations according to Helsinki declaration as well as information confidentiality, first written informed consent form was taken from all participants in the test. Also, they could refuse to participate in the test if they were not willing. Next, a questionnaire capturing demographic variables was completed for the participants. The patients were asked to refer to the clinic of Imam Reza educational hospital in case they experienced menstruation on days 3–5, and in the patients with amenorrhea, after bleeding (following daily prescription of 10 mg/dL of progesterone for 7 days) in order to undergo transvaginal sonography.
The patients with their sonography and biochemical tests results referred to the gynecology clinic of educational hospitals, and in case of confirmation of PCOS, they would be included in the study.
Next the patients would be randomly assigned into intervention and control groups based on the prepared software, and the drugs would be provided to the patients through the researcher based on the checklist. The first group were 35 individuals who received two chamomile capsules 500 mg for three months, and the second group were 35 subjects who received two placebo capsules for three months. The drugs were placed inside the packet and numbered by a person not related to the research. Indeed, the chamomile and placebo tablets which were absolutely similar to each other in appearance were placed inside packets A and B by a colleague, and for each patient, selection of packet would be randomized through the site. The executives of the plan and researchers were unaware of the packet content. As such, it could be stated that the study was performed as double–blind. For the control group, again a similar capsule (with the same color, shape, and size) was given which contained starch. Further, on day 12 of the third cycle, and in case of amenorrhea, at the end of day 90, the subjects were refered for transvaginal sonography in order to evaluate the effect of drug on the volume and follicles of ovaries.
The recorded data were analyzed by SPSS 23. The characteristics of the studied individuals were presented through descriptive statistical methods including central, dispersion, and frequency distribution indices in the form of proper tables and diagrams. In order to compare quantitative variables between the two groups, in case of normal data distribution, t-test, and otherwise Mann-Whitney test were applied. For comparing the qualitative variables between the two groups, chi-square test and if required Fisher’s exact test were employed. In all calculations, p
CONSORT Flow Diagram was showed in Figure 1 . The mean age (p=0.076), body mass index (p=0.831), marital status (p=0.436), history of infertility (p=0.99), and pregnancy (p=0.898) showed no significant difference between the two groups ( table 1 ).