STRENGTHS AND LIMITATIONS OF THIS STUDY

This was a cross-sectional study conducted at a single centre.

The study site is one of the largest tertiary hospitals in Jordan receiving patients from all over the country.

The benefits and risks of complementary and alternative medicine use were not investigated objectively.

Considering the nature of the study design, complete absence of social desirability cannot be assured.

Introduction

Polycystic ovary syndrome (PCOS) is a prevalent female reproductive and metabolic disorder that affects 8–13% of women worldwide in their reproductive ages with up to 70% of the cases being undiagnosed.1–4 A comparable prevalence of PCOS exists in Middle Eastern countries with percentages ranging from 5% to 19%3 5 6

Although the exact cause of PCOS is still not known, the available clinical literature suggests this complex condition results from a combination of genetic and environmental factors that cause multiple hormonal and metabolic abnormalities such as impaired glucose tolerance, diabetes, dyslipidaemia, hypertension as well as acne and obesity.2 3

According to the Rotterdam consensus, to diagnose PCOS, at least two of the following clinical manifestations must be present: irregular or absent ovulation, hyperandrogenism (in the absence of other causes of androgen excess) and the presence of polycystic ovaries detected by ultrasonography (≥12 follicles measuring 2–9 mm in diameter and/or an ovarian volume >10 mL in at least one ovary).3 7 8 Lifestyle modifications, such as changing dietary habits, reducing energy intake and moderate exercise, are considered the first-line non-pharmacological approaches to manage PCOS.2–4 7 Pharmacological treatments, recommended by the international PCOS guidelines, include combined oral contraceptives (COCs) for the long-term management of hirsutism and menstrual irregularities, if pregnancy is not desired. On the other hand, ovulating agents (clomiphene and letrozole) are used to manage infertility among women seeking pregnancy. In addition, metformin (off-label prescription) has been showing to improve menstrual cycles, glucose levels, insulin resistance and lipid profile. Surgical interventions (bariatric surgery and laparoscopic ovarian drilling) are also used sometimes to relieve PCOS-related symptoms.2 3 7

In addition to these ‘standard-of-care’ treatment options and like in many other conditions, an increasing number of patients seek help from complementary and alternative medicine (CAM), including in the Middle East and North Africa region, to cope with the physical and psychological effects of their disease.9–13

The term CAM is used to describe medical products and approaches that are not part of standard medical care but are used in different traditional practices either alone or alongside the conventional/orthodox medicine.9–12

Studies indicate that patients using CAM experienced benefits such as reducing pain and increasing well-being.12 14 Additionally, some CAM modalities have shown potential in enhancing immune responses to infections, including COVID-19.15 On the same line, the reproductive-age population seeking help with fertility-related health issues showed a significant prevalence of CAM usage due to perceived safety, natural approach and holistic benefits.16–18 In PCOS, CAM therapies, such as acupuncture, Chinese herbal medicine, Tai Chi, yoga, immunotherapy and medicinal plants, demonstrated success in treating this condition, reducing its severity and the associated complications, with fewer side effects compared with conventional clinical procedures.7 12 19 20 These therapies have potential endocrine, cardiometabolic and reproductive benefits, which could lead to a lower incidence of cardiovascular disease, diabetes, anxiety and depression associated with PCOS, ultimately enhancing the patients’ quality of life.19 21 In Jordan, no studies have ever investigated the use of CAM for the treatment of PCOS. This study aims to assess the use patterns of CAM among adult females diagnosed with PCOS in Jordan.

MethodologyStudy participants and settings

This study has been conducted at the gynaecology clinics of the Jordan University Hospital during 2022–2023. This site is one of the largest public tertiary hospitals in Jordan that receives patients from the central urban, rural and surrounding areas.22 Adult females (≥18-year-olds) with clinically diagnosed PCOS and visiting any of the four gynaecology outpatients’ clinics at the study centre (two in the morning and two in the evening) throughout the whole week were eligible to take part in the study. The study objective was explained to these selected patients and then they were invited to participate in the study (convenient sampling). The sample size was calculated using Raosoft for sample size calculation resulting in a total of 384 respondents, assuming type 1 error of 5% and power of 80%.

Data collection

Data were collected using a data collection tool available in the literature in English.23 After being translated into Arabic and then back translated into English, the tool has been piloted to five patients for face validity. The language turned out to be clear and understandable.

The data collection form comprised four parts. The first part aimed to gather information related to the demographic characteristics of the study participants (such as age, body mass index and educational level). The second part aimed to collect information regarding the participants’ clinical conditions (such as the date of PCOS diagnosis, signs and symptoms of PCOS). The third part collected information about the patients’ pharmacological (COCs, ovulating inducing agents, metformin, surgical intervention) and non-pharmacological (lifestyle modification) management of PCOS. The fourth and last part asked the informants about their use of CAM.

All the data were appropriately coded and analysed anonymously. Only patients who approved to take part in the research and gave informed consent were enrolled in the study. The patients, initially approached by the clinical pharmacist in the clinics’ waiting room, were interviewed in a separate room to assure privacy.

Patient and public involvement

None.

Data analysis

Statistical analysis was performed using SPSS V.23. Data were presented as frequency and percentage for categorical variables and median IQR for continuous variables. Binary logistic regressions were performed to investigate factors associated with CAM use among the participants. P value<0.05 indicates statistical significance.

ResultsParticipant demographic and clinical characteristics

A total of 402 women with PCOS participated in the study with a response rate of 99.5%. The responders were aged between 18 and 59 years, and the median (IQR) age was 25 (31–21) years. The participants’ general socio-demographic and disease-related characteristics are shown in table 1. Most of the respondents had a diploma/bachelor’s degree (70.6%), were unemployed (74.9%) and non-smokers (74.1%). The average time span for PCOS was 1–4 years (68.4%), and those without any other chronic disease counted for 79.9%.

Table 1

Demographic data of participants (n=402)

Women also reported manifesting different signs and symptoms related to PCOS. The number of clinical manifestations ranged between 0 and 11 with a median IQR of 6 (8–5). The most common were menses irregularity (81.8%), fatigue (71.6%), hyperandrogenism (77.6%), anxiety (68.4%), depression (67.9%) and overweight/obesity (63.4%). Almost half of the participants also reported sleep disturbances (55.7%) and food cravings (54.5%) while fewer women reported having infertility (27.4%), insulin resistance (15.7%) and other symptoms such as nausea, lower abdominal pain and breast tenderness (19.9%).

The participants adopted lifestyle changes and used various medications to manage the symptoms of PCOS. Lifestyle changes including diet change, exercise and weight loss were reported by 56.0%, 45.5% and 39.3% of the participants, respectively. 203 participants (50.5%) used oral contraceptive pills (OCPs) to reduce PCOS symptoms while more than half of the interviewees (61.4%) used other pharmaceuticals including metformin, clomiphene citrate (ovulation induction therapy) or statin. Surgical treatments such as laparoscopic ovarian drilling or bariatric (stomach) surgery were reported by 8.7% of the participants. In addition, only 5.2% of women reported the use of fertility medications for ovarian stimulation and in vitro fertilization (IVF) procedures. Yet, 34 respondents (8.5%) did not adapt to any lifestyle change or tried any traditional medication.

Use of CAM

Among the interviewed participants, 36.8% have never used any type of CAM. The remaining 63.2% reported the use of one or more CAM modalities for the management of PCOS. Among those using CAM, more than half of them (60.4%) have been using herbs as CAM. Examples of herbs included sage, marjoram, cinnamon, vitex (vitagnus), turmeric, lemon, rosemary, fennel, anise, clove, ginger and horse chestnut. Only a small percentage of the respondents reported taking vitamins (10.4%) and using holistic therapy such as cupping (5.7%) to reduce PCOS symptoms. The other CAM modalities—meditation, yoga, aromatherapy, massage therapy and chiropractic therapy—have been tried by just a few participants (0.2–1.2%).

Factors associated with CAM Use

The results from the binary logistic regression showed that being diagnosed with PCOS for more than 1 year and suffering from more PCOS signs and symptoms were factors significantly associated with CAM use (β=1.257, 95% CI 1.018 to 1.552, p<0.05; β=1.146, 95% CI 1.052 to 1.250, p<0.05, respectively). In addition, having a higher level of education was also associated with the use of CAM (table 2).

Table 2

Factors associated with CAM use among the study sample (n=402)

Source of information on CAM

The primary source of information for the use of CAM was family and friends (46.1%), followed by gynaecologists (38.2%) and social media (16.5%). Fewer respondents received information from other medical specialists (5.9%), pharmacists (4.3%) and CAM practitioners (3.1%).

Benefits and side effects of CAM

Among the participants who tried CAM, 57.5% reported amelioration in PCOS symptoms. This was significantly associated with the chronic use of CAM (for a period of 3 months or more) (β=12.759, 95% CI 6.789 to 23.976, p<0.001). Among all the CAM users, 40.2% indicated it was effective in improving menses irregularities, and 32.7% reported improvement in general well-being. Only a small percentage of the participants considered CAM effective for depression (7.9%), weight reduction (7.1%), infertility (6.3%), hirsutism (4.7%), sleep (4.7%) and acne (4.3%).

Participants were also asked to list the side effects or negative experiences witnessed from the use of CAM. Side effects were reported by 24 participants (9.4%). These included vomiting (3.9%), changes in bowel habit (1.6%), changes in menses cycles (1.6%), headache (0.8%), tachycardia (0.8%), sweating (0.4%), body malodor (0.4%), breast pain (0.4%) and dizziness (0.4%).

Discussion

This study investigated the use of CAM among 402 Jordanian females diagnosed with PCOS. The response rate was very high. Positive attitude towards participation in clinical studies was generally observed in Jordan, especially among females.24 The respondents, whose ages ranged between 18 and 59 years, reported suffering from a variety of signs and symptoms correlated to PCOS and adopting different treatments for its management. Despite being most frequently observed in young women (age 18–24 years), PCOS can also be present in perimenopausal and menopausal women.25 Hyperandrogenism plays a key role in the development of PCOS causing a series of pathophysiological changes that can lead to anovulation, obesity and insulin resistance, all further aggravated by hyperandrogenism.26 Women with PCOS have also been reported to have fatigue, an important barrier to lifestyle changes, that can contribute to depression, anxiety and sleep disorders.27

Despite no cure exists for PCOS, the available lifestyle approaches and therapies (such as exercises, hormonal contraception, ovulating agents and metformin) are considered effective in reducing patients’ symptoms and in restoring ovulation through the reduction of hyperandrogenism and insulin resistance.3 26 Diet modifications and OCPs were found to be common among the study participants. Since knowledge of Jordanian female towards OCPs has been shown to be generally low, proper education on this management and its correct use is mandatory.28

Metabolic surgery and IVF approaches were, on the other hand, reported by just a minority of the study population probably given their uncertain efficacy and potentially associated side effects29 30

Among all participants, almost two-thirds reported turning to CAM as an alternative method to alleviate PCOS symptoms with herbal remedies being the most used. A similar observation was also reported in Jordan among patients with chronic diseases, cancer and diabetes.31–33 Examples of herbs mentioned in this study were marjoram, cinnamon, vitex, turmeric, anise, clove and ginger. Earlier, research by Haj-Husein et al (2015) and Kolivand et al (2017) found marjoram tea to be useful in easing the symptoms of PCOS. These studies confirmed marjoram to cause a significant drop in dehydroepiandrosterone-sulphate levels in females with PCOS.34 35 Similarly, a recent report also showed patients with PCOS treated with vitex (Vitex agnus-castus) to have higher levels of progesterone, oestrogen and follicle-stimulating hormones (FSH) and lower levels of luteinizing hormone (LH) and testosterone. The researchers also reported that vitex can normalise the levels of the KISS-1 gene, overexpressed in PCOS.36 On the same line, oral cinnamon supplementation significantly decreases the serum levels of triacylglycerol, total cholesterol and low-density lipoprotein cholesterol (LDL-C) while increasing high-density lipoprotein cholesterol (HDL-C) levels in patients with PCOS suggesting a possible function of cinnamon supplements in ameliorating PCOS metabolic parameters.37 On the same line, the study conducted by Shah et al (2022) on turmeric extract revealed a reduction of the endocrine-metabolic disturbances mediated by letrozole. In letrozole-induced PCOS rats, turmeric extract significantly improved ovulation, ovarian shape, antioxidant status as well as the glycaemic, hormonal and rats’ lipid profile.38 These results highlight the ability of vitex, cinnamon and turmeric in ameliorating various aspects of PCOS manifestation suggesting new potential treatment options for this condition.

In addition to these herbs, citrus fruits, which contain the bioflavonoid hesperidin, also showed to have several advantages in PCOS, such as anti-inflammatory, antimicrobial and metabolism regulatory activities.39 Supplementation of hesperidin to non-pharmacological approaches, such as regular exercise, dietary modifications and weight loss, may allow these lifestyle changes to be more successful in controlling PCOS.

Other plants mentioned by the interviewees were ginger, liquorice, cinnamon and fenugreek. Atashpour et al (2017) investigated the effects of ginger extract on PCOS, observing amelioration in the hormonal profile of patients using this plant. In particular, patients treated with ginger extract showed higher levels of LH and oestrogen and lower concentrations of FSH and progesterone compared with the untreated group.40 Finally, liquorice, cinnamon and fenugreek also showed promising results in ameliorating PCOS by enhancing hormonal balance, regulating ovulation, tackling obesity, and improving insulin sensitivity.41

Remarkably, 57.5% of the individuals who tried CAM reported amelioration in PCOS symptoms. It is worth noting that this was significantly correlated to the long-term use of CAM (more than 3 months). Although no studies ever reported the long-term effect of CAM in the management of PCOS or the correct duration of treatment, like for most of the standard pharmaceutical therapies, a minimum of 3 months of treatment might be necessary to observe the desired outcomes. Yet, it is worth mentioning that a longer period of treatment can also put risk on patients in terms of side effects.

The time since PCOS diagnosis, the intensity of symptoms and the level of education were found to be important single determinants of the likelihood of using CAM among the study participants. Patients struggling with severe symptoms or those being diagnosed with PCOS for more than a year were more likely to use CAM. This goes in line with a general population-based study conducted in Europe also showing longstanding disease and poorer health to be associated with higher use of CAM.42 A similar association was also observed among patients with higher levels of education.43 44

In the present study, the main source of information for the use of CAM was identified as family members and friends. Despite the general satisfaction towards pharmacists’ role as healthcare providers in Jordan, just a few respondents reported them as a source of CAM information.45 Similar results were reported by Evans et al (2007), also observing family and/or friends to be the main source of information related to CAM use.46

This is the first study investigating the use of CAM among women with PCOS in Jordan. This cross-sectional study was conducted in a single centre in Jordan. The centre is one of the largest tertiary hospitals receiving patients from all over the country, yet the results might not be representative of other centres. The benefits and risks of CAM use have been assessed only subjectively. Considering the nature of the study design complete absence of social desirability cannot be assured.

Conclusions

In conclusion, this study demonstrated a variety of CAM approaches adopted by most of the interviewees to manage PCOS. Herbs were the most used CAM therapy. Considering the possible potential interactions between herbal medicine and the ‘standard-of-care‘ therapy in the management of PCOS, the so-called herb-drug interaction, efforts are needed by healthcare providers to better understand the use of CAM among their patients while keeping in mind that family/friends are the first sources of information in this regard.

Understanding the treatment choices in CAM, the duration of CAM treatment and the perceived benefits of using CAM can aid healthcare professionals in providing proper education regarding the benefits and potential harm of CAM products.

It is highly recommended that future research should aim to address some of the limitations identified in the current study by incorporating more comprehensive controlled trials or observational studies with a focus on clinically relevant outcomes. Specifically, the short- and long-term effects of specific CAM modalities should be investigated in a more balanced and evidence-based manner, ensuring that both advantages and disadvantages are objectively assessed. Such research will provide a more rigorous framework for evaluating CAM’s role in healthcare provision and the best duration of treatment for chronic diseases management, contributing with valuable insights for both practitioners and patients.

Data availability statement

Data are available upon reasonable request. Data may be obtained from a third party and are not publicly available.

Ethics statementsPatient consent for publication

Consent obtained directly from patient(s).

Ethics approval

Name of the ethical committee: Jordan University Hospital (JUH). Reference number: 229/2022. Participants gave informed consent to participate in the study before taking part.