|Year : 2021 | Volume
| Issue : 1 | Page : 12-23
Homoeopathic treatment of women with polycystic ovarian syndrome: A prospective observational study
Girish Gupta1, Naveen Gupta2, Santosh Singh1, Varanasi Roja3, Deepti Dewan3
1 Homoeopathic Research Foundation, Lucknow, Uttar Pradesh, India
2 Gaurang Clinic and Centre for Homoeopathic Research, Lucknow, Uttar Pradesh, India
3 Central Council for Research in Homoeopathy, New Delhi, India
|Date of Submission||05-Mar-2020|
|Date of Acceptance||18-Feb-2021|
|Date of Web Publication||31-Mar-2021|
Dr. Girish Gupta
Gaurang Clinic and Centre for Homoeopathic Research, B-1/41, Sector A, Near Novelty (Aliganj), Kapoorthala, Aliganj, Lucknow - 226 024, Uttar Pradesh
Source of Support: None, Conflict of Interest: None
Background: Polycystic ovarian syndrome (PCOS) is one of the most common hormonal disorders among women of reproductive age group and a leading cause of female sub-fertility. Objectives: This study was conducted to evaluate the effect of individualised homoeopathy on clinical and hormonal profile in women suffering from PCOS. Materials and Methods: A prospective, observational study was conducted from July 2015 to June 2017 at Homoeopathic Research Foundation, Lucknow, in which 80 cases were screened, and 38 cases fulfilling the eligibility criteria were enrolled. Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQ) was used to evaluate the quality of life. Serum levels of follicle-stimulating hormone, luteinising hormone, progesterone, prolactin, estrogen, testosterone and insulin were tested at the baseline and 12 months of treatment. Eighteen patients completed the follow-up of 12 months. The analysis was done with 'modified Intention to Treat' approach. Results: The comparison of PCOSQ from baseline to 12 months in 34 patients using the paired t-test showed significant improvement in the overall PCOSQ of the patients (mean increase ± standard error: −2.3 ± 0.5; 95% confidence interval CI: -3.2 to -1.3 P = 0.001). The number of cysts in both ovaries reduced with a statistically significant difference. There was a mean reduction of two cysts on each side of the ovary. The most prescribed medicines were Calcarea carbonica (38.24%) and Lycopodium. (26.47%) accounting to 64.71% of the total medicines. Conclusion: The present study gives positive leads in the management of PCOS with Homoeopathic medicines. Controlled trials are further warranted.
Keywords: Homoeopathy, Hyperandrogenism, Lifestyle modification, Menstrual irregularity, PCOSQ, Polycystic ovarian syndrome, Testosterone
|How to cite this article:|
Gupta G, Gupta N, Singh S, Roja V, Dewan D. Homoeopathic treatment of women with polycystic ovarian syndrome: A prospective observational study. Indian J Res Homoeopathy 2021;15:12-23
|How to cite this URL:|
Gupta G, Gupta N, Singh S, Roja V, Dewan D. Homoeopathic treatment of women with polycystic ovarian syndrome: A prospective observational study. Indian J Res Homoeopathy [serial online] 2021 [cited 2021 Apr 23];15:12-23. Available from: https://www.ijrh.org/text.asp?2021/15/1/12/312626
| Introduction|| |
Polycystic ovarian syndrome (PCOS) is one of the most well-known hormonal problems among ladies of reproductive age and a main cause of sub-fertility. It is portrayed by persistent anovulation and hyperandrogenism with variable clinical indications, for example, oligomenorrhoea, inability to conceive, hirsutism and skin inflammation. The prevalence is variable, going from 2.2% to 26% globally. The Rotterdam criteria require the presence of two of the following for diagnosis: Oligo/anovulation, hyperandrogenism or polycystic ovaries on ultrasound. Community-based studies using Rotterdam criteria among women of reproductive age in the Asian population have demonstrated varied prevalence from 2% to 7.5%. In India, the prevalence is 9.13%–36%.
The Endocrine Society Clinical Practice Guidelines for the treatment of polycystic ovaries advocate hormonal contraceptives (HCs) (i.e., oral contraceptives, patches or vaginal rings) as the first-line management for menstrual abnormalities, acne and hirsutism; lifestyle modification (LSM) such as exercise, calorie-restricted diet for overweight and obesity; metformin is prescribed for women with PCOS who have Type 2 diabetes mellitus or impaired glucose tolerance, menstrual irregularity who cannot take or do not tolerate HCs, and as adjuvant therapy for infertility to prevent ovarian hyper-stimulation syndrome in women undergoing in-vitro fertilisation. Clomiphene citrate (or comparable oestrogen modulators such as letrozole) is also recommended for treating anovulatory infertility. Although these treatments have shown some positive response, their long-term use is questionable with side effects.
Existing shreds of evidence from case reports, case series to randomised controlled trials show the positive role of Homoeopathy in PCOS. Rath successfully treated two cases with Homoeopathic medicines Pulsatilla nigricans (Puls.) and Sepia, respectively, followed by conception and delivery of a female child to each. Rath also reported successful treatment within 1.5 years by single individualised Homoeopathic medicine Calcarea carbonica (Calc. carb.) 30C-1M with improvement in ultrasonography (USG) findings and regular menstrual cycle for 3 years. A study in 1997 on 36 women treated with Puls. (6C potency) reported complete resolution of cysts with the disappearance of the symptoms of PCOS and production of normal ovulating follicles. Another comprehensive clinical study, reported an overall success rate of 68.81% in 218 cases of PCOS. Sharma in their clinical study on 132 patients of PCOS successfully treated 91 (68.9%) patients.
Lamba et al. in their randomised placebo-controlled trial concluded the beneficial role of individualised Homoeopathic intervention along with LSM resulting in regular menses with improvement in other signs/symptoms in 60% of the cases. However, the present study did not determine the effect of Homoeopathic medicines on hormonal assays.
There is no 'specific' remedy for PCOS in Homoeopathy. Its treatment involves the selection of a constitutional Homoeopathic remedy capable of working not only on the ovaries but also on the entire psycho-neuro-endocrine system of the patient. There are several homoeopathic medicines capable of influencing this condition when selected after understanding the constitution, genetic predisposition, miasmatic background and peculiarities in the menstrual cycle, if any. The present cohort study was undertaken to add to the existing evidence with an objective to evaluate the effect of individualised Homoeopathic therapy on the clinical and hormonal profile in PCOS patients after 1 year of treatment.
| Materials and Methods|| |
Study design and setting
A prospective, observational study was conducted from July 2015 to June 2017 for 2 years during which 38 patients of PCOS were enrolled and treated under the aegis of Homoeopathic Research Foundation. Ethical approval was taken from the Institutional Ethics Committee dated 28th May 2014. The study was undertaken between 2015 and 2017; during this period registration at CTRI was not mandatory. All procedures followed the ethical standards on human experimentation as per the Helsinki Declaration of 1975, as revised in 2013. The principal investigator (PI) has 38 years of Homoeopathic practice, having a degree to practice Homoeopathy from a Government recognised institution and responsible for the prescription of Homoeopathic medicines. The study staff including a senior research fellow, who also had institutional qualification as per the regulations of Government of India, assisted the PI in conduct of the study.
The convenience sampling technique was used to achieve a sample of 38 cases. The participants enrolled were based on the following inclusion and exclusion criteria.
- Patients between the age group of 18–40 years
- Oligo/amenorrhoea: The absence of menstruation for 45 days or more and/or <8 menses per year
- Serum testosterone level >70 ng/dl in the absence of other causes of hyperandrogenism
- Polycystic ovaries: Presence of >10 cysts, 2–8 mm in diameter, usually combined with increased ovarian volume of >10 cm3 and an echo-dense stroma in pelvic USG
- No use of birth control pill for at least 3 months before the study and no plans of pregnancy during the study.
- Elevated creatine kinase above two times the upper limit of normal or liver enzymes (transaminases) above two times of upper limit of normal range
- Current use of any of the following medications: Cyclosporine, fibrates, niacin, antifungal agents and macrolide antibiotics
- Use of oral contraceptives and other steroid hormones 3 months before the study
- Contraindications to oral contraceptives
- Clinical history of systemic illness such as cancer and HIV.
Intervention, treatment plan, baseline and follow-up assessment
All enrolled patients underwent a complete homoeopathic case taking with compulsory USG to confirm the diagnosis of PCOS and to assess the response during and after treatment.
After detailed case taking on a standard case taking proforma, the totality of symptoms was built for each patient based on mental generals, physical generals, constitution, miasmatic background, family history, previous medical history etc as per the Homoeopathic principles. Group of medicines were identified through repertorisation using 'Hompath Classic' software (Version 8.0) (Mind Technologies Private Limited, Mumbai, Maharashtra, India). Materia Medica guided the final selection of medicine. All the prescriptions started with 30 CH potency because this is neither too low nor too high to start the treatment. Thereafter, potency was either repeated, raised or medicine was changed depending on the response of the patient. The follow-up of the patient to check clinical status was done at an interval of 1 month. The timelines for the assessment of different parameters are mentioned under outcome measures.
The primary outcome was to determine the overall quality of life (QOL) using PCOS Questionnaire. This questionnaire measures the health-related QOL of a woman with polycystic ovarian disease consisting of a total of 26 items grouped into five domains: Emotions (8 items), body hair (5 items), weight (5 items), infertility (4 items) and menstrual problems (4 items). Each question is associated with a 7-point scale in which '7' represents optimal function and '1' represents the poorest function. Scoring is done by dividing each domain total score by the number of items in the domain. The PCOS Questionnaire (PCOSQ) was assessed at baseline and every 3 months for 12 months.
The secondary outcome was to assess the changes in hormonal, profiles and USG findings. USG was repeated at 3 months' interval for 12 months. Hormonal assays such as progesterone, estradiol, insulin, thyroid-stimulating hormone (TSH), testosterone, follicle-stimulating hormone (FSH), luteinising hormone (LH), LH/FSH and prolactin were evaluated at baseline and 12 months.
Statistical analysis was performed using the Statistical Package for the Social Sciences, SPSS Inc., Chicago, Illinois, USA (SPSS ver. 20.0) for Windows. The analysis was based on 'modified intention to treat' (mITT). Patients who had at least 3 months follow-up were included in the data analysis. Last observation 'carry forward method' was used to fill the missing values. Repeated measures analysis of variance (ANOVA) was applied for comparing the change over 12 months. A paired t-test (pre-post) was used analysing the outcome at 12 months. A two-tailed (α = 0.5) P value less than 0.05 (P < 0.05) was considered statistically significant.
| Results|| |
One hundred cases were registered for screening in the outpatient department, 20 cases did not turn up for a preliminary screening. Out of 80 patients screened, 4 were excluded; due to hypothyroidism (n= 3) and regular menses (n= 1). Seventy-six cases were further investigated, out of which 38 were excluded based on investigations and the remaining 38 were included [Figure 1]. Out of these 38 cases, four were lost to follow-up before 3 months hence considered as drop out and were not considered for the analysis. A total of the remaining 34 cases were analyzed on mITT approach. The missing values were filled with using last observation carried forward method. The flow of patients in the study is given in [Figure 1]. The baseline characteristics of the patients is given in [Table 1].
|Table 1: Baseline characteristics of the 34 patients treated with modified intention to treat|
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The outcome was assessed in three categories: PCOS questionnaire (PCOSQ), hormonal profile and USG.
The comparison of PCOSQ from baseline to 12 months after Homoeopathic treatment [Table 2] using the paired t-test showed significant improvement in the overall PCOSQ of the patients (mean increase ± standard error [SE]: −2.3 ± 0.5; 95% confidence interval [CI]: -3.2 to -1.3; P = 0.001), emotions (mean increase [SE]: −0.5 [0.1]; 95% CI: -0.8 to -0.3; P < 0.001) and menstrual complaints (mean increase [SE]: −0.9 [0.1]; 95% CI: -1.3 to -0.7; P < 0.001). However, the improvement was statistically insignificant in body hair (P = 0.15), body weight (P = 0.04) and infertility (P = 0.07). A repeated measure one-way ANOVA at time points (baseline, 3 months, 6 months, 9 months to 12 months) as seen in [Figure 2] shows statistically significant changes in emotions (F = 9.5, P < 0.001), weight (F = 3.4, P = 0.01), menstrual complaints (F = 17.5, P < 0.001) and overall PCOSQ scores (F = 8.81, P < 0.001). 'F' tests the multivariate effect of time. These tests are based on the linearly independent pairwise comparisons among the estimated marginal means.
The comparison of different hormones associated with PCOS before and 12 months after Homoeopathic treatment is shown in [Table 2]. The level of hormones such as progesterone, estradiol, insulin, TSH, testosterone and FSH did not show any statistically significant increase in their levels. However, the prolactin levels increased statistically (mean increase ± SE: −2.8 ± 0.9; 95% CI: -4.7 to -0.9; P = 0.004). Similarly, the LH reduced statistically (mean reduction ± SE: 1.5 ± 0.7; 95% CI: 0.04 to 2.9; P = 0.04). The insulin hormone though increased from baseline was statistically insignificant (mean increase- 1.5 ± 3.8; 95% CI: -9.2 to 6.2; P = 0.69). In 18 patients, repeat testosterone values at 1 month have shown the following: became normal (n = 8), decreased (n = 4), status quo (n = 1) and worsened (n = 5).
[Table 2] shows the USG findings comparing before and after individualised Homoeopathic treatment. There was a mean reduction in the number of cysts in both ovaries. The mean reduction of cysts in the right ovary was 1.8 ± 0.5; 95% CI: 0.8 to 2.8; P = 0.001. The mean reduction of cysts in the left ovary was 1.9 ± 0.5; 95% CI: 0.9 to 2.8; P = 0.001. Improvement in USG findings was observed in 16 patients, no improvement in 18 patients.
The medicines which were prescribed in the study are Calc. carb. (n = 13), Lycopodium clavatum (Lyco.) (n = 9), Natrum muriaticum (Nat. mur.) (n = 5), Puls. (n = 4), Nux vomica (Nux vom.) (n = 1), Sepia (n = 1) and Staphysagria (Staph.) (n = 1). [Table 3] shows the change of medicine required in patients after the first prescription. All the prescriptions began with 30CH potency. After follow-up at 1st month, potency was either repeated, raised or a change of medicine was done, if required. Change of potency was required in 33 patients: (200CH [n = 10]; 1M [n = 22]; 10M [n = 1]). Change of medicine was required in 5 patients. [Table 4] represents the indications of the prescribed medicines.
| Discussion|| |
This was a single-arm cohort study undertaken on 34 patients suffering from PCOS for 1 year. The outcome of this evidence-based study is encouraging and generates a hypothesis that Homoeopathy can provide safe and effective treatment to patients of PCOS along with improvement in the ultrasonographic findings and hormonal profile. The overall QOL of patients evaluated using PCOSQ improved with effect size of 0.51. The sub-items of PCOSQ score such as emotion, menstrual complaints and weight also had significant improvement. The same observations can also be found in the findings by Lamba et al. Other sub-items such as infertility and body hair did not show any changes over 12 months.
In the present study, the prolactin hormone was found to be increased. Studies have shown that it has no association with the progression of the disease. There was a statistically significant reduction in LH level after treatment. LH concentration has been associated with an increased risk of infertility and miscarriage. In the study conducted by Lamba et al. post-treatment hormonal profile was not carried out which could have added to the results of the clinical findings. This unexplored area can be further investigated on a larger sample size to find association of Homoeopathic medicines on biological markers.
In the study by Gupta et al. Calc. carb.(n = 80) was the most prescribed medicine with positive response in 23.39% patients, followed by Nat. mur.(n = 53), Puls.(n = 37) and Lyco.(n = 23). The Homoeopathic medicines prescribed in this study are similar; Calc. carb. (n = 13) and Lyco. (n = 9) were the most prescribed medicines followed by Nat. mur. (n = 5), Puls. (n = 4). However, in the study done by Lamba et. al. Puls.(n = 12) was the most prescribed medicine which may be due to the difference of perception of prescribing physician based on the totality of symptoms. Much focus was given to causation and mental generals for selection of medicine. Despite the clinical success and to some extent in USG and hormonal findings, the present study has certain limitations too.
This was an observational study with a single arm. In the absence of a control arm, there is always a chance of overestimation of the effect of treatment. This may be attributable to the placebo effect; regression effect to the mean. The sample size though determined for enrolling 50 patients, but the target could not be achieved due to prefixed inclusion and exclusion criteria. In future studies, biochemical parameters such as lipid profile, fasting blood sugar, Homeostatic Model Assessment of Insulin Resistance (Hom IR) levels, biological markers for PCOS may be considered and further explored.
| Conclusion|| |
The study gives positive leads in the management of PCOS with Homoeopathic medicines. The changes were observed in PCOS questionnaire (PCOSQ), hormonal profile and USG.
There was a significant change in PCOSQ and number of cysts. Controlled trials are further warranted; pragmatic randomised control trials/comparative cohort studies with a larger sample size will further investigate the cause and effect relationship of Homoeopathic treatment.
We acknowledge the expert opinion of Dr. Nilima Singh, Gynaecologist and technical expertise provided by Dr. Anil Khurana, Director General, Central Council for Research in Homoeopathy, Govt. of India. The authors also acknowledge the contribution of Mr. Arvind Dayal, Statistical Assistant, Central Council for Research in Homoeopathy, New Delhi, India.
Financial support and sponsorship
The project was funded by the Ministry of AYUSH under its Extra Mural Research Scheme vide: Letter no. Z.28015/120/2014-HPC (EMR)-AYUSH-D dated 25.6.2015.
Conflicts of interest
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[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3], [Table 4]