The overall goals of this project are to assess the efficacy of non-pharmacological, complementary therapies to improve outcomes in the treatment of women with polycystic ovary syndrome (PCOS). The studies proposed herein are designed to assess the efficacy of osteopathic manipulative medicine (OMM) in the assessment of sympathetic tone in these women, and the effectiveness of non-pharmacologic therapeutic interventions in improving participant metabolic, endocrine, reproductive, and psychological health.
Question 1: Can osteopathic structural assessment identify increased sympathetic tone in women with PCOS? Specific Aim 1: To use palpation of Chapman points and spinal viscerosomatic reflex regions to assess the presence and degree of increased sympathetic tone in women with PCOS. Chapman points and viscerosomatic reflexes reflect visceral dysfunction and are mediated by the sympathetic nervous system, and can be a very useful clinical diagnostic tool. There is increased sympathetic tone in women with PCOS as well as in obese individuals, as previously determined by physiologic measures. Increased sympathetic tone in the study population will be assessed by osteopathic structural assessment and confirmed by physiologic measures of heart rate, heart rate variability, resting blood pressure, and blood pressure and heart rate recovery following exercise. Hypothesis: Chapman points will be palpable at regions for the heart, adrenal glands, and ovaries to indicate hyperactivity of the sympathetic nervous system and will correlate with physiologic evidence of increased sympathetic tone. Hypothesis: Alterations of viscerosomatic reflexes associated with the heart, adrenal glands, and ovaries will reflect hyperactivity of the sympathetic nervous system and will correlate with physiologic evidence of increased sympathetic tone. Question 2: Can regular, sympathetic nervous system-targeted osteopathic manipulative treatment (OMT) improve endocrine and reproductive parameters, and sympathetic tone, in women with PCOS? Specific Aim 2: To use weekly manipulation of Chapman points and spinal regions associated with viscerosomatic reflexes in women with PCOS for improvement of endocrine and reproductive parameters, and sympathetic tone, after 3 months of treatment. Chapman points and viscerosomatic reflexes are useful in diagnosis, and may be manipulated to restore somatovisceral health. Hypothesis: Completion of 3 months of weekly manipulation of Chapman points and viscerosomatic reflexes will improve sympathetic tone (as assessed by both osteopathic structural assessment and physiologic parameters), androgen levels, and menstrual cycle length compared to women with PCOS and no intervention. Question 3: Can regular yoga improve metabolic, endocrine, reproductive, and psychological parameters in women with PCOS? Specific Aim 3: To use thrice-weekly yoga practice with mindfulness techniques in women with PCOS to improve metabolic, endocrine, reproductive, and psychological parameters after 3 months of intervention. The benefits of moderate and high-intensity aerobic activity on metabolic and overall health for women with PCOS have been reported, but the effects of low-impact exercise are less studied. Women with PCOS will participate in a yoga class with integrated mindfulness techniques 3 times per week for 3 months. Hypothesis: Thrice weekly yoga intervention for 3 months will result in an improvement in androgen levels, fasting blood glucose, menstrual cycle length, and patient-reported anxiety, compared to women with PCOS and no intervention.
Change in androgens
Change in serum androgen levels with intervention
Time frame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Change in menstrual cycle length
Change in average time between day 1 of consecutive menstrual cycles after intervention
Time frame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Change in acne
Acne score after intervention (none, mild, moderate, severe)
Time frame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Change in BMI
BMI value after intervention
Time frame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Change in waist:hip ratio
Waist:hip ratio after intervention
Time frame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Change in fasting blood glucose
Serum glucose levels after intervention
Time frame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Change in fasting insulin
Serum insulin levels after intervention
Time frame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Change in depression score
Beck Depression Index II score after intervention (total score 0 to 63, lower score means better outcome)
Time frame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Change in anxiety
Beck Anxiety index score after intervention (total score 0 to 63, lower score means better outcome)
Time frame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Change in blood pressure
Blood pressure after intervention
Time frame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Change in heart rate recovery
Heart rate recovery from exercise after intervention
Time frame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Change in heart rate variability
Heart rate variability measured by EKG after intervention
Time frame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)