Menopause is associated with a physiological shift towards a atherogenic lipid profile (1,2). Postmenopausal women have been found to have increased total cholesterol, LDL cholesterol, apolipoproteins and triglycerides and reduced levels of HDL, which is known to be pro-atherogenic (1,2,3,4). Decrease in estrogen levels in post-menopause which is a cardioprotective hormone is believed to contribute to dyslipidemia in postmenopausal women when compared to premenopausal women [5,6]. Dyslipidaemia has been found to be an independent risk factor for coronary artery disease (CAD) in post-menopausal women (7,8). CAD is the leading cause of death among the post-menopausal women(9) with the Framingham study suggesting an acceleration in the female CAD morbidity rates higher than that of males after menopause (10) and an increase in cholesterol levels coinciding with menopause, suggesting a causal role of menopause in altering lipid levels (11). Yoga has been explained by Sage Patanjali as “Yogah chitta vritti nirodhah”(12) and Sage Vasishta as “manah prashamana upayah yogah”(13).It is one the most ancient Indian holistic art of living meant to quieten the mind and achieve its union with the divine intelligence of the universe (14-16).Yogic practice includes various asanas, kriyas, mudras, bandhas, and conscious physical relaxation for the body; concentration and meditation for the mind and Pranayama techniques to absorb “prana,” the life energy of the universe for the sustenance of life (Chandogya Upanishad) (17-19). With improved healthcare system and prolongation of life span of human beings, the world postmenopausal women’s population continues to rise. Hence, there is pressing need for safe and effective intervention which can decrease the morbidity and mortality associated with deranged lipid profile and CVDs without the adverse effects of HRT. We propose to study the influence of Yoga on lipid profile in early postmenopausal women, an unchartered territory in the vast field of postmenopausal research.

Study settings and design The study is a prospective interventional study conducted in the Departments of Physiology, Biochemistry and Obstetrics and Gynaecology in Lady Hardinge Medical College and Associated Hospitals, New Delhi. Sampling strategy and sample size A convenient sample size of 67 subjects was taken due to constraints of duration of study and availability of patients willing to undertake Yogic practice. 67 women within 5 years of menopause between 45 and 60 years of age attending menopause clinic of Department of Gynaecology, Sucheta Kriplani Hospital were recruited as participants. Inclusion criteria for the participants were (1) diagnosis of menopause by a gynaecologist according to STRAWS (20) study criteria and menopausal for up to 5 years; (2) age group of 40–60 years, and (3) body mass index (BMI)<30. Participants excluded from study were (1) patients with past or present history of diabetes, hypertension, coronary event or any other any known systemic illness; (2) on drugs that influence autonomic nerve system as antihypertensives, antianginals, antipsychotics, antidepressants or HRT; (3) already practising yoga or any known regular exercise regime or (4) who were unwilling to participate. After confirming inclusion criteria and explaining the objective and design of the study in detail, voluntary and informed signed consent of participants were obtained. Participants were divided into two groups on the basis of their willingness to join Yoga: Group 1[Yoga group(n = 37)] postmenopausal patients receiving routine management along with Yogic intervention and Group 2[Non-Yoga group (n = 30)] postmenopausal patients receiving routine management. No financial benefit/ compensation was offered to the participants as incentive to participate in the program. Measurements BASELINE PARAMETERS After detailed history taking and general physical examination, major physiological parameters including anthropometric measurements[22] were measured and a semistructured proforma was filled with socio-demographic details. Participants were asked to report after an overnight fast of 12 hour after abstinence from caffeine, tea, coffee or nicotine for at least 24 h before the measurements to avoid known influences of these factors on autonomic nervous balance. The fasting blood samples and physiological parameters of subjects were taken between 9 a.m. and 12 noon to obviate any diurnal influences. LIPID PROFILE After an overnight fast, blood samples for assays were collected between 9 a.m. and 12 noon from postmenopausal women. Blood samples were drawn from the antecubital vein under aseptic conditions and collected and analyzed for S. Total Choleterol, S. Triglycerides and S.HDL in fully automated Beckman Coulter AU 480 machine. S.VLDL and S.LDL were calculated by the following formulae – S.VLDL = TG/5 LDL =TC-(HDL+TG/5) Intervention The Group 1 participants received intervention in the form of Integrated Yoga module comprising asanas, pranayama, savasana, and OM chanting in addition to routine gynaecological management. The module was exclusively designed for postmenopausal women based on the concepts from Patanjali’s yoga sutras by trained Yoga physicians from AYUSH Department, LHMC. They were asked to attend Yoga clinic at a convenient time between 8 am and 1 pm and with a minimum of 2 hours of fasting. The uniform Yoga module was meticulously taught to them for a minimum of 7 days by trained Yoga instructors from AYUSH Department, LHMC. Participants were made familiar with the program which was introduced to them in a phased manner and standardized for all [Table 1]. They were instructed to practice it regularly at their respective houses for 1 h every day for at least 6 days in a week for a total duration of 12 weeks. Participants suffering from arthritis or those having undergone knee replacement surgery were advised to perform yoga manoeuvres seated on chairs. The Group 2 participants continued for 3 months with routine gynaecological management without Yogic intervention. No other interventions were done in either group. The lipid profile measurements were done in both groups at the beginning and after 3 months of the study period. Outcome measurement A significant decrease in lipid profile if observed with yogic intervention suggests a beneficial effect of yoga on lipid profile in postmenopausal women which is an important causative determinant of cardiovascular morbidity and mortality. Ethics: The approval of the Institutional Ethics Committee for Human Research was sought and obtained for the complete experimental protocol. Statistics: 67 women within 5 years of menopause between 45 and 60 years of age attending menopause clinic of Department of Gynaecology, Sucheta Kriplani Hospital were recruited as participants. A convenient sample size of 67 subjects was taken due to constraints of duration of study and availability of patients willing to undertake Yogic practice. Participants were divided into two groups on the basis of their willingness to practice Yoga. The data were subjected to statistical evaluation using GraphPad Prism Version 5 software. After testing for normality of distribution of data with the Kolmogorov–Smirnov goodnessoffit test, data were presented as mean values ± standard error of mean. Intergroup comparison between Group 1 and Group 2 for parametric data was done using unpaired “t” test and for nonparametric data was done using Mann–Whitney Utest. Intragroup analysis after intervention was done using paired ttest for normally distributed and Wilcoxon matched pair test for nonparametric data. Statistical significance was set up at P < 0.05.

Due to dedicated motivation and follow-up by the authors and the Yoga Department, the study did not register any dropout. Table 1 depicts the Yoga protocol designed by the trained Yoga physicians from AYUSH Department, LHMC based on the concepts of Patanjali’s Yoga Sutras and directed towards improving IR of the postmenopausal women and taught to them. Table 1: The yogic schedule I. ASANAS(30 min) A. Standing Series- Any 3 1. Katichakrasana 2. Tadasana 3. Ardhakatichakrasana 4. Ardhachakrasana B.Supine Series- Any 2 1. Uttanapadasana(30,45,90) 2. Pavanamuktasana 3. Setubandhasana 4. Shavasana with Quick Relaxation Technique-3 min. C. Prone Series- 1. Bhujangasana 2. Shalabhasana(single leg)/Balasana D. Sitting Series – Any 3 1. Gomukhasana 2. Vakrasana 3. Yogamudra 4. Pelvic Stretch 5. Ushtrasana 6. Pashchimotanasana II. PRANAYAMA(30 min.) 1. Kapalbhati-3 min. 2. Anulomvilom-7 min. 3. Bhramari-24 rounds-5 min. 4. If subject is willing-AUM chanting-24 rounds over agya chakra(eyebrow centre) 5. If subject is not willing – • Akara chanting-3 rounds • Ukara chanting-9 rounds • Mkara chanting-12 rounds 6. Shavasana with Deep Relaxation Technique-7 min.(MAUNN i.e. Silence) Table 2: Depicts measurement of the basic demographic profile of Group 1 and Group 2 prior to any intervention. There was no significant difference in age (years), duration of menopause (years), weight (kg), height (m), BMI (kg/m²), neck circumference (cm), waist circumference (cm), hip circumference (cm), body fat percentage (%) between the two groups. However, weight and BMI of the two groups are significantly different making them noncomparable. Hence, we decided to proceed with pre and post intervention intragroup study as the chosen method of analysis. Table 2: Baseline demographic profile of Group 1 and Group 2 [Mean± SEM values] PARAMETERS GROUP 1 (YOGA) (n=37) GROUP 2 (NON-YOGA) (n=30) p Value AGE(yrs) 51.78± 0.82 52.97± 0.72 NS Duration of Menopause(yrs) 3.02±0.23 3.43± 0.23 NS WEIGHT(kg) 66.52±1.50 60.58± 2.31 0.0294* HEIGHT(m) 1.545± 0.01 1.54±0.09 NS B.M.I(kg/m2) 27.88±0.62 25.34±0.82 0.0294* NECK CIRCUMFERENCE(cm) 33.03±0.35 33.03±0.44 NS WAIST CIRCUMFERENCE(cm) 95±2.68 93.83±2.23 NS HIP CIRCUMFERENCE(cm) 104.8± 1.34 102.1± 2.21 NS BODY FAT (%) 43.83± 1.43 42.03±1.76 NS Unpaired t-test; P>0.05 = Non-significant, *P<0.05 (Significant), **P<0.01 (Very significant),***P<0.001 = Highly significant.[25] NS = Nonsignificant, BMI = Body mass index Table 3: Compares baseline physiological parameters of Group 1 and Group 2 prior to any intervention. It depicts no significant difference in resting heart rate (beats/min), respiratory rate (breaths/min) and systolic BP (mmHg) between the two groups under study. The diastolic BP (mmHg) of the two groups are however significantly different (p=0.0114). Hence, the two groups continue to remain non-comparable. Table 3: Baseline physiological parameters of Group 1 and Group 2 [Mean± SEM values] PARAMETER GROUP 1 (YOGA) (n=37) GROUP 2 (NON- YOGA) (n=30) P Value RestingHeartRate (beats/min) 74.46±2.04 77.47± 3.41 NS Respiratory Rate(breaths/min) 13.95± 0.26 14.2±0.244 NS Systolic B.P.(mmHg) 127.2± 1.28 125.2±2.08 NS Diastolic B.P.(mmHg) 84.72±0.74 80.77±1.41 0.0114* Unpaired t-test; P>0.05 = Non-significant, *P<0.05 (Significant), **P<0.01 (Very significant),***P<0.001 = Highly significant.[25] NS = Nonsignificant, B.P. = Blood pressure. TABLE 4: Lipid Profile of Group 1 and Group 2 pre and post intervention [Mean± SEM values] LIPID PROFILE PARAMETERS GROUP 1(NON-YOGA) (n=30) GROUP 2(Yoga) (n=37) PRE POST P Value PRE-YOGA POST-YOGA P Value S.TOTAL CHOLESTEROL(mg/dl) 187.6±6.36 196.4±5.58 NS 189.3±6.03 188.5±5.72 NS S.TRIGLYCERIDES(mg/dl) 153.2±14.93 152.8±10.66 NS 129.0±7.51 122.3±8.77 NS T.HDL(mg/dl) 44.60±1.48 43.2±1.57 NS 47.22±2.44 48.19±2.24 NS T.LDL(mg/dl) 113.8±4.82 121.2±4.69 NS 116.8±5.02 115.3±5.11 NS T.VLDL(mg/dl) 30.65±2.98 30.56±2.13 NS 25.8±1.50 24.46±1.75 NS Paired t-test P value->0.05-Non-Significant(NS),< 0.05-Significant*, <0.01-Very Significant**, <0.001-Highly Significant*** Table 4 depicts non-significant changes in all the parameters of lipid profile (T.Cholesterol, S.Triglycerides, S.HDL, S.LDL, S.VLDL) in both the study groups pre-intervention and after 3 months of intervention. An apparent larger fall in S.Total Cholesterol and S.Triglycerides was observed in Yoga group. However, when subjected to statistical scrutiny, the observed fall was non-significant.

To detect the association between Yoga and lipid profile in early postmenopausal women, if any was the starting point and primary goal of our research undertaking. Previous studies have suggested positive influences of Yogic practices on lipid profile in human population (21-32) postmenopausal women (33-35). Our data demonstrates a trend towards improvement, though non-significant in lipid profile in postmenopausal women practicing Yoga and a worsening of lipid profile which was non-significant in postmenopausal women not practicing Yoga. In the Yoga group, a definite decrease was observed in S. Total Cholesterol (mg/dl) [189.3±6.03(post) vs 188.5±5.72 (pre)], S.Triglycerides (mg/dl) [(129.0±7.51(post) vs 122.3±8.77(pre)], T.VLDL (mg/dl) [(25.8±1.50 (post) vs 24.46±1.75(pre)] post intervention but it failed to achieve statistical significance. In the Non-Yoga Group, S. Total Cholesterol (mg/dl) [(187.6±6.36 (post) vs 196.4±5.58 (pre)], T.LDL(mg/dl) [(113.8±4.82 (post) vs 121.2±4.69 (pre)] worsened after 3 months while S.Triglycerides (mg/dl) [(153.2±14.93 (post) vs 152.8±10.66 (pre)] and T.VLDL (mg/dl) (30.65±2.98 (post) vs 30.56±2.13 (pre)] remained relatively unchanged. S.HDL(mg/dl) remained predominantly unchanged in both groups. A beneficial though non-significant decrease in lipid profile in early postmenopausal women practicing Yoga and no change in lipid profile in the Non-Yoga group suggests that regular practice of Yoga Therapy has attenuated the worsening of lipid profile in early Indian postmenopausal women regular during the observation period. Studies by Anjana K et al (22), Sadhasivam S et al (23), Maharjan AS et al (24), Ghazvineh D et al (25), Papp ME et al (26), Salunkhe A et al (29), Bhavanani(30) and ACYTER, Pondicherry (31) have recorded significant improvement in lipid profiles in their patients post Yoga. Chen S R et al (21), Shantakumari N et al (27), Vedamurthachar A et al (28), Nisha Shantakumari et al and Nagarathna et al (31) too have reported a significant improvement in lipid profile after Yoga intervention in their diabetic subjects. Studies by Vyas R et al (33), Khadka, R et al (34) and Lee JA et al (35) have recorded a significant improvemrnt in all parameters of lipid profile in postmenopausal women after regular practice of Yogic practice. One important reason for our observations regarding lipid profile, which does not fall in line with these studies, could be a shorter duration of study and a smaller sample size. Also, we were assessing the women in their early postmenopause, a period of much turmoil in terms of the hormonal fluctuations entailing menopause. Hence, achievement of significant changes in lipid profile at this stage of their life post Yogic intervention might require more enduring study. Most of the other studies that came to our knowledge, have detected the effect of lipid profile on postmenopausal women, irrespective of the period of their menopause. Hence, our study stands unique, despite the absence of significant changes in lipid profile of subjects post-Yoga. Our study helps to explain the causative etiopathology of many of the adverse health events associated with menopause such as cardiovascular diseases which are often associated with a deranged lipid profile. It creates avenues for researchers to take up the cause of postmenopausal health. It further substantiates the already growing evidence for efficacy of Yoga in preventing and ameliorating health adversities faced by postmenopausal women. Regular practice of yoga could be a powerful tool to attenuate the deranged lipid profile brought about by hormonal imbalances in early postmenopausal women and thereby help prevent and decrease cardiovascular morbidity and mortality in them. Our study puts things in order for clinically important implications for Yoga as a non- clinical, cost-effective and safe lifestyle intervention for the promoting health in postmenopausal women.

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