Treating the Climacteric Symptoms in Indian Women With an Integrated Approach to Yoga Therapy: A Randomized Control Study

Ritu Chattha, MSc; Nagarathna Raghuram, MD, FRCP; Padmalatha Venkatram, FRCOG, MRCPI; Nagendra R. Hongasandra, ME, PhD

Disclosures

Menopause. 2008;15(5):862-870. 

In This Article

Methods

A sample size of 108 was derived for an effect size of 0.52 (calculated from the pre/post mean and SD values of the vasomotor outcome variable from an earlier study),[17] with α at 0.05 and power at 0.8. Because the power would be lower for between-group analysis, a larger sample size of 120 was planned for the study.

Of the 201 women experiencing menopausal symptoms screened, 120 women (married or single) who satisfied the inclusion criteria of (1) age between 45 and 55 years irrespective of whether they were menstruating regularly (symptomatic women who had stopped menstruating more than 3 years ago were also included) and (2) a serum follicle-stimulating hormone (FSH) level of 15 mIU/mL or more on the sixth day of the menstrual cycle if the woman was menstruating regularly or at the time of recruitment, if the woman had stopped menstruating or had irregular cycles were selected for the study. Women who had undergone hysterectomy with retained ovaries were also included. Exclusion criteria were (1) having practiced yoga for 1 month or more; (2) no knowledge of English; (3) less than high school education; (4) taking HT; (5) any surgery in past 3 months; (6) gynecological problems such as endometriosis, fibroids, ovarian cysts, and prolapsed uterus; (7) hypertension (β-blockers or centrally acting antihypertensive drugs may affect vasomotor symptoms); (8) diabetes mellitus (vasculopathy or autonomic neuropathy may affect vasomotor symptoms); (9) hypo-/hyperthyroidism, which may affect the sympathetic responses of climacteric; and (10) taking psychiatric medication.

The study was conducted at Swami Vivekananda Yoga Research Foundation (SVYASA), a yoga university, in Bangalore city. Participants were recruited from gynecological outpatient clinics in 14 different areas of Bangalore through posters, newspaper advertisements, and circulation of pamphlets as well as through word of mouth. Classes were conducted at 14 nodal centers (branches) of SVYASA in different parts of the city.

Formal approval was obtained by the institutional review board and ethics committee of SYVASA. Signed informed consent was provided by each participant before recruitment after addressing any questions about the design of the study.

This was a prospective, randomized, controlled trial in which 120 participants were randomly divided into two study arms: one arm practiced an IAYT and the other arm practiced a set of physical exercises. The women who satisfied the inclusion criteria were registered in different nodal centers, and roll numbers were assigned that were randomly divided into two groups using a computer-generated random number table (www.randomizer.org ) prepared for the specific number of participants available in the center. Participants were assessed for the menopausal and psychological symptoms before and after the eighth week of intervention. Both yoga and control groups were given their respective set of exercises, which were done for 1 hour per day, 5 days per week for 8 weeks, by trained instructors for both yoga and nonyoga groups.

Because this was an interventional study, it could not be a double-blind study, but attempts were made to blind and mask wherever feasible to reduce the bias. The statistician who did the randomization of the serial numbers of participants and the final analysis was blind to the source of the data. The response sheets for the Greene Climacteric Scale (GCS), Eysenck's Personality Inventory (EPI), and Perceived Stress Scale (PSS) were coded and kept away for final analysis and were decoded only after complete analysis. The questionnaires were administered by a psychologist (who was not involved in interacting with the participants) to the whole group before randomization. Care was taken to arrange the timing and venue of the classes for the two groups suitably to avoid interaction and exchange of information and techniques between participants of the two groups.

Biochemical. Serum FSH was used for initial screening of the women to satisfy one of the inclusion criteria. Blood samples for serum FSH levels were collected in Anand Diagnostic Laboratory, Bangalore. Estimation of FSH was carried out by the electrochemiluminescence method using Roche Elecsys 2010 FSH kit. Per the standardization, the normal range for the FSH values during the follicular phase for regularly menstruating Indian women is 3.5 to 12.5 mIU/mL (Anand Laboratory FSH reference value). For the present study, a value greater than 15 mIU/mL was considered for the inclusion criterion.[18]

Greene Climacteric Scale (GCS). The GCS is a menopause rating scale consisting of 21 items pertaining to the psychological, somatic, and vasomotor symptoms of menopause with a severity scale from 0 to 3 (0=not at all, 1=a little bit, 2=quite a bit, 3=extremely). The participants were instructed to indicate the most appropriate severity rating according to the present state of their health.[19] A study was conducted with Indian menopausal women (N=518) in which the GCS was administered. The scores for psychological, somatic, and vasomotor symptoms were calculated using the factor analysis done on a larger Indian perimenopausal population.[20] That analysis showed a slight difference from the factor structure derived by Greene in 1976 for a European population.[21] The test-retest reliability of 50 menopausal women over a 2-week period had yielded the following reliability coefficients: psychological scale=0.87, somatic (physical) scale=0.84, and vasomotor scale=0.83, which were statistically highly significant.[22] For content validity, only symptoms confirmed by other factorial studies as having a statistically significant factor loading were included in the final scale.[23]

Perceived Stress Scale (PSS). The PSS is a widely used psychological instrument for perception of stress. Items were designed to determine how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale also includes a number of direct queries about current levels of experienced stress. It has 10 questions about the feelings and thoughts during the past month.[24] Validity and reliability of the test has been documented in many studies.[25]

Eysenck's Personality Inventory (EPI). The EPI measures two major dimensions of personality: extroversion and neuroticism. It is a 57-item dichotomous questionnaire rating the two psychological states: neuroticism (24 items) and extroversion (24 items) with nine questions for lying scores. The scoring is accomplished by aligning the scoring keys furnished, with the manual counting one for each underlined answer uncovered by the holes in the keys. A lying score of 5 is set as the cutoff point where inventory answers cease to be accepted. The test-retest reliability of the EPI runs between 0.84 and 0.94.[26]

Yoga Intervention. The yoga module used for the IAYT experimental intervention for perimenopausal women was developed specifically for the purpose culled from original scriptures (Patanjali yoga sutras and Mandukaya karika) that highlight the concepts of a holistic approach to health management at physical, mental, emotional, and intellectual levels with techniques to improve mental equilibrium. All these practices are aimed at one common goal, ie, to "develop mastery over modifications of the mind" (chitta vritti nirodhah-Sage Patanjali) through "slowing down the rate of flow of thoughts in the mind" (manah prashamana upayah yogah-Sage Vasishta). Table 1 gives the list of practices:

  1. Sun salutation includes a flow of 12 postures combined with breathing and chanting.[27]

  2. Yogic breathing practices combined with simple body movements to achieve a slow, rhythmic breathing pattern, is the safest way to get mastery over the mind.[28] The principles involved in the technique of breathing were slow down the rate of breathing while synchronizing the body movements with breathing, ensure that exhalation was longer than inhalation, and practice with full awareness of the touch of the flow of air through the nostrils down the air passages.

  3. Cyclic meditation is considered to be a part of yoga that works directly at the mind level (Antaranga yoga), which is a valuable tool to reach a state of alertful rest (calming down or silencing the internal dialogue). Cyclic meditation is a 35-minute practice that includes a combination of activating and pacifying practices to reach deeper quietitude and equilibrium than meditating in a single posture.[29]

  4. The women were given lectures on the physiology of menopause and a healthy lifestyle including diet, exercise, and yogic stress management techniques. They were also given yogic concepts to achieve a notional correction to help each woman (1) recognize her ability to tap her inner energy, which is made of immense bliss that could keep up her youthful feeling and allay fears, (2) restore her built-in freedom to change her responses to situations, and (3) learn to touch the bed of silence, which is the source of all creativity that is essential for promotion of any psychological function.[30]

Control Intervention. The control group practiced a set of exercises comprising easy (nonsweating) body movements supervised by physical trainers for 1 hour daily 5 days per week for 8 weeks. They also had lectures and individual counseling on conventional modern medical concepts about a healthy lifestyle including diet, exercise, and physiology of menopause and stress management techniques.

Data Analysis. The answer sheets of the questionnaires were scored per the instructions in the manual by a psychologist and were analyzed by the statistician using SPSS version 10.0. The Kolmogorov-Smirnov test of normality was used. To compare the pre/post values, nonparametric tests (Mann-Whitney for between yoga and control groups and Wilcoxon for within-group analysis) were used for GCS as the data were not normally distributed and parametric tests (independent samples t test and paired samples t) were used for EPI and PSS, which were normally distributed. In view of the small number of dropouts, intent-to-treat analysis was not planned.

The baseline values for all the variables in both groups were compared using an independent samples t test. Effect sizes were calculated to measure the magnitude of change after 8 weeks within and between the two groups.[31] Based on the results of factor analysis of the GCS in the south Indian population,[20] the first question of the GCS ("Is the heart beating quickly or strongly?") was not taken into account as it did not contribute to any of the three factors (with nil factor loading). Correlations between the three factors with PSS and EPI were done by using Spearman's ρ test.

Comments

3090D553-9492-4563-8681-AD288FA52ACE
Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.

processing....