Abstract
Objective: This work aimed to study the efficacy of group therapy with applied relaxation on vasomotor symptoms and health-related quality of life in postmenopausal women.
Methods: In this open, randomized controlled trial, 60 healthy postmenopausal women with at least seven moderate to severe hot flashes per 24 hours were randomized to either group therapy with applied relaxation (n = 33) or untreated control group (n = 27) for 12 weeks. A follow-up visit was scheduled 3 months after the end of therapy or participation in the control group. Salivary cortisol was measured three times during a 6-month period. Hot flashes were recorded in self-registered diaries, and health-related quality of life was assessed with the Women’s Health Questionnaire.
Results: The number of hot flashes decreased by 5.0 per 24 hours in the applied relaxation group compared with 1.9 in the control group on the 12th week (P < 0.001) and still remained at the same level at the 3-month follow-up (P < 0.001). Health-related quality of life for vasomotor symptoms, sleep, and memory improved significantly on the 12th week measurement in the applied relaxation group compared with the control group. Salivary cortisol concentration was lowered markedly in the applied relaxation group on a single measurement but was otherwise mainly stable in both groups.
Conclusions: Applied relaxation can be used to treat vasomotor symptoms in healthy postmenopausal women.
Introduction
Women’s health-related quality of life (HRQoL) during climacteric is dependent on the interaction of different factors, including physical, social, cultural, and personal characteristics and ability to cope with stress. Approximately 70% of women in Europe and North America experience hot flashes and night sweats during menopause, and 15% to 20% of these women describe these as troublesome mainly because of discomfort, social embarrassment, and sleep disturbances.
Many women may not use hormone therapy (HT) because of adverse effects and contraindications. At present, prescription of HT has been significantly reduced owing to revised national and international treatment guidelines. These new guidelines have made healthcare providers and women, in general, more cautious, as demonstrated by this large reduction in the prescription of HT.
Different alternatives to HT for alleviation of vasomotor symptoms are described in the literature. These include pharmacological treatments, different types of natural remedies, acupuncture, lifestyle changes, and mind-body therapies.
Innes et al presented a systematic review of mind-body therapies for menopausal symptoms. The review consists of 21 articles representing 18 clinical trials from six countries that met the inclusion criteria, including 12 randomized controlled trials (N = 719), 1 nonrandomized controlled trial (N = 58), and 5 uncontrolled trials (N = 105). Nine trials found that breath-based and other relaxation therapies showed promising results for alleviating vasomotor and other menopausal symptoms. Most of the studies reviewed had methodological or other limitations, complicating interpretation of findings. Further studies of these techniques will contribute to our understanding of their limitations and potentials.
Applied relaxation (AR) is a technique based on cognitive-behavioral therapy (CBT) using coping mechanisms and conditioning. The method is frequently used within psychiatry to treat phobia, panic disorders, anxiety, and depression. AR focuses on muscle relaxation, where breathing is used for the conditioning of relaxation. The goal is to reach rapid relaxation through right breathing in situations with bothersome symptoms (ie, hot flashes). A previous study with healthy postmenopausal women showed promising results on hot flash frequency, with an average decrease of more than 70%. The effect persisted 3 months after therapy, and psychological well-being significantly improved probably owing to better sleep and diminished vasomotor symptoms. Similar results were seen in a group of women with breast cancer and vasomotor symptoms. The level of evidence was, however, low in both studies owing to the study design. Although the studies were randomized and controlled, there was no group of women without treatment.
The factors underlying how alternative treatment works and the mechanisms underlying improvements in symptoms are not fully understood.
Many studies show that women with vasomotor symptoms report sleep disturbances. If sleep is interrupted many times during nighttime, which is the reality in many women with vasomotor symptoms, the human stress system may be activated. An important part of the human stress system is the hypothalamic-pituitary-adrenal (HPA) axis. Activation of the HPA axis is initiated by the secretion of corticotrophin-releasing hormone, which in turn induces cortisol secretion from the adrenal cortex. Cortisol is a potent stress hormone regulated by the hypothalamic-pituitary axis with a specific secretion pattern. The HPA axis, besides responding to short-term stressors under resting conditions, follows a circadian rhythm, with a morning peak of cortisol as a response to awakening and with lower activity during the day and night until the early morning when HPA activity slowly increases before awakening. Cortisol excretion differs between men and women of different ages. The method of analyzing salivary cortisol excretion is often used to measure different types of stress reactions. Menopausal symptoms may be seen as stressors. Women who, in addition, sleep restlessly and are stressed from their symptoms may have a cortisol excretion profile different from that of otherwise asymptomatic women. One could expect women with disturbed sleep owing to nighttime flashes not to reach the normal morning peak of cortisol as a response to awakening.
We suggested that we could follow the biological effect of AR by sampling cortisol as a marker of vasomotor symptoms–induced stress.
Cortisol in saliva reflects the free, biologically active fraction of cortisol in the serum, and the concentration is therefore independent of the concentration of the binding protein in plasma. The sampling is noninvasive and painless and can be implemented in the home (http://www.salimetrics.com).
The objectives of the study were to compare the frequency of moderate to severe vasomotor symptoms between postmenopausal women treated with AR and an untreated control group (CG) and to investigate if HRQoL significantly improved in the treatment group (AR group) compared with the CG. Another objective was to measure salivary cortisol excretion three times in 24 hours in the treatment group before, during, and 3 months after treatment with AR and to compare these results with those from the CG.