Abstract
Objective
To systematically review the peer-reviewed literature regarding the effects of self-administered mind-body therapies on menopausal symptoms.
Methods
To identify qualifying studies, we searched 10 scientific databases and scanned bibliographies of relevant review papers and all identified articles. The methodological quality of all studies was assessed systematically using predefined criteria.
Results
Twenty-one papers representing 18 clinical trials from 6 countries met our inclusion criteria, including 12 randomized controlled trials (N = 719), 1 non-randomized controlled trial (N = 58), and 5 uncontrolled trials (N = 105). Interventions included yoga and/or meditation-based programs, tai chi, and other relaxation practices, including muscle relaxation and breath-based techniques, relaxation response training, and low-frequency sound-wave therapy. Eight of the nine studies of yoga, tai chi, and meditation-based programs reported improvement in overall menopausal and vasomotor symptoms; six of seven trials indicated improvement in mood and sleep with yoga-based programs, and four studies reported reduced musculoskeletal pain. Results from the remaining nine trials suggest that breath-based and other relaxation therapies also show promise for alleviating vasomotor and other menopausal symptoms, although intergroup findings were mixed. Most studies reviewed suffered methodological or other limitations, complicating interpretation of findings.
Conclusions
Collectively, findings of these studies suggest that yoga-based and certain other mind-body therapies may be beneficial for alleviating specific menopausal symptoms. However, the limitations characterizing most studies hinder interpretation of findings and preclude firm conclusions regarding efficacy. Additional large, methodologically sound trials are needed to determine the effects of specific mind-body therapies on menopausal symptoms, examine long-term outcomes, and investigate underlying mechanisms.
Keywords
1. Introduction
An estimated 75–85% of women experience some or all symptoms of menopause [
1
, 2
], including vasomotor disturbances (hot flashes/night sweats), fatigue, sleep impairment, mood disturbances, cognitive difficulties, musculoskeletal pain, and headaches [3
, 4
, 5
]. Symptoms typically begin at least 1 year prior to menstrual period cessation and persist for several years post-menopause; for example, findings from a recent meta-analysis indicate that approximately 50% of women continue to experience vasomotor symptoms 4 years after their final menstrual period [[6]
] with reported average duration of vasomotor symptoms ranging from 3.8 [[7]
] to over 7 years [[6]
]. Approximately 10–30% of post-menopausal women will continue to experience symptoms throughout their lives; in breast cancer survivors, symptoms are often more frequent or severe due to endocrine therapy and chemotherapy-induced menopause [8
, 9
]. Symptoms can result in significantly reduced quality of life that for some can be debilitating [[10]
], prompting an estimated 60% of women to seek medical treatment [[11]
]. Given that there are over 50 million women in the US aged 50 or older [[12]
], with at least 1.5 million reaching menopause every year, the financial, social, and psychological burden of menopause is considerable [US Census Bureau. Population estimates by five-year age groups and sex for the United States: 2006–2008 American Community Survey 3-Year Estimates [cited 2009 December 7]. Available from: http://factfinder.census.gov/servlet/STTable?_bm=y&-geo_id=01000US&-qr_name=ACS_2008_3YR_G00_S0101&-ds_name=ACS_2008_3YR_G00_.
13
, 14
].While hormone replacement therapy (HRT) has long been prescribed to alleviate hot flashes and other menopausal symptoms, HRT use has fallen dramatically in both the US and Europe due to evidence from recent large clinical trials that HRT increases risk for breast and endometrial cancer, coronary artery disease, stroke, and thromboembolism [
14
, 15
, - Faber A.
- Bouvy M.L.
- Loskamp L.
- van de Berg P.B.
- Egberts T.C.G.
- de Jong-van den Berg L.T.W.
Dramatic change in prescribing of hormone replacement therapy in the Netherlands after publication of the Million Women Study: a follow-up study.
British Journal of Clinical Pharmacology. 2005; 60 ([Article]): 641-647
16
, 17
, 18
]. An increasing number of women are turning to complementary and alternative therapies to help manage menopausal symptoms [[19]
], with current estimates ranging from 40% to over 70% of women in the peri- and post-menopausal period [19
, 20
, 21
]. Among the more commonly chosen therapies are mind-body practices, including active disciplines such as yoga and tai chi, as well as specific relaxation and other stress management techniques [19
, 20
]. Given that menopausal symptoms both contribute to and are exacerbated by psychosocial stress [22
, 23
], and a growing body of literature suggests mind-body practices can reduce perceived stress and stress reactivity, enhance mood and well being, and improve sleep [24
, 25
, 26
, 27
], mind-body therapies may have promise for the management of menopausal complaints. Moreover, several mind-body therapies (including yoga, meditation, qigong, tai chi, and several relaxation techniques) have been reported to decrease indices of sympathetic activation [25
, 28
, 29
, 30
], factors that characterize and may in part underlie the development and exacerbation of vasomotor and other menopausal symptoms [- Innes K.E.
- Vincent H.K.
- Taylor A.G.
Chronic stress and insulin resistance-related indices of cardiovascular disease risk. Part 2: A potential role for mind-body therapies.
Alternative Therapies in Health & Medicine. 2007; 13 ([erratum appears in Altern Ther Health Med 2007 (November–December (6));13:15]): 44-51
[7]
]. These factors may also play an important etiologic role in the development of insulin resistance, dyslipidemia, hypertension, and other atherogenic changes associated with menopause [[25]
].In this systematic review, we critically evaluate available evidence from the published scientific literature regarding the effects of self-administered mind-body therapies on common menopausal symptoms. We also briefly discuss possible mechanisms that may underlie observed benefits, outline major limitations in the current literature, and detail directions for future research.
2. Methods
Included in this review are original clinical trials published in the peer-reviewed scientific literature regarding the effects of any self-administered mind-body therapy (representing a broad range of relaxation and stress-reduction therapies, including, among others, biofeedback, imagery, yoga and meditation, breathing exercises, tai chi, qigong, pilates, mindfulness-based stress reduction programs, progressive muscle relaxation, and related programs) on menopausal symptoms. We excluded studies that evaluated only conventional exercise or cognitive behavioral therapy programs, did not specifically target menopausal symptoms, or were not available in English. Cross-sectional studies, case series, and case studies were excluded, as were trials published only in dissertation or abstract form or that did not report quantitative outcome data.
To identify potentially eligible studies, we searched 10 scientific databases from their inceptions through November 2009 for clinical trials regarding the effects of mind-body therapies on menopausal symptoms, including MEDLINE, CINAHL, Academic Search Complete, Cochrane Library (Cochrane Central Register of Controlled Trials), PsycINFO, PsycARTICLES, Alt HealthWatch, IndMED, Health Source: Nursing/Academic Edition, and SPORTDiscus with Full Text. Search terms included: [relaxation OR yog$ OR breathing OR pranayam$ OR mind body OR mind-body OR pilates OR qigong OR tai chi OR tai ji OR imagery OR meditation OR mindfulness OR progressive muscle OR dance OR stretch$ OR biofeedback OR complementary therap$ OR alternative therap$ OR health promotion OR physical activity] AND [menopaus$ OR peri-menopaus$ OR post-menopaus$ OR climacter$ OR vasomotor OR hot flash$ OR hot-flash$ OR hot flush$ OR hot-flush$ OR night sweat$ OR sleep OR depression OR anxiety OR mood OR pain OR ache OR fatigue]. Titles and abstracts of the citations were scanned to identify potential articles for the review. In addition, we manually searched our own files, the citation sections of all identified articles, and the reference sections of recent (2000–2010) review articles concerning treatment for menopausal symptoms. Potentially eligible papers were retrieved in hard copy form for more detailed review.
Data extraction for each eligible paper was performed by at least two of the three authors and information was recorded on standardized forms. Study quality was evaluated using predefined criteria based on those utilized in recent systematic reviews regarding the effects of mind-body therapies [
31
, 32
]. Criteria included (i) adequate sample size; (ii) explicit eligibility criteria and/or adequate description of study population; (iii) single, well-defined intervention; (iv) appropriate control group(s) or comparison condition(s); (v) randomization of treatment allocation, method used to generate the allocation sequence described and appropriate, random allocation sequence concealed until group assignment was made; (vi) blinding of outcome assessment; (vii) outcome measures appropriate, well-defined and validated; (viii) statistical methods well described and appropriate, with point estimates and measures of variability presented; (ix) drop-outs/withdrawals reported and less than 25%; (x) compliance reported and adequate; (xi) adequate accounting for confounders; and (xii) conclusions supported by findings. Discrepancies or disagreements during the data extraction and evaluation process were resolved by discussion and consensus by at least two reviewers (KEI and TKS).Due to the heterogeneity in content, duration, intensity, and delivery methods of the intervention, no meta-analyses were performed. However, to provide a clinically meaningful estimate of effect size and allow comparison across studies, we calculated, for each study, percent change from baseline to post-intervention (and follow-up when appropriate) in specific measures of common menopausal symptoms.
3. Results
Of over 3500 potentially relevant abstracts and citation indices scanned, 54 possibly eligible papers were identified for detailed review; of these, 33 were excluded for the following reasons: 11 did not involve an eligible mind-body therapy as a central component, 2 did not present original data or reported data included in another paper, 4 used an ineligible study design, 1 was an unpublished trial, 3 were not available in English, and 12 did not target symptoms of menopause. A total of 21 papers representing a total of 882 participants over 18 trials from 6 countries are included in this review, including 12 randomized controlled trials (RCTs) (N = 719 total participants), 1 non-randomized controlled trial (NRCT) (N = 58 total participants), and 5 uncontrolled trials (UCTs) (N = 105 total participants). Participants included 249 breast cancer patients. Most studies were conducted recently, with only 6 trials (all RCTs) published prior to 2004. Trials included five UCTs of yoga [
33
, 34
, 35
] and/or meditation-based programs [36
, 37
], one NRCT of tai chi [[38]
], three RCTs of yoga [39
, 40
, 41
, 42
, 43
], and nine RCTs of other relaxation practices as follows: muscle relaxation techniques [44
, 45
, 46
, 47
]; breath-based techniques (slow paced respiration [48
, 49
], deep breathing with guided imagery [[50]
] plus muscle relaxation [[51]
]); relaxation response training [[52]
]; and low-frequency sound audiotape [[53]
]. Characteristics of the studies, key outcomes, and major findings are detailed in Table 1. Percent change noted in specific measures of menopausal symptoms is given in Table 2.Table 1Studies evaluating the effects of mind-body therapies (yoga, tai chi, and meditation-based therapies) on menopausal symptoms: trial characteristics, outcomes, and major findings.
First author, year; location; tx duration | Study population | Sample size (enrolled/completed) | Mind-body intervention | Comparison condition | Outcomes and assessment times | Major findings |
---|---|---|---|---|---|---|
Uncontrolled clinical trials | ||||||
Booth-LaForce, 2007 [33] ; [WA], USA; 10 weeks | Healthy peri- and post-menopausal women experiencing ≥4 HF/day, ≥4 days/week Age: 47–59 years, X = 52.6 Race: White (82%) | 12/11 | Hatha yoga Class: 75 min × 1/week Home: ≥15 min/day Included: poses, breathing, relaxation, props | None | General menopausal sx: WMenSxCk Vasomotor sx: HF/24 h-mon; HF diary; HFRDIS Sleep: PSQI Times: pre and post tx | WMenSxCk (HF, NtSwt), HFRDIS, PSQI (sleep quality, sleep efficiency) |
Cohen, 2007 [34] ; CA, USA; 8 weeks | Post-menopausal women experiencing moderate to severe HFs (≥4/day or ≥30/week) Age: X = 57.6 ± 3.1 years Race: White (76.9%) BMI: X = 27.8 ± 4.3 | 14/13 | Restorative yoga Class: 3 h introductory workshop; 90 min × 1/week Home: 1 h × ≥3×/week Included: poses, relaxation; used props | None | General menopausal sx: MENQOL; MenSxQ Vasomotor sx: HF diary: HF/week and HF score (freq × sev) Sleep: ISI Times: pre and post tx (HF diary at week 4 as well) | MENQOL (physical), HF/week, HF score, ISI |
Delavar, 2008 [35] ; Iran; 12 weeks | Post-menopausal women Age: 44–62 years, X = 52.37 ± 0.66 BMI: 18.25–72 kg/m2, X = 27.63 ± 1.11 | 47/44 | Hatha yoga-restorative Class: 60 min × 3×/week Included: poses, breathing, relaxation; used props | None | General menopausal sx: MenSxCk (a 20 item checklist [0–3 severity score/item], includes HF, psych, sleep, fatigue, urogenital sx, ache/pains, etc.) Times: baseline, 4, 8, and 12 weeks | MenSxCk total score (12/20 items [incl: HF, depression, anxiety, tiredness], 18/20 items, 19/20 items) |
Carmody, 2006 [36] ; MA, USA; 7 weeks | Peri- and post-menopausal women experiencing ≥7 moderate to severe HF's/day on most days in last month Age: 48.54–60.65, X = 53.65 ± 3.66 BMI: 18.34–34.75, X = 25.47 | 18/13 [[email protected]/u] | Mindfulness-based stress reduction Class: eight 150 min classes over 7 weeks, plus an all-day class during weekend of the 6th week Home: 45 min × 6 days/week Included: body scan meditation, sitting meditation, mindful stretching exercises | None | General menopausal sx: MENQOL Vasomotor sx: Daily HF log; HFRDIS Psychological status: SCL-90R; PSS Sleep: WHIIRS Times: pre and post tx, and 1 month F/u (11 weeks) | MENQOL (total, vms), HF freq and HF sev maintained at F/u, HFRDIS activities, SCL-90R (global), PSS, WHIIRS |
Manocha, 2007 [37] ; Australia; 8 weeks | Healthy women >6 months amenorrheic experiencing ≥5 HF/day, aged 40–60 years | 14/10 [[email protected]/u] | Sahaja yoga meditation Class: 90 min × 2/week Home: 15 mins × 2/day Included: training to experience “mental silence” meditation | None | General menopausal sx: KI; GCS; MENQOL Vasomotor sx: Flash Count Diary Psychological status: STAI Times: pre, mid (4 weeks), and post tx, and 8 week F/u (16 weeks) | KI, GCS (vms, som, anxiety, psychometric), MENQOL (psychosocial, sexual); HF freq |
Non-randomized controlled trials | ||||||
Xu, 2004 [38] ; [Australia]; 4 months | Menopausal women Age: X = 49.3 years | [58]/40 Tx1: ?/12 Tx2: ?/14 Tx3: ?/14 | Tx1: Tai Ji 1 h × 2×/week. Included: movements to gather qi, focus mind, relax body, move qi and blood, and exercise muscles, joints, and lumbar region | 1. Acupuncture Tx: 30 min × 2×/week Included: KID-3, SP-6, ST-36, uniform reinforcing-reducing technique 2. Herbal therapy Decoction taken 2×/day Included: Shu Di Huang and Shan Zha formula | General menopausal sx: TCM dx was used to measure changes in participants’ observable and reported menopausal sx Times: pre and post tx [Note: Menopausal sx were secondary outcomes of this study] | Intergroup: n.r. Within group: Tai Ji: Abd distension, tired, HF, NtSwt Acu: LBP, tired, HF, NtSwt, insomnia, HA, thirst Herbal: LBP, knees/leg/feet, abd distension, swollen, tired, palpitations, HF, NtSwt, insomnia, HA, thirst |
Randomized controlled trials | ||||||
Carson, 2009 [39] ; NC, USA; 8 weeks | Breast cancer survivors (disease-free) experiencing ≥1 HF/day on ≥4 days/week Age: X = 54.4 ± 7.5 years Race: White (81.1%), African-Amer (18.9%) Educ: college degree (70.3%) Marital: Partnered (75.7%) | 37/30 Tx: 17/13; C: 20/17 | Yoga of awareness program [Kripalu] Class: 120 min × 1/week Home: daily home practice encouraged (CD and handbook) Included: poses, breathing, meditation, study of pertinent topics; and group discussions | Wait-list control | Daily menopausal sx using 0–9 scales: General menopausal sx: joint pain, fatigue, sx-related bother Vasomotor sx: HF freq, HF sev, HF Total score (HF freq × HF sev), NtSwt Mood: negative mood Sleep: sleep disturbance Other: relaxation, vigor, acceptance Times: pre and post tx, and 3-month F/u [Daily diaries collected for 2 weeks pre tx, final 2 weeks of tx (post), and 3 months post tx for 2 weeks (F/u)] | Intergroup (pre–post tx): HF freq, HF sev, HF score, joint pain, fatigue, sx-related bother, sleep disturbance, and vigor; others, NS Intergroup (3-month follow-up): HF freq, HF sev, HF total, joint pain, fatigue, sx-related bother, negative mood, relaxation, vigor, and acceptance; others, NS |
Chattha, 2008 40 , 41 ; India; 8 weeks | Pre-, peri-, and post-menopausal women experiencing menopausal sx, age 40–55 years Employment: housewives (88%) | 120/108 Tx: 59/54 C: 61/54 | Yoga [integrated approach to yoga therapy] Class: 1 h × 5 days/week Included: poses, breathing, meditation, lectures | Exercise (nonsweating) Class: 1 h × 5 days/week Included: brisk walk, loosening practices, supine rest, lectures | General menopausal sx: GCS Vasomotor sx: VCL (a checklist of vsm sx-HF, NtSwt, and sleep disturbances, with severity score ranging from 0 to 3) Psychological status: PSS; EPI Cognitive Function: SLCT; PGIMS Times: pre and post tx | Intergroup: GCS (vms, psych (p = 0.06)), VCL (HF, p = 0.08, NtSwt, p = 0.06, sleep disturbed, p = 0.08), SLCT, PSS, EPI neuroticism, SLCT, PGIMS (8 of 10 subgroups to ) Within group: Tx: GCS (vms, psych, som), VCL (HF, NtSwt, sleep disturbed), EPI neuroticismC: NtSwt, GCS psych |
Elavsky, 2007 42 , 43 ; [PA], USA; 4 months | Pre-, peri-, or post-menopausal, sedentary or low active women (age: 42–58 years) experiencing vasomotor sx w/in past month Age: X = 49.9 ± 3.6 years Race: White (83%) Educ: college (64%) Income: Above-avg (67%) 88% had poor sleep quality | 164/123 Tx1: 62/37 Tx2: 63/50 C: 39/36 | Tx1: Iyengar yoga Class: 90 min × 2×/week Home: asked to practice per handouts received wkly Included: poses and meditation; used props | 1. Walking Class: 1 h × 3×/week Home: individualized exercise prescription, 15–45 min; used heart rate monitors and motivational materials to maximize fitness gains 2. Wait-list control-no tx | General menopausal sx: GCS; UQOL Psych status: Aff2; BDI; SWLS Sleep: PQSI Times: pre and post tx | Intergroup: GCS: NS; UQOL; positive affect; negative affect; BDI, n.r.; SWLS, n.r.; PSQI, NS Within group: GCS: all groups (yoga, walk, and C) show trend to improvement in total sx: effect size (Cohen's d) for GCS: total sx (d = 0.37, 0.61, 0.30); psych sx (d = 0.41, 0.68, 0.35, respectively); sexual sx tend to decrease in yoga (d = 0.21), walking (d = 0.33); PSQI: NS |
Other relaxation therapies (all randomized controlled trials) | ||||||
Germaine, 1984 [44] ; MI, USA 6 weeks | Healthy menopausal women reporting ≥2 HF's per day Age: 44–61 years, X = 50.3 | 14/14 Tx: 7/7; C: 7/7 | Progressive muscle relaxation Class: 1 h × 1/week Home: 2×/day Included: training to tense and release 16, 7, then 4 ms grps (2 sessions each level) | α-EEG-biofeedback Class: 1 h × 1/week Home: 2×/day Included: visual feedback for the production of 8–13 Hz EEG activity | Vasomotor sx: Time latency for hot flash response to heat, HF freq Times: pre and post tx [HF diaries completed daily 1 week before, during, and 1 week after tx, then for 1 month at 6 months F/u] | Intergroup: latency, HF freq Within group: Tx: latency, HF freq (maintained at 6 months F/u); C: NS for latency or HF freq |
Nedstrand, 2005 [45] ; Sweden; 12 weeks | 30 healthy, sedentary women with a spontaneous menopause at least 6 months previously, experiencing moderate to severe vasomotor sx | 30/28 Tx: 15/13 [[email protected]/u]; C: 15/15 [[email protected]/u] | Applied relaxation-12 weeks Class: 60 min × 1/week Home: ≥once/day Included: (i) progressive muscle, (ii) release-only, (iii) cue-controlled, (iv) differential, and (v) rapid relaxation, (vi) application training, (vii) maintenance program | Estrogen 9 months Unopposed oral estradiol for 12 weeks (2 mg); then continue estrogen with progestagens added | General menopausal sx: modified KI; general climacteric sx VAS Vasomotor sx: HF/24 h log Psych status: SCL-90; mood scale Times: baseline, 4, 8, and 12 weeks; then 3 and 6 months F/u [HF logs completed daily from 2 weeks before tx, during tx, then 1 week/month during 6 months F/u] | Intergroup (pre–post tx): HF/24 h[estrogen] KI, VAS, SCL, MOOD: n.r. Within group: both AR and Est: HF/24 h at 12 weeks, 3 and 6 months; KI, VAS, SCL at 12 weeks. At 6 months: AR MOOD; Est MOOD |
Nedstrand, 2005 46 , 47 ; Sweden; 12 weeks | Breast cancer survivors, post-menopausal experiencing moderate to severe vasomotor sx, and ≥2 HFs/24 h Age: 30–64 years, X = 53 | 38/31 Tx: 19/14; C: 19/17 | Tx1: Applied relaxation Class: 60 min × 1/week Home: ≥once/day Included: (i) progressive muscle, (ii) release-only, (iii) cue-controlled, (iv) differential, and (v) rapid relaxation, (vi) application training, (vii) maintenance program | Tx2: Electro-acupuncture: Sessions: 30 min × 2×/week × 2 weeks, then 30 min × 1/week × 10 weeks | General menopausal sx: modified KI; general climacteric sx VAS Vasomotor sx: HF/24 h log Psych status: SCL-90; mood scale Times: baseline, 4, 8, and 12 weeks; then 3 and 6 months F/u [HF Logs completed daily from two weeks before tx, during tx, then 1 week/month during 6 months F/u | Intergroup: HF/24 h, n.r.; KI, VAS, SCL, mood, all NS Within group: both AR and EA: KI and HF/24 h at 4 weeks, 12 weeks, and 6 months. VAS and SCL; mood for EA only |
Freedman, 1992 [48] ; [MI], USA; 4 weeks | Healthy post-menopausal (≥1 year amenorrheic) women experiencing ≥5 HF's/day Race: White (64%) | 33/? Tx1: 11/? Tx2: 11/? C: 11/? | Tx1-Paced respiration Training: 1 h × 2/week Included: training to breathe at 6–8 cycles/min and to increase abdominal respiration volume Tx2-Muscle relaxation Training: 1 h × 2/week Included: training to tense and release 16, 7, then 4 ms grps (2 sessions each level) | α-Wave biofeedback (placebo control) Training: 1 h × 2/week Included: visual feedback for the production of 8–13 Hz EEG activity | Vasomotor sx: HF freq using 24-h ambulatory monitoring of sternal skin conductance level Times: pre and post tx | Intergroup: HF/24 h-mon Within group: Tx1: HF/24 h-mon; Tx2: NS; C: NS |
Freedman, 1995 [49] ; [MI], USA; 4 weeks | Healthy post-menopausal (≥1 year amenorrheic) women experiencing ≥5 HF's/day Race: White (66.67%) African-American (33.33%) | 24/? Tx: 13/? C: 11/? | Paced respiration Training: 1 h × 2×/week Home practice: 15 min × 2×/day and at onset of an HF or in situations likely to trigger HF (e.g., warm room) Included: training to breathe at 6–8 cycles/min and to increase abdominal respiration volume | α-Wave biofeedback (placebo control) Training: 1 h × 2×/week Included: visual feedback for the production of 8–13 Hz EEG activity | Vasomotor sx: HF freq using 24-h ambulatory monitoring of sternal skin conductance level Times: pre and post tx | Intergroup: HF freq, n.r. Within group: Tx: HF freq; C: NS |
Fenlon, 1999 [50] ; UK; 1 month | Women treated for breast cancer and suffering from hot flushes Age: 29–74 years, X = 49 Race: White (100%) | 24/16 Tx: ?/8 C: ?/8 | Relaxation Class: 2 individual training sessions, 1 week apart Home: *Daily Included: deep breathing and guided imagery | Wait-list control (no tx) | Vasomotor sx: HF/day, NtSwt/night, 10 cm VAS (HF and NtSwt: distress, problem factor, interference to normal life) Psych status: GHQ Assessment times: pre and post tx | Intergroup: GHQ; other measures, NS [HFdistress = 0.09] Within group: Tx: GHQ C: GHQ, NS |
Fenlon, 2008 [51] ; UK; 1 month (minimum) | Women with primary breast cancer, 6 months amenorrheic, suffering HFs Age: 36–77 years Race: White (93%) Marital: partnered (72%) | 150/104 [[email protected]/u] Tx: 76/50 [[email protected]/u]; C: 74/54 [[email protected]/u] | Relaxation Training: one, 60 min, one to one training session, then used tape for daily practice Home: 20 min × 1/day Included: deep breathing, muscle relaxation, and guided imagery | Attention control (no tx) Included: spending time with a specialist nurse discussing hot flashes and menopause management | Vasomotor sx: HF diary (freq and sev); HMS (distress, problem, interference to daily life) Psych status: STAI Other: FACT-ES Times: pre and post tx, and 2-month F/u (3 months) | Intergroup at 1 month: HF/week, HF sev, and HF distress; other measures NS [HF problem (p = 0.06), HF interference to daily life (p = 0.09)] Intergroup at 3 months: all NS [HF/week (p = 0.06), HF sev (p = 0.05)] Note: Study set alpha at 0.01 due to large number of tests |
Irvin, 1996 [52] ; MA, USA; 7 weeks | Healthy post-menopausal (≥6 months amenorrheic) women experiencing ≥5 HF's/24 h Age: 44–66 years | 45/33 Tx: ?/11; C1: ?/11; C2: ?/11 | Relaxation response Training: one, 1-h session with the investigator; then audio tape used for home practice Home: ≥20 min × 1/day Included: elicitation of the relaxation response using breath as mental focus and passive mental attitude toward distractions | Control 1-reading (placebo) Training: one session on reading technique Home: 20 min × 1/day Included: leisure reading; Control 2-Wait-list (no tx) | Vasomotor sx: HF Log (freq and intensity) Psych status: STAI; POMS Times: pre and post tx (Note: Baseline HF levels measured for 1st 3 weeks, then tx instruction was given) | Intergroup: n.r. Within group: tx: HF sev, tension-anxiety, depression-dejection; others, NS; C1-Reading: confusion-bewilderment, trait anxiety; others, NS; C2-No tx: all NS |
Rankin, 1989 [53] ; [NJ], USA; 2 weeks | Healthy menopausal women experiencing menopausal sx Age: 40–58 years, X = 49.3 Race: White (96%) Educ: college degree (67%) | 40/27 Tx: 20/14 C: 20/13 | Low-frequency sound-wave therapy Home: 20 min × 3×/week Included: listening to audiotape by Halpern of low freq sound waves designed to promote a sense of well being and muscle relaxation | Usual care control (no tx) | General menopausal sx: MIS Times: pre and post tx | Intergroup: MIS (sx freq, som, psych), number of sx (p = 0.075) |
Abbreviations: Acu = acupuncture; Aff2 = affectometer 2; AR = applied relaxation; BDI = Beck depression inventory; C = control; EA = electro-acupuncture; EPI = Eysenck's personality inventory; Est = estrogen; FACT-ES = Functional Assessment of Cancer Therapy with the Endocrine Sub-scale; freq = frequency; F/u = follow-up; GCS = Greene Climacteric Scale; GHQ = General Health Questionnaire; HF = hot flash; HF/24 h-mon = 24 h ambulatory monitoring of sternal skin conductance level; HFRDIS = Hot flash-related Daily Interference Scale; HMS = Hunter Menopause Scale; ISI = Insomnia Severity Index; KI = Kupperman's index; LBP = low back pain; MENQOL = Menopause specific Quality of Life; MenSxCk = Menopausal Symptom Checklist; MenSxQ = menopausal symptom questionnaire; MIS = Newgarten–Kraines Menopausal Index Scale; MR = muscle relaxation; n.r. = not reported; NS = not significant; NtSwt = night sweats; PGIMS = Punit Govil Intelligence Memory Scale; POMS = Profile of Mood States; PR = paced respiration; PSQI = Pittsburgh Sleep Quality Index; PSS = Perceived Stress Scale; Psych = psychological; R = reading group; RR = relaxation response; SCL-90 = Symptom CheckList-90; SCL-90-R = Hopkins Symptom Checklist; sev = severity; SLCT = Six Letter Cancellation Test; Som = somatic; STAI = State Trait Anxiety Inventory; SWLS = Satisfaction with Life Scale; tx = treatment/intervention; UQOL = Utian Quality of Life Scale; VAS = Visual Analog Scale; VCL = Vasomotor CheckList; VMS = VasoMotor Symptoms; WHIIRS = Women's Health Initiative Insomia Rating Scale; WMenSxCk = Wiklund Menopause Symptom Checklist. Tx group improved unless noted otherwise.
* p ≤ 0.05.
** p ≤ 0.01.
*** p ≤ 0.001.
a Outcome reported in another publication.
b 95% CI.
Table 2Observed percent change in overall menopausal and vasomotor symptoms by treatment group.
Endpoint | Study: first author, year | Treatment group | % Change post-intervention | % Change at follow-up | ||
---|---|---|---|---|---|---|
UCT | RCT | UCT | RCT | |||
Menopausal symptoms overall | ||||||
Kupperman index | Manocha, 2007 [37] | Yogic meditation | 58.2% | 40.4% | ||
Nedstrand, 2005 [46] | Applied relaxation | 46.0% | 47.6% | |||
Electro-acupuncture | 39.4% | 40.7% | ||||
Nedstrand, 2005 [45] | Applied relaxation | 37.4% | 41.9% | |||
HRT | 72.27% | 76.5% | ||||
Visual Analog Scale | Nedstrand, 2005 [46] | Applied relaxation | 46.15% | 47.7% | ||
Electro-acupuncture | 45.6% | 45.6% | ||||
Nedstrand, 2005 [45] | Applied relaxation | 50.0% | 57.8% | |||
HRT | 72.7% | 72.7% | ||||
Greene Climacteric Scale | ||||||
Psychosocial | Manocha, 2007 [37] | Yogic meditation | 74.3% | 21.4% | ||
Chattha, 2008 [41] | Yoga | 40.9% | ||||
Exercise | 12.5% | |||||
Elavsky, 2007 [43] | Yoga | 24.6% | ||||
Walking | 33.8% | |||||
Wait-list control | 18.6% | |||||
Somatic | Manocha, 2007 [37] | Yogic meditation | 80.3% | 29.3% | ||
Chattha, 2008 [41] | Yoga | 37.4% | ||||
Exercise | 28.2% | |||||
Elavsky, 2007 [43] | Yoga | 9.2% | ||||
Walking | 26.5% | |||||
Wait-list control | 10.4% | |||||
Vasomotor | Manocha, 2007 [37] | Yogic meditation | 71.1% | 52.4% | ||
Chattha, 2008 [41] | Yoga | 36.4% | ||||
Exercise | 9.7% | |||||
Elavsky, 2007 [43] | Yoga | 16.1% | ||||
Walking | 17.5% | |||||
Wait-list control | 5.8% | |||||
Sexual | Elavsky, 2007 [43] | Yoga | 19.6% | |||
Walking | 29.3% | |||||
Wait-list control | 5.4% | |||||
Wiklund Symptoms Checklist | Booth-LaForce, 2007 [33] | Yoga | 35.7% | |||
Menopause-related Quality of Life Questionnaire (MENQOL) | ||||||
Vasomotor | Manocha, 2007 [37] | Yogic meditation | 46.7% | 46.7% | ||
Cohen, 2007 [34] | Yoga | 26.2% | ||||
Carmody, 2006 [36] | MBSR | 26.2% | ||||
Physical | Manocha, 2007 [37] | Yogic meditation | 53.0% | 31.7% | ||
Cohen, 2007 [34] | Yoga | 24.4% | ||||
Carmody, 2006 [36] | MBSR | 17.8% | ||||
Psychosocial | Manocha, 2007 [37] | Yogic meditation | 45.9% | 37.2% | ||
Cohen, 2007 [34] | Yoga | 25.0% | ||||
Carmody, 2006 [36] | MBSR | 32.5% | ||||
Sexual | Manocha, 2007 [37] | Yogic meditation | 56.2% | 33.3% | ||
Cohen, 2007 [34] | Yoga | 18.2% | ||||
Carmody, 2006 [36] | MBSR | 38.7% | ||||
Menopausal Index Scale | ||||||
Number of symptoms | Rankin, 1989 [53] | Audiotape (low-frequency sound) | 8.5% | |||
Usual care | −5.2% | |||||
Frequency of symptoms | Rankin, 1989 [53] | Audiotape | 48.0% | |||
Usual care | −28.6% | |||||
Somatic symptoms | Rankin, 1989 [53] | Audiotape | 52.9% | |||
Usual care | −52.9% | |||||
Psychological symptoms | Rankin, 1989 [53] | Audiotape | 47.7% | |||
Usual care | −41.7% | |||||
Psychosomatic symptoms | Rankin, 1989 [53] | Audiotape | 43.5% | |||
Vasomotor symptoms | ||||||
Daily hot flash log/flash count diary | Manocha, 2007 [37] | Yogic meditation | 67.2% | 56.2% | ||
Carson, 2009 [39] | Yoga | 16.0% | 28.2% | |||
Wait-list control | −2.6% | −3.0% | ||||
Cohen, 2007 [34] | Restorative yoga | 26.6% | ||||
Carmody, 2006 [36] | Yoga | 34.3% | 39.4% | |||
Nedstrand, 2005 [46] | Applied relaxation | 51.1% | 57.6% | |||
Electro-acupuncture | 51.2% | 58.3% | ||||
Nedstrand, 2005 [45] | Applied relaxation | 50.0% | 71.7% | |||
HRT | 90.4% | 90.4% | ||||
Fenlon, 2008 [51] | Musc. Relaxation + breathing, imagery | 22.2% | 34.9% | |||
Attention control | 2.7% | 10.8% | ||||
Fenlon, 1999 [50] | Breathing + imagery | 25.0% | ||||
Usual care | −10.0% | |||||
Irvin, 1996 [52] | Relaxation response | 21.9% | ||||
Reading | 36.3% | |||||
No treatment control | 9.0% | |||||
Freedman, 1992 [48] | Paced respiration | 38.9% | ||||
Muscle relaxation | 4.2% | |||||
α-Wave biofeedback | −16.5% | |||||
Freedman, 1995 [49] | Paced respiration | 42.1% | ||||
α-Wave biofeedback | 3.3% | |||||
Germaine, 1984 [44] | Muscle relaxation | 54.5% | ||||
α-Wave biofeedback | −18.6% | |||||
Hot Flush Severity Score | Delavar, 2008 [35] | Yoga | 48.8% | |||
Carson, 2009 [39] | Yoga | 22.8% | ||||
Wait-list control | 5.6% | |||||
Carmody, 2006 [36] | MBSR | 40.6% | 40.6% | |||
Subjects reporting hot flashes | Xu, 2004 [38] | Tai chi | 50.0% | |||
Acupuncture | 35.7% | |||||
Herbal therapy | 57.1% | |||||
Subjects reporting night sweats | Xu, 2004 [38] | Tai chi | 41.7% | |||
Acupuncture | 71.4% | |||||
Herbal therapy | 21.4% | |||||
Vasomotor Symptom Checklist | ||||||
Hot flushes | Chattha, 2008 [40] | Yoga | 51.0% | |||
Exercise | 10.3% | |||||
Night sweats | Chattha, 2008 [40] | Yoga | 48.2% | |||
Exercise | 23.5% | |||||
Disturbed sleep | Chattha, 2008 [40] | Yoga | 40.5% | |||
Exercise | 12.9% | |||||
Hot flash-related Daily Interference Scale | Booth-LaForce, 2007 [33] | Yoga | 60.0% | |||
Carmody, 2006 [36] | MBSR | 33.3% | ||||
Symptom-related bother | Carson, 2009 [39] | Yoga | 36.4% | 38.3% | ||
Wait-list control | 2.8% | 2.8% |
Non-randomized controlled trial, % represents average reduction in total symptoms. Abbreviations: HRT = hormone replacement therapy; musc = muscle; MBSR = mindfulness-based stress reduction.
Yoga, an ancient discipline of the mind, body, and spirit originating in India at least 4000 years ago, incorporates physical poses, breathing exercises, and meditation to calm the mind, increase awareness, and enhance both mental and physical health [
[25]
]. Mindfulness-based stress reduction (MBSR) is a multi-component program first developed in the late 1970s by Jon Kabat-Zinn that combines the ancient practices of yoga and mindfulness meditation to cultivate awareness and reduce stress, typically including breathing, stretching, and other relaxation exercises [[54]
]. Originating in China centuries ago, tai chi uses slow, flowing, dance-like body movements, coupled with deep breathing to achieve mental and physical balance, relaxation, focus, and awareness [[25]
]. Paced breathing refers to slow, deep, abdominal breathing [[48]
], similar to that taught in yoga and other meditative disciplines. Progressive muscle relaxation, developed by Edmund Jacobson in the early 1920s [[55]
], is a technique for reducing stress and inducing calm by alternately tensing and relaxing the muscles. Building on existing muscle relaxation techniques, applied relaxation was developed in the late 1970s to train individuals to relax rapidly even when exposed to anxiety-provoking situations [[56]
]. Introduced in the 1970s by Herbert Benson, the relaxation response can be elicited by sitting quietly, adopting a passive disregard of distracting thoughts, and focusing on the breath or a simple repeated sound, word, or prayer (as in yogic breath-based and mantra meditation), to induce a state of deep rest that reduces the physical and emotional responses to stress, enhances well being, and promotes calm [[57]
].3.1 Yoga, meditation, and tai chi
3.1.1 Yoga and meditation-based practices
Our search identified 8 studies (10 articles) assessing the effects of yoga and meditation-based programs on symptoms of menopause, including 3 RCTs and 5 UCTs from 4 countries. As illustrated in Table 1, interventions ranged from 7 [
[36]
] to 16 [42
, 43
] weeks (X = 9.6 ± 3.0 weeks) in duration and included both yoga [33
, 34
, 35
, 39
, 40
, 41
, 42
, 43
] and/or yogic meditation [[37]
] alone and in combination with educational and/or other co-interventions [36
, 39
, 40
, 41
], including one uncontrolled study of mindfulness-based stress reduction (MBSR) [[36]
]. Classes ranged in frequency from 1 to 2 [33
, 34
, 36
, 37
, 39
, 42
, 43
] to 5 sessions per week [40
, 41
], with home practice varying from casual [42
, 43
] to daily structured practice [33
, 36
, 37
, 39
]. Trials include 7 studies (5 UCT, 2 RCT) of healthy pre-, peri- and post-menopausal women and 1 RCT of breast cancer survivors [[39]
] (Table 1), including a total of 426 participants (105 in UCTs, 321 in RCTs). Three studies, 2 UCTs [36
, 37
], and an RCT of breast cancer survivors [[39]
], included a follow-up assessment 1–3 months after completion of the intervention. Findings regarding effects on specific menopausal symptoms and on symptoms overall are discussed briefly below.3.1.1.1 Menopausal symptoms overall
Seven of the eight studies (including 4 UCTs [
33
, 34
, 35
, 37
] and 3 RCTs [39
, 41
, 43
]) assessed change in symptom burden using structured 6–20 item menopausal symptom questionnaires (Table 1). Six of these seven studies report significant attenuation of symptoms with yoga and meditation-based programs. For example, 4 of 4 uncontrolled studies of yoga [33
, 34
, 35
] or yogic meditation [[37]
] in healthy peri- and post-menopausal American [33
, 34
], Australian [[37]
], and Iranian women [[35]
] indicated significant reduction in symptoms overall [33
, 37
], and in vasomotor symptoms [33
, 34
, 35
, 37
], musculoskeletal pain and other somatic symptoms [33
, 34
, 35
, 37
], psychological distress [35
, 37
], sleep disturbance [34
, 35
], and other common symptoms [[35]
] relative to baseline; findings from 2 studies suggest reduction in overall symptom burden [[37]
], and particularly, in vasomotor symptoms [36
, 37
] were retained at 1 month follow-up. Similarly, two RCTs, including a large 12-week, 2-arm study of Indian women (N = 120) [[41]
], and a smaller 8-week trial of breast cancer survivors (N = 37) [[39]
] reported significant improvement in menopausal symptoms, including vasomotor [39
, 41
], mood (p = 0.06) [[41]
], symptom-related bother [[39]
], and vigor [[39]
] in participants assigned to a yoga vs. a comparable exercise program [[41]
] or wait-list control [[39]
]. Overall reduction in menopausal symptoms ranged from 36% [33
, 41
] to 80% [[37]
] depending on study design, study population, instrument used, and other factors (Table 2). Many of these improvements remained significant 3 months following program completion, including those in hot flashes, joint pain, mood, and vigor [[39]
] (Table 1). In contrast, a recent 3-arm RCT of US women (N = 164) comparing the effects of an Iyengar yoga program vs. a moderate intensity exercise program and a usual care control did not demonstrate significant differences between the yoga and exercise group in either total symptoms or symptom domains [[43]
]. However, the yoga program in this study (two 90-min classes/week) was lower intensity than the exercise intervention (three 1-h classes/week, plus individualized home exercise prescription 1–2 days/week, and home practice monitoring), class attendance was lower in the yoga vs. exercise group (63% vs. 70%, translating to an average of 20 classes vs. 34 classes, respectively) and participant attrition was substantially higher (40% for the yoga vs. 21% for the exercise group), possibly helping to explain the discrepancy in findings. The authors also present only an intent-to-treat analysis, which, given the considerably greater attrition rates in the yoga group, might be expected to differentially bias effect sizes of the yoga intervention toward the null [[58]
].3.1.1.2 Vasomotor symptoms
Hot flashes and night sweats are among the most common and troubling menopausal symptoms [
2
, 14
], associated with physical discomfort, and with disturbances in sleep, mood, and cognition; up to 85% of women report experiencing hot flashes [[2]
], with 33% or more symptomatic women experiencing at least 10 per day [[1]
]. All 8 studies collected data on vasomotor symptoms, either specifically [33
, 34
, 36
, 37
, 40
] and/or via menopausal symptom questionnaires [33
, 34
, 35
, 37
, 39
, 41
, 43
] as indicated above. All but one study [[43]
] reported improvement in vasomotor symptoms relative to baseline, usual care control, or physical activity. Uncontrolled studies of yoga [33
, 34
, 35
], yogic meditation [[37]
], and mindfulness-based stress reduction [[36]
] reported significant reductions in night sweats [[33]
], and in hot flash frequency [33
, 34
, 36
, 37
], severity [34
, 36
], and impact/interference in daily life/activities [33
, 35
, 36
, 37
]. Likewise, two of three RCTs reported significant declines in vasomotor symptoms overall [[41]
], and in hot flash frequency and severity [[39]
], following participation in an 8–12-week yoga program vs. an exercise program [[41]
] or usual care [[39]
]. Observed percent reduction in overall symptoms ranged from 16 to 80% post-intervention and from 21 to 58% at follow-up depending on outcome measure and domain, study design, population, and intervention (Table 2).3.1.1.3 Sleep disturbance and psychological symptoms
Sleep impairment and mood disturbances, including increased anxiety, irritability, depressive symptoms, and other adverse psychosocial changes are common menopausal complaints [
4
, 5
, 59
]. Seven studies reported findings on sleep disturbance from either sleep-specific instruments [33
, 34
, 36
, 42
] or menopausal symptom questionnaires [35
, 39
, 40
]. Again, all but one of the 7 studies [[42]
] reported significant improvements in sleep among participants of yoga or meditation-based programs relative to baseline [33
, 34
, 35
, 36
, 40
] or wait-listed controls [[39]
]; compared to those completing a comparable exercise program, yoga group participants also showed marginally significant improvement in night sweat-related sleep disturbance (p = 0.08) in a large RCT of Indian women [[40]
].Seven studies, including 4 UCTs and 3 RCTs, reported psychosocial outcome data from general menopausal [
35
, 39
] or mental health-specific- [34
, 36
, 37
, 41
, 43
] questionnaires. Six of the 7 trials (3 UCTs, 3 RCTs) reported significant pre–post improvement following an 8–12-week yoga or meditation-based program in psychological status, including overall psychological symptoms [35
, 36
, 37
, 41
, 43
], anxiety [35
, 36
, 37
], depression [35
, 36
], perceived stress [36
, 41
], vigor [36
, 39
], symptom-related distress [[39]
], and fatigue [35
, 39
]. Controlled trials of healthy women [41
, 43
] and breast cancer survivors [[39]
] also indicated significant improvement in psychological status overall [[41]
], and in positive affect [[43]
], perceived stress [[41]
], symptom-related distress [[39]
], fatigue [[39]
], and vigor [[39]
] in participants assigned to yoga vs. usual care/wait-list control [39
, 43
] or to a comparable exercise program [39
, 41
], with several of these differences persisting at 3-month follow-up [[39]
] (Table 1).3.1.1.4 Other menopause-related symptoms
Other common symptoms of menopause include musculoskeletal pain [
[59]
], as well as impairments in memory and concentration [4
, 60
]. Of the 8 studies reviewed here, four, including 3 UCTs in healthy women [33
, 34
, 35
] and 1 RCT in breast cancer survivors [[39]
] reported specific findings regarding muscle and joint pain; all indicated significant improvement in participants assigned to an 8–12-week yoga program relative to baseline [33
, 34
, 35
] or wait-list control [[39]
]. Only one study evaluated the effects of yoga on cognitive changes associated with menopause [[40]
]; this large RCT of healthy Indian women demonstrated significant enhancement of both concentration and memory following a moderately intensive yoga program [