Lotta Lindh-Åstrand

The Acupuncture on Hot Flushes Among Menopausal Women (ACUFLASH) study, a randomized controlled trial

Objective: This study compared the effectiveness of individualized acupuncture plus self-care versus self-care alone on hot flashes and health-related quality of life in postmenopausal women. Methods: This study involved a multicenter, pragmatic, randomized, controlled trial with two parallel arms. Participants were postmenopausal women experiencing, on average, seven or more hot flashes per 24 hours during seven consecutive days. The acupuncture group received 10 acupuncture treatment sessions and advice on self-care, and the control group received advice on self-care only. The frequency and severity (0-10 scale) of hot flashes were registered in a diary. Urine excretion of calcitonin gene-related peptide was assessed at baseline and after 12 weeks. The primary endpoint was change in mean hot flash frequency from baseline to 12 weeks. The secondary endpoint was change in health-related quality of life measured by the Womens Health Questionnaire. Results: Hot flash frequency decreased by 5.8 per 24 hours in the acupuncture group (n = 134) and 3.7 per 24 hours in the control group (n = 133), a difference of 2.1 (P < 0.001). Hot flash intensity decreased by 3.2 units in the acupuncture group and 1.8 units in the control group, a difference of 1.4 (P < 0.001). The acupuncture group experienced statistically significant improvements in the vasomotor, sleep, and somatic symptoms dimensions of the Womens Health Questionnaire compared with the control group. Urine calcitonin gene-related peptide excretion remained unchanged from baseline to week 12. Conclusions: Acupuncture plus self-care can contribute to a clinically relevant reduction in hot flashes and increased health-related quality of life in postmenopausal women.

Vasomotor symptoms and quality of life in previously sedentary postmenopausal women randomised to physical activity or estrogen therapy

OBJECTIVE To assess if regular physical exercise or oral oestradiol therapy decreased vasomotor symptoms and increased quality of life in previously sedentary postmenopausal women. SETTING A prospective, randomised trial at a University Hospital. METHODS 75 postmenopausal, sedentary women with vasomotor symptoms were randomised to: exercise three-times weekly over 12 weeks (15 women), oral oestradiol therapy for 12 weeks (15 women) and 45 women to three other treatment arms. Results from the exercise and oestradiol groups are presented here. The effects on vasomotor symptoms and wellbeing were assessed with logbooks and validated questionnaires. RESULTS Ten women fulfilled 12 weeks of exercise. The number of flushes was rather unchanged in five women and decreased to 28% (range 18-42%) of baseline in the other five women. Five of the ten women continued to exercise another 24 weeks, thus in all 36 weeks. The mean number of flushes decreased by about 50% in these five women (from 6.2/24 to 3.2 flushes/24 h at 36 weeks). In the same group a score made as the product of reduction in number and severity of flushes decreased by 92% at 12 weeks, 75% at 24 weeks and 72% at 36 weeks compared with baseline. In the estrogen group flushes decreased from 8.4 to 0.8 (P<0.001) after 12 weeks of therapy and remained at this level after 36 weeks. Well-being according to different measurements improved significantly in both groups, albeit more markedly in the estrogen group. CONCLUSIONS Apart from many other health benefits regular physical exercise may decrease vasomotor symptoms and increase quality of life in postmenopausal women, but this has to be further evaluated scientifically. Exercise should be introduced gradually to ensure compliance.

Long-term follow-up of acupuncture and hormone therapy on hot flushes in women with breast cancer: a prospective, randomized, controlled multicenter trial

Objective To evaluate the effects of electro-acupuncture (EA) and hormone therapy (HT) on vasomotor symptoms in women with a history of breast cancer. Methods Forty-five women were randomized to EA (n = 27) for 12 weeks or HT (n = 18) for 24 months. The number of and distress caused by hot flushes were registered daily before, during and up to 24 months after start of treatment. Results In 19 women who completed 12 weeks of EA, the median number of hot flushes/24 h decreased from 9.6 (interquartile range (IQR) 6.6–9.9) at baseline to 4.3 (IQR 1.0–7.1) at 12 weeks of treatment (p < 0.001). At 12 months after start of treatment, 14 women with only the initial 12 weeks of EA had a median number of flushes/24 h of 4.9 (IQR 1.8–7.3), and at 24 months seven women with no other treatment than EA had 2.1 (IQR 1.6–2.8) flushes/24 h. Another five women had a decreased number of flushes after having additional EA. The 18 women with HT had a baseline median number of flushes/24 h of 6.6 (IQR 4.0–8.9), and 0.0 (IQR 0.0–1.6; p = 0.001) at 12 weeks. Conclusion Electro-acupuncture is a possible treatment of vasomotor symptoms for women with breast cancer and should be further studied for this group of women.

Effects of acupuncture, applied relaxation, estrogens and placebo on hot flushes in postmenopausal women: an analysis of two prospective, parallel, randomized studies.

Objective To assess if transdermal or oral estrogens, acupuncture and applied relaxation decrease the number of menopausal hot flushes/24 h and improve climacteric symptoms, as assessed by the Kupperman index, more than transdermal placebo treatment. Setting An outpatient clinic at a Swedish university hospital. Methods A total of 102 postmenopausal women were recruited to two studies performed in parallel. In Study I, the women were randomized between transdermal placebo or estrogen treatment and, in Study II, between oral estrogens, acupuncture or applied relaxation for 12 weeks. Climacteric symptoms were measured with daily logbooks on hot flushes. Women completed the assessment questionnaire for the Kupperman index at baseline and after 12 weeks. Results The number of flushes/24 h decreased significantly after 4 and 12 weeks in all groups except the placebo group. Both at 4 and 12 weeks, acupuncture decreased the number of flushes more (p < 0.05; p < 0.01, respectively) than placebo. At 12 weeks, applied relaxation decreased the number of flushes more (p < 0.05) than placebo. The Kupperman index score decreased in all groups except the placebo group. The decrease in score was significantly greater in all treatment groups than in the placebo group (p < 0.01). Conclusion Acupuncture and applied relaxation both reduced the number of hot flushes significantly better than placebo and should be further evaluated as alternatives to hormone therapy in women with menopausal vasomotor complaints.

The prevalence of symptoms possibly related to the climacteric in pre- and postmenopausal women in Linköping, Sweden

BACKGROUND Some extragenital symptoms have been suggested to be associated with the menopause and thus to be affected by estrogen status. In such case extragenital symptoms may be more frequent in postmenopausal women without hormone replacement therapy (HRT) than in premenopausal women or women using HRT. OBJECTIVE To assess if the prevalence of a number of extragenital symptoms is higher in postmenopausal women without than with HRT, or in premenopausal women of the same age. MATERIAL AND METHODS All women aged 53 and 54 years in the community of Linköping (n=1760) were sent a validated questionnaire about use of HRT, time since last menstruation and about different extragenital symptoms. RESULTS 1298 (73.8%) women answered the questionnaire and answers from 1180 (67%) women were possible to analyze. Postmenopausal women woke up significantly more often during night than premenopausal, and those without HRT often due to hot flushes and sweating. Women with HRT reported more muscular pain than the others. We found no other significant difference in prevalence of extragenital symptoms between the three groups of women. CONCLUSIONS Sleeping disorders, arthralgia, xerophthalmia, xerostomia and dry skin are not more prevalent in 53 and 54 years old postmenopausal women without HRT than in women with HRT or in premenopausal women of the same age. It may still be that some of these symptoms are related to estrogen deficiency, but do not develop until some years after menopause. It may also be that women with the most severe symptoms decided to use HRT and thereby decreased symptoms to the same level as in non-users.

A randomized controlled study of taper-down or abrupt discontinuation of hormone therapy in women treated for vasomotor symptoms.

Objective: The aim of this study was to investigate whether tapering down of combined estrogen plus progestogen therapy (EPT) reduced the recurrence of hot flashes and resumption of therapy compared with abrupt discontinuation. A secondary aim was to evaluate whether health-related quality of life (HRQoL) was affected after discontinuation of EPT and to investigate the possible factors predicting resumption of EPT. Methods: Eighty-one postmenopausal women undergoing EPT because of hot flashes were randomized to tapering down or abrupt discontinuation of EPT. Vasomotor symptoms were recorded in self-registered diaries, and resumption of hormone therapy (HT) was asked for at every follow-up. The Psychological General Well-being Index was used to assess HRQoL. Results: Neither the number nor the severity of hot flashes or HRQoL or frequency of resumption of HT differed between the two modes of discontinuation of EPT during up to 12 months of follow-up. About every other woman had resumed HT within 1 year. Women who resumed HT after 4 or 12 months reported more deteriorated HRQoL and more severe hot flashes after discontinuation of therapy than did women who did not resume HT. Conclusions: Women who initiate EPT because of hot flashes may experience recurrence of vasomotor symptoms and impaired HRQoL after discontinuation of EPT regardless of the discontinuation method used, abrupt or taper down. Because, in addition to severity of flashes, decreased well-being was the main predictor of the risk to resume HT, it seems important to also discuss quality of life in parallel with efforts to discontinue HT.

Hormonal replacement therapy does not affect self-estimated pain or experimental pain responses in post-menopausal women suffering from fibromyalgia: a double-blind, randomized, placebo-controlled trial

OBJECTIVES FM is a condition that preferentially affects women. Sex hormones, and in particular oestrogens, have been shown to affect pain processing and pain sensitivity, and oestrogen deficit has been considered a potentially promoting factor for FM. However, the effects of oestrogen treatment in patients suffering from FM have not been studied. Here, we examined the effect of transdermal oestrogen substitution treatment on experimental as well as self-estimated pain in women suffering from FM. METHODS Twenty-nine post-menopausal women were randomized to either 8 weeks of treatment with transdermal 17β-oestradiol (50 µg/day) or placebo according to a double-blind protocol. A self-estimation of pain, a set of quantitative sensory tests measuring thresholds to temperature, thermal pain, cold pain and pressure pain, and a cold pressor test were performed on three occasions: before treatment, after 8 weeks of treatment and 20 weeks after cessation of treatment. RESULTS Hormonal replacement treatment significantly increased serum oestradiol levels as expected (P < 0.01). However, no differences in self-estimated pain were seen between treatment and placebo groups, nor were there any differences between the two groups regarding the results of the quantitative sensory tests or the cold pressor test at any of the examined time points. CONCLUSION Eight weeks of transdermal oestradiol treatment does not influence perceived pain, pain thresholds or pain tolerance as compared with placebo treatment in post-menopausal women suffering from FM. TRIAL REGISTRATION ClinicalTrials.gov Registration; http://www.clinicaltrials.gov; NCT01087593.

Vasomotor symptoms usually reappear after cessation of postmenopausal hormone therapy : a Swedish population-based study.

Objective: The purpose of this study was to investigate the extent of reappearance of vasomotor symptoms after cessation of postmenopausal hormone therapy (HT) in women who started HT because of hot flashes. Methods: A cross-sectional postal survey was conducted. A validated questionnaire was sent to all women 53 to 54 years old living in Linköping, Sweden (n = 1,733), including questions about menopause, HT, and vasomotor symptoms. Pearsons &khgr;2 test and logistic regression were used for statistical analyses. Results: Response rate after one reminder was 77.3%. After omitting incomplete answers, 72.9% remained for analysis. In all women, 319 (25.3%) were current users of HT, 242 (19.2%) were previous users, and 702 (55.6%) were never-users. Of the 242 previous users, 165 (69%) women stated that they had vasomotor symptoms before starting HT. Vasomotor symptoms recurred after cessation of HT in 143 (87%) of these 165 women. We found no significant difference in symptom recurrence in comparisons of the three groups based on usage of HT for 0 to 1, 2 to 4, or 5 years or more. Conclusions: Most women who had vasomotor symptoms when they initiated HT reported recurrence of symptoms after cessation of HT (87%), although the flashes were usually reported to be less frequent and bothersome than they were before HT. Effective and safe treatment approaches for women with recurrence of vasomotor symptoms are needed.

Effects of applied relaxation on vasomotor symptoms in postmenopausal women: a randomized controlled trial

ObjectiveThis work aimed to study the efficacy of group therapy with applied relaxation on vasomotor symptoms and health-related quality of life in postmenopausal women. MethodsIn 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. ResultsThe 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. ConclusionsApplied relaxation can be used to treat vasomotor symptoms in healthy postmenopausal women.

Prevention of menstrual migraine with perimenstrual transdermal 17-β-estradiol: a randomized, placebo-controlled, double-blind crossover study

The effect of treatment with percutaneous E(2) (100 μg/24 h) during 2 weeks perimenstrually on the number and severity of menstrual migraine attacks was studied in 27 women in a randomized, placebo-controlled, double-blind, crossover trial. We were not able to demonstrate any difference between E(2) supplementation and placebo on the number or severity of migraine attacks, but both regimens showed significant effects compared with before treatment. CLINICAL TRIAL IDENTIFICATION NUMBER: NCT00204074.