Applied Relaxation and Vasomotor Symptoms in Postmenopause
Applied Relaxation and Vasomotor Symptoms in Postmenopause
Of the 79 women screened for eligibility, 60 women were randomized to either the AR group (n = 33) or the untreated CG (n = 27; Figure. 1). Six women declined enrollment, three women started HT or other treatment of vasomotor symptoms, and three women declined because of personal reasons.
(Enlarge Image)
Figure 1.
Recruitment and flow of women included in the final analyses of the study. AR, applied relaxation; CG, control group.
All women in the AR group continued the 12-week program, but two women did not fulfill the requirement of keeping the weekly diaries and the WHQ at the 3-month follow-up. In the CG, one woman discontinued prematurely after the baseline visit because of health-related problems.
No significant differences in demographic variables or clinical characteristics were found between the two groups at baseline ( Table 1 ). Only one woman was a nighttime worker (included in the AR group), five women were retired, and the remaining women were part or full daytime workers.
Hot Flashes
The two groups did not differ in moderate and severe hot flash frequency per 24 hours at baseline. There was a statistically significant difference in the frequency of moderate and severe hot flashes between the two groups on the 12th week (P < 0.001) and at the 3-month follow-up (P < 0.001; Table 2 ). Repeated-measures analysis of variance showed that moderate and severe hot flash frequency significantly decreased over time in the AR group compared with the CG (F[2,106] = 12.99, P < 0.001; Figure. 2).
(Enlarge Image)
Figure 2.
Mean (SD) number of moderate and severe hot flashes per 24 hours registered by women in two randomization groups (at baseline, at 12 wk, and after 3 mo of follow-up). AR, applied relaxation; CG, control group; WHQ, Women’s Health Questionnaire.
In addition, the reduction in hot flashes in the AR group was 55% from baseline to the 12th week and 52% at the 3-month follow-up compared with a reduction of 20% and 18%, respectively in the CG.
In an analysis of the subgroup of women in the AR group defined as responders (n = 14), the mean reduction in hot flashes was 67% (range, 51%-83%) on the 12th week and 75% (range, 50%-96%) at the 3-month follow-up. In the CG, 2 of 26 women had a reduction in hot flashes of more than 50%.
Health-related Quality of Life
There were no differences in WHQ scores between the two groups at baseline. The median baseline scores and the changes in eight of the dimensions after 12 weeks and 3 months are shown in Table 3 . The dimension for menstrual symptoms was not analyzed because all women were postmenopausal. After 12 weeks, memory/concentration (P < 0.05), vasomotor symptoms (P < 0.05), and sleep (P < 0.05) dimension scores in the WHQ were statistically significantly improved in women randomized to the AR group compared with the CG ( Table 3 ). A clinically significant change within each domain of the WHQ has been proposed to be a difference of at least 0.10 to 0.20. The changes in the above-mentioned domains were even higher (0.14-0.50) in the AR group, whereas the CG had no significant changes at all according to the WHQ. Moreover, at 3 months, there were significant differences in the dimensions for somatic symptoms (P < 0.05), memory/concentration (P < 0.01), sleep (P < 0.01), and anxiety (P < 0.05) between the AR group and the CG. In addition, there were statistically significant improvements in the dimension for vasomotor symptoms for the women defined as responders (n = 14) in the AR group compared with nonresponders (n = 18).
Salivary Cortisol
There was no difference in the daily secretion of salivary cortisol between the two studied groups at baseline. Women participating in the study had a normal diurnal pattern of cortisol. The baseline median morning value in the AR group was 8.4 nmol/L, and the baseline median morning value in the CG was 8.8 nmol/L. The baseline median evening value for the AR group was 1.4 nmol/L, and that for the CG median evening value was 1.1 nmol/L. There was no significant difference between the groups at baseline.
A significantly lower value for morning secretion was observed only once; this lower value was observed in the AR group at the 3-month follow-up, as measured with the Mann-Whitney U test (P < 0.05). The median value for the AR group at this time was 7.1 versus CG 9.9 nmol/L.
Adverse Events
No woman discontinued treatment because of adverse effects.
Results
Of the 79 women screened for eligibility, 60 women were randomized to either the AR group (n = 33) or the untreated CG (n = 27; Figure. 1). Six women declined enrollment, three women started HT or other treatment of vasomotor symptoms, and three women declined because of personal reasons.
(Enlarge Image)
Figure 1.
Recruitment and flow of women included in the final analyses of the study. AR, applied relaxation; CG, control group.
All women in the AR group continued the 12-week program, but two women did not fulfill the requirement of keeping the weekly diaries and the WHQ at the 3-month follow-up. In the CG, one woman discontinued prematurely after the baseline visit because of health-related problems.
No significant differences in demographic variables or clinical characteristics were found between the two groups at baseline ( Table 1 ). Only one woman was a nighttime worker (included in the AR group), five women were retired, and the remaining women were part or full daytime workers.
Hot Flashes
The two groups did not differ in moderate and severe hot flash frequency per 24 hours at baseline. There was a statistically significant difference in the frequency of moderate and severe hot flashes between the two groups on the 12th week (P < 0.001) and at the 3-month follow-up (P < 0.001; Table 2 ). Repeated-measures analysis of variance showed that moderate and severe hot flash frequency significantly decreased over time in the AR group compared with the CG (F[2,106] = 12.99, P < 0.001; Figure. 2).
(Enlarge Image)
Figure 2.
Mean (SD) number of moderate and severe hot flashes per 24 hours registered by women in two randomization groups (at baseline, at 12 wk, and after 3 mo of follow-up). AR, applied relaxation; CG, control group; WHQ, Women’s Health Questionnaire.
In addition, the reduction in hot flashes in the AR group was 55% from baseline to the 12th week and 52% at the 3-month follow-up compared with a reduction of 20% and 18%, respectively in the CG.
In an analysis of the subgroup of women in the AR group defined as responders (n = 14), the mean reduction in hot flashes was 67% (range, 51%-83%) on the 12th week and 75% (range, 50%-96%) at the 3-month follow-up. In the CG, 2 of 26 women had a reduction in hot flashes of more than 50%.
Health-related Quality of Life
There were no differences in WHQ scores between the two groups at baseline. The median baseline scores and the changes in eight of the dimensions after 12 weeks and 3 months are shown in Table 3 . The dimension for menstrual symptoms was not analyzed because all women were postmenopausal. After 12 weeks, memory/concentration (P < 0.05), vasomotor symptoms (P < 0.05), and sleep (P < 0.05) dimension scores in the WHQ were statistically significantly improved in women randomized to the AR group compared with the CG ( Table 3 ). A clinically significant change within each domain of the WHQ has been proposed to be a difference of at least 0.10 to 0.20. The changes in the above-mentioned domains were even higher (0.14-0.50) in the AR group, whereas the CG had no significant changes at all according to the WHQ. Moreover, at 3 months, there were significant differences in the dimensions for somatic symptoms (P < 0.05), memory/concentration (P < 0.01), sleep (P < 0.01), and anxiety (P < 0.05) between the AR group and the CG. In addition, there were statistically significant improvements in the dimension for vasomotor symptoms for the women defined as responders (n = 14) in the AR group compared with nonresponders (n = 18).
Salivary Cortisol
There was no difference in the daily secretion of salivary cortisol between the two studied groups at baseline. Women participating in the study had a normal diurnal pattern of cortisol. The baseline median morning value in the AR group was 8.4 nmol/L, and the baseline median morning value in the CG was 8.8 nmol/L. The baseline median evening value for the AR group was 1.4 nmol/L, and that for the CG median evening value was 1.1 nmol/L. There was no significant difference between the groups at baseline.
A significantly lower value for morning secretion was observed only once; this lower value was observed in the AR group at the 3-month follow-up, as measured with the Mann-Whitney U test (P < 0.05). The median value for the AR group at this time was 7.1 versus CG 9.9 nmol/L.
Adverse Events
No woman discontinued treatment because of adverse effects.