Factors associated with a clinically relevant reduction in menopausal symptoms of a standardized acupuncture approach for women with bothersome menopausal symptoms.

BACKGROUND: Little is known about factors associated with a clinically relevant reduction in menopausal symptoms through a brief acupuncture approach for women with moderate-to-severe menopausal symptoms. METHODS: Post hoc analysis of a randomized controlled trial where participants were allocated to early versus late standardized acupuncture. Both the early group and the late group are included in this study. The late group got an identical intervention parallel staged by 6 weeks. By means of the relative importance, the effect was evaluated for both early versus late women with a 6-week follow-up. We included four symptom subscales from the validated MenoScores Questionnaire: hot flushes, day and night sweats, general sweating, menopausal-specific sleeping problems, as well as an overall score, which is the sum of the four outcomes in the analysis. RESULTS: 67 women with moderate to severe menopausal symptoms were included of whom 52 (77.6%) experienced a clinically relevant reduction in any of the four surveyed symptom subscales or overall score. 48 (71.6%) women experienced a clinically relevant reduction in any of the vasomotor symptom subscales: hot flushes, day and night sweats, general sweating. Women with vocational education were most likely to experience improvement compared to women with higher education. Beyond education, other factors of some importance for a clinically relevant reduction were no alcohol consumption, two or more births and urinary incontinence. CONCLUSIONS: Level of education was the most consistent factor associated with improvement. Beyond education, other factors of some importance were no alcohol consumption, two or more births and urinary incontinence. TRIAL REGISTRATION: This study was registered in ClinicalTrials.gov at April 21, 2016. The registration number is NCT02746497 .

Sustained effects of a brief and standardised acupuncture approach on menopausal symptoms: post hoc analysis of the ACOM randomised controlled trial.

BACKGROUND: Our objective was to investigate whether the effect of a brief and standardised acupuncture approach persists after the end of the acupuncture treatment (post-treatment effect) and whether the anticipation of future acupuncture treatment affects menopausal symptoms (pre-treatment effect). METHOD: This study is a post hoc analysis of data from a randomised controlled trial where women with moderate to severe menopausal symptoms were offered weekly acupuncture treatment over five consecutive weeks and randomised (1:1) to an early intervention group that received treatment immediately and a late intervention group with a 6-week delay. The acupuncture style was Western medical, administered at CV3, CV4 and bilateral LR8, SP6 and SP9. Acupuncturists were general practitioners. The effect was evaluated repeatedly during and after the interventions using scales from the validated MenoScores Questionnaire (MSQ) for hot flushes (HF), day and night sweats (DNS), general sweating (GS) and menopausal-specific sleeping problems (MSSP) with a 26-week follow-up period (corresponding to 21 or 15 weeks post-treatment for the early and late intervention groups, respectively). Multivariable linear mixed models were used to analyse the extent and duration of effects. RESULTS: Seventy participants were included in the study. Four participants dropped out. Furthermore, one participant was excluded from the short- and long-term follow-up analyses after the insertion of a hormonal intrauterine device, and nine participants were excluded from the long-term follow-up analysis due to the initiation of co-interventions. For each of the four outcomes, the effect was sustained up to 21 weeks post-treatment with an effect size that was only slightly diminished. A small, but significant, pre-treatment effect was observed in the HF scale scores. The same trend, although not significant, was observed in the DNS and MSSP scale scores. No serious harms were reported. CONCLUSION: This study demonstrated that the overall effect of a brief and standardised acupuncture treatment on menopause-relevant outcomes was sustained up to 21 weeks post-treatment and that there was a small pre-treatment effect.

Efficacy of a standardised acupuncture approach for women with bothersome menopausal symptoms: a pragmatic randomised study in primary care (the ACOM study).

OBJECTIVE: To investigate the efficacy of a standardised brief acupuncture approach for women with moderate-to-severe menopausal symptoms. DESIGN: Randomised and controlled, with 1:1 allocation to the intervention group or the control group. The assessor and the statistician were blinded. SETTING: Nine Danish primary care practices. PARTICIPANTS: 70 women with moderate-to-severe menopausal symptoms and nine general practitioners with accredited education in acupuncture. INTERVENTION: The acupuncture style was western medical with a standardised approach in the predefined acupuncture points CV-3, CV-4, LR-8, SP-6 and SP-9. The intervention group received one treatment for five consecutive weeks. The control group was offered treatment after 6 weeks. MAIN OUTCOME MEASURES: Outcomes were the differences between the randomisation groups in changes to mean scores using the scales in the MenoScores Questionnaire, measured from baseline to week 6. The primary outcome was the hot flushes scale; the secondary outcomes were the other scales in the questionnaire. All analyses were based on intention-to-treat analysis. RESULTS: 36 participants received the intervention, and 34 participants were in the control group. Four participants dropped out before week 6. The acupuncture intervention significantly decreased hot flushes: Δ -1.6 (95% CI [-2.3 to -0.8]; p<0.0001), day-and-night sweats: Δ -1.2 (95% CI [-2.0 to -0.4]; p=0.0056), general sweating: Δ -0.9(95% CI [-1.6 to -0.2]; p=0.0086), menopausal-specific sleeping problems: Δ -1.8 (95% CI [-2.7 to -1.0]; p<0.0001), emotional symptoms: Δ -3.4 (95% CI [-5.3 to -1.4]; p=0.0008), physical symptoms: Δ -1.7 (95% CI [-3 to -0.4]; p=0.010) and skin and hair symptoms: Δ -1.5 (95% CI [-2.5 to -0.6]; p=0.0021) compared with the control group at the 6-week follow-up. The pattern of decrease in hot flushes, emotional symptoms, skin and hair symptoms was already apparent 3 weeks into the study. Mild potential adverse effects were reported by four participants, but no severe adverse effects were reported. CONCLUSIONS: The standardised and brief acupuncture treatment produced a fast and clinically relevant reduction in moderate-to-severe menopausal symptoms during the six-week intervention. No severe adverse effects were reported. TRIAL REGISTRATION NUMBER: NCT02746497; Results.

Measuring bothersome menopausal symptoms: development and validation of the MenoScores questionnaire.

BACKGROUND: The experience of menopausal symptoms is common and an adequate patient-reported outcome measure is crucial in studies where women are treated for these symptoms. The aims of this study were to identify a patient-reported outcome measure for bothersome menopausal symptoms and, in the absence of an adequate tool, to develop a new measure with high content validity, and to validate it using modern psychometric methods. METHODS: The literature was reviewed for existing questionnaires and checklists for bothersome menopausal symptoms. Relevant items were extracted and subsequently tested in group interviews, single interviews, and pilot tests. A patient-reported outcome measure was drafted and completed by 1504 women. Data was collected and psychometrically validated using item-response theory Rasch Models. RESULTS: All questionnaires identified in the literature lacked content validity regarding bothersome menopausal symptoms and none were validated using item-response theory. Our content validation resulted in a draft measurement encompassing 122 items across eight domains. Following psychometrical validation, the final version of our patient-reported outcome measure, named the MenoScores Questionnaire, encompassed 51 items, including one single item, covering 11 scales. CONCLUSION: Menopausal symptoms are multidimensional with some symptoms unquestionably related to the menopausal transition. We identified four constructs of importance: hot flushes, day-and-night sweats, general sweating, and menopausal-specific sleeping problems. The MenoScores Questionnaire is condition-specific with high content validity and adequate psychometrical properties. It is designed to measure bothersome menopausal symptoms and all scales are developed and psychometrically validated using item-response theory Rasch Models. TRIAL REGISTRATION: Approved by the Danish Data Agency (J.nr. 2015-41-4057). Ethics Committee approval was not required.

The efficacy of acupuncture on menopausal symptoms (ACOM study): protocol for a randomised study.

INTRODUCTION: Around 75% of menopausal women experience hot flushes (HF) and 10-20% of all postmenopausal women find this very distressing. The aim of this study is to evaluate the efficacy of acupuncture on moderate-to-severe menopausal symptoms in general and HF in particular. METHODS: An un-blinded randomised trial (cross-over) with 1:1 allocation to early (intervention) versus late (control) acupuncture. The included women suffer from moderate-to-severe HF and will receive a weekly treatment during five consecutive weeks in the following predefined acupuncture points: CV-3, CV-4, LR-8, SP-6, SP-9. All acupuncturists will be medical doctors educated in acupuncture. The primary outcome is change in HF from baseline to week 6 measured by the HF scale from the MenoScores Questionnaire (MSQ). Secondary outcomes are change in other menopausal symptoms, in particular day and night sweats and menopausal-specific sleeping problems, also measured by other scales from the MSQ. A total of 68 patients must be enrolled to detect a relevant clinical reduction on the above MSQ scales. Both intention-to-treat and per-protocol analyses will be conducted; four or more treatments are considered adequate adherence. CONCLUSIONS: In the ACOM study, we explore the potential benefits of acupuncture on moderate-to-severe meno-pausal symptoms. The cross-over design offers the possi-bility of examining the legacy effect of acupuncture. FUNDING: The Idella Foundation, the University of Copenhagen and the Research Foundation of General Practice. TRIAL REGISTRATION: Clinicaltrials NCT02746497.

[Medical speciality, belief in Santa and the risk of divorce].

INTRODUCTION: Christmas is a unique time for family occasions - unfortunately the number of divorces increase in the months after Christmas. In this study, we examined the relationship between medical speciality, length of relationship, risk of divorce and if belief in Santa impacted on these outcomes. MATERIAL AND METHODS: A questionnaire was developed from the lived experiences of the authors and distributed to doctors of any speciality through links (SurveyXact) in emails, text messages and Facebook from June 28 2016 to August 1 2016. Multivariate regression models were used to analyze the results. RESULTS: A total of 1,100 completed questionnaires were included in the analyses. The divorce rate among respondents was 12%. Compared to the speciality "general practice" all other specialities had higher divorce rates. The highest risk of divorce was reported by physicians specialized in psychiatry (odds ratio 2.13 (95% confidence interval: 1.03-4.43)). Belief in Santa was associated with a slightly increased risk of divorce in all medical specialities, with the exception of psychiatry. General practitioners also exhibited the longest duration of relationships compared to peers in other medical specialities. CONCLUSION: Being a general practitioner was associated with a low risk of divorce and significantly longer relationships than in other medical specialities. Belief in Santa in regard to divorce only seemed to be beneficial for psychiatrists. So please participate in the joy of Christmas but do not rely on Santa - go shop your own presents for the family. FUNDING: none. TRIAL REGISTRATION: not relevant.