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2021 ◽  
Author(s):  
Beverley de Valois ◽  
Teresa Elaine Young ◽  
Pam Thorpe ◽  
Tarsem Degun ◽  
Karen Corbishley

Abstract PurposeWhile clinical trials provide valuable data about efficacy of interventions, findings often do not translate into clinical settings. We report real world clinical outcomes of a 15-year service offering breast cancer survivors auricular acupuncture to manage hot flushes and night sweats (HFNS) associated with adjuvant hormonal treatments. This service evaluation aims to 1) assess whether usual practice alleviates symptoms in a clinically meaningful way and 2) compare these results with scientific evidence. MethodsData were analysed from 415 referrals to a service offering women eight standardised treatments using the National Acupuncture Detoxification Association (NADA) protocol. Outcome measures administered at baseline, end of treatment (EOT), and four- and 18- weeks after EOT included Hot Flush Diaries, Hot Flush Rating Scale (HFRS) and Women’s Health Questionnaire (WHQ).Results2285 treatments were given to 300 women; 275 (92.3%) completed all eight treatments. Median daily frequency of HFNS reduced from 9.6 (IQR 7.3) to 5.7 (IQR 5.8) at EOT and 6.3 (IQR 6.5) 18 weeks after EOT. HFRS problem rating showed a clinically meaningful reduction of ≥2 points at all measurement points. WHQ showed improvements in several symptoms associated with the menopause. Two adverse events were reported, neither were serious. Results are comparable to published research.ConclusionThis first analysis of a long-term auricular acupuncture service compares favourably with outcomes of other studies for reducing HFNS frequency and associated menopausal symptoms. In day-to-day clinical practice, NADA appears to be a safe effective intervention for breast cancer survivors.


2021 ◽  
pp. 096452842110566
Author(s):  
Chang Liu ◽  
Zhijie Wang ◽  
Ting Guo ◽  
Lixing Zhuang ◽  
Xiao Gao

Objective: To evaluate the efficacy/effectiveness and safety of acupuncture for the treatment of hot flushes and its impact on serum hormone levels in menopausal women. Methods: A total of 10 databases were searched from their inception to August 2018. Reference lists of reviews and included articles were also hand-searched. Randomized controlled trials (RCTs) comparing the effect of acupuncture versus sham acupuncture, or acupuncture versus hormone therapy (HT), as treatment for menopausal hot flushes were included. Outcomes included hot flush frequency, hot flush severity and serum hormone levels of estradiol (E2), luteinizing hormone (LH) and follicle-stimulating hormone (FSH). Meta-analyses were performed using Review Manager 5.3 software. Results: Thirteen RCTs including 1784 patients were selected, seven of which were available for meta-analysis. Compared with sham acupuncture, acupuncture significantly decreased hot flush frequency (mean difference (MD) −0.84, 95% confidence interval (CI) [−1.64, −0.05], I2 = 54%) from baseline to the end of study, but did not impact end scores of hot flush frequency (MD 0.19, 95% CI [−0.61, 0.99], I2 = 0%) or severity (MD 0.02, 95% CI [−0.13, 0.17], I2 = 0%). No differences were found between acupuncture and HT in serum levels of E2 (MD 6.56, 95% CI [−3.77, 16.89], I2 = 76%), FSH (MD 1.06, 95% CI [−1.44, 3.56], I2 = 0%) or LH (MD −3.36, 95% CI [−13.37, 6.65], I2 = 89%). Conclusion: Acupuncture may not decrease hot flush frequency, but yet appears to have similar effects on serum hormone levels as HT, that is, increased E2 and decreased FSH and LH. Considering that no firm conclusions could be drawn due to the low quality and limited number of included trials included, further high-quality RCTs need to be conducted.


2021 ◽  
Vol 2 ◽  
Author(s):  
Robin Andrews ◽  
Gabrielle Hale ◽  
Bev John ◽  
Deborah Lancastle

Evidence suggests that monitoring and appraising symptoms can result in increased engagement in medical help-seeking, improved patient-doctor communication, and reductions in symptom prevalence and severity. To date, no systematic reviews have investigated whether symptom monitoring could be a useful intervention for menopausal women. This review explored whether symptom monitoring could improve menopausal symptoms and facilitate health-related behaviours. Results suggested that symptom monitoring was related to improvements in menopausal symptoms, patient-doctor communication and medical decision-making, heightened health awareness, and stronger engagement in setting treatment goals. Meta-analyses indicated large effects for the prolonged use of symptom diaries on hot flush frequencies. Between April 2019 and April 2021, PsychInfo, EMBASE, MEDLINE, CINAHL, Cochrane, ProQuest, PsychArticles, Scopus, and Web of Science were searched. Eighteen studies met the eligibility criteria and contributed data from 1,718 participants. Included studies quantitatively or qualitatively measured the impact of symptom monitoring on menopausal populations and symptoms. Research was narratively synthesised using thematic methods, 3 studies were examined via meta-analysis. Key themes suggest that symptom monitoring is related to improvements in menopausal symptoms, improved patient-doctor communication and medical decision-making, increased health awareness, and stronger engagement in goal-setting behaviours. Meta-analysis results indicated large effects for the prolonged use of symptom diaries on hot flush frequency: 0.73 [0.57, 0.90]. This review is limited due to the low number of studies eligible for inclusion, many of which lacked methodological quality. These results indicate that symptom monitoring has potential as an effective health intervention for women with menopausal symptoms. This intervention may be beneficial within healthcare settings, in order to improve patient-doctor relations and adherence to treatment regimes. However, findings are preliminary and quality assessments suggest high risk of bias. Thus, further research is needed to support these promising outcomes.Systematic Review Registration Number:https://www.crd.york.ac.uk/prospero/display_record.php?, PROSPERO, identifier: CRD42019146270.


2021 ◽  
Vol 2 (Supplement_1) ◽  
pp. A46-A47
Author(s):  
X Li ◽  
M Halaki ◽  
T Mahar ◽  
S Ropert ◽  
A Ireland ◽  
...  

Abstract Introduction Vasomotor symptoms and sleep disturbances are common in menopausal women. Different fabric types affect thermal comfort through moisture absorption and thermal insulation. This study examined the impact of cotton and wool sleepwear on menopausal women’s sleep quality. Methods This is a randomized, crossover, repeated-measures and triple-blinded trial comparing the sleep quality and vasomotor symptoms of healthy menopausal women between cotton and wool sleepwear at 30°C, 50% relative humidity. Participants undergo 6 laboratory visits. After a screening visit and a familiarization night, participants are randomized to 4 nights (2 nights in cotton and 2 nights in wool sleepwear) during which polysomnography and actigraphy recordings are taken including objective hot flush events, room temperature and relative humidity measurements, as well as subjective questionnaires on clothing comfort, mood and vasomotor symptoms. Results Eleven participants (age 51.2±4.7 years, BMI 26.8±2.9 kg.m-2, Insomnia Severity Index 11.1±5.5) completed all six visits so far. Reasons for exclusion: 3 didn’t have vasomotor symptoms; 1 on HRT, 5 had severe sleep disturbances, 3 on medications, 4 had diabetes, 1 asthma, and 1 had BMI>30. All sleep-related outcomes are pending analysis (blinding). Discussion Recruitment is a major study challenge. Many participants found it hard to arrange a time to attend overnight studies due to family/work commitments. The COVID-19 pandemic changed people’s attitude as some were hesitant to attend the laboratory. Menopause transition status is an important time during women’s lifespan. Effective management, e.g., through appropriate sleepwear, would be helpful to improve menopausal women’s symptom and quality of life.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yukifumi Sasamori ◽  
Kohei Takehara ◽  
Tsuyoshi Terashima ◽  
Takako Onodera ◽  
Keita Yatsuki ◽  
...  

Abstract Background Recently, relugolix, an oral gonadotropin-releasing hormone receptor antagonist, has been considered an effective therapy for leiomyoma based on a phase 3 study in Japanese women. Leiomyoma combined with severe adenomyosis occasionally occurs in perimenopausal women; however, little information on the effectiveness of relugolix against severe adenomyosis exists. Case presentation A 49-year-old woman was referred to our hospital with acute lower abdominal pain and abnormal uterine bleeding. Magnetic resonance imaging revealed multiple leiomyomas with diffuse adenomyosis. Left hydrosalpinx was also observed. The patient refused surgical treatment and preferred oral relugolix. Since she experienced a hot flush and headache induced by relugolix, a traditional Japanese Kampo, kamishoyosan, was added to improve the side effects of relugolix. The patient was asymptomatic at the time of this report and experienced a significant shrinkage in uterine volume. Ultimately, she avoided hysterectomy as desired. Conclusions To our knowledge, this is the first report of co-occurring adenomyosis and leiomyoma, which was effectively treated with relugolix. Although the management of adverse side effects, including hot flush and headache by relugolix, has recently attracted attention and controversy, relugolix add-on therapy with kamishoyosan may help treat menopausal symptoms.


Author(s):  
Bina Aquari
Keyword(s):  

Gejala paling umum yang dialami wanita menopause, yaitu hot flush. Hot Flush adalah perasaan panas yang muncul mulai dari bagian atas tubuh dan menyebar ke wajah. Intervensi yang dilakukan untuk mendinginkan hot flush dengan menggunakan body wipe. Body Wipe adalah alat penyeka tubuh yang memberikan kesegaran. Penelitian ini bertujuan untuk mengetahui pengaruh body wipe sebagai manajemen intervensi hot flush pada wanita menopause di Klinik/BP Anisa. Penelitian ini merupakan eksperimen dengan menggunakan rancangan eksperimen semu. Data diperoleh dengan kuisioner untuk karakteristik umur, pendidikan dan pekerjaan sedangkan observasi untuk suhu sebelum dan sesudah diberi manajemen intervensi body wipe. Sampel penelitian ini adalah wanita menopause berjumlah 12 orang yang berkunjung untuk berobat di Klinik/BP Anisa. Metode analisis data menggunakan uji statistik wilcoxon. Analisis Univariat menunjukan suhu tinggi pada suhu sebelum diberi manajemen intervensi body wipe (100%), sesudah diberi manajemen intervensi body wipe suhu normal (91.7%)  dan suhu tinggi (8.3%), umur fase menopause (100%), pendidikan bawah (100%), pekerjaan secara mandiri (100%). Untuk analisis bivariat terdapat 12 wanita menopause (100%) dengan hasil suhu inti tubuh lebih rendah setelah diberi manajemen intervensi body wipe dibandingkan sebelum diberi manajemen intervensi body wipe. Hasil penelitian ini menunjukan bahwa manajemen intervensi dengan menggunakan body wipe dapat berpengaruh dalam mengatasi hot flush pada ibu menopause di Klinik/BP Anisa dengan nilai nilai p= 0,001. Body wipe dapat digunakan sebagai manajemen intervensi untuk mengatasi hot flush.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 1058-1058
Author(s):  
Sarat Chandarlapaty ◽  
Hannah M. Linden ◽  
Patrick Neven ◽  
Katarina Petrakova ◽  
Aditya Bardia ◽  
...  

1058 Background: AMEERA-1 (NCT03284957) investigates amcenestrant, an oral SERD, as monotherapy and combined with targeted therapies in ER+/HER2– mBC. Here we report data from dose escalation (Part C) and dose expansion (Part D) of amcenestrant + palbo. Methods: Patients (pts) were postmenopausal women with ER+/HER2– mBC and ≥ 6 mos prior advanced endocrine therapy (ET) or adjuvant (adj) ET resistance (relapse on adj ET started ≥ 24 mos ago or < 12 mos after completing adj ET). Prior chemotherapy (≤ 1) for advanced disease was allowed; targeted therapies were not except ≤ 1 CDK4/6i in Part C. Part C assessed dose-limiting toxicities (DLTs) and aimed to establish the recommended phase 2 dose (RP2D) for amcenestrant (200 or 400 mg once daily [QD], in 28-day cycles) in combination with palbo (125 mg QD for 21 days on/ 7 days off). Safety (treatment-emergent adverse events [TEAEs] and lab abnormalities per CTCAE v4.03) and pharmacokinetics (PK) were evaluated. Antitumor activity at the RP2D for amcenestrant + palbo was evaluated in a subset of Part C pts and Part D, according to RECIST v1.1, determined locally by investigators. Results: Feb 8, 2021 data cutoff. In Part C (n = 15; 200 mg: 9; 400 mg: 6), no DLTs occurred and amcenestrant 200 mg QD was selected as the RP2D with palbo, based on PK and safety data. In the pooled safety population at the RP2D (n = 39; Part C: 9; Part D: 30), median (range) age was 59 y (33–86) with ECOG PS 0 (74.4%) or 1 (25.6%) and 2 (1–6) organs involved. Immediate prior therapy was neo/adj (41.0%, all ET resistant) or advanced (59.0%, range 1–4 lines). Median (range) exposure was 32 wks (1–66) with 59.0% pts on ongoing therapy. No amcenestrant dose reductions occurred; 25.6% had ≥ 1 palbo dose reduction. Most common non-hematological TEAEs related to amcenestrant were Grade 1–2 nausea and fatigue (17.9% each), asthenia and hot flush (10.3% each); to palbo were fatigue (30.8%), nausea (25.6%), asthenia and dysgeusia (10.3% each). Two pts discontinued due to AEs. The majority (94.9%) had neutrophil count decrease (53.8% Grade ≥ 3). Preliminary antitumor activity after at least 6 cycles of therapy (unless early treatment discontinuation) is reported in the table below. Conclusions: In pts with ER+/HER2– mBC, safety at the RP2D of amcenestrant + palbo was favorable, with no safety signals of bradycardia or eye disorders. Preliminary antitumor activity was observed (ORR: 31.4% and CBR: 74.3%). Clinical trial information: NCT03284957 .[Table: see text]


2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. A241-A242
Author(s):  
Yoon-Sok Chung ◽  
Dong-Yun Lee

Abstract Background: Preventing bone loss is an important concern for women during post-menopausal period. Menopause significantly speeds bone loss and increases the risk for osteoporosis. The aim of this study was to investigate the effectiveness on quality of life (QOL), patient satisfaction in postmenopausal women receiving raloxifene/cholecalciferol combination therapy. In addition, we analyzed adverse events to assess the safety profile of this drug. Methods: This study is a multicenter, prospective, non-interventional observational study of women receiving raloxifene/cholecalciferol (raloxifene 60 mg + cholecalciferol 800 IU, Rabone D®, Hanmi Pharma, South Korea) combination therapy to treat or prevent postmenopausal osteoporosis. Data have been collected from patients receiving routine clinical practice at 99 hospitals (local clinics and general hospitals) in South Korea. Patients were followed for more than 6 months to evaluate changes in, and QOL (EQ-5D-5L), patient satisfaction with efficacy and convenience (questionnaire), and safety. This study has been approved by Institutional Review Board and is in compliance with clinical research ethics regulations. Results: A total of 3,907 subjects with an average age of 67.68 ± 9.34 (Mean ± SD) were enrolled from November 2017 to July 2020. QOL was significantly improved from 0.77 ± 0.15 to 0.80 ± 0.12, 0.82 ± 0.11 (3 months, 6 months, respectively) after raloxifene/cholecalciferol therapy (p&lt;0.001). Compared to prior drug regimens of all types (bisphosphonates, bisphosphonates with vitamin D, selective estrogen receptor modulators, etc.), QOL after raloxifene/cholecalciferol treatment was significantly improved (p&lt;0.001). Patient satisfaction of efficacy was significantly increased from 37.25% to 67.70% over 6 months (p&lt;0.0001), and patient satisfaction of convenience was significantly increased from 42.75% to 74.07% (p&lt;0.0001). Serious adverse drug reaction (ADR) did not occur. Hot flush as ADR occurred in 12 subjects (0.30%), lower than Caucasian but similar with previous reports in Asians. Conclusion: In postmenopausal women, combination therapy with raloxifene/cholecalciferol significantly improved quality of life, and patient satisfaction with no serious adverse events. This drug regimen has been proven to be suitable therapy for postmenopausal women with osteoporosis in a real-world clinical setting. References: Kim et al., Expert Opin Drug Safety 2019; 18: 1001–8. Takeuchi et al., Menopause 2015; 22: 1134–7. Xu et al., Osteoporos Int 2011; 22: 559–65.


2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Timothy R. Smith ◽  
Egilius L. H. Spierings ◽  
Roger Cady ◽  
Joe Hirman ◽  
Barbara Schaeffler ◽  
...  

Abstract Background The humanized anti-CGRP monoclonal antibody eptinezumab has been evaluated in five large-scale clinical trials conducted in patients with migraine. This integrated analysis was conducted to evaluate the comprehensive safety and tolerability of eptinezumab in patients with migraine across these studies. Methods Data were pooled from four randomized, double-blind, placebo-controlled studies and the first year of one open-label study. Results The pooled population comprised 2867 adults with migraine: eptinezumab, n = 2076 (4797 infusions); placebo, n = 791 (1675 infusions). A total of 1137/2076 (54.8%) patients who received eptinezumab and 414/791 (52.3%) patients who received placebo experienced ≥1 treatment-emergent adverse event (TEAE); rates were similar across eptinezumab dose groups (10–1000 mg). For most patients with TEAEs, the events were mild or moderate in severity and considered unrelated to study drug by the investigators. Thirty infusion-site AEs occurred in 27/2076 (1.3%) patients who received eptinezumab and 7 in 7/791 (0.9%) patients who received placebo. Infusion-site AEs led to infusion interruption in 19/2076 (0.9%) and 5/791 (0.6%) patients in the eptinezumab and placebo groups, respectively. Nasopharyngitis occurred in ≥2% of patients in the eptinezumab 300-mg group and with an incidence of at least 2 percentage points greater than in the placebo group; however, in most patients (eptinezumab, 139/140; placebo 40/41), its occurrence was considered not related to study treatment. Adverse events coded to hypersensitivity occurred for 23/2076 (1.1%) patients treated with eptinezumab and no patients in the placebo group. If additional TEAE terms that could indicate hypersensitivity are considered (e.g., urticaria, flushing/hot flush, rash, and pruritus), hypersensitivity reactions in the two pivotal placebo-controlled phase 3 studies occurred in ≥2% of patients in the eptinezumab 100-mg and 300-mg groups, and the incidence was at least 2 percentage points greater in either of these groups than in the placebo group. Most hypersensitivity reactions were not serious and resolved with standard medical treatment or observation without treatment, usually within 1 day. Conclusions In adults with migraine, the intravenous administration of eptinezumab every 12 weeks demonstrated a favorable safety and tolerability profile. Trial registration ClinicalTrials.gov (Identifiers: NCT01772524, NCT02275117, NCT02559895, NCT02974153, NCT02985398).


2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 217-217
Author(s):  
Shan Jiang ◽  
Della Varghese ◽  
Sreevalsa Appukkuttan ◽  
Shelby Corman ◽  
Nehemiah Kebede ◽  
...  

217 Background: Second generation androgen receptor inhibitors (SGARIs), apalutamide (APA) and enzalutamide (ENZ) and darolutamide, are approved in the United States (US) for the treatment of nmCRPC. The objectives of this study were to describe the frequency of AEs and actions taken to manage AEs among nmCRPC patients treated with APA or ENZ and their downstream resource implications. Methods: This is a further descriptive analysis of a retrospective chart review study conducted in 43 US nmCRPC-treating sites. In our sample, the 43 physicians identified 699 nmCRPC patients initiating treatment with APA (N = 368) or ENZ (N = 333) with 2 patients receiving both, between February 1, 2018 and December 31, 2018 and AEs were collected as reported in regular clinical practice. A representative subset of patients, experiencing at least 1 AE for either APA (N = 125) or ENZ (N = 125), were selected randomly from the initial cohort, and their detailed chart data were extracted to understand the actions taken to manage AEs. Results: Of the initial cohort of nmCRPC patients, 72.0% and 78.7% of men receiving APA (N = 368) and ENZ (N = 333) experienced ≥1 AE, respectively. The three most common AEs reported were fatigue/asthenia (APA, 30.2%; ENZ, 38.7%), hot flush (APA, 14.1%; ENZ, 13.5%), and arthralgia (APA, 14.4%; ENZ, 12.9%). Cognitive and mental changes were observed in 5.4% (APA) and 7.8% (ENZA) men. The subset analysis of randomly selected patients experiencing ≥1 AE (APA, 125; ENZ, 125) were mostly Caucasian (APA, 72.8%; ENZ, 71.2%), ECOG score 0-1 (APA, 84%; ENZ, 88%), median prostate specific antigen (PSA) value 13 ng/ml and 11 ng/ml (APA, ENZ; respectively). Actions to address AEs included treatment of AE, SGARI discontinuation, dose reduction and hospitalization (Table). Specifically, treatment discontinuation due to AE was observed in 8.0% (APA) and 12.8 (%) of men. AEs were often not resolved (APA, 43.6%; ENZ, 39.4%), and the median duration of days to resolve AEs were 60.0 for APA and 56.0 for ENZ. Conclusions: This real-world study highlights the clinical and resource use burden of AEs among nmCRPC patients treated with APA and ENZ. The results demonstrate the importance of safety and tolerability as key considerations in shared clinician-patient decision-making regarding SGARI therapy in nmCRPC. [Table: see text]


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