Quantitative analysis of placebo response and factors associated with menopausal hot flashes

Author(s):  
Lujin Li ◽  
Ling Xu ◽  
Junyi Wu ◽  
Lidan Dong ◽  
Yinghua Lv ◽  
...  
Menopause ◽  
2021 ◽  
Vol Publish Ahead of Print ◽  
Author(s):  
Kentaro Miyazaki ◽  
Masayuki Kaneko ◽  
Mamoru Narukawa

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 9628-9628
Author(s):  
J. M. Jones ◽  
C. L. Loprinzi ◽  
R. Qin ◽  
D. L. Barton

9628 Background: As multiple treatments have been studied for the management of hot flashes in randomized, controlled trials, hot flash placebo responses have been quite variable across trials. Based on observations of trial reports, it was hypothesized that the magnitude of placebo effect might correlate with the number of baseline hot flashes in different studies. The current project examines the effect of the baseline hot flash frequency required for study participation and also the actual number of baseline hot flashes observed as these individually relate to the eventual reductions of hot flash frequency observed in patients receiving placebos. Methods: Data were collected from placebo-controlled, double-blinded, randomized trials, identified by a PubMed search, which reported hot flash frequency at baseline, 4–6 weeks and 12 weeks. Trials were excluded if they had less than 20 participants completing the placebo arm. Data gathered, in each study, included the number of hot flashes required to enroll in the study, the average hot flash number during the baseline period, and the hot flash changes in the placebo arms of each study (percent reduction from the baseline period). A simple statistical analysis was conducted in a descriptive fashion since standard deviation was not available in many trials. Scatter plots and Pearson's correlation coefficients demonstrated the relationships between the placebo hot flash percent reduction from baseline and both the minimum required number of hot flashes at baseline, and the mean number of hot flashes at baseline. Results: 45 trials with 49 placebo arms were included in this analysis. A significant positive correlation was seen between the number of hot flashes required to enroll in a study and the percent reduction of hot flashes from baseline at 4–6 weeks (Rho = 0.481, p = 0.003). There was also a significant positive correlation between the number of hot flashes at baseline and the percent reduction of hot flashes from baseline at 4–6 weeks (Rho = 0.481, p= 0.002) and at 12 weeks (Rho = 0.573, p= 0.003). Conclusions: These data support that higher baseline hot flash enrollment requirements and also higher baseline hot flash frequencies are associated with an increased placebo response. No significant financial relationships to disclose.


Maturitas ◽  
2009 ◽  
Vol 63 (1) ◽  
pp. 94-98 ◽  
Author(s):  
Qiaoli Zhang ◽  
Fen Li ◽  
Ying Yu ◽  
Xuewen Yu ◽  
Qiu Sheng ◽  
...  

2021 ◽  
Author(s):  
Santhosshi Narayanan ◽  
Akhila Reddy ◽  
Gabriel Lopez ◽  
Wenli Liu ◽  
Sara Ali ◽  
...  

Abstract Background Sleep disturbance (SD) is highly prevalent in oncology and negatively affects quality of life and mortality. Evidence supports the use of integrative oncology (IO) practices to treat SD, but there is limited published data on the characteristics of SD and factors associated with SD in IO. We determined the prevalence, severity, and factors associated with SD. Methods Patients with cancer referred for initial outpatient IO consultation in 2017 were eligible. Patient demographics, clinical characteristics, and patient-reported outcomes [Edmonton Symptom Assessment Scale, (ESAS), Measure Yourself Concerns and Wellbeing (MYCaW), PROMIS-10] were retrospectively reviewed. Results 1520 patients were included in the analysis. The majority (70%) were women with breast cancer (42%). 971 (64%) patients reported significant SD with ESAS Sleep ≥ 4, yet only 11% expressed poor sleep as their primary or secondary concern for the IO consultation. The median SD (IQR) was 5 (3,7). ESAS scores for fatigue (adjusted OR 1.16; CI 1.07–1.26, p < 0.001), pain (adjusted OR 1.07; CI 1.00-1.15, p < 0.05), hot flashes (adjusted OR 1.14; CI 1.07–1.22, p < 0.001), well-being (adjusted OR 1.33; CI 1.22–1.46, p < 0.001), and psychological distress score (anxiety and depression) (adjusted OR 1.16; CI 1.01–1.11, P < 0.01) were independently associated with SD in multivariate analysis. Acupuncture was the most frequent intervention prescribed 175 (35%). Other modalities included oncology massage (15%), health psychology (5%) and meditation (1%). Conclusions Although 64% of patients seeking IO consultation reported clinically significant SD, only 11% were seeking integrative approaches for managing SD. ESAS fatigue, hot flashes, well-being, and psychological symptoms were significantly associated with SD.


2012 ◽  
Vol 2012 ◽  
pp. 1-6 ◽  
Author(s):  
Carl J. Stepnowsky ◽  
Wei-Chung Mao ◽  
Wayne A. Bardwell ◽  
José S. Loredo ◽  
Joel E. Dimsdale

Study Objectives. Continuous positive airway pressure (CPAP) therapy is efficacious for treating obstructive sleep apnea (OSA), but recent studies with placebo CPAP (CPAP administered at subtherapeutic pressure) have revealed nonspecific (or placebo) responses to CPAP treatment. This study examined baseline psychological factors associated with beneficial effects from placebo CPAP treatment.Participants. Twenty-five participants were studied with polysomnography at baseline and after treatment with placebo CPAP.Design. Participants were randomized to either CPAP treatment or placebo CPAP. Baseline mood was assessed with the Profile of Mood States (POMS). Total mood disturbance (POMS-Total) was obtained by summing the six POMS subscale scores, with Vigor weighted negatively. The dependent variable was changed in apnea-hypopnea index (ΔAHI), calculated by subtracting pre- from post-CPAP AHI. Negative values implied improvement. Hierarchical regression analysis was performed, with pre-CPAP AHI added as a covariate to control for baseline OSA severity.Results. Baseline emotional distress predicted the drop in AHI in response to placebo CPAP. Highly distressed patients showed greater placebo response, with a 34% drop (i.e., improvement) in AHI.Conclusion. These findings underscore the importance of placebo-controlled studies of CPAP treatment. Whereas such trials are routinely included in drug trials, this paper argues for their importance even in mechanical-oriented sleep interventions.


2015 ◽  
Vol 48 (2) ◽  
pp. 303-309 ◽  
Author(s):  
Justine A. Assenga ◽  
Lucas E. Matemba ◽  
Joseph J. Malakalinga ◽  
Shabani K. Muller ◽  
Rudovick R. Kazwala

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jin Kyun Park ◽  
Se Han Ahn ◽  
Kichul Shin ◽  
Yun Jong Lee ◽  
Yeong Wook Song ◽  
...  

Abstract Background Placebo can have a significant therapeutic effect in patients with hand osteoarthritis (OA). This aim of the study is to identify factors associated with a clinically meaningful placebo response in patients with hand OA. Methods This post-hoc analysis of two double-blind, placebo-controlled, randomized trials (RCTs) investigating the efficacy of GCSB-5 or diacerein as treatments for hand OA analyzed the efficacy of a placebo. Clinical and laboratory factors associated with a clinically meaningful response, defined as an improvement in the Australian/Canadian Osteoarthritis Hand Index (AUSCAN) pain score > 10 at 4 weeks relative to baseline, were identified. Results The mean improvement in the AUSCAN pain score was − 6.0 ± 20.3, with marked variation between 143 hand OA patients (range: − 76.4 to 33.2). A clinically meaningful improvement was observed in 54 (37.8%) patients. Placebo responders had worse AUSCAN pain scores (55.7 ± 19.7 vs. 43.6 ± 21.6, p = 0.001) and a worse AUSCAN stiffness (68.2 ± 20.5 vs. 57.5 ± 24.5, p = 0.008) at baseline than non-responders. Improvements in pain correlated with the baseline pain level (Pearson r = − 427, p < 0.001). Structural joint changes such as tender, swollen, enlarged, or deformed joint counts did not differ between placebo responders and non-responders. In a multivariable analysis, only baseline AUSCAN pain was associated with a clinically meaningful placebo response (OR: 1.054, 95% CI [1.019–1.089], p = 0.002). Conclusions High levels of pain at baseline are predictive of a clinically meaningful placebo response in patients with hand OA. Further studies are needed to optimize and utilize the benefit of placebo responses in patients with hand OA.


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