Factors associated with high placebo response in clinical studies of hot flashes

Menopause ◽  
2021 ◽  
Vol Publish Ahead of Print ◽  
Author(s):  
Kentaro Miyazaki ◽  
Masayuki Kaneko ◽  
Mamoru Narukawa
Keyword(s):  
Clinical Studies ◽  
Hot Flashes ◽  
Placebo Response ◽  
Factors Associated

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

2017 ◽  
Vol 24 (8) ◽  
pp. 932-937 ◽  
Author(s):  
Lujin Li ◽  
Ling Xu ◽  
Junyi Wu ◽  
Lidan Dong ◽  
Yinghua Lv ◽  
...  
Keyword(s):  
Quantitative Analysis ◽  
Hot Flashes ◽  
Placebo Response ◽  
Factors Associated

The Nature of Placebo Response in Clinical Studies of Major Depressive Disorder

2015 ◽  
Vol 76 (04) ◽  
pp. 456-466 ◽  
Author(s):  
George I. Papakostas ◽  
Søren D. Østergaard ◽  
Nadia Iovieno
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Clinical Studies ◽  
Placebo Response ◽  
Major Depressive

Hot flash placebo responses: Related to baseline hot flash frequency?

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 9628-9628
Author(s):  
J. M. Jones ◽  
C. L. Loprinzi ◽  
R. Qin ◽  
D. L. Barton
Keyword(s):  
Significant Positive Correlation ◽  
Hot Flashes ◽  
Placebo Response ◽  
Correlation Coefficients ◽  
Baseline Period ◽  
Percent Reduction ◽  
Hot Flash ◽  
Positive Correlation ◽  
Pubmed Search ◽  
Multiple Treatments

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.

scholarly journals Adherence and Persistence with Methotrexate in Rheumatoid Arthritis: A Systematic Review

2016 ◽  
Vol 43 (11) ◽  
pp. 1997-2009 ◽  
Author(s):  
Jeffrey R. Curtis ◽  
Vivian P. Bykerk ◽  
Maher Aassi ◽  
Michael Schiff
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Outcomes ◽  
Clinical Studies ◽  
Reference Lists ◽  
Included Study ◽  
Inclusion Criteria ◽  
Factors Associated ◽  
Patient Demographics ◽  
Persistence Rates ◽  
Persistence Factors

Objective.Medication adherence in patients with rheumatoid arthritis (RA) is typically suboptimal. Nonadherence has been associated with symptom worsening and increased disability. We systematically reviewed published clinical studies to evaluate methotrexate (MTX) adherence and persistence, factors associated with MTX adherence and persistence, and the effect of MTX nonadherence on clinical outcomes in RA.Methods.MEDLINE and Embase were systematically searched (inception to February 2016) using relevant keywords. Observational or interventional clinical studies in patients with RA that specifically reported adherence to or persistence with MTX were included. Data were extracted using a predesigned, standardized template that included study design, patient demographics, and relevant outcomes. Main outcomes were MTX adherence and persistence rates in patients with RA treated with MTX and factors associated with MTX adherence and persistence.Results.Of 365 references screened, 31 articles met inclusion criteria and another 10 were identified from searching reference lists. Estimates of MTX adherence varied from study to study because of heterogeneity in patient populations, duration of followup, definitions of adherence, and methods of assessment. Rates of MTX persistence ranged from 50% to 94% at 1 year and 25% to 79% at 5 years. No clear trends were identified in factors that influence MTX adherence and persistence. Two studies suggested that MTX adherence was associated with superior clinical outcomes.Conclusion.MTX adherence and persistence are highly variable in patients with RA. Research is necessary to determine the effect of nonadherence on health outcomes and to identify independent predictors of nonadherence to inform evidence-based interventions.

Differential factors associated with hot flashes in Chinese perimenopausal and postmenopausal women

Maturitas ◽  
2009 ◽  
Vol 63 (1) ◽  
pp. 94-98 ◽  
Author(s):  
Qiaoli Zhang ◽  
Fen Li ◽  
Ying Yu ◽  
Xuewen Yu ◽  
Qiu Sheng ◽  
...  
Keyword(s):  
Postmenopausal Women ◽  
Hot Flashes ◽  
Factors Associated

scholarly journals Sleep Disturbance in Cancer Patients Referred to an Ambulatory Integrative Oncology Consultation

2021 ◽  
Author(s):  
Santhosshi Narayanan ◽  
Akhila Reddy ◽  
Gabriel Lopez ◽  
Wenli Liu ◽  
Sara Ali ◽  
...  
Keyword(s):  
Sleep Disturbance ◽  
Eligible Patient ◽  
Hot Flashes ◽  
Well Being ◽  
Published Data ◽  
Poor Sleep ◽  
Integrative Oncology ◽  
Factors Associated ◽  
Patient Reported ◽  
Edmonton Symptom Assessment Scale

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.

scholarly journals Mood Predicts Response to Placebo CPAP

2012 ◽  
Vol 2012 ◽  
pp. 1-6 ◽  
Author(s):  
Carl J. Stepnowsky ◽  
Wei-Chung Mao ◽  
Wayne A. Bardwell ◽  
José S. Loredo ◽  
Joel E. Dimsdale
Keyword(s):  
Positive Airway Pressure ◽  
Placebo Response ◽  
Hierarchical Regression ◽  
Apnea Hypopnea Index ◽  
Drug Trials ◽  
Factors Associated ◽  
Beneficial Effects ◽  
Cpap Treatment ◽  
Total Mood Disturbance ◽  
Obstructive Sleep

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.

scholarly journals Predictors of a placebo response in patients with hand osteoarthritis: post-hoc analysis of two randomized controlled trials

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jin Kyun Park ◽  
Se Han Ahn ◽  
Kichul Shin ◽  
Yun Jong Lee ◽  
Yeong Wook Song ◽  
...  
Keyword(s):  
Pain Score ◽  
Multivariable Analysis ◽  
Placebo Response ◽  
Hand Osteoarthritis ◽  
Double Blind ◽  
Meaningful Improvement ◽  
Post Hoc Analysis ◽  
Factors Associated ◽  
Pain Scores ◽  
Post Hoc

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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