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.

Gabapentin for hot flashes in men: NCCTG trial N00CB

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 9005-9005 ◽  
Author(s):  
C. L. Loprinzi ◽  
B. S. Khoyratty ◽  
A. Dueck ◽  
D. L. Barton ◽  
S. Jafar ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Androgen Deprivation Therapy ◽  
Hot Flashes ◽  
Baseline Period ◽  
Androgen Deprivation ◽  
Hot Flash ◽  
Treatment Termination ◽  
Patient Reported ◽  
Double Blinded ◽  
To Receive

9005 Background: Hot flashes can be a major problem in men with prostate cancer; effective non-hormonal options are needed. Methods: A four-arm, double-blinded, placebo-controlled randomized trial was developed to evaluate gabapentin for hot flashes. Men with bothersome hot flashes (at least 14/week) related to androgen deprivation therapy were randomized to receive either a placebo or gabapentin doses of 300 mg qd, 300 mg bid or 300 mg tid; men were treated for 4 weeks. Hot flashes numbers and scores (hot flash number times mean severity) were measured using a validated daily hot flashes diary. A one-week baseline period preceded initiation of study tablets. The primary endpoint was the average intrapatient difference in hot flash score between baseline and treatment termination. With the planned sample size of 50 evaluable patients per arm, the study provided 80% power to detect a difference in change from baseline at 4 weeks between each gabapentin arm and the placebo arm of 1.3 hot flashes per day or 3.3 points in hot flash score. Results: 223 patients were randomized between 12/21/2001 and 11/10/2006. The study arms were well balanced. The following table illustrates the percentage of baseline hot flash scores and frequencies during the fourth treatment week, compared to the baseline week for 179 eligible patients, utilizing the data available at time of this abstract preparation. Patients receiving 900 mg/d dose of gabapentin also reported significantly less hot flash distress and more hot flash control satisfaction than did the placebo group. The gabapentin was remarkably well tolerated, without any statistically significantly worse patient-reported side effects on the gabapentin arms. Conclusion: Gabapentin at the 900 mg/d dose can reduce hot flashes, in men receiving androgen deprivation therapy for prostate cancer. No significant financial relationships to disclose. [Table: see text]

Pilot evaluation of venlafaxine hydrochloride for the therapy of hot flashes in cancer survivors.

1998 ◽  
Vol 16 (7) ◽  
pp. 2377-2381 ◽  
Author(s):  
C L Loprinzi ◽  
T M Pisansky ◽  
R Fonseca ◽  
J A Sloan ◽  
K M Zahasky ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Survivors ◽  
Breast Cancer Survivors ◽  
Low Dose ◽  
Hot Flashes ◽  
Daily Diary ◽  
Clinical Problem ◽  
Baseline Period ◽  
Hot Flash ◽  
Venlafaxine Hydrochloride

PURPOSE Hot flashes can be a prominent clinical problem for breast cancer survivors and men who undergo androgen-deprivation therapy. Anecdotal information suggested a low dose of a relatively new antidepressant, venlafaxine, could abrogate this clinical problem. MATERIALS AND METHODS This study included 28 consecutive assessable patients entered onto a phase II clinical trial. Hot flash data were collected by daily diary questionnaires during a 1-week baseline period and then for 4 weeks, during which time patients received venlafaxine 12.5 mg orally twice daily. RESULTS Fifty-eight percent of patients who completed the study had a greater than 50% reduction in hot flash scores (frequency times severity) during the fourth treatment week as compared with the baseline week. Median weekly hot flash scores were reduced by 55% from baseline during the fourth week of venlafaxine therapy. Therapy was generally well tolerated and appeared to alleviate fatigue, sweating, and trouble sleeping. CONCLUSION Venlafoxine appears to represent an efficacious new method to alleviate hot flashes. Further evaluation of this compound for alleviating hot flashes is indicated.

Pregabalin for hot flashes in women: NCCTG trial N07C1

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 9513-9513
Author(s):  
C. L. Loprinzi ◽  
R. Qin ◽  
P. J. Stella ◽  
K. M. Rowland ◽  
D. L. Graham ◽  
...  
Keyword(s):  
Information Quality ◽  
Type I Error ◽  
Treatment Options ◽  
Hot Flashes ◽  
Baseline Period ◽  
Type I ◽  
Hot Flash ◽  
Double Blinded ◽  
Oral Doses

9513 Background: Hot flashes are a major problem in many women for which better treatment options are needed. Given the known efficacy of gabapentin for decreasing hot flashes, it was decided to evaluate pregabalin, with hopes that it would work better and/or with fewer toxicities. Methods: A three-arm, double-blinded, placebo-controlled randomized trial was developed. Women with bothersome hot flashes (at least 28/week) were randomized to receive either a placebo or target pregabalin oral doses of 75 mg bid or 150 mg bid (starting at 50 mg/d and then increasing the dose at weekly intervals to 50 mg bid, then 75 mg bid, and then, in the higher dose arm, 150 mg bid); patients were treated for 6 weeks. Hot flash numbers and scores (hot flash number times mean severity) were measured using a validated daily hot flash diary. A one-week baseline period preceded initiation of study tablets. The primary endpoint was the average intra-patient difference in hot flash score between baseline and week six, comparing the higher dose pregabalin arm and the placebo arm. With the planned sample size of 55 patients per arm, there was an 80% power and two-sided 5% Type I error rate to detect a difference of 0.54 standard deviations, or 1.08 hot flashes per day, or 2.7 units of hot flash score per day. Results: 207 patients were randomized between 6/20/2008 and 8/21/2008. The study arms were well balanced. Mean/median daily hot flash scores and frequencies for all pts at baseline were 15.7/13.4 and 8.3/7.7, respectively. The table shows the decreases in hot flashes from the baseline to the sixth treatment week. Larger numbers illustrate greater hot flash reductions. Toxicity information, quality of life information, and information regarding the effects of hot flashes on subjective symptoms will be available at the meeting time. Conclusions: Pregabalin reduces hot flashes in women. There appears to be similar effects with both studied doses. [Table: see text] No significant financial relationships to disclose.

Multicenter, Randomized, Cross-Over Clinical Trial of Venlafaxine Versus Gabapentin for the Management of Hot Flashes in Breast Cancer Survivors

2010 ◽  
Vol 28 (35) ◽  
pp. 5147-5152 ◽  
Author(s):  
Louise Bordeleau ◽  
Kathleen I. Pritchard ◽  
Charles L. Loprinzi ◽  
Marguerite Ennis ◽  
Olivera Jugovic ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Survivors ◽  
Patient Preference ◽  
Breast Cancer Survivors ◽  
Negative Mood ◽  
Hot Flashes ◽  
Baseline Period ◽  
Open Label ◽  
Group Sequential ◽  
Hot Flash

Purpose Nonhormonal pharmacologic interventions are recommended for the treatment of hot flashes in breast cancer survivors. Antidepressants and gabapentin have been shown to be both effective and well tolerated; however, it is not clear which is preferred. Patients and Methods This was a group-sequential, open-label, randomized, cross-over trial of 4 weeks of venlafaxine (37.5 mg daily for 7 days followed by 75 mg daily for 21 days) versus gabapentin (300 mg once per day for 3 days, then 300 mg twice per day for 3 days, then 300 mg three times per day for 22 days), with patient preference as the primary outcome. Postmenopausal women with at least 14 bothersome hot flashes per week for the prior month were eligible. A 2-week baseline period and a 2-week tapering/washout time was used before the first and second treatment periods, respectively. Diaries were used to measure hot flashes and potential toxicities throughout the study. Participants completed a preference questionnaire at the end of the study. A predefined Pocock stopping rule was applied. Patient preference and hot flash and toxicity outcomes were compared between treatments. Results Sixty-six patients were randomly assigned, 56 of whom provided a preference (eight dropped out and two had no preference); 18 (32%) preferred gabapentin and 38 (68%) preferred venlafaxine (P = .01). Both agents reduced hot flash scores to a similar extent (66% reduction). Venlafaxine was associated with increased nausea, appetite loss, constipation, and reduced negative mood changes compared with gabapentin, whereas gabapentin was associated with increased dizziness and appetite compared with venlafaxine (all P < .05). Conclusion Breast cancer survivors prefer venlafaxine over gabapentin for treating hot flashes.

Prospective evaluation of vitamin E for hot flashes in breast cancer survivors.

1998 ◽  
Vol 16 (2) ◽  
pp. 495-500 ◽  
Author(s):  
D L Barton ◽  
C L Loprinzi ◽  
S K Quella ◽  
J A Sloan ◽  
M H Veeder ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Vitamin E ◽  
Cancer Survivors ◽  
Breast Cancer Survivors ◽  
Hot Flashes ◽  
Clinical Problem ◽  
Baseline Period ◽  
Similar Reduction ◽  
Hot Flash ◽  
Crossover Analysis

PURPOSE Hot flashes represent a substantial clinical problem for some breast cancer survivors. Although estrogen or progesterone preparations can alleviate these symptoms in many patients, concern remains regarding the use of hormonal preparations in such women. Thus, there is a perceived need for nonhormonal treatments for hot flashes for breast cancer survivors. Based on anecdotal evidence that vitamin E was helpful, we designed a trial to investigate this matter. METHODS We developed and conducted a placebo-controlled, randomized, crossover trial where, after a 1 week baseline period, patients received 4 weeks of vitamin E 800 IU daily, then 4 weeks of an identical-appearing placebo, or vice versa. Diaries were used to measure potential toxicities and hot flashes during the baseline week and the two subsequent 4-week treatment periods. RESULTS The 120 patients evaluated for toxicity failed to show any. The 105 patients who finished the first treatment period showed a similar reduction in hot flash frequencies (25% v 22%; P = .90) for the two study arms. A crossover analysis, however, showed that vitamin E was associated with a minimal decrease in hot flashes (one less hot flash per day than was seen with a placebo) (P < or = .05). At the study end, patients did not prefer vitamin E over the placebo (32% v 29%, respectively). CONCLUSION Although this trial was able to show a statistically significant hot flash reduction with vitamin E compared to a placebo, the clinical magnitude of this reduction was marginal.

scholarly journals Study Assessing the Quality of Quantification of Estrogen Receptor Protein Expression by Immunohistochemistry and Gene Expression in Breast Cancer

2014 ◽  
Vol 2014 ◽  
pp. 1-8 ◽  
Author(s):  
Sas Leen ◽  
Van Laere Steven ◽  
Dierick Anne Marie ◽  
Duwel Valérie ◽  
De Pauw Annemie ◽  
...  
Keyword(s):  
Gene Expression ◽  
Significant Positive Correlation ◽  
Target Genes ◽  
Correlation Coefficients ◽  
Receptor Protein ◽  
Estrogen Receptor Protein ◽  
Positive Correlation ◽  
Esr1 Gene ◽  
Er Positive

Although immunohistochemistry (IHC) is a widely used technique to classify tumors in ER-positive versus ER-negative ones, interlab variabilities can occur. This study aims to investigate the influences of preanalytical and analytical factors on IHC results. For this purpose, the different steps of the preparation of IHC sections and scoring procedures were compared between two participating laboratories and a central lab. There was a significant positive correlation between the IHC results of the participating laboratories and those of the central lab (correlation coefficient > 0.600; P<0.05). Nevertheless, some discordant cases for immunostaining (5.3% for ER and 5.6% for PR) and for scoring (10.5% for PR) occur at site 1. Comparing IHC results with ESR1 gene expression results revealed a significant positive correlation (correlation coefficients > 0.769; P<0.05). PCR results of ER target genes showed some heterogeneity in the ER-signalling pathway. These results suggest that differences in the IHC procedure between these laboratories did not have a big influence on the end result. Nevertheless, discordant cases caused by preanalytical and analytical lab-specific procedures have been identified.

scholarly journals Validity of Four Commercial Bioelectrical Impedance Scales in Measuring Body Fat among Chinese Children and Adolescents

2015 ◽  
Vol 2015 ◽  
pp. 1-8 ◽  
Author(s):  
Lin Wang ◽  
Stanley Sai-chuen Hui
Keyword(s):  
Children And Adolescents ◽  
Body Fat ◽  
Significant Positive Correlation ◽  
Correlation Coefficients ◽  
Bioelectrical Impedance ◽  
Chinese Children ◽  
Fat Percentage ◽  
Positive Correlation ◽  
Model C ◽  
Chinese Children And Adolescents

The aim of the study is to examine the validity in predicting body fat percentage (%BF) of different bioelectrical impedance (BIA) devices among Chinese children and adolescents. A total of 255 Chinese children and adolescents aged 9–19 years old participated in the study. %BF was assessed by BIA scales, namely, Biodynamics-310 (Model A), Tanita TBF-543 (Model B), Tanita BC-545 (Model C), and InBody 520 (Model D). Dual-energy X-ray absorptiometry (DXA) was used as the criterion measurement. Lin’s concordance correlation coefficients of estimated %BF between Model A, Model B, Model C, and DXA showed poor agreements for both genders. Moderate agreements for %BF were found between DXA and Model D measurements. In boys, differences in %BF were found between DXA and Model B and Model C. No significant %BF differences were found between Model A, Model D, and DXA. However, the two BIA analyzers showed a significant positive correlation between the bias and average %BF between BIA and DXA. In girls, differences in %BF were observed between Model B, Model C, Model D, and DXA. Model A and DXA showed no significant differences of %BF; however, the bias and the average %BF between the BIA and DXA had a significant positive correlation. Using embedded equations in BIA devices should be validated in assessing the %BF of Chinese children and adolescents.

A comparison of two methods for evaluating surface properties of the lung

1965 ◽  
Vol 20 (4) ◽  
pp. 782-784 ◽  
Author(s):  
W. F. Howatt ◽  
L. B. Strang
Keyword(s):  
Surface Tension ◽  
Significant Positive Correlation ◽  
Correlation Coefficients ◽  
Stability Index ◽  
Positive Correlation ◽  
Tension Properties ◽  
Fetal Lamb ◽  
Stability Method ◽  
Positive Correlation Coefficient ◽  
Surface Balance

Indices of the surface tension properties of fetal lamb lungs were obtained by the bubble stability method and from direct measurements of a lung extract on a Langmuir-Wilhelmy balance. A comparison of 102 determinations by each method on 31 fetal lamb lungs gave a statistically significant positive correlation coefficient. A comparison of the surface balance index with a pressure-volume deflation index and with gestation and of the bubble stability index with gestation gave statistically significant positive correlation coefficients. Storage by freezing for 21—112 days did not alter either index of surface tension. lung surface tension; measurement of lung surface tension; surface balance; lung bubbles Submitted on October 15, 1964

scholarly journals Heavy Metal Distribution in Street Dust of Urban and Industrial Areas in Jeddah, Saudi Arabia

2012 ◽  
Vol 23 (2) ◽  
pp. 55-75
Author(s):  
Mansour A. Al Ghamdi Mansour A. Al Ghamdi
Keyword(s):  
Heavy Metals ◽  
Saudi Arabia ◽  
Urban Area ◽  
Significant Positive Correlation ◽  
Correlation Coefficients ◽  
Industrial Area ◽  
Street Dust ◽  
Positive Correlation ◽  
Main Streets ◽  
Cu And Zn

The concentrations of heavy metals namely: Pb, Ni, Cd, Cr, Cu, Zn, Fe and Mn were measured in street dust samples. The samples were collected from the urban (Aljamaa district, main streets and substreets) and industrial areas of Jeddah city, Saudi Arabia. The concentrations of the measured metals were significantly higher in the main streets of the urban area than those found in the industrial area and substrates of the urban area. However, Pb was found in the highest levels in industrial area. The concentrations of the individual metals in street dust collected from the main streets and substreets of the urban area and industrial area averaged 70.36, 53.51 and 105.76 µg/g for Pb; 39.71, 24.00 and 27.28 µg/g for Ni; 2.24, 1.32 and 1.57 µg/g for Cd; 72.93, 40.10 and 47.67 µg/g for Cr; 125.52, 83.32 and 93.66 µg/g for Cu; 340.85, 214.10 and 240.50 µg/g for Zn; 10199.42, 7678.84 and 7918.42 µg/g for Fe and 514.15, 389.69 and 400.64 µg/g for Mn, respectively. The ratios of main streets/substreets metal concentration in the urban area were 1.31, 1.65, 1.70, 1.82, 1.51, 1.59, 1.33 and 1.32 for Pb, Ni, Cd, Cr, Cu, Zn, Fe and Mn, respectively. The mean concentrations of measured heavy metals in street dust from both study areas were lower / higher or similar to those detected in other cities of the world. The average concentrations of Cu and Zn in street dust of the main street dusts of the urban area exceeded the permissible limit value of soil. Significant positive correlation coefficients were found between the concentrations of Cr, Cd, Cu and Zn and also between the concentrations of Fe, Mn and Ni, Cr, Cu and Zn in the street dust of the urban area. On the other hand, insignificant positive correlation coefficients were found between the concentrations of Pb and other metals in street dust of the urban area. In the industrial area, significant positive correlation coefficients were found between the concentrations of heavy metals in the street dust.

Influence of Lung Volume on the Airflow-Intensity Relationship

1984 ◽  
Vol 27 (3) ◽  
pp. 430-435 ◽  
Author(s):  
Phillip Schneider ◽  
R. J. Baken
Keyword(s):  
Fundamental Frequency ◽  
Lung Volume ◽  
Significant Positive Correlation ◽  
Correlation Coefficients ◽  
Intrasubject Variability ◽  
Lung Inflation ◽  
Positive Correlation ◽  
Subglottal Pressure

This study reports airflow-intensity relationships observed in crescendo and decrescendo phonations produced at three fundamental frequency levels by l0 men. The purpose of the investigation was to study the possible influence of lung volume on airflow-intensity relationships. Of the 30 decrescendo phonations, 26 showed statistically significant correlation coefficients and none showed significant negative correlations. The crescendo phonations, however, showed greater inter- and intrasubject variability. Of the 30 crescendo phonations, 16 showed statistically significant positive correlation coefficients and 6 showed significant negative correlations. Because lung inflation varied directly with intensity in the decrescendo task and indirectly in the crescendo task, it was concluded that lung volume does influence the consistency and strength of relationship between airflow and intensity. The findings are discussed in terms of the influence of lung volume on the relative contributions of glottal resistance and expiratory force to the regulation of subglottal pressure.

Sign in / Sign up

Export Citation Format

Share Document