scholarly journals Adverse Events and Perception of Benefit from Duloxetine for Treating Aromatase Inhibitor–Associated Arthralgias

2021 ◽  
Author(s):  
Patrick M Schnell ◽  
Maryam B Lustberg ◽  
N Lynn Henry
Keyword(s):  
Adverse Events ◽  
Aromatase Inhibitor ◽  
Short Form ◽  
Credible Interval ◽  
Self Report ◽  
Musculoskeletal Symptoms ◽  
Favorable Effect ◽  
Low Grade ◽  
Double Blind ◽  
Perceived Benefit

Abstract Background Duloxetine effectively treats aromatase inhibitor–associated musculoskeletal symptoms (AIMSS) in women with breast cancer but causes low-grade toxicities. This secondary analysis examines the relationship between adverse events (AE) and patient-perceived benefit, based on patient self-report that the treatment received was beneficial despite side effects. We hypothesized that duloxetine had a favorable effect on patient-perceived benefit, even among duloxetine-treated patients who experienced AEs and who, had they been treated with placebo, would have experienced none. Methods Principal stratification was used to estimate the effect of duloxetine versus placebo on patient-perceived benefit and FACT-ES functional quality of life (FQOL) in the randomized, double-blind trial SWOG S1202 (n = 289). Subgroups of patients were defined by observed and counterfactual (what would have occurred had they been randomized to the opposite study arm) experiences of AEs and the original primary outcome, reduction of average pain after 12 weeks of ≥ 2 points on the Brief Pain Inventory–Short Form. Results Duloxetine caused an estimated 23.4% (95% credible interval [CI] = 13.4% to 33.7%) of patients to experience an AE even though they would have experienced none on placebo. Those patients remained more likely to report that their received treatment was beneficial than comparable patients assigned placebo (73.3% vs 41.8%, respectively, 95%CI for difference = 15.4 to 47.2 percentage points), though there was no statistically significant effect of duloxetine on FQOL (11.3 vs 9.0, 95%CI for difference = -2.2 to + 6.7). Conclusion Duloxetine resulted in higher patient-perceived benefit, even among those who would have an AE on duloxetine but none on placebo. Treatment of AIMSS with duloxetine should be considered for appropriate patients.

scholarly journals Randomized, Multicenter, Placebo-Controlled Clinical Trial of Duloxetine Versus Placebo for Aromatase Inhibitor–Associated Arthralgias in Early-Stage Breast Cancer: SWOG S1202

2018 ◽  
Vol 36 (4) ◽  
pp. 326-332 ◽  
Author(s):  
N. Lynn Henry ◽  
Joseph M. Unger ◽  
Anne F. Schott ◽  
Louis Fehrenbacher ◽  
Patrick J. Flynn ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adverse Events ◽  
Aromatase Inhibitor ◽  
Pain Score ◽  
Joint Pain ◽  
Early Stage ◽  
Early Stage Breast Cancer ◽  
Phase Iii ◽  
Musculoskeletal Symptoms ◽  
Low Grade

Purpose Adherence to aromatase inhibitor (AI) therapy for early-stage breast cancer is limited by AI-associated musculoskeletal symptoms (AIMSS). Duloxetine is US Food and Drug Administration approved for treatment of multiple chronic pain disorders. We hypothesized that treatment of AIMSS with duloxetine would improve average joint pain compared with placebo. Methods This randomized, double-blind, phase III trial included AI-treated postmenopausal women with early-stage breast cancer and who had average joint pain score of ≥ 4 out of 10 that developed or worsened since AI therapy initiation. Patients were randomly assigned 1:1 to duloxetine or placebo for 13 weeks. The primary end point was average joint pain through 12 weeks, examined using multivariable linear mixed models, adjusted for stratification factors (baseline pain score of 4 to 6 v 7 to 10 and prior taxane use). Clinically significant change in average pain was defined as a ≥ 2-point decrease from baseline. Results Of 299 enrolled patients, 127 patients treated with duloxetine and 128 who received placebo were evaluable for the primary analysis. By 12 weeks, the average joint pain score was 0.82 points lower for patients who received duloxetine compared with those who received placebo (95% CI, −1.24 to −0.40; P = .0002). Similar patterns were observed for worst joint pain, joint stiffness, pain interference, and functioning. Rates of adverse events of any grade were higher in the duloxetine-treated group (78% v 50%); rates of grade 3 adverse events were similar. Conclusion Results of treatment with duloxetine for AIMSS were superior to those of placebo among women with early-stage breast cancer, although it resulted in more frequent low-grade toxicities.

scholarly journals 0740 Quality of Life in Phase 3, Placebo-Controlled, Double-Blind, Randomized Withdrawal Study of JZP-258 in Adults with Narcolepsy with Cataplexy

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A281-A282
Author(s):  
N Foldvary-Schaefer ◽  
M J Thorpy ◽  
Y Dauvilliers ◽  
A Roy ◽  
L Tang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Short Form ◽  
Standard Of Care ◽  
Sodium Oxybate ◽  
Self Report ◽  
Double Blind Study ◽  
Open Label ◽  
Double Blind ◽  
Sf 36

Abstract Introduction Narcolepsy negatively impacts health-related quality of life (HRQoL). Sodium oxybate is a standard of care for the treatment of cataplexy and excessive daytime sleepiness in narcolepsy. JZP-258 is an oxybate product candidate with 92% less sodium. Efficacy and safety of JZP-258 were established in a double-blind randomized withdrawal study in adults with narcolepsy with cataplexy. Methods Participants 18-70 years of age began JZP-258 treatment during a 12-week, open-label, optimized treatment and titration period, followed by a 2-week stable-dose period (SDP). Participants were then randomized to receive placebo or continue JZP-258 treatment during a 2-week, double-blind, randomized withdrawal period (DBRWP). HRQoL assessments included the 36-Item Short Form Health Survey Version 2 (SF-36) and 5-level EuroQoL 5-Dimensions Self-Report Questionnaire (EQ-5D-5L). Results 201 participants enrolled; 134 were randomized and received at least 1 dose of double-blind study medication (efficacy population; placebo, n=65; JZP-258, n=69). Decreased scores (worsening) were observed in participants randomized to placebo compared with participants randomized to continue JZP-258 treatment for the SF-36 physical component summary (median [Q1, Q3], −1.92 [−3.46, 1.73] for placebo and −0.03 [−2.07, 2.41] for JZP-258; nominal P=0.02), SF-36 mental component summary (−1.92 [−6.28, 1.34] for placebo and 1.55 [−1.88, 3.78] for JZP-258; nominal P=0.03), and EQ-5D-5L visual analog scale (−5.00 [−10.0, 5.00] for placebo and 0 [0, 5.00] for JZP-258; nominal P=0.01). No change was observed in the EQ-5D-5L crosswalk index (0 [−0.05, 0.03] for placebo and 0 [−0.01, 0.03] for JZP-258; nominal P=0.39). The overall safety profile of JZP-258 was similar to sodium oxybate. Conclusion HRQoL worsened in those randomized to placebo during DBRWP but remained stable in participants who continued JZP-258 treatment. Support Jazz Pharmaceuticals

Efficacy of a standardised saffron extract (affron®) as an add-on to antidepressant medication for the treatment of persistent depressive symptoms in adults: A randomised, double-blind, placebo-controlled study

2019 ◽  
Vol 33 (11) ◽  
pp. 1415-1427 ◽  
Author(s):  
Adrian L Lopresti ◽  
Stephen J Smith ◽  
Sean D Hood ◽  
Peter D Drummond
Keyword(s):  
Depressive Symptoms ◽  
Outcome Measures ◽  
Short Form ◽  
Self Report ◽  
Secondary Outcome ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Persistent Depression ◽  
Saffron Extract

Background: As a stand-alone intervention, saffron has efficacy for the treatment of mild-to-moderate depression. However, research as an adjunct agent is limited. Aims: The effects of saffron as an adjunct to pharmaceutical antidepressants in adults with persistent depression was investigated. Methods: In this eight-week, randomised, double-blind, placebo-controlled study, adults with persistent depression, currently taking a pharmaceutical antidepressant were given a placebo or a saffron extract (affron®, 14 mg b.i.d.). Primary outcome measures included the clinician-rated Montgomery–Åsberg Depression Rating Scale (MADRS) and self-rated MADRS (MADRS-S). Secondary outcome measures included the Antidepressant Side-Effect Checklist (ASEC) and Short Form-36 Health Survey (SF-36). Results: Of the 160 participants enrolled, 139 provided usable data. Based on the MADRS, depressive symptoms decreased more in participants taking saffron compared with a placebo, with reductions of 41 and 21%, respectively ( p = 0.001). However, scores on the MADRS-S decreased 27 and 26% in the saffron and placebo conditions, respectively ( p = 0.831). Saffron was associated with a greater reduction in adverse effects of antidepressants ( p = 0.019), although this was non-significant after covarying for baseline values ( p = 0.449). Quality of life improved in both groups with no significant between-group differences ( p = 0.638). Conclusion: Adjunctive administration of a standardised saffron extract (affron®) for eight weeks was associated with a greater improvement in depressive symptoms as measured by the clinician-rated MADRS but not the self-report MADRS-S. Given the conflicting results, further research is needed to clarify the clinical benefits of saffron as an adjunctive treatment for adults with persistent depressive symptoms despite antidepressant drug treatment.

Pilot study of modafinil for treatment of neurobehavioral dysfunction and fatigue in adult patients with brain tumors

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 1503-1503 ◽  
Author(s):  
T. A. Kaleita ◽  
D. K. Wellisch ◽  
C. A. Graham ◽  
B. Steh ◽  
P. Nghiemphu ◽  
...  
Keyword(s):  
Adverse Events ◽  
Tumor Therapy ◽  
Depression Scale ◽  
Cns Lymphoma ◽  
Low Grade ◽  
Hamilton Depression Scale ◽  
Open Label ◽  
Double Blind ◽  
Open Label Extension ◽  
Low Incidence

1503 Background: Patients with brain cancer develop neurobehavioral dysfunction and fatigue that compromise their performance of daily activities. We report results from evaluating the efficacy and safety of modafinil treatment for tumor/therapy sequelae in this medically fragile patient population. Methods: Patients: 21–65 years old with primary malignant disease or nonmalignant cerebral tumors treated with neurosurgical resection, radiotherapy, and/or chemotherapy. Clinical Global Impression of Severity ratings of mild to severe attention/memory impairment and/or fatigue. Measures: Trail Making (TM) A and B, Symbol Digit Modalities (SDM), Verbal Fluency (VF), Hamilton Depression Scale (HAM-D), Fatigue Severity Scale (FSS), Visual Analogue Fatigue Scale (VAFS), Modified Fatigue Impact Scale (MFIS). Design: Double-blind dose-controlled randomization (200 or 400 mg/day modafinil in divided doses) 3 wks; Washout 1wk; Open label extension 8 wks. Statistical analyses: Changes from baseline at scheduled visits (1, 3, 4, 8, 12 wks) using paired t-tests or Wilcoxon Signed Rank tests as appropriate. Results: Thirty patients, 63% male, mean age (SD) = 45.3 (11.7) yrs were accrued from 6/03–10/05. Illness severity: moderate 3 (10%), marked 13 (43%), severe 14 (47%). Tumor histology: glioblastoma multiforme 8 (27%), anaplastic glioma 10 (33%), low grade glioma 10 (33%), meningioma 1 (3%), CNS lymphoma 1 (3%). Treatment: neurosurgical resection 93%, radiotherapy 87%, chemotherapy 70%. The table shows relationships of nine variables at baseline and 8 and 12 weeks after initiation of modafinil. Adverse events reported by ≥4 patients: headache 13 (42%); insomnia 8 (26%); dizziness 7 (23%); dry mouth 7 (23%); depressed consciousness 5 (16%); nausea 4 (13%). Conclusions: Results show improvement across cognitive, mood, and fatigue outcome measures. Modafinil was generally well tolerated, with a low incidence of adverse events. Greatest improvements in outcomes were observed 8 wks after baseline. [Table: see text] [Table: see text]

scholarly journals Efficacy of a curcumin extract (Curcugen™) on gastrointestinal symptoms and intestinal microbiota in adults with self-reported digestive complaints: a randomised, double-blind, placebo-controlled study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Adrian L. Lopresti ◽  
Stephen J. Smith ◽  
Alethea Rea ◽  
Shavon Michel
Keyword(s):  
Intestinal Microbiota ◽  
Short Form ◽  
Gastrointestinal Symptoms ◽  
Self Report ◽  
Trial Registration ◽  
Controlled Study ◽  
Double Blind ◽  
Microbial Profile ◽  
Report Data ◽  
Self Report Data

Abstract Background There is preliminary evidence to suggest curcumin can alleviate digestive symptoms in adults with self-reported digestive complaints and irritable bowel syndrome. However, in all these trials, curcumin was used as a component of a multi-herbal combination and there were consistent concerns associated with risk of bias in most studies. The goal of this study was to investigate the effects of a curcumin extract (Curcugen™) on gastrointestinal symptoms, mood, and overall quality of life in adults presenting with self-reported digestive complaints. Moreover, to determine the potential therapeutic mechanisms of action associated with curcumin, its effects on intestinal microbiota and small intestinal bowel overgrowth (SIBO) were examined. Methods In this 8-week, parallel-group, double-blind, randomised controlled trial, 79 adults with self-reported digestive complaints were recruited and randomised to receive either a placebo or 500 mg of the curcumin extract, Curcugen™. Outcome measures included the Gastrointestinal Symptom Rating Scale (GSRS), intestinal microbial profile (16S rRNA), Depression, Anxiety, and Stress Scale – 21 (DASS-21), Short Form-36 (SF-36), and SIBO breath test. Results Based on self-report data collected from 77 participants, curcumin was associated with a significantly greater reduction in the GSRS total score compared to the placebo. There was also a greater reduction in the DASS-21 anxiety score. No other significant between-group changes in self-report data were identified. An examination of changes in the intestinal microbial profile and SIBO test revealed curcumin had no significant effect on these parameters. Curcumin was well-tolerated with no significant adverse events. Conclusions The curcumin extract, Curcugen™, administered for 8 weeks at a dose of 500 mg once daily was associated with greater improvements in digestive complaints and anxiety levels in adults with self-reported digestive complaints. Compared to the placebo, there were no significant changes in intestinal microbiota or SIBO; however, further research using larger samples and testing methods that allow more detailed microbial analyses will be important. An investigation into other potential mechanisms associated with curcumin’s gastrointestinal-relieving effects will also be important such as examining its influence on the intestinal barrier function, inflammation, neurotransmitter activity, and visceral sensitivity. Trial registration Australian New Zealand Clinical Trials Registry, Trial ID. ACTRN12619001236189. Registered 6 September 2019.

Vitamin D and aromatase inhibitor-induced musculoskeletal symptoms (AIMSS): a phase II, double-blind, placebo-controlled, randomized trial

2011 ◽  
Vol 129 (1) ◽  
pp. 107-116 ◽  
Author(s):  
Antonella L. Rastelli ◽  
Marie E. Taylor ◽  
Feng Gao ◽  
Reina Armamento-Villareal ◽  
Shohreh Jamalabadi-Majidi ◽  
...  
Keyword(s):  
Vitamin D ◽  
Randomized Trial ◽  
Aromatase Inhibitor ◽  
Phase Ii ◽  
Musculoskeletal Symptoms ◽  
Double Blind ◽  
Double Blind Placebo

A European Multicenter Randomized Double-blind Placebo-controlled Monotherapy Clinical Trial of Milnacipran in Treatment of Fibromyalgia

2010 ◽  
Vol 37 (4) ◽  
pp. 851-859 ◽  
Author(s):  
JAIME C. BRANCO ◽  
OLOF ZACHRISSON ◽  
SERGE PERROT ◽  
YVES MAINGUY
Keyword(s):  
Short Form ◽  
Fibromyalgia Impact Questionnaire ◽  
European Population ◽  
Self Report ◽  
Primary Efficacy ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Stable Dose ◽  
Responder Analysis ◽  
Sf 36

Objective.This randomized, double-blind, placebo-controlled, multicenter study investigated the efficacy and safety of milnacipran in the treatment of fibromyalgia (FM) in a European population.Methods.Outpatients diagnosed with FM according to 1990 American College of Rheumatology criteria (N = 884) were randomized to placebo (n = 449) or milnacipran 200 mg/day (n = 435) for 17 weeks (4-week dose escalation, 12-week stable dose, 9-day down-titration), followed by a 2-week posttreatment period. The primary efficacy criterion was a 2-measure composite responder analysis requiring patients to achieve simultaneous improvements in pain (≥ 30% improvement from baseline in visual analog scale, 24-hour morning recall) and a rating of “very much” or “much” improved on the Patient Global Impression of Change scale. If responder analysis was positive, Fibromyalgia Impact Questionnaire (FIQ) was included as an additional key primary efficacy measure.Results.At the end of the stable dose period (Week 16), milnacipran 200 mg/day showed significant improvements from baseline relative to placebo in the 2-measure composite responder criteria (p = 0.0003) and FIQ total score (p = 0.015). Significant improvements were also observed in multiple secondary efficacy endpoints, including Short-Form 36 Health Survey (SF-36) Physical Component Summary (p = 0.025), SF-36 Mental Component Summary (p = 0.007), Multidimensional Fatigue Inventory (p = 0.006), and Multiple Ability Self-Report Questionnaire (p = 0.041). Milnacipran was safe and well tolerated; nausea, hyperhidrosis, and headache were the most common adverse events.Conclusion.Milnacipran is an effective and safe treatment for pain and other predominant symptoms of FM. Registered as trial no. NCT00436033.

scholarly journals Treatment of Vertigo: A Randomized, Double-Blind Trial Comparing Efficacy and Safety ofGinkgo bilobaExtract EGb 761 and Betahistine

2014 ◽  
Vol 2014 ◽  
pp. 1-6 ◽  
Author(s):  
Larysa Sokolova ◽  
Robert Hoerr ◽  
Tamara Mishchenko
Keyword(s):  
Adverse Events ◽  
Outcome Measures ◽  
Clinical Global Impression ◽  
Short Form ◽  
Egb 761 ◽  
Efficacy And Safety ◽  
Symptom Scale ◽  
Double Blind ◽  
Treatment Groups ◽  
Disability Scale

A multicenter clinical trial was performed to compare the efficacy and safety ofGinkgo bilobaextract EGb 761 and betahistine at recommended doses in patients with vertigo. One hundred and sixty patients (mean age 58 years) were randomly assigned to double-blind treatment with EGb 761 (240 mg per day) or betahistine (32 mg per day) for 12 weeks. An 11-point numeric analogue scale, the Vertigo Symptom Scale—short form, the Clinical Global Impression Scales and the Sheehan Disability Scale were used as outcome measures. Both treatment groups were comparable at baseline and improved in all outcome measures during the course of treatment. There was no significant intergroup difference with regard to changes in any outcome measure. Numerically, improvements of patients receiving EGb 761 were slightly more pronounced on all scales. Clinical global impression was rated “very much improved” or “much improved” in 79% of patients treated with EGb 761 and in 70% receiving betahistine. With 27 adverse events in 19 patients, EGb 761 showed better tolerability than betahistine with 39 adverse events in 31 patients. In conclusion, the two drugs were similarly effective in the treatment of vertigo, but EGb 761 was better tolerated. This trial is registered with controlled-trials.comISRCTN02262139.

Identification and Utility of a Short Form of the Pediatric Symptom Checklist-Youth Self-Report (PSC-17-Y)

2020 ◽  
Vol 36 (1) ◽  
pp. 56-64
Author(s):  
Paul Bergmann ◽  
Cara Lucke ◽  
Theresa Nguyen ◽  
Michael Jellinek ◽  
John Michael Murphy
Keyword(s):  
Psychosocial Functioning ◽  
Short Form ◽  
Parent Report ◽  
Self Report ◽  
Symptom Checklist ◽  
Factor Analyses ◽  
Youth Self Report ◽  
Confirmatory Factor Analyses ◽  
Pediatric Symptom Checklist ◽  
Exploratory Factor Analyses

Abstract. The Pediatric Symptom Checklist-Youth self-report (PSC-Y) is a 35-item measure of adolescent psychosocial functioning that uses the same items as the original parent report version of the PSC. Since a briefer (17-item) version of the parent PSC has been validated, this paper explored whether a subset of items could be used to create a brief form of the PSC-Y. Data were collected on more than 19,000 youth who completed the PSC-Y online as a self-screen offered by Mental Health America. Exploratory factor analyses (EFAs) were first conducted to identify and evaluate candidate solutions and their factor structures. Confirmatory factor analyses (CFAs) were then conducted to determine how well the data fit the candidate models. Tests of measurement invariance across gender were conducted on the selected solution. The EFAs and CFAs suggested that a three-factor short form with 17 items is a viable and most parsimonious solution and met criteria for scalar invariance across gender. Since the 17 items used on the parent PSC short form were close to the best fit found for any subsets of items on the PSC-Y, the same items used on the parent PSC-17 are recommended for the PSC-Y short form.

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