Assessment of Placebo Response in Objective and Subjective Outcome Measures in Rheumatoid Arthritis Clinical Trials

Vollert, Jan; Cook, Nancy R.; Kaptchuk, Ted J.; Sehra, Shiv T.; Tobias, Deirdre K; Hall, Kathryn T.

doi:10.1001/jamanetworkopen.2020.13196

Cited by 33 publications

(29 citation statements)

References 31 publications

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“…Although the CAT score of our participants met the minimum of clinical important differences (33) of a 2-unit reduction in both groups, its mean differences was not signi cant between groups (mean difference [95% CI]: 0.57 [-2.5, 3.7]). The CAT score reduction in the placebo group can be explained by placebo effect (34). In contrary to our ndings, Maneechotesuwan et al, studied the effect of simvastatin 20 mg daily versus placebo on sputum in ammatory markers, airway in ammation, and CAT score of 30 patients with stable COPD (35), and found clinically signi cant important reduction in CAT score after statin administration.…”

Section: Discussioncontrasting

confidence: 99%

The effect of atorvastatin on inflammatory markers in sulfur mustard gas induced bronchitis; a randomized double-blinded, placebo-control clinical trial

Momeni

Nazer

Masoompour

et al. 2020

Preprint

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Background: This study was performed to evaluate the anti-inflammatory effect of atorvastatin in patients with chronic bronchitis, exposed to sulfur mustard gas. Methods: In this randomized double-blinded clinical trial we recruited patients with chronic bronchitis after exposure to sulfur mustard gas. Ninety men 45-75 years old diagnosed with chronic bronchitis after exposure to mustard gas during the Iran-Iraq war, were randomly assigned to receive either atorvastatin (40 mg) or placebo once a day for 3 months. The interleukin 6 (IL-6), tumor necrosis factor α (TNF-α), procalcitonin, highly sensitive CRP and COPD assessment test (CAT) score was compared at baseline and after 12 weeks. Results: After consuming atorvastatin for 12 weeks, IL-6 level (mean difference [95%CI]; 0.2[-0.05, 0.5]), TNF-α(mean difference [95%CI]; -0.07[-0.2, 0.07]), high sensitive CRP(mean difference [95%CI] -0.1[-1.2, 0.9]), and procalcitonin (mean difference [95%CI]; 0.003[-0.02, 0.03]) did not change significantly. However, in the placebo group, only IL-6 (mean difference [95%CI]; 0.6[0.2, 1.05]) decreased significantly after 12 weeks, but levels of high sensitive CRP (mean difference [95%CI]; -0.3[-1.4, 0.8]) TNF-α (mean difference [95%CI]; -0.2[-0.34, -0.06]) and procalcitonin (mean difference [95%CI]; 0.02[-0.001, 0.04]) did not change significantly. After 12 weeks, the mean differences in TNF- α, IL-6 level, high sensitive CRP, procalcitonin, and CAT score did not significantly differ between the two groups. Conclusions: The administration of 40 mg atorvastatin for 3 months did not significantly change the inflammatory markers or the quality of life of patients exposed to mustard gas with chronic bronchitis.Trial registration: IRCT, IRCT138904144312N1. Registered 16 August 2014, https://en.irct.ir/trial/4577

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Section: Discussioncontrasting

confidence: 99%

The effect of atorvastatin on inflammatory markers in sulfur mustard gas induced bronchitis; a randomized double-blinded, placebo-control clinical trial

Momeni

Nazer

Masoompour

et al. 2020

Preprint

View full text Add to dashboard Cite

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“…The small sample size makes it difficult to draw conclusions about the performance of either arm, though both subjective and objective measures have been seen to improve in the placebo arms of trials in other conditions. 36 We performed multiple baseline fatigue measurements prior to commencing medications given the subjective nature of fatigue, in line with previous suggestions, 36 though other aspects of the trial design may have influenced the outcomes in the placebo arm. The high level of contact with the study team may have reduced anxiety levels 37 38 ; anxiety is known to moderate fatigue.…”

Section: Discussionmentioning

confidence: 99%

Feasibility of investigating methylphenidate for the treatment of sarcoidosis-associated fatigue (the FaST-MP study): a double-blind, parallel-arm randomised feasibility trial

et al. 2021

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IntroductionSarcoidosis-associated fatigue (SAF) is a common clinical problem with limited treatment options. This study was undertaken to determine the feasibility of performing a definitive trial to determine the clinical efficacy methylphenidate in SAF.MethodsThis was a parallel-arm, double-blind, placebo-controlled randomised controlled feasibility trial enrolling sarcoidosis patients reporting significant fatigue. Patients with a Fatigue Assessment Scale score of more than 21 were randomised to receive up to either 10 mg two times per day methylphenidate or identical placebo capsules two times per day, in a dose escalation fashion, for up to 24 weeks. Outcomes included number of participants eligible and willing to participate, withdrawal rates, adherence rates and ability to maintain blinding.ResultsOf 385 patients screened, 56 (14.5%) were eligible and 23 (41% of eligible patients) were randomised. No withdrawals occurred. One participant in the methylphenidate arm discontinued study medications due to chest pain. The side effect profile was not different between the groups. Median medication adherence rates were 98% and 99% in the methylphenidate and placebo arms, respectively. A greater proportion of participants receiving methylphenidate predicted their allocated treatment while blinded compared with those receiving placebo (93.3% vs 57.1%). The investigator could not predict the treatment allocation. Both groups showed clinically meaningful improvements in fatigue from baseline, although no between-group difference was seen.ConclusionsThe data support the feasibility of performing a double-blind parallel trial powered to determine the clinical efficacy of methylphenidate for SAF, however, a multicentre study will be required.Trial registration numberNCT02643732.

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“…Although the CAT score of our participants met the minimum of clinical important differences [ 33 ] of a 2-unit reduction in both groups, its mean differences was not significant between groups (mean difference [95% CI]: 0.57 [− 2.5, 3.7]). The CAT score reduction in the placebo group can be explained by placebo effect [ 34 ]. In contrary to our findings, Maneechotesuwan et al [ 35 ] studied the effect of simvastatin 20 mg daily versus placebo on sputum inflammatory markers, airway inflammation, and CAT score of 30 patients with stable COPD, and found clinically significant important reduction in CAT score after statin administration.…”

Section: Discussionmentioning

confidence: 99%

The effect of atorvastatin on inflammatory markers in sulfur mustard gas induced bronchitis: a randomized double-blinded, placebo-control clinical trial

et al. 2021

View full text Add to dashboard Cite

Background This study was performed to evaluate the anti-inflammatory effect of atorvastatin in patients with chronic bronchitis, exposed to sulfur mustard gas. Methods In this randomized double-blinded clinical trial we recruited patients with chronic bronchitis after exposure to sulfur mustard gas. Ninety men 45–75 years old diagnosed with chronic bronchitis after exposure to mustard gas during the Iran-Iraq war, were randomly assigned to receive either atorvastatin (40 mg) or placebo once a day for 3 months. The interleukin 6 (IL-6), tumor necrosis factor α (TNF-α), procalcitonin, highly sensitive CRP and COPD assessment test (CAT) score was compared at baseline and after 12 weeks. Results After consuming atorvastatin for 12 weeks, IL-6 level (mean difference [95%CI]; 0.2 [− 0.05, 0.5]), TNF-α (mean difference [95%CI]; − 0.07 [− 0.2, 0.07]), high sensitive CRP (mean difference [95%CI] − 0.1 [− 1.2, 0.9]), and procalcitonin (mean difference [95%CI]; 0.003 [− 0.02, 0.03]) did not change significantly. However, in the placebo group, only IL-6 (mean difference [95%CI]; 0.6 [0.2, 1.05]) decreased significantly after 12 weeks, but levels of high sensitive CRP (mean difference [95%CI]; − 0.3 [− 1.4, 0.8]) TNF-α (mean difference [95%CI]; − 0.2 [− 0.34, − 0.06]) and procalcitonin (mean difference [95%CI]; 0.02 [− 0.001, 0.04]) did not change significantly. After 12 weeks, the mean differences in TNF- α, IL-6 level, high sensitive CRP, procalcitonin, and CAT score did not significantly differ between the two groups. Conclusions The administration of 40 mg atorvastatin for 3 months did not significantly change the inflammatory markers or the quality of life of patients exposed to mustard gas with chronic bronchitis. Trial registration: IRCT, IRCT138904144312N1. Registered 16 August 2014, https://en.irct.ir/trial/4577.

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Assessment of Placebo Response in Objective and Subjective Outcome Measures in Rheumatoid Arthritis Clinical Trials

Cited by 33 publications

References 31 publications

The effect of atorvastatin on inflammatory markers in sulfur mustard gas induced bronchitis; a randomized double-blinded, placebo-control clinical trial

The effect of atorvastatin on inflammatory markers in sulfur mustard gas induced bronchitis; a randomized double-blinded, placebo-control clinical trial

Feasibility of investigating methylphenidate for the treatment of sarcoidosis-associated fatigue (the FaST-MP study): a double-blind, parallel-arm randomised feasibility trial

The effect of atorvastatin on inflammatory markers in sulfur mustard gas induced bronchitis: a randomized double-blinded, placebo-control clinical trial

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