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Placebo response

Joseph Ben-Sheetrit, Miriam Peskin, Jeffrey H Newcorn, Yaron Daniely, Liat Shbiro, Ann Rotem, Abraham Weizman, Iris Manor
OBJECTIVE: Several ADHD pharmacological trials reported high placebo response (PR) rates. This study aims to characterize the PR in adult ADHD. METHOD: A retrospective cohort analysis of the placebo arm (140 adults with ADHD, 18-55 yrs, M:F 46.4%-53.6%) of a 6-week randomized, multicenter, double-blind metadoxine study, using Conners' Adult ADHD Rating Scale (CAARS) and the Adult ADHD Self-Report Scale (ASRS), was conducted. RESULTS: Pre-post changes in placebo-treated adults were significant for both the CAARS and ASRS, F(2...
June 1, 2018: Journal of Attention Disorders
Seetal Dodd, Adam J Walker, Alan J M Brnabic, Nancy Hong, Amber Burns, Michael Berk
OBJECTIVES: In the clinical setting, the nocebo phenomenon is where clinical worsening or adverse events occur as a response to a treatment, in a situation in which conditioning from previous treatment exposure and/or expectations of sickness or symptoms lead to sickness and symptoms in a conditioned or expectant individual. The nocebo response may thus be a confounder in clinical treatment and clinical research. There is a need to know how to predict if an individual is likely to be a nocebo responder, and how significant and commonplace the nocebo effect might be...
June 21, 2018: Bipolar Disorders
Sezaneh Haghpanah, Tahereh Zarei, Peyman Eshghi, Omidreza Zekavat, Mohammadreza Bordbar, Mahmood Hoormand, Mehran Karimi
Recently, resveratrol showed induction of γ-globin mRNA synthesis in human erythroid precursors and reducing oxidative stress in red cells of thalassemia patients in many in vitro studies. We aimed to investigate the efficacy and safety of resveratrol, for the first time, in non-transfusion-dependent beta-thalassemia intermedia (B-TI) in Southern Iran. In this double-blind randomized clinical trial, 54 patients with B-TI were investigated during 6 months between October 2016 and March 2017. Patients were randomly allocated into three groups by simple randomization method...
June 21, 2018: Annals of Hematology
Elisabeth M Dykens, Jennifer Miller, Moris Angulo, Elizabeth Roof, Michael Reidy, Hind T Hatoum, Richard Willey, Guy Bolton, Paul Korner
BACKGROUND: Prader-Willi syndrome (PWS) is a genetic neurodevelopmental disorder of life-threatening hyperphagia, obesity, intellectual deficits, compulsivity, and other behavioral problems. The efficacy and safety of i.n. carbetocin, an oxytocin analog, was evaluated in a prospective, randomized, double-blinded trial in adolescents with PWS. METHODS: Eligible patients aged 10-18 years with genetically confirmed PWS were randomized (1:1) to i.n. carbetocin or placebo 3 times daily for 14 days...
June 21, 2018: JCI Insight
Ahmed A Badawy, Samaa A Kasem, Doaa Rashwan, Tarek Al Menesy, Ghada Adel, Ali M Mokhtar, Yasmin A Badawy
BACKGROUND: Short acting inhalational anesthetic (Desflurane) produces emergence agitation (EA) in pediatrics with an incidence up to 80%. The aim of the present study was to examine the role of Gabapentin oral solution in attenuating desflurane associated EA in children after strabismus surgery under general anesthesia. METHODS: Seventy patients, 2-6 years old, scheduled for strabismus surgery were randomly allocated into two groups (35 each); Control group (c): received 5 ml of oral strawberry juice (placebo) and Gabapentin group (G) received 5 mg/Kg gabapentin oral solution in 5 ml strawberry juice, 1 h before anesthesia...
June 20, 2018: BMC Anesthesiology
Robin Emsley, Isaac Nuamah, Srihari Gopal, David Hough, W Wolfgang Fleischhacker
BACKGROUND: It has been proposed that relapse rates after antipsychotic discontinuation may be artificially inflated and that some of these symptom recurrences may be due to rebound or withdrawal phenomena rather than due to illness recurrence. METHODS: Post hoc analysis of data from a relapse-prevention study (conducted from March 2005 to February 2007) of paliperidone palmitate once-monthly (PP1M) versus placebo was conducted to compare the nature of operationally defined relapse events in schizophrenia patients (diagnosed by DSM-IV criteria) experiencing relapses after randomization to placebo (n = 97) with those in patients receiving maintenance PP1M treatment (n = 36)...
June 19, 2018: Journal of Clinical Psychiatry
David J Kazierad, Kristin Chidsey, Veena R Somayaji, Arthur J Bergman, Roberto A Calle
AIMS: To conduct a dose-response assessment of the efficacy and safety of the glucagon receptor antagonist PF-06291874 in adults with type 2 diabetes (T2DM) receiving stable doses of metformin. MATERIALS AND METHODS: This randomized, double-blind, statin-stratified, placebo-controlled, 4-arm, parallel-group study was conducted in patients with T2DM receiving background metformin. After an 8-week, non-metformin oral antidiabetic agent washout period, 206 patients were randomized to placebo or PF-06291874 (30, 60, or 100 mg once daily) for 12 weeks...
June 19, 2018: Diabetes, Obesity & Metabolism
Jacqueline S Birks, Richard J Harvey
BACKGROUND: Alzheimer's disease is the most common cause of dementia in older people. One approach to symptomatic treatment of Alzheimer's disease is to enhance cholinergic neurotransmission in the brain by blocking the action of the enzyme responsible for the breakdown of the neurotransmitter acetylcholine. This can be done by a group of drugs known as cholinesterase inhibitors. Donepezil is a cholinesterase inhibitor.This review is an updated version of a review first published in 1998...
June 18, 2018: Cochrane Database of Systematic Reviews
Guilherme A Ferreira, Leandro C Felippe, Rômulo Bertuzzi, David J Bishop, Emiliano Barreto, Fernando R De-Oliveira, Adriano E Lima-Silva
We examined the effect of acute and chronic sprint interval training (SIT), with or without prior caffeine intake, on levels of exercise-induced inflammatory plasma cytokines [interleukin (IL)-6, IL-10, tumor necrosis factor (TNF)-α]. Twenty physically-active men ingested either a placebo ( n = 10) or caffeine ( n = 10) 1 h before each SIT session(13-s × 30-s sprint/15 s of rest) during six training sessions (2 weeks). The early (before, immediately after, and 45 min after the exercise) and late (24 and 48 h after the exercise) cytokine and creatine kinase (CK) responses were analyzed for the first and last training sessions...
2018: Frontiers in Physiology
Vytautas Jankauskas, Candace Necyk, James Chue, Pierre Chue
Up to 20% of depressed patients demonstrate treatment resistance to one or more adequate antidepressant trials, resulting in a disproportionately high burden of illness. Ketamine is a non-barbiturate, rapid-acting general anesthetic that has been increasingly studied in treatment resistant depression (TRD), typically at sub-anesthetic doses (0.5 mg/kg over 40 min by intravenous infusion). More recent data suggest that ketamine may improve response rates to electroconvulsive therapy (ECT) when used as an adjunct, but also as a sole agent...
2018: Neuropsychiatric Disease and Treatment
Jing Liu, Jin-Jin Lu, Kun Zhou, Jie Wan, Yan Li, Xiao-Yun Cui, Qun Gao, Yan-Chao Huang, Si-Nai Li, Qiao-Zhi Dong, Qian Lin
INTRODUCTION: Heart failure with reduced ejection fraction (HFrEF) is defined as the clinical diagnosis of heart failure (HF) and ejection fraction (EF) ≤40%, which is a severe public healthcare issue and brings a heavy social and economic burden for patients with HFrEF. Chinese herbal medicine (CHM) has a long history in treating HF. Questions concerning the efficacy and acceptability of CHM-related interventions in adult patients with HFrEF led us to use the method of systematic review and network meta-analysis to integrate direct and indirect evidence to create hierarchies for all CHM...
June 19, 2018: BMJ Open
Soo-Kyung Kang, Yeon-Hee Lee, Hyeji Park, Jin Y Ro, Q-Schick Auh
OBJECTIVES: This placebo-controlled randomized double-blinded clinical study assessed the analgesic efficacy of intramuscular morphine in TMD patients with myofascial pain and sex dependent responses of the morphine treatment. SUBJECTS AND METHODS: Men and women with TMD were treated with morphine (1.5 or 5 mg), lidocaine or saline in the masseter muscle. VAS of pain intensity, PPT and PPtol were compared between treatment groups and gender. An additional group was treated with morphine in the trapezius muscle to evaluate the systemic effect of morphine that may reduce pain in the masseter muscle...
June 19, 2018: Oral Diseases
S Singh, M Fumery, W J Sandborn, M H Murad
BACKGROUND: There are limited data to inform positioning of agents for treating moderate-severe Crohn's disease (CD). AIM: We assessed comparative efficacy and safety of first-line (biologic-naïve) and second-line (prior exposure to anti-tumour necrosis factor [TNF]-α) agents) biologic therapy for moderate-severe CD, through a systematic review and network meta-analysis, and appraised quality of evidence (QoE) using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach...
June 19, 2018: Alimentary Pharmacology & Therapeutics
Yong-Gui Yu, Jian Yang, Xin-Hua Cheng, Wei Shang, Bing-Hao Zhao, Fei Zhao, Zhi-Guo Chen, Zhen-Hua Huang
Context/Objective Following acute spinal cord injury (ASCI) in rabbits, subarachnoid space injection of Danshen was performed to protect the neurological damage. In this study, we established rabbit models of spinal cord injury using a modified Allen's method. Design After the operation introducing the injuries, the rabbits were randomized into two different groups, control group (normal saline, NS) and Danshen, a component extracted from Chinese herb, treatment group. Each rabbit was supplied with either the drug or placebo at 0...
June 19, 2018: Journal of Spinal Cord Medicine
Ashley Vena, Andrea King, Royce Lee, Harriet de Wit
INTRODUCTION: Preclinical and clinical evidence suggest that the neuropeptide oxytocin may be of value in treating alcohol use disorder, either by reducing the rewarding effects of alcohol or reducing negative affect induced by alcohol withdrawal. However, the effect of a single dose of oxytocin on subjective and psychomotor responses to alcohol in social drinkers is not known. METHODS: The present study examined the effect of intranasal oxytocin on subjective, behavioral, and physiological responses to a moderate dose of alcohol (0...
June 19, 2018: Alcoholism, Clinical and Experimental Research
Y Chen, K Men, X-F Li, J Li, M Liu, Z-Q Fan
OBJECTIVE: Dipeptidyl peptidase-4 (DPP-4) inhibitors are a new class of oral antidiabetic agents for type 2 diabetes mellitus (T2DM) patients. However, the effects and safety of DPP-4 inhibitors in T2DM patients with renal impairment (RI) remain controversial. Therefore, we conducted this meta-analysis to assess the efficacy and safety of DPP-4 inhibitors in T2DM patients with moderate to severe RI. MATERIALS AND METHODS: The PubMed, Embase, and Web of Science database were searched for published randomized controlled trials (RCTs), which compared DPP-4 inhibitors with placebo or a control regimen...
June 2018: European Review for Medical and Pharmacological Sciences
Hanne Hauger, Christian Mølgaard, Charlotte Mortensen, Christian Ritz, Hanne Frøkiær, Taryn J Smith, Kathryn Hart, Susan A Lanham-New, Camilla T Damsgaard
Background: Low serum 25-hydroxyvitamin D [25(OH)D] has been associated with unfavorable cardiometabolic risk profiles in many observational studies in children, but very few randomized controlled trials have investigated this. Objective: We explored the effect of winter-time cholecalciferol (vitamin D3) supplementation on cardiometabolic risk markers in young, white, 4- to 8-y-old healthy Danish children (55°N) as part of the pan-European ODIN project. Methods: In the ODIN Junior double-blind, placebo-controlled, dose-response trial, 119 children (mean ± SD age: 6...
June 15, 2018: Journal of Nutrition
Bruce E Sands, William J Sandborn, Brian G Feagan, Gary R Lichtenstein, Hongyan Zhang, Richard Strauss, Philippe Szapary, Jewel Johanns, Julian Panes, Severine Vermeire, Christopher D O'Brien, Zijiang Yang, Kirk Bertelsen, Colleen Marano
Background and Aims: Janus kinase (JAK) inhibitors have shown efficacy in ulcerative colitis (UC). We studied the dose-response, efficacy, and safety of peficitinib, an oral JAK inhibitor, in patients with moderate-to-severe UC. Methods: In this Phase 2b, dose-ranging trial, we evaluated peficitinib at 25mg once daily (qd), 75mg qd, 150mg qd, and 75mg twice daily versus placebo for efficacy and safety in 219 patients with moderate-to-severe UC. The primary outcome was peficitinib dose-response at Week 8 with response assessed using Mayo score change from baseline...
June 15, 2018: Journal of Crohn's & Colitis
Suzanne Hoogeveen, Uffe Schjoedt, Michiel van Elk
This study examines the effects of expected transcranial stimulation on the error(-related) negativity (Ne or ERN) and the sense of agency in participants who perform a cognitive control task. Placebo transcranial direct current stimulation was used to elicit expectations of transcranially induced cognitive improvement or impairment. The improvement/impairment manipulation affected both the Ne/ERN and the sense of agency (i.e., whether participants attributed errors to oneself or the brain stimulation device): Expected improvement increased the ERN in response to errors compared with both impairment and control conditions...
June 19, 2018: Journal of Cognitive Neuroscience
Akiko Matsusaki, Masayuki Kaneko, Mamoru Narukawa
In the original publication, the Estimate column with values under Multivariate meta-regression (LOCF) in Table 1 was missed. The corrected table is shown below.
June 19, 2018: Clinical Drug Investigation
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