Purpose: This study aims to quantify the magnitude of the placebo effect of an injected placebo ("OxyRBX") purporting to have effects similar to those of recombinant human erythropoietin on endurance running performance in "real-world" field-based head-to-head competition settings.
Methods: Fifteen endurance-trained club-level men (mean ± SD: age, 27.5 ± 6.8 yr; body mass index, 22.9 ± 2.0 kg·m) with 10-km personal-best record times of 39.3 ± 4.4 min completed a randomized cross-over study of 3-km races before and after 7-d "control" and "placebo" phases. During the placebo phase, participants self-administered subcutaneous saline injections daily, believing it to be OxyRBX, with no intervention during the control phase. At the start and end of each 7-d phase, 3-km running performance was assessed. Qualitative assessments of participants' perceptions and experiences were recorded throughout and during semistructured interviews on completion.
Results: Race time improved significantly more in response to placebo intervention (9.73 ± 1.96 s faster, P = 0.0005) than in response to control (1.82 ± 1.94 s faster, P = 0.41; Pinteraction = 0.02). In response to placebo, participants reported reductions in physical effort, increased potential motivation, and improved recovery. Beliefs and congruence between positive expectations of the effects of placebo and perceptions of physical change during training also appeared to impact on competitive performance.
Conclusions: Compared to control, the injected placebo improved 3-km race time by 1.2%. This change is of clear sporting relevance but is smaller than the performance improvement elicited by recombinant human erythropoietin administration. Qualitative data suggest that placebo may have improved performance by both reducing perception of effort and increasing potential motivation, in accord with the psychobiological model for exercise performance, and that cognitive and noncognitive processes appear to have influenced placebo response.
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http://dx.doi.org/10.1249/MSS.0000000000000584 | DOI Listing |
Lipids Health Dis
December 2024
Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Bundang Hospital, Seongnam, 13620, Republic of Korea.
Background: Excessive submental fat under the chin is a known aesthetic concern because of its negative impact on facial appearance and psychological well-being. AYP-101 is a newly developed injectable agent containing 93% soybean phosphatidylcholine (SPC) designed to reduce submental fat. We conducted a phase 1 study to evaluate the safety, pharmacokinetic (PK), and lipid profile effects of AYP-101.
View Article and Find Full Text PDFJ Pain
December 2024
The Cheryl Spencer Department of Nursing, Faculty of Social Welfare and Health Sciences, University of Haifa, Mount Carmel, Haifa, Israel. Electronic address:
The within-subject variability (WSV) of pain-intensity reports has gained attention as a predictor of the placebo response but has demonstrated mixed results. We hypothesized that participants' inward- and outward-directed attention will moderate WSV's prediction of the analgesic placebo response. In this sham randomized clinical trial (protocol number NCT05994118); placebo response was induced in chronic back-pain patients (n=113) through a saline injection plus verbal suggestion.
View Article and Find Full Text PDFBMJ Open Ophthalmol
December 2024
Department of Ophthalmology, Oslo University Hospital, Oslo, Norway.
Aims: To assess the feasibility of a study protocol for a randomised controlled trial of zoledronic acid (ZA) as adjuvant therapy for neovascular age-related macular degeneration (nAMD).
Methods: In this 1-year, randomised, double-blinded, placebo-controlled pilot study, nAMD patients were allocated 1:1 to receive intravenous ZA 5 mg or placebo at baseline and after 6 months in addition to intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy following a treat-and-extend regimen. Bevacizumab was the first-line anti-VEGF drug, but eyes with refractory nAMD were switched to aflibercept.
Naunyn Schmiedebergs Arch Pharmacol
December 2024
Department of Biology, Parand Branch, Islamic Azad University, Bahonar Blvd, Tehran, Iran.
The research investigated the capacity of myo-inositol (MI) in order that it improves biochemical markers in serum and follicular fluid and, ultimately, intracytoplasmic sperm injection (ICSI) outcomes of women with PCOS. Sixty infertile patients with PCOS, who were undergoing ovulation induction for ICSI, were randomly divided to two groups. The MI group received 2000 mg myo-inositol + 1 mg folic acid twice a day for 6 weeks with starting the ICSI cycle.
View Article and Find Full Text PDFJ Diabetes Sci Technol
December 2024
Clinical Diabetes, Appetite and Metabolism Laboratory, Garvan Institute of Medical Research, Sydney, NSW, Australia.
Introduction: Two phase 3 randomized controlled studies (ADJUNCT ONE (Clinicaltrials.gov: NCT01836523), ADJUNCT TWO (Clinicaltrials.gov: NCT02098395)) evaluated liraglutide (1.
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