The Elastic Ruler: Placebo Responses, Clinical Trials, and Medical Knowledge

Philosophy of Science, Journal Year: 2025, Volume and Issue: unknown, P. 1 - 26

Published: Jan. 16, 2025

Abstract This paper first poses a skeptical challenge to clinical trials in medicine. The efficacy of treatments is measured against placebo; but placebo responses are not constant. They fluctuate with demographic variables, and they seem be increasing over time. We therefore find ourselves measuring the equivalent what Wittgenstein termed an “elastic ruler”. I then propose “skeptical solution” problem. Elastic rulers suitable tools for dynamic, floating networks values, like foreign currency exchanges. can assuage concerns by understanding this way; suggest several practical guidelines doing so.

Language: Английский

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Placebo analgesia in physical and psychological interventions: Systematic review and meta‐analysis of three‐armed trials

European Journal of Pain, Journal Year: 2023, Volume and Issue: 28(4), P. 513 - 531

Published: Nov. 20, 2023

Abstract Background The magnitude of placebo effects from physical and psychological ‘sham’ is unknown but could impact efficacy trials treatment understanding. To quantify effects, this systematic review three‐armed randomised controlled (RCTs) interventions for pain compared outcomes in control intervention non‐exposure arms. Methods RCTs with treatment, intervention, groups were included, enrolling adults any pain. A protocol was pre‐registered (PROSPERO: CRD42023413324), twelve databases searched 2008 to July 2023. Trial methods blinding analysed descriptively risk bias assessed. Meta‐analysis measures at short‐, medium‐ long‐term performed random‐effects models standardised mean differences (SMD).Studies sub‐grouped according type. Results Seventeen included. average short‐term effect small (0.21 SMD, 0.1–0.33 95% CI, p = 0.0002, 1440 participants). It showed no heterogeneity (Tau 2 0.1, I 11%, 0.3), preventing meta‐regression analyses modifiers. However, sub‐group revealed larger manual disabled devices miscellaneous interventions. Overall, analgesia accounted 39% treatments’ effectiveness. No found medium‐term (7 RCTs, 381 participants) or follow‐up (3 173 Conclusions observed has mechanistic methodological implications, though its clinical importance may be limited. Control design affects highlighting the considering methodology RCT interpretation. Review limitations include a number studies sample heterogeneity. Significance This directly quantifies compares them overall By doing so, enhances our understanding their relative contribution trials, susceptibly trial design. poses further questions regarding influence blinding, participant expectations, features therapeutic context. insights provided by carry significance are important interpretation synthesis field.

Language: Английский

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The Perceived Value of Pharmacogenetic Testing in Depression Treatment: Mixed-Methods Results From the PRIME Care Study

Psychiatric Services, Journal Year: 2025, Volume and Issue: unknown

Published: April 16, 2025

This mixed-methods study explored providers' perceptions of the value using pharmacogenetic (PGx) testing in depression treatment after they had used test during a pragmatic clinical trial. Data were drawn from baseline and follow-up surveys (mental health primary care providers; N=217) qualitative interviews (N=61) with trial participants. Pre-post changes agreement statements about PGx testing's examined generalized estimating equations cumulative logit ordinal regression model two time points robust standard errors. Interviews analyzed via rapid analysis. Analyses showed greater at comfort testing, feeling well informed strength evidence base. Mental providers stronger levels compared providers. Interview data indicated that although found also thought was useful only for some patients. Several felt main may be facilitating patient buy-in to trying medication. Overall, this demonstrated that, trial, mental have overall positive its potential utility treatment.

Language: Английский

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Effects of a Wearable-Based Intervention on the Hemiparetic Upper Limb in Persons With Stroke: A Randomized Controlled Trial

Neurorehabilitation and neural repair, Journal Year: 2024, Volume and Issue: unknown

Published: Sept. 27, 2024

Introduction Wearables have emerged as a transformative rehabilitation tool to provide self-directed training in the home. Objective. In this study, we examined efficacy of novel wearable device, “Smart Reminder” (SR), home-based telerehabilitation for hemiparetic upper limb (UL) persons with stroke. Methods Forty stroke survivors from community support groups were randomized (stratified by period after onset and impairment severity) either SR group or sham device group. Participants received 20 hours using pictorial handouts over 4 weeks. addition, all participants wore standard accelerometer 3 each day, 5 times week, outside prescribed training. assessed masked assessor at baseline, post-intervention (week 4), follow-up 8). The outcome measures included Fugl-Meyer Assessment Upper Extremity (FMA-UE), Action Research Arm Test, Motor Activity Log, muscle strength, active range motion amount movement UL, compliance rate Results improved substantially their FMA-UE scores treatment (mean difference = 2.05, P .036) compared Also, adherence was significantly higher, 97%, than group, 82.3% ( .038). Conclusion 4-week program “SR” demonstrated potential improving limb. However, it did not enhance performance affected daily activities. trial registered on ClinicalTrial.gov (URL: http://www.clinicaltrials.gov ) identifier NCT05877183.

Language: Английский

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“Ready-to-use” two-week home exercise program targeting depressive symptoms: pilot study

Frontiers in Psychiatry, Journal Year: 2023, Volume and Issue: 14

Published: Sept. 22, 2023

Exercise is an evidence-based treatment for depressive symptoms, yet it often requires specialised knowledge, equipment, or professional supervision. Lay people in certain contexts, example remote locations under pandemic restrictions, lack these resources and thus cannot use exercise to manage their symptoms. We developed a two-week home program that bypasses barriers tested university students during restrictions. In online study, we recruited 49 participants complete week of baseline symptom monitoring then follow the 2 weeks (6 sessions) at home. The involved aerobic resistance training; each session lasted approximately 45 min. After intervention, reported lower (standardised β = −0.71 [−1.05, −0.38]) anxiety ( id="M2">β −0.87 [−1.19, −0.55]) Although make causal conclusions, our results suggest brief may have potential reduce symptoms young adults.

Language: Английский

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Placebo–Placebo, Nocebo–Nocebo, Placebo–Nocebo, and Nocebo–Placebo Effects: A Review of Eastern and Western Perspectives

Published: May 13, 2024

This study examined placebo and nocebo effects, characterized by classical conditioning, operant expectancy effects. The placebo–placebo nocebo–nocebo effects can be categorized to function independently, including the influence of various factors such as pill color, size, genetics (including other biological factors), branding, demeanor healthcare providers, treatment settings also considering beyond science understandings (spiritual perspective). To enhance understanding optimize outcomes, these under effect follows in dominating pre-dominants nature beliefs ranging respective involuted evolutionary probability occurrence: 1) effect, driven optimistic belief leading pure which divided into double yogic effect; 2) influenced a pessimistic vamamarya 3) placebo–nocebo where optimism counters belief, resulting impure 4) nocebo–placebo undermines that not an individual will go through only one categories discussed here. It is recommended future studies adopt this categorization consider adjusting definitions accommodate Eastern Western (Universal) perspectives.

Language: Английский

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Balancing Placebo Use with Evidence-Based Treatments: The Placebo Effect in Clinical Practice and Research

European Journal of Medical and Health Research, Journal Year: 2024, Volume and Issue: 2(5), P. 107 - 123

Published: Sept. 1, 2024

The placebo effect has notable implications for clinical practice and research, demonstrating its ability to enhance therapeutic outcomes through psychological physiological mechanisms. Evidence shows that placebos can impact treatment responses by influencing patients’ expectations mental states, with mechanisms including neurobiological changes such as endogenous opioid release brain activity alterations. However, their use raises ethical concerns, especially regarding patient trust autonomy. Psychological factors like belief, expectation, mindset play a significant role in efficacy, affecting physical health outcomes. In settings, integrating effects requires careful management care without replacing evidence-based treatments. Ethical integration involves boosting transparently maintaining adherence standards prevent misuse, non-disclosure or substituting proven therapies, which damage Future research aims refine mechanisms, genetic biomarkers—to personalize medicine improve efficacy—and evaluate the long-term of on care. Placebos are essential drug development approval. Placebo-controlled trials help differentiate between active influences. about withholding effective treatments, remain. Guidelines U.S. Food Drug Administration (FDA) European Medicines Agency (EMA) crucial upholding these trials. While offers valuable insights, application must be managed transparency rigor balance benefits high medical practice.

Language: Английский

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Highlights of three metabolites HDL and reduction in blood pressure values after dietary fiber supplementation in overweight and obese normotensive women: a metabolomic study

Metabolomics, Journal Year: 2023, Volume and Issue: 19(12)

Published: Nov. 17, 2023

The prevalence of hypertension and obesity are a worldwide concern.Assess the metabolites profile after intervention with mixed dietary fiber in overweight obese normotensive women.This is randomized double blind placebo-controlled study. Through simple randomization process, two groups were allocated, eleven women (group 1) receiving 12 g thirteen 2) placebo (corn starch) for eight weeks. Anthropometric biochemical tests lifestyle analyzed. As evaluation metabolomics, used 1H NMR. data matrix generated 96 samples 225 variables, which was exported ASCII format "The Unscrumbler" statistics software (version 9.7, CAMO Process).After fiber, significant differences observed between main types metabolites, referring to increase relative peak areas three HDL 4.94 ppm (0.0086*), 1.28 (0 .0337*), 0.88 (0.0224*) an α-glucose metabolite 4.90 (0.0106) reduction systolic blood pressure (SBP) (0.0292*) 7 mmHg reference range group there SBP (0.0118*) 4 choline 3.65 (0.0266*), does not call into question validity these results literature.The synergism functions statistically highlighted contributed prevention women.

Language: Английский

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