Nocebo and its importance in clinical practice

Author(s):  
Helen Laycock

The landmark paper discussed in this chapter is ‘When words are painful: unravelling the mechanism of the nocebo effect’, published in 2007 by Benedetti et al. This major review considered the placebo and nocebo effect in a more scientific framework compared to the previous nebulous concept of a placebo as an agent whose only role is was to act as a comparator for controlled trials. By expounding robust evidence, Benedetti added credence to the placebo effect with not just psychological but physiological data acknowledging it as an effective therapeutic action. Furthermore the importance of endogenous opioids and cholecystokinin in the mechanism underlying the relief of pain by placebos was put into sharp relief, giving an intuitive basis and scientific validation to this effect.

Author(s):  
Lesley Bromley

The landmark paper discussed in this chapter is ‘The neurobiology of placebo analgesia: From endogenous opioids to cholecystokinin’, published by Benedetti and Amanzio in 1997. This major review considered the placebo and nocebo effect in a more scientific framework compared to previous treatise of a nebulous concept whose only role is to act as a comparator for controlled trials. By expounding robust evidence, Benedetti and Amanzio added credence to the placebo effect, with not just psychological but also physiological data, acknowledging it as an effective therapeutic action. Furthermore, the importance of endogenous opioids and cholecystokinin in the mechanism of placebo were put into sharp relief, giving an intuitive basis and scientific validation to this effect.


2015 ◽  
Vol 105 (4) ◽  
pp. 357-366 ◽  
Author(s):  
Aditya K. Gupta ◽  
Deanne Daigle ◽  
Maryse Paquet

New therapies for onychomycosis continue to be developed, yet treatments are seldom directly compared in randomized controlled trials. The objective of this study was to compare the rates of mycological cure for oral and topical onychomycosis treatments using network meta-analysis. A systematic review of the literature on onychomycosis treatments published before March 25, 2013, was performed, and data were analyzed using network meta-analysis. Terbinafine, 250 mg, therapy was significantly superior to all treatments except itraconazole, 400 mg, pulse therapy; itraconazole, 200 mg, therapy was significantly superior to fluconazole and the topical treatments; and fluconazole, efinaconazole, ciclopirox, terbinafine nail solution, and amorolfine treatments were significantly superior to only placebo. These results support the superiority of 12-week continuous terbinafine, 250 mg, therapy and itraconazole, 400 mg, pulse therapy (1 week per month for 3 months) while suggesting the equivalence of topical therapies. These results reflect findings from the literature and treatment efficacy observed in clinical practice.


1997 ◽  
Vol 111 (7) ◽  
pp. 611-613 ◽  
Author(s):  
K. W. Ah-See ◽  
N. C. Molony ◽  
A. G. D. Maran

AbstractThere is a growth in the demand for clinical practice to be evidence based. Recent years have seen a rise in the number of randomized controlled clinical trials (RCTS). Such trials while acknowledged as the gold standard for evidence can be difficult to perform in surgical specialities. We have recently identified a low proportion of RCTS in the otolaryngology literature. Our aim was to identify any trend in the number of published RCTS within the ENT literature over a 30-year period and to identify which areas of our speciality lend themselves to this form of study design. A Medline search of 10 prominent journals published between 1966 and 1995 was performed. Two hundred and ninety-six RCTS were identified. Only five were published before 1980. Two hundred (71 per cent) of RCTS were in the areas of otology and rhinology. An encouraging trend is seen in RCTS within ENT literature.


Stroke ◽  
2012 ◽  
Vol 43 (suppl_1) ◽  
Author(s):  
Norine C Foley ◽  
Shelialah Pereira ◽  
Katherine Salter ◽  
Matthew Meyer ◽  
Andrew McClure ◽  
...  

Background and Purpose: While it remains unclear how much therapy patients should receive to maximize motor recovery, specifically during inpatient rehabilitation, recommendations regarding the daily minimum dose of therapy are included in many clinical practice guidelines. Since these documents are evidence-based, we examined the related literature to determine if a specific recommendation could be supported. Methods: Six clinical practice guidelines were retrieved and examined to determine what recommendation, if any, had been made regarding the daily provision of therapy during inpatient rehabilitation. We then identified all studies cited by the guideline authors to support their recommendations. Studies in which treatment was focused on motor recovery, were initiated during inpatient rehabilitation and provided within 3 months of stroke onset were reviewed in greater detail. Study design, details of the therapy contrasts, the duration of scheduled daily therapy (min/day), actual therapy received (min/day), the primary outcome and the results, were noted for each trial. Results: Three of the 6 identified guidelines recommended daily minimum amounts of therapy, ranging from 45 to 60 minutes each day of occupational (OT) and physiotherapy (PT), one made no recommendation, and two made general statements indicating that increased intensity of therapy was either recommended or was not recommended. Among the 6 guidelines, a total of 73 studies had been cited to support the recommendations. Sixteen randomized controlled trials and 2 controlled trials were reviewed in detail. The majority of trials not reviewed further examined treatments provided in the chronic stage of stroke and/or were non-hospital based. Treatment contrasts included comparisons of intensive inpatient rehabilitation vs. standard inpatient therapy or standard inpatient therapy plus additional therapy provided by OT and/or PT vs. standard therapy only. Details of daily therapy either prescribed or received was included in 9 studies. Patients in the control condition received an average of 48 minutes of therapy per day while those in the experimental group received an average of 61% more, or 77 minutes per day. In only 6 (33%) studies did patients in the experimental group perform significantly better on the primary outcome compared with those in the control group. Conclusions: Although included in several best practice guidelines, we believe the evidence base cannot support a specific recommendations related to therapy intensity during inpatient rehabilitation following stroke.


Depression ◽  
2019 ◽  
pp. 345-356
Author(s):  
Chad D. Rethorst

Beginning with epidemiological evidence and moving to randomized controlled trials, researchers have established evidence supporting the effectiveness of exercise in the treatment of depression. This chapter will provide an overview of the benefits of exercise for patients with depression, discuss the challenges clinicians face in using exercise as a treatment in clinical practice, and provide practical advice on exercise prescription. The chapter concludes with a discussion of areas of need for future research, focusing on three areas: identifying strategies to ensure patient adherence with exercise prescriptions, identifying predictors of treatment response that will facilitate a personalized medicine approach to exercise prescription, and the use of exercise as a complementary agent with other depression treatments.


2020 ◽  
Vol 6 (6) ◽  
pp. 385-394
Author(s):  
Miguel Hueso ◽  
Lluís de Haro ◽  
Jordi Calabia ◽  
Rafael Dal-Ré ◽  
Cristian Tebé ◽  
...  

<b><i>Background:</i></b> The 2019 Science for Dialysis Meeting at Bellvitge University Hospital was devoted to the challenges and opportunities posed by the use of data science to facilitate precision and personalized medicine in nephrology, and to describe new approaches and technologies. The meeting included separate sections for issues in data collection and data analysis. As part of data collection, we presented the institutional ARGOS e-health project, which provides a common model for the standardization of clinical practice. We also pay specific attention to the way in which randomized controlled trials offer data that may be critical to decision-making in the real world. The opportunities of open source software (OSS) for data science in clinical practice were also discussed. <b><i>Summary:</i></b> Precision medicine aims to provide the right treatment for the right patients at the right time and is deeply connected to data science. Dialysis patients are highly dependent on technology to live, and their treatment generates a huge volume of data that has to be analysed. Data science has emerged as a tool to provide an integrated approach to data collection, storage, cleaning, processing, analysis, and interpretation from potentially large volumes of information. This is meant to be a perspective article about data science based on the experience of the experts invited to the Science for Dialysis Meeting and provides an up-to-date perspective of the potential of data science in kidney disease and dialysis. <b><i>Key messages:</i></b> Healthcare is quickly becoming data-dependent, and data science is a discipline that holds the promise of contributing to the development of personalized medicine, although nephrology still lags behind in this process. The key idea is to ensure that data will guide medical decisions based on individual patient characteristics rather than on averages over a whole population usually based on randomized controlled trials that excluded kidney disease patients. Furthermore, there is increasing interest in obtaining data about the effectiveness of available treatments in current patient care based on pragmatic clinical trials. The use of data science in this context is becoming increasingly feasible in part thanks to the swift developments in OSS.


2019 ◽  
Vol 33 (10) ◽  
pp. 1586-1595 ◽  
Author(s):  
Marie-Louise Bird ◽  
Tiev Miller ◽  
Louise A Connell ◽  
Janice J Eng

Objective: The aim of this study was to investigate the effectiveness of interventions aimed at moving research evidence into stroke rehabilitation practice through changing the practice of clinicians. Data sources: EMBASE, CINAHL, Cochrane and MEDLINE databases were searched from 1980 to April 2019. International trial registries and reference lists of included studies completed our search. Review methods: Randomized controlled trials that involved interventions aiming to change the practice of clinicians working in stroke rehabilitation were included. Bias was evaluated using RevMan to generate a risk of bias table. Evidence quality was evaluated using GRADE criteria. Results: A total of 16 trials were included (250 sites, 14,689 patients), evaluating a range of interventions including facilitation, audit and feedback, education and reminders. Of which, 11 studies included multicomponent interventions (using a combination of interventions). Four used educational interventions alone, and one used electronic reminders. Risk of bias was generally low. Overall, the GRADE criteria indicated that this body of literature was of low quality. This review found higher efficacy of trials which targeted fewer outcomes. Subgroup analysis indicated moderate-level GRADE evidence (103 sites, 10,877 patients) that trials which included both site facilitation and tailoring for local factors were effective in changing clinical practice. The effect size of these varied (odds ratio: 1.63–4.9). Education interventions alone were not effective. Conclusion: A large range of interventions are used to facilitate clinical practice change. Education is commonly used, but in isolation is not effective. Multicomponent interventions including facilitation and tailoring to local settings can change clinical practice and are more effective when targeting fewer changes.


2011 ◽  
Vol 366 (1572) ◽  
pp. 1905-1912 ◽  
Author(s):  
Klaus Linde ◽  
Margrit Fässler ◽  
Karin Meissner

This article reviews the role of placebo interventions and placebo effects in clinical practice. We first describe the relevance of different perspectives among scientists, physicians and patients on what is considered a placebo intervention in clinical practice. We then summarize how placebo effects have been investigated in randomized controlled trials under the questionable premise that such effects are produced by placebo interventions. We further discuss why a shift of focus from the placebo intervention to the overall therapeutic context is necessary and what research methods can be used for the clinical investigation of the relevance of context effects. In the last part of the manuscript, we discuss why placebo or context effects are seen as positive in clinical practice when they are associated with active treatments, while placebo interventions pose major ethical and professional problems and have to be avoided.


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