Examination of overall treatment effect and the proportion attributable to contextual effect in osteoarthritis: meta-analysis of randomised controlled trials

Zou, Kun; Wong, Jean; Abdullah, Norazharuddin Shah; Chen, Xi; Smith, Toby; Doherty, Michael; Zhang, Weiya

doi:10.1136/annrheumdis-2015-208387

Cited by 144 publications

(151 citation statements)

References 27 publications

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“…Indeed, a recent meta-analysis found that nonspecific and contextual effects were responsible for 75% of treatment effects in clinical trials in patients with osteoarthritis. 70 To minimize recall bias, subjects received daily text message reminders to record amount of home practice. We doubt that these messages affected adherence to the home practice, because most subjects (80%) reported at least one full week without any home practice, despite having received the daily text reminders.…”

Section: Discussionmentioning

confidence: 99%

Mindfulness-Based Stress Reduction for Adolescents with Functional Somatic Syndromes: A Pilot Cohort Study

Ali¹,

Weiss²,

Dutton³

et al. 2017

The Journal of Pediatrics

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Objective To assess the feasibility of a Mindfulness-based stress reduction (MBSR) program for adolescents with widespread chronic pain and other functional somatic symptoms, and to make preliminary assessments of its clinical utility. Study design Three cohorts of subjects completed an 8-week MBSR program. Child- and parent-completed measures were collected at baseline and 8 and 12 weeks later. Measures included the Functional Disability Inventory (FDI), the Fibromyalgia/Symptom Impact Questionnaire (FIQR/SIQR), the Pediatric Quality of Life Inventory (PedsQL), the Multidimensional Anxiety Scale (MASC2), and the Perceived Stress Scale (PSS). Subjects and parents were interviewed following the program to assess feasibility. Results Fifteen of 18 subjects (83%) completed the 8-week program. No adverse events occurred. Compared with baseline scores, significant changes were found in mean scores on the FDI (33% improvement, p=0.026), FIQR/SIQR (26% improvement, p=0.03), and MASC2 (child: 12% improvement, p=0.02; parent report: 17% improvement, p=0.03) at 8 weeks. MASC2 scores (child and parent) and PSS scores were significantly improved at 12 weeks. More time spent doing home practice was associated with better outcomes in the FDI and FIQR/SIQR (44% and 26% improvement, respectively). Qualitative interviews indicated that subjects and parents reported social support as a benefit of the MBSR class, as well as a positive impact of MBSR on activities of daily living, and on pain and anxiety. Conclusions MBSR is a feasible and acceptable intervention in adolescents with functional somatic syndromes, and has preliminary evidence for improving functional disability, symptom impact, and anxiety, with consistency between parent and child measures. Trial registration ClinicalTrials.gov: NCT02190474

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Section: Discussionmentioning

confidence: 99%

Mindfulness-Based Stress Reduction for Adolescents with Functional Somatic Syndromes: A Pilot Cohort Study

Ali¹,

Weiss²,

Dutton³

et al. 2017

The Journal of Pediatrics

View full text Add to dashboard Cite

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“…Although placebo effects are greater after invasive interventions such as surgery,31 32 they are also present from non-invasive passive treatments such as inactive ultrasonography and inert gel 33. In exercise studies, where the patient, not the therapist, performs the intervention, placebo effects are less obvious, although attention effects cannot be excluded.…”

Section: Discussionmentioning

confidence: 99%

Exercise therapy versus arthroscopic partial meniscectomy for degenerative meniscal tear in middle aged patients: randomised controlled trial with two year follow-up

et al. 2016

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ObjectiveTo determine if exercise therapy is superior to arthroscopic partial meniscectomy for knee function in middle aged patients with degenerative meniscal tears.DesignRandomised controlled superiority trial.SettingOrthopaedic departments at two public hospitals and two physiotherapy clinics in Norway.Participants140 adults, mean age 49.5 years (range 35.7–59.9), with degenerative medial meniscal tear verified by magnetic resonance imaging. 96% had no definitive radiographic evidence of osteoarthritis.Interventions12 week supervised exercise therapy alone or arthroscopic partial meniscectomy alone.Main outcome measuresIntention to treat analysis of between group difference in change in knee injury and osteoarthritis outcome score (KOOS4), defined a priori as the mean score for four of five KOOS subscale scores (pain, other symptoms, function in sport and recreation, and knee related quality of life) from baseline to two year follow-up and change in thigh muscle strength from baseline to three months.ResultsNo clinically relevant difference was found between the two groups in change in KOOS4 at two years (0.9 points, 95% confidence interval −4.3 to 6.1; P=0.72). At three months, muscle strength had improved in the exercise group (P≤0.004). No serious adverse events occurred in either group during the two year follow-up. 19% of the participants allocated to exercise therapy crossed over to surgery during the two year follow-up, with no additional benefit.ConclusionThe observed difference in treatment effect was minute after two years of follow-up, and the trial's inferential uncertainty was sufficiently small to exclude clinically relevant differences. Exercise therapy showed positive effects over surgery in improving thigh muscle strength, at least in the short term. Our results should encourage clinicians and middle aged patients with degenerative meniscal tear and no definitive radiographic evidence of osteoarthritis to consider supervised exercise therapy as a treatment option.Trial registrationwww.clinicaltrials.gov (NCT01002794).

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“…An effect size of 0.5, or thereabouts, is of considerable clinical value, and comparable to that of many of our commonly used interventions [16]. The same group published a further analysis, in which they used random-effects modelling to calculate the amount of pain relief that could be attributed to placebo (contextual) effects, and how much to the treatment being tested for its effects on pain in OA [17]. They report that on average 75% of the overall treatment effect is due to the contextual factors rather than the specific intervention.…”

Section: The Efficacy and Effectiveness Of Placebo On Pain In Oamentioning

confidence: 98%

The power and value of placebo and nocebo in painful osteoarthritis

Dieppe

Goldingay

Greville-Harris

2016

Osteoarthritis and Cartilage

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This paper reviews some recent advances in our understanding of the effects of sham or dummy interventions on pain and other symptoms in osteoarthritis (OA), and outlines two new approaches to the investigation of placebo and nocebo effects. We argue that the placebo effect provides us with a valuable way of investigating the nature of conditions like OA. For example, by examining which symptoms, biochemical markers or imaging features do or do not respond to placebo, we might learn more about the relationships between pathology and symptoms in OA. Placebo and nocebo effects are positive or negative outcomes resulting from the human interactions and contexts in which healthcare consultations take place. Subtle changes in behaviours and the environments in which consultations take place can have major effects on pain and other symptoms being experienced by people with OA. Nocebo effects are particularly powerful, leading to many health-care professionals (HCPs) causing unintended harm to their clients. Based on our own research, we conclude that beneficial outcomes are most likely to occur when both the (HCP) and the client feel safe and relaxed, and when the experiences of the client are validated by the (HCP). These findings have important implications for clinical practice. We believe that research in this field needs to be 'trans-disciplinary', escaping from the constraints of the purely biomedical, deterministic, positivist paradigm of most medical research. We provide the example of our own work which combines performance studies and scholarship, with psychology and medicine.

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Examination of overall treatment effect and the proportion attributable to contextual effect in osteoarthritis: meta-analysis of randomised controlled trials

Cited by 144 publications

References 27 publications

Mindfulness-Based Stress Reduction for Adolescents with Functional Somatic Syndromes: A Pilot Cohort Study

Mindfulness-Based Stress Reduction for Adolescents with Functional Somatic Syndromes: A Pilot Cohort Study

Exercise therapy versus arthroscopic partial meniscectomy for degenerative meniscal tear in middle aged patients: randomised controlled trial with two year follow-up

The power and value of placebo and nocebo in painful osteoarthritis

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