An Evaluation of Internal-Mammary-Artery Ligation by a Double-Blind Technic

La, Cobb; Gi, Thomas; Dh, Dillard; Ka, Merendino; Ra, Bruce

doi:10.1056/nejm195905282602204

Cited by 469 publications

(205 citation statements)

References 10 publications

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“…It has not been clearly established that interventions to address triangular fibrocartilage complex variations are better than the natural history owing to varying surgical outcomes [3] and the absence of sham surgery controlled trials. We know from studies on knee arthritis [18] and other conditions [7,22,27] that the placebo affect associated with surgery is very strong and that surgical interventions with entirely subjective outcomes (eg, pain) require sham surgery controls to be certain of their effectiveness. It is possible that the majority of operative interventions for the triangular fibrocartilage complex are no better than regression to the mean, the natural history of wrist symptoms, or the placebo effect.…”

Section: Discussionmentioning

confidence: 99%

Prevalence of Triangular Fibrocartilage Complex Abnormalities Regardless of Symptoms Rise With Age: Systematic Review and Pooled Analysis

Chan

Teunis

Ring

2014

Clin Orthop Relat Res

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Background Triangular fibrocartilage complex abnormalities seem to be more common with age, but the degree to which this is so, and the degree to which the presence of an abnormality is associated with symptoms, are topics of controversy. Questions/purposes We wished to perform a systematic review to determine the prevalence of triangular fibrocartilage complex abnormalities, and to determine if the prevalence of abnormalities are greater with increasing age. In addition, we stratified age groups based on symptoms. Methods We searched MEDLINE, EMBASE, and the Cochrane Library through August 15, 2013. Studies that reported triangular fibrocartilage complex abnormalities by age were included. Fifteen studies including 977 wrists met our criteria and reported a total of 368 (38%) triangular fibrocartilage complex abnormalities. Eight studies included symptomatic patients; the remainder studied cadavers (six studies) or asymptomatic volunteers (one study). Patients were divided into four age groups (\30, 30-49, 50-69, and 70 years and older) for pooled analysis, comparing the proportions of patients with and without abnormalities between groups using chi-square analysis. We also evaluated the proportions after stratifying each age group by symptoms. Results Overall, the prevalence of triangular fibrocartilage complex abnormalities increased with age, from 27% (80/301) in patients younger than 30 years to 49% (130/ 265) in patients 70 years and older (p \ 0.001), odds ratio (OR), 2.7, 95% CI, 1.9-3.8 (p \ 0.001). In asymptomatic patients, triangular fibrocartilage complex prevalence abnormality increased from 15% (24/159) to 49% (129/ 263) in the same age groups (p \ 0.001), OR, 5.4, 95% CI, 3.3-8.9 (p \ 0.001). For symptomatic patients prevalence ranged from 39% (56/142) to 70% (14/20) in patients between 50 and 69 years old (p\0.034), OR, 3.6, 95% CI, 1.3-9.9 (p \ 0.014). Conclusion Triangular fibrocartilage complex abnormalities are common in symptomatic and asymptomatic wrists, and they are increasingly common with age. As in all situations where abnormalities are so common that they may be incidental, we need (1) a reliable and accurate method for determining whether these abnormalities are the cause of symptoms; and (2) evidence that treatment of these abnormalities improves symptoms better than placebo.

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Section: Discussionmentioning

confidence: 99%

Prevalence of Triangular Fibrocartilage Complex Abnormalities Regardless of Symptoms Rise With Age: Systematic Review and Pooled Analysis

Chan

Teunis

Ring

2014

Clin Orthop Relat Res

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“…There have been very few trials involving full skin incision, in both the surgical and placebo arms. In the seminal trials on internal mammary artery ligation 31, 32 a skin incision was made to expose the arteries in all patients but no ligation was made in the placebo group. Similarly, Guyuron and colleagues used a skin incision to expose superficial nerves and muscles, which were cut during the active surgery but, in the placebo group, the integrity of these structures was maintained 33 .…”

Section: Strategies Used To Maintain Blinding In Interventional Placementioning

confidence: 99%

Blinding in trials of interventional procedures is possible and worthwhile

2017

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In this paper, we have used evidence from our earlier review of surgical randomised controlled trials with a placebo arm to show that blinding in trials of interventional procedures is feasible, and that many creative methods can be used to make the active and the placebo procedure as similar as possible. We give examples of ingenious strategies used to simulate the active procedure and make the placebo control indistinguishable from the active treatment. We discuss why it is important to blind of patients, assessors, and caregivers and the types of bias that may occur in interventional trials. Finally, we describe the benefits of blinding, from the obvious ones such as avoiding bias, as well as less evident benefits such as avoiding patient drop out in the control arm.

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“…The surprising result -which the meaning-theories help us appreciate -is that the range of aspects which can have a therapeutic effect is both large and in many cases unintuitive. So for example: the mere number of pills (Blackwell et al 1972;de Craen et al 1999;Moerman 2000), the branding of pills (Branthwaite and Cooper 1981), whether one is given a pill or an injection (Amanzio et al 2001), and the justified belief that one has undergone surgery (Cobb et al 1959;Dimond et al 1960), are just some examples of the different aspects of treatments that have been shown to have therapeutic consequences (See for more references: Koshi and Short 2007;Price et al 2008;StewartWilliams and Podd 2004). That is to say, more pills are better than fewer, branded pills are better than unbranded, injections work better than pills, and the justified belief that one has undergone surgery is itself sufficient for patients to improve.…”

Section: Meaning-theories Of Placebo Demonstrate Which Aspects Of a Tmentioning

confidence: 99%

‘Placebos’ and the logic of placebo comparison

Turner

2011

Biol Philos

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Robin Nunn has argued that we should stop using the terms 'placebo' and 'placebo effect'. I argue in support of Nunn's position by considering the logic of why we perform placebo comparisons. Like all comparisons, placebo comparison is just a case of comparing one thing with another, but it is a mistake, I argue, to think of placebo comparison as a case where something is compared to 'a placebo'. Rather, placebo comparison should be understood as a situation which sets-up the treatment and control groups in a particular way; not as a case involving objects or procedures called 'placebos' employed in order to control for 'placebo effects'.

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An Evaluation of Internal-Mammary-Artery Ligation by a Double-Blind Technic

Cited by 469 publications

References 10 publications

Prevalence of Triangular Fibrocartilage Complex Abnormalities Regardless of Symptoms Rise With Age: Systematic Review and Pooled Analysis

Prevalence of Triangular Fibrocartilage Complex Abnormalities Regardless of Symptoms Rise With Age: Systematic Review and Pooled Analysis

Blinding in trials of interventional procedures is possible and worthwhile

‘Placebos’ and the logic of placebo comparison

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