Surgery versus corticosteroid injection for carpal tunnel syndrome (DISTRICTS): an open-label, multicentre, randomised controlled trial

In this large, randomized trial, initial referral to surgery in carpal tunnel syndrome led to better results at 18 months than initial corticosteroid injection. James W. Mold, MD, MPH

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Background: Surgery and corticosteroid injections are established treatments for carpal tunnel syndrome, but the optimal treatment strategy remains unclear. This study aimed to compare starting treatment with surgery versus starting with a corticosteroid injection.

Methods: We conducted an open-label, randomised controlled trial across 31 hospitals in the Netherlands. Eligible patients, diagnosed with carpal tunnel syndrome for at least 6 weeks and confirmed by electrophysiological or sonographic testing, were randomly assigned (1:1) to start treatment with either surgery or an injection via a web-based system. Randomisation was stratified by unilateral or bilateral symptoms, carpal tunnel syndrome with or without concomitant disease as risk factor, and previous ipsilateral injections. If needed, additional treatments were allowed, such as additional injections or surgery. The primary outcome, assessed in the intention-to-treat population, was the proportion of patients who were recovered (defined as a score of less than eight points on the six-item carpal tunnel syndrome scale) at 18 months. The trial was preregistered with the ISRCTN Registry (ISRCTN13164336) and is now completed.

Findings: From Nov 7, 2017, to Nov 4, 2021, 934 participants (545 female and 389 male participants) were included. 468 were randomised to the surgery group and 466 to the injection group. At 18 months, 805 (86%) of 934 participants had primary outcome data. In the surgery group, 243 (61%) of 401 participants had recovered, significantly higher than the 180 (45%) of 404 participants recovered in the injection group (relative risk 1·36; 95% CI 1·19-1·56; p<0·0001). One or more adverse event occurred in 376 (86%) of 436 participants in the surgery group and in 384 (85%) of 453 participants in the injection group. One participant in the surgery group was hospitalised due to complications. No treatment-related deaths were reported.

Interpretation: In patients with carpal tunnel syndrome, initiating treatment with surgery offers a higher chance of recovery after 18 months compared with starting with a corticosteroid injection, even with the possibility of additional interventions.

Funding: The Netherlands Organization for Health Research and Development and Zorgverzekeraars Nederland.

Author/s:

Wijnand A C Palmbergen, Roy Beekman, A Marijne Heeren, Bart F L van Nuenen, Tim W H Alleman, Esther Verstraete, Korné Jellema, Wim I M Verhagen, Leo H Visser, Godard C W de Ruiter, Diederik van de Beek, Corianne A J M de Borgie, Johannes A Bogaards, Rob M A de Bie, Camiel Verhamme, Dutch CTS study group

Glucocorticoids for croup in children

John Bayhi — Tue, 24 Sep 2019 22:49:32 +0000

Date Added:

September 24, 2019

Journal/Publication:

Cochrane Database of Systematic Reviews

Publisher:

The Cochrane Collaboration / John Wiley & Sons, Ltd.

Publication Date:

August 22, 2018

URL:

Glucocorticoids for croup in children

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1002/14651858.CD001955.pub4

Keywords

croup

children

randomized control trial

adolescent

PMID (1):

30133690

MeSH

Randomized Controlled Trials as Topic

Corticosteroids reduce symptoms of croup in children for at least 24 hours. The optimal dose and route have not been established. James W. Mold, MD, MPH

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BACKGROUND:

Glucocorticoids are commonly used for croup in children. This is an update of a Cochrane Review published in 1999 and previously updated in 2004 and 2011.

OBJECTIVES:

To examine the effects of glucocorticoids for the treatment of croup in children aged 0 to 18 years.

SEARCH METHODS:

We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, Issue 2, 2018), which includes the Cochrane Acute Respiratory Infections Group's Specialised Register, Ovid MEDLINE Epub Ahead of Print, In-Process & Other Non-Indexed Citations and Ovid MEDLINE (1946 to 3 April 2018), and Embase (Ovid) (1996 to 3 April 2018, week 14), and the trials registers ClinicalTrials.gov (3 April 2018) and the World Health Organization International Clinical Trials Registry Platform (ICTRP, 3 April 2018). We scanned the reference lists of relevant systematic reviews and of the included studies.

SELECTION CRITERIA:

We included randomised controlled trials (RCTs) that investigated children aged 0 to 18 years with croup and measured the effects of glucocorticoids, alone or in combination, compared to placebo or another pharmacologic treatment. The studies needed to report at least one of our primary or secondary outcomes: change in croup score; return visits, (re)admissions or both; length of stay; patient improvement; use of additional treatments; and adverse events.

DATA COLLECTION AND ANALYSIS:

One author extracted data from each study and another verified the extraction. We entered the data into Review Manager 5 for meta-analysis. Two review authors independently assessed risk of bias for each study using the Cochrane 'Risk of bias' tool and the certainty of the body of evidence for the primary outcomes using the GRADE approach.

MAIN RESULTS:

We added five new RCTs with 330 children. This review now includes 43 RCTs with a total of 4565 children. We assessed most (98%) studies as at high or unclear risk of bias. Compared to placebo, glucocorticoids improved symptoms of croup at two hours (standardised mean difference (SMD) -0.65, 95% confidence interval (CI) -1.13 to -0.18; 7 RCTs; 426 children; moderate-certainty evidence), and the effect lasted for at least 24 hours (SMD -0.86, 95% CI -1.40 to -0.31; 8 RCTs; 351 children; low-certainty evidence). Compared to placebo, glucocorticoids reduced the rate of return visits or (re)admissions or both (risk ratio 0.52, 95% CI 0.36 to 0.75; 10 RCTs; 1679 children; moderate-certainty evidence). Glucocorticoid treatment reduced the length of stay in hospital by about 15 hours (mean difference -14.90, 95% CI -23.58 to -6.22; 8 RCTs; 476 children). Serious adverse events were infrequent. Publication bias was not evident. Uncertainty remains with regard to the optimal type, dose, and mode of administration of glucocorticoids for reducing croup symptoms in children.

AUTHORS' CONCLUSIONS:

Glucocorticoids reduced symptoms of croup at two hours, shortened hospital stays, and reduced the rate of return visits to care. Our conclusions have changed, as the previous version of this review reported that glucocorticoids reduced symptoms of croup within six hours.

Author/s:

Gates, A, Gates, M, Vandermeer, B, Johnson, C, Hartling, L, Johnson, DW, Klassen, TP