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Meta-Analysis
. 2012 Jul 11;2012(7):CD007114.
doi: 10.1002/14651858.CD007114.pub2.

Orbital radiotherapy for adult thyroid eye disease

Rathie Rajendram  1 , Catey Bunce, Richard W J Lee, Ana M S Morley
Affiliations
Meta-Analysis

Orbital radiotherapy for adult thyroid eye disease

Rathie Rajendram et al. Cochrane Database Syst Rev. .

Abstract

Background: Thyroid eye disease is an autoimmune inflammatory condition of the orbital and periorbital tissues. Orbital radiotherapy is an anti-inflammatory treatment used in the treatment of active thyroid eye disease. It is administered as an outpatient procedure in 10 to 12 fractionated doses.

Objectives: To assess the effectiveness and adverse events of orbital radiotherapy in thyroid eye disease. The effectiveness was dependent on the level of 'success' of the intervention predefined in each randomised controlled trial (RCT).

Search methods: We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2012, Issue 2), MEDLINE (January 1950 to March 2012), EMBASE (January 1980 to March 2012), Latin American and Caribbean Literature on Health Sciences (LILACS) (January 1982 to March 2012), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not restrict the electronic searches for trials by date or language. We last searched the electronic databases on 12 March 2012. We screened reference lists of reports of included studies, other reviews and book chapters to find additional trials. We contacted trial investigators and experts in the field to identify additionally published studies.

Selection criteria: We included RCTs of orbital radiotherapy versus sham radiotherapy or other interventions enrolling adults, with a minimum of three months' follow-up and an endpoint of two years or less post treatment.

Data collection and analysis: Two review authors independently assessed trial quality and extracted data. Trial authors were contacted for missing data. The risk ratio was used for our primary outcome. For our secondary outcomes, the odds ratio and mean difference were reported where possible.

Main results: We obtained full-text copies of nine potential studies and included five trials with a total of 244 participants in this review. Orbital radiotherapy was compared to sham radiotherapy in two studies and to glucocorticoids in three studies, as a monotherapy or combination therapy. There was heterogeneity (as defined in our protocol) of trial outcome measures. Our primary outcome of a composite score was used in the two trials comparing radiotherapy versus sham radiotherapy and showed a risk ratio of success of 1.92 (95% confidence interval (CI) 1.27 to 2.91) in favour of orbital radiotherapy. The primary outcome was not used in the other three trials.

Authors' conclusions: This review found that orbital radiotherapy is more effective than sham radiotherapy for the treatment of mild-to-moderate thyroid eye disease. In a single trial no difference between radiotherapy and steroid monotherapy was found. A meta-analysis of our secondary outcome of disease severity was not possible but results from individual trials suggest a better outcome with combination treatment with steroids versus steroids alone. No significant changes in quality-of-life scores following treatment with radiotherapy versus alternative treatments were found. Short-term adverse events related to radiotherapy that were reported were local and mild but long-term data were lacking and development of retinal changes following radiotherapy was not reported on.

PubMed Disclaimer

Conflict of interest statement

The three authors (RR, CB, RL) are investigators in an RCT of medical treatment for TED.

Figures

1
1
Results from searching for studies for inclusion in the review.
1.1
1.1. Analysis
Comparison 1 Radiotherapy versus other intervention or sham radiotherapy, Outcome 1 Success ‐ composite outcomes score.
1.3
1.3. Analysis
Comparison 1 Radiotherapy versus other intervention or sham radiotherapy, Outcome 3 NOSPECS improvement at 24 weeks.
1.4
1.4. Analysis
Comparison 1 Radiotherapy versus other intervention or sham radiotherapy, Outcome 4 Clinical Activity Score ‐ change from baseline to 12 months.
2.1
2.1. Analysis
Comparison 2 Radiotherapy plus steroids versus steroids, Outcome 1 Change in total eye score from baseline to 52 weeks.
2.3
2.3. Analysis
Comparison 2 Radiotherapy plus steroids versus steroids, Outcome 3 Ophthalmopathy Index change from baseline to final visit.
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  • doi: 10.1002/14651858.CD007114

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