A prospective, randomized, double-blind, placebo-controlled study of orbital radiotherapy for Graves’ ophthalmopathy

Gorman, Colum A.; Garrity, James A.; Fatourechi, Vahab; Bahn, Rebecca S.; Petersen, Ivy A.; Stafford, Scott L.; Earle, John D.; Forbes, Glenn S.; Kline, Robert W.; Bergstralh, Erik J.; Offord, Kenneth P.; Rademacher, Diana M.; Stanley, Nancy; Bartley, George B.

doi:10.1016/s0161-6420(01)00632-7

Cited by 227 publications

(81 citation statements)

References 35 publications

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“…Orbital radiotherapy has been shown in randomized clinical trials to be effective in improving diplopia (75,76), with the exception of one randomized trial that has questioned its efficacy (77). In general, the administered dose is 20 Gray (Gy) per orbit fractionated in 10 daily doses over 2 weeks (78), but also 1 Gy per week over a 20-week period was shown to be equally effective and better tolerated (79).…”

Section: What To Do If Gcs Fail and Moderate-to-severe Go Is Still Acmentioning

confidence: 99%

THERAPY OF ENDOCRINE DISEASE: Endocrine dilemma: management of Graves’ orbitopathy

Campi

Vannucchi

Salvi

2016

European Journal of Endocrinology

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Management of Graves' orbitopathy (GO) must be based on the correct assessment of activity and severity of the disease. Activity is usually assessed with the Clinical Activity Score, whereas severity is classified according to a European Group On Graves' Orbitopathy (EUGOGO) consensus statement as mild, moderate-to-severe, and sight-threatening. Myopathic and chronic congestive forms are uncommon clinical presentations of GO. Restoration and maintenance of stable euthyroidism are recommended in the presence of GO. In moderate-to-severe disease, steroids have been widely employed and have shown to possess an anti-inflammatory activity, but about 20 -30% of patients are not responsive and present recurrence. Some novel immunosuppressors have already been employed in clinical studies and have shown interesting results, although the lack of randomized and controlled trials suggests caution for their use in clinical practice. Potential targets for therapy in GO are the thyroid-stimulating hormone and the insulin-like growth factor 1 receptor on the fibroblasts, inflammatory cytokines, B and T cells, and the PIK3/mTORC1 signaling cascades for adipogenesis. A recent open study has shown that tocilizumab, an anti-sIL-6R antibody, inactivates GO. Consistent reports on the efficacy of rituximab have recently been challenged by randomized controlled trials. As the main goal of treatment is the well-being of the patient, the therapeutic strategy should be addressed to better suit the patient needs, more than improving one or more biological parameters. The increasing availability of new therapies will expand the therapeutic options for GO patients and allow the clinician to really personalize the treatment to better suit the patients' personal needs.

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Section: What To Do If Gcs Fail and Moderate-to-severe Go Is Still Acmentioning

confidence: 99%

THERAPY OF ENDOCRINE DISEASE: Endocrine dilemma: management of Graves’ orbitopathy

Campi

Vannucchi

Salvi

2016

European Journal of Endocrinology

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“…27,36 -38 The success of blinding in sham radiotherapy studies has been demonstrated by the finding that end point evaluators have been unable to distinguish between patients who had received real or sham radiotherapy. 36 Developing this aspect of radiotherapy clinical studies appears to be of high priority. In addition, adequately reporting future studies is essential.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of the quality of radiotherapy randomized trials for painful bone metastases

Shakespeare

Thiagarajan

Gebski

2005

Cancer

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BACKGROUNDThe quality of randomized radiotherapy studies investigating the palliation of painful bone metastases has been questioned, with some authors recognizing the potential impact of bias on result interpretation. However, there has been no published comprehensive evaluation of quality assessment. The goals of the current study were to evaluate the quality of randomized studies using a validated checklist and to discuss implications and future directions.METHODSThe authors performed a search for studies that could be reliably assessed using the validated quality assessment instrument. Independent assessors scored study quality using the instrument.RESULTSThe median quality score of the 17 identified randomized studies was 1 of 5 (range, 0–3). The majority (71%) of points were awarded for the authors describing the study as “randomized.” The method of randomization and description of withdrawals and dropouts were scored poorly for most studies. None of the studies were awarded points for allocation concealment (blinding). The overall quality was deemed poor (a score of 0–2) for 16 of 17 (94%) studies.CONCLUSIONSThe quality of published randomized evidence comparing efficacy of fractionation schedules for the palliation of bone metastases was suboptimal. As a result of the potential biases present, subjective end points (e.g., retreatment rates) cannot be reliably evaluated. Greater efforts are required by radiation oncology trial groups to improve quality, with a particular focus on developing methods of allocation concealment and comprehensively reporting results. Cancer 2005. © 2005 American Cancer Society.

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“…The authors concluded that this kind of therapy is efficient, but only to treat motility impairment. Gorman et al [28] on the other hand showed no beneficial therapeutic effects of orbital radiotherapy compared to sham-irradiation. In this study, 42 patients with moderate-to-severe Graves's orbitopathy received orbital radiotherapy to only one orbit.…”

Section: Orbital Radiotherapy -Efficacymentioning

confidence: 95%

Rola radioterapii oczodołów w leczeniu orbitopatii tarczycowej — aktualny stan wiedzy

Ruchała¹,

Hernik²,

Zybek

2014

Endokrynologia Polska

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The treatment of Graves' orbitopathy (GO) remains a diagnostic and therapeutic challenge for clinicians worldwide. The elimination of risk factors, such as encouraging smoking cessation and achieving euthyroidism, are the most important and usually sufficient treatment methods in most mild cases. A course of selenium may also be beneficial. High-dose systemic corticosteroid therapy remains the first-line therapy in moderate-to-severe orbitopathy; however in some patients such treatment may be insufficient. Radiotherapy for GO has been used for decades and is considered to be effective in active GO, although less than systemic corticosteroids. Unfortunately, there are only eight randomised studies that may be analysed to assess its true effectiveness and applicability. It has been indicated that radiotherapy affects mainly eye motility and soft tissue changes, with almost no influence on exophthalmos. The combination of these two therapies has proven to be even more effective than either treatment alone, especially in subjects with resistant or recurrent GO. Orbital radiotherapy seems to be a safe procedure with few adverse effects observed long after the therapy. It should be avoided in patients with retinopathy, due to diabetes mellitus and hypertension, and in young subjects (< 35 years old). Orbital radiotherapy, as a safe and generally effective second-line therapy, is used in some countries as a supporting method during the second course of systemic corticosteroid therapy, if the response to the first course is unsatisfactory. StreszczenieLeczenie orbitopatii tarczycowej w przebiegu choroby Gravesa-Basedowa (GO, Graves' orbitopathy) nadal pozostaje dla klinicystów z całe-go świata dużym wyzwaniem terapeutycznym. Modyfikacja czynników ryzyka poprzez zaprzestanie palenia papierosów, wyrównanie hormonalne czy środki działające miejscowo uważane są za najważniejsze, a zarazem najskuteczniejsze metody leczenia w przypadku łagodnej GO. Korzyści może przynieść również stosowanie preparatów selenu. Leczenie dożylne preparatami glikokortykosteroidów pozostaje terapią pierwszego rzutu w przypadku umiarkowanej oraz ciężkiej GO, chociaż u niektórych pacjentów takie leczenie jest niewystarczające. Radioterapia jest stosowana w leczeniu GO od wielu dziesięcioleci i jest uznawana za skuteczną w przypadku aktywnej postaci choroby, jednak dającą gorsze wyniki niż systemowa terapia glikokortykosteroidami. Aktualnie dostępnych jest jedynie 8 randomizowanych prac, które dostarczają rzetelnych informacji do analizy skuteczności i radioterapii w GO. Wykazano, że efektem radioterapii jest głównie zwiększenie ruchomości gałek ocznych oraz pozytywny wpływ na zmiany patologiczne tkanek miękkich oczodołu, bez istotnego wpływu na stopień wytrzeszczu. Połączenie obu metod leczenia okazało się być bardziej efektywne niż każda z terapii zastosowana osobno, szczególnie w przypadku opornej bądź nawracającej GO. Radioterapia oczodołów wydaje się metodą bezpieczną, obarczoną niewielkim ryzykiem działań niepożądanych, pojawiających s...

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A prospective, randomized, double-blind, placebo-controlled study of orbital radiotherapy for Graves’ ophthalmopathy

Cited by 227 publications

References 35 publications

THERAPY OF ENDOCRINE DISEASE: Endocrine dilemma: management of Graves’ orbitopathy

THERAPY OF ENDOCRINE DISEASE: Endocrine dilemma: management of Graves’ orbitopathy

Evaluation of the quality of radiotherapy randomized trials for painful bone metastases

Rola radioterapii oczodołów w leczeniu orbitopatii tarczycowej — aktualny stan wiedzy

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