Fast 2010.
| Study characteristics | ||
| Methods | Study design: parallel randomised controlled trial | |
| Participants |
Inclusion criteria: non‐pregnant, non‐lactating participants older than 18 yr, with a nontoxic nodular goitre (i.e. thyroid volume more than 28 mL, and two or more nodules larger than 1 cm), and the presence of goitre‐related symptoms (i.e. pressure or cosmetic complaints, or both), or subclinical hyperthyroidism (i.e. serum TSH < 0.30 mU/L and normal serum T4 and T3 levels), or a combination Exclusion criteria: participants with subclinical hyperthyroidism could not have hyperthyroid symptoms necessitating antithyroid drugs or blockers Diagnostic criteria: the diagnostic set‐up included clinical examination, thyroid function tests, 99mTc scintigraphy, and ultrasonography Setting: outpatient clinic Age group: adults (> 18 years) Gender distribution: 87% female Country where trial was performed: Denmark |
|
| Interventions |
Intervention(s): a vial containing 0.9 mg rhTSH was reconstituted to a concentration of 0.1 mg/mL (administered in the gluteal region), followed by a thyroid dose of 50 Gy. RhTSH was given 24 hr, 48 hr, or 72 hr before radioiodine Comparator(s): placebo injection constituted 1 mL isotonic saline, followed by a thyroid dose of 100 Gy. Placebo was given 24 hr, 48 hr, or 72 hr before radioiodine Duration of intervention: 1 to 3 days Duration of follow‐up: 12 months Run‐in period: none Number of trial centres: 1 |
|
| Outcomes | Reported outcome(s) in full text of publication: goitre volume reduction, hospitalisation, goitre‐related symptoms, thyroid function tests, thyroid peroxidase antibodies, TSH receptor antibodies, thyroid size, patient satisfaction (visual analogue scale), prevalence of myxoedema | |
| Study details |
Trial identifier: NCT00275171 Trial terminated early: no |
|
| Publication details |
Language of publication: English Funding: commercial and non‐commercial funding (Novo Nordisk Foundation, The Strategic Research Council at Odense University Hospital, The Agnes and Knut MørkFoundation, The National Thyroid League, The Institute of Clinical Research at University of Southern Denmark, The Hans Skouby and wife Emma Skouby Foundation, Dagmar Marshalls Foundation, Oda Pedersen’s Research Foundation, The Ingemann O. Buck Foundation, The Else Poulsen Memorial Foundation, Desirée and Niels Yde Foundation, and the Danish Agency for Science Technology and Innovation) Publication status: peer‐reviewed journal |
|
| Stated aim for study | Quote: "to evaluate whether a reduced thyroid dose of 50 Gy, in combination with 0.1 mg rhTSH would result in a GVR comparable to that of a conventional dose of 100 Gy without rhTSH stimulation (placebo). Furthermore, the impact of the interval between rhTSH and 131I‐therapy on GVR was examined" | |
| Notes | "Only one of the 60 patients (2%) receiving rhTSH had to be hospitalized for 1 d, whereas hospitalization between 1 and 3 d was required in 14 of the 30 patients (47%) in the placebo group (P < 0.0001 between groups). Importantly, 37 patients in the combined rhTSH group compared with zero in the placebo group could be treated without any post‐therapeutic restrictions (P < 0.0001). The maximum131I‐activity that can be employed without any patient restrictions in Denmark is 200 MBq" | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Quote: "In a two‐factorial design, patients were randomised (by an independent pharmacist) to receive either 0.1 mg of rhTSH (N = 60) followed by a thyroid dose of 50 Gy, or placebo followed by 100 Gy (N = 30). Furthermore, patients were randomised to receive rhTSH or placebo 24, 48, or 72 h before 131I‐therapy" Comment: not enough details |
| Allocation concealment (selection bias) | Unclear risk | Comment: no details |
| Blinding of participants and personnel (performance bias) Objective outcomes | Low risk | Quote from ClinicalTrials.gov: "masking: quadruple (participant, care provider, investigator, outcomes assessor)" |
| Blinding of participants and personnel (performance bias) Subjective outcomes | Low risk | Quote from ClinicalTrials.gov: "masking: quadruple (participant, care provider, investigator, outcomes assessor)" |
| Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Quote from ClinicalTrials.gov: "masking: quadruple (participant, care provider, investigator, outcomes assessor)" |
| Blinding of outcome assessment (detection bias) Subjective outcomes | Low risk | Quote from ClinicalTrials.gov: "masking: quadruple (participant, care provider, investigator, outcomes assessor)" |
| Incomplete outcome data (attrition bias) Objective outcomes | Low risk | Quote: "Of the 93 patients who had signed informed consent, 90 completed the protocol (three patients withdrew their informed consent before randomization)" |
| Incomplete outcome data (attrition bias) Subjective outcomes | Low risk | Quote: "Of the 93 patients who had signed informed consent, 90 completed the protocol (three patients withdrew their informed consent before randomization)" |
| Selective reporting (reporting bias) | Low risk | Comment: data available on ClinicalTrials.gov |
| Other bias | Low risk | Comment: none detected |