Nielsen 2006.
| Study characteristics | ||
| Methods | Study design: parallel randomised controlled trial | |
| Participants |
Inclusion criteria: participants with symptoms of cervical compression, cosmetic discomfort, or subclinical hyperthyroidism (serum thyroid‐stimulating hormone (TSH) 0.10 mU/L, and normal serum thyroxine (T4) and serum triiodothyronine (T3) levels), or a combination Exclusion criteria: participants who were averse to any treatment, younger than 18 years, had nodules suggestive of malignancy, had intrathoracic goitre > 100 mL, had previous 131I therapy, were unable to complete follow‐up, had a 24‐hr thyroid 131I uptake < 20% Diagnostic criteria: the diagnosis was obtained by clinical examination, ultrasonography, and sodium pertechnetate 99 m Tc thyroid scintigraphy Setting: outpatient clinic Age group: adults (> 18 years) Gender distribution: 89% female Country where trial was performed: Denmark |
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| Interventions |
Intervention(s): each participant received 0.3 mg of recombinant human thyrotropin injected intramuscularly, into the gluteal region, 24 hr prior to 131I therapy Comparator(s): placebo injection constituted 1 mL isotonic saline into the gluteal region, 24 hr prior to 131I therapy Duration of intervention: 1 to 2 days Duration of follow‐up: 12 months Run‐in period: none Number of trial centres: 1 |
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| Outcomes | Reported outcome(s) in full text of publication: T3, T4, TSH | |
| Study details |
Trial identifier: NCT00145366 Trial terminated early: no |
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| Publication details |
Language of publication: English Funding: commercial and non‐commercial funding (research grants from The Agnes and Knut Mørk Foundation, Hans Skouby and Wife Emma Skouby Foundation, Dagmar Marshall Foundation, King Christian the X Foundation, Oda Pedersens Research Foundation, Frode V. Nyegaard and Wife Foundation, The Research Foundation of the County of Funen, The Institute of Clinical Research – University of Southern Denmark, The National Thyroid League, The Novo Nordisk Foundation, and The A. P. Møller Relief Foundation Publication status: peer‐reviewed journal |
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| Stated aim for study | Quote: "to evaluate, in a double‐blind, placebo controlled set‐up, the goiter‐reducing effect and adverse effects of prestimulation with 0.3 mg of recombinant human thyrotropin 24 hours prior to 131I therapy, in a homogeneous, well‐characterized group of patients with nontoxic nodular goiter" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "The study was performed in a randomised, placebo controlled double‐blinded set‐up" Comment: no details |
| Allocation concealment (selection bias) | Unclear risk | Comment: no details |
| Blinding of participants and personnel (performance bias) Objective outcomes | Low risk | Quote: "The study was performed in a randomised, placebo controlled double‐blinded set‐up" |
| Blinding of participants and personnel (performance bias) Subjective outcomes | Low risk | Quote: "The study was performed in a randomised, placebo controlled double‐blinded set‐up" |
| Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Quote: "The study was performed in a randomised, placebo controlled double‐blinded set‐up" |
| Blinding of outcome assessment (detection bias) Subjective outcomes | Low risk | Quote: "The study was performed in a randomised, placebo controlled double‐blinded set‐up" |
| Incomplete outcome data (attrition bias) Objective outcomes | Low risk | Quote: "No patient dropped out during the study period" |
| Incomplete outcome data (attrition bias) Subjective outcomes | Low risk | Quote: "No patient dropped out during the study period" |
| Selective reporting (reporting bias) | Low risk | Comment: none detected |
| Other bias | Low risk | Comment: none detected |
—: denotes not reported
Note: where the judgement is 'unclear' and the description is blank, the trial did not report that particular outcome
Gy: Gray; 131I: radioiodine; rhTSH: recombinant human thyrotropin; T3: triiodothyronine;T4: thyroxine; Tc: technetium; TSH: thyroid stimulating hormone; US: ultrasound