Bonnema 2007.
| Study characteristics | ||
| Methods | Study design: parallel randomised controlled trial | |
| Participants |
Inclusion criteria: people with a very large nodular goitre, resulting in cervical compression or cosmetic discomfort, or both; surgery was not feasible because of concomitant medical disorders, previous neck surgery, personal aversions, or a combination Exclusion criteria: a history of cardiac failure or ventricular arrhythmias, previous malignant disease, or physical or psychiatric disabilities suggestive of difficulties in adherence to the protocol Diagnostic criteria: the diagnosis was based on clinical examination, ultrasonography, and 99 mTc‐pertechnetate thyroid scintigraphy. Fine‐needle aspiration biopsy of any scintigraphically dominant hypoactive nodule was performed to exclude malignancy Setting: inpatients Age group: adults Gender distribution: 76% female Country where trial was performed: Denmark |
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| Interventions |
Intervention(s): 1.0 mL of the solution (0.3 mg rhTSH) was intramuscularly injected into the gluteal region, 24 hr before 131I therapy Comparator(s): 1.0 mL isotonic saline was intramuscularly injected 24 hr prior to the 131I therapy Duration of intervention: 1 day 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: goitre volume reduction, thyroid function tests, adverse effects (thyroid pain and cervical compression), patient satisfaction, all cause mortality | |
| Study details |
Trial identifier: not reported Trial terminated early: no |
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| Publication details |
Language of publication: English Funding: The Agnes and Knut Mørk Foundation, Hans Skouby’s and Wife Emma Skouby’s Foundation, Dagmar Marshall’s Foundation, King Christian the X’s Foundation, Oda Pedersens Research Foundation, Frode V. Nyegaard and Wife’s 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 the principle of rhTSH stimulated 131I therapy in patients with a very large goiter" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Randomization was performed by an independent pharmacist at the hospital, using a random number generator" |
| 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 |