Albino 2010.
| Study characteristics | ||
| Methods | Study design: parallel randomised controlled trial | |
| Participants |
Inclusion criteria: participants had euthyroid goitres larger than 40 mL and either had a contraindication for surgery or declined surgery. None of the participants had previous surgery or treatment with radioiodine. Prior to the treatment, malignancy was excluded by ultrasound‐guided fine needle aspiration biopsy of the dominant and suspect nodules, and by cytology studies. Normal levels of creatinine, transaminases, and fasting glucose, as well as normal electrocardiogram excluded the presence of comorbidities. None of the participants had used amiodarone or iodinated contrast in the past 12 months Exclusion criteria: participants with below normal TSH levels Diagnostic criteria: participants with normal TSH levels, multinodular goitre, and malignancy excluded Setting: outpatients Age group: adults Gender distribution: 91% female Country where trial was performed: Brazil |
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| Interventions |
Intervention(s): 1.0 mL of the solution (0.01 mg or 0.1 mg rhTSH) was intramuscularly injected 24 hr prior to the radioiodine treatment Comparator(s): 1.0 mL isotonic saline was intramuscularly injected 24 hr prior to the radioiodine treatment Duration of intervention: 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: thyroid function tests, TSH receptor antibodies, anti‐thyroperoxidase antibodies (TPOAb), antithyroglobulin antibodies, thyroid volume, tracheal compression, adverse effects (clinical assessment and frequent measures of thyroid hormone levels) | |
| Study details |
Trial identifier: not reported Trial terminated early: no |
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| Publication details |
Language of publication: English Funding: non‐commercial funding Publication status: peer‐reviewed journal |
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| Stated aim for study | Quote: "we assessed the efficacy and safety (including airway compression) of different doses of rhTSH associated with a fixed activity of 131I for treating multinodular goitre" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Quote: "Patients were randomly and consecutively selected from the thyroid outpatient clinic" Quote: "This was a prospective, randomised, double‐blind, placebo‐controlled study" Quote: "Patients were assigned to a previously predefined treatment group by simple randomization" Comment: no details |
| Allocation concealment (selection bias) | Unclear risk | Comment: no details |
| Blinding of participants and personnel (performance bias) Objective outcomes | Low risk | Quote: "Patients and investigators were blind to the treatment throughout the study, including the physicians responsible for the interpretation of the results" |
| Blinding of participants and personnel (performance bias) Subjective outcomes | Low risk | Quote: "Patients and investigators were blind to the treatment throughout the study, including the physicians responsible for the interpretation of the results" |
| Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Quote: "Investigators were blind to the treatment throughout the study, including the physicians responsible for the interpretation of the results" |
| Blinding of outcome assessment (detection bias) Subjective outcomes | Low risk | Quote: "Investigators were blind to the treatment throughout the study, including the physicians responsible for the interpretation of the results" |
| Incomplete outcome data (attrition bias) Objective outcomes | Low risk | Quote: "No case was lost during follow‐up" |
| Incomplete outcome data (attrition bias) Subjective outcomes | Low risk | Quote: "No case was lost during follow‐up" |
| Selective reporting (reporting bias) | Low risk | Comment: none detected |
| Other bias | Low risk | Comment: none detected |