Cubas 2009.
| Study characteristics | ||
| Methods | Study design:parallel randomised controlled trial | |
| Participants |
Inclusion criteria: people with diagnosis of multinodular goitre; all of them had subclinical hyperthyroidism (which was treated with methimazole), or were euthyroid Exclusion criteria: people had previous surgery, TSH‐suppressive therapy with T4, or radioactive iodine treatment, serious medical conditions Diagnostic criteria: the diagnosis was based on either by palpation or US, and 131I thyroid scintigraphy. US‐guided fine needle aspiration biopsy of suspicious and dominant nodules to exclude malignancy Setting: outpatients Age group: adults Gender distribution: 93% female Country where trial was performed: Brazil |
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| Interventions |
Intervention(s): participants in group A (N = 9)received a single intramuscular dose of 1.0 mL (0.1 mg) of rhTSH; participants in group B (N = 9) received 0.005 mg of rhTSH, also in a single intramuscular injection, 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: 24 months Run‐in period: none Number of trial centres: 1 |
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| Outcomes | Reported outcome(s) in full text of publication: thyroid volume reduction, radioactive iodine uptake, thyroid function tests, adverse effects (hyperthyroidism and thyroid enlargement) | |
| Study details |
Trial identifier: not reported Trial terminated early: no |
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| Publication details |
Language of publication: English Funding: Genzyme do Brasil Publication status: peer‐reviewed journal |
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| Stated aim for study | Quote: "to evaluate whether rhTSH increases the efficacy of a fixed activity of 131I for the treatment of multinodular goitre" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "three treatment protocols were designed and patients were randomly assigned" Comment: not enough details |
| Allocation concealment (selection bias) | Unclear risk | Comment: no details |
| Blinding of participants and personnel (performance bias) Objective outcomes | Low risk | Comment: outcomes unlikely influenced by lack of blinding |
| Blinding of participants and personnel (performance bias) Subjective outcomes | Unclear risk | Comment: no details |
| Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Comment: outcomes unlikely influenced by lack of blinding |
| Blinding of outcome assessment (detection bias) Subjective outcomes | Unclear risk | Comment: no details |
| Incomplete outcome data (attrition bias) Objective outcomes | Low risk | Quote: "In the placebo group, a 71‐year‐old female died 8 months after treatment of complications of an unrelated ischemic cerebral stroke" |
| Incomplete outcome data (attrition bias) Subjective outcomes | Low risk | Quote: "In the placebo group, a 71‐year‐old female died 8 months after treatment of complications of an unrelated ischemic cerebral stroke" |
| Selective reporting (reporting bias) | Low risk | Comment: none detected |
| Other bias | Low risk | Comment: none detected |