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. 2021 Dec 28;2021(12):CD010622. doi: 10.1002/14651858.CD010622.pub2
Study ID  
Albino 2010 Endpoints quoted in trial document(s) (ClinicalTrials.gov, FDA/EMA document, manufacturer's website, published design paper)a,c
Source: NT
Endpoints quoted in publication(s)b,c
Primary outcome measure(s): —
Secondary outcome measure(s): —
Other outcome measure(s): thyroid volume, tracheal compression (tracheal cross‐sectional area), antithyroid antibodies, and thyroid hormones, hypothyroidism
Endpoints quoted in abstract of publication(s)b,c
Primary outcome measure(s): —
Secondary outcome measure(s): —
Other outcome measure(s): thyroid function tests, TSH receptor antibodies, thyroid peroxidase antibodies (TPOAb), antithyroglobulin antibodies, thyroid volume, tracheal compression, adverse effects (clinical assessment and frequent measures of thyroid hormone levels)
Bonnema 2007 Endpoints quoted in trial document(s) (ClinicalTrials.gov, FDA/EMA document, manufacturer's website, published design paper)a,c
Source: NT
Endpoints quoted in publication(s)b,c
Primary outcome measure(s):
1. Permanent hypothyroid
2. Adverse effects related to thyroid pain and cervical compression
Secondary outcome measure(s):
1. Goitre volume reduction
Other outcome measure(s): thyroid function tests, TSH receptor antibodies, thyroid peroxidase antibodies (TPOAb), antithyroglobulin antibodies, patient satisfaction
Endpoints quoted in abstract of publication(s)b,c
Primary outcome measure(s):
1. Adverse effects related to thyroid pain and cervical compression
2. Hypothyroidism
Secondary outcome measure(s):
1. Goitre volume reduction
Other outcome measure(s): thyroid function tests, TSH receptor antibodies, thyroid peroxidase antibodies (TPOAb), antithyroglobulin antibodies, thyroid volume, tracheal compression, adverse effects (clinical assessment and frequent measures of thyroid hormone levels)
Cubas 2009 Endpoints quoted in trial document(s) (ClinicalTrials.gov, FDA/EMA document, manufacturer's website, published design paper)a,c
Source: NT
Endpoints quoted in publication(s)b,c
Primary outcome measure(s):
1. Hypothyroidism
2. Adverse events related to radioiodine treatment
Secondary outcome measure(s):
1. Thyroid volume reduction
Other outcome measure(s): thyroid function tests, thyroglobulin, thyroid volume, adverse effects (clinical assessment and frequent measures of thyroid hormone levels), all cause mortality
Endpoints quoted in abstract of publication(s)b,c
Primary outcome measure(s):
1. Hypothyroidism
2. Hyperthyroidism related to radioiodine treatment
Secondary outcome measure(s):
1. Thyroid volume reduction
Other outcome measure(s): thyroid function tests, thyroglobulin, thyroid volume, adverse effects (clinical assessment and frequent measures of thyroid hormone levels), all cause mortality
Fast 2010 Endpoints quoted in trial document(s) (ClinicalTrials.gov, FDA/EMA document, manufacturer's website, published design paper)a,c
Source:NCT00275171
Primary outcome measure(s):
  1. An intra‐individual comparison of the thyroid 131I‐uptake before and after stimulation with rhTSH /placebo; time frame: 24 and 96 hours after tracer administration

  2. An inter‐individual comparison of the thyroid 131I uptake between those who receive placebo and those who receive rhTSH; time frame: 24 and 96 hours after tracer administration

  3. An estimation of which time interval, injecting rhTSH, that is more favourable before 131I therapy (24 hours, 48 hours, or 72 hours); time frame: 24 and 96 hours after tracer administration

  4. A comparison of the degree of goitre reduction when patients are pre‐stimulated with rhTSH, and receive a thyroid 131I dose of 50 Gy; or when receiving conventional 131I, receiving a thyroid dose of 100 Gy; time frame: 3, 6, 9, and 12 months after 131I therapy


Secondary outcome measure(s):
  1. A registration of adverse effects following rhTSH/placebo; time frame: all adverse effects occurring within one year of follow‐up

  2. Patient satisfaction (visual analogue scale) before, 3 months post 131I therapy, and at the end of follow‐up (1 year); time frame: baseline, 3, and 12 months after 131I therapy

  3. Development of TPOab or TSHRab; time frame: at 12‐month follow‐up

  4. Thyroid function; time frame: at 12‐month follow‐up


Other outcome measure(s): —
Trial results available in trial register: no
Endpoints quoted in publication(s)b,c
Primary outcome measure(s): —
Secondary outcome measure(s): —
Other outcome measure(s): goitre volume reduction, hospitalisation, goitre‐related symptoms, thyroid function tests, thyroid peroxidase antibodies, TSH receptor antibodies, thyroid size, patient satisfaction (visual analogue scale)
Endpoints quoted in abstract of publication(s)b,c
Primary outcome measure(s): —
Secondary outcome measure(s): —
Other outcome measure(s): goitre volume reduction, hospitalisation (according to the official radiation regulation), goitre‐related symptoms, prevalence of myxoedema
Fast 2014 Endpoints quoted in trial document(s) (ClinicalTrials.gov, FDA/EMA document, manufacturer's website, published design paper)a,c
Source: NT
Endpoints quoted in publication(s)b,c
Primary outcome measure(s):
1. The ThyQoL questionnaire contained17 goitre‐specific items and several overall quality‐of life items before and after stimulation with rhTSH or placebo
2. Thyroid function was monitored every three months, until 36 months. Antibodies against the TSH receptor were measured at baseline and repeated at six months
3. Adverse events were continuously monitored, and were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v10.0 or higher
Secondary outcome measure(s):
1. Thyroid volume was monitored by computed tomography (CT) scan of the neck, and performed at baseline, six months, and 36 months following therapy
Other outcome measure(s): thyroid antithyroid antibodies, cross‐sectional area of trachea
Endpoints quoted in abstract of publication(s)b,c
Primary outcome measure(s):
1. The quality of life was improved
2. Permanent hypothyroidism at 3 years
Secondary outcome measure(s):
1. Thyroid volume reduction at 6 mo and 36 mo
Other outcome measure(s): radioiodine uptake, cross‐sectional area of trachea
Nielsen 2006 Endpoints quoted in trial document(s) (ClinicalTrials.gov, FDA/EMA document, manufacturer's website, published design paper)a,c
Source:NCT00145366
Primary outcome measure(s):
1. Permanent hypothyroidism after treatment
2. Adverse effects related to hyperthyroid
Secondary outcome measure(s):
1. Goitre volume reduction
Other outcome measure(s): TSH receptor antibodies, thyroid peroxidase antibodies (TPOAb), antithyroglobulin antibodies, patient satisfaction
Trial results available in trial register: no
Endpoints quoted in publication(s)b,c
Primary outcome measure(s):
1. Permanent hypothyroidism after treatment
2. Adverse effects related to hyperthyroid
Secondary outcome measure(s):
1. Goitre volume reduction
Other outcome measure(s): patient satisfaction
Endpoints quoted in abstract of publication(s)b,c
Primary outcome measure(s): —
Secondary outcome measure(s): —
Other outcome measure(s): —
— denotes not reported
aTrial document(s) refers to all available information from published design papers and sources other than regular publications (e.g. FDA/EMA documents, manufacturer's websites, trial registers).
bPublication(s) refers to trial information published in scientific journals (primary reference, duplicate publications, companion documents, or multiple reports of a primary trial).
cPrimary and secondary outcomes refer to verbatim specifications in publication/records. Unspecified outcome measures refer to all outcomes not described as primary or secondary outcome measures.
EMA: European Medicines Agency; FDA: Food and Drug Administration (US); NT: no trial document available.