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Comparison of the efficacy of 131I versus anti-thyroid drugs in the treatment of hyperthyroidism

A 9-year Prospective, Randomized, Open-label, Blinded End point (PROBE) treatment study to compare the efficacy of 131I versus anti-thyroid drugs in the treatment of hyperthyroidism

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10856337
Enrollment
460
Registered
2007-12-21
Start date
1998-01-01
Completion date
Unknown
Last updated
2021-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperthyroidism Nutritional, Metabolic, Endocrine Hyperthyroidism

Interventions

Recruitment took place in the province of Guangdong, China. Participants were randomised to the intervention and control groups in equal numbers. Intervention group: Participants rece

Sponsors

Sun Yat-sen University (China)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed hyperthyroid patients 2. No previous thyroid treatment 3. Elevated levels of a recent set of general serum and thyroid function tests, indication of hyperthyroidism 4. 24-hour uptake of 131I >=40%

Exclusion criteria

Exclusion criteria: 1. Severe liver or kidney damage 2. Agranulocytosis 3. Pregnancy or lactation 4. Less than 8 years of age

Design outcomes

Primary

MeasureTime frame
The outcomes above were assessed at monthly follow-up visits during the first year and then every 3 to 6 months thereafter. Duration of follow-up was 98.4 +/- 5.5 months (range: 89 - 108 months) for participants who were included in both primary and secondary outcomes measures. 1. Euthyroidism 2. Persistent hyperthyroidism 3. Recurrence 4. Clinical hypothyroidism 5. Sbclinical Hypothyroidism

Secondary

MeasureTime frame
The outcomes above were assessed at monthly follow-up visits during the first year and then every 3 to 6 months thereafter. Duration of follow-up was 98.4 +/- 5.5 months (range: 89 - 108 months) for participants who were included in both primary and secondary outcomes measures. 1. Changes in ophthalmopathy and complications 2. Side effects 3. Safety 4. Efficacy

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026