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

ISRCTN	ISRCTN10856337
DOI	https://doi.org/10.1186/ISRCTN10856337
Protocol serial number	1.0
Sponsor	Sun Yat-sen University (China)
Funder	Sun Yat-sen University (China)

Submission date: 13/12/2007
Registration date: 21/12/2007
Last edited: 08/04/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Dan Yun Chen
Scientific

Sun Yat-sen University
The First Affiliated Hospital
Dongshan Division
Hyperthyroidism Treatment Center
Guangzhou
510080
China

Email	chendanyun@sohu.com

Study information

Primary study design	Interventional
Study design	Prospective, randomized, open-label, blinded end point study, with intention-to-treat principle.
Secondary study design	Randomised controlled trial
Scientific title	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
Study objectives	1. 131I therapy is considered cheaper, safer, simpler to use and has less side effects compared with anti-thyroid drugs 2. Time to cure hyperthyroidism using radioiodine (131I) is shorter compared with anti-thyroid drugs 3. Rate of hypothyroidism when using 131I is low, if carefully dosed
Ethics approval(s)	Approved by the Dongshan Ethics Committee on 22 December 1997.
Health condition(s) or problem(s) studied	Hyperthyroidism
Intervention	Recruitment took place in the province of Guangdong, China. Participants were randomised to the intervention and control groups in equal numbers. Intervention group: Participants received one application of 131I (oral), followed by a second application after 3 months, if the first was unsuccessful. The dose/activity of 131I (in MBq) was estimated using a standard procedure (mass of the lesion or gland, uptake of a test activity after 24 hours) to achieve a gland dose to cure hyperthyroidism. Control group: Administration of an anti-thyroid drug, either methimazole (oral) or propylthiouracil (oral), as needed at a dose aimed at achieving euthyroidism, for at least 18 months. The treatment continued until primary outcome data were collected. If euthyroidism was not achieved, the patient was treated with anti-thyroid drug until the end of the study (98.4 +/- 5.5 months [range: 89 - 108 months]).
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	131I, anti-thyroid drugs (methimazole and propylthiouracil)
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	31/01/2007

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	460
Total final enrolment	460
Key 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%
Key exclusion criteria	1. Severe liver or kidney damage 2. Agranulocytosis 3. Pregnancy or lactation 4. Less than 8 years of age
Date of first enrolment	01/01/1998
Date of final enrolment	31/01/2007

Locations

Countries of recruitment

China

Study participating centre

Sun Yat-sen University

Guangzhou
510080
China

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/02/2009	08/04/2021	Yes	No

Editorial Notes

08/04/2021: Publication reference and total final enrolment added.