Comparison of the efficacy of 131I versus anti-thyroid drugs in the treatment of hyperthyroidism
| ISRCTN | ISRCTN10856337 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10856337 |
| Secondary identifying numbers | 1.0 |
- 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
Scientific
Sun Yat-sen University
The First Affiliated Hospital
Dongshan Division
Hyperthyroidism Treatment Center
Guangzhou
510080
China
| chendanyun@sohu.com |
Study information
| Study design | Prospective, randomized, open-label, blinded end point study, with intention-to-treat principle. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 131I, anti-thyroid drugs (methimazole and propylthiouracil) |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 01/01/1998 |
| Completion date | 31/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 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
510080
China
Sponsor information
Sun Yat-sen University (China)
University/education
University/education
The First Affiliated Hospital
Guangzhou
510080
China
| chendanyun@sohu.com | |
| Website | http://www.sysu.edu.cn/en/index.html |
"ROR" |
https://ror.org/0064kty71 |
Funders
Funder type
University/education
Sun Yat-sen University (China)
Private sector organisation / Universities (academic only)
Private sector organisation / Universities (academic only)
- Alternative name(s)
- SYSU
- Location
- China
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| 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.
