- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04686006
Effective Iodide Therapy for Untreated Patients With Graves' Hyperthyroidism Avoiding Thionamide Drugs With Many Side Effects
December 24, 2020 updated by: Ken Okamura, Kyushu University
Effectiveness of Classical Potassium Iodide Therapy for the Treatment of Untreated Patients With Graves' Hyperthyroidism, Avoiding Thionamide Drugs With Serious Side Effects of Agranulocytosis, Liver Injury, Vasculitis, Embryopathy or Frequent Side Effects of Skin Eruption
As the drug treatment of Graves' hyperthyroidism, Plummer reported the effectiveness of excess iodide in 1923 and iodide was used as the therapy for Graves' hyperthyroidism starting from the 1930s.
After the introduction of more potent antithyroid drug, thionamide, most thyroidologists preferred to use thionamide expecting potent antithyroid effect, but some careful thyroidologists continued to prescribe iodide in mild type Graves' hyperthyroidism.
Recently, American and Europe Thyroid Association recommended methylmercaptoimidazole (MMI), one of the potent thionamide drugs, as the first-choice drug for Graves' hyperthyroidism.
However, it became apparent that thionamide has serious side effects such as not only agranulocytosis, but also severe liver injury, MPO-ANCA related vasculitis and embryopathy in the pregnant women.
In Japan, one patient died of thionamide-induced agranulocytosis every year.
The incidence of side effects including minor side effect of drug eruption is more than 10%.
We used to treat the patients with Graves' hyperthyroidism with MMI, as we reported in J Clin Endocrinol Metab 65:719, 1987.
However, many side effects of thionamide prompted us to revive the treatment with classical KI in our outpatient clinic and found that KI was effective in the patients who showed side effects to thionamide, resulting in remission (reported in J Clin Endocrinol Metab 99:3995, 2014).
Therefore, we began to treat the patients without serious complications such as heart failure or arrhythmia, with 100mg KI since 1996 and followed for 180 days.
We were surprised to find that serum thyroid hormone level decreased in all the patients.
Thionamide drugs were added only when euthyroidism could not be achieved by KI alone.
Compared with thionamide, side effect of KI was almost none.
Between 1996 and 2004, about 504 patients were treated with KI and a third of the patients were successfully treated with KI alone and other patients were also successfully treated with the combination of KI and thionamide, suggesting additive effect, or by radioactive iodine therapy.
The long term prognosis of the patients initially treated with KI was almost the same as the patients initially treated with MMI.
Our clinical experience suggested that patients with Graves' hyperthyroidism are also susceptible to excess iodide, as in the cases with Hashimoto thyroiditis, and this suppressive effect of excess iodide on the thyroid gland is a useful information for many patients suffering from Graves' hyperthyroidism and thionamide side effects.
Study Overview
Study Type
Observational
Enrollment (Actual)
504
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 90 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
primary care clinic
Description
Inclusion Criteria: Untreated Graves' hyperthyroidism. (elevated serum free T4 and/or free T3 level, suppressed serum TSH level, positive anti-TSH receoptor antibody and high thyroidal radioactive iodine uptake -
Exclusion Criteria: dropped out patients within 180 days
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Graves disease
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement of thyroid function
Time Frame: 180 days
|
Normalization of serum free T4 level and TSH level during first 180 days on potassium iodide
|
180 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 1996
Primary Completion (Actual)
July 1, 2005
Study Registration Dates
First Submitted
December 22, 2020
First Submitted That Met QC Criteria
December 24, 2020
First Posted (Actual)
December 28, 2020
Study Record Updates
Last Update Posted (Actual)
December 28, 2020
Last Update Submitted That Met QC Criteria
December 24, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KyushuU Iodide 1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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