Abstract | Background: Objective: Design: Randomized trial. (ClinicalTrials.gov: NCT02319538). Setting: Secondary care hospital in Norway. Patients: 150 patients aged 18 to 79 years with persistent Hashimoto-related symptoms despite euthyroid status while receiving hormone replacement therapy and with serum antithyroid peroxidase (anti-TPO) antibody titers greater than 1000 IU/mL. Intervention: Total thyroidectomy or medical management with hormone substitution to secure euthyroid status in both groups. Measurements: The primary outcome was general health score on the Short Form-36 Health Survey (SF-36) at 18 months. Secondary outcomes were adverse effects of surgery, the other 7 SF-36 subscores, fatigue questionnaire scores, and serum anti-TPO antibody titers at 6, 12, and 18 months. Results: During follow-up, only the surgical group demonstrated improvement: Mean general health score increased from 38 to 64 points, for a between-group difference of 29 points (95% CI, 22 to 35 points) at 18 months. Fatigue score decreased from 23 to 14 points, for a between-group difference of 9.3 points (CI, 7.4 to 11.2 points). Chronic fatigue frequency decreased from 82% to 35%, for a between-group difference of 39 percentage points (CI, 23 to 53 percentage points). Median serum anti-TPO antibody titers decreased from 2232 to 152 IU/mL, for a between-group difference of 1148 IU/mL (CI, 1080 to 1304 IU/mL). In multivariable regression analyses, the adjusted treatment effects remained similar to the unadjusted effects. Limitation: Results are applicable only to a subgroup of patients with Hashimoto disease, and follow-up was limited to 18 months. Conclusion: Total thyroidectomy improved health-related quality of life and fatigue, whereas medical therapy did not. This improvement, along with concomitant elimination of serum anti-TPO antibodies, may elucidate disease mechanisms. Primary Funding Source: Telemark Hospital.
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Authors | Ivar Guldvog, Laurens Cornelus Reitsma, Lene Johnsen, Andromeda Lauzike, Charlotte Gibbs, Eivind Carlsen, Tone Hoel Lende, Jon Kristian Narvestad, Roald Omdal, Jan Terje Kvaløy, Geir Hoff, Tomm Bernklev, Håvard Søiland |
Journal | Annals of internal medicine
(Ann Intern Med)
Vol. 170
Issue 7
Pg. 453-464
(04 02 2019)
ISSN: 1539-3704 [Electronic] United States |
PMID | 30856652
(Publication Type: Journal Article, Randomized Controlled Trial)
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Chemical References |
- Antibodies
- Triiodothyronine
- Iodide Peroxidase
- Thyroxine
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Topics |
- Adolescent
- Adult
- Aged
- Antibodies
(blood)
- Drug Therapy, Combination
- Fatigue
(prevention & control)
- Female
- Follow-Up Studies
- Hashimoto Disease
(immunology, physiopathology, surgery, therapy)
- Hormone Replacement Therapy
- Humans
- Iodide Peroxidase
(immunology)
- Male
- Middle Aged
- Patient Reported Outcome Measures
- Postoperative Complications
- Quality of Life
- Thyroid Gland
(physiology)
- Thyroidectomy
(adverse effects)
- Thyroxine
(therapeutic use)
- Triiodothyronine
(therapeutic use)
- Young Adult
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