Methods |
1. Generation of allocation sequence: No description
2. Allocation concealment: No description
3. Blinding: Double‐blinding
4. Sample size calculation: No description
5. Loss to follow‐up: 3 (during the first
study period) 6. Intention‐to‐treat analysis:
No description 7. Similarity between groups:
Yes |
Participants |
1. Inclusion criteria: Women with SH ‐ FT4, T3, T4
normal serum levels; TSH response (delta TSH > 30 mU/L) upon TRH
administration. 2. Exclusion criteria:
Cardiovascular disease 3. Characteristics (Age
(mean (SD)), gender, ethnicity, other): Women, aged
51‐73 years |
Interventions |
1. Intervention in experimental group (including number of patients,
dosage, mode of administration, duration of treatment):
L‐thyroxine tablets 50 mcg daily for the first 2 weeks,
100 mcg daily for the next 2 weeks, and 150 mcg daily for the rest of the
study period. 2. Intervention in control group 1 (including
number of patients, dosage, mode of administration, duration of treatment):
Placebo tablets |
Outcomes |
1. Symptoms: Physical tiredness, mental lethargy, dry skin,
cold intolerance, dry hair and constipation. 2. Clinical
neurological examination: Psychometric tests
1‐ Identical forms test according to Thurstone
2 ‐ Bingley's memory test 3 ‐
Reaction time 3. Cardiac function: Systolic time
intervals LVET, PEP, PEP/LVET, pulse rate 4. Creatine kinase
activity 5. Procollagen‐III‐peptide
6. Sex‐hormone binding globulin 7. Thyroid
Hormones 8. Cholesterol |
Notes |
1. Setting: Göteborg, Sweden 2. Funding
source: Supported by grants from "Torsten Söderbergs
och Ragnar Söderbergs stiftelse" and the Swedish National
Association against Heart and Chest Disease. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment? |
Unclear risk |
B ‐ Unclear |