Early effects of LT3 + LT4 combination therapy on quality of life in hypothyroid patients: a randomized, double-blind, parallel-group comparison trial.

Combination LT4+LT3 therapy resulted in a significant reduction in TSH levels compared to baseline.

• TSH reduction was statistically significant (p < 0.05) in the LT4+LT3 group compared to baseline.
• The trial enrolled 151 Iranian patients with primary hypothyroidism between 2020 and 2021.
• The LT4+LT3 group consisted of 71 patients and the LT4-alone group consisted of 80 patients.
• Treatment duration was a minimum of six months.

Patients receiving LT4+LT3 combination therapy showed notable improvements in physical functioning and bodily pain compared to those receiving LT4 alone.

• Improvements were observed specifically in the SF-36V1 subscales of physical functioning and bodily pain in the LT4+LT3 group versus the LT4+placebo group.
• Quality of life was assessed using the SF-36V1 questionnaire as the primary outcome.
• The combination therapy group showed significant increase in physical component summary score after six months compared with baseline, but the difference between groups was not significant.

No significant differences were found between the LT4+LT3 and LT4-alone groups in blood pressure, most lipid profile measures, or body weight.

• Low-density lipoprotein cholesterol was the only lipid profile measure that showed a significant difference between groups.
• Blood pressure, triglycerides, total cholesterol, HDL cholesterol, and body weight did not differ significantly between the two groups.
• These were classified as secondary endpoints in the study.

The overall impact of combination therapy on quality of life remained inconclusive, particularly regarding the mental component.

• The mental component summary score did not show a significant difference with combination therapy.
• The study used a randomized, double-blind, parallel-group design to evaluate these outcomes.
• The authors concluded that 'the overall impact on quality of life remains inconclusive, as evidenced by the scores for the mental component.'

The study was designed as a randomized, double-blind, parallel-group trial of Iranian patients with primary hypothyroidism.

• A total of 151 patients were enrolled between 2020 and 2021.
• Patients were randomized to LT4 alone (n=80) or LT4+LT3 (n=71) for a minimum of six months.
• The study was registered with the Iranian Registry of Clinical Trials under number IRCT20200410047012N1.
• The primary outcome was quality of life assessed using the SF-36V1 questionnaire.