Objective: To observe the clinical efficacy of treating primary hypothyroidism by Fuzheng Fujia Mixture (FFM) with formula composing principles of warming and tonifying Pi and Shen, and eliminating blood stasis and removing turbid substances.

Methods: Totally 60 patients with primary hypothyroidism were randomly assigned to the treated group and the control group, 30 in each group. All were treated by Levothyroxine Sodium Tablet (LST) as routines. Those in the treated group took FFM additionally, 3 times daily, one month as 1 therapeutic course. The therapeutic efficacy was assessed after three therapeutic courses.

Results: After treatment the symptom scores were significantly reduced in the two groups (P < 0.05). The decrement was larger in the treated group than in the control group (P < 0.05). The dose of LST was significantly lower in the treated group than in the control group (P < 0.05). The blood lipids levels were significantly reduced in the two groups after treatment (P < 0.05). The decrement was significantly larger in the treated group than in the control group (P < 0.05).

Conclusion: FFM could obviously improve the symptoms of hypothyroidism patients, reduce the replacement dose of thyroid hormone, and lower the blood lipids levels.

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