Objective

2

To observe the clinical effectiveness and safety of

Sanjie Waifu Formula

（散结外敷方） application therapy for benign thyroid nodules of

qi

constraint and phlegm obstruction syndrome.

Methods

2

Eighty patients with benign thyroid nodules of

qi

constraint and phlegm obstruction syndrome were randomly divided into 40 cases each in a treatment group and a control group. The control group was given health education and follow-up observation， while the treatment group applied

Sanjie Waifu Formula

externally on the basis of the control group，6~8 h each time ， once a day. Both groups took 30 days as a course， and were observed for 3 consecutive courses. The main effectiveness indexes of both groups were compared before and after treatment， including the volume of thyroid nodules， the maximum diameter of the largest nodule， the scores of traditional Chinese medicine （TCM） syndrome， and the secondary effectiveness indexes of serum thyroid function including free triiodothyronine （FT

3

）， free thyroxine （FT

4

）， thyrotropin （TSH） levels were also observed. The effectiveness of the TCM syndrome of both groups was compared after treatment. Meanwhile， the safety indexes were observed before and after treatment， such as the blood routine， liver and kidney function indexes， and the occurrence of adverse reactions during the study was recorded.

Results

2

Compared with in group before treatment， the volume of thyroid nodules， the maximum diameter of the largest nodule， and the TCM symptom scores were lowered in both groups after treatment （

P

＜0.05 or

P

＜0.01）. Comparing between groups after treatment， the difference in thyroid nodule volume was not statistically significant （

P

＞0.05）， but the maximum diameter of the largest nodule and the TCM symptom scores of the treatment group were lower than those of the contr

ol group （

P

＜0.01）. The total effective rate of TCM syndrome in the treatment group was 77.50% （31/40）， which was significantly higher than that of the control group with 52.5% （21/40，

P

＜0.01）. Thyroid function， blood routine and liver and kidney function indexes of both groups before and after treatment were compared between and within groups， and the differences were not statistically significant （

P

＞0.05）， and they were all within the normal range. During the treatment period， no allergic reactions such as skin itching， red rash and blisters occurred in the treatment group.

Conclusion

2

The external application of

Sanjie Waifu Formula

can improve the clinical symptoms of patients with benign thyroid nodules， reduce volume and the maximum diameter of nodules， and has no significant effects on thyroid function and show good safety.