Effectiveness of ZiYin Xiehuo granules and Zishen Qinggan granules on partial precocious puberty in girls: a multicenter, randomized, single-blind, controlled trial

OBJECTIVE: To evaluate the effect of ZiYin Xiehuo granules(ZYXH) and Zishen Qinggan granules(ZSQG) on partial precocious puberty(PPP).METHODS: This was a multicenter, randomized, single-blind, positive-controlled trial. A total of 143 pa-tients were assigned to either the ZYXH group or the ZSQG group using a random number table. The ZYXH group received ZYXH three times daily for 6 months and the ZSQG group received ZSQG three times daily for 6 months. Mammary nucleus diameter; the results of uterus, ovarian, and maximum follicle measures; and Chinese medicine symptom pattern scores were compared at baseline and after 3 months and 6 months of treatment.RESULTS: After 3 months' treatment, there were no significant differences between the two groups in mammary nucleus index changes(left 3.4 ± 3.1 vs3.5 ± 3.1, P = 0.790; right 3.0 ± 2.9 vs 3.6 ± 3.0, P =0.719). The uterine volume in the ZYXH group was smaller than that in the ZSQG group(2.1 ± 1.6 vs2.6 ± 2.2, P = 0.006). There were no significant between-group differences in ovarian volume and maximum follicular diameter on either side(ovarian volume: left 1.2 ± 0.7 vs 1.3 ± 0.6, P = 0.8; right1.2 ± 0.7 vs 1.4 ± 1.1, P = 0.984; maximum follicular diameter: left 3.9 ± 1.7 vs 3.5 ± 2.2, P = 0.158; right3.5 ± 1.7 vs 3.9 ± 2.1, P = 0.314).CONCLUSION: ZYXH granules and ZSQG granules both affected the size of the mammary nucleus in girls with PPP, and improved Chinese medicine symptom patterns. ZYXH granules showed slight advantages over ZSQG granules in terms of the decrease in the size of the uterus, ovaries, and ovarian follicles.