SUMMARY: 128 patients with fibrocystic breast disease (FBD) were divided into treatment and control groups, with 64 cases in each group. All subjects met the diagnostic criteria of FBD according to the standards of Breast Disease Committee of Surgical Society of Chinese Medical Association. There was no significant difference in terms of age, course of disease and clinical data before the treatment between the treatment and control groups, and the two groups were statistically comparable (P>0.05). Subjects in the treatment group were treated with Jie Yu San Jie Tan (Relieving Stagnation and Dispersing Nodule Decoction, 解鬱散結湯), which included the following Chinese herbal medicine: Chai Hu 10g (柴胡 Radix Bupleuri), Bai Shao 15g (白芍 Radix Paeoniae Alba), Xia Ku Cao 30g (夏枯草 Spica Prunellae), Mao Zhao Cao 10g (貓爪草 Ranunculus ternatus), Dang Gui 15g (當歸 Radix Angelicae Sinensis), Xiang Fu 12g (香附 Rhizoma Cyperi), Bai Zhu 12 g (白朮 Rhizoma Atractylodis Macrocephalae), Yun Ling 15g (云苓 Poria), Yu Jin 15g (郁金 Radix Curcumae), Gan Cao 5g (甘草 Radix Glycyrrhizae), Yuan Hu 12g (元胡Rhizoma Corydalis). The herbal medicine was decocted and taken in two divided doses daily. In the control group, subjects were treated with tamoxifen, 10mg twice a day. The two groups received three courses of treatment, with one month as a course of treatment. A subject was considered as:
- Cured: if the breast lump and breast pain resolved, and no recurrence for 3 months after the treatment.
- Markedly Improved: The maximum diameter of the breast lump was reduced by more than 1/2, and the breast pain resolved.
- Improved: The maximum diameter of the lump was reduced by less than 1/2 and the breast pain was relieved; or the maximum diameter of the lump was reduced by more than 1/2, but the breast pain was not relieved.
- Non-Responsive: no reduction in the size of breast lump, or lump enlarged and hardens; or the breast pain was relieved but the size of lump was not reduced.
Total effective rate = cured cases + markedly improved cases + improved cases
Table 1. Comparison of Clinical Efficacy between the Treatment and Control Groups (n, %)
|Group||n||Cured||Markedly Improved||Improved||Non-Responsive||Total Effective Rate|
|Treatment||64||33 (51.6)||15 (23.4)||13 (20.3)||3 (4.7)||61 (95.3)#|
|Control||64||26 (40.6)||13 (20.3)||15 (23.4)||10 (15.6)||54 (84.4)|
The results showed that the total effective rate of the treatment group was 95.3%, and the total effective rate of the control group was 84.4%. The difference between the two groups was statistically significant (P<0.05). While no serious adverse effect was observed in either group, the relapse rate of control group is expected to be higher as tamoxifen works by modulating estrogen receptor and symptoms tend to recur once the medication is stopped. Therefore, Jie Yu San Jie Tan is not only effective and safe in treating FBD, but may also be a better choice to improve the quality of life to FBD patients.
Haihong Huang. Journal of China Traditional Chinese Medicine Information. 2012. 4 (5): 79