SUMMARY: 64 patients diagnosed with Graves’ Disease (GD) due to excessive liver fire were included in this study, and were divided into the treatment group (32 subjects) and the control group (32 subjects) according to the random number table methods. All subjects met the diagnostic criteria of GD according to the “Guidelines for Diagnosis and Treatment of Thyroid Diseases in China – Hyperthyroidism”, as well as the diagnosis of Goiter due to Excessive Liver Fire according to the “Guideline for Clinical Research of Traditional Chinese Medicine New Drugs (2002)” and “Internal Medicine of Traditional Chinese Medicine (2nd edition)”. There was no significant difference in the general data between the treatment and control groups, and the two groups were therefore statistically comparable (P>0.05).
In the control group, subjects received methimazole tablets, 10 mg twice a day. The dosage of methimazole was adjusted every 2-4 weeks according to the examination results and symptoms. The dosage was decreased by 5 mg at a time until the dosage reduced to 5-10 g a day. The duration of treatment was 3 months.
In the treatment group, subjects received Modified Danzhi Xiaoyao Powder (丹栀逍遥散加減) with the routine treatment (one herbal pack decocted into two divided doses, taken twice a day). The ingredients of the formula included: Mu Dan Pi 10g (牡丹皮 Cortex Moutan Radicis), Chao Zhi Zi 10g (炒梔子 Fructus Gardeniae, baked), Dang Gui 10g (當歸 Radix Angelicae Sinensis), Bai Shao 30g (白芍 Radix Paeoniae Alba), Chai Hu 15g (柴胡 Radix Bupleuri), Fu Ling 15g (茯苓 Poria), Bai Zhu 10 g (白朮 Rhizoma Atractylodis Macrocephalae), Xia Ku Cao 10g (夏枯草 Spica Prunellae), Xiang Fu 10g (香附 Rhizoma Cyperi), Yu Jin 10g (郁金Radix Curcumae), Suan Zao Ren 10g (酸棗仁 Semen Ziziphi Spinosae), Gan Cao 5g (甘草 Radix Glycyrrhizae), and Sheng Jiang 2 pieces (生薑 Rhizoma Zingiberis Recens). The duration of treatment was also 3 months, with 4 weeks as one course of treatment.
In both groups, the Traditional Chinese Medicine Syndrome Score Scale (TCMSSS) were evaluated according to the “Guiding Principles of Clinical Research on New Chinese Medicines for the Treatment of Hyperthyroidism”, and serum free triiodothyronine (FT3) and serum free thyroxine (FT4) levels were monitored before and after treatment. A subject was considered as: 1). Cured: if excessive sweating, irritability, palpitations, exophthalmos, hand tremors and other clinical signs and symptoms resolved, heart rate and pulse returned to normal, and FT3 and FT4 returned to the normal range; 2). Markedly Effective: if signs and symptoms basically resolved, the heart rate and pulse rate significantly reduced and were close to the normal range, and FT3 and FT4 were close to the normal range; 3). Effective: if signs and symptoms improved, heart rate and pulse decreased, FT3 and FT4 reduced by 30-50%; 4). Ineffective: if no improvement in signs and symptoms, FT3 and FT4 increased or no significant improvement.
Table 1. Comparison of Clinical Efficacy between Treatment and Control Group (n)
| Group | n | Cured | Markedly Effective | Effective | Ineffective | Total Effective Rate (%) |
| Treatment | 32 | 6 | 11 | 12 | 3 | 90.6 |
| Control | 32 | 4 | 8 | 10 | 10 | 68.8 |
The result of this study showed that the total effective rate in the treatment group was significantly higher compared to the control group (90.6% vs. 68.8%) (P<0.05). In addition, the treatment group also showed a more significant improvement in TCMSSS, FT3 and free FT4 level, and the adverse reaction was also significantly lower in the treatment group (6.3% vs. 25.0%) (P < 0.05). This suggested that adding Modified Danzhi Xiaoyao Powder to the routine treatment may be a safe and effective option for patients with GD.
Gao, Rui and Zhou, Hujian. Clinical Journal of Traditional Chinese Medicine. 2021. 33 (4): 730-733.