| Methods |
Parallel design. Due to the randomisation method wasn't mentioned in original article, we telephone interviewed the original author. The randomisation method was made clear that allocation sequence was generated by random number table. Single blindness: the patients didn't know which group they were in. |
| Participants |
73 patients that suffered from Grave's disease with light to moderate liver impairment were included. The patients whose liver were impairment by virus hepatitis or the causes were excluded. 38 cases were in the intervention group (M/F=8/30, aged between 18 and 60, 31.2 years old on average). 35 cases were in the control group (M/F=6/29, aged between 19 and 63, 32.7 years old on average). Baseline of two groups were similar. |
| Interventions |
Chinese medicine and anti‐thyroid drugs (ATD, including Tapazole and Propylthiouracil) was used in the intervention group. Chinese medicine was decocted with water, 1 ampoule/d, for 4 weeks. Then take the pills made by Chinese herb, 1 ampoule/d, for 4˜8 weeks; Tapazole (5 mg/d, t.i.d.) or Propylthiouracil (50 mg/d, t.i.d.) was also used in the control group. Change the dosage from the 5th weeks after the function of thyroid gland turned to normal. The control group only used ATD. The method was similar to the intervention group. |
| Outcomes |
Thyroid gland function (including T3, T4, TSH, FT3, FT4), thyroid gland auto‐antibody (including TGA, TMA) and liver function (including ALT, AST, TBil) was taken into consideration.
1. The decrease of ALT and AST: The intervention group (ALT: from 67.2+/‐20.3 IU/L to 30.6+/‐4.5 IU/L, AST: from 54.6+/‐13.7 IU/L to 29.3+/‐5.1 IU/L, TBil: from 23.1+/‐7.3 IU/L to 12.3+/‐4.7 IU/L) had better effects than the control group after 12 weeks;
2. The time needed for liver function's improvement: The intervention group (it took 25.7+/‐9.2 days to be normal and 94% cases turned to be normal within 8 weeks.) was better than the control group (It took 36.8+/‐12.4 days to be normal and only 57.1% cases turned to be normal within 8 weeks);
3. The improvement of the thyroid gland and the changes of relative antibody: The improvement of FT3, FT4, TGA, TMA and TSH showed no statistical significance between two groups. |
| Notes |
1. We telephone interviewed the pharmaceutical company and learned that the formulation of the Chinese medicine and the pills made by Chinese herb used in the intervention group was provided by the authors themselves, and the company provided processed raw material needed;
2. There was potential conflict of interest in the study. |
