| Methods |
Parallel design. Due to the randomisation method wasn't mentioned in original article, we telephone interviewed the original author and made clear that the allocation sequence was generated by computer software. No blindness. |
| Participants |
368 cases were included (M/F=82/286, aged between 18 and 62, 35.6 years old on average). The diagnoses criterion included FT3>10 pmol/L, FT4>30 pmol/L, or TT3>3.0 pmol/L, TT4>155 nmol/L and sTSH<0.5 mU/L. 260 were in the intervention group (34.8 years old on average). 108 were in control group (36.2 years old on average). Baseline of two groups were similar. |
| Interventions |
The intervention group was treated by Erdong Tang with Xiaoluowan Jiawei (ETXJ) on the basis of west medicine treatment. 1 ampoule/day, decocted with water, b.i.d. When the symptoms were lightened, decreased the dosage to 1 ampoule/3‐day and keep the minimum dosage of 1 ampoule/15‐day for 1.5˜2 years; Tapazole (p.o., 30˜40 mg/day) or Propylthiouracil (p.o., 300˜450 mg/day) was used in control group. The dosage was decreased when the symptoms were lightened. Then the patients were treated by the minimum dosage (tapazole: 5 mg/day, propylthiouracil: 50 mg/day) for 1.5˜2 years. |
| Outcomes |
1. Recovery: The symptoms subsided completely, thyroid gland shank, negative TSAb and T3, T4, TSH sustained the normal level for 1 year after discontinuing drugs. (I/C=186(71.5%)/59(54.6%)) There was statistical significance between two groups, showing that the effect of intervention group was better than control group;
2. Relapse Rate: Hyperthyroidism was ameliorated but then relapsed within 1 year after discontinuing drugs, symptoms recurred and FT3, FT4 (or TT3,TT4) increased. (I/C=29(15.6%)/20(33.9%)) There was statistical difference between two groups that was the recurrence rate of intervention group was lower than control group;
3. Granulocytes decreasing: WBC<4*109/L and neutrophils were the mainly cells that decreased. (I/C=72(27.7%)/48(44.4%)) There was statistical difference between two groups, showing that the adverse effect of intervention group was less than control group. |
| Notes |
1. Funded by patients themselves.
2. Both the Xiaying Wan and Erdongtang decoction were prepared by the original authors themselves;
3. There was potential conflict of interest in the study. |
