| Methods |
Parallel design. Due to the randomisation method did not be mentioned in original article, we telephone interviewed the original author. The randomisation method was made clear that allocation sequence was generated by randomisation computer software. Single blindness: the patients didn't know which group they were in. |
| Participants |
86 diagnosed patients were included . Among them, 76 were suffered from diffuse toxic goitre and the rest were at the early stage of subacute thyroiditis. 44 cases were in the intervention group (M/F=18/26, aged between 18 and 65, 35.6+/‐12.0 years old on average, with the length of the disease between 1 month and 8 years, 4.5+/‐8.6 months on average). 42 cases were in the control group (M/F=15/27, aged between 15 and 67, 30.6+/‐14.1 years old on average, with the length of disease between 2 months and 5 years, 3.5+/‐6.8 months on average). Baseline of two groups were similar. |
| Interventions |
Propylthiouracil was used in both groups, t.i.d., 100 mg each time. Decreased the dosage to 50˜100 mg/d. Jiakangmianyi Jiaonang were used in the intervention group, p.o., t.i.d., 4 capsules each time, for 90 days. The control group used Jiakangning Pian, p.o., t.i.d., 6 tablets each time, for 90 days. |
| Outcomes |
1. Clinical control: the symptoms subsided completely, body weight increased, sphygmus turned to be normal, tremor of the thyroid gland and vascular murmur disappeared, goitre and exophthalmos was lightened and the concentration of TSH, FT3, FT4 came to the normal level (I/C=15/13);
2. Improvement: Main symptoms subsided, body weight increased, sphygmus was almost normal, thyroid tremor and vascular murmur disappeared, goitre and exophthalmos was lightened and the concentration of TSH, FT3, FT4 became almost normal (I/C=21/19);
3. Moderate improvement: The symptoms were improved, sphygmus slowed down, the vascular murmur was lightened, goitre became smaller and the concentration of TSH, FT3, FT4 was almost normal (I/C=5/5);
4. No improvement: No change on the symptoms, signs and laboratory examination (I/C=5/5);
5. Total effective rate: I/C=93.2%/88.1% and there was no statistical significance between two groups;
6. Adverse effects: Decreasing of WBC and impairment of the liver function was observed in one and two cases in the intervention group respectively. In the control group, two patients got iatric tetters, two had WBC decreasing and one patient's liver function was impaired. |
| Notes |
1. The drug was made and provided by the author's hospital;
2. It was a local government supported project. |
