| 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. No blindness. |
| Participants |
96 diagnosed patients were included. 52 cases were in the intervention group (M/F=11/41, aged between 18 and 66, 38.5+/‐3.6 years old on average; the length of disease within 0.5 year /within 10 years/longer than 10 years=38/11/3; first on set/recurrence after discontinuing drugs=42/10). 44 cases were in the control group (M/F=9/35, aged between 19 and 65, 40.5+/‐2.4 years old on average, with the length of disease between 2 months and 5 years, 3.5+/‐6.8 months on average; the length of disease within 0.5 year /within 10 years/longer than 10 years=32/10/2; first on set/recurrence after discontinuing drugs=36/8). Baseline of two groups were similar. |
| Interventions |
Tapazole was used in both groups, p.o., t.i.d., 10 mg each time, decreased the dosage to 5˜15 mg/day; Tapazole, Huangqi injection and Shengmai injection was given in the intervention group. The usage of Tapazole was similar to control 2 group. 20 ml/day Huangqi injection diluted in 250 ml 5% GNS infusion and 30 mL/day Shengmai injection diluted in 250 5% GNS was transfused through veins. |
| Outcomes |
1. Clinical recovery: The symptoms subsided completely, body weight increased, sphygmus turned to be normal, thyroid gland function and the results of immunology test turned to be normal. (I/C=38 (73.1%) / 13 (29.5%) )
2. Improvement: The symptoms were improved, sphygmus slowed down, thyroid gland function was almost normal. (I/C=11 (94.23%) / 20 (45.5%) )
3. Inefficacy: The results didn't reach improvement criterion or discontinued the drugs because of adverse effects or accepted other treatment. (I/C=3 (5.7%) / 11 (25%) )
4. Total effective rate: I/C=94.23%/75.00%. There was statistical significance between two groups, showing that the effect of intervention group was better than control group;
5. Comparison of changes of T3, T4, FT3, FT4 before and after the treatment: both groups decreased. There was statistical between two groups, showing that intervention group decreased more obviousely than control group;
6. Adverse effects: Decreasing of WBC, tetter and impairment of the liver function was observed in 9, 3 and 1 cases in the intervention group respectively. In the control group, no adverse effect was observed;
7. The dates for thyroid gland function turned to be normal: I/C=25.96+/‐3.84/30.77+/‐3.61. There was statistical significance between two groups, showing that the time needed of intervention group was shorter than control group. |
| Notes |
1. The study was a local government support project.
2. Both Huangqi injection and Shengmai injection were made by pharmaceutic company. |
