Methods |
Parallel design. Due to the randomisation method was not 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 |
84 patients of hyperthyroidism were included. The symptoms and laboratory examinations: polyphagia, irritability or depression, emaciation, fatigue, sweating, palpitation, dizziness, enlarged thyroid gland, thyroid murmur and vascular murmur, hand tremor, tachycardia (HR>90/min), exophthalmos, carmoisine tongue, increased T3,T4 and decreased TSH concentration. 36 cases were with liver function impairment, 24 were with decrease of WBC, 18 were with decrease of platelets. 66 cases were in the intervention group (M/F=12/54, 30.8 years old on average, 1.4 years on average of the length of disease). 18 were in the control group (M/F=3/15, 31.4 years old on average, 1.6 years on average of the length of disease). |
Interventions |
Tapazole and Chinese medicine was used in the intervention group, 1 ampoule/day, decocted with water, b.i.d.; Tapazole was used in the control group, 5˜10 mg each time, t.i.d., for 2 months, examined FT3, FT4, TSH, liver function and blood routine test once a month. |
Outcomes |
1. Control: FT3, FT4 turned to normal level and symptoms of hyperthyroidism disappeared (I/C=54(81.8%)/12(22.2%));
2. Improvement: FT3, FT4 decreased by more than 50%, symptoms improved obviousely (I/C=8(12.1%)/4(22.2%));
3. No improvement: FT3, FT4 decreased by less than 50% or increased, symptoms didn't improve (I/C=4(6.1%)/2(11.1));
4. Total effective rate: I/C=93.9%/88.9%. There was no statistical significance between two groups;
5. Adverse effects: in the control group, WBC decrease/platelets decrease/tetter and exophthalmos aggravation=8/3/2; in the intervention group, only 1 case appeared to have tetter and exophthalmos aggravation;
6. Relapse rate within 1 year: I/C=16(29.6%)/10(83.3%). There was statistical significance between two groups, showing that the recurrence rate of the intervention group was lower than the control group. |
Notes |
1. Chinese medicine used in the intervention group was prepared by the trialist;
2. There was potential conflict of interest in the study;
3. Two cases in control group were withdrawn from the study for aggravation of the disease. |