Zhu 2005.
| 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 | 121 cases that were diagnosed as hyperthyroidism were included. 62 cases were in the intervention group (M/F=15/47, aged between 12 and 53, 30 years old on average; with the length of disease between 3 months and 6 years, 1.2 years on average; ¢Ù all had the symptoms of sweating,dysphoria, palpitation, hard breath and emaciation; ¢Ú 41 cases had thyroid gland tremor; ¢Û The cases of¢ñ, ¢ò, ¢ó degree of thyroid gland enlargement=12/48/2; ¢Ü 53 cases were accompanied by sinus arrythmia, and ¢Ý 1 cases was atrial fibrillation; ¢Þ The concentration of TSH, T3, T4, FT3 and FT4 increased lightly in 11 cases, moderately in 31 cases and obviousely in 20 cases; ¢ß 20 cases' BMR>30%, 42 cases' BMR>60%.) 59 were in the control group (M/F=13/46, aged between 13 and 51, 29.5 years old on average; with lengths of disease between 4 months and 5 years, 1.3 years on average; ¢Ù all had the symptoms of sweating, dysphoria, palpitation, hard breath and emaciation; ¢Ú 40 cases had thyroid gland tremor; ¢Û The cases of¢ñ, ¢ò, ¢ó degree of thyroid gland enlargement=11/46/2; ¢Ü 48 cases were accompanied by sinus arrythmia, and ¢Ý 2 cases was atrial fibrillation; ¢Þ The concentration of TSH, T3, T4, FT3 and FT4 increased lightly in 10 cases, moderately in 30 cases and obviousely in 19 cases; ¢ß 21 cases' BMR>30%, 38 cases' BMR>60%. ) Baseline of two groups were similar. | |
| Interventions | Tapazole and Propranolol was used in the control group. Tapazole: 30 mg/d, t.i.d. The dosage was decreased to 5˜15 mg/d. For 1.5˜2 years. Propranolol:30 mg/d,t.i.d. and discontinued using it when HR<80/min; Besides the drugs listed above, Chinese medicine was used in the intervention group. 1 ampoule/d, decocting with water, and orally drank 200 ml in the morning and evening respectively. | |
| Outcomes | The outcomes were evaluated after 50 days. The patients were followed up for 1 year. 1. Clinical recovery: The symptoms subsided completely, body weight increased, the size of tyroid gland reduced by 30% or more, the concentration of thyroxin came to the normal level and gained the normal ECG and BMR. (I/C=9/5) 2. obviousely improvement: Symptoms were obviousely alleviated, body weight increased, sphygmus reduced by more than 20/min, the size of thyroid gland reduced by 20% or more, the concentration of thyroxin obviousely decreased and BMP<=30%. (I/C=32/13) 3. Improvement: The symptoms were improved, sphygmus slowed down by more than 10/min, the concentration of thyroxin decreased and BMR<=40%. (I/C=14/18) 4. Inefficacy: No change on the symptoms, the concentration of thyroxin and BMR stay the same. (7/23) 5. Total effective rate: I/C=88.6%/36.1%. There's statistical significance between two groups, showing that the effect of intervention group was better than the control group's. 6. Relapse Rate: After taking Chinese medicine and using tapazole alone, the symptoms recurred in once recovery and obviousely improving cases or the improving cases' weight gained and concentration of thyroxin increased. (I/C=7/13) There was statistical significance between two groups, showing that the recurrence of intervention group was lower than control group. | |
| Notes | 1. The formulation of Chinese medicine used in the intervention group was provided by the original authors; 2. There was potential conflict of interest in the study. | |
Abbreviations P.O.=per os (orally) B.i.d.=Eis in die (two times a day) T.i.d.=Ter in die (three time a day) Q.d.=Quaque die (one time a day) MBq = megabecquerel T3 = triiodothyronine T4 = thyroxine FT3 = free triiodothyronine FT4 = free thyroxine TT3 = total triiodothyronine TT4 = total thyroxine TSH = thyroid stimulating hormone TGA = anti‐thyroglobulin antibody TMA = anti‐thyroid‐microsome antibody ATD = anti‐thyroid drugs GNS = glucose and sodium chloride NAG = N‐acetyl‐¦Â‐D‐glucosaminidase BMR = basic metabolic rate WBC = white blood cell GD = grave's disease