SUMMARY: In this study, 42 patients with primary Grave’s Disease (GD) were divided into the treatment group and the control group according to the random number table methods, with 21 subjects in each group. All subjects met the diagnostic criteria of primary GD according to the “Guidelines for Diagnosis and Treatment of Thyroid Diseases in China”. Subjects also met the Traditional Chinese Medicine diagnosis of Goiter due to Phlegm Fire (瘿病痰火) according to the symptom manifestations. There was no significant difference in gender, age and course of diseases between the two groups, and the two groups were statistically comparable (P>0.05).
In the control group, subjects received 10 mg methimazole tablets three times a day. In the treatment group, in addition to 10mg methimazole tablets twice a day, subjects also received seaweed granules (30g once in the morning) and kelp granules (25 g once in the morning). Initial course of treatment was 4 weeks in each group; after 4 weeks, dosage of methimazole was adjusted according to individual needs in both groups, and the treatment group stopped receiving seaweed and kelp granules.
In both groups, liver function and routine blood test were monitored 1 week before and after the treatment; in addition, thyroid function (serum FT4, FT3, TSH), thyroid stimulating hormone receptor antibody (TRAb), thyroid ultrasound, CD4+CD25+Treg cell ratio in peripheral blood mononuclear cells, PD-1 + Treg, PD-L1 + Treg and PD-1 + /PD-L1+Treg ratio, liver function, and routine blood test were monitored 4 weeks before and after the treatment. The adverse reaction and Traditional Chinese Medicine Syndrome Score Scale (TCMSSS) were also examined in both groups.
The clinical efficacy was evaluated according to the standards in “Guideline for Clinical Research of Traditional Chinese Medicine New Drugs (Trail)”, and was categorized into “Cured”, “Markedly effective”, “Effective”, and “Ineffective” according to signs, symptoms and laboratory testing result. Total effective rate = (number of cured cases + number of markedly effective cases + number of effective cases)/total number of cases x 100%.
Table 1. Comparison of Clinical Efficacy between Treatment and Control Group (n)
| Group | n | Cured | Markedly Effective | Effective | Ineffective | Total Effective Rate |
| Treatment | 21 | 12 | 5 | 3 | 1 | 95.24 a |
| Control | 21 | 8 | 3 | 6 | 4 | 80.95 |
According to the result of this study, the total effect rate (94.24% vs. 80.95%) and the cure rate (57.14% vs. 38.10%) were both significantly higher in the treatment group (P<0.05). The treatment group also showed a more significant decrease in TCMSSS and goiter, and a more significant improvement in laboratory markers (thyroid function, PD-1 + Treg, PD-L1 + Treg and PD-1 + /PD-L1+Treg ratio) (P<0.05). In addition, the adverse reaction in the treatment group was significantly lower than the control group (4.76% vs. 19.05%). This study suggested that combining seaweed and kelp with methimazole in treating primary GD may increase both the efficacy and safety of the treatment.
Cao, Yongjun, et al. Journal of Yunnan University of Traditional Chinese Medicine. 2020. 43 (6): 38-42