Traditional Chinese medicine’s effect on syndrome-types of active Systemic Lupus Erythematosus
Gu Junhua, Chen Xiangjun., Su Li Division of Rheumatology & Immunology,
Long-hua Hospital，Shanghai Traditional Chinese Medicine University
In order to study the effect of Traditional Chinese medicine（TCM）on Yin deficiency and toxic heat patterns of active Systemic Lupus Erythematosus（SLE）, 60 patients were randomly divided into group treated with TCM plus steroids and group treated only with systemic steroids.
Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disorder that can affect any part of the body. The course of the disease is unpredictable, with periods of illness alternating with remissions. After long time observation in the TCM treatment of over 500 cases of SLE, we found that according to the TCM theory, the differentiation of SLE mostly due to the Yin deficiency or toxic heat and the treatment done by integrative medicine (TCM plus steroids) is better than using steroids only.
1. Subjects and Methods
1.1 Case Dates
1.1.1 Diagnostic criteria: The diagnosis of all cases were in accordance with the Diagnostic criteria for SLE revised by American College of Rheumatology in 1982, and to stage SLE activity by Chubick’s modified scoring method  and Becker, H's AI score criteria : the patients whose Chubick score ³ 4points, AI score ³20 points were taken into the range of the observation.
1.1.2 TCM criteria: The TCM treatments were nourishing liver and kidney, clearing heat and removing toxicity, so here mainly discussed the syndrome-type of heat toxicity flourishing and liver-kidney yin deficiency. The criteria was according to “guiding principles of Chinese medicine drug research” , relating to classification of SLE description of typical syndromes. The patients must have two or more symptoms of this type: ⑴ heat toxicity nourishing: ① burning bright erythema, sore tongue; ② burning sore joints; ③ fever; ④ red tongue and thin or yellow greasy; ⑤ string and rapid pulse. ⑵ liver-kidney yin deficiency: ① light or dark purple erythema, or red and heat face; ② recurrent aphthous, eyes and throat dry, hair loss, tinnitus; ③ sour pain of joints and muscles; ④ lingering fever or dysphoria with feverish sensation in chest，palms and soles; ⑤ soreness of loins and weakness, frequent urination at night, heel pain; ⑥ red and delicate tongue, little coating or eroded fur, string and rapid pulse.
1.1.3 Research subjects: 60 cases of SLE patients were collected from Longhua Hospital Rheumatology & Immunology clinics and wards in 1995-1998, 21 cases were from clinics and 39 cases were from wards. Two groups were similar in gender ratio, age, disease duration, treatment, activity score and steroids dosage, which had not significantly difference by T test (P> 0.05), they had comparability. The treatment group’s ratio of yin deficiency to heat toxicity was 15:14, while the control’s ratio was 16:12.
1.2.1 Drugs: The decoction“Zi-Sheng-Qing”(ZSQ) was constituted by Rehmannia (sheng di huang), Astragalus (sheng huang qi), Atractylodes (sheng bai shu), Licorice (sheng gan cao), Hedyotis diffusa (bai hua she she cao), Moutan(mu dan pi), etc, extracted into 200ml / bag by extracting machines, twice a day, one bag once.
1.2.2 Delivery methods: The 60 cases of active SLE patients were randomly divided into control group treated only with systemic steroids and treatment group treated with TCM plus steroids, and the treatment group acquired extracted 200ml decoction , twice a day. The steroids for oral gave to two group were prednisone or prednisolone (5mg/flim), the steroids for infusion were methylprednisolone (40mg/support),Steroids requirement were converted into the calculation of the amount of prednisone, and gradually reduced by general principles.
1.3 Efficacy evaluation: there wasn’t a unified clinical standard of SLE so far, so modified the standard related to Zhu’s as follows:
① Markedly effective: The clinical symptoms and signs disappeared or there or more dates of laboratory parameters for activity were eliminated, and the patients could do easy work, the activity score significantly reduced (AI score ³30 points, Chubick score ³3 points), and steroids reduced to maintenance dose or zero dose;
② Effective: The clinical symptoms and laboratory parameters were improved, and the activity score significantly reduced (AI score ³20 points, Chubick score ³2 points), and steroids reduced to maintenance dose;
③ invalid: The clinical symptoms and laboratory parameters for activity weren’t improved, and the activity score significantly weren’t reduced (AI score <20 points , Chubick score <2 points), and steroids didn’t reduce.
④ Worse: The clinical symptoms and laboratory parameters were worse or the patients died, and the activity score increased, and steroids increased too.
1.4 Statistical analysis: The improvement rate of clinical symptoms and effect were analyzed by Χ2 test, clinical data distribution and laboratory parameters were analyzed by t test.
2.1 Clinical effect: See graph1. After 6 months, the improvement rate in the TCM group was 90.0%, and 86.7% in the control group. There were no significant difference between the two groups (p<0.05).
Graph 1.The improvement rate between two groups
2.2 The dosage of steroids: See graph2. In the graph, the steroids dosage of the two groups were Significantly reduced after 3 months of treatment, after treatment compared with the average amount of hormone treatment significantly reduced (P <0.05), and the reduction degree was similarity (P> 0.05), but after 6 months the steroids dosage of the treatment group was reduced further(P <0.05), while the steroids dosage of the control group wasn’t reduced significantly(P> 0.05), there was significant difference in the two groups (P <0.05).
Graph2. The dose of steroids in 3-6 months
2.3 Change of TCM symptoms: See graph 3,4,5. The two groups had similarity on the improvement degree of heat toxicity nourishing type, while in yin deficiency type, only the treatment group improved, and the degree of improvement were better than heat toxicity nourishing type, which indicated that the decoction’s major role in nourishing yin.
Graph3.The improvement rate with different type in control group
Graph4.The improvement rate of different type in TCM group.
Graph5. The improvement rate of two group with different type
In TCM theory, Yin deficiency of Liver and Kidney is the important reason of SLE. The current treatment of steroids can’t improve the Yin, otherwise, it will destroy the Yin. From our observation about ten years, most of SLE patients with Yin deficiency and heat toxicity type, treated by steroids and decoction together could nourish Yin and Qi, clear heat and remove toxicity, which was a worthy idea to long-term treatment for SLE.
 Tan EM, Cohen AS, Fries JF, et al. The 1982 revised criteria for the classification of systemic lupus erythematosus. Arthritis Rheum. 1982; 25 (11) :1271-1277
 Du Zhenbo, Liu Rongqing, YE Qingyi, et al. The research on the clinical relationship between Antibody-secreting cells and SLE. Journal of Dermatology 1991; 24:372.
 Becker H, Schauer U, Helmke K. B lymphocyte activiation by insoluble anti-μ antibodies in patients with systemic lupus erythematosus. Clin Exp Immunol, 1986; 66 (2) :365-372.
 《Practical diagnosis and treatment of Integrated Traditional and Western science 》Chen Guiting, Yang Sishu editor, China Medical and Science Technology Publishing House, 1991 11th Edition, P.633