A Clinical Evaluation Of Treating Atopic Dermatitis With Traditional Chinese Medicine

Objective:To evaluate the efficacy, safety, recurrence rate and the improvement of patient’s quality of life of Suppress-The-Heart-and-Calm-The-Mind Method in treatment of atopic dermatitis with open, multicenter, randomized controlled clinical trials, and trying to prove the efficacy, safety and scientific of this method by exploring its possible mechanism.Method:1.Randomly assigning patients to Traditional Chinese Medicine test group and the Western Medicine control group with a ratio of1:1using stratified, block randomization method. The Traditional Chinese Medicine test group was further divided into two types:Wind-Dampness-Stagnating-Skin and Syndrome-of-Wind-and Dryness-due-to-Blood-Deficiency by symptoms and signs.2. Treatment. The Chinese medicine group included96cases. Oral administration and using externally of Chinese Herbal Medicine No.1or Chinese Herbal Medicine No.2. Ingredients of Chinese Herbal Medicine No.1:Raw Os Draconis30g, Calcined Concha Osterae30g, Poria with peel30g, Herba Lophatheri15g. Ingredients of Chinese Herbal Medicine No.2:Raw Os Draconis30g, Calcined Concha Osterae30g, Rhizoma Drynariae10g, Fructus Kochiae30g. Taking the extract twice a day and covering the affected part with the same extract twice a day for8weeks. The western medicine included96cases, taking Loratadine tablets orally once a night and smearing0.1%Hydrocortisone Butyrate cream twice a day for8weeks. Visits were scheduled on preliminary diagnosis (before treatment),1,2,4weeks after treatment and the end of the treatment. Recorded the change of symptoms and the physical signs, including lesion area of skin, disease severity, pruritus degree, SCORAD score, dermatology life quality index, adverse reaction, recurrence rate, ect. Took photos for targeted skin lesions at every visit.4. Efficacy was evaluated by investigator observation and patientself-assessment before and after the therapy. Efficacy criteria refer to "scoring atopic dermatitis (SCORAD)" instituted by European Task Force on Atopic Dermatitis (ETFAD) and evaluation of quality of life refer to dermatology life quality index(DLQI) for adult and children dermatology life quality index(CDLQI) for children.5.Safety was evaluated by recording patients’blood, urine, liver and kidney function, safety class and the occurrence of adverse reactions.6.Statistical methods:Using SAS6.12Statistical software, P<0.05means significant.Result:1. Comparison of improvement of symptoms between2groups:Both Chinese medicine group and western medicine group experienced significant improvement (P<0.05). The Comparison between2groups were not significant (P>0.05). The Traditional Chinese Medicine group showed improvement in2weeks after the beginning of treatment in terms of the severity of skin lesions and sleep, but the improvement of area of skin lesions were not significant. All symptoms were improved after8weeks of treatment. Both subgroups, Wind-Dampness-Stagnating-Skin group and Syndrome-of-Wind-and Dryness-due-to-Blood-Deficiency group, showed equal improvement, but the subgroup of Wind-Dampness-Stagnating-Skin group take effect earlier than another. There were no significant difference (P>0.05) between2groups after8weeks’ treatment.2. Comparison of effectiveness between2groups:the total effective rate in treatment group is88.54%and83.33%in controlled group which showed no Statistically significant (P>0.05).3. Comparison of Recurrence rate:The western medicine group showed an effect rapidly for their improvement after a week of treatment, but the effect were not significant with the treatment lasted. In a follow-up visit to cured and effective patients in both groups after3months, there were11of recurrence in treatment group, the recurrence rate is20.37%, recurrence time (37.28±8.51days) is respectively later. There were25recurrence in controlled group, the recurrence rate is20.37%, recurrence time (12.35±4.67days) is respectively earlier. The difference between2groups are significant (P<0.05).4. Comparison of DLQI\CDLQI scores:Both Chinese medicine group and western medicine group experienced significant improvement respectively in symptoms and feelings,daily activities,leisure and total DLQI\CDLQI scores,but there was no significant difference between two groups(P>0.05). Both syndrome of wind-dampness stagnating skin group and syndrome of wind and dryness due to blood deficiency group experienced significant improvement respectively, with non-significance difference between them (P>0.05). Relevant analysis found that DLQI and CDLQI scores were positively related to the SCORAD scores(P<0.05).5. Immune indicators analysis:serum total IgE, ECP level in AD patients before treatment was significantly higher than the healthy control group (P<0.01). After treated with Suppress-The-Heart-and-Calm-The-Mind Method, serum total IgE, ECP level had been significantly lowered (P<0.01) with the disease condition under control. Peripheral blood EOS counts showed no significant difference (P>0.05) before and after treatment and compared with the healthy control group, indicating the EOS may have no significant relation with state of the illness.6.Comparison of security between2groups:In chinese medicine group,1patient had gastrointestinal discomfort after taking the initial chinese medication during treatment,but was relieved quickly after telling him the the correct way of taking chinese medicine.In western medicine group, there are two cases of patients with mild dizziness, drowsiness. The difference was not statistically significant.Never found the drug-related and possibly related serious adverse reactions.Conclusion:Suppress-The-Heart-and-Calm-The-Mind Method can significantly improve the symptoms and quality of life of patients suffering from atopic dermatitis and have a similar effect with the western medicine group. Its main advantage is reflected in the significantly reduced the recurrence rate of atopic dermatitis and safe,comparing western medicine.2weeks after treatment symptoms and signs can be improved. Long-term treatment by long-mu liquid can achieve a significant improvement which is superior to the patients who use western medicine. After treatment the quality of life of the patients is improved. Long-mu liquid in the treatment of Syndrome of wind-dampness stagnating skin is superior to syndrome of wind and dryness due to blood deficiency. At the same time DLQI and CDLQI scores are positively related to SCORAD scores. Serum total IgE, ECP level had been significantly lowered in TCM group, which shows the possible mechanism is to reduce the allergy and regulate the immune function.Innovative Points:Most previous TCM treatment on AD use clear heat and drain dampness, fortify the spleen and drain dampness, nourish the blood and dispel wind methods. However, we focus on aspects of heart and spirit on this topic and observed good clinical results, which opened brand new ways and methods on treatments of dermatitis, eczema and itching.