| 1 Aims1.1 To summarize Wang Jusheng’s academic origin, treatment characteristics, clinical experiences and inductive principle and prescriptions on common skin diseases such as vitiligo, psoriasis, eczema, urticaria, Sjogren syndrome, scleroderma, herpes zoster neuralgia and pruritus and pulmonary diseases, through learning with her, recording medical cases, and literature reviewing.1.2 To evaluate the clinical curative effect of standardized prescriptions by blood syndrome differentiation treating psoriasis, optimize the treatment of psoriasis treatment program from the blood and provide reference for clinical practice guidelines, a randomized, double blind, controlled research was designed.2 Methods2.1 Experience summaryThe teacher’s academic origin and characteristics and treatment characteristics were summarized through clinical recording, analysis medical records, and reviewing the ancient and modern literature.2.2 Clinical researchA prospective, randomized, double blind, and placebo controlled research was designed to evaluate the effect of decoctions determined by blood syndrome differentiation. Three syndrome groups included 120 cases each, and according to 2:1 scale, the patients were randomized into the treatment group and the control group. The treatment group was given Liangxue Jiedu Decoction for blood-heat syndrome, Yangxue Jiedu Decoction for blood-dryness syndrome, Huoxue Jiedu Decoction for blood-stasis syndrome, and the control group was given placebo. The treatment group and the control group had topical white vaseline. The course was 8 weeks, and every 2 weeks once again to observe the illness changes and record the related indexes before and after treatment respectively.. Recovery patients were followed up at the 3rd,6th,9th and 12th month after treatment. The clinical symptoms and psoriasis area and severity of index (PASI) scores were taken to evaluate the efficacy.Per-Protocol Set was for analysis. The baseline characteristics, efficacy and safety were analyzed. SAS9.1.3 statistic software was used to undertake analysis.3 Results3.1 Academic originProfessor Wang Jusheng inherited traditional Chinese medicine dermatology Master Zhao Bingnan’s and integrated dermatology founder professor Zhang Zhili’s academic thoughts and experiences, and learned from the experiences of many famous doctors of internal medicine, and formed her own local syndrome differentiation and integral syndrome differentiation combined features.3.2 The characteristics of treating skin disease teacher3.2.1 The prominent of overall concepts, including human and nature, human and society is unified, the body as a whole, the treatment is not only confined to the skin, attentions should also be paid to the adjustment of psychological state of viscera, adjustment, and the adjustment of daily life, environmental factors and so on.3.2.2 Highlights the treatment of liverFocusing on the importance of emotion factors on skin disease affects seriously, soothing the liver to remove stagnancy of liver-Qi, psychological counseling, along with nourishing the liver and kidney, clearing liver and purging fire, hyperactive liver yang.3.2.3 Attached to the treatment from lungThe Lung governs body fur, and wind-dampness also easily infringes on lung. The wind-dampness pathogen was a leading cause of skin disease. Dispelling wind and dispersing lung, clearing away lung heat were the main methods.3.2.4 Generous weight decoctionsSkin diseases always were chronic, complex, and resistant. Non heavy decoctions it was difficult to cure, and not easy to deal with the complicated pathogenesis.3.3 Experiences in the treatment of common skin diseases3.3.1 Experiences in the treatment of psoriasisThe treatment of blood and viscera were combined in treating psoriasis and the importance of poison and wet in this disease were focused on. That the causes related to mental factors, the treatment of this disease was stressed on liver. Hepatic stagnation existed in the whole pathogenesis. The syndromes of blood-heat connotation, heat-toxin invading lung, blood-deficiency and wind-attack, weakness of the spleen and stomach, liver-yin and kidney-yin deficiency, stagnation of Qi and blood stasis, and stagnation of liver Qi and blood stasis were differentiated for treatment.3.3.2 Experiences in the treatment of vitiligoThe deficiency of liver and kidney was the basis pathogenesis. Hepatic stagnation, irascibility exuberant and hyperactivity of liver Yang were the different periods of performance. Treating liver was the keystone, which including nourishing the liver and kidney, soothing liver Qi stagnation, clearing liver and purging fire and soothing hyperactive liver yang. Promoting blood circulation to remove obstruction from meridians and expelling the wind were needed to cooperate. The insect drugs, generous and heavy decoctions were skillfully used. Psychological counseling was also much accounted of. The basic drugs were Tribulus terrestris, Morus alba, Radix Angelicae dahuricae, Bombyx Batryticatus, psoralen, Caulis Polygoni Multiflori, Platycladus orientalis, sandy, black sesame, mulberry, scorpion and Saposhnikovia divaricata Schischk. The herbs were used according to the lesions position and meridians.3.3.3 Herpes zoster neuralgia treatment experiencesThe key pathogenesis was Qi stagnation and blood stasis, but the nature of stasis was different, including deficiency, excessive, cold, and heat. The prescriptions of Huoxue Sanyu decoction, Dahuang Zhechong pill, Xuefu Zhuyu decoction, were commonly used to promote blood circulation, and Chaihu Shugan decoction for regulating Qi, Sijunzi decoction for invigorating Qi, Danggui Sini decoction for warming meridian.3.3.4 Experiences in the treatment of eczemaThe occurrence of eczema was the result of joint action of internal and external pathogens. Internal causes included congenital intolerance, liver fire, spleen dampness, and external pathogens were the wind, wet and heat evil. The invasion of external pathogens and deficiency of internal viscera were the main pathogenesis. Three syndromes were differentiated, which were damp heat syndrome treated by Longdan Xiegan decoction, spleen deficiency and dampness syndrome treated by Chushi Weiling decoction, and blood deficiency and wind attack syndrome treated by Yangxue Runfuying combined with Quanchongfang decoction. The treatment emphasized both eliminating pathogenic factors and adjusting the internal organs’functions. In addition, the importance of dispelling the wind evil besides heat evil and dampness evil, adjusting liver besides spleen was emphsized.3.3.5 Experiences in the treatment of Sjogren syndromeThe occurrence of this disease was on body weak attacked by various etiological factors, which leading to organ dysfunction and blood fluid deficiency, which was Yin-deficiency syndrome. The whole body conditioning, nourishing the five internal organs of Yin, and supplemented with warming yang was emphasized. And the nourishing yin and visera decoction was created for the treatment.3.3.6 Experiences in the treatment of sclerodermaSpleen and kidney deficiency, blood deficiency, Wei Qi deficiency, cold evil passage barrier, meridians stagnation, Qi and blood stagnation resistance between the muscles and skin were the main pathogenesis. Strengthening spleen besides the application of promoting blood circulation to remove blood stasis and Yang collaterals agent was the characteristic. The Zhenwu decoction combined with Taohongsiwu decoction, which warming and invigorating spleen and kidney, activating blood circulation, were mainly used.3.3.7 Experiences in the treatment of urticariaBesides wind evil, spleen and lung were also very important in the treatment and the combined treatment of six-evil and visceral organ was used. The main four syndromes were wind evil attacking lung, wind dampness obstructing lung, blood-deficiency and wind-attack, spleen and lung deficiency.3.3.8 The pruritus treatment experiencesThe pruritus was related to wind, wet, worms, and deficiency, and spiritual factors was also very closely. Treatment, In addition to the treatment of eliminating wind, dampness, insecticidal, nourishing blood, a variety of emotional adjustment methods were also used, which including clearing heart fire, liver fire and soothing the liver Qi.3.3.9 Experiences in the treatment of chronic coughThe cough was caused by airway sensitization, which was the performance of the wind. The Treatment of cough was dealing with the wind. Chronic cough, because of the long course duration, was related to the viscera function disorders. Treating wind and adjusting the internal organ functions were the principle.3.4 Clinical researchThe efficacy of cooling blood and detoxification decoction treating blood heat syndrome, nourishing blood and detoxification decoction treating blood dryness syndrome were better than placebo. The response of symptoms of irritability, scales, itching and dry mouth were significant improved of psoriasis patients treated by standardized TCM prescriptions based on blood syndrome differentiation, compared with the placebo.4 Conclusions4.1 The treatment of skin disease needs to highlight the overall concept, not only focus on the skin, but also the viscera, Qi and blood. 4.2 Treating psoriasis through blood differentiation was effective, but optimized scheme and improved research method were needed. 1. ObjectiveTo evaluate the standardized traditional Chinese medical prescriptions effect in psoriasis.2. Methods2.1 Methods:This randomized, blind, placebo-controlled,8-week study assessed the efficacy of 3 standardized prescriptions, which were cooling blood and detoxification decoction treating blood heat syndrome group, nourishing blood and detoxification decoction treating blood dryness syndrome group and promoting blood circulation and detoxification treating blood stasis syndrome group. According to the methods of clinical epidemiology and statistical calculation of sample size requirements, this experiments needs 360 patients, and which divided according to a 2:1 ratio into treatment group and control group. Treatment group and control group were both topical white petroleum jelly. Clinical and laboratory assessments were done at screening, baseline, and every 2 weeks thereafter until 8 weeks after the start of therapy. The security checks and lesions photography were taken before and after the treatments. And the cured patients were followed at the 3rd,6th,9th an 12th month to find the recurrence.2.2 Clinical assessments included physical examinations, vital signs, concomitant medications, monitoring for adverse events, and measures of Psoriasis Area Severity Index (PASI).A response was defined as attaining a poor (0-29% clearing with little or no change), good (30-59% clearing with moderate improvement), excellent (60-94% clearing with striking improvement), or clear (95-100% clearing) rating on the PASI. 2.3 Statistical analysis The primary analysis was done according to Per-protocol. The subjects demographic and other baseline characteristics, efficacy analysis and safety were analyzed. A two-sidedα=0.05 was regarded as significant. Student’s t-test was used to analyze differences between groups. Then, group-by-time repeated measures analysis of variance (ANOVA) and Wilcoxon rank sum test were used to examine changes.3. Results3.1358 patients were included in the study, and 318 cases were analyzed according to Per-protocol, in which 209 were assigned TCM treatment, and 109 placebo. The three treatment groups were similar with regard to age range, sex, marital status, family history, combination with other diseases baseline disease severity and TCM clinical symptoms score.3.2 Efficacy3.2.1 PASI efficacy Twelve of 209 (5.74%) patients in the TCM group achieved the primary endpoint of a clear, 72 (34.45%) achieved an excellent,57 (27.27%) achieved a good, and 68 (32.54%) attained a poor rating on the PASI at week 8, compared with 3 of 109 (2.75%) patients clear,34 (31.19%) excellent,26(23.86%) good,46(42.20%) poor, in the placebo group (P=0.0884>0.05). The response was no difference that who achieved the primary endpoint of a good, excellent, or clear rating on the PASI at week 8, compared the placebo group(P=0.2762>0.05).3.2.1 TCM symptoms efficacy Ten of 209 (4.78%) patients in the TCM group achieved the primary endpoint of a clear,24 (11.48%) achieved an excellent,90 (43.07%) achieved a good, and 85 (40.67%) attained a poor rating on the TCM symptoms at week 8, compared with 0 of 109 (0.00%) patients clear, 11 (10.09%) excellent,53(48.63%) good,45(41.28%) poor, in the placebo group (P= 0.2025>0.05). The response was no difference that who achieved the primary endpoint of a good, excellent, or clear rating on the TCM symptoms at week 8, compared the placebo group(P=0.1337>0.05).3.2.3 PASI efficacy in different syndromes 3.2.3.1 Blood heat syndrome Four of 70 (5.71%) patients in the blood heat syndrome group achieved the primary endpoint of a clear,28(40.00%) achieved an excellent,18 (25.72%) achieved a good, and 20 (28.57%) attained a poor rating on the PASI at week 8, compared with 2 of 35 (5.71%) patients clear,7 (20.00%) excellent,13(37.15%) good,13(37.15%) poor, in the placebo group (P= 0.1382>0.05). The response was significantly greater in patients who achieved the primary endpoint of a excellent, or clear rating on the PASI at week 8, compared the placebo group(P =0.0477<0.05).3.2.3.2 Blood dryness syndrome Five of 71 (7.04%) patients in the blood dryness group achieved the primary endpoint of a clear,25 (35.21%) achieved an excellent,19 (26.76%) achieved a good, and 22 (30.99%) attained a poor rating on the PASI at week 8, compared with 0 of 37 (0.00%) patients clear,11 (29.73%) excellent,6(16.22%) good,20(54.05%) poor, in the placebo group (P= 0.0279<0.05). The response was no difference in patients who achieved the primary endpoint of a excellent, or clear rating on the PASI at week 8, compared the placebo group(P=0. 2031>0.05). 3.2.3.3 Blood stasis syndrome Three of 68 (4.41%) patients in the blood stasis group achieved the primary endpoint of a clear,19(27.94%) achieved an excellent,20 (29.41%) achieved a good, and 26 (38.24%) attained a poor rating on the PASI at week 8, compared with 1 of 37 (2.70%) patients clear, 16(43.24%) excellent,7(18.92%) good,13(35.14%) poor, in the placebo group (P= 0.4300>0.05). The response was significantly greater in patients who achieved the primary endpoint of a excellent, or clear rating on the PASI at week 8, compared the placebo group(P =0.1685>0.05).3.2.4 TCM symptoms efficacy in different syndromes3.2.4.1 Blood heat syndromeThree of 70 (4.29%) patients in the blood heat syndrome group achieved the primary endpoint of a clear,12(17.14%) achieved an excellent,28 (40.00%) achieved a good, and 27 (38.57%) attained a poor rating on the TCM symptoms at week 8, compared with 0 of 35 (0.00%) patients clear,5(14.29%) excellent,17(48.57%) good,13(37.14%) poor, in the placebo group (P=0.5450>0.05). The response was no difference in patients who achieved the primary endpoint of a excellent, or clear rating on the TCM symptoms at week 8, compared the placebo group(P=0.3796>0.05).3.2.4.2 Blood dryness syndrome Six of 71 (8.45%) patients in the blood dryness syndrome group achieved the primary endpoint of a clear,10(14.08%) achieved an excellent,33 (46.68%) achieved a good, and 22 (30.99%) attained a poor rating on the TCM symptoms at week 8, compared with 0 of 37(0.00%) patients clear,4(10.81%) excellent,14(37.84%) good,19(51.35%) poor, in the placebo group (P=0.0184<0.05). The response was no difference in patients who achieved the primary endpoint of a excellent, or clear rating on the TCM symptoms at week 8, compared the placebo group(P=0.1366>0.05).3.2.4.3 Blood stasis syndromeOne of 68 (1.47%) patients in the blood stasis syndrome group achieved the primary endpoint of a clear,2(2.94%) achieved an excellent,29 (42.65%) achieved a good, and 36 (52.94%) attained a poor rating on the TCM symptoms at week 8, compared with 0 of 37 (0.00%) patients clear,2(5.41%) excellent,22(59.45%) good,13(35.14%) poor, in the placebo group (P=0.1681>0.05). The response was no difference in patients who achieved the primary endpoint of a excellent, or clear rating on the TCM symptoms at week 8, compared the placebo group(P=1.0000>0.05).3.2.5 PASI efficacy in different points At 4 weeks, the TCM groups showed significant improvement in PASI compared with the placebo group (P=0.0429<0.05), and no difference in the other weeks. The response was significantly greater on PASI at all measured time points in patients who received TCM decoctions in blood dryness group relative to those receiving placebo (P<0.05), but for the blood heat and blood stasis groups (P>0.05).3.2.6 TCM symptoms efficacy The response of symptoms of irritability in the blood heat group and scales, itching and dry mouth in the blood dryness group were significant improved compared with the placebo group, but for the other symptoms in different groups.4. Conclusions4.1 The overall efficacy was fairly between standardized TCM prescriptions, based on blood syndrome differentiation which including blood heat, blood dryness and blood stasis syndromes, treating psoriasis and placebo.4.2 The efficacy of cooling blood and detoxification decoction treating blood heat syndrome group, nourishing blood and detoxification decoction treating blood dryness syndrome group were better than placebo.4.3 The response of symptoms of irritability, scales, itching and dry mouth were significant improved of psoriasis patients treated by standardized TCM prescriptions based on blood syndrome differentiation, compared with the placebo. |
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