Snake Dan Mixture Treatment Unusual Acne Clinical Efficacy Evaluation Studies

Background: Shedan Mixture has been used to treat acne vulgaris clinically for several decades, which is based on a experiential prescription of the famous TCM doctors. There are many prophase studies about shedan mixture. Preliminary studies show, its effective rate is 76. 2%. In this study, we evaluate the effectivity and safety of Shedan Mixture on 184 acne patient ,detect the level of sex hormones include FT, DHEAS, E₂ by competitive ELISA method and approach methodology of clinical trial and evaluation.Methods: It is a randomized controlled clinical trial which evaluate the effectivity and safety of Shedan Mixture objectively. Approach methodology of clinical trial and evaluation on TCM in a way of DME (design, measure, evaluation). Check up the level of sex hormone by competitive ELISA method, to assess the curative effect of Shedan Mixture on sex hormone.Results: 184 patients (age 18 - 35 years old) were enrolled in the research. Patients were divided randomly to Shedan Mixture treatment group(92 patients) and control group(92 patients). No significant differences on age, history, course and heredity between two groups were found on the baseline. 171 patients complete the 8-week treatment course. 13 patients were lost, adverse events occurred to 8 patients. In treatment group with oral administrating of Shedan Mixture twice a day, 5 patients (5.43%) were cured, 9 patients (9.78% ) were effected excellently, 58 patients(63.06%) has effective results and 20 (21.73%) patients ineffective. In contral group with oral Qingre Anchuang Tablets 3 tabs tid, the rate of cure> excellently effective, effective and ineffective is 2 patient(2.17%), 2 patient (2.17%), 39 patients (42.39%), 49 patients (53. 26 %) , respectively. Total effective rate of two groups is 78.26%, 46.74% respectively(P=0. 005). Syndromes of Chinese medicine Score has nosignificant differences between patients treated with Shedan Mixture for two weeks and with Qingre Anchuang Tablets for four weeks(P>0.05).The comparative result of scores on type, amount and swelling of rash shows, the statistical significant difference is observed after 6-week treatment on type of rash, after 2 weeks on amount of rash and after 4 weeks on swelling of rash.Correlation between diet, heredity, age and severity of acne were approached in this trial. Statistics show, no significant differences between diet, heredity and course in different severity of acne, but patients with age less than 25 has severe acne than those with age above 25.Comparing three decocting modes of Shedan Mixture, total effective rate of decocting by hospital, free-decocting, and decocting by patients are 69.23%, 78. 57%and 82. 69%respectly (P=0. 509) .82 patients in treatment group and 77 patients in control group are followed up for 2 months. In treatment group, no worsen patients were found compare with pretreatment, 2 patients worse than the last visit . in control group, 2 patients aggratate compare with baseline, 10 patients worse than the last visit.We evaluate the rate of adverse events of the two group. 1 patients in treatment group 7 patients of control group has adverse events (P=0. 034).40 patients in treatment group completed the check-up of blood, urine , function of liver and kidney. No abnormality correlated to Shedan Mixture were found when treat with it for 8 weeks.Using DME method, we approach the methodology of clinical trial and evaluation on TCM. The whole patients in the research are studied, and we report the baseline and results of them which included the source of patients, norm of diagnoses and curative effect. Therapeutic method weintroduced in this trial is practical and effective which has a long history of application.Sex hormone including FT\ DHEASn E2of 37 patients were checked up pretreatment and posttreatment by ELISA competitive methods. According to the result, serum FT level is above the normality in nearly half of patients pretreatment. 35. 14% patients has a higher serum DHEAS.Female with age less than 25 has no diffence in DHEAS^ E2 compare with those with age above 25, but FT and FT/E2 has striking differences, (p=0.037, P=0.020) .Using LSD method compare the level of FT between different severity of acne, we find gradelllof acne patients has higher level than grade II which suggested that level of FT is correlated to the severity of acne.Patients with 8-week Shedan Mixture treatment, serum FT and DHEAS lowered significantly (P=0. 026, P=0.033) .For female the improvement of FT and DHEAS but not E2is obviously (P=0. 000, P=0. 002) . For male the improvement of E2 but not FT and DHEAS is significant (P=0. 047)oThe study show, ratio of F and E2 has been improved significantly (P=0.006) .Conclusion: Shedan Mixture has the function of clearing heat, resolving toxin, bind-dissipating and dampness eliminating, It is an effective and safety therapeutic method which may produce effect by regulating serum sex hormone. DME method should be best used in the clinical trial and evaluation to make TCM accepted by the whole world.