| Objective:To generally evaluate the curative efficacy and safety of Hua-ye-jie-du decoction, which is used to cure acne vulgaris, by performing a clinical study. And also to discover the mechanism of action of Hua-ye-jie-du decoction.Methods:1.Randomly devide the patients into tow groups, including an experimental group and a control group.2.The experimental group contains 116 cases, and is further devided into tow sub-groups based on the differentiation of the syndrome. And the treatment of the experimental group is based on Hua-ye-jie-du decoction. The ingredients of Hua-ye-jie-du decoction are:15g Honeysuckle Flower,15g Dyer Woad Leaf,15g Herba Violet,15g Wild Chrysanthemum,15g Capillary Artemisia, lOg Fructus Forsythiae, lOg Raw Garden Burnet, lOg Loquat Leaf, lOg Raw Liquoric Root,6g Raw Rhubarb,20g Salvia Miltiorrhiza and 30g Oldenlandia. Accordingly the prescription should be modified for each group. For the group of wind-heat on lung meridian, there should be additional 15g Root-bark of White Mulberry and 6g Divaricate Saposhnikovia Root. And for the group of dampness-heat in the lung and stomach, there should be additional lOg Golden Thread and lOg Fructus Gardeniae. The decoction should be taken twice a day, and the amount for each time is 150ml. The control group contains 60 cases. And the treatment of the experimental group is based on Tanshinone capsules. The Tanshinone capsules should be taken 3 times a day, and 4 capsules for each time. All patients take a six-week course of treatment during which the patients'conditions should be recorded. After the six-week course of treatment, the efficacies of the tow ways of treatment shall be compared.3.The records taken during and after the treatment shall be analyzed. For every case, the analysis results should include the numbers of skin lesions before/after the treatment, the change in acne severity, the testosterone level and the safety indicators(CBC, URT, hepatic/renal function, safety level, and adverse reactions). The evaluation to the curative efficacy refers to the standards defined in Chinese Medicine ClinicalResearch Guidelines.Results:1. After the treatment, the improvements on all types of skin lesions of the patients in experimental group are significant(P<0.05). And for the control group, the improvements on overall and inflammatory skin lesions are significant(P<0.05), while the improvement on non-inflammatory skin lesions is non-significant(P>0.05). After the treatment, the improvement on acne severity of the patients in experimental group is significant(P<0.05). Therefore, after the treatment, the diference of improvement on acne severity between the tow groups is significant(P<0.05). After the treatment, there is no significant change(P>0.05) in testosterone level of male patients. And there is significant change(P<0.05) in testosterone level of female patients.2.The overall efficacies of the experimental group and the control group are respectively 88.24% and 71.19%, which indicates significant difference between the efficacies of the two ways of treatment. The overall efficacies of the group of wind-heat on lung meridian and the group of dampness-heat in the lung and stomach are respectively 85.00% and 91.53%, which indicates no significant difference.Conclusions:1.Hua-ye-jie-du decoction has better efficacy and safety in treating acne vulgaris with syndromes of wind-heat on lung meridian and dampness-heat in the lung.2.Hua-ye-jie-du decoction has good efficacy in treating both inflammatory and non-inflammatory skin lesions caused by acne vulgaris.3.Hua-ye-jie-du decoction has same efficacy in treating acne vulgaris with syndromes of wind-heat on lung meridian and dampness-heat in the lung.4.The testosterone level of female patients with acne vulgaris, who are differentiate by the syndrome as wind-heat on lung meridian or dampness-heat in the lung and stomach and graded as severity I toⅢacne vulgaris according to Pillsbury scale, may be in normal range. |
PDF Full Text Request