Clinical Effect Evaluation Of A RCT For Cotton-sheet Moxibustion Therapy In Patients With Herpes Zoster

OBJECTIVE:To evaluate the clinical effect of Cotton-sheet Moxibustion Therapy in patients with herpes zoster. To establish the standards of dignosis and treatment of Cotton-sheet Moxibustion Therapy for herpes zoster. To enact the criterion of Cotton-sheet Moxibustion, popularize the clinical application. And through the designing and execution of this study, put forward the discussion for design of acupuncture clinical trials.METHODS:The central-randomized, allocated and data management are assumed by the GCP center of Chengdu University of TCM. Patients are from 9 centers in cities of Chengdu, Guangzhou and Wuhan during January 4^th,2008 to December 31^th,2008.This study is a summary of 167 patients from 6 centers in cities of Chengdu and Wuhan. Treatment Group 1(Cotton-sheet Moxibustion Therapy), n=61; treatment group 2 (Skin-needle tapping&cupping Therapy), n=55;controlled group(Western medicine Therapy), n=51. Adopt the guidelines of comprehensive effect, blister, pain, safety, tolerance, etc.to evaluate the comprehensive effect of Cotton-sheet Moxibustion Therapy.RESULT:Comparison of baseline:The level from baseline of the treatment groups are similar to that of the control (P＞0.05) in both intention-to-treat analysis (ITT) and pre-protocol (PP). Comparison of comprehensive effect:The effective percentage of the Cotton-sheet Moxibustion group is 91.7%. No significant difference among the three groups. There are quite obvious diversity of the figures between the prior and posterior to the treatment in the Cotton-sheet Moxibustion group. But no significant difference from the Skin-needle tapping&cupping group and the Western medicine group(P>0.05). Comparison of blister:Cotton-sheet Moxibustion Therapy can shorten the time of incrustation. The difference is significant between the Cotton-sheet Moxibustion group and the other groups (P＜0.05). Comparison of Pain:①Cotton-sheet Moxibustion Therapy can release the pain caused by hepers zoster and shorten the continuance.The VAS points of Cotton-sheet Moxibustion group is significantly lower than the other groups (P＜0.05). The continuance of pain is shorter than the others(P＜0.05), too.②As treatment times increasing the instant analgesia time of Cotton-sheet Moxibustion Therapy short, but the time of instant analgesia become longer.③The comparison of the incidence of the postherpetic neuralgis. In the 30^th and the 60^th day of the treatment, there is significant diffenrence between the Cotton-sheet Moxibution group and the others (P＜0.05). Comparison of Dynamic Index:①The VAS points in Cotton-sheet Moxibution group decreased obviously from the 8^th day to the 22^th. There is significant diffenrence between the Cotton-sheet Moxibution group and the other groups (P＜0.05).②The pain relief is bigger than the others.There is significant diffenrence (P＜0.05).③Comparison of single indexs:Partial pain released in the 8^th day to the 11^th, there is significant difference between the Cotton-sheet Moxibustion group and the others. Burning sensation of Cotton-sheet Moxibustion group is more obvious in the third day (P＜0.05).The number of blister is less in the Cotton-sheet Moxibustion group in the day of 8^th and 9^th (P＜0.05). Provement of pimple is not better in the Cotton-sheet Moxibustion group than the other groups (P＜0.05).Comparison of safety:The safety of all the three groups are good(P＞0.05). Comparison of acceptance:The acceptance of patients to all the three groups is good(P>0.05).CONCLUSION:The comprehensive effect of the Cotton-sheet Moxibustion group is not bad'than the Skin-needle.tapping&cupping group and the Western medicine group. In the aspects of improving the incrustation and pain, releasing the incidence of the postherpetic neuralgia the Cotton-sheet Moxibustion group is better than the other two groups.The manipulation of Cotton-sheet Moxibustion Therapy in patients with herpes zoster is feasible, effective, safe, acceptable, and has promotional clinical value.