Clinical Trial For The Acupuncture-medicinal Treatment To Anti-depression And Evaluation Of Methodology Of Clinical Literatures Background

BackgroundWith the obvious symptoms of lasting and obvious low mood, depression is a common emotional disorder. In clinic, the major complains lie in the slow reflection, lose of interest and some obvious cognitive and behavior disorders. In recent years, with the ever-growing stress in modern life, depression is getting more and more popular. In the treatment for depression, acupuncture is a commonly applied approach. However, little high level evidence have been found in the effctiveness and safety. In this research, the EBM (evidence-based medicine) based randomized controlled methodology has been applied in the evaluation of clinic effect of acupuncture in the treatment of depression.Object1 various acupuncture treatments compared with the commonly recognized controlled medicinal paroxetine hydrochloride in the clinic trials to detect the actual effctiveness of acupuncture treatment in the clinic practice.2 To confirm various patients'reflections to different acupuncture treatments for analyzing the features and advantages of acupuncture treatment for depression.3 To testify different effective time of various treatments.4 To evaluate the influences of various treatments to patients'life quality.5 To analyze research types of acupuncture to anti-depression clinic literature and the features of randomized controlled literature, find problems in the current situation for the evaluation of traditional Chinese Medicine acupuncture effctiveness based on EBM.Method1 Clinical researchFrom June,2008 to September,2009,72 participants have been selected in the 6th hospital of Baotou City from both the outpatient and inpatient departments. The participants are divided into three groups,23 for electro-acupuncture,32 for acupuncture, and 17 for western medicine. HAMD, SDS and SERS scales have been applied in the evaluation at the 0,1,2,4,6 weeks period. Before and after the treatment, the participants have been evaluated by CGI and WHOQOL-BREF scale.4 weeks after the treatment, the participants have been reviewed according to HAMD.2 Methodology evaluationAccording to the analysis to all the literatures on acupuncture treatment for depression retrieved from 1979 to 2009 from CNKI, the literatures can be classified as randomized controlled trial, controlled trial, case series study and experts'experiences conferences. Of all the randomized controlled trial literatures, the ones which fit the EBM (Evidence-based Medicine) standards are further reviewed.Results1 Clinical research1.1 The ITT and PP analysis showed that effctiveness of acupuncture group are 74.55% and 87.23%, effctiveness for medicinal group are 47.06% and 50%, both of which are significant different (P＜0.05).1.2 ITT and PP analysis presented the significant difference between two groups at the period of 1,2,4,6 weeks according to HAMD scores. The HAMD scores fro acupuncture are significantly lower than the medicinal group. The significant deference can also be detected after the treatment(P<0.05).1.3 The ITT analysis showed no statistical meaning was founded from electro-acupuncture, acupuncture and medicinal groups (P>0.05),but the response rate of the electro-acupuncture group and acupuncture group is higher than medicine. However, the PP analysis presented the significant deference in the effctiveness of the three groups (P＜0.05).1.4 Of the three groups, according to the HAMD scores at the period of 1,2,4,6 weeks, significant differences could be presented. The HAMD scores of electro-acupuncture and acupuncture groups are much lower than the medicinal group. Meanwhile, no significant deference was detected between electro-acupuncture and acupuncture.1.5 Significant differences have been showed in the anxiety/somatization, sleep disorder factor between three groups at 1,2,4,6 weeks. For the scores of retardation and body weight factors, no significant differences have been detected at all the weeks evaluation.Either after the treatment. Electro-acupuncture and acupuncture presented better effctiveness than before. Except 4 weeks of the treatment, no significant differences have been presented for HAMD cognitive disorder scores.1.6 No significant difference has been detected after 1 and 2 weeks (P＞0.05). After 4.6 weeks, electro-acupuncture and acupuncture groups presented much lower SDS scores than medicinal group. However, no significant difference has been founded within the electro-acupuncture and acupuncture groups.1.7 After 6 weeks of treatments, SI, GI and EI of electro-acupuncture and acupuncture groups are much lower than those of medicinal group. No significant differences have been detected within the electro-acupuncture and acupuncture groups.1.8 Participants'life quality, health sensation, psychology and physical condition as well as the circumstances of electro-acupuncture and acupuncture groups are much better than the medicinal group with no significant difference presented within electro-acupuncture and acupuncture groups. No significant differences of social relationship can be presented within three groups.1.9 Adverse events rate of three groups are 17.4%,12.5% and 23.5% which are not significantly different. SERS scores of electro-acupuncture and acupuncture groups are much lower than that of medicinal group. Meanwhile the SERS scores of electro-acupuncture and acupuncture groups presented no significant difference.2 Methodology evaluationWithin the total 146 literatures,86 are randomized controlled trials which weighs 58.9%,18 are controlled trials weighing 12.3%, case series study adds up to 31 weighing 21.2%, the left 11 are experts experiences weighing 7.6%. Of the 86 randomized controlled trials,12 of which described the randomization,9 introduced blinding,4 applied placebo as controlled,20 recorded the losing cases. Only 1 applied ITT analysis as the outcome measurement. Conclusion1 Clinical research1.1 Effctiveness of treatment combined acupuncture and medicine are better than that of paroxetine hydrochloride, with no significant difference can be founded within effctiveness of electro-acupuncture and acupuncture groups.1.2 Acupuncture can obviously improve the patients'anxiety/somatization, sleeping disorders and cognitive factor.1.3 Acupuncture can improve patients'living quality, psychological and physical conditions.1.4 Acupuncture can eliminate the side effects of medicine and detoxine the medicinal treatment for the depression patients.2 Methodology evaluationCurrently the qualities of literature for the acupuncture treatment of depression are quite low which can be analyzed as the lack understanding of methodology of researchers, and can also be because the limited function of EBM approaches due to the differences between Traditional Chinese Medicine and modern medicine. It is suggested important to establish the EBM evaluation for the Traditional Chinese Medicine acupuncture according to its feature.