| Objective:1. By the systematic evaluation of previous literature, this study was to look for the evidence of evidence-based medicine to objectively evaluate the clinical efficacy、Security2. The purpose was to evaluate the validity of electro-acupuncture treatment for severe functional constipation by clinical randomized single-blind placebo-controlled study.Methods:1. Literature evaluation: Quality assessment and meta-analysis form the clinical randomized controlled trial literature of electro-acupuncture treatment of functional constipation in domestic and international in the recent two decades (January1993to December2012).Retrieval database1.1.1Chinese database China Academic Journal Full-text Database(CNKI), the China Biology Medicine disc,(VIP), Chinese Biomedical Literature Database (CBM), Chinese Medical citation Index (CMCI), Wanfang Chinese Medical Association Periodical database. There was not hand searches1.1.2English database PubMed database、Embase medicine database.1.1.3Retrieval time January1993to December2012.1.2Search term1.2.1Chinese search termA:Determiners of disease definition:1. Constipation;2. Defecation difficulties;3. Dry defecation; B:Determiners of intervention method:5electro-acupuncture;6. Acupuncture;7. Acupuncture and moxibustion English search term Electro-acupuncture、 Acupuncture、Constipation、Astriction、 Coprostasis Functional constipation. After reading the title、abstract and the full text, whose quality was systematically evaluated and meta analysed.2. Clinical research According to stratified blocked randomization,64patients with severe functional constipation, in accordance with the inclusive criteria, were randomly divided into test group (Electro-acupuncture group, EA).and the control group, that is the sham electro-acupuncture group (Sham EA). There are32patients in each group.2.1. The test group (EA group): Acupoints:(Bilaterally)Tianshu, Fujie, Shangjuxu Manipulation Methods:EA group:For Tianshu and Fujie, stainless steel needles(2~3inch) were adopted to have a slow and vertical insertion into the parietal peritoneum. Then the needle handles of the above points were horizontally and bilaterally connected to the electrodes of the electro-acupuncture device. For Shangjuxu, Filiform needles(1.5inch) were vertically inserted1inch, then slightly and uniformly lifted and thrusted three times until Deqi (the desired sensation) was brought about. When retaining the needle, the needles were manipulated every10minutes. Totally there are three times. The Electro-acupuncture device is adjusted according to the following standard:A Sparse-dense wave should be applied, with a frequency of2/15Hz and a current intensity between0.1mA-1.0mA until the abdominal muscle vibrates slightly.SOP of the manipulation of electro-acupuncture: The frequency and the current intensity is set respectively between2-15Hz and0.1mA-1.0mA. They are allowed to be adjusted until the abdominal muscle vibrates slightly.The course and the duration of treatment:the duration of30minutes are recommended for each treatment. And the course which is5times per week in the first two weeks and3times per week in the rest6weeks are recommended, namely8weeks and28times of treatment in total.2.2. the control group (the Sham EA group): Acupoints:The non-acupoints located beside the bilateral Tianshu, Fujie and Shangjuxu, which are respectively described as next-to-Tianshu, next-to-Fujie, next-to-Shangjuxu in the following content.Location:The next-to-Tianshu is lcun lateral to Tianshu, in the middle point of line linking the Spleen and the Stomach meridian. The next-to-Fujie is lcun lateral to the Fujie, also in the middle point of the line linking the Spleen and the Stomach meridian. The next-to-Shangjuxu is lateral to the Shangjuxu, in the middle point of the line linking the Gallbladder and the Stomach Meridian.Sham EA group:1inch stainless steel needles were adopted which were matched with the needle tubing in specific length, the needle were just the vertically knocked into the subcutaneous fat layer(3-5inch under the skin). Without lifting and thrusting, the needle handles of both points were connect to the special electrodes of the electro-acupuncture device. The frequency and the current intensity are respectively set as2/15Hz and0.5mA.Special electric wires are made for this group, in the middle of which are cut while they look the same as the normal ones. That is to say, Although the device is turned on, indicating a successful connection, there is actually no electricity through the wire. The frequency and the course of the treatment are the same as the test group.Patients are informed that effective and slight current is put in, which may hardly feel by the body, but it is really put out by the device.Results:1Systematic EvaluationThrough strict screening,17randomized controlled trials involving1429cases were ultimately meet the standards, all of them are Chinese literature. In all of the10trials, the main intervention measure was electro-acupuncture. According to the characteristics of the interventions, there were EA and sham EA control group,、EA and EA control group,、EA and drug control group、EA and biological Feedback control group.5studies reported the treatment efficiency.3three studies reported the change of SBM in one week before and after treatment.4studies reported the changes in colonic transit function test before and after treatment.8studies reported the Cleveland Clinic Score (CCS) changes before and after treatment.2studies reported changes of the constipation symptom scores before and after treatment, including shape and properties, BRISTOL, the degree of difficulty in defecation and decreased force of defecation.7research reported the safety indicators. Others are the quality of life questionnaire, self-rating scale of anxiety, depression, etc.. Meta-analysis showed that, after acupuncture treatment of chronic functional constipation, the improvement of efficiency and SBM in one week were as good as the oral drug therapy and superior to placebo acupuncture therapy. When comparing the improvement of colon running test, the efficacy of acupuncture therapy was as good as the oral drug therapy, and was superior to the placebo acupuncture therapy; When the improvement of CCS in short-term and long-term efficacy, acupuncture treatment was as good as oral drug therapy. Thereinto the efficacy of abdominal acupuncture with deep insertion was superior to the shallow insertion. When comparing short-term and long-term efficacy in the changes of the constipation symptom scores, the acupuncture treatment is superior to the placebo therapy; None obvious adverse events of acupuncture treatment of chronic functional constipation has been found.2clinical research2.1baseline data comparison64patients were randomly divided into electro-acupuncture group and sham electro-acupuncture group, with32cases in each group. There was no significant difference in sex ratio, degree of education, average age, height, weight, course of the disease, defecation situation before treatment and the score of scale PAC-QOL between the two groups (P>0.05).2.2defecation situation2.2.1CSBM:Through variance analysis, there was statistical significance between the two groups when the average of CSBM was increased each week in the cure period of week1to2, week1to4, week1to6, week1to8and follow-up period (p<0.05). Compared with before treatment, each point has statistical significance (p<0.05), except the sham electro-acupuncture group treated for2weeks (p>0.05). There was no significant difference in the average of CSBM between electro-acupuncture group treated for8weeks and patients in the cure period (p>0.05). While it has statistical significance between sham electro-acupuncture group treated for8weeks and patients in the cure period (p<0.05)2.2.2SBM:Through variance analysis, compared with before treatment, the frequency of defecation of each group was statistically significant in the cure period of week1to2, week1to4, week1to6, week1to8and the follow-up period of4weeks (p<0.05).And there were not statistically significant in two groups (p>0.05)2.2.3Stool consistency score in Bristol Through variance analysis, there was statistical significance between the two groups when the average of stool consistency score was increased or decreased each week in the cure period of week1to2, week1to4, week1to6, week1to8and follow-up period (p<0.05)2.2.4The rating of defecate exertion Through variance analysis, there was not statistical significance between the two groups when the average of exertion score was increased or decreased each week in the cure period of week1to2(p>0.05).But there was statistical significance between the two groups when the average of exertion score was increased or decreased each week in the cure period of week1to4, week1to6and week1to8(p<0.05)2.2.5Effective rate After the end of the treatment period, the treatment group fall off2cases, there are30cases in the treatment group and32cases in the control group were finally statistics. By chi-square test, there are differences between the two groups, with statistical significance (p<0.05)。There was statistical significance between the two groups’effective rate follow-up of4weeks There is no statistical significance between after8weeks of treatment with follow-up period of the electro-acupuncture group.(p>0.05)。But there is nstatistical significance between after8weeks of treatment with follow-up period of the sham electro-acupuncture group (p<0.05)。2.3The PAC-QOL scale Through variance analysis, there is statistical significance of the score of PAC-QOL scale and four dimensions (except satisfaction) between after treatment with before treatment of two groups (p<0.05)。 It prove that treatment group each dimension and the whole can improve the life quality of severe functional constipation. Specific to the dimensions, In terms of physical state and satisfaction of EA group than the sham EA group p<0.05. In terms of fear of psychological state of anxiety, no difference between the two groupsConclusion: 1Through systematic evaluation, Acupuncture treatment of chronic functional constipation is safe, with efficacy in various aspects as good as the oral drug therapy. The efficacy of acupuncture therapy is relevant to the insertion depth within safety range. And no significant relationship between the high and low frequency of electro-acupuncture. However, some problems do exist in the literatures of this systematic evaluation, which have some effect on the conclusion, such as publication bias, systematic evaluation, small sample capacity, lack of unified outcome indices, low quality, etc. More high-quality randomized controlled trials are needed to further confirm the conclusion above.2Through clinical research, the SBM times is increased through both electro-acupunture and pseudo-electro-acupunture, and they share the same therapeutic effect. In case of increasing the times of CSBM, reducing the difficulties in stool exclusion, improving the shape and properties of stool and the PAC-QOL scale, both of two groups are therapeutically effective generally. However, the EA group is superior to the sham EA group. In addition, the therapeutic effects appear in a shorter time in the EA group, which also has long-time therapeutic effects... |
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