Exploration Of Expressive Elements And Control Modes For Clinical RCT Of Acupuncture And Moxibustion,Taking Peptic Ulcer As An Example

ObjectiveTo explore the expressive elements and control modes for clinical randomized controlled trials(RCT) of acupuncture and moxibustion so as to provide reference for them, taking peptic ulcer as an example.MethodsFirstly, literature related to peptic ulcer from 1996 to 2015 was collected in domestic and overseas databases, including China National Knowledge Infrastructure(CNKI), WANFANG, VIP, China Biology Medicine(CBM), PubMed, Web of Science, Sciencedirect, Springer, Wiley, etc.Then, two parts were studied. Part A:a) Sum up the incidence and pathogenic factors of peptic ulcer, b) Sort out the diagnostic and therapeutic effects criteria, c) Summarize the therapies and acupoints selection law. Part B:a) According to CONSORT and STRICTA, compare the qualities of the articles of acupuncture and moxibustion from 1996 to 2005 with those from 2006 to 2015. b) Evaluate the expression of title and abstract, preface, experimental design, intervention, result and discussion of the above papers, c) Appraise the clinical controls of studying acupuncture and moxibustion.ResultsPart A Review of incidence, diagnosis and treatment of peptic ulcerThe literature of treating peptic ulcer was mostly delivered from Shandong and Guangxi Province domestically, and Asia overseas. The pathogenic factors demonstrated the infection of helicobacter pylori(Hp), non steroidal anti-inflammatory drugs(NSAID), glucocorticoid, clopidogrel, heredity, emotion disorder, smoke and excessive drinking, etc.As for the western medication of Hp-induced peptic ulcer, we needed to eliminate the bacterium by triple therapy and then medicate H2 receptor antagonists, PPI or other drugs for a long time. When it comes to the disease caused by NSAID that could not be withdrawed, medicines of suppressing acid and protecting gastric mucosa must be applied according to medical order. Speaking of Chinese medicine therapy, the diagnostic and efficacy criteria frequently used represented Guiding principles of clinical research on new drugs of traditional Chinese Medicine, Standard of diagnosis and curative effect of TCM Syndrome, Internal Medicine, Practice of Internal Medicine. Acupuncture, moxibustion, Chinese herbs and acupoints implantation were mainly used based on syndrome differentiation. The main acupoints showed Zhongwan(CV 12) and Zusanli(ST 36). Weishu(BL21), Pishu(BL20), Neiguan(PC 6) were matched for the syndrome of deficiency-cold of spleen and stomach; Weishu(BL 21), Pishu(BL 20), Neiguan(PC 6), Geshu(BL 17), the syndrome of qi stagnation and blood stasis; Weishu(BL 21), Pishu(BL 20), Qimen(LR 14), the pattern of liver depression and qi stagnation; Weishu(BL 21), Pishu(BL 20), Neiguan(PC 6), Taichong(LR 3), acid regurgitation.Part B Evaluation of expressions and control modes of clinical RCT of acupuncture and moxibustionThe qualities of clinical RCT reports of peptic ulcer treated with acupuncture and moxibustion were assessed according to CONSORT. The articles from 2006 to 2015 were better compared with those from 1996 to 2005(45.5% vs 40.9%, P<0.05). As for STRICTA, the two phases presented imperfect expression(46.3% vs 53.5%, P>0.05). Furthermore, it was poorly reported in terms of title and abstract, preface, experimental design, intervention, but better discussed comparatively. The above five parts from 2006 to 2015 did not present statistical difference from those 1996 to 2005(all P>0.05). The results of latter ten years were seen as a rising trend without statistical significance(P>0.05).Statistical analyses for baselines could be found in 71.2 percent papers, and the results were(P>0.05. There were 28.8 percent articles failing to describe the contents of baselines, which showed the uncertain comparability. Details including the course, frequency and dose were reported in the 86 percent drug-control papers, indicating less bias for interventions and reasonable control modes. However, little variable factors presented only in the 37.5 percent articles taken acupuncture and moxibustion as the contrast methods.ConclusionThe poor clinical RCT reports of peptic ulcer treated with acupuncture and moxibustion mean normal composition need to be attached importance to, especially preface, trial design and intervention. When it comes to clinical control modes, variable factors must be avoided to a large extent, and we need to underline the comparability of baselines and interventions.