Objectives We aimed to assess the methodological qual ity of RCT on acupuncture for migraine prophylaxis. Methods With the searching terms including acupuncture, migraine, prophylaxis and prevent, etc, the database of the Cochrane Library (Issue 4, 2007), MEDLINE (1966-2007), EMBase (1966-2007), CBM (1978-2007) and CMCC (1994-2007) were searched from their date of start publ ication. Chinese medical journals and relevant academic conference proceedings were hand searched as well. Several items in included trials were assessed, including methodology, diagnostic criteria, inclusion/exclusion criteria, acupuncture/control interventions, outcome measures and follow-up, etc. Result Among the 12 included trials, 9 trials overseas were high-qual ity and 3 in China were low-quality. Frequency or days of migraine attacks and SF-36/SF-12 were often evaluated as outcome measures in western countries, while headache index was used in China. Among the 12 trials, 9 reported the follow-up outcomes and 8 mentioned adverse events. Conclusion There was no high qual ity trial on acupuncture for migraine prophylaxis in China. The outcome measures in trials published in China by now can not evaluate the outcomes of acupuncture for migraine prophylaxis accurately. To study designs, advantages of trials oversea can be used for reference. To Chinese cl inical physicians, prophylactic therapy and abortive therapy of migraine should be distinguished in order to design high-qual ity study on acupuncture for migraine prophylaxis.
ObjectiveTo systematically sort out acupuncture therapy research report specification issues and provide a reference for the selection of key problems in the specification of acupuncture therapy network meta-analysis reports. MethodsComputer searches of PubMed, Embase, Web of Science, Cochrane Library, CNKI, WanFang Data, and VIP databases were conducted to collect studies related to reporting norms for acupuncture therapy, with a search time from inception to November 2022. Questions were constructed according to the SPIDER model and inclusion and exclusion criteria were developed. CASP was used to evaluate the methodological quality of the included literature, and a qualitative systematic evaluation thematic synthesis method was used to analyze, summarize, and integrate the questions on reporting norms for acupuncture therapy research evidence to create a pool of question entries. ResultsA total of 66 papers covering four countries were included, including 17 papers from qualitative studies and 49 papers from quantitative studies. The CASP evaluation results showed that the overall quality of the included studies was high, and the quality of the English studies was higher than that of the Chinese studies. The thematic synthesis method resulted in 22 question entries in 7 categories. The 7 categories of questions included title, abstract, preface, methods, results, discussion and other report specification questions. The 22 entries included "Is there a need to report specific types of acupuncture therapy", "Is there a need to report based on the type of original study and its number", etc. ConclusionThere are many problems with reporting norms in existing acupuncture studies, so it is necessary to collate and summarize the key issues of reporting norms for acupuncture network meta-analysis to provide a scientific and theoretical basis for the development of reporting guidelines for acupuncture network meta-analysis.
Objective To assess the quality reports on acupuncture in the treatment of postherpetic neuralgia. Methods MEDLINE, CBM, CMCC and CNKI from 1994 to 2006 were searched electronically. Handsearching was also done. The retrieved articles were assessed in terms of several factors, including the type of clinical research, methodology, diagnostic criteria, inclusion/exclusion criteria, effectiveness measurements, calculation of sample size, follow-up, etc. Results Among the 109 included articles, only 6 were true randomized controlled trials. There were 17 quasi-randomized controlled trials, 13 non-randomized concurrent controlled trials, 1 case-control study and 63 narrative studies. 29 of the reports clearly described the diagnostic criteria, 14 mentioned the inclusion/exclusion criteria, 79 reported the effectiveness measurements, none mentioned the calculation of sample size, 24 reported the follow-up outcomes, and only 1 mentioned adverse reactions. Conclusion More prospective, multicenter, large-scale, high-quality randomised trials are needed, and recommendations should also be made for future evaluations of methodological quality.
Objective To systematically review the efficacy and safety of acupuncture for the treatment of tumor-related cognitive dysfunction. Methods The PubMed, The Cochrane Library, EMbase, CNKI, WanFang Data, VIP and CBM databases were electronically searched to collect studies on acupuncture for the treatment of tumor-related cognitive dysfunction from the establishment of the database to February 13th, 2022. Two reviewers independently screened the literature, extracted data, and assessed the risk of bias of the included studies. Meta-analysis was then performed using RevMan 5.4.1 software. Results A total of 16 studies involving 1 361 patients were included. The results of meta-analysis showed that the mini-mental state examination (MD=1.82, 95%CI 1.49 to 2.15, P<0.000 01) and Montreal cognitive assessment (MD=1.56, 95%CI 0.83 to 2.29, P<0.0001) scores of the acupuncture treatment group were superior to those in the control group. Furthermore, the acupuncture treatment group showed a reduced incidence of postoperative cognitive dysfunction (RR=0.50, 95%CI 0.39 to 0.63, P<0.000 01) and decreased levels of interleukin-6 (MD=−10.43, 95%CI −14.91 to −5.95, P<0.000 01), interleukin-1β (MD=−47.14, 95%CI −63.92 to −30.36, P<0.000 01), and tumor necrosis factor-α (MD=−9.13, 95%CI −12.38 to −5.89, P<0.000 01). In contrast, the visual analog scale score of the acupuncture treatment group (MD=−1.26, 95%CI −2.06 to −0.47, P=0.002) was better than that of the control group. No significant difference was found in the level of central nervous system-specific protein (S100β) (MD=−0.06, 95%CI −0.13 to 0.01, P=0.12) between the two groups. Conclusion Acupuncture therapy can improve tumor-related cognitive function in patients. Its curative effect is better than that of non-acupuncture therapy; however, its ability to reduce S100β levels is not significantly different from that of non-acupuncture therapy. Due to the limited quantity and quality of the included studies, more high-quality studies are needed to verify the above conclusion.
Objective To assess the efficacy and safety of acupuncture versus western medicine in the treatment of depression neurosis. Methods Randomized controlled trials (RCTs) involving acupuncture versus western medicine in the treatment of depression neurosis were identified from CBM (1978 to 2009),VIP (1989 to 2009),WANFANG Database (1998 to 2009), CNKI (1979 to 2009), PubMed (1966 to 2009), EMbase (1980 to 2009), and The Cochrane Library (Issue 4,2008). We also hand searched relevant journals from Tianjin University of Traditional Chinese Medicine. Data were extracted and evaluated by two reviewers independently with a specially designed extraction form. The Cochrane Collaboration’s RevMan 5.0.2 software was used for data analyses. Results A total of 9 trials involving 903 patients were included. Meta-analyses showed that the total effective rate in the acupuncture group was similar when compared with Dailixin (RR= 1.01, 95%CI 0.82 to 1.23) on 20 d, fluoxetine (RR= 1.06, 95%CI 0.82 to 1.37) at week 8, but showing difference between acupuncture and fluoxetine (RR= 1.15, 95CI 1.07 to 1.22) at week 12. As for the HAMD score, no significant difference was noted between acupuncture and Dailixin (WMD= 0.45, 95%CI – 2.47 to 3.37) at 20 d, or amitriptyline at week 6, or fluoxetine on 30 d, and weeks 4, 8, 12; there was a difference between acupuncture and amitriptyline observed at week 1 (WMD= – 2.67, 95%CI – 4.38 to – 0.96) and week 2 (WMD= – 2.18, 95%CI – 3.28 to – 1.08). In terms of the SDS scores, significant difference was found between acupuncture and fluoxetine (WMD= – 4.26, 95%CI – 6.67 to – 1.85) at week 6, but no difference at week 4 and 12. Four trials reported adverse events. One trial found that no adverse events existed in acupuncture according with TESS score, contrasting with thirst, constipation, vision vague, shimmy, fast heart rate, and some change in liver function and cardiogram in amitriptyline group.Two trials reported very low score in acupuncture showing difference when compared with the drugs. And one trial described that four people had stomach and intestinal tract disorders. While no adverse reactions happened in the acupuncture group. Conclusion Acupuncture is not inferior to western medicine, and it is worth noting that acupuncture is associated with few adverse reactions. Further large-scale trials are required to define the role of acupuncture in the treatment of depression neurosis.
Functional dyspepsia (FD) is a common functional gastrointestinal disorder in clinical practice. Due to its long-term natural history, FD significantly impacts patients' quality of life and imposes a heavy social burden. Existing evidence suggests that acupuncture can effectively alleviate FD symptoms and is safe for treatment. However, current studies still face fragmented evidence regarding acupoint combinations, standardized procedures, and subtype interventions. Moreover, the existing clinical guidelines for FD do not provide specific recommendations on acupuncture treatment. To address the series of clinical issues faced by acupuncture in treating FD and to offer a scientific and standardized clinical protocol for acupuncture in FD treatment, the establishment of the "Clinical Practice Guidelines for Acupuncture Treatment of Functional Dyspepsia" was initiated by the Wangjing Hospital of the China Academy of Chinese Medical Sciences. This protocol systematically introduces the background, basic steps, working group members and their responsibilities, scope of application, the collection and determination of clinical issues and outcome indicators, evidence retrieval and evaluation methods, formulation of recommendations, external review and approval of recommendations, release and updating of the final draft, and the processes of promotion and implementation.
ObjectiveTo systematically review the efficacy and safety of acupuncture as adjuvant treatment on sepsis related gastrointestinal dysfunction. MethodsThe PubMed, Web of Science, Cochrane Library, WanFang Data, CNKI, VIP and SinoMed databases were electronically searched to collect randomized controlled trials (RCTs) related to the objectives from inception to July, 2024. Two reviewers independently screened literature, extracted data and assessed the risk of bias of the included studies. Meta-analysis was then performed by using RevMan 5.3 software. ResultsA total of 20 RCTs involving 1 384 patients were included. The results of meta-analysis showed that the bowel sound frequency per minute on the 7th day (MD=0.82, 95%CI 0.57 to 1.07, P<0.01), the effective rate of improvement in sepsis-related gastrointestinal dysfunction on the 7th day (RR=1.38, 95%CI 1.25 to 1.54, P<0.01), intra-abdominal pressure at 7th day (MD=−1.52, 95%CI −2.21 to −0.83, P<0.01), gastric residential volume on the 7th day (MD=−14.94, 95%CI −24.72 to −5.16, P<0.01), APACHE-Ⅱ score at 7th day (MD=−2.40, 95%CI −3.56 to −1.24, P<0.01), concentrations of procalcitonin on the 7th day (MD=−1.82, 95%CI −2.68 to −0.97, P<0.01) in the acupuncture group were all superior to the conventional treatment group. However, there was no significant difference between the two groups concerning the 28-day mortality. ConclusionCurrent evidence shows that acupuncture adjuvant treatment can promote the recovery of bowel sounds, reduce intra-abdominal pressure, and decrease gastric residual volume in patients with sepsis and gastrointestinal dysfunction, with good safety. Due to the limited quality and quantity of the included studies, more high quality studies are needed to verify the above conclusion.
The use of placebo controls in acupuncture trials has been an international concern for many years. We discussed some common problems in placebo controls and introduced four kinds of control methods (sham acupuncture, non-points acupuncture, minimal acupuncture and non-specific sites acupuncture). For sham acupuncture, non-points acupuncture and non-specific sites acupuncture, patients who have received acupuncture are liable to doubt the intervention they are taking. Minimal acupuncture has better reliability but is limited to use in many diseases for its physiological effect. Needling on some special parts of the body, for example, head and back side of the body, can make balance among factors as reliability, physiological effect and feasibility. This paper recommends a control method needling special parts according to the tradiontional acupuncture theory, which provides references for acupuncture clinical trials.
To explore clinical design methods that suit the characteristics of acupuncture science, this article mainly analyzes the design features of pragmatic randomized controlled trials and the advantages and current problems in clinical research on acupuncture. We discuss the differences between pragmatic randomized controlled trials and explanatory randomized controlled trials and the application status of clinical research about acupuncture. We consider that pragmatic randomized controlled trials suit the characteristics of in clinical research on acupuncture with complicated interventions. Exploring the application of pragmatic randomized controlled trials clinical research on acupuncture is beneficial to exploring appropriate clinical research methods that suit the specific characteristics of acupuncture subject, and to objectively and comprehensively assessing clinical efficacy and safety of acupuncture.
ObjectiveTo evaluate whether and to what extent the new risk of bias (ROB) tool has been used in Cochrane systematic reviews (CSRs) on acupuncture. MethodsWe searched the Cochrane Database of Systematic Review (CDSR) in issue 12, 2011. Two reviewers independently selected CSRs which primarily focused on acupuncture and moxibustion. Then the data involving in essential information, the information about ROB (sequence generation, allocation concealment, blindness, incomplete outcome data, selective reporting and other potential sources of bias) and GRADE were extracted and statistically analyzed. ResultsIn total, 41CSRs were identified, of which 19 CSRs were updated reviews. Thirty-three were published between 2009 and 2011. 60.98% reviews used the Cochrane Handbook as their ROB assessment tool. Most CSRs gave information about sequence generation, allocation concealment, blindness, and incomplete outcome data, however, half of them (54.55%, 8/69) showed selective reporting or other potential sources of bias. Conclusion"Risk of bias" tools have been used in most CSRs on acupuncture since 2009. However, the lack of evaluation items still remains.