Standards For Reporting Interventions In Controlled Trials Of Acupuncture Research Articles

Assessment of Reporting Quality in Randomized Controlled Trials of Acupuncture for Primary Insomnia with CONSORT Statement and STRICTA Guidelines

Aim To assess the reporting quality of randomized controlled trials (RCTs) on acupuncture for primary insomnia (PI). Methods Seven Chinese and English databases were searched for publication reporting RCTs on acupuncture for PI from the inception of the databases to August 6, 2021. The internationally recognized Consolidated Standards of Reporting Trials (CONSORT) statement and the International Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) guidelines were used to evaluate the reporting quality. The agreement between two researchers was calculated by Cohen's kappa. Results A total of 102 eligible RCTs were assessed. According to the CONSORT statement (2017), the positive reporting rates of items such as “abstract,” “background,” “participants,” and “numbers analyzed” were above 80%. However, the positive reporting rates of items such as “sample size,” “randomization implementation,” “Outcomes and estimation,” “Ancillary analyses,” and “Registration” were below 20%. According to STRICTA guidelines, the positive reporting rates of items such as “style of acupuncture,” “reasons for acupuncture treatment,” “Number of needles inserted,” “Needle retention time,” “Treatment regimen,” and “precise description of the control intervention” were above 80%. However, the positive reporting rates of items such as “setting and context of treatment” and “practitioner background” were below 20%. Conclusion It is essential to advocate the endorsement of the CONSORT statement and STRICTA guidelines to improve the quality of acupuncture RCT reports.

Placebo Response Rates in Acupuncture Therapy Trials for Functional Dyspepsia: A Systematic Review and Meta-Analysis.

Background:Functional dyspepsia (FD) is a functional digestive disease with limited management selection. Previous studies revealed that acupuncture therapy is effective for FD. However, because sham controls were not implemented in most clinical trials following acupuncture therapy, it is difficult to differentiate overall treatment responses from placebo. This study aims to quantify placebo responses in clinical trials in which FD patients received sham manual acupuncture (MA) and sham electroacupuncture (EA).Materials and Methods:Randomized controlled trials of MA and EA for FD patients were searched in PubMed, Web of Science, Cochrane Library, and Embase databases, as well as 4 Chinese language databases from inception to January 2021. RevMan 5.20 software was used for pooled analysis of symptom scores and quality of life. The symptom scores were combined using standard mean difference (SMD) or weighted mean difference (WMD) with a 95% confidence interval (CI). The quality of included studies was tested using modified Jadad scale and Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) checklist. Egger’s test, Begg’s test, and sensitivity analyses were conducted using Stata 11.0 statistical software. The protocol of this study is registered in PROSPERO as CRD42021233858.Results:After screening, the current systematic review included 13 randomized controlled trials, of which 8 studies were used in the meta-analysis. Regarding subjective outcomes, the combined effect of sham MA on FD symptoms was [SMD=−0.42, 95% CI (−0.72, −0.12); P=0.005], whereas sham EA treatment was [SMD=−0.54, 95% CI (−0.81, −0.27); P<0.001]. The combined effect on FD quality of life of post-sham MA group was [SMD=−0.32, 95% CI (−0.52, −0.12); P=0.002]. With regard to objective outcomes, the combined effect of sham EA on dominant frequency was [WMD=−0.11, 95% CI (−0.30, −0.08); P=0.24], while the combined effect of sham EA on dominant power was [WMD=−3.35, 95% CI (−8.04, 1.35); P=0.16].Conclusions:Sham MA and sham EA remarkably improve symptoms and quality of life scores of FD without influencing objective outcomes, highlighting the significance of sham controls in acupuncture therapy clinical trials.

Abstracts from Society for Acupuncture ResearchPandemics, Pain, &amp; Public Health:Roles and Relevance of Traditional East Asian MedicineJune 14–17, 2021

Abstracts from Society for Acupuncture ResearchPandemics, Pain, &amp; Public Health:Roles and Relevance of Traditional East Asian Medicine<i>June 14–17, 2021</i>

Overall Reporting Descriptions of Acupuncture for Chronic Pain in Randomized Controlled Trials in English Journals.

BackgroundWhether the clinical effect of acupuncture in chronic pain is effective has always been a hot topic of research, which has a great relationship with the overall reporting descriptions of acupuncture, especially the sham acupuncture intervention. To confirm the effectiveness of acupuncture, more clinical studies are often required. Therefore, it is necessary to report high-quality and complete descriptions of acupuncture in clinical trials. This study aims to assess the overall reporting quality of acupuncture for chronic pain in randomized controlled trials (RCTs).MethodsThree databases from inception to March 2020 were searched, to assess the quality of acupuncture reports included the RCTs based on the pain-specific supplement to Consolidated Standards for Reporting Trials (CONSORT) and Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) guidelines. The quality of sham acupuncture descriptions was evaluated based on the Template for Intervention Description and Replication (TIDieR)-placebo checklist. Descriptive statistics and analysis of the results were carried out according to the percentage of each item.ResultsA total of 74 RCTs were included which met the inclusion criteria. Based on the pain-specific CONSORT, the reporting rates of “Statistical methods”, “Participant flow”, and “Blinding” were “52.70%”, “70.27%”, and “77.03%”, respectively. The weakest reported items in STRICTA were related to the depth of insertion (Item 2c, 54.05%) and the setting and context of treatment (Item 4b, 0.00%). Based on the TIDieR-placebo checklist, the reporting rates of “Item 12”, “Item 11”, “Item 13”, “Item 3”, and “Item 4” were “8.11%”, “10.81%”, “29.73%”, “ 44.59% ”, and “47.30%”, respectively.ConclusionAt present, the overall report quality of acupuncture treatment for chronic pain in English journals is acceptable, but the report rate in some aspects is still low. In the future, researchers should report RCTs of acupuncture following cleaner checklists and guidelines.

Reporting quality of RCTs of acupuncture for vascular dementia

To evaluate the reporting quality of randomized controlled trials (RCTs) of acupuncture for vascular dementia. The RCTs of acupuncture for vascular dementia were systematically retrieved from the Cochrane Library, PubMed, EMbase, CNKI, SinoMed, VIP and Wanfang databases from the date of establishment to October 31, 2018. The reporting quality of RCT was evaluated based on the internationally-recognized Consolidated Standards for Reporting of Trials (CONSORT) statement and Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA). A total of 33 RCTs were included. According to the CONSORT statement, 12 items had a reporting rate of 0%, including important changes to methods after trial commencement, sample size, blind method, trial registry, etc.; 5 items had a reporting rate of below 10%, including trial design, type of randomization, random allocation sequence, randomization implementation and participant flow. The reporting rate was 36.36% for baseline data and 57.58% for randomization sequence generation. According to the STRICTA statement, the reporting rate was 21.21% for description of acupuncture depth, 60.61% for description of acupuncture response, 27.27% for description of additional intervention details and 0% for qualification of acupuncturists, respectively. At present, the reporting quality of RCTs of acupuncture for vascular dementia is generally low. In the future, the RCTs of acupuncture for vascular dementia should be normatively reported according to the CONSORT statement and STRICTA statement.

Acupuncture versus Various Control Treatments in the Treatment of Migraine: A Review of Randomized Controlled Trials from the Past 10 Years.

BackgroundMigraine is defined as a recurrent headache of moderate to severe intensity that seriously affects the quality of life. Recent clinical trials have confirmed that acupuncture is effective in treating migraine. We aimed to review the effectiveness of acupuncture in the treatment of migraine by comparing treatment and various control groups in accordance with the newly published guidelines for systematic reviews.Materials and MethodsThe following databases were searched for relevant articles published from January 1, 2010 to December 31, 2019: Embase, PubMed, Medline, Cochrane Library, and four Chinese databases. The present review included randomized controlled trials in which acupuncture was the sole treatment or an adjunctive treatment for migraine. Two researchers independently conducted the study selection, data extraction, and quality assessment processes. Disagreements between reviewers were solved by discussion and data reanalysis. The quality of each included study was evaluated using the Cochrane Collaboration risk-of-bias assessment method and the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) checklist.ResultsForty-nine studies were analyzed and ranked based on the latest STRICTA and Cochrane Collaboration risk-of-bias assessment standards. The analysis revealed that acupuncture reduced headache frequency compared with no treatment (mean difference [MD] = −1.80, P < 0.00001, 95% confidence interval [CI] −2.34 to −1.26) and western medicine (MD = −1.75, P = 0.003, 95% CI −2.91 to −0.58). Headache frequency did not significantly differ between patients who received real acupuncture versus those who received sham acupuncture (MD = −0.64, P = 0.24, 95% CI −1.70 to 0.42).ConclusionThe present review evaluated the current research on the use of acupuncture for migraine, compared with various control treatments. The evidence for the effectiveness of acupuncture in controlling migraine is still limited due to the low quality of the published studies.

Reporting quality of randomized controlled trials of acupuncture for cancer pain

Based on the internationally-recognized Consolidated Standards for Reporting of Trials (CONSORT) statement and Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA), the reported quality of randomized controlled trials (RCTs) of acupuncture for cancer pain during last 10 years were evaluated. The RCTs of acupuncture for cancer pain were searched by computer. The English databases included PubMed and EMbase while the Chinese databases included CNKI, Wanfang, VIP and SinoMed. The publication date of the literature was from March 2009 to March 2019. As a result, 22 Chinese RCTs and 13 English RCTs were included. According to the CONSORT statement, among the Chinese studies, 1 RCT reported primary and secondary outcomes, 8 RCTs reported randomization, none of RCTs reported allocation concealment and blind method, and 4 RCTs reported baseline data; among the English studies, 8 RCTs reported primary and secondary outcomes, 8 RCTs reported randomization, 6 RCTs reported described allocation concealment, 7 RCTs reported blind method, and 13 RCTs reported baseline data. According to the STRICTA statement, among the Chinese studies, 17 RCTs reported the name of acupoints, 6 RCTs reported depth of insertion, 17 RCTs reported acupuncture response sought, and none of RCTs reported the qualifications of acupuncturists; among the English studies, 12 RCTs reported the name of acupoints, 7 RCTs reported depth of insertion, 8 RCTs reported acupuncture response sought, and 7 RCTs reported the qualifications of acupuncturists. The Chinese RCTs have more detailed description of acupuncture intervention and theory, but not enough attention is paid to methodological description such as randomization, blindness, data analysis. On the other hand, the English RCTs have better description of methodology, but the description of theory and details of acupuncture is relatively weak. It is concluded that more efforts were needed to further improve the clinical trial design according to the CONSORT statement and STRICTA statement to improve the quality of clinical evidence.

Systematic review and meta-analysis of effects of acupuncture on pain and function in non-specific low back pain.

To assess the effectiveness of acupuncture for non-specific low back pain (NSLBP) through systematic review of published randomised controlled trials (RCTs). Studies were identified in electronic databases from their inception to February 2018, and were grouped according to the control interventions. The outcomes of interest were pain intensity and disability. Methodological quality was evaluated using the Cochrane risk-of-bias criteria and the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) checklist. The review was reported according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. 25 trials (n=7587 participants) were identified and included in a meta-analysis. The results showed that acupuncture was more effective at inducing pain relief than: no treatment (standardised mean difference (SMD) -0.69, 95% CI -0.99 to -0.38); sham acupuncture in the immediate term (SMD -0.33, 95% CI -0.49 to -0.18), short term (SMD -0.47, 95% CI -0.77 to -0.17), and intermediate term (SMD -0.17, 95% CI -0.28 to -0.05); and usual care in the short term (SMD -1.07, 95% CI -1.81 to -0.33) and intermediate term (SMD -0.43, 95% CI -0.77 to -0.10). Also, adjunctive acupuncture with usual care was more effective than usual care alone at all time points studied. With regard to functional improvement, the analysis showed a significant difference between acupuncture and no treatment (SMD -0.94, 95% CI -1.57 to -0.30), whereas the other control therapies could not be assessed. We draw a cautious conclusion that acupuncture appears to be effective for NSLBP and that acupuncture may be an important supplement to usual care in the management of NSLBP.

Classic Chinese Acupuncture versus Different Types of Control Groups for the Treatment of Chronic Pain: Review of Randomized Controlled Trials (2000-2018).

Objective To review the effectiveness of classic Chinese acupuncture in the treatment of chronic pain by comparing treatment groups with different types of control groups in accordance with the newly published guidelines for systematic reviews. Methods We searched EMBASE, PubMed, and the Cochrane Central Register of Controlled Trials databases from 2000 to 2018. We included randomized controlled trials that included acupuncture as the sole treatment or as an adjunctive treatment for chronic pain. The outcome was pain intensity measured by the visual analogue scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale, 11-point numeric rating scale (NRS), and other tools. Two researchers conducted the study selection, data extraction, and quality assessment processes independently. Disagreements were solved by discussion and reanalysis of the data. The quality of all included studies was evaluated using the CBNG (the Cochrane Back and Neck Group) and the STRICTA (Standards for Reporting Interventions in Controlled Trials of Acupuncture) checklists. Results Sixty-one studies were fully analyzed and ranked based on the newest STRICTA and CBNG standards. We found good evidence that receiving acupuncture is better than not receiving treatment or being placed on a waiting list and reasonable evidence that it is better than conventional or usual care. Limited evidence was found regarding placebo treatments that involve the expectation of needling (real or fake). Conclusion Sham acupuncture may not be appropriate as a control intervention for assessing the effectiveness of acupuncture. Acupuncture effectiveness in controlling chronic pain is still limited due to the low quality of the studies published.

Literature quality analysis of RCTs regarding acupuncture for chronic neck pain

The internationally-accepted Consolidated Standards for Reporting of Trials (CONSORT) and Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) were applied to evaluate the literature quality of randomized controlled trials (RCTs) regarding acupuncture for chronic neck pain in past 10 years. The literature of RCTs regarding acupuncture for chronic neck pain was searched by computer; the English literature was searched in PubMed and EMbase, while the Chinese literature was searched in CNKI, Wanfang database, VIP database and China Biomedical Literature Database. The literature published from January 2008 to January 2018 was searched. As a result, 29 Chinese articles and 10 English articles were included. According to CONSORT, among Chinese articles, 28 articles (96.6%) described baseline data, 23 articles (79.3%) described randomization, 0 articles (0.0%) described allocation concealment, 3 articles (10.3%) described blind method; among English articles, 6 articles (60.0%) described baseline data, 8 articles (80.0%) described randomization, 8 articles (80.0%) described allocation concealment, and 7 articles (70.0%) described blind method. According to STRICTA, among Chinese articles, 8 articles (27.6%) described needle instrument selection, 18 articles (62.1%) described needle depth, 24 articles (82.8%) described needling sensation, and 0 articles (0.0%) described acupuncturist' qualifications; among English articles, 5 articles (50.0%) described needle instrument selection, 8 articles (80.0%) described needle depth, 3 articles (30.0%) described needling sensation, and 4 articles (40.0%) described acupuncturist' qualifications. In conclusion, the reporting of acupuncture details in Chinese literature is superior to that in English literature, while the reporting of trial design in English literature is slightly superior to that in Chinese literature. Moreover, both Chinese and English literature need to further improve clinical trial design to improve the reporting quality of clinical evidence based on CONSORT and STRICTA.

Zusanli (ST36) Acupoint Injection for Diabetic Peripheral Neuropathy: A Systematic Review of Randomized Controlled Trials.

Background: Acupuncture point (acupoint) injection is a common practice in China. Some trials showed that Chinese herbal extracts and/or conventional medication are injected at the Zusanli (ST36) acupoint for the treatment of diabetic peripheral neuropathy (DPN). The study aimed to assess the effectiveness and safety of acupoint injection for DPN at the ST36 by systematically evaluating the evidence published to date. Methods: Six databases were searched for randomized controlled trials (RCTs) of ST36 injection for DPN with primary outcome of pain, global symptom improvement, and quality of life. Methodological quality was assessed by the Cochrane risk of bias (ROB) tool. Data were analyzed using RevMan 5.3. Results: Fourteen RCTs involving 1,071 participants with DPN were included. All RCTs were assessed as unclear or high ROB. Few RCTs adequately reported methodology-related items and needling details according to Consolidated Standards of Reporting Trials (CONSORT) and Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) statement. Medications injected at ST36 included conventional medications (11 RCTs) and Chinese herbal extracts (3 RCTs). The authors of this study did not perform any meta-analysis due to the heterogeneity of medications used for injections. Two individual RCTs favored ST36 injection in relieving pain compared with intramuscular injection of the same medication. For global symptom measured by Toronto clinical scoring system, one RCT showed that ST36 injection of Fufang Danggui was more effective than intramuscular injection of vitamin B12, two RCTs demonstrated that ST36 injection of mecobalamin or Danhong with cointervention was superior, while one RCT showed no significant differences between ST36 injection and intramuscular injection of mecobalamin. For improving nerve conduction velocity (NCV), three of four individual RCTs showed that ST36 injection was better than intramuscular or intravenous injection of the same medication, two RCTs favored ST36 injection with cointervention, and one RCT favored ST36 injection without cointervention. Four RCTs reported monitoring adverse events, all of which showed no significant difference between groups. Conclusions: Limited evidence suggests that ST36 injection appears to be safe, and potentially effective in reducing pain score and improving NCV compared with intramuscular injection of the same medication. However, poor methodological and reporting quality reduced confidence in the findings. Rigorously designed and well-reported RCTs evaluating the effectiveness of ST36 injection for DPN are warranted.

The impact of STRICTA and CONSORT on reporting of randomised control trials of acupuncture: a systematic methodological evaluation

BackgroundClear and unambiguous reporting is essential for researchers and clinicians to be able to assess the quality of research. To enhance the quality of reporting, consensus-based reporting guidelines are commonly...

Analysis on Randomized Controlled Trials for Acupuncture Treatment of Simple Obesity Collected from PubMed

To analyze studies published in journals included in PubMed in terms of randomized controlled trials (RCTs) examining the therapeutic effect of acupuncture for simple obesity, so as to provide a reference for subsequent RCT-related designs and results. RCT literature about acupuncture treatment of simple obesity from the PubMed database and from 2000 to 2016 was retrieved by using keywords of "obesity" "fat" "acupuncture" "joint application of acupuncture and herbal medicine" or "auricular point" "electroacupuncture", "acupoint application", or "cupping", followed by screening, extraction and evaluation of the design methodology and outcomes using Consolidated Standards for Reporting of Trials (CONSORT) and Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA). Fourteen articles from six countries in Asia examining the therapeutic effect of acupuncture in the treatment of simple obesity mainly by using acupoints of the Stomach Meridian were included. Generally, acupuncture was found to be more effective than sham acupuncture. However, PubMed did not include any RCTs comparing acupuncture with western medicine for weight loss and many problems (as details of needling manipulation, etc.) remained in the the research reports available in the database. All the existing RCTs generally affirm the positive efficacy of acupuncture for simple obesity, but high-quality RCTs, particularly those comparing acupuncture with western medicines for weight loss are lacking.

Updated systematic review and meta-analysis of acupuncture for chronic knee pain.

To assess the effectiveness and safety of acupuncture for the treatment of chronic knee pain (CKP). We searched the MEDLINE, EMBASE, Cochrane CENTERAL, CINAHL and four Chinese medical databases from their inception to June 2017. We included randomised controlled trials of acupuncture as the sole treatment or as an adjunctive treatment for CKP. The primary outcome was pain intensity measured by visual analogue scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale and 11-point numeric rating scale. Secondary outcome measurements included the 36-Item Short Form Health Survey and adverse events. The quality of all included studies was evaluated using the Cochrane risk-of-bias criteria and the STRICTA (Standards for Reporting Interventions in Controlled Trials of Acupuncture) checklist. Nineteen trials were included in this systematic review. Of these, data from 17 studies were available for analysis. Regarding the effectiveness of acupuncture alone or combined with other treatment, the results of the meta-analysis showed that acupuncture was associated with significantly reduced CKP at 12 weeks on WOMAC pain subscale (mean difference (MD) -1.12, 95% confidence interval (CI) -1.98 to -0.26, I2=62%, 3 trials, 608 participants) and VAS (MD -10.56, 95% CI -17.69 to -3.44, I2=0%, 2 trials, 145 patients). As for safety, no difference was found between the acupuncture and control groups (risk ratio 1.08, 95% CI 0.54 to 2.17, I2=29%). From this systematic review, we conclude that acupuncture may be effective at relieving CKP 12 weeks after acupuncture administration, based on the current evidence and our protocol. However, given the heterogeneity and methodological limitations of the included trials, we are currently unable to draw any strong conclusions regarding the effectiveness of acupuncture for chronic knee pain. In addition, we found that acupuncture appears to have a satisfactory safety profile, although further studies with larger numbers of participants are needed to confirm the safety of this technique. Systematic review without language restrictions. Only a few high-quality and consistent trials could be included in this review.

Efficacy and safety of the \u201cXingnao Kaiqiao\u201d acupuncture technique via intradermal needling to treat postoperative gastrointestinal dysfunction of laparoscopic surgery: study protocol for a randomized controlled trial

BackgroundXingnao Kaiqiao acupuncture involves needling of the Neiguan (PC6), Renzhong (DU26), and Sanyinjiao (SP6) acupoints. The technique has a significant clinical effect in many neurological diseases. In the present report, we have developed a protocol for a scientific trial to analyze whether Xingnao Kaiqiao can be used to treat gastrointestinal dysfunction after laparoscopic surgery. In this context, we intend to execute a double-blind, randomized controlled trial to assess the efficacy and safety of Xingnao Kaiqiao acupuncture via intradermal needling.Methods/designThis will be a single-center, double-blind, randomized controlled clinical trial. It has been designed on the basis of the Consolidated Standards of Reporting Trials (CONSORT 2010) guidelines and the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA). The subjects will be recruited from among inpatients scheduled for laparoscopic surgery at the Department of Minimally Invasive Surgery, Tianjin Nankai Hospital, Tianjin, China. Using random numbers generated in SPSS 19.0, the recruited subjects will be allocated to either the “Xingnao Kaiqiao” group or the sham stimulation group. A specially appointed investigator will be in charge of the randomization. Xingnao Kaiqiao via intradermal needling (or sham needling) will be administered 6 h after laparoscopic surgery, and then every 12 h for a total of six sessions, each of which will last 3 min. The subjects will undergo their first evaluation shortly before the first treatment (6 h after laparoscopic surgery); evaluations will be repeated every 12 h until a total of seven evaluations have been completed. The primary outcome will be the time until the first postoperative flatus. The secondary outcomes will be: the time until the first postoperative defecation; levels of abdominal pain, abdominal distension, and nausea; blood ghrelin level; occurrence of vomiting; psychological status; and quality of life.DiscussionThis upcoming randomized clinical trial was designed as a standardized method to assess the efficacy and safety of Xingnao Kaiqiao acupuncture using intradermal needles on PC6, DU26, and SP6 in the treatment of gastrointestinal dysfunction after laparoscopic surgery. We aim to provide evidence and thus improve the clinical application of this technique.Trial registrationChinese Clinical Trial Registry, ChiCTR-IOR-17010763. Registered on 2 March 2017.

Assessing the quality of reports about randomized controlled trials of scalp acupuncture treatment for vascular dementia

BackgroundThis study aimed to evaluate the quality of reports about randomized controlled trials (RCTs) of scalp acupuncture (SA) for the treatment of vascular dementia (VD).MethodA systematic search of reports published through to December 2015 was performed in eight databases. The quality of RCTs that used SA as an intervention for VD was evaluated based on the 2010 Consolidated Standards for Reporting of Trials (CONSORT) and 2010 Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) guidelines. Thirteen items from the CONSORT guideline were scored to give an overall quality score (OQS, range 0–13), and a combined key methodological index score (MIS) (range 0–5) of five key methodological items was measured. The OQS of 17 items from the STRICTA guideline (range 0–17) was also measured.ResultsIn total, 26 reports were evaluated. The median OQS based on the CONSORT guideline was 8 (minimum 5, maximum 11), and “trial design,” “sample size,” “ancillary analyses,” and “harms” had a positive rate of less than 10%. The median MIS was 2 (minimum 0, maximum 5), with “allocation concealment and implementation,” “blinding,” and “intent-to-treat analysis” having a positive rate of less than 15%. The median OQS based on the STRICTA guideline was 12 (minimum 8, maximum 14), with “extent to which treatment was varied (1c),” “number of needle insertions per subject per session (2a),” and “setting and context of treatment (4b)” having a positive rate of less than 10%.ConclusionsThe overall quality of reports on RCTs of SA treatment for VD was moderate to low. The quality of methodological items was markedly lower than that of other items. The CONSORT and STRICTA guidelines should be used more frequently to standardize the quality of RCT reports of SA treatment for VD.

Assessment of Reporting Quality in Randomised Controlled Trials of Acupuncture for Post-Stroke Rehabilitation Using the Consort Statement and Stricta Guidelines

To evaluate the completeness of reporting of randomised controlled trials (RCTs) of acupuncture for post-stroke rehabilitation in order to provide information to facilitate transparent and more complete reporting of acupuncture RCTs in this field. Multiple databases were searched from their inception through September 2015. Quality of reporting for included papers was assessed against a subset of criteria adapted from the Consolidated Standards for Reporting Trials (CONSORT) 2010 statement and the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) guidelines. Each item was scored 1 if it was reported, or 0 if it was not clearly stated. Descriptive statistical analysis was performed. Cohen's κ-statistics were calculated to assess agreement between the two reviewers. A total of 87 RCTs were included in the full text. Based on CONSORT, good reporting was evident for items ''Randomised' in the title or abstract', 'Participants', 'Statistical methods', 'Recruitment', 'Baseline data', and 'Outcomes and estimation', with positive rates >80%. However, the quality of reporting for the items 'Trial design', 'Outcomes', 'Sample size', 'Allocation concealment', 'Implementation', 'Blinding', 'Flow chart', 'Intent-to-treat analysis', and 'Ancillary analyses' was very poor with positive rates <10%. Based on STRICTA, the items 'Number of needle insertions per subject per session', 'Responses sought', and 'Needle type' had poor reporting with positive rates <50%. Substantial agreement was observed for most items and good agreement was observed for some items. The reporting quality of RCTs in acupuncture for post-stroke rehabilitation is unsatisfactory and needs improvement.

Acupuncture for enhancing early recovery of bowel function in cancer

Cancer patients undergoing surgical procedure often suffer from bowel dysfunction and postoperative ileus (POI). Cancer management for early recovery of bowel function is still a challenging topic. Acupuncture has been commonly used in a variety of gastrointestinal diseases. The aim of this study is to evaluate the effects of acupuncture therapy to reduce the duration of POI and enhance bowel function in cancer patients. We will systematically screen all randomized controlled trials (RCTs) published through electronically and hand searching. The following search engines including Medline, EMBASE, Cochrane CENTRAL, the Cumulative Index to Nursing and Allied Health Literature, Allied and Complementary Medicine Database, the Chinese Biomedical Literature Database, the China National Knowledge Infrastructure, VIP Information, Wanfang Data, one Japanese database (Japan Science and Technology Information Aggregator, Electronic) and 2 Korean Medical Databases (Korean Studies Information, and Data Base Periodical Information Academic) will be retrieved. Supplementary sources will be searched including gray literature, conference proceedings, and potential identified publications. Two reviewers will independently conduct the trial inclusion, data extraction and assess the quality of studies. The time to first passing flatus and time to first bowel motion will be assessed as the primary outcomes. Adverse effects, time to first bowel sound, visual analog scale (VAS) pain score, hospital stay, and postoperative analgesic requirement will be measured as secondary outcomes. Methodological quality will be evaluated according to the Cochrane risk of bias. Details of interventions will be assessed by the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) checklist. All analyses will be applied by RevMan (version 5.3) and StataSE (version 12). This systematic review will provide up-to-date information on acupuncture therapy for early recovery of bowel function in cancer patients. This review does not require ethical approval and will be reported in a peer-reviewed journal and presented at a relevant conference. PROSPERO CRD42016049633.

Efficacy and safety of auricular point acupressure treatment for gastrointestinal dysfunction after laparoscopic cholecystectomy: study protocol for a randomized controlled trial.

BackgroundPractitioners of traditional Chinese medicine know that auricular point acupressure (APP) using vaccaria seeds on the large intestine point (CO7) has a significant effect on postoperative gastrointestinal dysfunction. A standardized, clinical, research design will transform this clinical experience into scientific evidence, thus providing a basis to promote the wider use of this therapy. We aim to carry out a double-blind, randomized, controlled trial (RCT) to evaluate the efficacy and safety of APP treatment for gastrointestinal dysfunction after laparoscopic cholecystectomy.Methods/designThis study is a randomized, double-blind, controlled, single-center, clinical, pilot trial. It has been designed according to the Consolidated Standards of Reporting Trials (CONSORT 2010) guidelines as well as the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA). Study subjects are being selected from among hospitalized patients who have undergone laparoscopic cholecystectomy at the Department of Minimally Invasive Surgery of Tianjin Nankai Hospital. Qualified subjects will be assigned randomly either to the APP group or to the APP sham stimulation group on the basis of random numbers generated using SPSS 19.0. A specifically appointed investigator will be responsible for the randomization. The APP therapy (or sham stimulation) will be performed 6 h after surgery and every 12 h subsequently; six sessions will be conducted, each lasting 3 min. The first evaluation will be performed immediately before the first treatment (6 h after surgery) and, then, every 12 h for seven evaluations. The primary outcome is the time to first passage of flatus after surgery; the secondary outcome measures are abdominal distension, nausea, vomiting, time to first defecation, psychological status, and quality of life.DiscussionThis pilot trial is a standardized, scientific, clinical trial designed to evaluate the efficacy and safety of APP treatment—using vaccaria seeds on CO7—for gastrointestinal dysfunction after laparoscopic cholecystectomy. We aim to provide objective evidence to promote this therapy in clinical practice.Trial registrationChinese Clinical Trial Registry, ChiCTR-IPR-15007643. Registered on 14 December 2015.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1404-3) contains supplementary material, which is available to authorized users.

Effectiveness of acupuncture in postoperative ileus: a systematic review and Meta-analysis

ObjectiveTo conduct a systematic review and Meta-analysis of the effectiveness of acupuncture and common acupoint selection for postoperative ileus (POI). MethodsRandomized controlled trials (RCTs) comparing acupuncture and non-acupuncture treatment were identified from the databases PubMed, Cochrane, EBSCO (Academic Source Premier and MEDLINE), Ovid (including Evidence-Based Medicine Reviews), China National Knowledge Infrastructure, and Wanfang Data. The data from eligible studies were extracted and a Meta-analysis performed using a fixed-effects model. Results were expressed as relative risk (RR) for dichotomous data, and 95% CI (confidence intervals) were calculated. Each trial was evaluated using the CONSORT (Consolidated Standards of Reporting Trials) and STRICTA (STandards for Reporting Interventions in Controlled Trials of Acupuncture) guidelines. The quality of the study was assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. ResultsOf the 69 studies screened, eight RCTs were included for review. Among these, four RCTs (with a total of 123 patients in the intervention groups and 124 patients in the control groups) met the criteria for Meta-analysis. The Meta-analysis results indicated that acupuncture combined with usual care showed a significantly higher total effective rate than the control condition (usual care) (RR 1.09, 95% CI 1.01, 1.18; P = 0.02). Zusanli (ST 36) and Shangjuxu (ST 37) were the most common acupoints selected. However, the quality of the studies was generally low, as they did not emphasize the use of blinding. ConclusionThe results suggested that acupuncture might be effective in improving POI; however, a definite conclusion could not be drawn because of the low quality of trials. Further large-scale, high-quality randomized clinical trials are needed to validate these findings and to develop a standardized method of treatment. We hope that the present results will lead to improved research, resulting in better patient care worldwide.