Dataset Information

Electroacupuncture for Functional Constipation: A Multicenter, Randomized, Control Trial.

ABSTRACT: Background and Aim. To investigate the efficacy and safety of electroacupuncture (EA) with different current intensities for functional constipation (FC) and to assess whether the effects of EA with different current intensities are superior to the mosapride. Methods. Patients with FC were randomly divided into low current intensity group (LCI), high current intensity group (HCI), and mosapride group (MC). The primary outcome was three or more spontaneous bowel movements (SBMs) per week and an increase of one or more SBMs from baseline during at least 3 of the 4 weeks. Results. The primary outcome was reached by 53.45%, 66.15%, and 52.24% of the patients who received LCI, HCI, and mosapride, respectively. EA can significantly improve the weekly SBMs and stool consistency and reduce straining severity (p < 0.0001, all). HCI improved the quality of life better than mosapride (p < 0.05) and reduced the proportion of severe constipation more than LCI and mosapride (p < 0.05, both). Conclusions. EA is effective and safe at both current intensities for FC; therapeutic effects of LCI and HCI are not superior to mosapride. EA is superior to mosapride in improving patients' life quality and satisfaction level of treatment; EA has fewer adverse events than mosapride.

SUBMITTER: Wu X

PROVIDER: S-EPMC5307003 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Electroacupuncture for Functional Constipation: A Multicenter, Randomized, Control Trial.

Wu Xiao X Zheng Cuihong C Xu Xiaohu X Ding Pei P Xiong Fan F Tian Man M Wang Ying Y Dong Haoxu H Zhang Mingmin M Wang Wei W Xu Shabei S Xie Minjie M Huang Guangying G

Evidence-based complementary and alternative medicine : eCAM 20170131

<i>Background and Aim</i>. To investigate the efficacy and safety of electroacupuncture (EA) with different current intensities for functional constipation (FC) and to assess whether the effects of EA with different current intensities are superior to the mosapride. <i>Methods</i>. Patients with FC were randomly divided into low current intensity group (LCI), high current intensity group (HCI), and mosapride group (MC). The primary outcome was three or more spontaneous bowel movements (SBMs) per ...[more]

PMID: 28250788

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Project description:BackgroundElectroacupuncture (EA) has been found to be effective for treating chronic severe functional constipation (CSFC). However, the initial effects of treatment usually affect the acceptability and compliance of patients with chronic disease in particular. Which class of CSFC patients will have a better initial response to EA remains uncertain and requires investigation.MethodsThis was a secondary analysis of an original multicenter randomized controlled trial in which patients with CSFC were randomly assigned to receive 28 sessions of EA or sham electroacupuncture (SA) over 8 weeks with 12 weeks of follow-up. The primary outcome, namely, response with complete spontaneous bowel movements (CSBMs), required participants to have ≥ 3 CSBMs and an increase of ≥ 1 CSBM from the baseline over the first week of treatment. Logistic regression analysis with bootstrapping techniques was performed to determine independent factors related to the response.ResultsA total of 1051 eligible patients were included in this study of whom 161 patients were classified as responders at week 1. The CSBM response rate was higher in the EA group (17.5%) than in the SA group (13.2%). And the proportion of these 1-week early responders remained to have higher clinical response at the end of 8-week treatment and 12 weeks after treatment. Age and higher baseline CSBMs were related to CSBM response within the first week: with every 1-year increase in age, the likelihood of clinical response was reduced by 1.7% (odds ratio [OR] 0.983, 95% confidence interval [CI] 0.972 to 0.993; P=0.001). The odds of a CSBM response in patients with 1< CSBMs ≤ 2 at baseline were 4.64 times higher than that in patients with CSBMs ≤ 1 (OR 4.64, 95%CI 4.01 to 5.27).ConclusionsEA produced its initial effects within the first week of treatment. And the effects could last until week 8 and week 20. A younger age and higher number of CSBMs at baseline may increase likelihood of a response.

Project description:Aupuncture is widely used for functional constipation. Effect of acupuncture might be related to the depth of needling; however, the evidence is limited. This trial aimed to evaluate the effect and safety of deep needling and shallow needling for functional constipation, and to assess if the deep needling and shallow needling are superior to lactulose. We conducted a prospective, superiority-design, 5-center, 3-arm randomized controlled trial. A total of 475 patients with functional constipation were randomized to the deep needling group (237), shallow needling group (119), and lactulose-controlled group (119) in a ratio of 2:1:1. Sessions lasted 30 minutes each time and took place 5 times a week for 4 weeks in 2 acupuncture groups. Participants in the lactulose group took lactulose orally for 16 continuous weeks. The primary outcome was the change from baseline of mean weekly spontaneous bowel movements (SBMs) during week 1 to 4 (changes from the baselines of the weekly SBMs at week 8 and week 16 in follow-up period were also assessed simultaneously). Secondary outcomes were the weekly SBMs of each assessing week, the mean score change from the baseline of constipation-related symptoms over week 1 to 4, and the time to the first SBM. Emergency drug usage and adverse effects were monitored throughout the study.SBMs and constipation-related symptoms were all improved in the 3 groups compared with baseline at each time frame (P<0.01, all). The changes in the mean weekly SBMs over week 1 to 4 were 2 (1.75) in the deep needling group, 2 (1.75) in the shallow needling group, and 2 (2) in the lactulose group (P>0.05, both compared with the lactulose group). The changes of mean weekly SBMs at week 8 and week 16 in the follow-up period were 2 (2), 2 (2.5) in the deep needling group, 2 (3), 1.5 (2.5) in the shallow needling group, and 1 (2), 1 (2) in the lactulose group (P<0.05, all compared with the lactulose group). No significant difference was observed among the 3 groups regarding the score changes of straining, incomplete evacuation, abdominal distention during spontaneous defecating, or Cleveland Clinic Scores over week 1 to 4. However, the lactulose group got better effect than other 2 acupuncture groups in improving stool consistency (P<0.01, both) and shortening the time to the first SBM (P<0.05, both). The percentage of emergency drugs used in the 2 acupuncture groups were both lower than in the lactulose group at each time frame (P<0.01, all). No obvious adverse event was observed in the deep or shallow needling group. Deep and shallow needling at Tianshu (ST25) can improve intestinal function remarkably and safely. Therapeutic effects of deep and shallow needling are not superior to that of lactulose; however, the sustained effects of deep and shallow needling after stopping the acupuncture treatments are superior to the therapeutic effect of lactulose, which might qualify the superiority of deep and shallow needling.

Project description:ImportanceOpioid-induced constipation (OIC) is prevalent among patients treated with opioids for cancer pain. Safe and effective therapies for OIC in patients with cancer remain an unmet need.ObjectiveTo determine the efficacy of electroacupuncture (EA) for OIC in patients with cancer.Design, setting, and participantsThis randomized clinical trial was conducted at 6 tertiary hospitals in China among 100 adult patients with cancer who were screened for OIC and enrolled between May 1, 2019, and December 11, 2021.InterventionsPatients were randomized to receive 24 sessions of EA or sham electroacupuncture (SA) over 8 weeks and then were followed up for 8 weeks after treatment.Main outcomes and measuresThe primary outcome was the proportion of overall responders, defined as patients who had at least 3 spontaneous bowel movements (SBMs) per week and an increase of at least 1 SBM from baseline in the same week for at least 6 of the 8 weeks of the treatment period. All statistical analyses were based on the intention-to-treat principle.ResultsA total of 100 patients (mean [SD] age, 64.4 [10.5] years; 56 men [56.0%]) underwent randomization; 50 were randomly assigned to each group. Among them, 44 of 50 patients (88.0%) in the EA group and 42 of 50 patients (84.0%) in the SA group received at least 20 (≥83.3%) sessions of treatment. The proportion of overall responders at week 8 was 40.1% (95% CI, 26.1%-54.1%) in the EA group and 9.0% (95% CI, 0.5%-17.4%) in the SA group (difference between groups, 31.1 percentage points [95% CI, 14.8-47.6 percentage points]; P < .001). Compared with SA, EA provided greater relief for most OIC symptoms and improved quality of life among patients with OIC. Electroacupuncture had no effects on cancer pain and its opioid treatment dosage. Electroacupuncture-related adverse events were rare, and, if any, all were mild and transient.Conclusions and relevanceThis randomized clinical trial found that 8-week EA treatment could increase weekly SBMs with a good safety profile and improve quality of life for the treatment of OIC. Electroacupuncture thus provided an alternative option for OIC in adult patients with cancer.Trial registrationClinicalTrials.gov Identifier: NCT03797586.

Project description:ImportanceDespite the adoption of the optimized Enhanced Recovery After Surgery (ERAS) protocol, postoperative ileus (POI) severely impairs recovery after colorectal resection and increases the burden on the health care system.ObjectiveTo assess the efficacy of electroacupuncture (EA) in reducing the duration of POI with the ERAS protocol.Design, setting, and participantsThis multicenter, randomized, sham-controlled trial was conducted in China from October 12, 2020, through October 17, 2021. There was a 1:1 allocation using the dynamic block random method, and analyses were by intention to treat. Patients 18 years or older undergoing laparoscopic resection of colorectal cancer for the first time were randomly assigned to treatment group by a central system.InterventionsPatients were randomly assigned to 4 sessions of EA or sham electroacupuncture (SA) after surgery. All patients were treated within the ERAS protocol.Main outcomes and measuresThe primary outcome was the time to first defecation. Secondary outcomes included other patient-reported outcome measures, length of postoperative hospital stay, readmission rate within 30 days, and incidence of postoperative complications and adverse events.ResultsA total of 249 patients were randomly assigned to treatment groups. After the exclusion of 1 patient because of a diagnosis of intestinal tuberculosis, 248 patients (mean [SD] age, 60.2 [11.4] years; 153 men [61.7%]) were included in the analyses. The median (IQR) time to first defecation was 76.4 (67.6-96.8) hours in the EA group and 90.0 (73.6-100.3) hours in the SA group (mean difference, -8.76; 95% CI, -15.80 to -1.73; P = .003). In the EA group compared with the SA group, the time to first flatus (median [IQR], 44.3 [37.0-58.2] hours vs 58.9 [48.2-67.4] hours; P < .001) and the tolerability of semiliquid diet (median [IQR], 105.8 [87.0-120.3] hours vs 116.5 [92.0-137.0] hours; P = .01) and solid food (median [IQR], 181.8 [149.5-211.4] hours vs 190.3 [165.0-228.5] hours; P = .01) were significantly decreased. Prolonged POI occurred in 13 of 125 patients (10%) in the EA group vs 25 of 123 patients (20%) in the SA group (risk ratio [RR], 0.51; 95% CI, 0.27-0.95; P = .03). Other secondary outcomes were not different between groups. There were no severe adverse events.Conclusions and relevanceResults of this randomized clinical trial demonstrated that in patients undergoing laparoscopic surgery for colorectal cancer with the ERAS protocol, EA shortened the duration of POI and decreased the risk for prolonged POI compared with SA. EA may be considered as an adjunct to the ERAS protocol to promote gastrointestinal function recovery and prevent prolonged POI after surgery.Trial registrationChinese Clinical Trial Registry Identifier: ChiCTR2000038444.

Dataset Information

Electroacupuncture for Functional Constipation: A Multicenter, Randomized, Control Trial.

Publications

Electroacupuncture for Functional Constipation: A Multicenter, Randomized, Control Trial.

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