Jiani Wu

Acupuncture for Chronic Severe Functional Constipation: A Randomized Trial

Chronic constipation affects approximately 16% of the worlds population (1), 17.1% of persons in Europe (2), 12% to 19% of those in North America (3), and 10.8% of those in Asia (1). Patients with severe chronic constipation have complete spontaneous bowel movements (CSBMs) no more than twice per week, with hard stools, frequent straining, and the sensation of incomplete evacuation (4). Most chronic constipation is functional and is associated with decreased quality of life (5). Laxatives produce only temporary relief, and constipation tends to reoccur after discontinuing medication (6, 7). Nearly half of patients are dissatisfied with their traditional therapies, such as laxatives (8). Other treatment options may include prokinetic agents. In a trial, 1 to 2 mg of prucalopride (an agonist for 5-hydroxytryptamine receptor 4) per day was reported to normalize BMs in 37.9% of patients with severe chronic constipation (9). However, the adverse cardiac effects induced by some prokinetic agents cannot be ignored (10), and their long-term effects remain unknown. A systematic review supports the use of acupuncture for chronic constipation (11), and our previous study indicates that electroacupuncture (EA) might have some sustained effects (12). However, the evidence for the therapeutic effects of acupuncture is limited because many randomized, controlled trials have had small sample sizes or other methodological limitations (11). Our goal was to determine the efficacy of EA for the treatment of chronic severe functional constipation (CSFC) over an 8-week treatment period and evaluate the maintenance of effects throughout the 12-week follow-up. We hypothesized that EA would be superior to sham EA (SA) at both end points. Methods Design Overview We conducted a multicenter, randomized, parallel, sham-controlled trial at 15 sites in China. The study duration per patient was 22 weeks: 2 weeks before randomization (baseline assessment); 8 weeks of treatment; and 12 weeks of follow-up without treatment. Researchers screened candidates for study participation, and experienced physicians at digestive or anorectal departments made diagnoses. Participants Participants were included if they met the diagnosis of functional constipation based on the Rome III diagnostic criteria for functional gastrointestinal disorders (13), had CSFC with 2 or fewer mean weekly CSBMs for more than 3 months, were aged between 18 and 75 years, had not taken constipation medication for a minimum of 2 weeks before enrollment except for rescue medicine (glycerol or sorbitol anal enema), had not received acupuncture for constipation, and had not participated in any other trial in the previous 3 months. The exclusion criteria were constipation caused by irritable bowel syndrome or drugs or that was secondary to endocrine, metabolic, neurologic, or postoperative diseases; severe cardiovascular, hepatic, or renal diseases; cognitive dysfunction, aphasia, mental disorders, or illness that could affect patient cooperation; pregnant or lactating women; abdominal aortic aneurysm or hepatosplenomegaly; blood coagulation disorders or regular anticoagulant use, including warfarin or heparin (an exception was antiplatelet treatment using aspirin or clopidogrel); and cardiac pacemaker implantation. Candidates signed informed consent. After the 2-week baseline assessment, eligible participants were randomly assigned and received their first treatment on the same day. The study was performed according to common guidelines for clinical trials (Declaration of Helsinki and International Conference on Harmonisation Good Clinical Practice E6 guidance). The study protocol (14) adhered to the Standards for Reporting Interventions in Clinical Trials of Acupuncture guidelines and was approved by the ethics committees of each responsible site. Randomization and Blinding Participants were allocated to the EA or SA group using stratified block randomization. The randomization sequences were generated by using PROC PLAN in SAS, version 9.4 (SAS Institute), with the study site as the stratification factor and the block length as 4. Acupuncturists obtained each patients random number and assignment through the central randomization system (Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences). All participants were treated separately to prevent communication. Except for acupuncturists, all relevant parties were blinded to the intervention (EA vs. SA) groups. Participants were informed that they had an equal chance of allocation to the EA or SA group before study participation. To test the success of blinding, we randomly selected 140 participants (70 from each group, with 9 to 10 participants at each site) for the blinding assessment; the acupuncturists asked them to guess whether they received EA or SA after treatments in weeks 4 and 8. Intervention Study interventions were developed by the consensus of acupuncture experts and per the results of our pilot study (Cai Y, Wu J, Liu Z. Electroacupuncture versus sham electroacupuncture for chronic severe functional constipation: a randomized controlled pilot study. 2012. Unpublished data.). Fifteen acupuncturists with 2 to 3 years of experience at the 15 sites administered the EA and SA treatments. All acupuncturists had at least a 5-year undergraduate education and were registered practitioners of traditional Chinese medicine. All research assistants and acupuncturists received a 2-day training session before study initiation. Both treatments consisted of 28 sessions, each for 30 minutes, and were administered over 8 weeks (5 sessions in each of the first 2 weeks, and 3 sessions in each of the remaining 6 weeks). Disposable needles (Huatuo) and the SDZ-V EA apparatus (Suzhou Medical Appliance) were used. Participants in the EA group received EA at the bilateral acupoints of Tianshu (ST25), Fujie (SP14), and Shangjuxu (ST37) (15). When participants were supine, 0.3050mm or 0.3575mm needles were inserted approximately 30 to 70 mm into ST25 and SP14 slowly and vertically, without manipulation, until they pierced the muscle layer of the abdominal wall. Paired alligator clips from the EA apparatus were attached transversely to the needle holders at bilateral ST25 and SP14. The EA stimulation lasted for 30 minutes with a dilatational wave of 10/50 Hz and a current intensity of 0.1 to 1 mA depending on the participants comfort level (preferably with skin around the acupoints shivering mildly without pain). In addition, 0.3040mm needles were inserted vertically about 30 mm into ST37 and 3 small, equal manipulations of twirling, lifting, and thrusting (once every 10 minutes) were performed to reach acupuncture de qia soreness, heaviness, and distension sensation when needling (16). Participants in the SA group received shallow needling at bilateral sham ST25, sham SP14, and sham ST37 (nonacupoints that were located at different physical locations than ST25, SP14, and ST37 for EA) (Supplement). Specifically, 0.3025mm needles were inserted vertically about 3 to 5 mm into nonacupoints without manipulation. Similar to EA, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders of sham ST25 and sham SP14. When switched on, the EA apparatus in the SA group had the same working power indicator and sound without actual current output. Supplement. Data Supplement In both groups, participants without BMs for 3 or more consecutive days were allowed to use 110-mL glycerol or 40- to 60-mL sorbitol anal enema as rescue medicine with documentation in the stool diary. Outcomes and Follow-up Participants completed a stool diary during the 22-week study period and the Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL) (17) at baseline and weeks 4 and 8. The main components of the stool diary included BMs, SBMs, CSBMs, stool consistency, straining, and medication use. Participants documented their stool consistency according to the Bristol Stool Form Scale (18) (scored from 1 to 7 for stool types 1 to 7, respectively). Straining was rated with scores of 0, 1, 2, and 3 indicating not difficult; a little difficult, need some straining to defecate; difficult, need straining to defecate; and very difficult, need hard straining to defecate, respectively. An SBM was defined as a BM that occurred without use of any medication or other methods to assist defecation in the previous 24 hours (4). A BM was not considered as an SBM when it occurred within 24 hours after the use of any assisted method for defecation. The PAC-QOL allowed participants to score the effects of constipation on physical discomfort, psychosocial discomfort, worriedness and concerns, and satisfaction in their daily lives. Higher scores indicate greater impairment or dissatisfaction. The primary outcome was the change from baseline in mean CSBMs per week, calculated as the total number of CSBMs divided by the number of weeks in the assessment period, during weeks 1 to 8. Secondary outcomes included the changes from baseline in mean CSBMs per week during weeks 9 to 20, mean SBMs per week during weeks 1 to 8, mean scores for stool consistency and straining of SBMs during weeks 1 to 8, and health-related quality of life via PAC-QOL score at weeks 4 and 8; the proportion of participants with 3 or more mean CSBMs per week (4); the proportion of participants using rescue medicine and other defecation measures; and the mean weekly frequency of using rescue medicine and other defecation aids during weeks 1 to 4, 1 to 8, and 9 to 20. We also assessed the CSBMs per week and their change from baseline during treatment and follow-up (not prespecified). Adverse events (AEs) were appropriately assessed, managed, and categorized by the acupuncturists and related clinical specialists within 24 hours. Severe AEs had to be reported to the principal investigator and the independent data and safety monitoring

Effect of Electroacupuncture on Urinary Leakage Among Women With Stress Urinary Incontinence: A Randomized Clinical Trial

Importance Electroacupuncture involving the lumbosacral region may be effective for women with stress urinary incontinence (SUI), but evidence is limited. Objective To assess the effect of electroacupuncture vs sham electroacupuncture for women with SUI. Design, Setting, and Participants Multicenter, randomized clinical trial conducted at 12 hospitals in China and enrolling 504 women with SUI between October 2013 and May 2015, with data collection completed in December 2015. Interventions Participants were randomly assigned (1:1) to receive 18 sessions (over 6 weeks) of electroacupuncture involving the lumbosacral region (n = 252) or sham electroacupuncture (n = 252) with no skin penetration on sham acupoints. Main Outcomes and Measures The primary outcome was change from baseline to week 6 in the amount of urine leakage, measured by the 1-hour pad test. Secondary outcomes included mean 72-hour urinary incontinence episodes measured by a 72-hour bladder diary (72-hour incontinence episodes). Results Among the 504 randomized participants (mean [SD] age, 55.3 [8.4] years), 482 completed the study. Mean urine leakage at baseline was 18.4 g for the electroacupuncture group and 19.1 g for the sham electroacupuncture group. Mean 72-hour incontinence episodes were 7.9 for the electroacupuncture group and 7.7 for the sham electroacupuncture group. At week 6, the electroacupuncture group had greater decrease in mean urine leakage (−9.9 g) than the sham electroacupuncture group (−2.6 g) with a mean difference of 7.4 g (95% CI, 4.8 to 10.0; P < .001). During some time periods, the change in the mean 72-hour incontinence episodes from baseline was greater with electroacupuncture than sham electroacupuncture with between-group differences of 1.0 episode in weeks 1 to 6 (95% CI, 0.2-1.7; P = .01), 2.0 episodes in weeks 15 to 18 (95% CI, 1.3-2.7; P < .001), and 2.1 episodes in weeks 27 to 30 (95% CI, 1.3-2.8; P < .001). The incidence of treatment-related adverse events was 1.6% in the electroacupuncture group and 2.0% in the sham electroacupuncture group, and all events were classified as mild. Conclusions and Relevance Among women with stress urinary incontinence, treatment with electroacupuncture involving the lumbosacral region, compared with sham electroacupuncture, resulted in less urine leakage after 6 weeks. Further research is needed to understand long-term efficacy and the mechanism of action of this intervention. Trial Registration clinicaltrials.gov Identifier: NCT01784172.

Electroacupuncture for Moderate and Severe Benign Prostatic Hyperplasia: A Randomized Controlled Trial

Purpose To evaluate the effects of electroacupuncture (EA) on the International Prostate Symptom Score (IPSS), postvoid residual urine (PVR), and maximum urinary flow rate (Qmax), and explore the difference between EA at acupoints and non-acupoints in patients with moderate to severe benign prostate hyperplasia (BPH). Subjects and Methods Men with BPH and IPSS ≥8 were enrolled. Participants were randomly allocated to receive EA at acupoint (treatment group, n = 50) and EA at non-acupoint (control group, n = 50). The primary outcome measure includes the change of IPSS at the 6th week and the secondary outcome measures include changes of PVR and Qmax at the 6th week and change of IPSS at the 18th week. Results 100/192 patients were included. At the 6th week, treatment group patients had a 4.51 (p<0.001) and 4.12 (p<0.001) points greater decline in IPSS than the control group in the intention to treat (ITT) and per-protocol (PP) populations. At the 18th week, a 3.2 points (p = 0.001) greater decline was found in IPSS for the treatment. No significant differences were found between the two groups in Qmax at the 6th week (p = 0.819). No significant difference was observed in PVR (P = 0.35). Conclusion Acupoint EA at BL 33 had better effects on IPSS, but no difference on PVR and Qmax as compared with non-acupoint EA. The results indicate that EA is effective in improving patients quality of life and acupoint may have better therapeutic effects than non-acupoints in acupuncture treatments of BPH. Trial Registration ClinicalTrials.gov NCT01218243.

Effect and safety of deep needling and shallow needling for functional constipation: a multicenter, randomized controlled trial.

AbstractAupuncture 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.

A Pilot Randomized Placebo Controlled Trial of Electroacupuncture for Women with Pure Stress Urinary Incontinence.

Background Acupuncture is a potential conservative therapy for women with stress urinary incontinence (SUI). There is limited evidence to support its effectiveness due to the poor quality of existing studies. Methods We performed a pilot randomized, controlled trial to preliminarily assess the efficacy of electroacupuncture (EA) in women with pure SUI. A total of 80 women with pure SUI were randomly assigned to receive EA with deep needling at BL33 and BL35 (n = 40) or sham EA with non-penetrating needling at sham acupoints (n = 40) three sessions per week for 6 weeks. The women were followed for 24 weeks. The primary outcome was the change from baseline in the amount of urine leakage measured by a 1-hour pad test after 6 weeks. The secondary outcomes included the 72-hour incontinence episode frequency (IEF), International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) score, and patient self-evaluation of therapeutic effect. Adverse events (AEs) were monitored throughout the trial. Results The median decrease from baseline of urine leakage measured by the 1-hour pad test was 2.5 g [interquartile range (IQR): 1.80–14.6 in the EA group, which was greater than the median decrease of 0.05 g (IQR: -2.80–+0.50) in the sham EA group after 6 weeks (p<0.01). The differences between groups in the decrease from baseline of 72-hour IEF became statistically significant at week 30 with a median decrease of 3.25 g (IQR: 1.25–5.69) in the EA group, and a median decrease of 1.00 g (IQR: -0.69–+2.88) in the sham EA group (p = 0.01). The participants in the EA group showed greater decreases in ICIQ-SF score and higher ratings in the help they received from the treatment than those in the sham EA group at weeks 6,18 and 30 (all p<0.05). No obvious AEs were observed in either group. Conclusion EA may effectively and safely relieve urinary incontinence symptoms and improve quality of life in women with pure SUI. EA demonstrated more than a placebo effect. Since this is a pilot study, results should be interpreted with caution. Trial Registration ClinicalTrials.gov NCT02445573.

Acupuncture for Chronic Severe Functional Constipation: A Randomized, Controlled Trial.

Chronic constipation affects approximately 16% of the worlds population (1), 17.1% of persons in Europe (2), 12% to 19% of those in North America (3), and 10.8% of those in Asia (1). Patients with severe chronic constipation have complete spontaneous bowel movements (CSBMs) no more than twice per week, with hard stools, frequent straining, and the sensation of incomplete evacuation (4). Most chronic constipation is functional and is associated with decreased quality of life (5). Laxatives produce only temporary relief, and constipation tends to reoccur after discontinuing medication (6, 7). Nearly half of patients are dissatisfied with their traditional therapies, such as laxatives (8). Other treatment options may include prokinetic agents. In a trial, 1 to 2 mg of prucalopride (an agonist for 5-hydroxytryptamine receptor 4) per day was reported to normalize BMs in 37.9% of patients with severe chronic constipation (9). However, the adverse cardiac effects induced by some prokinetic agents cannot be ignored (10), and their long-term effects remain unknown. A systematic review supports the use of acupuncture for chronic constipation (11), and our previous study indicates that electroacupuncture (EA) might have some sustained effects (12). However, the evidence for the therapeutic effects of acupuncture is limited because many randomized, controlled trials have had small sample sizes or other methodological limitations (11). Our goal was to determine the efficacy of EA for the treatment of chronic severe functional constipation (CSFC) over an 8-week treatment period and evaluate the maintenance of effects throughout the 12-week follow-up. We hypothesized that EA would be superior to sham EA (SA) at both end points. Methods Design Overview We conducted a multicenter, randomized, parallel, sham-controlled trial at 15 sites in China. The study duration per patient was 22 weeks: 2 weeks before randomization (baseline assessment); 8 weeks of treatment; and 12 weeks of follow-up without treatment. Researchers screened candidates for study participation, and experienced physicians at digestive or anorectal departments made diagnoses. Participants Participants were included if they met the diagnosis of functional constipation based on the Rome III diagnostic criteria for functional gastrointestinal disorders (13), had CSFC with 2 or fewer mean weekly CSBMs for more than 3 months, were aged between 18 and 75 years, had not taken constipation medication for a minimum of 2 weeks before enrollment except for rescue medicine (glycerol or sorbitol anal enema), had not received acupuncture for constipation, and had not participated in any other trial in the previous 3 months. The exclusion criteria were constipation caused by irritable bowel syndrome or drugs or that was secondary to endocrine, metabolic, neurologic, or postoperative diseases; severe cardiovascular, hepatic, or renal diseases; cognitive dysfunction, aphasia, mental disorders, or illness that could affect patient cooperation; pregnant or lactating women; abdominal aortic aneurysm or hepatosplenomegaly; blood coagulation disorders or regular anticoagulant use, including warfarin or heparin (an exception was antiplatelet treatment using aspirin or clopidogrel); and cardiac pacemaker implantation. Candidates signed informed consent. After the 2-week baseline assessment, eligible participants were randomly assigned and received their first treatment on the same day. The study was performed according to common guidelines for clinical trials (Declaration of Helsinki and International Conference on Harmonisation Good Clinical Practice E6 guidance). The study protocol (14) adhered to the Standards for Reporting Interventions in Clinical Trials of Acupuncture guidelines and was approved by the ethics committees of each responsible site. Randomization and Blinding Participants were allocated to the EA or SA group using stratified block randomization. The randomization sequences were generated by using PROC PLAN in SAS, version 9.4 (SAS Institute), with the study site as the stratification factor and the block length as 4. Acupuncturists obtained each patients random number and assignment through the central randomization system (Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences). All participants were treated separately to prevent communication. Except for acupuncturists, all relevant parties were blinded to the intervention (EA vs. SA) groups. Participants were informed that they had an equal chance of allocation to the EA or SA group before study participation. To test the success of blinding, we randomly selected 140 participants (70 from each group, with 9 to 10 participants at each site) for the blinding assessment; the acupuncturists asked them to guess whether they received EA or SA after treatments in weeks 4 and 8. Intervention Study interventions were developed by the consensus of acupuncture experts and per the results of our pilot study (Cai Y, Wu J, Liu Z. Electroacupuncture versus sham electroacupuncture for chronic severe functional constipation: a randomized controlled pilot study. 2012. Unpublished data.). Fifteen acupuncturists with 2 to 3 years of experience at the 15 sites administered the EA and SA treatments. All acupuncturists had at least a 5-year undergraduate education and were registered practitioners of traditional Chinese medicine. All research assistants and acupuncturists received a 2-day training session before study initiation. Both treatments consisted of 28 sessions, each for 30 minutes, and were administered over 8 weeks (5 sessions in each of the first 2 weeks, and 3 sessions in each of the remaining 6 weeks). Disposable needles (Huatuo) and the SDZ-V EA apparatus (Suzhou Medical Appliance) were used. Participants in the EA group received EA at the bilateral acupoints of Tianshu (ST25), Fujie (SP14), and Shangjuxu (ST37) (15). When participants were supine, 0.3050mm or 0.3575mm needles were inserted approximately 30 to 70 mm into ST25 and SP14 slowly and vertically, without manipulation, until they pierced the muscle layer of the abdominal wall. Paired alligator clips from the EA apparatus were attached transversely to the needle holders at bilateral ST25 and SP14. The EA stimulation lasted for 30 minutes with a dilatational wave of 10/50 Hz and a current intensity of 0.1 to 1 mA depending on the participants comfort level (preferably with skin around the acupoints shivering mildly without pain). In addition, 0.3040mm needles were inserted vertically about 30 mm into ST37 and 3 small, equal manipulations of twirling, lifting, and thrusting (once every 10 minutes) were performed to reach acupuncture de qia soreness, heaviness, and distension sensation when needling (16). Participants in the SA group received shallow needling at bilateral sham ST25, sham SP14, and sham ST37 (nonacupoints that were located at different physical locations than ST25, SP14, and ST37 for EA) (Supplement). Specifically, 0.3025mm needles were inserted vertically about 3 to 5 mm into nonacupoints without manipulation. Similar to EA, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders of sham ST25 and sham SP14. When switched on, the EA apparatus in the SA group had the same working power indicator and sound without actual current output. Supplement. Data Supplement In both groups, participants without BMs for 3 or more consecutive days were allowed to use 110-mL glycerol or 40- to 60-mL sorbitol anal enema as rescue medicine with documentation in the stool diary. Outcomes and Follow-up Participants completed a stool diary during the 22-week study period and the Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL) (17) at baseline and weeks 4 and 8. The main components of the stool diary included BMs, SBMs, CSBMs, stool consistency, straining, and medication use. Participants documented their stool consistency according to the Bristol Stool Form Scale (18) (scored from 1 to 7 for stool types 1 to 7, respectively). Straining was rated with scores of 0, 1, 2, and 3 indicating not difficult; a little difficult, need some straining to defecate; difficult, need straining to defecate; and very difficult, need hard straining to defecate, respectively. An SBM was defined as a BM that occurred without use of any medication or other methods to assist defecation in the previous 24 hours (4). A BM was not considered as an SBM when it occurred within 24 hours after the use of any assisted method for defecation. The PAC-QOL allowed participants to score the effects of constipation on physical discomfort, psychosocial discomfort, worriedness and concerns, and satisfaction in their daily lives. Higher scores indicate greater impairment or dissatisfaction. The primary outcome was the change from baseline in mean CSBMs per week, calculated as the total number of CSBMs divided by the number of weeks in the assessment period, during weeks 1 to 8. Secondary outcomes included the changes from baseline in mean CSBMs per week during weeks 9 to 20, mean SBMs per week during weeks 1 to 8, mean scores for stool consistency and straining of SBMs during weeks 1 to 8, and health-related quality of life via PAC-QOL score at weeks 4 and 8; the proportion of participants with 3 or more mean CSBMs per week (4); the proportion of participants using rescue medicine and other defecation measures; and the mean weekly frequency of using rescue medicine and other defecation aids during weeks 1 to 4, 1 to 8, and 9 to 20. We also assessed the CSBMs per week and their change from baseline during treatment and follow-up (not prespecified). Adverse events (AEs) were appropriately assessed, managed, and categorized by the acupuncturists and related clinical specialists within 24 hours. Severe AEs had to be reported to the principal investigator and the independent data and safety monitoring

Effect of electroacupuncture versus pelvic floor muscle training plus solifenacin for moderate and severe mixed urinary incontinence in women: a study protocol

BackgroundIn women with mixed urinary incontinence, pelvic floor muscle training and solifenacin is the recommended conservative treatment, while electroacupuncture is a safe, economical and effective option.Methods/DesignIn this prospective, multi-center, randomized controlled trial, five hundred women with mixed urinary incontinence, from 10 centers will be randomized to receive either electroacupuncture or pelvic floor muscle training plus solifenacin. Women in the acupuncture group will receive electroacupuncture for 3 sessions per week, over 12 weeks, while women in the control group will receive pelvic floor muscle training plus solifenacin (5 mg once daily) for 36 weeks. The primary outcome measure is the proportion of change in 72-hour incontinence episode frequency from baseline to week 12. The secondary outcome measures include eleven items, including proportion of participants with ≥50% decrease in average 72-h incontinence episode frequency, change from baseline in the amount of urine leakage and proportion of change from baseline in 72-h incontinence episode frequency in week 25–36, and so forth. Statistical analysis will include covariance analysis, nonparametric tests and t tests.DiscussionThe objective of this trial is to compare the efficacy and safety of electroacupuncture versus pelvic floor muscle training plus solifenacin in women with moderate and severe mixed urinary incontinence.Trial registrationClinicalTrials.gov Identifier: NCT02047032

Effect of electroacupuncture versus prucalopride for severe chronic constipation: protocol of a multi-centre, non-inferiority, randomised controlled trial

BackgroundAcupuncture is safe and may be effective for severe chronic constipation. The World Gastroenterology Organisation recommends prucalopride for patients for whom previous laxative use failed to provide satisfactory relief.Methods/designIn this prospective, multi-centre, randomised controlled trial, five hundred sixty patients with severe chronic constipation (two or less spontaneous complete bowel movements per week) from 14 centres will be randomised to receive either electroacupuncture or prucalopride. Participants in the electroacupuncture group will receive electroacupuncture for eight weeks, while participants in the control group will take prucalopride (2 mg once daily) for 32 weeks. The primary outcome measure is the proportion of patients having ≥3 spontaneous, complete bowel movements per week, averaged over week three to eight. The secondary outcome measures include eight items, including the proportion of patients having ≥3 spontaneous, complete bowel movements per week averaged over week 9–32, the proportion of patients with one or more increases in spontaneous, complete bowel movements per week from baseline, mean Bristol Stool Scale, etc. Statistical analysis will include the CMH test, nonparametric tests and t tests.DiscussionWe aimed to compare the effect of electroacupuncture versus prucalopride for severe chronic constipation. The limitation of this study is that participants and acupuncturists will not be blinded.Trial registrationClinicalTrials.gov Identifier: NCT02047045.

The efficacy and safety of electroacupuncture for women with pure stress urinary incontinence: study protocol for a multicenter randomized controlled trial

BackgroundAlthough available evidence relating to its effectiveness is weak, acupuncture is used as an alternative therapy for stress urinary incontinence. We report a protocol of a randomized controlled trial using electroacupuncture (the passing of a weak current between inserted acupuncture needles) to treat women with pure stress urinary incontinence.Methods/DesignThis is a large-scale multicenter subject-blinded randomized controlled trial. A total of 500 women with pure stress urinary incontinence will be randomly assigned to two groups: a treatment group and a control group. The treatment group will receive electroacupuncture with deep needling at acupuncture points BL33 and BL35. The control group will receive sham electroacupuncture with non-penetrating needling at sham locations for the acupuncture points of BL33 and BL35. Participants will be given three sessions a week for 6 weeks. A 24-week-long follow-up will be conducted. The primary outcome will be the change in amount of urine leakage at the sixth week from a baseline measured by a 1-h pad test. The secondary outcomes include: the 72-h incontinence episode frequency based on a 72-h bladder diary; the score of International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form; the degree of urinary incontinence based on a 72-h bladder diary; self-assessment of the therapeutic effect; weekly consumption of pads; application of other treatments for stress urinary incontinence; and subgroup analysis stratified by incontinence severity. The safety of electroacupuncture will also be assessed.DiscussionThis trial will help to identify whether electroacupuncture is effective for stress urinary incontinence, and, if so, whether it is a therapeutic effect rather than a placebo effect.Trial RegistrationClinical Trials.gov NCT01784172

Efficacy of electroacupuncture for symptoms of menopausal transition: study protocol for a randomized controlled trial

BackgroundPrevious studies have shown that acupuncture can alleviate postmenopausal symptoms, such as hot flashes, but few studies have assessed symptoms during the menopausal transition (MT) period. Thus, the effect of acupuncture upon MT symptoms is unclear. We designed a large-scale trial aimed at evaluating the efficacy of electroacupuncture for MT symptoms compared with sham electroacupuncture and at observing the safety of electroacupuncture.Methods/designIn this multicenter randomized controlled trial, 360 women will be randomized to either an electroacupuncture group or a sham electroacupuncture group. During the 8-week-long treatment, a menopause rating scale, average 24-hour hot flash score, Menopause-Specific Quality of Life Questionnaire score, and level of female hormones will be observed. Follow-ups at the 20th and 32nd week will be made.DiscussionThough there is no completely inert placebo acupuncture and blinding is difficult in acupuncture trials, the placebo effect of EA can still be partially excluded in this study. For the placebo control, we use non-points and a tailor-made sham needle. This needle is different from a retractable needle, which is usually used for sham acupuncture. The needle in this trial is more simply constructed and more acceptable to Chinese people. We expect to evaluate the efficacy of electroacupuncture for MT symptoms and clarify its effect on these symptoms.Trial registrationClinicalTrials.gov Identifier: NCT01849172 (Date of registration: 05/05/2013).