| Title | Claps | Level | Year | L/Y |
|---|---|---|---|---|
|
Acupuncture for Chronic Severe Functional Constipation
24 auth. Zhishun Liu, Shiyan Yan, Jiani Wu, Liyun He, Ning Li, Guirong Dong, J. Fang, W. Fu, Lixin Fu, Jianhua Sun, ...
Chronic constipation affects approximately 16% of the world's 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 spontaneo…
Chronic constipation affects approximately 16% of the world's 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 patient's 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 participant's 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
Published in
Annals of Internal Medicine
|
1
|
7 | 2016 |
Social Media Posts