N/A
Completed N=560
Effect Comparison of Electro-acupuncture and Prucalopride for Severe Chronic Constipation: a Randomized Controlled Trial
Source: ClinicalTrials.gov NCT02047045 ↗Enrolled (actual)
560
Serious AEs
0.2%
Results posted
Jan 2020
Primary outcomePrimary: the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 3-8 — 36.2; 37.8 percentage of participants
Summary
This trial is primarily aimed to compare the effect and safety of electro-acupuncture and prucalopride for severe chronic constipation: if the short-term effect of electro-acupuncture is no inferior to prucalopride? Besides, the investigators will also mainly confirm the superiority of electro-acupuncture: if the effect of electro-acupuncture can last for 3~6 months? Then, assess the patients' acceptance of electro-acupuncture.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 3-8 |
36.2; 37.8 | — |
| SECONDARY the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 1-2, 11-12, 15-16, 19-20, 31-32. |
27.1; 33.8; 38.3; 43.2; 38.0; 41.0 | — |
| SECONDARY the Proportion of Participants With ≥1 Increase in Mean Weekly CSBMs From Baseline Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. |
49.5; 61.5; 66.4; 63.3; 63.5; 63.7 | — |
| SECONDARY Mean Weekly CSBMs and Its Change From Baseline Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. |
1.27; 1.78; 1.96; 1.97; 2.00; 2.01 | — |
| SECONDARY Mean Weekly SBMs and Its Change From Baseline Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. |
1.85; 2.91; 2.13; 2.60; 1.87; 2.43 | — |
| SECONDARY the Change From Baseline in Mean Score of Stool Consistency for Each SBM Over Weeks 1-2 and 3-8. |
0.48; 0.67; 0.78; 0.74 | — |
| SECONDARY the Change From Baseline in Mean Score of Straining for Each SBM Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. |
-0.33; -0.52; -0.54; -0.63; -0.60; -0.58 | — |
| SECONDARY Time to the First CSBMs |
4; 5 | — |
| SECONDARY Change From Baseline in Mean Score of Patient Assessment of Constipation Quality of Life |
-0.71; -0.72; -1.09; -1.00 | — |
Eligibility Criteria
Inclusion Criteria
- meeting Rome Ⅲ criteria for diagnosing functional constipation;
- severe chronic constipation (two or fewer CSBMs per week for more than 3 months）;
- the weekly mean CSBMs are no more than 2 times during the 2-week baseline
- aged from 18 to 75 years old
- no use of drugs for constipation (emergency treatments should be excepted) during at least 2 weeks before enrollment; no acupuncture treatment for constipation in the previous 1 month; never joined any other trial in progress;
- volunteered to join this research and signed the informed consent
Exclusion Criteria
- irritable bowel syndrome, organic constipation or secondary constipation caused by endocrine, metabolic, nervous, postoperative diseases, or by drugs;
- mushy stool or watery stool are showed more than once during baseline when defecating spontaneously without any laxative (Bristol stool type 6 or 7);
- history of pelvic floor dysfunction;
- taking medicine in progress which can induce constipation;
- severe hemorrhoid or anal fissure;
- constipation with serious cardiovascular, hepatic or renal diseases, cognitive dysfunction, abdominal aortic aneurysm or hepatosplenomegaly, aphasia, mental disorders, or illness which affects the cooperation for examination and treatment;
- women in gestation or lactation period;
- blood coagulation disorders or using anticoagulants regularly such as Warfarin and Heparin;
- cardiac pacemaker carrier.
Data sourced from ClinicalTrials.gov (NCT02047045). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.