| BackgroundChronic constipation is a common gastrointestinal disease characterized by reducing of frequency of defecation,dry and hard stool,having difficulty in defecation.The prevalence of chronic constipation in Asia was about 37%to 1.4%.This disease is more common in women than men.At present,western medical treatments include conventional therapy,drug therapy and other therapies.However,some patients are not satisfied with the effectiveness of drugs in terms of improvement of symptoms.As the appearance of cardiovascular events and other adverse reactions of some drugs,biofeedback and sacral nerve stimulation have been increasingly used to enhance effectiveness of drugs.Acupuncture plays a vital part in the treatment of chronic constipation in China.In recent years,some studies have shown that acupuncture has effectiveness on improving the symptoms of chronic constipation with fewer associated adverse events occurring.ObjectivesThe purpose of this study was to observe the short-term and long-term therapeutic effects of electro-acupuncture(EA)compared with prucalopride for treating female patients with severe chronic functional constipation.MethodsIn this prospective,randomized controlled trial,40 female participants with severe chronic constipation were randomized to either EA group or prucalopride group.The acupoints used in treatment group were bilateral ST25,SP14 and ST 37 and prucalopride was used in control group.The duration of the trial is 34 weeks,including a 2-week baseline assessment,8-week treatment period and 24-week follow-up period.EA was given 5 sessions a week in the first 2 weeks and 2 sessions a week in the following 6 weeks with a total of 28 sessions.Prucalopride was given orally one time a day with 2mg for continuous 8 weeks.Participants will undergo an electrocardiogram(ECG)examination at the 8th week and the drug will be taken for another 24 weeks in the absence of Q-t interval elongation and other serious adverse reactions.Results40 female participants were included in this study,2 participants withdrew informed consents voluntarily and 38 participants finally completed this study.The primary outcome is change of complete spontaneous bowel movements(CSBMs)/week averaged over 8 weeks from baseline after treatment.The baseline of CSBMs/week of EA group is 1.5(0.88)and change from baseline is 1.13(0.75)(P<0.01)while the baseline of CSBMs/week of prucalopride group is 1.5(0.75)and change from baseline is 1.13(0.5)(P<0.01).There was significant statistical difference in both groups while no statistical difference between the two groups(P>0.05).The secondary outcomes:1.After 24-week follow-up,change of SCBMs/week from baseline in EA group is 1.13(0.63)(P<0.01)and in the prucalopride group is 1.70±1.54(P<0.01).There was significant statistical difference in both groups while no statistical differenee between the two groups(P>0.05).2.Change of spontaneous bowel movements(SBMs)/week averaged over 8 weeks and 24 weeks from baseline.After 8-week treatment and 24-week follow-up,there was significant statistical difference(P<0.01)in terms of the change of SBMs/week from baseline in both groups while there was no statistical difference between the two groups(P>0.05).3.After 8-week treatment,there was sig1ificant statistical difference(P<0.01)in terms of change of Bristol stool form scale and straining degree during spontaneous defecation from baseline in both groups,but there was no statistical difference between the two groups(P>0.05).4.Change of Patient Assessment of Constipation Quality of Life(PAC-QOL)scale from baseline after 8-week treatment.There was significant statistical difference(P<0.01)in both groups as well as between t,Aro groups,5.During treatment period,there were no significant adverse reactions happened neither in EA group nor in prucalopride group.The incidence of adverse reactions in EA group was 5.26%and 15.79%in control group.The incidence of adverse reactions in two groups was not statistically significant(P>0.05).ConclusionsEA has significant effect in enhancing CSBMs,SBMs and improving the stool form,straining degree and quality of life of female patients with severe chronic functional constipation.The efifect can last for 24 weeks.Although the effect of EA is not better than prucalopride,EA may be as good as prucalopride in treating this disease.However,there are still more trials with large sample size needed to prove the effect of EA when compared with prucalopride.There were no significant adverse reactions during the course of treatment,thus EA are safe for treating female patients with severe chronic functional constipation. |
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