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2014 ; 93
(28
): e284
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Effect and safety of deep needling and shallow needling for functional
constipation: a multicenter, randomized controlled trial
#MMPMID25526462
Wu J
; Liu B
; Li N
; Sun J
; Wang L
; Wang L
; Cai Y
; Ye Y
; Liu J
; Wang Y
; Liu Z
Medicine (Baltimore)
2014[Dec]; 93
(28
): e284
PMID25526462
show ga
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.