PMID- 29903020
OWN - NLM
STAT- MEDLINE
DCOM- 20180723
LR  - 20220409
IS  - 1472-6882 (Electronic)
IS  - 1472-6882 (Linking)
VI  - 18
IP  - 1
DP  - 2018 Jun 15
TI  - Efficacy and safety of acupuncture for functional constipation: a randomised, 
      sham-controlled pilot trial.
PG  - 186
LID - 10.1186/s12906-018-2243-4 [doi]
LID - 186
AB  - BACKGROUND: The prevalence of functional constipation (FC) is 3-27%, and FC has 
      been reported to cause discomfort in daily life and various complications. The 
      treatment for FC depends on laxatives, and thus, effective and non-toxic 
      alternative treatments are needed. METHODS: We conducted a randomised, 
      sham-controlled parallel-design, pilot trial. Participants with FC were randomly 
      assigned to either the real acupuncture (RA) or sham acupuncture (SA) group. The 
      RA consisted of eight fixed acupuncture points (bilateral ST25, ST27, BL52 and 
      BL25) and four additional points targeted to the individual based on Traditional 
      Korean medicine (TKM). SA consisted of shallow acupuncture insertion at 12 
      non-acupuncture points. Twelve sessions were provided over 4 weeks. The outcome 
      measures were weekly defecation frequency (DF), spontaneous complete bowel 
      movement (SCBM), Bristol stool scale (BSS) score and constipation assessment 
      scale (CAS) score. The participants were followed for 4 weeks after the 
      treatment. RESULTS: Thirty participants were enrolled (15:15). The mean DF were 
      5.86 +/- 5.62, 5.43 +/- 3.39 and 5.79 +/- 3.64 in the RA group and 3.73 +/- 1.62, 
      5.00 +/- 1.77 and 5.40 +/- 1.96 in the SA group at weeks 1, 5, and 9, respectively. 
      The increases in weekly SCBMs were 2.50 +/- 3.86 and 2.71 +/- 4.01 with RA and 
      2.33 +/- 2.74 and 1.93 +/- 2.25 with SA at weeks 5 and 9, respectively (mean 
      difference [MD] 0.78). The BSS scores were 0.57 +/- 1.72 and 1.09 +/- 1.30 with RA 
      and 0.15 +/- 1.06 and 0.14 +/- 0.88 with SA at weeks 5 and 9, respectively (MD 0.95). 
      The CAS score changes were - 3.21 +/- 2.91 and - 3.50 +/- 3.98 with RA 
      and - 2.67 + +/-2.82 and - 2.87 +/- 2.95 with SA at weeks 5 and 9, respectively. 
      Greater improvements were observed in subgroup analysis of participants with hard 
      stool. The numbers of participants who developed adverse events (AEs) were equal 
      in both groups (four in each group), and the AEs were not directly related to the 
      intervention. CONCLUSIONS: This clinical trial shows feasibility with minor 
      modifications to the primary outcome measure and comparator. Acupuncture showed 
      clinically meaningful improvements in terms of SCBMs occurring more than 3 times 
      per week and in these improvements being maintained for 4 weeks after treatment 
      completion. As this is a pilot trial, future studies are warranted to confirm the 
      efficacy and safety. TRIAL REGISTRATION: KCT0000926 (Registered on 14 November 
      2013).
FAU - Lee, Hye-Yoon
AU  - Lee HY
AD  - National Clinical Research Center, Pusan National University Korean Medicine 
      Hospital, Yangsan, Republic of Korea.
FAU - Kwon, Oh-Jin
AU  - Kwon OJ
AD  - Clinical Research DivisionKorea Institute of Oriental Medicine, Daejeon, Republic 
      of Korea.
FAU - Kim, Jung-Eun
AU  - Kim JE
AD  - Clinical Research DivisionKorea Institute of Oriental Medicine, Daejeon, Republic 
      of Korea.
FAU - Kim, Mikyeong
AU  - Kim M
AD  - Clinical Research DivisionKorea Institute of Oriental Medicine, Daejeon, Republic 
      of Korea.
FAU - Kim, Ae-Ran
AU  - Kim AR
AD  - Clinical Research DivisionKorea Institute of Oriental Medicine, Daejeon, Republic 
      of Korea.
FAU - Park, Hyo-Ju
AU  - Park HJ
AD  - Clinical Research DivisionKorea Institute of Oriental Medicine, Daejeon, Republic 
      of Korea.
FAU - Cho, Jung-Hyo
AU  - Cho JH
AD  - Department of Internal Korean Medicine, Daejeon Oriental Hospital of Daejeon 
      University, Daejeon, Republic of Korea.
FAU - Kim, Joo-Hee
AU  - Kim JH
AD  - Department of Acupuncture and Moxibustion Medicine, College of Korean Medicine, 
      Sangji University, Wonju, Republic of Korea. jhkim712@sangji.ac.kr.
FAU - Choi, Sun-Mi
AU  - Choi SM
AD  - KM Standards Centre, Korea Institute of Oriental Medicine, Daejeon, Republic of 
      Korea. smchoi@kiom.re.kr.
LA  - eng
GR  - K13011 and K17122/Korea Institute of Oriental Medicine/
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20180615
PL  - England
TA  - BMC Complement Altern Med
JT  - BMC complementary and alternative medicine
JID - 101088661
SB  - IM
MH  - *Acupuncture Points
MH  - *Acupuncture Therapy/adverse effects/methods/statistics & numerical data
MH  - Adult
MH  - Constipation/*therapy
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
PMC - PMC6002973
OTO - NOTNLM
OT  - Acupuncture
OT  - Constipation
OT  - Functional constipation
OT  - Randomised controlled trial
COIS- ETHICS APPROVAL AND CONSENT TO PARTICIPATE: This study was approved by the IRB of 
      the Daejeon Oriental Hospital, Daejeon University (approval No. djomc-112). KMDs 
      explained the context of the clinical trial, including possible benefits and 
      harms, and obtained written informed consent from the participants. COMPETING 
      INTERESTS: The authors declare that they have no competing interests. PUBLISHER'S 
      NOTE: Springer Nature remains neutral with regard to jurisdictional claims in 
      published maps and institutional affiliations.
EDAT- 2018/06/16 06:00
MHDA- 2018/07/24 06:00
PMCR- 2018/06/15
CRDT- 2018/06/16 06:00
PHST- 2017/05/13 00:00 [received]
PHST- 2018/05/30 00:00 [accepted]
PHST- 2018/06/16 06:00 [entrez]
PHST- 2018/06/16 06:00 [pubmed]
PHST- 2018/07/24 06:00 [medline]
PHST- 2018/06/15 00:00 [pmc-release]
AID - 10.1186/s12906-018-2243-4 [pii]
AID - 2243 [pii]
AID - 10.1186/s12906-018-2243-4 [doi]
PST - epublish
SO  - BMC Complement Altern Med. 2018 Jun 15;18(1):186. doi: 10.1186/s12906-018-2243-4.