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Effect of acupuncture and its influence on visceral hypersensitivity in IBS-D patients: Study protocol for a randomized controlled trial.

Abstract Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder associated with visceral hypersensitivity. Increased expression of colonic TRPV1 and decreased expression of microRNA-199 are implicated in the pathogenesis of visceral hypersensitivity in IBS-D patients. Acupuncture is one of the frequently used complementary and alternative therapies for the treatment of IBS. The existing clinical studies mostly use IBS-SSS or other subjective scales, so there is a lack of objective biochemical evidence regarding the effect of acupuncture on IBS. Therefore, we designed this study to investigate whether acupuncture alleviate visceral hypersensitivity by influencing the expression of TRPV1 and microRNA-199.
PMID
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Authors

Mayor MeshTerms
Keywords
Journal Title medicine
Publication Year Start




PMID- 29794793
OWN - NLM
STAT- MEDLINE
DCOM- 20180604
LR  - 20180604
IS  - 1536-5964 (Electronic)
IS  - 0025-7974 (Linking)
VI  - 97
IP  - 21
DP  - 2018 May
TI  - Effect of acupuncture and its influence on visceral hypersensitivity in IBS-D
      patients: Study protocol for a randomized controlled trial.
PG  - e10877
LID - 10.1097/MD.0000000000010877 [doi]
AB  - BACKGROUND: Irritable bowel syndrome (IBS) is a common functional
      gastrointestinal disorder associated with visceral hypersensitivity. Increased
      expression of colonic TRPV1 and decreased expression of microRNA-199 are
      implicated in the pathogenesis of visceral hypersensitivity in IBS-D patients.
      Acupuncture is one of the frequently used complementary and alternative therapies
      for the treatment of IBS. The existing clinical studies mostly use IBS-SSS or
      other subjective scales, so there is a lack of objective biochemical evidence
      regarding the effect of acupuncture on IBS. Therefore, we designed this study to 
      investigate whether acupuncture alleviate visceral hypersensitivity by
      influencing the expression of TRPV1 and microRNA-199. METHOD: This study is a
      randomized, sham-controlled trial involving 40 patients and 10 healthy
      volunteers. A total of 40 eligible patients with IBS-D will be randomly assigned 
      to a traditional acupuncture group or sham acupuncture group in a 1:1 ratio.
      Patients will receive 3 acupuncture treatment sessions per week for 12
      consecutive weeks, for a total of 36 sessions during the study. The primary
      outcome measure is the IBS-Symptom Severity Score (IBS-SSS). Secondary outcomes
      are Visceral Pain Scale and levels of TRPV1 and microRNA-199 in colonic tissues. 
      Healthy volunteers will not receive any clinical intervention. The safety of
      interventions will be assessed at every visit. DISCUSSION: The purpose of this
      trial is to evaluate the efficacy of acupuncture for IBS-D through IBS-SSS and
      Visceral Pain Scale. Furthermore, we want to explore the intervention mechanism
      of acupuncture in improving visceral hypersensitivity by analyzing the colonic
      TRPV1 and microRNA-199. TRIAL REGISTRATION: This trial is registered with Chinese
      Clinical Trials Register, ChiCTR-IOR-
      17010860(http://www.chictr.org.cn/showproj.aspx?proj=18445).
FAU - Pei, Lixia
AU  - Pei L
AD  - Department of acupuncture, Jiangsu Province Hospital of Traditional Chinese
      Medicine, Affiliated Hospital of Nanjing University of Traditional Chinese
      Medicine, Hanzhong Road, Qinhuai District.
FAU - Chen, Hao
AU  - Chen H
AD  - Nanjing University of Traditional Chinese Medicine, Xianlin Road, Qixia District,
      Nanjing, China.
FAU - Guo, Jing
AU  - Guo J
AD  - Nanjing University of Traditional Chinese Medicine, Xianlin Road, Qixia District,
      Nanjing, China.
FAU - Chen, Lu
AU  - Chen L
AD  - Department of acupuncture, Jiangsu Province Hospital of Traditional Chinese
      Medicine, Affiliated Hospital of Nanjing University of Traditional Chinese
      Medicine, Hanzhong Road, Qinhuai District.
FAU - Wu, Xiaoliang
AU  - Wu X
AD  - Department of acupuncture, Jiangsu Province Hospital of Traditional Chinese
      Medicine, Affiliated Hospital of Nanjing University of Traditional Chinese
      Medicine, Hanzhong Road, Qinhuai District.
FAU - Xu, Wanli
AU  - Xu W
AD  - Nanjing University of Traditional Chinese Medicine, Xianlin Road, Qixia District,
      Nanjing, China.
FAU - Weng, Shengjie
AU  - Weng S
AD  - Nanjing University of Traditional Chinese Medicine, Xianlin Road, Qixia District,
      Nanjing, China.
FAU - Yang, EunMee
AU  - Yang E
AD  - Nanjing University of Traditional Chinese Medicine, Xianlin Road, Qixia District,
      Nanjing, China.
FAU - Hammer, Trine
AU  - Hammer T
AD  - Nanjing University of Traditional Chinese Medicine, Xianlin Road, Qixia District,
      Nanjing, China.
FAU - Sun, Jianhua
AU  - Sun J
AD  - Department of acupuncture, Jiangsu Province Hospital of Traditional Chinese
      Medicine, Affiliated Hospital of Nanjing University of Traditional Chinese
      Medicine, Hanzhong Road, Qinhuai District.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - Medicine (Baltimore)
JT  - Medicine
JID - 2985248R
RN  - 0 (MicroRNAs)
RN  - 0 (TRPV Cation Channels)
RN  - 0 (TRPV1 protein, human)
RN  - 0 (mirn199 microRNA, human)
SB  - AIM
SB  - IM
MH  - Acupuncture Therapy/*methods/statistics & numerical data
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Colon/*immunology/physiopathology
MH  - Complementary Therapies/methods
MH  - Female
MH  - Humans
MH  - Hypersensitivity/genetics/*immunology/therapy
MH  - Irritable Bowel Syndrome/genetics/*immunology/physiopathology/therapy
MH  - Male
MH  - MicroRNAs/metabolism
MH  - Middle Aged
MH  - Pain Measurement/methods
MH  - Severity of Illness Index
MH  - TRPV Cation Channels/metabolism
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2018/05/26 06:00
MHDA- 2018/06/05 06:00
CRDT- 2018/05/26 06:00
PHST- 2018/05/26 06:00 [entrez]
PHST- 2018/05/26 06:00 [pubmed]
PHST- 2018/06/05 06:00 [medline]
AID - 10.1097/MD.0000000000010877 [doi]
AID - 00005792-201805250-00069 [pii]
PST - ppublish
SO  - Medicine (Baltimore). 2018 May;97(21):e10877. doi: 10.1097/MD.0000000000010877.