PMID- 34633753
OWN - NLM
STAT- MEDLINE
DCOM- 20211124
LR  - 20211124
IS  - 1751-2980 (Electronic)
IS  - 1751-2972 (Linking)
VI  - 22
IP  - 11
DP  - 2021 Nov
TI  - Efficacy and safety of lubiprostone for the treatment of functional constipation 
      in Chinese adult patients: A multicenter, randomized, double-blind, 
      placebo-controlled trial.
PG  - 622-629
LID - 10.1111/1751-2980.13058 [doi]
AB  - OBJECTIVES: Functional constipation is a gastrointestinal disorder prevalent 
      around the world. Lubiprostone is the first locally acting type-2 chloride 
      channel activator to be used for treating constipation. This study aimed to 
      evaluate the efficacy and safety of lubiprostone in Chinese adults with 
      functional constipation. METHODS: This was a multicenter, randomized, 
      double-blind, placebo-controlled study. Patients with functional constipation 
      were randomized to receive either lubiprostone (24 mcg twice daily) or placebo 
      for 4 weeks. The primary end-point was the frequency of spontaneous bowel 
      movements (SBMs) during the first week of treatment. The secondary end-points 
      included the median time of the first SBM, SBM frequency at weeks 2, 3 and 4, 
      weekly response rate of SBMs, the stool consistency score and average number of 
      complete spontaneous bowel movements (CSBMs) per week. RESULTS: In total, 259 
      patients were randomized, with 130 in the lubiprostone group and 129 in the 
      placebo group. SBM frequency was higher in the lubiprostone group 
      (4.88 +/- 4.09/wk) than that in the placebo group (3.22 +/- 2.01/wk) at week 1 
      (P < 0.0001). SBM frequency was also higher in the lubiprostone group at weeks 2, 
      3 and 4. The average number of CSBMs and the stool consistency score in the 
      lubiprostone group were significantly higher than that in the placebo group at 
      each week. No drug-related serious adverse events (AEs) occurred. The most 
      commonly reported AE was nausea. CONCLUSION: Lubiprostone was superior to placebo 
      in treating Chinese patients with functional constipation, together with good 
      safety profile.
CI  - (c) 2021 Chinese Medical Association Shanghai Branch, Chinese Society of 
      Gastroenterology, Renji Hospital Affiliated to Shanghai Jiaotong University 
      School of Medicine and John Wiley & Sons Australia, Ltd.
FAU - Xiao, Ying Lian
AU  - Xiao YL
AUID- ORCID: 0000-0002-4223-4943
AD  - Department of Gastroenterology, First Affiliated Hospital of Sun Yat-sen 
      University, Guangzhou, Guangdong Province, China.
FAU - Dai, Ning
AU  - Dai N
AD  - Department of Gastroenterology, Sir Run Run Shaw Hospital, Zhejiang University 
      School of Medicine, Hangzhou, Zhejiang Province, China.
FAU - He, Shui Xiang
AU  - He SX
AUID- ORCID: 0000-0001-6208-2484
AD  - Department of Gastroenterology, The First Affiliated Hospital of Xi'an Jiaotong 
      University, Xi'an, Shaanxi Province, China.
FAU - Tian, De An
AU  - Tian A
AD  - Department of Gastroenterology, Tongji Hospital, Tongji Medical College of 
      Huazhong University of Science and Technology, Wuhan, Hubei Province, China.
FAU - Liu, Si De
AU  - Liu S
AD  - Department of Gastroenterology, Nanfang Hospital, Southern Medical University, 
      Guangzhou, Guangdong Province, China.
FAU - Tian, Zi Bin
AU  - Tian ZB
AD  - Department of Gastroenterology, The Affiliated Hospital of Qingdao University, 
      Qingdao, Shandong Province, China.
FAU - Wang, Xiao Yan
AU  - Wang XY
AD  - Department of Gastroenterology, The Third Xiangya Hospital of Central South 
      University, Changsha, Hunan Province, China.
FAU - Li, Yan Qing
AU  - Li YQ
AUID- ORCID: 0000-0003-0575-0399
AD  - Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, 
      Shandong Province, China.
FAU - Hou, Xiao Hua
AU  - Hou XH
AD  - Department of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, Hubei Province, China.
FAU - Fang, Xiu Cai
AU  - Fang XC
AUID- ORCID: 0000-0002-5600-8779
AD  - Department of Gastroenterology, Peking Union Medical College Hospital, Chinese 
      Academy of Medical Sciences, Beijing, China.
FAU - Wen, Zhi Li
AU  - Wen ZL
AD  - Department of Gastroenterology, The Second Affiliated Hospital of Nanchang 
      University, Nanchang, Jiangxi Province, China.
FAU - Zeng, Wei Zheng
AU  - Zeng WZ
AD  - Department of Gastroenterology, General Hospital of the Western Theater of 
      Chinese People's Liberation Army, Chengdu, Sichuan Province, China.
FAU - Xu, Hong
AU  - Xu H
AD  - Department of Gastroenterology, The First Bethune Hospital of Jilin University, 
      Changchun, Jilin Province, China.
FAU - Sun, Ming Jun
AU  - Sun MJ
AD  - Department of Gastroenterology, The First Hospital of China Medical University, 
      Shenyang, Liaoning Province, China.
FAU - Liu, Yu Lan
AU  - Liu YL
AD  - Department of Gastroenterology, Peking University People's Hospital, Beijing, 
      China.
FAU - Wu, Yong Dong
AU  - Wu YD
AD  - Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical 
      University, Beijing, China.
FAU - Shen, Xi Zhong
AU  - Shen XZ
AD  - Department of Gastroenterology, Zhongshan Hospital, Fudan University, Shanghai, 
      China.
FAU - Liu, Xiao Wei
AU  - Liu XW
AD  - Department of Gastroenterology, Xiangya Hospital, Central South University, 
      Changsha, Hunan Province, China.
FAU - Liu, De Liang
AU  - Liu L
AD  - Department of Gastroenterology, The Second Xiangya Hospital of Central South 
      University, Changsha, Hunan Province, China.
FAU - Chen, Min Hu
AU  - Chen MH
AD  - Department of Gastroenterology, First Affiliated Hospital of Sun Yat-sen 
      University, Guangzhou, Guangdong Province, China.
LA  - eng
GR  - 81770544/National Natural Science Foundation of China/
GR  - 81970479/National Natural Science Foundation of China/
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - Australia
TA  - J Dig Dis
JT  - Journal of digestive diseases
JID - 101302699
RN  - 0 (Chloride Channel Agonists)
RN  - 7662KG2R6K (Lubiprostone)
SB  - IM
MH  - Adult
MH  - China
MH  - *Chloride Channel Agonists/adverse effects
MH  - *Constipation/drug therapy
MH  - Defecation
MH  - Double-Blind Method
MH  - Humans
MH  - Lubiprostone
MH  - Treatment Outcome
OTO - NOTNLM
OT  - adult Chinese patients
OT  - functional constipation
OT  - lubiprostone
OT  - randomized placebo-controlled trial
EDAT- 2021/10/12 06:00
MHDA- 2021/11/25 06:00
CRDT- 2021/10/11 12:40
PHST- 2021/09/12 00:00 [revised]
PHST- 2021/07/19 00:00 [received]
PHST- 2021/10/03 00:00 [accepted]
PHST- 2021/10/12 06:00 [pubmed]
PHST- 2021/11/25 06:00 [medline]
PHST- 2021/10/11 12:40 [entrez]
AID - 10.1111/1751-2980.13058 [doi]
PST - ppublish
SO  - J Dig Dis. 2021 Nov;22(11):622-629. doi: 10.1111/1751-2980.13058.