Review Article

Kangfuxinye Enema Combined with Mesalamine for Ulcerative Colitis: A Systematic Review and GRADE Approach

Table 2

Characteristics of 19 included trials.
(a)

StudiesNumber of participantsAge (mean ± SD/range, y)Sex (male, %)Degree of UCDisease course (mean ± SD/range, y)Diagnosis
ExperimentControlExperimentControlExperimentControlExperimentControl

Gong 2015 [24]404045.045.0Mild to moderateWGOPGDMIBD (revised 2010)
Han 2015 [25]202035.035.0NRNR
Huang 2013 [26]404042.550.0Mild to severeNRNRWGOPGDMIBD (revised 2010)
Jin 2015 [27]909054.454.4NRCTCMDTUC 
(revised 2010)
Kan 2013 [28]464620~74NRNRNRNRNRCCDTIBD (revised 2007)
Li 2015 [29]505066.066.0NRWGOPGDMIBD (revised 2010)
Liu 2015 [30]303024~6227~6340.040.0NR1~80.75~6CCDTIBD (revised 2007)
Ma 2014 [31]303020~5017~5060.060.0Mild to moderate0.5~20.25~2NR
Ouyang 2014 [32]3433NRNRMild to moderateNRNRCCDTIBD 
(revised 2007)
Ouyang 2011 [33]424220~78NRNRMild to moderateNRNRNR
Tan 2014 [34]353554.354.3NR0.5~160.5~14WGOPGDMIBD (revised 2010)
Wang 2013 [35]363618~70NRNRMild to moderateNRNRCCDTIBD 
(revised 2007)
Xu 2014 [36]202023~55NRNRMild to moderateNRNRNR
Yin 2014 [37]272748.148.1Moderate to severNR
Yue 2013 [38]555520~7419~7441.841.8Mild to moderateCCDTIBD 
(revised 2012)
Zeng 2013 [39]202040.040.0Mild to moderate8.5 ± 1.5CCDTIBD 
(revised 2007)
Zhang 2012 [40]2828NRNRNRNRNRNRNRNR
Zhang 2014 [41]303046.746.7Mild to moderateNRNRNR
Zheng 2013 [42]303022~6329~5863.363.3NR0.7~140.9~9CCDTIBD 
(revised 2007)

(b)

StudiesIntervention strategyControl strategyCourseAdverse eventsRecurrenceFollow-up time (month)
ExperimentControlExperimentControl

Gong 2015 [24]KFXY enema (50 ml of KFX in 150 ml of normal saline; 37°C) + mesalamine Enteric-coated Tablets 1.0 g tidMesalamine Enteric-coated Tablets 1.0 g tidNR533116
Han 2015 [25]KFXY enema (50 ml of KFX in 150 mL of normal saline; 37°C) + mesalamine 1.0 g qidMesalamine 1.0 g qidNRNRNRNRNRNR
Huang 2013 [26]KFXY enema (30 ml of KFX in 150 ml of normal saline; 37°C; 20 min) + mesalamine 1.0 g qidMesalamine 1.0 g qid4 w3071912
Jin 2015 [27]KFXY enema (50 ml of KFX in 150 mL of normal saline; 37°C) + mesalamine 1.5–4.0 g/dayMesalamine 1.5–4.0 g/day4 wNRNRNRNRNR
Kan 2013 [28]KFXY enema (50 ml of KFX in 50 mL of normal saline; 37°C) + mesalamine Slow Release Tablets 1.0 g qdMesalamine Slow Release Tablets 1.0 g qd4 w32NRNRNR
Li 2015 [29]KFXY enema (50 ml of KFX in 50 mL of normal saline; 37°C; 45 min) + mesalamine Slow Release Tablets 1.0 g qdMesalamine Slow Release Tablets 1.0 g qd4 w233103
Liu 2015 [30]KFXY enema (100 ml; 20 min) + mesalamine 1.0 g tidMesalamine 1.0 g tid8 wNRNRNRNRNR
Ma 2014 [31]KFXY enema (38–41°C; 45 min) + mesalamine Slow Release Tablets 1.0 g tidMesalamine Slow Release Tablets 1.0 g tid4 w10NRNRNR
Ouyang 2014 [32]KFXY enema (30 ml of KFX in 120 mL of normal saline; 37°C; 45 min) + mesalamine Slow Release Tablets 1.0 g qdMesalamine Slow Release Tablets 1.0 g tid4 w12NRNRNR
Ouyang 2011 [33]KFXY enema (50 ml of KFX in 50 mL of normal saline) + mesalamine 1.0 g tidMesalamine 1.0 g tid4 w00NRNRNR
Tan 2014 [34]KFXY enema (50 ml of KFX in 150 mL of normal saline; 37-38°C) + mesalamine 1.0 g tidMesalamine 1.0 g tid4 w00NRNRNR
Wang 2013 [35]KFXY enema (50 ml of KFX in 100 mL of normal saline) + mesalamine 1.0 g qidMesalamine 1.0 g tid4 wNRNRNRNRNR
Xu 2014 [36]KFXY enema (50 ml of KFX in 150 mL of normal saline; 37°C) + mesalamine 1.0 g qidMesalamine 1.0 g tidNRNRNRNRNRNR
Yin 2014 [37]KFXY enema (50 ml of KFX in 50 mL of normal saline) + mesalamine 1.0 g tidMesalamine 1.0 g tid4 wNRNRNRNRNR
Yue 2013 [38]KFXY enema (50 ml of KFX in 50 mL of normal saline; 38°C; 45 min) + mesalamine 1.0 g tidMesalamine 1.0 g tid4 w00NRNRNR
Zeng 2013 [39]KFXY enema + mesalamine 1.0 g tidMesalamine 1.0 g tidNR00026
Zhang 2012 [40]KFXY enema + mesalamine 1.0 g tidMesalamine 1.0 g tid2 wNRNRNRNRNR
Zhang 2014 [41]KFXY enema (50ml of KFX in 150 ml of normal saline; 37-38°C) + mesalamine 1.0 g tidMesalamine 1.0 g tid4 w2051412
Zheng 2013 [42]KFXY enema (50 ml of KFX in 100 ml of normal saline; 37.5°C; >30 min) + mesalamine 1.0 g tidMesalamine 1.0 g tid2 w00NRNRNR

WGOPGDMIBD = World Gastroenterology Organization Practice Guidelines for the Diagnosis and Management of IBD, CTCMDTUC = Consensus of Traditional Chinese Medicine Diagnosis and Treatment for Ulcerative Colitis. CCDTIBD = Chinese Consensus on the Diagnosis and Treatment of Inflammatory Bowel Disease (IBD). NR = not reported. KFXY = Kangfuxinye.