Author (year) Diagnosis criteria TCM syndrome Age (year) Disease duration (months) TCM therapy Outcome measurements Duration (weeks) Followup (weeks) (T versus C) T C T C Bensoussan et al. (1998) [27 ] Rome I Stagnation of liver qi and deficiency in the spleen 43 versus 17 NR NR Soothing the liver and invigorating the spleen (1) BSS score; (2) global symptom improvement 16 w 14 w NR 38 versus 18 NR NR Individualized Luo (2002) [28 ] Rome II Stagnation of liver qi and deficiency in the spleen 20 versus 20 Soothing the liver and invigorating the spleen (1) Global symptom improvement; (2) serum and mucosal VIP 4 w NR Shen et al. (2005) [29 , 30 ] Rome II Stagnation of liver qi and deficiency in the spleen 14 versus 10 Soothing the liver and invigorating the spleen (1) Anorectal manometry; (2) functional MR test; (3) global symptom score 4 w NR Wang et al. (2006) [31 ] Rome II Stagnation of liver qi and deficiency in the spleen 29 versus 28 NR NR Soothing the liver and invigorating the spleen (1) Abdominal pain improvement; (2) diarrhea improvement; (3) TCM syndrome improvement 3 w 4 w Leung et al. (2006) [18 ] Rome II Stagnation of liver qi and deficiency in the spleen 60 versus 59 NR NR Soothing the liver and invigorating the spleen (1) Global symptom improvement; (2) individual symptom score; (3) daily bowel frequency; (4) SF-36 8 w 8 w Cheng (2008) [32 ] Rome II Stagnation of liver qi and deficiency in the spleen 25 versus 25 Soothing the liver and invigorating the spleen (1) Anorectal manometry; (2) serum and mucosal 5-HT 4 w NR Li et al. (2010) [33 ] Rome III Stagnation of liver qi and deficiency in the spleen 30 versus 30 Soothing the liver and invigorating the spleen (1) IBS-SSS; (2) global IBS symptom improvement 4 w 4 w Chen et al. (2010) [34 ] Rome III Stagnation of liver qi and deficiency in the spleen 360 versus 120 NR NR NR NR Soothing the liver and invigorating the spleen (1) Diarrhea improvement; (2) abdominal pain improvement 3 w NR Tang et al. (2011) [35 ] Rome III NR 30 versus 30 Soothing the liver and invigorating the spleen (1) IBS-SSS; (2) IBS-QOL 8 w NR Li (2011) [36 ] Rome III Yang deficiency of the spleen and kidney41 versus 41 Warming the kidney and invigorating the spleen (1) Global symptom improvement; (2) IBS-SSS 4 w 1 m Su et al. (2013) [37 ] Rome III Yang deficiency of the spleen and kidney120 versus 120 Warming the kidney and invigorating the spleen (1) Global symptom improvement; (2) TCM symptom improvement; (3) recurrence rate 4 w 6 m Cai et al. (2012) [38 ] Rome III Stagnation of liver qi and deficiency in the spleen 18 versus 19 Soothing the liver and invigorating the spleen (1) IBS-SSS; (2) TCM syndrome score 8 w NR Ko et al. (2013) [39 ] Rome III NR 14 versus 12 NR NR Resolving dampness to move qi (1) Adequate relief (AR); (2) proportion of responders (PR); (3) IBS-QoL; (4) patient diary 8 w 2 w Li et al. (2014) [40 ] Rome III NR 80 versus 80 NR NR NR NR Soothing the liver and invigorating the spleen Global symptom improvement 4 w NR
