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

Table 4

Assessment of quality and summarizing the findings with the GRADE approach.

Quality assessment							Summary of findings
Participants (studies); Follow-up	Risk of bias	Inconsistency	Indirectness	Imprecision	Publication bias	Overall quality of evidence	Study event rates (%)		Relative effect; (95% CI)	Anticipated absolute effects
							With control	With Kangfuxinye + mesalazine		Risk with control	Risk difference with Kangfuxinye + mesalazine (95% CI)
Recurrence rate (critical outcome)
360 (5 studies) 8 months	Serious^1	No serious inconsistency	No serious indirectness	No serious imprecision^2	Undetected^3	⊕⊕⊕⊝; MODERATE^1,2,3; due to risk of bias	56/180; (31.1%)	18/180 (10%)	RR 0.33; (0.2 to 0.53)	Study population
										311 per 1000	208 fewer per 1000  (from 146 fewer to 249 fewer)
										Moderate
										275 per 1000	184 fewer per 1000  (from 129 fewer to 220 fewer)
Response rate (critical outcome)
1236; (16 studies); 4 weeks	Very serious^4	No serious inconsistency	No serious indirectness	No serious imprecision^5	Undetected	⊕⊕⊝⊝; LOW^4,5; due to risk of bias	483/618; (78.2%)	575/618; (93%)	RR 1.19; (1.14 to 1.25)	Study population
										782 per 1000	148 more per 1000  (from 109 more to 195 more)
										Moderate
										764 per 1000	145 more per 1000  (from 107 more to 191 more)
Inflammation reduction rate (important outcome)
326; (5 studies); 4 weeks	Very serious^6	No serious inconsistency	No serious indirectness	No serious imprecision^7	Undetected^3	⊕⊕⊝⊝; LOW^3,6,7; due to risk of bias	113/163; (69.3%)	147/163; (90.2%)	RR 1.3; (1.16 to 1.46)	Study population
										693 per 1000	208 more per 1000  (from 111 more to 319 more)
										Moderate
										700 per 1000	210 more per 1000  (from 112 more to 322 more)
Symptom remission rate (important outcome)
269; (4 studies); 4 weeks	Very serious^8	Serious^9	No serious indirectness	Serious^10	Undetected^3	⊕⊝⊝⊝; VERY LOW^3,8,9,10; due to risk of bias, inconsistency, imprecision	108/134; (80.6%)	124/135; (91.9%)	RR 1.12; (0.96 to 1.3)	Study population
										806 per 1000	97 more per 1000  (from 32 fewer to 242 more)
										Moderate
										802 per 1000	96 more per 1000  (from 32 fewer to 241 more)
Time of remission (important outcome; better indicated by lower values)
19; (1 study); 4 weeks	Serious^11	No serious inconsistency	No serious indirectness	Very serious^12	Undetected^3	⊕⊝⊝⊝; VERY LOW^3,11,12; due to risk of bias, imprecision	8	11	MD-5.99; (−14.15 to 2.17)		The mean time of cure in the intervention groups was 5.99 lower  (14.15 lower to 2.17 higher)
Adverse effects rate (important outcome)
531; (7 studies)  4 weeks	Serious^13	No serious inconsistency	No serious indirectness	Serious^14	Undetected^3	⊕⊕⊝⊝; LOW^3,13,14; due to risk of bias, imprecision	10/262; (3.8%)	17/269; (6.3%)	RR 1.58; (0.77 to 3.24)	Study population
										38 per 1000	22 more per 1000  (from 9 fewer to 85 more)
										Moderate
										44 per 1000	26 more per 1000  (from 10 fewer to 99 more)

2 studies used random number table to generate random sequence, whereas the 3 remaining trials just reported “randomly assigned” but no mention was made of sequence. Details on how allocation was concealed were unclear in these studies. 95% CI excluded a relative risk of 1.0 and the sample size () met the optimal information size (OIS) criterion, which was calculated approximately as 114. was impossible to check publication bias because of limited number of trials for this outcome. 2 studies used random number table to generate random sequence, whereas the 14 remaining trials just reported “randomly assigned” but no mention was made of sequence. Details on how allocation was concealed were unclear in these studies. 95% CI excluded a relative risk of 1.0 and the sample size () met the optimal information size (OIS) criterion, which was calculated as 176. of the 5 trials just reported “randomly assigned” but no mention was made of sequence. Details on how allocation was concealed were unclear in these studies. 95% CI excluded a relative risk of 1.0 and the sample size () met the optimal information size (OIS) criterion,  which was calculated approximately as 114. of the 4 trials just reported “randomly assigned” but no mention was made of sequence. Details on how allocation was concealed were unclear in these studies. were found among the 4 studies in the pooled results with a considerable heterogeneity (, ). 95% CI included a relative risk of 1.0 and the sample size () failed to meet the optimal information size (OIS) criterion, which was calculated approximately as 290. study just reported “randomly assigned” but no mention was made of sequence. Details on how allocation was concealed were unclear in these studies. sizes and number of events () were far less than the number of patients generated by a conventional sample size () calculation for a single adequately powered trial, and the change of our confidence for this outcome was very serious, thus downgrading. 2 studies used random number table to generate random sequence, whereas the 5 remaining trials just reported “randomly assigned” but no mention was made of sequence. Details on how allocation was concealed were unclear in these studies. 95% CI included a relative risk of 1.0 and the sample size () failed to meet the optimal information size (OIS) criterion, which was calculated approximately as 1204.