Table 2.
Characteristics of studies included.
| Study ID | Participants | Interventions b | Control b | Outcomes | Setting | Adverse events | |||
|---|---|---|---|---|---|---|---|---|---|
| Sample size | Age (years) a | Gender (M/F) | Disease Course (months) | ||||||
| He 21 | E: 24 C: 24 |
E: 39.36 ± 6.23 C: 37.76 ± 7.12 |
E: 16/8 C: 15/9 |
E: 56.10 ± 4.50 C: 48.30 ± 3.50 |
SBS, 90 d | Mesalazine, 90 d | AE | Outpatient, inpatient | No SAEs were found |
| Kang 22 | E: 25 C: 23 |
E: 28.62 ± 0.74 C: 30.01 ± 0.31 |
Not available | E: 4.97 ± 0.43 C: 3.84 ± 0.58 |
mSBS, 3 wk | Pinaverium bromide, 3 wk | PRS | Outpatient, inpatient | Not reported |
| Lee et al13 | E1: 20 E2: 20 Ca: 20 Cb: 20 |
E1: 42.90 ± 15.13 E2: 38.05 ± 15.27 Ca: 41.65 ± 14.26 Cb: 45.20 ± 13.56 |
E1: 17/3 E2: 16/4 Ca: 16/4 Cb: 11/9 |
E1: 150.96 ± 127.08 E2: 112.44 ± 84.6 Ca: 137.40 ± 109.92 Cb: 111.36 ± 138.84 |
E1: SBB + OB, 8 wk E2: SBS + P-OB, 8 wk |
Ca: P-SBS + OB, 8 wk Cb: P-SBS + P-OB, 8 wk |
SF SC PRS QOL AE |
Hospital | One ALT increase in Ca and two abdominal pain/fever in Cb |
| Lei 23 | E: 48 C: 48 |
Not available | E: 27/21 C: 26/22 |
Not available | mSBS, 3 mo | Sulfasalazine + Anisodamine Tablets + Codeine + Montmorillonite, 3 mo | PRS | Hospital | Not reported |
| Li et al 24 | E: 40 C: 40 |
E: 35.2 C: 34.6 |
E: 16/24 C: 17/23 |
Not available | mSBS + Paroxetine, 1 mo | Paroxetine, 1 mo | PRS | Outpatient, inpatient | Not reported |
| Li and Jiang 25 | E: 40 C: 40 |
E: 38.35 ± 11.85 C: 40.13 ± 11.75 |
E: 19/21 C: 17/23 |
E: 35.76 ± 21.36 C: 41.88 ± 24.36 |
SBS, 4 wk | Montmorillonite, 4 wk | PRS AE |
Hospital | Constipation |
| Ma 26 | E: 75 C: 75 |
E: 39.6 C: 38.9 |
E: 45/30 C: 47/28 |
E: 12–84 C: 12–72 |
mSBS, 30 d | Norfloxacin + fluid therapy + correction of electrolyte disorder + symptomatic support therapy, 30 d | PRS | Hospital | Not reported |
| Quan and Tan 27 | E: 50 C: 50 |
E: 44.02 ± 10.35 C: 43.51 ± 10.29 |
E: 27/23 C: 29/21 |
E: 2.4-228 C: 1.2-240 |
mSBS, 24 wk | Mesalazine, 24 wk | AE | In hospital | Nausea, vomiting, rash, allergy |
| Tian 28 | E: 30 C: 30 |
E: 40.92 ± 11.04 C: 40.13 ± 11.59 |
E: 16/14 C: 18/12 |
E: 25.92 ± 15.24 C: 34.44 ± 23.16 |
mSBS + Trimebutine maleate, 6 wk | Trimebutine maleate, 6 wk | PRS AE |
Outpatient | No SAEs or ADRs were found |
| Wang 29 | E: 47 C: 47 |
E: 45.40 ± 4.82 C: 45.35 ± 4.74 |
E: 23/24 C: 21/26 |
E: 14.16 ± 3.6 C: 13.32 ± 2.88 |
mSBS, 10 d | Montmorillonite, 10 d | PRS AE |
Hospital | Nausea, abdominal distention, constipation |
| Zhang 30 | E: 33 C: 32 |
E: 38.73 ± 12.64 C: 38.53 ± 12.69 |
E: 18/15 C: 19/13 |
E: 9.18 ± 3.92 C: 9.97 ± 4.39 |
mSBS, 4 wk | Montmorillonite, 4 wk | PRS AE |
Outpatient | No AEs were found |
| Zhang and Zhou 31 | E: 30 C: 30 |
Not available | E: 18/12 C: 14/16 |
E: 47.04 ± 29.88 C: 49.08 ± 27.60 |
mSBS, 4 wk | Pinaverium bromide, 4 wk | PRS AE |
Hospital | No AEs were found |
| Zhao and Cao 32 | E: 58 C: 59 |
E: 38.57 ± 6.94 C: 39.02 ± 6.95 |
E: 27/31 C: 30/29 |
E: 37.08 ± 28.92 C: 38.04 ± 29.28 |
mSBS + Pinaverium bromide, 1 mo | Pinaverium bromide, 1 mo | PRS | Hospital | Not reported |
| Zhong and Wu 33 | E: 40 C: 40 |
E: 46.1 C: 44.7 |
E: 19/21 C: 18/22 |
E: 4-108 C: 2-132 |
SBS + Montmorillonite, 4 wk | Montmorillonite, 4 wk | PRS | Outpatient | Not reported |
Abbreviations: E, experimental intervention; C, control intervention; OB, otilonium bromide; P-OB, placebo otilonium bromide; SBS, Shenling Baizhu San; P-SBS, placebo Shenling Baizhu San; mSBS, modified Shenling Baizhu San; SF, stool frequency; SC, stool consistency; PRS, patient-reported satisfaction; QOL, quality of life; ALT, alanine transaminase; AE, adverse event; SAE, serious adverse event; ADR, adverse drug reactions; SADE, serious adverse drug events.
Age of the participants is reported as mean ± standard deviation, or median (minimum-maximum), or mean, or (minimum-maximum), depending on the availability of data.
Both the name of the treatment and course length are reported in the column.
Randomized controlled trial with 4-arm, parallel-group design with 4 different intervention groups. According to the allocation principle of this study, 2 experimental groups (E1 and E2) and 2 control groups (Ca and Cb) were defined.