Table 1.
Studies included in the present analysis with corresponding sample size.
| Comparator | Reference | Sample size per arm | Reported efficacy parameters |
|---|---|---|---|
| Placebo-controlled studies on racecadotril | |||
| Placebo | Vetel et al. (45) | 54–59 | Duration of diarrhea (P); number and appearance of stools; percentage of patients cured; concomitant symptoms |
| Placebo | Baumer et al. (31) | 96–102 | Duration of diarrhea (P); percentage of patients cured; Kaplan–Meier analysis of presence of diarrhea; reduction of anal burning, spontaneous abdominal pain, nausea, weight loss, pain on abdominal palpation, and meteorism; global efficacy |
| Placebo | Hamza et al. (36) | 32–38 | Stool weight on first day of treatment; number of loose stools; pain on abdominal palpation; anal burning; painful anal contraction; spontaneous abdominal pain; abdominal distension; nausea; vomiting; loss of appetite |
| Placebo | Coffin and Rampal (46) | 86–87 | Number of diarrheic stools until day 5 (P) and on first day of treatment; duration of diarrhea; associated symptom index; well-being index; global index |
| Standard treatment | Yao and Xi (47) | 54–55 | Duration of diarrhea (P); treatment duration; percentage of patients cured |
| Actively controlled studies on racecadotril | |||
| Loperamide | Roge et al. (48) | 32–37 | Duration of diarrhea (P); cumulative recovery on day 2 (P); abdominal pain; abdominal distension |
| Loperamide | Vetel et al. (49) | 75–82 | Number of stools until recovery (P); time to cure; physician’s global evaluation; asthenia; abdominal distension; anorexia; pain on abdominal palpation; spontaneous abdominal pain; nausea; anal burning; vomiting |
| Loperamide | Prado and Global Adult Racecadotril Study Group (50) | 472–473 | Duration of diarrhea (P); recovery rate after 72 h; overall clinical success; duration of abdominal pain and of abdominal distension |
| Loperamide | Wang et al. (51) | 31 | Duration of diarrhea, abdominal pain, and abdominal distension; improvement rate of anal burn and nausea; physician-determined overall clinical success |
| Loperamide | Hu and Sun (52) | 111–112 | Duration of diarrhea in Kaplan–Meier analysis (P); resolution rate at 24, 48, and 72 h; percentage of patients reporting resolution of spontaneous abdominal pain, pain on abdominal palpation, abdominal distension, anorexia, nausea, and anal burning |
| Loperamide | Coulden et al. (53) | 60 | Duration of diarrhea (P); time to resolution of spontaneous abdominal pain and abdominal distension; prevalence of spontaneous abdominal pain, pain on abdominal palpation, abdominal distension, anorexia, nausea, and anal burning |
| Loperamide | Galleli et al. (54) | 30–31 | Number of diarrhea episodes; duration of abdominal pain and diarrhea; stool weight until recovery |
| Saccharomyces boulardii | Moraes et al. (55) | 161–175 | Clinical success as judged by investigator; duration of diarrhea; number of bowel movements until recovery; prevalence of spontaneous abdominal pain, pain on abdominal palpation, abdominal distension, anorexia, nausea, and anal burning on day 2; Kaplan–Meier analysis of probability of cure |
| Octreotide | Mehta et al. (56) | 50 | Daily number of stools until recovery (P); daily quantity of stools; required volume of fluid substitution |
See main text and references for details.
(P), primary endpoint; where not stated, no efficacy parameter has been reported as primary endpoint.