In a small RTC pregabalin 450mg/day decreased pain intensity and improved symptom control more than placebo in patients suffering irritable bowel syndrome about 30%. However, the evidence was limited by high risk of bias due to large drop out rate and imprecision.
Overall symptom score [scale 0-100] mean was 31 (sd 17) in the pregabalin arm and 43 (25) in placebo group. 13 (32%) patients in the pregabalin group and 2 (5%) in placebo group reported dizziness. The study reported no differences in total adverse events.
| Reference | Study type | Population | Intervention and comparison | Outcomes | Risk of bias |
|---|---|---|---|---|---|
| RCT=randomized controlled trial; SR=systematic review; MA=meta-analysis | |||||
| «Saito YA, Almazar AE, Tilkes KE, et al. Randomised...»1 | RCT | Patients with irritable bowel syndrome (Rome III criteria) EX: concurrent ge disease, depression, pregnancy, lactation, medical comorbidities, dependence, cognitive impairtment USA |
Pregabalin started 150mg/day for 3 days, 300mg/day 3 days, 450mg/day vs Placebo |
Bowel symptom score | High |
| Reference | Comments |
|---|---|
| «Saito YA, Almazar AE, Tilkes KE, et al. Randomised...»1 | Patients were required to have at least 3 pain attacks a month with pain intensity
over50/100, one attack exceeding intensity 50/100 in last two weeks before the study. Bowel symptom score: overall IBS, pain or discomfort, constipation, diarrhoea, bloating, each 0-100, over last 4 wks of the study, mean BBS score at 12 wks Primary outcome BSS score for pain or discomfort, 30 point reduction Global endpoint: adequate symptom control at least 50% relief over last 4 wks of the study Planned n of 100 patients was not reached, stopped at 85 patients Dropout rate about 20% in both arms. |
Results
| Reference | Number of studies and number of patients (I/C) | Follow-up time | Mean (sd) I | Mean (sd) C | Mean difference |
|---|---|---|---|---|---|
| Level of evidence: low Assess the risk of bias and delete irrelevant sources of bias: The quality of evidence is downgraded due to study limitations, and imprecision. Medication doses were higher than usually in clinical practice, probably leading to indirectness of the evidence. I=intervention; C=comparison; CI=confidence interval |
|||||
| «Saito YA, Almazar AE, Tilkes KE, et al. Randomised...»1 | 41/44 | 12 wks | 29 (16) | 41 (27) | 12 points, p-value 0.02 |
| Reference | Number of studies and number of patients (I/C) | Follow-up time | Absolute number of events (%) I | Absolute number of events (%) C | Relative effect (95% CI) |
|---|---|---|---|---|---|
| Level of evidence: high/moderate/low/very low Assess the risk of bias and delete irrelevant sources of bias: The quality of evidence is downgraded due to study limitations, and imprecision. Medication doses were higher than usually in clinical practice, probably leading to indirectness of the evidence. I=intervention; C=comparison; CI=confidence interval |
|||||
| «Saito YA, Almazar AE, Tilkes KE, et al. Randomised...»1 | 41/44 | 12 wks | 63% | 45% | |