In a small RTC «Olesen SS, Bouwense SA, Wilder-Smith OH ym. Pregab...»1 pregabalin 600mg/day as an add on medication decreased average pain intensity about 12% in patients suffering from pain related to chronic pancreatitis at 3 weeks (the point estimate is mean difference translated to percentage change). Patients in pregabalin group reported more feeling drunk (35% vs 7%) and light-headedness (24% vs 3%). The evidence was limited by small sample size and high risk of bias.
| Reference | Study type | Population | Intervention and comparison | Outcomes | Risk of bias |
|---|---|---|---|---|---|
| RCT=randomized controlled trial; SR=systematic review; MA=meta-analysis; PGIC= Patients' global impression of change | |||||
| «Olesen SS, Bouwense SA, Wilder-Smith OH ym. Pregab...»1 | RCT | Patients chronic pancreatitis and chronic abdominal pain | Pregabalin 600mg/day vs Placebo |
Change in pain intensity at 3 weeks PGIC, Brief pain inventory short form |
High |
| Reference | Comments |
|---|---|
| «Olesen SS, Bouwense SA, Wilder-Smith OH ym. Pregab...»1 | Exclusion criteria generalized painful conditions, pregnancy/lactation, depression,
renal impairment, abnormal EKG. Pregabalin started 150mg/day, after 3 day 300mg/day, after 1 wk 600mg/day. Patients were using stable concomitant medication (NSAIDS, paracetamol opioids) during study. Pharmaceutical company provided identical active and placebo capsules, no other involvement in the study. Conducted in the Netherlands and Denmark. Dropouts rate was unclear, likely about 20-30%. |
Results
| Reference | Number of studies and number of patients (I/C) | Follow-up time | Mean change (sd) I | Mean change (sd) C | Difference in difference (95% CI) |
|---|---|---|---|---|---|
| *change scores were converted from mean changes to relative mean changes by study
authors. Translates to about 16% less pain versus control group Level of evidence: Low The quality of evidence is downgraded due to study limitations and imprecision (confidence intervals included clinically not meaningful impact). Medication doses were higher (and titration was faster) than usually in clinical practice, probably leading to indirectness of the evidence. I=intervention; C=comparison; CI=confidence interval |
|||||
| «Olesen SS, Bouwense SA, Wilder-Smith OH ym. Pregab...»1 | 34/30 | 3 wks | -36% (-43%–29%) | -24% (-31%–16%) |
-12% (-22% to -2%)* |
| 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: low 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 |
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| «Olesen SS, Bouwense SA, Wilder-Smith OH ym. Pregab...»1 | 34/30 | 3 wks | 14/34 (41%) | 6/30 (20%) | |