Table 1.
Demographic and clinical characteristics of patients
| Placebo responders (n=12) | Placebo nonresponders (n=17) | Pregabalin responders (n=16) | Pregabalin nonresponders (n=15) | |
|---|---|---|---|---|
| Age (years) | 54 (41–63) | 59 (49–64) | 52 (50–59) | 49 (43–57) |
| Males, n (%) | 9 (75) | 10 (59) | 9 (56) | 9 (60) |
| Etiology, n (%) | ||||
| – Toxic, metabolic | 9 (75) | 7 (41) | 6 (38) | 9 (60) |
| – Idiopathic | 2 (17) | 9 (53) | 6 (38) | 5 (33) |
| – Genetic | 0 (0) | 0 (0) | 1 (6) | 1 (7) |
| – Autoimmune | 0 (0) | 0 (0) | 1 (6) | 0 (0) |
| – Recurrent and severe acute pancreatitis | 0 (0) | 1 (6) | 1 (6) | 0 (0) |
| – Obstructive | 1 (8) | 0 (0) | 1 (6) | 0 (0) |
| Diary pain score (VAS before) | ||||
| – Average pain | 4 (2–5) | 4 (2–5) | 4 (3–5) | 4 (2–7) |
| – Maximum pain | 5 (2–7) | 5 (4–7) | 6 (4–9) | 7 (4–8) |
| Diary pain score (VAS after)* | ||||
| – Average pain | 1 (0–2)# | 4 (2–6) | 1 (0–2)# | 4 (2–6) |
| – Maximum pain | 1 (0–4)# | 5 (4–7) | 2 (1–5)# | 5 (4–7) |
| Concomitant analgesics, n (%)† | ||||
| – None | 2 (17) | 0 (0) | 2 (13) | 1 (7) |
| – Weak analgesics | 3 (25) | 8 (47) | 4 (25) | 3 (20) |
| – Strong analgesics | 7 (558) | 9 (53) | 10 (63) | 11 (73) |
| MEQ/day | 45 (23–135) | 48 (8–120) | 71 (4–127) | 80 (10–180) |
| Duration of chronic pancreatitis (months) | 151 (77–212) | 84 (73–112) | 83 (54–131) | 117 (100–166) |
| Diabetes mellitus, n (%) | 6 (50) | 4 (24) | 7 (44) | 3 (20) |
| Previous interventions for chronic pancreatitis, no (%) | ||||
| – Pancreas resection/drainage procedures | 2 (17) | 3 (18) | 3 (19) | 3 (20) |
| – Thoracoscopic splanchnic denervation | 1 (8) | 3 (18) | 0 (0) | 2 (13) |
| – Celiac blockade | 1 (8) | 0 (0) | 1 (6) | 0 (0) |
| Enzyme treatment for pancreatic exocrine insufficiency, n (%) | 6 (50) | 6 (35) | 7 (44) | 8 (53) |
| Ongoing alcohol abuse, n (%)‡ | 4 (33) | 6 (35) | 3 (19) | 3 (20) |
| Current smoker, n (%) | 9 (75) | 13 (76) | 12 (80) | 12 (75) |
Notes: All values are medians with IQRs unless mentioned otherwise. Percentages may not total 100 due to rounding. VAS: 0–10.
Weak analgesics were defined as NSAIDs, paracetamol, codeine, and tramadol. Strong analgesics were defined as opioid-based therapies. “Pregabalin” is pregabalin study group and “placebo” is placebo study group;
alcohol-abusing patients were defined as female patients drinking 14 units of alcohol per week or male patients drinking 21 units of alcohol per week;
a significant reduction in mean and maximum VAS scores was observed within the treatment group after study treatment (P-value ≤0.010);
statistical differences between groups where the placebo responders and pregabalin responders differed significantly (P-value ≤0.010) from the placebo nonresponders and pregabalin nonresponders.
Abbreviations: IQR, interquartile range; MEQ, morphine equivalents; NSAID, nonsteroidal anti-inflammatory drug; VAS, visual analog scale.