Randomized clinical trial: the effects of pregabalin for centrally mediated abdominal pain syndrome

Abstract

Background: Pregabalin is worldwidely licensed for the treatment of a variety of pain syndromes and supposed to be a potential candidate for the centrally mediated abdominal pain syndrome (CAPS). Objectives: To investigate the efficacy of pregabalin on nociceptive and emotional symptoms in CAPS patients. Design: This is an open-label randomized controlled trial. Methods: CAPS patients were randomized to receive pregabalin 75 mg (P group), pinaverium bromide 50 mg (PB group), or pregabalin combined pinaverium bromide regimen (P + PB group) three times daily for 4 weeks. Questionnaires were completed biweekly. The primary outcomes were defined as the average abdominal pain scores of severity and frequency at weeks 2 and 4. Secondary outcomes included the reduction in abdominal pain scores, Somatic Self-rating Scale (SSS), Patient Health Questionnaire-15 (PHQ-15), and Generalized Anxiety Disorder Scale 7 (GAD-7) scales obtained at the end of trial to the baseline. Results: Totally, 102 eligible patients were recruited and randomized. The mean severity scores of abdominal pain were 1.39 ± 1.28, 0.97 ± 1.43 versus 2.91 ± 1.44 ( p < 0.0001) in P or PB + P group versus PB group at week 2 and were 0.90 ± 1.21, 1.28 ± 1.87 versus 2.74 ± 1.75 ( p < 0.0001) at week 4. The mean frequency scores were 2.55 ± 2.55, 2.03 ± 2.80 versus 5.12 ± 2.09( p < 0.0001) in P or PB + P group versus PB group at week 2 and were 1.72 ± 2.46, 2.00 ± 2.90 versus 4.55 ± 2.55 ( p < 0.0001) at week 4. When comparing the changes in SSS, PHQ-15, and GAD-7 scores, patients accepting pregabalin or pregabalin combination regimen reported a more decrease than pinaverium bromide recipients ( p = 0.0002, p = 0.0002, and p = 0.0033). Conclusion: This trial suggests that pregabalin may be beneficial for CAPS abdominal pain and concomitant somatic or anxiety symptoms. Registration: www.chictr.org.cn (ChiCTR1900028026)

Management of Refractory Functional Gastrointestinal Disorders: What Role Should Psychiatrists Have?

“…Bupropion can be an alternative treatment option in situations where depression, fatigue, and sleepiness are the dominant features [61]. Anticonvulsants like gabapentin and pregabalin as adjunctive drugs may be effective in alleviating the severity of gastrointestinal symptoms (except for bloating) among patients with refractory functional gastrointestinal disorders [62][63][64][65]. Benzodiazepines are useful in controlling anxiety in the short term but are not suitable for long-term treatment due to mild transient cognitive dysfunction and the risk of addiction.…”