Dataset Information

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).

SUBMITTER: Xu R

PROVIDER: S-EPMC9989377 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Xu Ri R Wang Yanyan Y Han Wei W

Therapeutic advances in gastroenterology 20230303

<h4>Background</h4>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).<h4>Objectives</h4>To investigate the efficacy of pregabalin on nociceptive and emotional symptoms in CAPS patients.<h4>Design</h4>This is an open-label randomized controlled trial.<h4>Methods</h4>CAPS patients were randomized to receive pregabalin 75 mg (P group), pinaverium bromide 50 mg (PB gro ...[more]

PMID: 36895281

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Project description:ImportanceOptimal pharmacologic treatment for chronic sciatica (CS) is currently unclear. While gabapentin (GBP) and pregabalin (PGB) are both used to treat CS, equipoise exists. Nevertheless, pharmaceutical regulation authorities typically subsidize one drug over the other. This hinders interchange wherever the favored drug is either ineffective or ill-tolerated.ObjectiveTo assess GBP vs PGB head to head for the treatment of CS.Design, setting, and participantsA preplanned interim analysis of a randomized, double-blind, double-dummy crossover trial of PGB vs GBP for management of CS at half the estimated final sample size was performed in a single-center, tertiary referral public hospital. A total of 20 patients underwent randomization from March 2016 to March 2018, and 2 were excluded with 1 lost to follow-up and the other requiring urgent surgery unrelated to the study. Patients attending a specialist neurosurgery clinic with unilateral CS were considered for trial recruitment. Chronic sciatica was defined as pain lasting for at least 3 months radiating into 1 leg only to, at, or below the knee level. Imaging (magnetic resonance imaging with or without computed tomography) corroborating a root-level lesion concordant with symptoms and/or signs was determined by the trial clinician. Inclusion criteria included patients who had not used GBP and PGB and were 18 years or older. Analyses were intention to treat and began February 2018.InterventionsRandomly assigned participants received GBP (400 mg to 800 mg 3 times a day) then PGB (150 mg to 300 mg twice daily) or vice versa, each taken for 8 weeks. Crossover followed a 1-week washout.Main outcomes and measuresThe primary outcome was pain intensity (10-point visual analog scale) at baseline and 8 weeks. Secondary outcomes included disability (using the Oswestry Disability Index) and severity/frequency of adverse events.ResultsThe total trial population (N = 18) consisted mostly of men (11 [61%]) with a mean (SD) age of 57 (16.5) years. A third of the cohort were smokers (5 [28%]), and more than half consumed alcohol (12 [67%]). Gabapentin was superior to PGB, with fewer and less severe adverse events. Both GBP (mean [SD], 7.54 [1.39] to 5.82 [1.72]; P < .001) and PGB (mean [SD], 7.33 [1.30] to 6.38 [1.88]; P = .002) displayed significant visual analog pain intensity scale reduction and Oswestry Disability Index reduction (mean [SD], 59.22 [16.88] to 48.54 [15.52]; P < .001 for both). Head to head, GBP showed superior visual analog pain intensity scale reduction (mean [SD], GBP: 1.72 [1.17] vs PGB: 0.94 [1.09]; P = .035) irrespective of sequence order; however, Oswestry Disability Index reduction was unchanged. Adverse events for PGB were more frequent (PGB, 31 [81%] vs GBP, 7 [19%]; P = .002) especially when PGB was taken first.Conclusions and relevancePregabalin and GBP were both significantly efficacious. However, GBP was superior with fewer and less severe adverse events. Gabapentin should be commenced before PGB to permit optimal crossover of medicines.Trial registrationanzctr.org.au Identifier: ACTRN12613000559718.

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Dataset Information

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

Background

Objectives

Design

Methods

Results

Conclusion

Registration

Publications

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

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