Xu Ri, Wang Yanyan, Han Wei
Department of Pharmacy, Qilu Hospital of Shandong University, Jinan, Shandong, China.
Phase I Clinical Trial Center, Qilu Hospital of Shandong University, Jinan, Shandong, China.
Therap Adv Gastroenterol. 2023 Mar 3;16:17562848231152334. doi: 10.1177/17562848231152334. eCollection 2023.
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).
To investigate the efficacy of pregabalin on nociceptive and emotional symptoms in CAPS patients.
This is an open-label randomized controlled trial.
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.
Totally, 102 eligible patients were recruited and randomized. The mean severity scores of abdominal pain were 1.39 ± 1.28, 0.97 ± 1.43 2.91 ± 1.44 ( < 0.0001) in P or PB + P group PB group at week 2 and were 0.90 ± 1.21, 1.28 ± 1.87 2.74 ± 1.75 ( < 0.0001) at week 4. The mean frequency scores were 2.55 ± 2.55, 2.03 ± 2.80 5.12 ± 2.09( < 0.0001) in P or PB + P group PB group at week 2 and were 1.72 ± 2.46, 2.00 ± 2.90 4.55 ± 2.55 ( < 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 ( = 0.0002, = 0.0002, and = 0.0033).
This trial suggests that pregabalin may be beneficial for CAPS abdominal pain and concomitant somatic or anxiety symptoms.
www.chictr.org.cn (ChiCTR1900028026).
普瑞巴林在全球范围内被批准用于治疗多种疼痛综合征，被认为是中枢介导性腹痛综合征（CAPS）的潜在候选药物。
研究普瑞巴林对CAPS患者伤害性和情绪症状的疗效。
这是一项开放标签随机对照试验。
将CAPS患者随机分为三组，分别每日三次接受75毫克普瑞巴林（P组）、50毫克匹维溴铵（PB组）或普瑞巴林联合匹维溴铵方案（P + PB组）治疗，为期4周。每两周完成一次问卷调查。主要结局定义为第2周和第4周时腹痛严重程度和频率的平均评分。次要结局包括试验结束时相对于基线时腹痛评分、躯体自评量表（SSS）、患者健康问卷-15（PHQ-15）和广泛性焦虑障碍量表7（GAD-7）评分的降低情况。
共招募并随机分配了102名符合条件的患者。在第2周时，P组或P + PB组的腹痛平均严重程度评分为1.39±1.28、0.97±1.43，PB组为2.9l±1.44（P<0.0001）；在第4周时，分别为0.90±1.21、1.28±1.87，PB组为2.74±1.75（P<0.0001）。在第2周时，P组或P + PB组的腹痛平均频率评分为2.55±2.55、2.03±2.80，PB组为5.12±2.09（P<0.0001）；在第4周时，分别为1.72±2.46、2.00±2.90，PB组为4.55±2.55（P<0.0001）。在比较SSS、PHQ-15和GAD-7评分的变化时，接受普瑞巴林或普瑞巴林联合治疗方案的患者报告的下降幅度比接受匹维溴铵治疗的患者更大（P = 0.0002、P = 0.0002和P = 0.0033）。
本试验表明，普瑞巴林可能对CAPS的腹痛及伴随的躯体或焦虑症状有益。
