Mebeverine and the Influence of Labeling in Adolescents With Irritable Bowel Syndrome or Functional Abdominal Pain Not Otherwise Specified: A 2 × 2 Randomized, Placebo-Controlled Trial.

The efficacy of mebeverine, an antispasmodic agent, and the effect of labeling within a pediatric cohort were evaluated.

评估了抗痉挛药物美贝维林的疗效以及在儿童队列中贴标签的效果。

Methods

This randomized trial was conducted across 13 hospitals.

这项随机试验在13家医院进行。

Participants (12-17 years) with irritable bowel syndrome or functional abdominal pain-not otherwise specified received mebeverine (200 mg twice daily) or placebo for 8 weeks.

参与试验的患者（12-17岁）患有肠易激综合症或功能性腹痛-未特定，他们接受了美贝维林（每日两次，每次200毫克）或安慰剂治疗，持续8周。

Treatment was labeled as "mebeverine or placebo" (blinded trial label) or "mebeverine" (mebeverine label), creating the following 4 groups: (1) mebeverine-blinded trial label, (2) mebeverine-mebeverine label, (3) placebo-blinded trial label, and (4) placebo-mebeverine label.

治疗被标记为“美贝维林或安慰剂”（盲法试验标签）或“美贝维林”（美贝维林标签），从而形成了以下4组：(1) 美贝维林-盲法试验标签，(2) 美贝维林-美贝维林标签，(3) 安慰剂-盲法试验标签，以及(4) 安慰剂-美贝维林标签。

Randomization (1:1:1:1) was masked to physicians, except for drug labeling.

随机分组（1:1:1:1）对医生进行了掩蔽，除了药物标签。

Primary end point was treatment success (>50% reduction of abdominal pain intensity and frequency) after 8 weeks.

主要终点是在8周后治疗成功（腹部疼痛强度和频率减少超过50%）

The key secondary end point was adequate relief of symptoms.

关键次要终点是症状的适当缓解。

Results

Of the 269 randomized patients, treatment success was similar between those receiving mebeverine (groups 1 and 2) (n = 31 [23.4%]) and placebo (groups 3 and 4) (n = 30 [22.0%]; odds ratio [OR], 1.08; 95% CI, 0.59-1.99; P = .81).

在269名随机患者中，接受美贝维林治疗的患者（1组和2组）（n = 31 [23.4%]）与接受安慰剂治疗的患者（3组和4组）（n = 30 [22.0%]；优势比[OR]，1.08；95%置信区间[CI]，0.59-1.99；P = .81）的治疗成功率相似。

Treatment success was higher in groups with the mebeverine label (groups 2 and 4) (n = 42 [31.6%]) compared with the blinded trial label (groups 1 and 3) (n = 19 [14.1%]; OR, 2.84; 95% CI, 1.52-5.34; P = .001).

在贴有美贝维林标签的组别（2组和4组）中（n = 42 [31.6%]），治疗成功率高于盲试标签组（1组和3组）（n = 19 [14.1%]；优势比[OR]，2.84；95%置信区间[CI]，1.52-5.34；P = .001）。

Adequate relief rates were similar between mebeverine (n = 55 [41.0%]) and placebo groups (n = 61 [45.5%]; OR, 0.83; 95% CI, 0.51-1.35; P = .46), but higher in mebeverine-labeled groups (n = 67 [50.4%]) compared with blinded trial-labeled groups (n = 49 [36.3%]; OR, 1.78; 95% CI, 1.1-2.9; P = .02).

有效缓解率在美贝维林组(n = 55 [41.0%])和安慰剂组(n = 61 [45.5%]; OR, 0.83; 95% CI, 0.51-1.35; P = .46)之间相似，但在美贝维林标记组(n = 67 [50.4%])中高于盲法试验标记组(n = 49 [36.3%]; OR, 1.78; 95% CI, 1.1-2.9; P = .02)。

Adverse events were mild and infrequent.

不良事件轻微且不常见。

Conclusions

Mebeverine was ineffective in treatment of pediatric irritable bowel syndrome and functional abdominal pain-not otherwise specified.

Mebeverine在治疗儿童肠易激综合症和功能性腹痛-未特指型方面无效。

However, a positive drug label significantly enhanced treatment outcomes compared with a blinded trial label.

然而，与盲试标签相比，积极的药物标签显著提高了治疗结果。

(International Clinical Trials Registry Platform, Number: NL-OMON55563.).

（国际临床试验注册平台，编号：NL-OMON55563。）