CHICAGO (EGMN) – Adults with irritable bowel syndrome experienced significantly less abdominal pain when they took a combination of alverine citrate and simethicone, compared with a placebo, based on data from 409 patients.

“Alverine citrate acts on both intestinal motility and sensitivity while simethicone has an antifoaming action,” said Dr. Tibor Wittmann of the University of Szeged, Hungary, and his colleagues. The combination of alverine citrate/simethicone (ACS) is approved in several countries to treat the symptoms of functional intestinal disorders, and the manufacturer is seeking approval in the United States.

The researchers randomized 409 patients aged 18 years and older to take three ACS capsules (each containing 60 mg alverine citrate and 300 mg simethicone) or three placebo capsules daily for 4 weeks. Most (72%) of the patients were women, and the average patient age was 46 years. The patients had a history of IBS of less than 5 years, and their baseline abdominal pain was at least 60 mm based on visual analog scale (VAS) scores. The results were presented in a poster at the annual Digestive Disease Week.

After 4 weeks of treatment, abdominal pain and discomfort significantly improved in the ACS group, compared with the placebo group, according to VAS scores. Overall, 96 patients (47%) showed more than a 50% improvement in symptoms, compared with 70 patients (34%) in the placebo group.

The percentage of patients with abnormal stools decreased in both groups during the study period, based on patients’ daily records and investigators’ weekly evaluations. There was a greater improvement in patients with diarrhea in the ACS group than in the placebo group, although the difference was not statistically significant.

The percentage of patients with any adverse events was 18% in the ACS group and 24% in the placebo group. The most common treatment-related adverse event was nausea, reported by 6 patients in the ACS group and 11 patients in the placebo group. Other adverse events included upper abdominal pain, headache, and vertigo, each of which occurred in fewer than 4% of patients in the ACS group and fewer than 6% of patients in the placebo group.

In addition, significantly more patients in the treatment group than in the placebo group said they “agree” or “strongly agree” that their bowel problems had improved after the 4-week study (63% vs. 49%).

The study was limited by the use of self-reports, but the improvement in symptoms and minor adverse effects suggest that ACS may be a useful treatment option for IBS patients of any subtype, the researchers noted.

The study was sponsored by Laboratoires Mayoly Spindler – SAS. Dr. Tibor had no personal financial conflicts to disclose.

 

Copyright (c) 2009 Elsevier Global Medical News. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

芝加哥 (EGMN)——通过对409例肠易激综合征(IBS)成人患者的观察，与服用安慰剂相比，联合服用枸橼酸乙双苯丙胺/二甲基硅油(ACS)时，腹部疼痛症状会明显减轻。

 

匈牙利Szeged大学的Tibor Wittmann医生及其同事说，“枸橼酸乙双苯丙胺可改善肠道运动和敏感性，而二甲基硅油的作用是消泡。”ACS已被很多国家批准用于改善肠道功能紊乱的症状，ACS的生产商正在申请美国的批准。

 

研究者随机选取了409例18岁及18岁以上的IBS患者，分别服用ACS  3片/日(每片含枸橼酸乙双苯丙胺60mg和二甲基硅油300mg)或安慰剂3片/日，连服4周。患者以为女性为主(72%)，平均46岁。患者IBS病史均不足5年，以直观类比标度法(VAS)评分，他们基线水平的腹痛值至少为60mm。他们的研究结果在每年一度的消化疾病周(DDW) 的壁报上登出。

 

经过4周治疗，ACS组与安慰剂组的VAS评分相比，前者的腹痛和腹部不适明显改善。ACS组中96例患者(47%)的症状获得50%以上程度的改善，而安慰剂组只有70例(34%)得到相同程度的改善。

 

根据患者每日记录以及研究者每周的评估，在研究期间，两组中大便异常的患者的百分比均出现下降。ACS组较安慰剂组腹泻症状的改善更为显著，尽管这种差别没有统计学意义。

 

出现药物不良反应的比例在ACS组是18%，而安慰剂组为24%。最常见的治疗相关的不良反应是恶心，ACS组出现6例，安慰剂组出现11例。其他的不良反应如上腹痛、头痛、眩晕，每一种在ACS组中出现不足4%，在安慰剂组不足6%。

 

另外，经过4周的研究之后，治疗组对疗效表示“认同”或“非常认同”的患者要显著多于安慰剂组(63%比49%)。

 

研究者强调，尽管本研究存在患者“自报告”方式的局限性，但鉴于ACS对症状的改善以及不良反应很小，ACS可能对于任何亚型的IBS患者都是一个有效的治疗选择。

 

本研究得到Laboratoires Mayoly Spindler SAS的赞助。Tibor医生声明无利益冲突。