Schoenfeld Philip, Talley Nicholas J
Am J Gastroenterol. 2006 May;101(5):1066-8. doi: 10.1111/j.1572-0241.2006.00519.x.
The treatment options for the irritable bowel syndrome (IBS) are expanding as new therapies, including probiotics and serotonin receptor agents, become available. Before any new agents gain widespread use, they must be studied in appropriately designed clinical trials. Symptom improvement remains the key clinically but the best technique to measure symptom improvement is unclear. Many IBS therapy studies have used a binary endpoint such as "Have you had satisfactory relief of your IBS symptoms in the past week? Yes/No?" The study by Whitehead and colleagues in this issue suggests that "satisfactory relief" is affected by baseline symptom severity and may not always truly reflect the symptom burden. Future research needs to determine whether "satisfactory relief" is truly adequate, or whether alternatives such as the proportion of patients achieving a > or = 50% reduction in symptom severity would represent a superior approach to capture clinically important improvement.
随着包括益生菌和血清素受体药物在内的新疗法问世，肠易激综合征（IBS）的治疗选择正在不断增加。在任何新药广泛应用之前，必须在设计合理的临床试验中进行研究。症状改善仍然是关键的临床指标，但衡量症状改善的最佳方法尚不清楚。许多IBS治疗研究采用二元终点，例如“在过去一周中，您的IBS症状是否得到了满意的缓解？是/否？”怀特黑德及其同事在本期发表的研究表明，“满意的缓解”受基线症状严重程度影响，可能并不总能真正反映症状负担。未来的研究需要确定“满意的缓解”是否真正足够，或者诸如症状严重程度降低≥50%的患者比例等替代指标是否是一种更好的方法来体现临床上的重要改善。
