Prescript-assist™ probiotic-prebiotic treatment for irritable bowel syndrome:: A methodologically oriented, 2-week, randomized, placebo-controlled, double-blind clinical study
Prescript-assist™ probiotic-prebiotic treatment for irritable bowel syndrome:: A methodologically oriented, 2-week, randomized, placebo-controlled, double-blind clinical study
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DOI：
10.1016/j.clinthera.2005.06.005
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发表时间：
2005-06-01
影响因子：
3.2
通讯作者：
Stranahan, MC
中科院分区：
文献类型：
--
作者：
Bittner, AC;Croffut, RM;Stranahan, MC
背景：Prescript-Assist（TM）（Safer Medical，Inc.，Fort Benton，Montana），一种结合益生菌和益生菌成分的治疗方法，以前仅在患有各种胃肠道疾病（包括肠易激综合征（IBS））的患者的开放标签研究中进行了临床评估。为了实现这一目标，一个次要的方法学目标是确定的数量和性质的症状集群（“亚综合征因素”）的特点IBS.Methods：这是一个双盲，安慰剂对照的临床研究中，患者被随机分配到接受处方辅助一个500毫克胶囊BID或1安慰剂胶囊BID 2周。从临床文献中识别出的13种IBS症状被嵌入到更大的研究工具中。使用0 - 5分量表，患者在治疗开始前即刻、每个研究周结束时和随后2周的每一周后（在此期间，所有患者均接受开放标签处方辅助，作为评价方法学方法以加强药物疗效/安全性评估的大型研究的一部分）对7天期间这些症状的强度进行评分。强度数据进行最大似然因子分析与方差最大旋转，以确定任何IBS亚综合征的因素，并对每个确定的因素的治疗效果进行了评估，使用协方差分析与适当的基线周评估作为协变量controls.Results：该研究包括25例IBS患者（23名女性，2名男性;年龄范围，20-70岁）。确定了三个亚综合征因素，共占总IBS症状变异的60.2%：因素1，一般不适/恶心;因素2，消化不良/肠胃气胀;和因素3，结肠炎。处方辅助治疗与每个亚综合征因素的显著减少相关。因子1显著降低0.345标准分单位（F-1，F-46 4.26; P = 0.042），因子2，0.544标准评分单位（F-1，F-46 = 7.83; P = 0.008），因子3为0.826标准评分单位（F-1，F-46 = 10.20; P = 0.003）。结论：本研究确定了IBS的3个亚综合征因素：全身不适/恶心、消化不良/胃肠胀气和结肠炎。在这项针对IBS患者的方法学导向的双盲研究中，益生菌-益生元联合处方辅助治疗与这些因素的显着减少相关。
Background: The symptomatic efficacy of Prescript-Assist (TM) (Safer Medical, Inc., Fort Benton, Montana), a treatment combining probiotic and probiotic components, has previously been evaluated clinically only in an open-label study in patients with various gastrointestinal conditions, including irritable bowel syndrome (IBS).Objectives: This study was conducted primarily to compare the effects of Prescript-Assist with placebo in patients with a diagnosis of IBS. Toward this objective, a secondary methodologic goal was to determine the number and nature of symptom clusters ("subsyndromic factors") that characterize IBS.Methods: This was a double-blind, placebo-controlled clinical study in which patients were randomly assigned to receive either Prescript-Assist one 500-mg capsule BID or 1 placebo capsule BID for 2 weeks. Thirteen IBS symptoms identified from the clinical literature were embedded in a larger research instrument. Using a scale from 0 to 5, patients rated the intensity of these symptoms for the 7-day period immediately before the start of treatment, at the end of each study week, and after each of the 2 subsequent weeks (during which all patients received open-label Prescript-Assist as part of a larger study evaluating methodologic approaches to enhancing assessments of medication efficacy/safety). The symptom-intensity data were subjected to maximum likelihood factor analysis with varimax rotation to identify any IBS subsyndromic factors, and the effect of treatment on each of the identified factors was evaluated using analyses of covariance with appropriate baseline-week assessments as covariate controls.Results: The study included 25 patients with IBS (23 women, 2 men; age range, 20-70 years). Three subsyndromic factors were identified that together accounted for 60.2% of total IBS symptom variance: factor 1, general ill feelings/nausea; factor 2, indigestion/flatulence; and factor 3, colitis. Treatment with Prescript-Assist was associated with significant reductions in each of the subsyndromic factors. Factor 1 was significantly reduced by 0.345 standard score units (F-1,F-46 4.26; P = 0.042), factor 2 by 0.544 standard score units (F-1,F-46 = 7.83; P = 0.008), and factor 3 by 0.826 standard score units (F-1,F-46 = 10.20; P = 0.003).Conclusions: This study identified 3 subsyndromic factors of IBS: general ill feelings/nausea, indigestion/flatulence, and colitis. In this methodologically oriented double-blind study in patients with IBS, combined probiotic-prebiotic treatment with Prescript-Assist was associated with significant reductions in these factors.