Tongxie Formula Reduces Symptoms of Irritable Bowel Syndrome
Tongxie Formula Reduces Symptoms of Irritable Bowel Syndrome
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痛泻方可减轻肠易激综合症的症状
DOI：
10.1016/j.cgh.2017.06.026
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发表时间：
2017-11-01
影响因子：
12.6
通讯作者：
Xiao, Jun
中科院分区：
文献类型：
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作者：
Fan, Heng;Zheng, Liang;Xiao, Jun
背景与目的：肠易激综合征(IBS)是最常见的慢性胃肠道疾病，但很少有药物能有效缓解症状。大约50%的IBS患者至少尝试过一次草药治疗。方法：2012年8月至2015年1月，我们在中国的5家医院进行了一项随机对照试验，以比较痛泻制剂与安慰剂或匹维溴铵(一种解痉剂)在缓解IBS症状方面的疗效。受试者按1：1：1随机分为3组，分别给予痛泻、安慰剂或匹维溴铵(50 mg片剂)，每日3次，每次3次。与服用安慰剂或匹维溴铵的患者相比，服用痛泻的患者的主要终点是腹痛和Bristol大便评分(在为期4周的研究期之前与之后相比)显著降低。次要终点是疼痛和大便频率的减少以及腹部不适及其频率的减少。结果：与服用安慰剂的患者相比，服用痛泻的受试者在研究之前与研究后相比，所有6项评估的症状都显著减少(P<；.001)。服用痛泻的患者大便稠度增加的比例(75.6%)显著高于服用匹维溴铵的患者(50.6%)，服用痛泻的患者每天大便减少的比例(72.7%)显著高于服用匹维铵的患者(58.3%)(P<；.001)。然而，服用匹维溴铵的患者中，疼痛减轻(63.5%)和疼痛频率(69.5%)的比例明显高于服用痛泻的患者(分别为51.4%和58.6%；P<；0.005)。结论：在中国进行的一项针对IBS患者的随机对照试验中，我们发现痛泻4周的症状缓解效果明显优于安慰剂，大便稠度的增加和大便频率的减少均高于服用匹纳维铵的患者。因此，对于常规治疗效果不佳的IBS患者，痛泻可以被认为是一种有效的替代疗法。临床试验。政府编号：NCT01641224。
BACKGROUND & AIMS: Irritable bowel syndrome (IBS) is the most common chronic gastrointestinal disorder, yet few drugs are effective in reducing symptoms. Approximately 50% of patients with IBS attempt herbal therapy at least once. We performed a randomized controlled trial to compare the efficacy of the herb formulation tongxie vs placebo or pinaverium (an antispasmodic agent) in reducing symptoms of IBS.METHODS: We performed a trial of 1044 adult patients with IBS (based on Rome III criteria) at 5 hospitals in China, from August 2012 through January 2015. Subjects were randomly assigned (1: 1: 1) to groups given tongxie (a combination of A macrocephalae, P lactiflora, C reticulata, S divaricata, C pilosula, C wenyujin, C medica, and P cocos, along with other herbs, based on patient features), placebo, or pinaverium (50 mg tablets) 3 times daily for 4 weeks. Primary end points were significantly greater reductions in abdominal pain and Bristol stool score (before vs after the 4-week study period) in patients given tongxie compared with patients given placebo or pinaverium. Secondary end points were reductions in pain and stool frequencies and abdominal discomfort and its frequency.RESULTS: Subjects given tongxie had significant reductions, before vs after the study period, in all 6 symptoms assessed, compared to patients given placebo (P < .001). A significantly higher proportion of patients given tongxie had increased stool consistency (75.6%) than patients given pinaverium (50.6%), and a significantly higher proportion of patients given tongxie had fewer daily stools (72.7%) than subjects given pinaverium (58.3%) (P < .001 for both). However, significantly higher proportions of patients given pinaverium had reduced pain (63.5%) and pain frequency (69.5%) than patients given tongxie (51.4% and 58.6%, respectively; P < .005 for both).CONCLUSIONS: In a randomized controlled trial of patients with IBS in China, we found 4 weeks of tongxie to produce significantly greater reduction in symptoms than placebo, and greater increases in stool consistency and reductions in stool frequency, than patients given pinaverium. Tongxie can therefore be considered an effective alternative therapy for patients with IBS who do not respond well to conventional therapies. Clinicaltrials. gov no: NCT01641224.