Bensoussan A, Talley N J, Hing M, Menzies R, Guo A, Ngu M
Research Unit for Complementary Medicine, University of Western Sydney Macarthur, Campbelltown, New South Wales, Australia.
JAMA. 1998 Nov 11;280(18):1585-9. doi: 10.1001/jama.280.18.1585.
Irritable bowel syndrome (IBS) is a common functional bowel disorder for which there is no reliable medical treatment.
To determine whether Chinese herbal medicine (CHM) is of any benefit in the treatment of IBS.
Randomized, double-blind, placebo-controlled trial conducted during 1996 through 1997.
Patients were recruited through 2 teaching hospitals and 5 private practices of gastroenterologists, and received CHM in 3 Chinese herbal clinics.
A total of 116 patients who fulfilled the Rome criteria, an established standard for diagnosis of IBS.
Patients were randomly allocated to 1 of 3 treatment groups: individualized Chinese herbal formulations (n = 38), a standard Chinese herbal formulation (n = 43), or placebo (n = 35). Patients received 5 capsules 3 times daily for 16 weeks and were evaluated regularly by a traditional Chinese herbalist and by a gastroenterologist. Patients, gastroenterologists, and herbalists were all blinded to treatment group.
Change in total bowel symptom scale scores and global improvement assessed by patients and gastroenterologists and change in the degree of interference in life caused by IBS symptoms assessed by patients.
Compared with patients in the placebo group, patients in the active treatment groups (standard and individualized CHM) had significant improvement in bowel symptom scores as rated by patients (P=.03) and by gastroenterologists (P=.001), and significant global improvement as rated by patients (P=.007) and by gastroenterologists (P=.002). Patients reported that treatment significantly reduced the degree of interference with life caused by IBS symptoms (P=.03). Chinese herbal formulations individually tailored to the patient proved no more effective than standard CHM treatment. On follow-up 14 weeks after completion of treatment, only the individualized CHM treatment group maintained improvement.
Chinese herbal formulations appear to offer improvement in symptoms for some patients with IBS.
肠易激综合征(IBS)是一种常见的功能性肠道疾病,目前尚无可靠的药物治疗方法。
确定中药(CHM)对IBS治疗是否有益。
1996年至1997年进行的随机、双盲、安慰剂对照试验。
通过2家教学医院和5位胃肠病学家的私人诊所招募患者,并在3家中草药诊所接受中药治疗。
共有116例符合罗马标准(IBS既定诊断标准)的患者。
患者被随机分配到3个治疗组中的1组:个体化中药配方(n = 38)、标准中药配方(n = 43)或安慰剂(n = 35)。患者每天3次,每次服用5粒胶囊,持续16周,并由一位中医和一位胃肠病学家定期进行评估。患者、胃肠病学家和中医均对治疗组不知情。
患者和胃肠病学家评估的肠道症状总评分变化和总体改善情况,以及患者评估的IBS症状对生活造成的干扰程度变化。
与安慰剂组患者相比,活性治疗组(标准和个体化中药)患者的肠道症状评分在患者评估中(P = 0.03)和胃肠病学家评估中(P = 0.001)均有显著改善,患者评估的总体改善情况(P = 0.007)和胃肠病学家评估的总体改善情况(P = 0.002)也有显著改善。患者报告治疗显著降低了IBS症状对生活造成的干扰程度(P = 0.03)。事实证明,为患者量身定制的个体化中药配方并不比标准中药治疗更有效。在治疗完成后14周的随访中,只有个体化中药治疗组保持了改善。
中药配方似乎能改善部分IBS患者的症状。