一项关于改良麻子仁丸的前瞻性随机安慰剂对照研究：一种用于缓解癌症姑息治疗患者便秘的中药制剂。
A pilot randomized placebo-controlled study on modified MaZiRenWan: a formulated Chinese medicine to relieve constipation for palliative cancer patients.
作者信息
Cheng Chung-Wah, Mok Hoi-Fung, Yau Cora W S, Chan Jasmine T M, Kang Yu-Chen, Lam Pui-Yan, Zhong Linda L D, Zhao Chen, Ng Bacon F L, Kwok Annie O L, Tse Doris M W, Bian Zhao-Xiang
机构信息
Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University, 3/F, Jockey Club School of Chinese Medicine Building, 7 Baptist University Road, Hong Kong, SAR, People's Republic of China.
Yan Chai Hospital - Hong Kong Baptist University Clinical Centre for Training and Research in Chinese Medicine (West Kowloon), Yan Chai Hospital, Hong Kong, SAR, People's Republic of China.
出版信息
Chin Med. 2022 Mar 2;17(1):31. doi: 10.1186/s13020-022-00580-0.
BACKGROUND
Constipation is a common problem among advanced cancer patients; however, many of them find limited effective from current therapies. Thus, we aimed to test the effect of a traditional Chinese herbal formula, modified MaZiRenWan (MZRW), by comparing with placebo among palliative cancer patients with constipation.
METHODS
This is a randomized, double-blind, placebo-controlled trial. Participants aged over 18 were recruited and randomized to MZRW or placebo group in addition to current prescriptions (including ongoing laxatives treatment) for two weeks. Exclusion criteria included cognitive impairment, presence of a colostomy or gastrointestinal obstruction and estimated life expectancy of less than one month. Individualized modification of MZRW was allowed according to the traditional Chinese medicine (TCM) pattern of patient. The primary outcome was the global assessment of improvement, which reflected whether the constipation had improved, remained the same or worsened.
RESULTS
Sixty patients, with mean age 75.2 years (range 47-95 years), were randomized to MZRW or placebo group. Among the MZRW group, 59.3% (16/27) had improvement in the global assessment score, as compared with 28.6% (8/28) of the placebo group (p-value = 0.022). Besides, the MZRW group had significant increase in stool frequency, and reduction in constipation severity and straining of defecation (p-value < 0.05). No serious adverse event was reported due to the research medication.
CONCLUSION
This pilot trial suggests modified MZRW is well-tolerated and effective for relief of constipation in patients with advance cancer. It could be considered as a potential treatment option for constipation in palliative care.
TRIAL REGISTRATION
The trial had been registered in ClinicalTrials.gov with identifier number NCT02795390 [ https://clinicaltrials.gov/ct2/show/NCT02795390 ] on June 10, 2016.
背景
便秘是晚期癌症患者的常见问题；然而，他们中的许多人发现目前的治疗方法效果有限。因此，我们旨在通过在患有便秘的姑息性癌症患者中与安慰剂进行比较，来测试一种传统中药配方——加味麻子仁丸（MZRW）的效果。
方法
这是一项随机、双盲、安慰剂对照试验。招募年龄超过18岁的参与者，并在除当前处方（包括正在进行的泻药治疗）外，将其随机分为MZRW组或安慰剂组，为期两周。排除标准包括认知障碍、存在结肠造口术或胃肠道梗阻以及预期寿命少于一个月。允许根据患者的中医证型对MZRW进行个体化调整。主要结局是改善的总体评估，反映便秘是改善、保持不变还是恶化。
结果
60名患者，平均年龄75.2岁（范围47 - 95岁），被随机分为MZRW组或安慰剂组。在MZRW组中，59.3%（16/27）的总体评估得分有所改善，而安慰剂组为28.6%（8/28）（p值 = 0.022）。此外，MZRW组的大便频率显著增加，便秘严重程度和排便费力程度降低（p值 < 0.05）。未报告因研究用药导致的严重不良事件。
结论
这项试点试验表明，加味麻子仁丸耐受性良好，对晚期癌症患者的便秘缓解有效。它可被视为姑息治疗中便秘的一种潜在治疗选择。
试验注册
该试验于2016年6月10日在ClinicalTrials.gov注册，标识符为NCT02795390 [https://clinicaltrials.gov/ct2/show/NCT02795390] 。
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