A pilot randomized placebo-controlled study on modified MaZiRenWan: a formulated Chinese medicine to relieve constipation for palliative cancer patients

Abstract

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.

Current Characteristics of Herbal Medicine Interventions for Cancer on Clinical Databases: A Cross-Sectional Study

“…Among the 8 publications, only one was published as a meeting abstract (NCT00669656), 28 and others were journal articles (NCT02795390, NCT02468141, NCT00076609, NCT03911921, NCT02900742, IRCT20180722040556N2, IRCT20180722040556N1). [29][30][31][32][33][34][35] The highest number of enrolled participants was 83; the lowest was 32. Only 2 studies (NCT00669656, NCT00076609) used the single-arm design, having the intervention group, while all others used the double-arm.…”

Synergistic and Additive Effects of Herbal Medicines in Combination with Chemotherapeutics: A Scoping Review

“… 6 - 9 Rooted in extensive experience, the exploration of herbal medicines for cancer symptom management has been intensively studied. 10 , 11 There is also a considerable body of research investigating herbal medicines as potential anticancer agents. According to prior studies, the anticancer properties of herbal medicines can be traced back to their ability to inhibit tumor angiogenesis, promote apoptosis, induce autophagic cell death, and alter the tumor microenvironment.…”