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Effects of Shen Cao Granules on Chemotherapy-Induced Thrombocytopenia in Gastrointestinal Cancer Patients: A Randomized Controlled Trial.

ABSTRACT: BACKGROUND:To observe clinical effects of Shen Cao granules on thrombocytopenia in patients with gastrointestinal cancer undergoing chemotherapy. PATIENTS AND METHODS:Patients under a FOLFIRI chemotherapy regimen (n = 92) were randomly divided into study and control groups (n = 46 for each group) and were given 10 g of Shen Cao granules and a placebo, respectively, once daily on chemotherapy treatment days. Platelet counts were measured every other day and any adverse reaction recorded during the study and at follow-up. RESULTS:The incidence of thrombocytopenia (grades II-IV) in the study group was significantly decreased, and the length of hospitalization significantly reduced compared with the control group (11.21 ± 2.46 vs 15.34 ± 3.68 days, P < .05). The minimum numbers of post-chemotherapy platelets and the values of platelet counts 21 days after chemotherapy were significantly increased ([100.65 ± 63.16] × 109/L vs [60.21 ±37.22] × 109/L, P < .05; [267.81 ± 81.32] × 109/L vs [146.42 ± 70.54] × 109/L, P < .001), and the duration of thrombocytopenia and treatment with recombinant human interleukin-11 was significantly decreased in the Shen Cao treatment compared with the control group. No serious adverse events were observed. CONCLUSIONS:Shen Cao granules were effective in decreasing chemotherapy-induced thrombocytopenia, shortened the duration of thrombocytopenia, and reduced the length of hospital stay and costs.

SUBMITTER: Yu C

PROVIDER: S-EPMC6432674 | biostudies-literature | 2019 Jan-Dec

REPOSITORIES: biostudies-literature

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Effects of Shen Cao Granules on Chemotherapy-Induced Thrombocytopenia in Gastrointestinal Cancer Patients: A Randomized Controlled Trial.

Yu Chunfeng C Liu Wei W Mu Yuejun Y Hou Aihua A Li Yin Y

Integrative cancer therapies 20190101

<h4>Background</h4>To observe clinical effects of Shen Cao granules on thrombocytopenia in patients with gastrointestinal cancer undergoing chemotherapy.<h4>Patients and methods</h4>Patients under a FOLFIRI chemotherapy regimen (n = 92) were randomly divided into study and control groups (n = 46 for each group) and were given 10 g of Shen Cao granules and a placebo, respectively, once daily on chemotherapy treatment days. Platelet counts were measured every other day and any adverse reaction rec ...[more]

PMID: 30741025

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Project description:BackgroundAmnestic mild cognitive impairment (aMCI) is a syndrome characterized by significant forgetfulness that does not meet the criteria of dementia. Individuals with aMCI are at greater risk of progressing to dementia. Current studies suggest that good sleep quality is linked with preserved cognition in the elderly, and sleep complaints are common among the elderly with amnesia. Therefore, improving their sleep may be helpful for maintaining and improving their cognitive capacity. According to the theory of traditional Chinese medicine, Yi-Zhi-An-Shen is an herbal compound which may ameliorate forgetfulness and sleep disorders. As growing evidence indicates that the gut microbiome is associated with major mental symptoms, a hypothesis was proposed that Yi-Zhi-An-Shen granules (YZASG) might work by alternating microbial abundance and diversity. In this study, the investigators intend to assess the efficacy of YZASG on global cognition in the elderly suffering from aMCI and evaluate its safety as well as its potential mechanisms via sleep quality, fecal microbial 16S ribosomal DNA and metagenomics analyses, and serum markers.Methods/designThis study is a randomized, double-blind, placebo-controlled clinical trial. A total of 80 patients (aged 60-85 years) will be recruited and allocated randomly to a treatment group and a placebo group in a 1:1 ratio and will then be administered YZASG or isodose placebo three times a day. The intervention course is 16 weeks, with an 18 months follow-up. The primary outcome is the Alzheimer's Disease Assessment Scale-Cognitive Subscale. Secondary outcome measures are the Mini-Mental State Examination, Montreal Cognitive Assessment, Pittsburgh Sleep Quality Index, serum concentrations of immunological factors and inflammatory cytokines, and fecal microbiota. Fecal microbiota will only be collected at the baseline and endpoint of the intervention.DiscussionThe results of this trial will be conducive to assessing the safety and effectiveness on cognition of YZASG in intervening aMCI among the elderly and determining if it takes effect via the improvement of sleep quality, regulation of gut microbiota, and concentration of certain serum markers.Trial registrationClinicalTrials.gov, NCT03601000 . Registered on 26 July 2018.

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Dataset Information

Effects of Shen Cao Granules on Chemotherapy-Induced Thrombocytopenia in Gastrointestinal Cancer Patients: A Randomized Controlled Trial.

Publications

Effects of Shen Cao Granules on Chemotherapy-Induced Thrombocytopenia in Gastrointestinal Cancer Patients: A Randomized Controlled Trial.

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