Chinese Herbal Medicine (Xiaoaiping) Injections for Chemotherapy-Induced Thrombocytopenia: A Randomized, Controlled, Multicenter Clinical Trial
Abstract
Objectives: The study aims to evaluate the therapeutic efficacy and safety of Chinese herbal medicine (Xiaoaiping) injections for chemotherapy-induced thrombocytopenia (CIT) in nonsmall cell lung cancer (NSCLC) and gastric cancer. Design: A randomized, controlled, multicenter study from December 2013 to August 2015. Settings/Location: All patients are from China. Subjects: One hundred forty patients with either NSCLC or gastric cancer were enrolled in this trial. Interventions: The intervention group (n = 70) was given Xiaoaiping injections (1 dose/day for 10 days) with chemotherapy, whereas the control group (n = 70) was given chemotherapy only. The follow up period was 11 days after the final injection. Outcome measures: Platelet (PLT) count was tested at day 0, 7, 14, and 21 as the primary outcome for evaluation. Safety measurements, including red blood cells (RBC), hemoglobin (HBG), white blood cells (WBC), neutrophil (NE)#, aspartate aminotransferase (AST), alanine aminotransferase (ALT), lactate dehydrogenase (LDH), creatine kinase (CK), creatinine (Cr), and blood urea nitrogen (BUN) were tested at day 0 and 21 as the secondary outcomes. Results: (1) Two patients in the intervention group and four patients in the control group were lost upon follow-up. (2) PLT count: there was no significant difference in PLT count between the two groups from baseline (day 0), day 7, and day 14. At day 21, the intervention group indicated an upward trend of PLT count with a…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 70 participants or records.
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