Abstract：
BACKGROUND: Chamomile administration may have desirable effects in the perioperative setting. Current practice, however, discourages perioperative chamomile use due to a theoretical increase in bleeding. Therefore, we evaluated if chamomile acutely (within 4 h of ingestion) prolongs coagulation assays.
METHODS: Eight healthy volunteers were randomized to receive 2 interventions in a crossover design: (a) single dose of chamomile extract capsule (500 mg) and (b) single dose of chamomile tea (3 g in 150 mL water). Interventions were separated at least 3 days apart from each other. Blood was sampled pre-ingestion, 2 h post-ingestion, and 4 h post-ingestion for each intervention. The primary outcome was the maximal change in prothrombin time (PT) before vs after each intervention. Secondary outcomes included changes in international normalized ratio, activated partial thromboplastin time, thrombin time, reptilase time, and fibrinogen levels.
RESULTS: All 8 subjects completed the study. The average pre-ingestion PT values for tea and capsules were 11.9 (1.1) s and 12.0 (0.9) s, respectively. Tea significantly increased the average maximum PT by 0.7 (0.2) s (P = 0.0078). Extract capsules increased the maximum PT by 0.3 (0.2) s (P = 0.06). Neither PT prolongation met the predefined 10% threshold for clinical significance. No significant changes in secondary outcomes were observed.
CONCLUSIONS: Chamomile tea ingestion prolongs PT. However, the clinical significance of this is unclear at this time and warrants further investigation. ClinicalTrials.gov Registration Number: NCT05272475.
METHODS: Eight healthy volunteers were randomized to receive 2 interventions in a crossover design: (a) single dose of chamomile extract capsule (500 mg) and (b) single dose of chamomile tea (3 g in 150 mL water). Interventions were separated at least 3 days apart from each other. Blood was sampled pre-ingestion, 2 h post-ingestion, and 4 h post-ingestion for each intervention. The primary outcome was the maximal change in prothrombin time (PT) before vs after each intervention. Secondary outcomes included changes in international normalized ratio, activated partial thromboplastin time, thrombin time, reptilase time, and fibrinogen levels.
RESULTS: All 8 subjects completed the study. The average pre-ingestion PT values for tea and capsules were 11.9 (1.1) s and 12.0 (0.9) s, respectively. Tea significantly increased the average maximum PT by 0.7 (0.2) s (P = 0.0078). Extract capsules increased the maximum PT by 0.3 (0.2) s (P = 0.06). Neither PT prolongation met the predefined 10% threshold for clinical significance. No significant changes in secondary outcomes were observed.
CONCLUSIONS: Chamomile tea ingestion prolongs PT. However, the clinical significance of this is unclear at this time and warrants further investigation. ClinicalTrials.gov Registration Number: NCT05272475.
摘要：
背景：洋甘菊给药在围手术期可能有理想的效果。目前的做法,然而,由于理论上出血增加，不鼓励围手术期使用洋甘菊。因此,我们评估洋甘菊是否急性（在摄入4小时内）延长凝血测定。
方法：8名健康志愿者随机接受2种交叉设计干预：（a）单剂量洋甘菊提取物胶囊（500mg）和（b）单剂量洋甘菊茶（3g在150mL水中）。干预彼此分开至少3天。采血前取样，摄入后2小时，每次干预摄入后4小时。主要结果是每次干预前后凝血酶原时间（PT）的最大变化。次要结果包括国际标准化比率的变化，活化部分凝血活酶时间，凝血酶时间,爬虫酶时间，和纤维蛋白原水平。
结果：所有8名受试者完成研究。茶和胶囊的平均摄入前PT值分别为11.9（1.1）s和12.0（0.9）s，分别。茶显著增加平均最大PT0.7(0.2)s(P=0.0078)。提取物胶囊使最大PT增加0.3（0.2）s（P=0.06）。PT延长均未达到临床意义的预定义的10%阈值。观察到次要结果没有显著变化。
结论：洋甘菊茶摄入延长PT。然而,其临床意义目前尚不清楚,需要进一步研究.ClinicalTrials.gov注册号：NCT05272475。
方法：8名健康志愿者随机接受2种交叉设计干预：（a）单剂量洋甘菊提取物胶囊（500mg）和（b）单剂量洋甘菊茶（3g在150mL水中）。干预彼此分开至少3天。采血前取样，摄入后2小时，每次干预摄入后4小时。主要结果是每次干预前后凝血酶原时间（PT）的最大变化。次要结果包括国际标准化比率的变化，活化部分凝血活酶时间，凝血酶时间,爬虫酶时间，和纤维蛋白原水平。
结果：所有8名受试者完成研究。茶和胶囊的平均摄入前PT值分别为11.9（1.1）s和12.0（0.9）s，分别。茶显著增加平均最大PT0.7(0.2)s(P=0.0078)。提取物胶囊使最大PT增加0.3（0.2）s（P=0.06）。PT延长均未达到临床意义的预定义的10%阈值。观察到次要结果没有显著变化。
结论：洋甘菊茶摄入延长PT。然而,其临床意义目前尚不清楚,需要进一步研究.ClinicalTrials.gov注册号：NCT05272475。
