Background and Objective: Previous studies on Danqi Piantan Jiaonang (DPJ, NeuroAid®), a traditional Chinese medicine, in stroke patients showed promising results. Our aim was to determine the safety of DPJ in normal subjects and stroke patients through a series of studies assessing its immediate and long-term effects, alone and in combination with aspirin, on hematological, hemostatic, and biochemical parameters. Methods: We conducted 3 studies from December 2004 to May 2006. Study 1 was a case series which recruited 32 healthy volunteers who were given 2 oral doses of 4 DPJ capsules (0.4 g/capsule) 6 h apart. Study 2 was a randomized controlled trial of 22 healthy volunteers who received either 1 oral dose of aspirin 300 mg alone or a combination of 1 dose of aspirin 300 mg and 2 doses of 4 DPJ capsules taken 6 h apart. For both studies 1 and 2, hemostatic parameters (prothrombin time, activated partial thromboplastin time, fibrinogen, platelet aggregation, D-dimer) were tested at baseline, and after 2 and 8 h. Study 3 was a case series which recruited 10 patients with recent ischemic stroke (within 7 days) who were given 4 DPJ capsules taken orally 3 times a day for 1 month. Blood tests for hemostatic, hematological (complete blood count), and biochemical parameters (glucose, creatinine, alanine aminotransferase, aspartate transaminase, C-reactive protein) were performed at baseline, and after 1 and 4 weeks. Results: Apart from the expected changes in platelet aggregation in subjects taking aspirin, no significant differences were detected in hemostatic parameters at baseline, and 2 and 8 h after oral intake of DPJ alone or in combination with aspirin. Likewise, no significant differences were observed in hematological, hemostatic, and biochemical parameters at baseline, and after 1 and 4 weeks of oral intake of DPJ. Conclusion: DPJ does not significantly modify hematological, hemostatic, and biochemical parameters in normal subjects and stroke patients.

Keywords:
Danqi Piantan Jiaonang, stroke, Traditional Chinese medicine, Safety studies
1.
World Health Organization: The World Health Report 2004: Changing History. Geneva, World Health Organization, 2004.
2.
Strong K, Mathers C, Bonita R: Preventing stroke: saving lives around the world. Lancet Neurol 2007;6:182–187.
3.
Wardlaw JM, Zoppo G, Yamaguchi T, Berge E: Thrombolysis for acute ischaemic stroke. Cochrane Database Syst Rev 2003;3:CD000213.
4.
C hen ZM, Sandercock P, Pan HC, Counsell C, Collins R, Liu LS, Xie JX, Warlow C, Peto R: Indications for early aspirin use in acute ischemic stroke: a combined analysis of 40,000 randomized patients from the Chinese Acute Stroke Trial and the International Stroke Trial. Stroke2000;31:1240–1249.
5.
Stroke Unit Trialists’ Collaboration: Organised inpatient (stroke unit) care for stroke. Cochrane Database Syst Rev 2002;1:CD000197.
6.
O’Collins VE, Macleod MR, Donnan GA, Horky LL, van der Worp BH, Howells DW: 1,026 experimental treatments in acute stroke. Ann Neurol 2006;59:467–477.
7.
Registry review shows many factors hinder acute stroke care. AHA rapid access journal report. Stroke journal report, 12 May 2005.
8.
Wu B, Liu M, Liu H, Li W, Tan S, Zhang S, Fang Y: Meta-analysis of traditional Chinese patent medicine for ischemic stroke. Stroke 2007;38:1973–1979.
9.
Feigin VL: Herbal medicine in stroke. Does it have a future? Stroke 2007;38:1734–1736.
10.
Adams JD, Wang R, Yang J, Lien EJ: Preclinical and clinical examinations of Salvia miltiorrhiza and its tanshinones in ischemic conditions. Chin Med 2006;1:3.
11.
Antithrombotic Trialists’ Collaboration: Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. BMJ 2002;324:71–86.
© 2008 S. Karger AG, Basel
2008
Copyright / Drug Dosage / Disclaimer
Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.
You do not currently have access to this content.