Background: Tongxinluo capsules are a compound of Chinese traditional medicine which contain substances that are thought to have vasodilatory, antiplatelet, anticoagulant, thrombolytic and even lipid-lowering properties, and therefore may improve outcome after acute ischaemic stroke. To date the evidence of its effect has not been systematically reviewed, making it difficult to derive robust conclusions about its actual benefits, and indeed, possible harms.
Objectives: To assess the effectiveness and possible harms of tongxinluo capsule for acute cerebral infarction compared with control.
Search strategy: We searched the Cochrane Stroke Group trials register (last searched on 24 January 2008) the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 4, 2007), MEDLINE (1995 to 2006), EMBASE (1995 to 2006), China National Knowledge Infrastructure (CNKI, 1994 to 2006), CBM (Chinese Biomedical Database) (1995 to 2006), Current Controlled Trials (www.controlled-trials.com), National Research Register (http://www.update-software.com/national/). We handsearched 30 journals (1995 to 2006), and contacted drug companies and the principal of included trials.
Selection criteria: Randomised controlled trials comparing tongxinluo with placebo or open control (or tongxinluo plus standard therapy versus standard therapy alone) in people with definite acute stroke. We excluded trials if they sought to recruit patients with transient ischaemic attacks (TIA), intracerebral haemorrhage, heart failure, or renal failure.
Data collection and analysis: Two review authors extracted data and assessed trial quality.
Main results: Only two poor quality studies with a total of 232 participants were included in this review. Neither study reported any of our pre-specified outcomes, so no reliable estimate of the effect of treatment on major clinical outcomes could be obtained.
Authors' conclusions: It was not possible to reliably determine whether tongxinluo has a favourable or unfavourable effect in acute ischaemic stroke. High quality trials are required to assess the efficacy and safety of tongxinluo capsule for acute ischaemic stroke.