Salvia Miltiorrhiza Root Water-Extract (Danshen) Has No Beneficial Effect on Cardiovascular Risk Factors. A Randomized Double-Blind Cross-Over Trial

Abstract

PurposeDanshen is the dried root extract of the plant Salvia Miltiorrhiza and it is used as traditional Chinese medicinal herbal product to prevent and treat atherosclerosis. However, its efficacy has not been thoroughly investigated. This study evaluates the effect of Danshen on hyperlipidemia and hypertension, two well known risk factors for the development of atherosclerosis.MethodsThis was a randomized, placebo-controlled, double-blind crossover study performed at a tertiary referral center. Participants were recruited by newspaper advertisement and randomized to treatment with Danshen (water-extract of the Salvia Miltiorrhiza root) or placebo for 4 consecutive weeks. There was a wash out period of 4 weeks. Of the 20 analysed participants, 11 received placebo first. Inclusion criteria were: age 40-70 years, hyperlipidemia and hypertension. At the end of each treatment period, plasma lipids were determined (primary outcome), 24 hours ambulant blood pressure measurement (ABPM) was performed, and vasodilator endothelial function was assessed in the forearm.ResultsLDL cholesterol levels were 3.82±0.14 mmol/l after Danshen and 3.52±0.16 mmol/l after placebo treatment (mean±SE; p<0.05 for treatment effect corrected for baseline). Danshen treatment had no effect on blood pressure (ABPM 138/84 after Danshen and 136/87 after placebo treatment). These results were further substantiated by the observation that Danshen had neither an effect on endothelial function nor on markers of inflammation, oxidative stress, glucose metabolism, hemostasis and blood viscosity.ConclusionFour weeks of treatment with Danshen (water-extract) slightly increased LDL-cholesterol without affecting a wide variety of other risk markers. These observations do not support the use of Danshen to prevent or treat atherosclerosis.Trial RegistrationClinicalTrials.gov NCT01563770

Efficacy of Chinese herbal medicine for stroke modifiable risk factors: a systematic review

“…Six RCTs exploring the efficacy of CHM on one or more of the stroke risk factors were identified in the systematic review. Specifically, one trial examined the ‘CHM plus lifestyle’ intervention for the treatment of ‘IGT and obesity’ compared to ‘placebo plus lifestyle’ intervention, showing significant efficacy on both IGT and obesity before and after treatment and a significant effect on obesity control between groups after treatment [ 58 ]; Two trials examined the ‘CHM plus biomedicine’ interventions for the treatment of ‘diabetes and hyperlipidemia’ and ‘hypertension and hyperlipidemia’ compared to the ‘biomedicine’ intervention [ 59 ] and ‘placebo plus biomedicine’ intervention [ 60 ], respectively—both of these studies found similar effect on the combined stroke risk factors between groups after treatment. Moreover, three trials examined the ‘CHM, biomedicine plus lifestyle’ interventions for the treatment of ‘metabolic syndrome’ [ 61 ], ‘hypertension and metabolic syndrome’ [ 62 ], and ‘hypertension and obesity’ [ 63 ] compared to the ‘biomedicine plus lifestyle’ interventions with or without placebo, respectively, indicating significant effects on all included stroke risk factors by the CHM interventions compared to the control groups after treatment.…”

“…Except the Bofu - tsusho - san (防风通圣散) used in two trials, all the other CHM interventions involved exploring a combination of multiple stroke risk factors were different and therefore it is unable to report the commonly used Chinese herbs which are vital for the efficacy of combined stroke risk factors across these six RCTs. The sample size of the RCTs focused upon combined stroke risk factors ranged from 20 to 106, and two of these RCTs failed to provide the age and gender profile of participants in the CHM and control groups [ 58 , 60 ]. The duration of the RCTs exploring the combined stroke risk factors ranged from 4 to 6 months.…”

“…All RCTs focusing upon combined stroke risk factors reported safety-related information and no deaths were noted. Five out of these six RCTs reported that side effects only occurred in the CHM group [ 58 , 60 – 63 ] including headache, dizziness, gastrointestinal reactions, and skin allergy. Only two RCTs focusing upon combined stroke risk factors identified their study limitations [ 60 , 63 ], including failure to double-blind the RCT, short study period and carry-over effect.…”

“…Five out of these six RCTs reported that side effects only occurred in the CHM group [ 58 , 60 – 63 ] including headache, dizziness, gastrointestinal reactions, and skin allergy. Only two RCTs focusing upon combined stroke risk factors identified their study limitations [ 60 , 63 ], including failure to double-blind the RCT, short study period and carry-over effect. As for risk of bias of the RCTs focusing upon combined stroke risk factors, no trial reported appropriate allocation concealment and blinding of outcome assessment, and two trials were found to have a high risk of bias regarding the random sequence generation [ 60 , 61 ].…”

Tanshinone IIA pretreatment attenuates ischemia/reperfusion-induced renal injury

“…In China, S. miltiorrhiza has been widely applied in the treatment of cardiovascular and cerebrovascular diseases (13). Tanshinone IIA is a key active monomer extracted from S. miltiorrhiza (14).…”