Safety Analysis of Panax Ginseng in Randomized Clinical Trials: A Systematic Review

Abstract

Background: Panax ginseng C.A. Meyer is one of the most frequently used herbs in the world. The roots of Panax ginseng have been used as a traditional tonic and medicine for thousands of years in Korea and China. Today, ginseng root is used as a dietary supplement and complementary medicine and for adjuvant therapeutics worldwide. The efficacy of ginseng has been studied in a wide range of basic research and clinical studies. However, it has been reported that the results from clinical studies are conflicting, and they depend on the parameters of the protocol design including the conditions of the participants and the types of ginseng used such as red ginseng, white ginseng, fermented ginseng and cultured ginseng. Meanwhile, in addition to clinical efficacy, the safety of ginseng is a highly important matter for customers. With globally increasing demand for Panax ginseng as a dietary supplement or complementary medicine, it is necessary to provide information on its safe use to customers to improve their health conditions. Although the safety of Panax ginseng in pre-clinical studies is well known, the evaluation of safety in clinical studies has so far been insufficient. This systematic review was conducted to assess the safety of ginseng in randomized controlled clinical trials (RCT) over the last 10 years. We chose the last 10 years because many clinical trials have been conducted in the past 10 years, and it will help to understand the recent trends in RCTs of ginseng.Methods: Articles on ginseng studies were searched with keywords in MEDLINE and four other Korean online database sites. Studies with ginseng as a monopreparation were selected while studies with single administration, preparations combined with other herbs or drug combinations were excluded from the selected studies. Data from the selected studies meeting the criteria were extracted and reviewed in terms of study design, condition and number of participants, type of ginseng, dosage, duration, main results, adverse events and adverse reactions.Results: Forty-four studies met the selection criteria. These studies covered the efficacy of ginseng in areas such as cardiovascular function, glucose metabolism, sexual function, anti-oxidation, anti-fatigue and psychomotor function. Twenty-nine studies showed positive results while fifteen studies showed no effect. Sixteen studies reported adverse events while five studies had no adverse events. Twenty-three studies did not mention any adverse events. The main adverse events of ginseng reported were general symptoms such as hot flushes, insomnia and dyspepsia with no significant difference in frequency and symptoms between the ginseng and placebo groups. The symptoms were mild and temporary with no serious or severe adverse events.Conclusion: Panax ginseng showed a very safe profile in a limited number of RCTs with a small number of participants with various conditions ranging from healthy participants to patients with symptoms. However, to increase the usefulness and lower the health risk of Panax gins...

Effects of ginseng supplementation on selected markers of inflammation: A systematic review and meta‐analysis

“…Oral administration of ginseng in animal models in doses between 500 and 2,000 mg·kg −1 ·day −1 for 4 weeks did not impose adverse events (Park et al, ) such as abnormalities in body and organ weight, food intake, blood parameters, or gross histopathological findings. P. ginseng showed a safe profile with no significant differences between placebo and ginseng groups in more than 40 human studies (Kim, Woo, Han, & Chang, ) although different side effects also reported in different conditions (Kim et al, ). The use of ginseng when coadministered with other drugs should be undertaken cautiously in the clinic.…”

Red ginseng monograph

“…The determination of the intake of ginseng as a health functional food is based on both the traditional intake of ginseng as a food and effective doses in clinical research results. The most frequent ginseng doses in traditional Korean medicine have been 2.7–4.5 g, and the most frequent red ginseng powder dose in research conducted in the past 10 years has been 3 g, found in nine cases [124] . In data on the “fatigue relief and immunity improvement” functions, red ginseng was in the powder form and amounted to 0.5–5 g, with the daily intake of 3–80 mg consisting of combinations of Rb1 + Rg1 + Rg3.…”

“…Ginseng Abuse Syndrome has been reported to develop in cases in which abnormally excessive doses (15 g/day or above) of ginseng have been taken [8] , [133] . A systematic literature review evaluating safety in randomized controlled trials of red ginseng, white ginseng, fermented ginseng, and black ginseng administered to healthy individuals not on medication in the past 10 years (2005–2014) was recently published [124] . Out of a total of 44 studies, 30 studies were on the Korean Red Ginseng, thus taking up the largest share.…”

Potential benefits of garlic and other dietary supplements for the management of hypertension (Review)

“…These inconsistent results may be due to the differences in the ginsenoside concentrations in ginseng preparations, the study population and the measurement methods. Systematic reviews evaluating the safety have concluded that ginseng has a good safety profile with no specific adverse events (39,41).…”