An open‐label, single institutional, phase I study done by the researchers from Japan suggested that a daily dose of 12 g of GBS‐01, containing approximately 4g burdock fruit extract rich in arctigenin, may be clinically safe and may have possible benefits in patients with advanced pancreatic cancer refractory to Gemcitabine therapy. However, well defined large scale trials are required to establish these findings.
Burdock and its Active Compounds
Arctium lappa, commonly known as burdock, is a perennial plant native to Asia and Europe. Burdock is now popular worldwide and is cultivated and used as a vegetable in many parts of the world. The roots, leaves, and seeds of this plant are used in Traditional Chinese medicine as a remedy for various ailments. Burdock roots are packed with antioxidants and are also considered to have anti-cancer effects.
Different preclinical studies have previously suggested that burdock may have anti-inflammatory, antibacterial, antidiabetic, antiulcerogenic, hepatoprotective, and anticancer properties. The key compounds of burdock extracts include caffeoylquinic acid derivatives, lignans and various flavonoids.
The leaves of burdock mainly contains two kinds of lignans:
Apart from these, phenolic acids, quercetin, quercitrin and luteolin may also be found in burdock leaves.
Burdock seeds contain phenolic acids such as Caffeic acid, Chlorogenic acid and Cynarin.
The key active compounds in Burdock roots are Arctiin, Luteolin and Quercetin rhamnoside which may attribute to their possible anti-cancer effects.
Purported Uses of Burdock Extracts
Burdock has been widely used in Traditional Chinese Medicine for the following purposes, though there is no clinical evidence to support its use for many of these conditions:
- Purifying the blood
- Reducing hypertension
- Reducing gout
- Reducing hepatitis
- Reducing microbial infections
- Reducing blood sugar in diabetic patients
- Treating skin disorders such as eczema and psoriasis
- Reducing wrinkles
- Treating inflammatory disorders
- Treating AIDS
- Treating Cancer
- As a diuretic
- As antipyretic tea for treating fever
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Will Burdock Extracts Benefit Pancreatic Cancer patients refractory to Gemcitabine?
According to American Cancer Society, pancreatic cancer is the ninth most common cancer in women and the tenth most common cancer in men and accounts for 7% of all cancer deaths.
It is also the fourth leading cause of cancer deaths in men and women.
Gemcitabine is a standard first-line chemotherapeutic agent for pancreatic cancer. However, pancreatic cancer microenvironment is well known to be characterized by severe hypoxia, a condition in which the body is deprived of adequate oxygen supply at the tissue level, and nutrient deprivation, especially glucose. Hypoxia enhances the chemoresistance against gemcitabine, thereby limiting the benefits of this chemotherapy.
Hence, researchers from the National Cancer Center Hospital East, Meiji Pharmaceutical University, National Cancer Center, Kracie Pharma, Ltd. in Toyama, and Tokyo University of Science, Japan screened different compounds that may attenuate the tolerance of the cancer cells to glucose starvation and hypoxia, and identified arctigenin, a key compound found in Burdock extracts, as the best candidate compound for a clinical trial, due to its antitumor activity observed in many xenograft models of cancer and sufficient safety profiles when given at doses up to 100 times the daily dose required for antitumor activity in mice. (Masafumi Ikeda et al, Cancer Sci., 2016)
The researchers used the oral drug GBS‐01, an extract from the fruit of Burdock, rich in arctigenin, in 15 patients with advanced pancreatic cancer refractory to gemcitabine. In the trial, they investigated the maximum tolerated dose of GBS‐01 and looked out for Dose-limiting toxicities. Dose‐limiting toxicities (DLTs) refers to the appearance of grade 4 hematological/blood toxicity and grade 3 or 4 non‐hematological/blood toxicity during the first 28 days of treatment.
In the study, they found that there were no signs of grade 4 blood toxicities and grade 3 or 4 non-blood toxicities in any of the patients enrolled, at any of the three doses used (daily 3.0 g, 7.5 g or 12.0 g). However, mild toxicities were observed such as increased serum γ‐glutamyl transpeptidase, increased blood glucose, and increased serum total bilirubin.
The study determined the recommended dose of GBS‐01, the extract rich in arctigenin from Burdock, to be 12.0 g daily, because no DLTs were seen at any of the three dose levels. A daily dose of 12.0 g GBS‐01 was approximately equivalent to 4.0 g burdock fruit extract.
Out of the patients who consumed the Burdock extract, 4 patients had stable disease and 1 showed a partial response during the course of observation. To be precise, the response rate was 6.7% and the disease control rate was 33.3%. The study also found that the median progression‐free and overall survival of the patients were 1.1 months and 5.7 months, respectively.
Burdock extracts and roots are considered to have anti-inflammatory, antibacterial, antidiabetic, antiulcerogenic, hepatoprotective, and anti-cancer properties. A 2016 phase I clinical study done by the researchers from Japan suggested that a daily dose of 12 g of GBS‐01 (containing approximately 4.0 g burdock fruit extract rich in arctigenin) may be clinically safe and may have possible benefits in patients with advanced pancreatic cancers refractory to Gemcitabine therapy. However, more well defined large scale trials are necessary to establish these findings, before recommending arctigenin usage in pancreatic cancer patients.
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