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Want to learn more about the science behind goldenseal's effectiveness?

Click Here For Descriptions of More Than 100 Articles Supporting the Use of Goldenseal in Cases of Oral and Digestive Tract Disorders, Cardio-Vascular Disease, Parasites, Inflammation and Skin Problems Plus Much More!!

Frequently Asked Questions

What is Hydrastis Complete™?

 Hydrastis Complete™ is a new paradigm in goldenseal product quality and reliability.  Hydrastis Complete™ is a whole plant combination of the berberine rich root and rhizome of Goldenseal (Hydrastis canadensis) plus the myriad of synergistic compounds found only in the leaf. 

 Why is it important to use organically cultivated goldenseal?

 Herbal medicines, dietary supplements, and other natural products have been traditionally produced from wild collected raw material.  Several of the more popular plants including Hydrastis canadensis, commonly known as goldenseal, have been over collected from the wild to the point of being declared endangered specie.  By definition, wild collected raw material has been produced in an environment without controls leading to wide variations in raw material quality and subsequent consumer disappointment in the effectiveness and reliability of the products they purchase.

 Goldenseal is native to the deciduous forests of Eastern North America.  It has been an item of commercial trade since the 1700’s when it was first shown to European settlers by the Native Americans.   Used for infections, digestive disorders, sore mouth, and wound healing, the plant became a mainstay in the arsenal of 19^th and early 20^th century physicians.  Goldenseal became so popular that by the mid 1880’s concern began to be expressed for its survival in the wild due to over collection.  As a result, in the early 1900’s, the newly formed USDA started urging farmers to initiate cultivation of the plant in order to reduce the need for wild collection. 

Demand for goldenseal waned during the 1940’s and 50’s due to the advent of mold based antibiotics but a dramatic resurgence occurred in the 1970’s and 80’s as consumers began searching for natural alternatives to synthetic pharmaceuticals.  USDA and conservationist calls for cultivation of the plant went largely unheeded and by 1997 the market was consuming more than 60 million wild plants per year amounting to approximately 98% of the raw material used to produce goldenseal products. 

A lack of fundamental information regarding methods of profitably cultivating the plant combined with extremely slow growth (4 years to maturity) plus very little price premium for cultivated goldenseal vs wild collected material resulted in no incentive for growers to risk the time and/or effort required to cultivate the plant.  This set of circumstances coupled with major habitat loss due to land development led the US Fish and Wildlife Service to recommend placement of goldenseal on the Convention on International Trade in Endangered Species (CITES) Appendix List II in 1997in an effort to “buy time for the plant while sustainable production methods are developed”.

 In 2001 Sleepy Hollow Farm was granted a USDA Small Business Innovation Research award to develop a USDA National Organic Program (NOP) certified production system for goldenseal usable by small family operated farms.  The project was successful and we taught the system to more than 20 small farmers across four states GA, AL, TN, and NC.  These growers have established more than 10 acres of wild simulated, USDA NOP certified organic goldenseal, effectively doubling the organic goldenseal acreage in the US and providing a sustainable supply of raw material from which we produce Sleepy Hollow Farm’s Hydrastis Complete^tm products.

Where are the growers located?

How does Sleepy Hollow Farm insure product purity? 

Berberine (chemical structure left) is an alkaloid present in a number of clinically-important medicinal plants including goldenseal and plants often used to adulterate pure goldenseal such as Coptis chinensis (coptis or goldenthread), Berberis aquifolium (oregon grape), Berberis vulgaris (barberry), and Berberis aristata (tree turmeric). 

The alkaloids berberine and hydrastine are commonly used by industry as markers to indicate the quality of raw goldenseal although the most common level of consumer product assurance is that  of a specified percentage of total alkaloid content, unspecified as to which alkaloid or how much of each. (Brown 2008, Abourashed, 2001, Govindan, 1999).  These two compounds are also thought to be the primary bioactive compounds in the plant. (NTP, 1997).  In addition to berberine and hydrastine, goldenseal also contains minor amounts of canadine, canadaline, and other less active alkaloids.  The alkaloids palmatine, coptisine, and jatrorrhizine are not produced by goldenseal but are produced by several other plants commonly found to adulterate goldenseal products.  Discovery of these compounds in material purported to be goldenseal is an indication that the material is not pure (Weber, 2003). 

The alkaloid content variability of both raw goldenseal and consumer products on the market was clearly demonstrated in Govindan (1999), where ten samples (eight - raw powdered material, and two - powdered material from off-the-shelf capsules) were analyzed using Thin-Layer Chromatography (TLC). Five of the samples contained both berberine and hydrastine, four contained only berberine, and one contained neither.  These results were verified by High Pressure Liquid Chromatography (HPLC)(Govindan, 1999). In addition only three of the ten samples approximated the profile of the raw goldenseal used by the National Toxicological Program for their studies (MRI, 2001).

The results and conclusions of a more recent study, Edwards (2003), revealed little improvement.  This study compared the hydrastine/berberine content of 20 products purchased at local pharmacies or health food stores.  Only 10 of 17 products labeled as containing goldenseal root met proposed USP standards for hydrastine/berberine content of goldenseal root.  Five products contained little or no hydrastine, unusual berberine:hydrastine ratios, and additional peaks not observed with other products.  The report concluded that “the alkaloid content of goldenseal products varies widely and that given the absence of regulation of the quality of herb products, pharmacists should take care to ensure that substandard goldenseal products are not sold in their pharmacies” (Edwards, 2003).  Most recently, Abidi, 2006 indicated that only two of six off-the-shelf goldenseal products could meet the standard of the presence of berberine, hydrastine, and canadine with no detection of palmatine (Abidi, 2006).   

United States Pharmacopoeia (USP) standards for dried goldenseal root/rhizome are not less than 2.0% hydrastine and not less than 2.5% berberine, a hydrastine/berberine ratio of 4:5.  Since several other plants produce berberine, its use as a marker to establish identity is limited to verification of its presence.  The alkaloids hydrastine and canadine are unique to goldenseal and their presence is absolutely required for positive identification.  As mentioned above, palmatine is not produced by goldenseal therefore its absence is required.  Accordingly, Sleepy Hollow Farm’s initial chemical analysis SOP requires the presence of berberine, hydrastine, and canadine combined with no detection of palmatine in order to release any particular lot for further processing thereby insuring Hydrastis Complete™ product purity.

Why should we even try to standardize goldenseal products, aren’t they natural?  Isn’t it normal for natural products to have some variation?

Since almost 80% of the market for goldenseal products is supplied from wild collected sources, the range of variation can be quite substantial.   The most common method of smoothing out the variations in goldenseal products through standardization is to insure a specified quantity of compounds known as alkaloids.  One of these compounds, berberine has been shown to be primarily responsible for the activity of goldenseal.  This has resulted in the widely held belief that the potency of goldenseal products is directly proportional to the quantity of berberine in the product.

This would be true if goldenseal only contained berberine plus other constituents that were completely without influence on berberine.  However, the whole goldenseal plant contains numerous compounds which complement and augment the activity of berberine while also limiting any harmful effects of the isolated alkaloid. 

An example is presented in the chart to the left. The chart is a comparison of the relative activity, toxicity, and quantity of berberine required to achieve 100% inhibition of Shigella sonnei (an intestinal pathogen) between Hydrastis Completetm , individual goldenseal plant parts and a similar quantity of a berberine reference standard. Equivalent quantities of an optimal blend of goldenseal plant parts (Hydrastis Complete^tm) and a berberine reference standard produced equivalent levels of bioactivity even though the mixture contained only about 1/10 as much berberine as the standard.  In addition, the whole plant combination delivered the equivalent amount of activity with a corresponding 92% reduction in relative toxicity as measured by the assays.  Note that all root/rhizome delivered only 50% of the activity of the optimal blend while containing 345% more berberine and producing 60% more relative toxicity.

 Hydrastis Complete^tm is formulated based on data obtained from a series of bioassays which measure activity against more than 10 oral and digestive pathogens, three colon and/or stomach cancer cell types, plus anti-inflammatory potential.  This data is combined with the results of other bioassays designed to measure potential toxicity such as inhibitory activity against beneficial organisms like Lactobacillus acidophilus and normal intestinal lining cell types.  In addition any inflammatory or mutagenic potential is determined.  The extracts are then blended to achieve a level of bioactivity indexed to a known reference standard. 

The end result is repeatable potency that you can depend on!!

How was Hydrastis Complete™ developed? 

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