[caption id="attachment_655" align="alignright" width="300" caption="kidney stones"]
[/caption]The herbal supplement URIFLOW has been marketed as a method of breaking up and dissolving kidney stones. It is widely available online for purchase. Reviews of its action and efficacy on the websites where it is sold has been largely positive. However some individuals claim that it provided no benefit to them. While one is unable to make a judgment of the efficacy of any product simply by consumer feedback it does give a general idea of the feeling regarding the product. Given that the feedback has been largely positive I think its appropriate to take a closer look at what might be a natural remedy for kidney stones.
Based on the URIFLOW website the ingredients are as follows.
•.Boerhaavia Diffusa
•.Crataeva Nurvala
•.Tribulus Terrestris
•.Lawsonia Inermis
•.Bergenia Ligulata
•.Ficus Racemosa
•.Didymocarpus Pedicellata
•.Achyranthes Aspera
•.Raphanus Sativus
•.Hemidesmus Indicus -.
URIFLOW CLAIMS: Boerhaavia Diffusa - The pharmacology of this herbal extract has been extensively studied and has shown to have a dual diuretic and anti-inflammatory effect.
WE WERE ABLE TO FIND:
Evidence of
•.Positive immunomodulatory activity in rodents.
•.Possible anticancer effect in rodents on melanoma cells.
•.A study of herbal extracts of this drug to dissolve urinary crystals (the precursor of kidney stone formation) revealed no effect. Interestingly it was compared again other herbs which did have a positive effect non of which are constituents of uriflow.
•.A protective effect against radiation damage.
•.A possible effect that reduced breast cancer resistance to conventional chemotherapy.
•.Good evidence that the drug is an antispasmodic agent. (Baralgin a pharmaceutical anti-spasmodic agent is used to relax the ureters allowing the passage of a stone.)
•.Antifungal activity exact potency is being established.
•.Possible immunosuppressive activity mechanism not established.
•.Antidiabetic activity in rats of similar potency to mainstream pharmaceuticals.
•.The juice of fresh leaves has a significant pain relieving effect believed to be narcotic in nature.
•.Antiviral effect in plants primarily.
URIFLOW CLAIMS: Crataeva Nurvala - The water extract of the bark has been shown to cause spontaneous passage of renal and bladder stones. The triterpenoids and varunol isolated from the bark can also act as an anti-inflammatory as the stone passes.
WE WERE ABLE TO FIND:
Evidence of .
•.A study suggesting that the herb has properties which may aid in the dissolution of renal calculi in the upper urinary tract. However the authors suggest a phase III trial be done before making any claims.
•.A study showing that the bark of Crataeva nurvula has the highest antioxidant capacity among 5 Indian herbal remedies tested.
•.Extract of the herb was able to ameliorate against kidney injury in mice.
•.Inhibition of complement and hence a reduction in inflammation, possible pain relief.
URIFLOW CLAIMS: Tribulus Terrestris - There are alkaloids in this ingredient that are responsible for an increase in renal perfusion and aspartic and glutamic acid contents have shown to have stone disintegrating properties.
N.B Of concern this herb has been found to cause motorneurone disease in sheep. We do not know if this can occur in humans. However many of the potential benefits of herbs are derived from their effect in animals. If you accept the positive effects you must be willing to accept the negative effects.
We were able to find the following evidence.
•.The herb lowers blood pressure in rats and has an effect similar to viagra on the dilation of blood vessels.
•.It increases sexual desire and performance in rats.
•.It modulates receptors for testosterone
•.It was implicated in a case of a male growing breasts ( gynaecomastia). This suggests it may have an effect on sex hormones maybe due to its effects to modulate testosterone.
URIFLOW CLAIMS: Lawsonia Inermis - An alcoholic extract of the leaves has shown to have an effective anti-bacterial activity that has been confirmed in three separate clinical studies.
This is otherwise known as henna.
We were able to find the following evidence .
•.It has been shown to aid wound healing
•.Some studies have shown that it has significant toxicity
•.It has been implicated as a cause of hemolytic anemia when taken topically on the skin.
URIFLOW CLAIMS: Bergenia Ligulata - Shah et al has concluded in an independent study that an exact concentration of crude extract has marked antilithic property in dissolving preformed stones
We were able to find th efollowing evidence.
•.Mechanism of the anti kidney stone effect of this herbal remedy was proven to be due to inhibition of calcium oxalate crystallization in rats.
•.Among other studies.
URIFLOW CLAIMS: Ficus Racemosa An extract from the bark has clinically been validated as an effective carminative and can help ease gripping pains.
We were able to find evidence of.
•.An antioxidant effect and evidence of blood glucose lowering effect.
•.A anti diuretic effect (reduces urine flow, making the urine more concentrated)
•.An antiflammatory and anti fever effect.
Didymocarpus Pedicellata - The active compound in this extract known as Pedicellic acid has been established as a successful treatment for kidney stones
Evidence of being a potent antixodant
Achyranthes Aspera - The extract from the seeds have saponins which have proven to have a stimulating effect on the kidneys and can help in flushing out gravel.
We were able to find evidence of.
•.That this herb may stimulate abortion and is a possible antifertility drug.
•.Contraceptive spermicidal effect
•.Of increasing thyroid hormone levels as well as antioxidant activity.
Raphanus Sativus - Several studies report the antibacterial effect against S.aureus, E.coli, Ps. aeruginosa, S.typhi and B.sublitis which can help prevent urinary infections from erupting after a stone passage.
Good evidence of the main claim in terms of its effect against bacteria in the pub med database
Hemidesmus Indicus - An aqueous extract has shown to increase urinary output within the kidneys that can aid in calculi being flushed out
•.One study showed that it does not have anti diuretic effect in fact has an anti diuretic effect leading to increased water uptake from the intestine of rats
•.It could be argued that this retention effect on fluids would lead to more fluid being excreted through the kidney. However no study has shown this in the pubmed database.
•.No studies examining the effect of kidney stone formation could be found.
OVERALL VERDICT.
This herbal preparation was marketed to patients suffering from kidney stones. It claims to decrease the size of kidney stones so that they may be passed out.
Several of the herbs utilized as ingredients do have the effect of decreasing kidney stone formation as well as increasing the solubility of kidney stones under laboratory conditions in experimentally created kidney stone disease in rats.
Some herbs utilized have been shown to relax smooth muscle possibly reducing the pain associated with passage of the kidney stone and allowing kidney stones to pass. There are already several pharmaceutical agents that provide this same effect and there efficacy in humans is determined by the size of the kidney stone. Kidney stones above 9 mm in diameter being very unlikely to pass. It is conceivable that the kidney stone may be reduced in size depending on the efficacy of the other ingredients in humans which remains unknown.
Unfortunately some of the herbs were found to have possibly dangerous effects in experimental animals such as motor neurone disease. One of the herbs was found to have hormonal effects that lead to gynaecomastia and another herb was found to have toxic effects on the heart. Interestingly the toxic effects were demonstrated in humans unlike the many beneficial effects demonstrated in rats. This may have been due to bias in motivation of investigators to perform the studies in the first place as negative effects need to investigated quickly. While claims of positive effects are put through a longer series of methodological proofs.
At this time the FDA has released the following.
Public Health Service Food and Drug Administration College Park, Maryland 20740 |
NOV 07 2006
CERTIFIED MAIL RETURN RECEIPT REQUESTED
Vikram Sodhi Uriflow Online, Inc. aka BioNeutrix Healthcare 2774 A Coney Island Avenue Brooklyn, New York 11235
Ref. No. CL-06-HFS-810-235
Dear Mr. Sodhi:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your web site at the Internet address http://www.uriflow.com and has determined that the product “Uriflow™” is promoted for conditions that cause the product to be a drug under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)]. The therapeutic claims on your web site establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of this product with these claims violates the Act.
Examples of some of the claims observed on your web sites include:
Uriflow™ “Kidney StoneTreatment [sic] That Dissolve & Flushes OutStones [sic] -Quickly Painlessly!”
“How URIFLOW™ Flushes Out Stones”
“Uriflow™ acts on the stone's surface to disintegrate it and then uses the kidney's own functions to flush them out quickly & painlessly...”
“Uriflow™ is the only dissolvent on the market that controls the kidneys [sic] internal environment and directs minerals and pH levels into a stone disintegrating (non-lithogenic) state. It's unique 4-Step therapeutic action makes Uriflow the most complete kidney stone treatment anywhere:”
“Works on stone surface To break it down” “Uriflow™ has specific ingredients that are targeted to cause the stones tiny particles to separate by micro-pulverization and dissolve back into your urine. As soon as you take Uriflow™ it immediately goes to work within your kidneys and begins to mobilize the stone by shrinking it.”
“It doesn't stop there, once the stone becomes smaller it stops pushing against the sensitive urinary lining and starts moving with ease without causing damage or pain.”
“Flushes Out Stone Fragment With Urinary Flow”
“Once reduced to gravel, kidney stones are easily flushed out.”
“Specific ingredients in Uriflow™ cause the kidneys to naturally increase urine output so that the gravel can be flushed out quickly and painlessly.”
“Prevents Urinary Infections By Protecting The Tract”
“Usually when a kidney stone has passed without treatment, there is a good chance that there will be a burning sensation from the painful exit. This is a sign of a urinary infection caused by the irritation to the urinary tract.”
“The revolutionary Uriflow™ formulation has properties that protect the urinary system from any such infections or inflammation.”
“Not only does the stone shrink in size so that irritation is relieved, but Uriflow™ also has anti-microbial properties that prevent harmful bacteria from infecting the urinary tract.”
“Dr. Saini Malta Board Certified Urologist Hope Medical Clinic “A very effective aid for eliminating kidney stones. In my professional opinion Uriflow is a tremendously helpful solution to anyone with kidney stones. I have been recommending it with great success so far”.”
“Prevents Your Kidneys From Forming Stones Again”
“Until recently there was no way to help your condition and prevent stones from occurring again. Since kidney stones recur in almost 70% of patients, it is of extreme importance to prevent them.”
“Finally, there has been a remarkable breakthrough in kidney stone prevention. Uriflow™'s 100% natural formulation has been designed so that it can also be taken as a daily supplement to prevent stones from occurring in the future.”
“Keep your kidneys well flushed and protect your urinary system from infections. With Uriflow™ your kidneys can function optimally and you will never have to worry about painful kidney stones again.”
“Try Uriflow™ risk - free today and you too can enjoy a healthier, noticeably better quality of life, free from kidney stones”
“Over 80,000 Successful Cases For Uriflow™ Customers Who Flushed Out Their Stones”
“The 10 Best Ways To Find Kidney Stone Relief At Home”
Furthermore, your product is not generally recognized as safe and effective for the above referenced conditions and therefore, the product is also a “new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
FDA is aware that Internet distributors may not know that the products they offer are regulated as drugs or that these drugs are not in compliance with the law. Many of these products may be legally marketed as dietary supplements if claims about diagnosis, cure, mitigation, treatment, or prevention are removed from the promotional materials and the products otherwise comply with all applicable provisions of the Act and FDA regulations.
Under the Act, as amended by the Dietary Supplement Health and Education Act, dietary supplements may be legally marketed with truthful and non-misleading claims to affect the structure or function of the body (structure/function claims), if certain requirements are met. However, claims that dietary supplements are intended to prevent, diagnose, mitigate, treat, or cure disease (disease claims), excepting health claims authorized for use by FDA, cause the products to be drugs. The intended use of a product may be established through product labels and labeling, catalogs, brochures, audio and videotapes, Internet sites, or other circumstances surrounding the distribution of the product. FDA has published a final rule intended to clarify the distinction between structure/function claims and disease claims. This document is available on the Internet at <http://vm.cfsan.fda.gov/~lrd/fr000106.html> (codified at 21 C.F.R. § 101.93(g)).
In addition, only products that are intended for ingestion may be lawfully marketed as dietary supplements. Topical products and products intended to enter the body directly through the skin or mucosal tissues, such as transdermal or sublingual products, are not dietary supplements. For these products, both disease and structure/function claims may cause them to be new drugs.
Certain over-the-counter drugs are not new drugs and may be legally marketed without prior approval from FDA. Additional information is available in Title 21 of the Code of Federal Regulations (21 C.F.R.) Parts 310 and 330-358, which contain FDA's regulations on over-the-counter drugs.
This letter is not intended to be an all-inclusive review of your web site and products your firm markets. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.
If you need additional information or have questions concerning any products distributed through your web site, please contact FDA. You may respond in writing to Linda J. Webb, Compliance Officer, Food and Drug Administration, Division of Dietary Supplement Programs, 5100 Paint Branch Parkway, College Park, Maryland 20740-3835. If you have any questions concerning this letter, please contact Ms. Webb at (301) 436-2375.
Sincerely yours,
/s/
Vasilios H. Frankos, Ph.D. Acting Director Division of Dietary Supplement Programs Office of Nutritional Products, Labeling and Dietary Supplements Center for Food Safety and Applied Nutrition
They recognize that this agent does have effects and that these effects need to be regulated.
Also many of the herbs have effects which are broad involving multiple systems in clude blood pressure reduction and reductions in blood sugar. These systems are also targetted by several prescription medications and the chances of interaction are high.
URIFLOW is therefore a mixed bag and should be used with extreme caution if at all.
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