A recurring topic at Science-Based Pharmacy has been the sale of “natural health” products in the pharmacy that lack evidence of efficacy and/or safety. Over the next few weeks I’d like to examine this state of affairs, and put the question to you, the readers of this blog: What level of regulation is appropriate for “natural health products” and other products sold in the pharmacy? And what standard of safety and efficacy do you expect to see in products sold in the pharmacy? Do you hold pharmacies to a different standard, compared to locations like health food stores?
To kick off the discussion, we’ll consider a few “natural” products with specific health claims that are openly advertised on the Canadian market, and sold in Canadian pharmacies. We’ll look at the claims, the evidence, and the context – that is, how the current regulatory framework impacts on their availability, and the claims they make. The Canadian Health Food Association warns that Health Canada’s standards may keep many “natural” products off Canadian shelves: Is this a good, or a bad thing for Canadians? (If you’re not Canadian, this discussion is relevant to any jurisdiction with some form of public health protection.)
The first product we’ll examine in this series is called Bio-Fen Plus – it’s marketed to “STOP HAIR LOSS”, according to the full-page advertisement (Toronto Metro, October 2-4, 2009). (Here’s a version of the ad, (PDF)
The website states Bio-Fen Plus is “scientifically formulated” to “stop” hair loss. Sounds remarkable, as prescription products seem to offer only modest effects. So does Bio-Fen Plus have the evidence to justify its claims?
Alopecia is the medical term for hair loss. The most common form of alopecia is heriditary androgenetic alopecia: male/female pattern baldness. Other causes of hair loss include stress (due to illness), hormone changes (especially post-pregnancy), certain drugs, and some diseases. A physician can rule out the different causes. Androgenetic alopecia has a strong genetic component – it’s inherited. Bio-Fen Plus is claimed to treat androgenic (androgenetic) alopecia, which appears as hair thinning on the temples and crown of the head, sparing the sides and back.
Androgenetic alopecia is a result of androgen (male hormone) sensitive hair follicles that shrink, causing gradual hair thinning. Women can experience androgenetic alopecia; though they typically don’t lose hair on the frontal scalp area, but have general thinning over the scalp.
The treatment goals with androgenetic alopecia are to increase hair growth, and reduce the progression of hair loss. Treatment options are focused on reducing the effects of androgen on androgen-sensitive follicles. Usual treatments for androgenetic alopecia include minoxidil (Rogaine) and finasteride (Propecia). Both seem to be modestly effective.
Minoxidil (Rogaine) is a liquid that’s applied to the scalp twice daily. It’s been show to be effective in clinical trials, though the exact mechanism of action is not known. It must be used indefinitely to remain effective – when you stop, the hair falls out again. It is recommended that users consider a one-year trial to evaluate whether it works – it can take this long for effects to be noticeable. It has few side effects, costs about $35/month, and is available (in Canada) without a prescription.
Finasteride reduces dihydrotestosterone levels, and has been shown in clinical trials to reduce hair loss and promote hair growth in men, but not women. Finasteride is well tolerated and costs about $60-70/month by prescription.
Women with androgenetic alopecia have a few additional treatment options, including contraceptives and spironolactone, which may provide some benefit.
Non-drug options for hair loss include surgical options like transplantation.
In Canada, there are currently two products approved for the treatment of hair loss. Both are supported by clinical trials – and while they’re not miracle drugs, they have been demonstrated to be moderately effective in reducing hair loss and promoting hair growth.
The Evidence for Bio-Fen Plus
What is Bio-Fen Plus? According to the manufacturer,
“Bio-Fen Plus is a natural health product used in the treatment of hereditary androgenic alopecia (AGA) in adults. It contains scientifically calculated proportions of extracts of fenugreek seeds, saw palmetto berries and flax lignans. Each are known to possess an inhibitor of the enzyme responsible for causing male or female pattern baldness. It also contains a mixture of B vitamins, folate and biotin to help metabolize these herbal extracts so they are more bio-available, and to support the growth of strong and healthy hair.”
So what is the evidence supporting Bio-Fen Plus? A search of Medline reveals there is no published evidence supporting this particular combination of herbs and vitamins. No additional information is listed on the manufacturer’s website to indicate that clinical trials have been conducted. So let’s look at the individual ingredients to see if any have been studied for hair loss:
Fenugreek (260mg) – there is no published evidence of effectiveness for the prevention or treatment of hair loss.
Saw palmetto berry extract (160mg) – The Journal of Alternative and Complementary Therapy reports one randomized, double-blind “pilot” trial that evaluated saw palmetto 200mg and beta-sitosterol 50mg reported positive results in 6 of 10 subjects randomized to the active treatment, but only 1 of 9 in the placebo group. No statistical analysis was performed. Seven patients dropped out of the study before completion. Side effect were reported as mild. Overall this looked promising, and the authors recommend larger trials.
Flax lignans (100mg) – no evidence of effectiveness for hair loss.
Vitamin B5 (10.4mg) – no evidence of effectiveness to show it helps metabolize herbal extracts.
Vitamin B3 (10.25mg) – no evidence of effectiveness to show it helps metabolize herbal extracts.
Vitamin B6 (2mg) – no evidence of effectiveness to show it helps metabolize herbal extracts.
Vitamin B2 (1.58mg) – no evidence of effectiveness to show it helps metabolize herbal extracts.
Folic acid (0.095mg) – no evidence of effectiveness to show it helps metabolize herbal extracts.
Biotin (400mcg) – no evidence of effectiveness to show it helps metabolize herbal extracts.
Overall, there’s little published evidence to suggest that the ingredients in Bio-Fen Plus have any efficacy in treating or preventing hair loss. The saw palmetto data are interesting, but the single clinical trial used a version combined with beta-sitosterol, which is not present in Bio-Fen Plus. The trial is also too small to draw any conclusions from. And with any herbal medicine, the manufacturing process is critical – without standardization, there is no assurance that one product is similar to another. So we cannot infer the active components in one version of saw palmetto will be present in another version.
Let’s look at some of the manufacturer’s specific claims:
“Bio-Fen Plus™ capsules are usually effective at stopping hair loss within the first two months.”
– there is no published evidence to substantiate this claim.
“It also contains a mixture of B vitamins, folate and biotin to help metabolize these herbal extracts so that they are more bio-available, and to support the growth of strong and healthy looking hair.”
– there is no scientific evidence to suggest that vitamins will make these herbal extracts more bioavailable. Bioavailabilty refers to the absorption of a drug, not the metabolism, so the statement made is unclear.
“It contains scientifically calculated proportions of extracts of fenugreek seeds, saw palmetto berries and flax lignans.”
– “scientifically calculated” sounds promising, but there’s no published evidence to suggest this particular combination of ingredients has been studied for hair loss treatment.
“Bio-Fen Plus also contains vitamins to increase blood flow to the small capillaries that feed the hair roots, to deliver the active herbal compounds and remove waste.”
– there is no evidence to suggest that vitamins increase capillary blood flow, whether you’re vitamin deficient or not.
“Bio-Fen Plus provides a natural, safer alternative to these expensive drugs, and/or expensive & painful hair transplants.”
– There is no published safety data with Bio-Fen Plus. No clinical trials have been done comparing the product to any other hair loss treatment, so it is difficult to draw conclusions between products. Generic versions of Rogaine (minoxidil) cost about $1.10 per day (based on 1mL twice per day). Finasteride costs about $2.15 per day by prescription. In comparison, Bio-Fen Plus costs about $1.80 per day (assuming the recommended one capsule daily). So depending on dose, Bio-Fen Plus may be more expensive than proven conventional drug therapy.
Bio-Fen Plus is an unlicensed natural health product in Canada: According to Health Canada’s online database, it has not been granted a Natural Product Number (NPN) yet, though the manufacturer states one has been applied for. The claims made about Bio-Fen Plus been not been approved by Health Canada for factual accuracy. The consequence of this lack of regulation and oversight is that there has been no independent evaluation of the efficacy and safety claims made about the product.
The policy issues related to regulation are ones that I’ll revisit again over the next few weeks. Ultimately this becomes a public policy issue – should societies allow loosely- or un-regulated, even potentially hazardous products to be sold on the market? Or should regulators restrict access, allowing only products that can demonstrate some minimal level of safety and efficacy? Is it fair to hold prescription, non-prescription, and “natural” health products to similar standards? If we lower standards for natural products, how low is acceptable with respect to risk to consumers? Are we better off restricting the sale of unproven products? Finally, should pharmacies, owing to their specialized and preferred role in the provision of prescription drugs, only sell products that held to a different (higher) standard of efficacy?
Bio-Fen Plus is natural health product of herbs and vitamins that is claimed to “Stop Hair Loss”. There is no published evidence to demonstrate that Bio-Fen Plus has any effectiveness. From an science-based perspective, conventional treatment options have more evidence to support their use as treatments for androgenetic alopecia. Conventional treatment options may also be less expensive than Bio-Fen Plus. Finally, conventional products are more tightly regulated by Health Canada, as they are treated as drugs, and not natural health products. There’s no compelling reason for Bio-Fen Plus to be sold in science-based pharmacies.
For More Information
Male Pattern Hair Loss – DermNet NZ
Female Pattern Hair Loss – DermNet NZ
Drake LA, Dineart SM, et al. Guidelines of care for androgenetic alopecia. J Am Acad Dermatol 1996;35:465-9.
Prager N, Bickett K, et al. A randomized, double-blind, placebo-controlled trial to determine the effectiveness of botanically derived inhibitors of 5-α-reductase in the treatment of androgenetic alopecia. J Anter Complem Med 2002;8(2)143-52.
Saw Palmetto; Flax; Fenugreek: Natural Medicines Comprehensive Database [Internet Database]. Stockton, CA: Therapeutic Research Faculty. Updated (periodically).
Springer K, Brown M, Stulberg DL. Common hair loss disorders. Am Fam Phys 2003; 68(1):93-102.