Label Review
With Comments by Gregor Reid, PhD
Jarrow Formulas Fem-Dophilus
March 2000; Volume 2: 24
Package Information
"Contains 10 capsules and an applicator"
"4 billion organisms per capsule"
"Each vaginal capsule for feminine hygiene contains: Highly concentrated lactic acid bacteria cultures, in a base of lactose and 7 mg Vitamin C."
Suggested Usage
"At bedtime, with the aid of the applicator, insert one Fem-Dophilus capsule into vagina. To assist in restoring and maintaining normal vaginal flora, use 1 capsule per night for 5-10 days and then 2-3 capsules per month thereafter. Also use after douching. Keep refrigerated. Keep applicator and capsules out of reach of children."
Supplement Facts
| Lactobacillus rhamnosus R011 | 80% | 3.2 billion |
| Lactobacillus acidophilus R052 | 5% | 200 million |
| Lactobacillus bulgaricus R187 | 5% | 200 million |
| Streptococcus thermophilus R081, R083 | 10% | 400 million |
| Total | 100% | 4 billion |
Other ingredients: magnesium stearate. Capsule consists of gelatin.
Jarrow Formulas is based in Los Angeles, CA.
Comments
Vaginal infections are extremely common, and many women will have used antibiotics and yeast therapies at one or more times in their lives. There is a strong association between reduction in naturally occurring normal bacteria (mainly lactobacilli) in the vagina and recurrent infection.
The Jarrow Formulas Fem-Dophilus product is one of many containing lactobacilli, but one of the few that can be obtained by prescription. It is produced by a reputable fermentation facility in Quebec and so the viable content should be reliable. Inclusion of vitamin C and lactose should act to stimulate the growth of the lactobacilli once inserted.1
The claims are fairly general. Reference to "hygiene" is a bit misleading in that it suggests that women get these infections through being unhygienic, which of course is not the case. The second claim "to assist in restoring and maintaining normal vaginal flora" is made through association with literature rather than any proven scientific evidence. It is likely assumed that women associate Lactobacillus acidophilus and Lactobacillus bulgaricus with health. In fact, both have been more commonly associated with the intestine, as that is where the majority of such products are aimed. Having said that, the species name is of minor importance: It is the mode of action of particular strains that is critical.2 For example, I have no knowledge of strains RO11, RO52, R187, RO81, or RO83 inhibiting growth, adhesion, or colonization of the organisms that cause vaginitis. Nor am I aware of any peer-reviewed studies showing that they restore and maintain a normal vaginal flora. In fact, I do not know of any lactobacillus organism that inhibits yeast; rather, their ability to maintain a normal vaginal bacterial flora keeps the candida in check.
Consumers must be given more information, in my view, on the mode of action of specific contents of products including but by no means limited to Fem-Dophilus. Also, if they are indeed to take it for 5-10 days and then 2-3 times per month thereafter (forever?), the rationale and clinical evidence to indicate this dosage protocol should be accessible. Unlike many probiotic products found to be unreliable,3 this one should have reliable contents, and it is feasible that data on the organisms and their efficacy also exist—in which case it would be helpful to patients, scientists, and physicians if the results were made accessible.
References
1. Reid G, et al. Effect of nutrient composition on the in vitro growth of urogenital lactobacillus and uropathogens. Can J Microbiol 1998;44:866-871.
2. Reid G. The scientific basis for probiotic strains of Lactobacillus. Appl Environ Microbiol 1999;65:3763-3766.
3. Hamilton-Miller JM, et al. Public health issues arising from microbiological and labelling quality of foods and supplements containing probiotic microorganisms. Public Health Nutr 1999,2:223-229.
March 2000; Volume 2: 24
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