Once again, dietary supplements are in the news, and as usual the journalists charged with covering this story aren’t necessarily asking the right questions. On March 18th, 2012, Dateline NBC featured an investigation by Chris Hansen into one particular supplement laboratory and one particular weight loss product. While the message most people will take home from the story (as indicated by the headline of the story itself) will be that the safety of dietary supplements, including herbal remedies and nutritional supplements, is in question, Chris Hansen stated at the beginning of the broadcast that “the majority of dietary supplement manufacturers and laboratories are responsible and produce safe supplements.”
I chose the formulas for the PMS Comfort products myself, and have seen the positive effects they’ve had in the lives of women with PMDD and PMS. I have inspected the plant where these products are manufactured – and so has the United States Food and Drug Administration. In fact, every lab that meets current FDA standards has had to invest millions of dollars in testing equipment, and has to submit every product they produce to a rigorous manufacturing and testing protocol to make the process, and the product, is safe and secure.
Nearly every dietary supplement produced in the United States is manufactured in a plant with stringent safety and cleanliness standards. It’s unfortunate that millions of consumers might conclude that the shabby practices revealed in the investigation are representative of the industry as a whole.
Women with premenstrual dysphoric disorder, premenstrual syndrome, and other premenstrual problems like breast tenderness or migraines need to know that there are safe, reliable alternatives to pharmaceutical drugs. Many women simply cannot tolerate hormonal birth control or antidepressants for PMS and PMDD—those are the two main drug solutions available—and many more prefer to avoid synthetic medications, and are looking for natural, alternative remedies in order to live a healthier, more holistic lifestyle.
By providing high quality, Good Manufacturing Practices (GMP)-approved herbal and nutritional supplements, we are doing our part to both help women, and to help restore the reputation of alternative medicine. We wish that there were no stories about wayward labs and marketers to even be told—but that if they have to be told, it is reported responsibly, so that an accurate picture of the overall dietary supplement business, and alternative remedies in general, is given.
“Do I need more vitamin D?” With the evidence for the benefits of vitamin D for women’s health growing—and really, vitamin D is essential for everyone—this question is common. And while vitamin D for PMS or PMDD treatment isn’t important clinically, we still believe that vitamin D testing is one of the most simple and important things you can do for your health.
There’s some confusion about what vitamin D tests are best, and what the tests mean, so read on to find out what you need to know before you get tested for Vitamin D.
1. The correct test for vitamin D is 25-hydroxy-vitamin D, sometimes referred to as 25-OH Vitamin D. There is another test for 1,25 hydroxy vitamin D, and even though this is the active form that your body actually uses, this latter test is useless for most purposes, and unnecessary.
2. Vitamin D deficiency is indicated by a test result of less than 20 mg/dL. If your vitamin D test is 19 mg/dL or under, the best way to quickly get your vitamin D into the correct range is to take 5000 IU of vitamin D supplement every day for two or three months, at which point you should get retested to make sure your levels are going up. It’s also possible to get higher doses of Vitamin D that are meant to be taken just once per week.
3. If your vitamin D test level is between 20 and 34 mg/dL, you are in the suboptimal range. While this is not ideal, most of the studies that show problems from low vitamin D find it at the deficiency level mentioned above, rather than the suboptimal range. Still, if you have suboptimal vitamin D you should take 2000 IU per day of vitamin D supplement.
4. If your test result is between 35 and 75 mg/dL, we would still recommend you take 2000 IU vitamin D per day, because at this dosage you will almost certainly never get excessive vitamin D. However, if your result is above 50 mg/dL, you can pass on taking vitamin D supplements during the summer months, assuming you spend some time outside. A vitamin D level above 75 mg/dL is rare, but anyone with this amount of vitamin D in their bloodstream doesn’t need to take additional vitamin. It’s impossible to get excessive vitamin D from time spent in the sun.
5. If you are dark-skinned, it is harder for you to make vitamin D from spending time in the sun. So dark-skinned people (African-Americans, Asians, South Asians, and others) need to be more vigilant about getting tested, about taking vitamin D supplements, and about spending adequate time outdoors.
6. You can’t make vitamin D from sunshine if your skin is covered by clothing or if you are wearing sunscreen. Although this is another excellent reason to take vitamin D supplements, you can still make vitamin D and protect yourself from sun damage, while being outdoors in the shade. Or, we recommend you go outside, in the sun, in shirtsleeves without sunscreen for 15-20 minutes before covering up.
7. Lastly, only take vitamin D3 supplements, or cholecalciferol. Vitamin D2, ergocalciferol, is not as well absorbed, and isn’t the natural form your body uses. Vitamin D2 is up to 33% less efficient as a source of vitamin D compared to D3.
We recommend vitamin D for PMS and PMDD if you’ve already taken care of the basics of diet, lifestyle, and nutritional and herbal supplementation. But we recommend you make sure you have adequate vitamin D in your body for its overall benefits.
The more we learn about vitamin D, the better it sounds. The latest study from Denmark was announced this week at the American Heart Association conference. It shows that vitamin D deficiency in women increases the risk of heart attack, heart failure, stroke, and death by 50%. This joins a long list of studies that show that Vitamin D is essential, not just for heart health, but also for proper immune function, bone health, cancer prevention, and more. Although there are no studies yet to prove it, we suspect that there is a Vitamin D-PMS connection as well as a Vitamin D-PMDD relationship.
The best way to get vitamin D is from sunlight. Of course, many people avoid the sun because of skin damage and skin cancer concerns. Did you know, though, that your skin can make vitamin D even when you’re in the shade? The sun rays that allow your skin to make vitamin D can be absorbed when they bounce off of leaves, rocks, and buildings. So spending time outside, even if it is not directly in the sun, will work to boost your vitamin D level. Of course, if you are wearing clothing or sunscreen that blocks sunlight from reaching your skin, this won’t work.
One of most overlooked vitamin D issues is that if you are dark-skinned, for instance Asian, South Asian, African-American, Native American, or otherwise have highly pigmented skin, the melanin (coloring) in your skin prevents you from being able to manufacture vitamin D without being outside, or out in the sun, for a prolonged period of time. This is particularly important in northern climates with long, cold winters.
Although most media sources mention eating fish livers (who does that?!) and drinking milk and orange juice as sources of vitamin D, this isn’t helpful advice. The best way to get vitamin D other than sunlight is from taking vitamin D supplements. It’s too hard, if not impossible, to get adequate vitamin D from food. This is especially true if a test determines you are deficient; if you have dark skin; or if you live in a northern climate.
Since the media doesn’t seem capable of telling the truth about supplements (or, perhaps, of telling truth from fiction when it comes to supplements) here is what a woman needs to know about vitamin D supplements: it is nearly impossible to overdose on vitamin D. We recommend taking 2000-5000 IU of vitamin D per day during the indoor months, particularly if you live in a northern part of the country.
Vitamin D isn’t first line treatment for PMS or for PMDD. But it is essential, and too many women just don’t have adequate an vitamin D level. We’ll be talking more about how to understand lab tests for vitamin D in another post.
We’re a little tired of watching the media bandy about the supposed death of dietary supplements, based on a study on older women and multivitamins published earlier this month. Fox News and The Wall Street Journal ran the headline “Studies suggest case for dietary supplements is collapsing,” and we had to shake our heads.
The problem with this idea is that the study itself was so flawed that it’s hard to draw anything but flawed conclusions from it.
Published in the Archives of Internal Medicine—a very good journal—the study looked at older women who take multivitamins, and concluded that those who do take them are more likely to die than those who don’t. This is what was reported in the press, along with much wrinkling of brows, wringing of hands, and gnashing of teeth.
What the study itself did not address—and the stories in the press ignored this, or didn’t even realize it—is that the study looked for factors that might have confused the results, such as smoking, weight, blood pressure, diabetes, weight, eating fruits and vegetables. For every one of these risk factors, the women who took vitamins were in the healthier category.
So, the researchers performed some statistical sleight of hand: they adjusted their data, allowing them to analyze their data as if the only difference between the vitamin takers and not vitamin takers was the vitamins. But it wasn’t! They were healthier in almost every way imaginable. This means that the researchers had to artificially, statistically increase the apparent likelihood of the vitamin takers dying.
Scratching your head? Now you know why Mark Twain said: “There are lies, damn lies, and then there are statistics.”
In other words, we don’t know what actually happened to the women who took multivitamins. We only know that, after statistical manipulation, the authors got a certain answer—maybe even the one they were looking for.
One other note: the women in this study were 62 years old when they began the study. Among the many things this study doesn’t tell us is what happens if you start taking vitamins when you are 25 or 35 or 45.
OK, a second note: this type of study, called an observational study, is never able to tell us anything about cause and effect. It’s only able to tell us that two factors, such as vitamins and living longer, may or may not be related. The results from such a study must then be confirmed, or refuted, by a Randomized Controlled Trial (RCT.) We’d bet that if this study had said vitamins make you live longer and healthier, the media and the medical establishment would have warned people against taking vitamins until an RCT confirmed the results. But when a flawed observational study suggests vitamins might be bad, those same authorities urge us to rush for the exits.
There was an article this week in Maclean’s, the Canadian news weekly, that was making the point that alternative treatments and holistic medicine are unscientific. One of the conditions mentioned was in the article was PMS, and the article said herbs for the treatment of PMS haven’t been proven. Having been involved in natural medicine for decades, I find that the same old weary arguments are trotted out over and over by people with little knowledge of their subject, and with an enormous bias.
I too have a bias, but in my case it favors natural medicine. But there is absolute evidence that dietary supplements do help PMS. In fact, it’s more than evidence, it’s proof. The Maclean’s article mentioned only herbs for PMS, but some of the best evidence for natural treatment of PMS is for nutritional supplements, not herbs: calcium, magnesium, and vitamin B6 supplements have all been found effective. As to claims about herbs, Vitex agnus castus (Chaste Tree Berry) and Hypericum perforatum (St. John’s Wort) have both been extensively studied and are somewhere between solidly proven and extremely promising for PMS symptoms. In Germany, medical doctors have made Vitex the leading prescription medication for PMS.
A holistic approach to any condition, including PMS and PMDD, involves multiple healing modalities. This brings us to a major methodological problem with science as it is conventionally understood, and natural medicine. The gold standard of clinical trials is the double-blind, placebo-controlled, crossover study, which means that neither the patient nor the provider knows who is getting the real treatment. If this were the only way to glean useful information, though, we’d have no useful trials on food and diet, exercise, physical therapy, surgery, or any other intervention where one party knows who is getting the real treatment.
That brings us to another problem. The standard for concluding that a treatment works requires that the researchers be 95% certain that the result is not the result of random chance. That is a very high and difficult standard, one that only high-powered trials are likely to be able to meet: meaning, very expensive studies with hundreds or thousands of participants. This usually means that only large, well-funded (often by drug or medical device companies) studies can reach “statistical significance.”
The other problem with this approach is that it holds meaningful results hostage to an arbitrary statistical definition. If a treatment is studied in just 35 people, and results in a 50% improvement—their symptoms are half as severe as they were before the intervention—but the degree of certainty is only 75% rather than 95%, most researchers and medical commentators will say the treatment did nothing! Nothing! That, obviously, is throwing the baby out with the bathwater. Most of us would be happy to use a condition if we were 75% sure it would work to reduce our symptoms by half.
Finally, herbal and dietary supplements have a very low risk of side effects, and so shouldn’t be directly compared to drugs and devices that have a very steep risk of major problems. Most natural approaches, when used correctly, have side benefits instead of side effects.