HAIFA, Israel, February 22, 2016 /PRNewswire/ —
Lipogen Ltd. attained a US patent for its proprietary phospholipid formulation designed to tackle Premenstrual Syndrome (PMS) and premenstrual dysphoric disorder (PMDD). These sometimes debilitating conditions occur in some 15% of pre-menopausal women aged 25-44. The patent was approved for “compositions and methods for alleviating symptoms associated with premenstrual syndrome (PMS) and premenstrual dysphoric disorder (PMDD).”
PMS is a combination of physical and emotional symptoms linked to the menstrual cycle. PMS symptoms occur 1 to 2 weeks before a woman’s period. Up to 80% of women report having some symptoms prior to menstruation. These symptoms qualify as PMS in 20% to 30% of pre-menopausal women. According to the Medical University of South Carolina, current available treatments include SSRIs and other drug treatments that treat side effects and can cost from US$60.00 – US$535.00 per month.
More than 200 different symptoms have been associated with PMS, including emotional symptoms such as: stress, anxiety, insomnia, fatigue, mood swings, emotional sensitivity and/or changes in libido. Physical symptoms can include bloating, abdominal cramps, constipation, lower back pain, acne, breast swelling, muscle pain and others.
“When the benefits of phospholipids on PMS and PMDD came to light through Lipogen’s research, we immediately explored its potential,” says David Rutenberg, CEO for Lipogen. “Realizing the significance of this discovery, it encouraged us to further explore a product line for women’s health utilizing Lipogen’s proprietary phospholipid ingredients.”
The previously unrecognized PMS/PMDD benefit of PS Plus came about when 2,000 volunteers received and consumed Lipogen’s PS Plus for brain health and stress management. At the end of the 2-month study, out of 220 women under the age of 40 who consumed the product regularly, 23 women (10.45%) reported that they noticed relief of premenstrual syndromes. They also reported that it helped them sleep better, experience fewer mood swings, fewer hot flashes and reduced stress.
“Based on these strong results, we improved the formulation and applied for a patent in the US market,” explains Rutenberg. “We also have begun an ongoing, double-blind, randomized, placebo-controlled clinical trial with daacro GmbH, Trier, Germany, to learn more how Lipogen’s formulation can help alleviate PMS and PMDD symptoms. Our patented solution is made of natural ingredients, is GMO-free, and can save significant health costs over medication alternatives, all with no reported side-effects.”
With 25 years of specializing in natural phospholipid research, development and production, Lipogen guarantees its customers ingredient systems that are supported by the highest level of scientific data, technical quality and safety to meet the growing demand for natural cognitive health solutions.
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SOURCE Lipogen Ltd.
This news release announces an Israel-based company’s success in obtaining a U.S. patent for a proprietary “phospholipid formulation” called PS Plus, which is purported to treat physical and “emotional” symptoms of premenstrual syndrome (PMS) and premenstrual dysphoric disorder (PMDD). Somewhat misleadingly, the release suggests the formulation was “designed” to address PMS and PMDD, when in fact it appears to be the same single-ingredient supplement already sold to provide “brain support,” “sharpen memory” and ameliorate “stress.” Prevalence statistics presented in the release are contradictory and qualitatively lightweight. There is evidence in the literature of some clinical testing of phosphatidic acid, a natural phospholipid, or fatty acid derivative of soy lecithin, used as a carrier for some experimental drugs, but it is the only active ingredient mentioned on the product website – and not at all in the release — and there is precious little information about other ingredients or costs anywhere.
PMS is a very common health condition in women of reproductive age. As such, women in this age group and in many countries may be interested in “natural” remedies to alleviate some of the symptoms.
Additionally, Americans are high users of complementary and alternative medicine (CAM) interventions. Recent studies have noted that in the United States, “approximately 38 percent of adults (about 4 in 10) and approximately 12 percent of children (about 1 in 9) are using some form of CAM.” Moreover, CAM use among adults is greater among women and those with higher levels of education and higher incomes – exactly the population this news release is trying to reach.
The supplement industry’s so-called “orthomolecular” therapies, which claim to maintain health with the use of natural compounds, have long been the subject of public health and scientific controversy, and come-and-go fads among consumers who spends millions on supplements for which rigorous evidence of clinical value is at best scant. For an aging population of boomers, in particular, the promise of protecting and boosting brain health (and by inference reducing the risk of age-related dementia), has been especially appealing, particularly if the products claim to be “natural” and with no ill effects. Similarly, for younger women, claims of safe, natural relief for PMS and related syndromes are appealing, given that the conditions have long been “medicalized,” and such treatments as hormone replacement therapy and anti-depressants — all carrying risks and adverse effects — have been over-prescribed and costly. Consequently, there is likely to be substantial interest in a product that promises to relieve what the release says are “more than 200 different symptoms” of PMS, and protect and enhance brain function.
Although the release points out the high costs of selective serotonin re-uptake inhibitors (SSRIs) and other drug treatments for PMS cost $60 to $535 per month, it fails to mention that a 30-day supply of its product costs $54.95.
According to a website showing the product patent application, it appears to be a combination of phosphatidylserine (PS) as the active ingredient along with phosphatidic acid (PA) and magnesium. These products are available from other manufacturers for purchase on the internet for varying costs.
Of interest, the patent application (but not the news release) states that various formulations were given “four times a day”…”from three weeks before the expected monthly menstruation until the commencement of menstruation.” That would amount to more than 80 pills or tablets per cycle, which would be quite expensive compared to daily dosing of other medications.
The description of the benefits is very poor, vague and unscientific. No information is given on study participants such as ages, inclusion criteria, type of symptoms, duration, and severity of symptoms at baseline and post-intervention. The release does report that 23 out of a subset of 220 women among 2,000 volunteers who took PS Plus for brain health and stress management over a two-month period, “noticed relief of premenstrual syndromes.” The company claims these are “strong” results.
There is no description of potential harms. The company CEO is quoted saying there are “no reported side-effects.”
However, a look at a commonly used scientific database for CAM product ingredients reveals there are side effects associated with phosphatidilserine, the active ingredient found in the product. Those include nausea, gastric distress and insomnia. There also may be an increased risk for acquiring infectious diseases, such as bovine spongiform encephalopathy (mad cow disease) if the phosphatidilserine is derived from bovine cortex, according to the database site.
As noted above, there is precious little information about the volunteer subjects except that they are women, and under age 40. At one point, the release states that premenstrual syndromes occur in 15 percent of pre-menopausal women ages 25-44, and later that symptoms “qualify” as PMS in 20 to 30 percent of such women. But there is no citation for these numbers, nor is it clear that they are meant to reflect the experience in the United States or elsewhere. The essential concern here is that there are no published data, based on standard clinical trial protocols, to provide credible evidence of benefits that are consistent and predictable. That has been an issue and challenge for the supplement industry, regulators, and consumers, and one not likely to end anytime soon.
The release and the study upon which the evidence is based lumps together two conditions — PMS and PMDD — which have different diagnostic criteria and severity. Their citations are inaccurate (PMS occurs in women outside of the age range 25-44, for example) and confusing.
It is true that PMS can be annoying and disruptive, but many women’s symptoms are not disruptive enough to require any medication interventions. Additionally, lumping PMS it together with PMDD (which is much more severe and intense) is uncalled for and bordering on disease mongering. In addition, the release offered no explanation for how it came up with the claim that “More than 200 different symptoms have been associated with PMS.”
It’s clear from the release that Lipogen, the company that issued the release, also funded the study. According to the release:
“When the benefits of phospholipids on PMS and PMDD came to light through Lipogen’s research, we immediately explored its potential,” says David Rutenberg, CEO for Lipogen.
Other than mentioning anti-depressants, which are not routinely prescribed for PMS, the release does not discuss any of the many other alternatives to managing PMS/PMDD symptom relief. Many interventions have been studied, from exercising (from which there is insufficient evidence) to other CAM therapies. According to a review published in American Family Physician journal, “A 2009 systematic review found 62 studies of herbal supplements, vitamins, and minerals with published claims for PMS symptom relief, only 10 of which were [randomized controlled trials] RCTs.” The review found that data are insufficient to evaluate the effectiveness of ginkgo, saffron, St. John’s wort, soy, or vitamin E, because only one study existed for each. However, results suggested that chasteberry and vitamin B6 may reduce PMS symptoms.” Other pharmacologic interventions include: SSRIs, oral-contraceptives, GnRH agonists, and anxyolitics.
The release might have been strengthened somewhat if there had been some acknowledgement of some other non-pharmalogical interventions.
The release doesn’t mention when or in which formulation the supplement might be available in the U.S. market, even though the release is introducing the supplement to a U.S. audience.
The release does, albeit somewhat confusingly, make the point that the observation about its purported benefits in PMS were made, apparently serendipitously, during a study of its effects on brain health and stress. That’s newsworthy, but could have benefited from more detail.
The claims made were not supported by the evidence provided. Some of the unsupported or misleading claims:
“Realizing the significance of this discovery”
“Can save significant health costs over medication alternatives”
“No reported side-effects”
“Lipogen guarantees its customers ingredient systems that are supported by the highest level of scientific data.” What are these “ingredient systems” and why didn’t they include the “highest level of scientific data?”