HEALTH

Study: Vitamin D supplementation may reduce pain in fibromyalgia patients

BY Michael Johnsen

PHILADELPHIA — Patients with fibromyalgia syndrome typically have widespread chronic pain and fatigue. For those with low vitamin D levels, vitamin D supplements can reduce pain and may be a cost-effective alternative or adjunct to other treatment, reported researchers in the current issue of Pain.

Researchers hypothesized that vitamin D supplementation would reduce the degree of chronic pain experienced by FMS patients with low levels of calcifediol and also might improve other symptoms. "Low blood levels of calcifediol are especially common in patients with severe pain and fibromyalgia. But although the role of calcifediol in the perception of chronic pain is a widely discussed subject, we lack clear evidence of the role of vitamin D supplementation in fibromyalgia patients," stated lead investigator Florian Wepner of the Department of Orthopaedic Pain Management, Spine Unit, Orthopaedic Hospital, Speising, Vienna, Austria. "We therefore set out to determine whether raising the calcifediol levels in these patients would alleviate pain and cause a general improvement in concomitant disorders."

Calcifediol (also known as calcidiol, 25-hydroxycholecalciferol, or 25-hydroxyvitamin D (OH)D) is a prehormone produced in the liver by the enzyme cholecalciferol (vitamin D3). Calcifediol is then converted to calcitriol (1,25-(OH)2D3), which is the active form of vitamin D. The concentration of calcifediol in blood is considered the best indicator of vitamin D status.

In a randomized controlled trial, 30 women with FMS with low serum calcifediol levels (below 32ng/ml) were randomized to a treatment or control group. The goal for the treatment group was to achieve serum calcifediol levels between 32 and 48ng/ml for 20 weeks via oral cholecalciferol supplements. Serum calcifediol levels were reevaluated after five and 13 weeks, and the dose was reviewed based on the results. The calcifediol levels were measured again 25 weeks after the start of the supplementation, at which time treatment was discontinued, and after a further 24 weeks without supplementation.

Twenty-four weeks after supplementation was stopped, a marked reduction in the level of perceived pain occurred in the treatment group. Between the first and the 25th week on supplementation, the treatment group improved significantly on a scale of physical role functioning, while the placebo group remained unchanged. The treatment group also scored significantly better on a Fibromalgia Impact Questionnaire on the question of "morning fatigue." However, there were no significant alterations in depression or anxiety symptoms.

"We believe that the data presented in the present study are promising. FMS is a very extensive symptom complex that cannot be explained by a vitamin D deficiency alone. However, vitamin D supplementation may be regarded as a relatively safe and economical treatment for FMS patients and an extremely cost-effective alternative or adjunct to expensive pharmacological treatment as well as physical, behavioral, and multimodal therapies," Wepner reported. "Vitamin D levels should be monitored regularly in FMS patients, especially in the winter season, and raised appropriately."

 

 

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National Consumers League survey finds 1-in-5 adults never received a flu shot

BY Michael Johnsen

WASHINGTON — A survey released by the National Consumers League found that more than 1-in-5 (22%) U.S. parents surveyed admitted they’ve never received a flu shot, and only half (53%) of parents with children ages 17 years and younger have received a flu vaccination within the last year. 

“According to our survey, only 44% of these parents said their child has received the vaccine,” said Sally Greenberg, NCL executive director. “And 20% of Americans who do not get the vaccine say they avoid it because they mistakenly fear the vaccine increases one’s chance of contracting the virus. Consumers are clearly confused about the value of the flu shot for both individuals and for their community, and they need better education." 

The most common reason for not receiving the flu vaccine among adults who reported they have never received a flu shot was their good health (45%), side effects (29%) and perceived ineffectiveness of the vaccine (24%). 

Additionally, 1-in-5e (21%) said the reason they have not received the flu vaccine is because they do not believe the flu is a serious illness. One-in-5 (20%) also said the fear of contracting the flu from the vaccination is a reason they have not received the flu vaccine.

NCL’s survey also polled adult Americans about their perspectives on vaccines in general. The most common reasons adults cite for not vaccinating include side effects (41%) and ineffectiveness of the vaccines (27%).  

The majority of adults (87%) support mandatory vaccinations for school-aged children, however. 

The national survey was conducted online by Harris Interactive among 1,756 U.S. adult Americans, of whom 993 are parents of children under age 18 years, from August through September 2013. The survey was commissioned by NCL with an unrestricted educational grant from Pfizer.

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CHPA responds to Food and Drug Administration’s APAP recommendation

BY Michael Johnsen

WASHINGTON — The Consumer Healthcare Products Association on Thursday responded to the Food and Drug Administration’s recommendation to discontinue prescribing and dispensing prescription combination medicines that contain more than 325 mg of acetaminophen per dosage unit, suggesting it would not impact use of over-the-counter formulations containing acetaminophen.

“By limiting prescription products to no more than 325 mg acetaminophen, the FDA is addressing the biggest cause of unintentional acetaminophen overdose," the association stated. "More than half (63%) of reported overdose cases involve the use of prescription opioid-acetaminophen combination medicines, such as Vicodin and Percocet. Lowering the amount in prescription products will help reduce the risk of consumers accidentally exceeding the maximum daily dose of 4,000 mg."

The industry has taken several proactive steps to educate consumers about acetaminophen safe-use and increase the visibility of acetaminophen on OTC product labels to help consumers better understand how to avoid accidental overdose. This has included enhanced labeling on both the front package panel and the Drug Facts label to call out the word “acetaminophen” on all OTC medicines that contain the ingredient. It is now prominently listed on the principal display panel (front of package) and bolded or highlighted in the ingredients section of the Drug Facts label. 

These initiatives are in tandem with FDA’s and others’ efforts on the prescription side to drive and improve acetaminophen safe use. 

In addition, the CHPA Educational Foundation co-founded and actively participates on the Acetaminophen Awareness Coalition and its Know Your Dose campaign, which educates consumers to read and follow the medicine label, know if acetaminophen is an ingredient in your medicines, and never take two medicines with acetaminophen at the same time. Advisors to those initiatives include the FDA’s Safe Use Initiative and the Centers for Disease Control and Prevention.

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