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Fibromyalgia pain reduced with vitamin D intervention that achieved 30-48 ng – RCT Feb 2014

Effects of vitamin D on patients with fibromyalgia syndrome:
A randomized placebo-controlled trial

PAIN Volume 155, Issue 2, February 2014, Pages 261–268
Florian Wepner a florian.wepner at oss.at, Raphael Scheuer a, Birgit Schuetz-Wieser a, Peter Machacek a, Elisabeth Pieler-Bruha a, Heide S. Cross b, Julia Hahne a, Martin Friedrich a
a Department of Orthopedic Pain Management, Spine Unit, Center of Excellence for Orthopaedic Pain Management, Speising, Vienna, Austria
b Department of Pathophysiology, Medical University of Vienna, Vienna, Austria

The role of calcifediol in the perception of chronic pain is a widely discussed subject. Low serum levels of calcifediol are especially common in patients with severe pain and fibromyalgia syndrome (FMS). We lack evidence of the role of vitamin D supplementation in these patients. To our knowledge, no randomized controlled trial has been published on the subject. Thirty women with FMS according to the 1990 and 2010 American College of Rheumatology criteria, with serum calcifediol levels <32 ng/mL (80 nmol/L), were randomized to treatment group (TG) or control group (CG).
The goal was to achieve serum calcifediol levels between 32 and 48 ng/mL for 20 weeks via oral supplementation with cholecalciferol. The CG received placebo medication.
Re-evaluation was performed in both groups after a further 24 weeks without cholecalciferol supplementation. The main hypothesis was that high levels of serum calcifediol should result in a reduction of pain (visual analog scale score). Additional variables were evaluated using the Short Form Health Survey 36, the Hospital Anxiety and Depression Scale, the Fibromyalgia Impact Questionnaire, and the Somatization subscale of Symptom Checklist-90-Revised.
A marked reduction in pain was noted over the treatment period in TG: a 2 (groups) × 4 (time points) variance analysis showed a significant group effect in visual analog scale scores. This also was correlated with scores on the physical role functioning scale of the Short Form Health Survey 36. Optimization of calcifediol levels in FMS had a positive effect on the perception of pain. This economical therapy with a low side effect profile may well be considered in patients with FMS. However, further studies with larger patient numbers are needed to prove the hypothesis.

Images from web site of publisher. Apologize for fuzzy quality. The good images cost $35 and cannot be posted to the public

Update Oct 2017  Download the PDF via [https://www.researchgate.net/home |ResearchGate] from VitaminDWiki

Vitamin D Levels

Image
Mean serum calcifediol levels over time, including error bars with standard deviation.
Time points have been shifted to clarify the results (control group to the left, treatment group to the right).

Fibromyalgia Pain levels

Image
Mean score of the severity of pain during the preceding 7 days using a visual analog scale (VAS7), including error bars with standard deviation.
Time points have been shifted to clarify the results (control group to the left, treatment group to the right).

VitaminDWiki wonders why the pain increased at week 26 – while people were still getting vitamin D. The first chart hints that the researchers reduced the Vitamin D dose to keep < 48 ng. The abstract does not indicate what actually happened.

Fibromyalgia morning fatigue

Image
Mean FIQ–Morning fatigue, including error bars with standard deviation.
Time points have been shifted to clarify the results (control group to the left, treatment group to the right). FIQ = Fibromyalgia Impact Questionnaire.

VitaminDWiki suspect that the increase in morning fatigue at week 26 corresponds to the earlier decreased Vitamin D dose

Press Release

Researchers say vitamin D may be cost-effective treatment or adjunct for patients with fibromyalgia syndrome and low vitamin D Levels, reports PAIN®

Philadelphia, PA, January 17, 2014

Patients with fibromyalgia syndrome (FMS) 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, say researchers in the current issue of PAIN®.

In addition to pain and fatigue, individuals diagnosed with FMS may experience sleep disorders, morning stiffness, poor concentration, and occasionally mild-to-severe mental symptoms such as anxiety or depression. The condition can have a significant impact on the patient's quality of life, resulting in loss of employment and/or withdrawal from social life. There is no cure, and no treatment will address all of the symptoms, but some symptoms may be alleviated by physical therapy, cognitive behavioral therapy, temporary drug therapy (such as amitriptyline, duloxetine, or pregabaline) and multimodal therapies.

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.

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,” says lead investigator Florian Wepner, MD, 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.”

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 (FIQ) 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,” says Wepner. “Vitamin D levels should be monitored regularly in FMS patients, especially in the winter season, and raised appropriately.”


See also VitaminDWiki

Items in both categories Chronic Pain and Intervention are listed here:

Pain scale used was something like the following

Image

See also web

Attached files

ID Name Comment Uploaded Size Downloads
8507 Fibro 2014.pdf PDF 2014 admin 03 Oct, 2017 15:30 1.04 Mb 460
3561 Visual analog pain scale.gif admin 20 Jan, 2014 03:45 18.33 Kb 18245
3560 Fibro morning fatigue.jpg admin 20 Jan, 2014 03:01 12.18 Kb 1608
3559 Fibro Pain levels.jpg admin 20 Jan, 2014 03:00 17.06 Kb 1907
3558 Fibro Viramin D levels.jpg admin 20 Jan, 2014 03:00 44.97 Kb 1595
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