Fibromyalgia Breakthrough?

Did I miss something? Fibrolief is advertised as a breakthrough. “Clinical studies indicate that the ingredients in this formulation are highly effective at reducing the symptoms related to Fibromyalgia”. This is topped with claims that “for others” (who?) “ingredients have achieved”:

  * “Reduction of lower back pain, headaches, joint and muscle pain

  * Reduced inflammation

  * Improved energy levels

  * Increased mental clarity diminishing the effects of fibro fog

  * A full nights sleep without waking up groggy”

I'm not sure if these are legally called health claims; anyway that would be the duty of the FDA to decide. Theses claims, however, warrant a closer look at the ingredients.

Turmeric

There’s turmeric/curcumin in Fibrolief. Sorry, no study on PubMed – search has been done with this strategy: ("Curcuma"[Mesh] OR "Curcumin"[Mesh] OR "curcuminoid synthase, Curcuma longa" [Supplementary Concept] OR "turmeric extract" [Supplementary Concept]) AND "Fibromyalgia"[Mesh]. As fibromyalgia isn’t an inflammatory disease, why should turmeric work?

Boswellia

“Boswellia is a popular herb used for its benefits in fighting inflammation.” It doesn’t even work in arthritis.  And so sorry, nothing on PubMed, too.

White Willow Bark Extract

“White Willow Bark extract contains the active ingredient salicin which is a Cox-1 and Cox-2 inhibitor, and acts as an anti-inflammatory and also reduces pain by inhibiting prostaglandins.” That’s true, but … NSAIDs work like a key, which has to be but on a slot, the enzyme Cox-a or Cox-2. No matter whether you take salicin, aspirin or any other NSAID, you need the same number of key to lock the enzymes. Salicin is more toxic like aspirin, which is more toxic than naproxen, Diclofenac, ibuprofen or Cox-2-inhibitors. Salicin doesn’t work in fibromyalgia, which isn’t surprising as NSAIDs generally aren’t of much use in fibromyalgia. Please look here: http://www.ncbi.nlm.nih.gov/pubmed/19746561. One could cite a plethora of studies that proved the inefficacy of NSAIDs in fibromyalgia pain.

Celery Seed Extract

“Celery seed extract has been used as a pain reliever for arthritis, fibromyalgia and gout. It is known to help reduce muscle spasms and to alleviate painful gas and bloating. It is also known to aid in improving the painful symptoms of fibromyalgia sufferers by reducing inflammation.” How could symptoms of fibromyalgia be alleviated by reducing inflammation? And you guessed right, there’s no study on PubMed addressing fibromyalgia and celery seed extract.

Malic Acid/Malate

There has indeed be a study in 1995. IJ Russell and colleagues published: “Treatment of fibromyalgia syndrome with Super Malic: a randomized, double blind, placebo controlled, crossover pilot study.” The study had been done in 24 patients, which is quite low. In results we are informed: “No clear treatment effect attributable to Super Malic was seen in the blinded, fixed low dose trial.” Conclusions: “These data suggest that Super Malic is safe and may be beneficial in the treatment of patients with FM. Future placebo-controlled studies should utilize up to 6 tablets of Super Malic bid and continue therapy for at least 2 months.” There have no further studies and may be is wishful thinking. The results didn’t show an effect.

Rhodiola Rosea

No study on rhodiola rosea and fibromyalgia. There is a study in mice on nociceptive pain: “Synergistic interactions between the antinociceptive effect of Rhodiola rosea extract and B vitamins in the mouse formalin test.” But pain in fibromyalgia is non-nociceptive!

Coenzyme Q10

“Coenzyme Q10 (CoQ10) A powerful Antioxidant”. There are studies going on, but in the last decade only small studies (N=5) or other pilot studies have been published. I don’t think that there’s the foundation for a breakthrough, but waiting for the result, especially for the dosing is a good idea.

Bacopa Monnieri

Nothing on fibromyalgia and bacopa monnieri.

SAM-e

“SAM-e is made from amino acid methionine and ATP. Studies have shown its effective for arthritis pain and shows both analgesic and anti-inflammatory properties.” I’ve already written about the futility of using SAM-e in fibromyalgia n this blog: http://rheumatologe.blogspot.de/2014/08/sam-e-and-fibromyalgia.html.

Magnesium

There is a deficiency in the general public. Eat a banana!

Vitamin D3

There also is a deficiency in the general public in vitamin D3. But in the US you already have lots of D3 fortified foods. And most people live 10° South of for instance Germany. Four times 3000 IU vitamin D3 per day might be an overdose.

Stabilized R-Alpha Lipoic Acid

Nothing on fibromyalgia and alpha lipoic acid on PubMed.

Zinc

There has been a Turkish study in 2008 seeing low levels of zinc in fibromyalgia patients, but there’s no study showing that substitution of zinc improves fibromyalgia.

Black Pepper Bioperine

Nothing on fibromyalgia and black pepper bioperine on PubMed.

The ingredients of Fibrolief aren’t convincing in reducing fibromyalgia symptoms. And Fibrolief is a dietary supplement, which hasn’t to show efficacy like a drug. But the producers should be careful with health claims. As you would spend around 750 US $ per year on Fibrolief, you should be pretty sure that it works. I would feel better with a scientific study on the effects of this product, but there is none. Would I buy Fibrolief? Nope!