Fibromyalgia Treatment With Enzyme DAO
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      Fibromyalgia is a complex and common chronic pain disorder that affects 12 million Europeans.
      Fibromyalgia causes persistent widespread pain in muscles, tendons, ligaments, and joints, as
      well as widespread tenderness to touch and the presence of extreme fatigue and weakness.

      Histamine is a molecule derived from an essential amino acid, histidine. It is stored in mast
      cells and basophils and is excreted through the intestine, being degraded as it passes
      through the intestinal mucosa by the enzyme Diamine Oxidase (DAO), which is found in this
      area. If there is any alteration in its metabolism and normal concentrations of histamine in
      the blood (50-70 mg/l) are not maintained, the free circulation of this amine in high
      concentrations triggers undesired effects, such as migraine, fibromyalgia, asthenia and
      atopy.

      DAO deficiency is an alteration in the metabolism of dietary histamine that occurs when there
      is little activity of the DAO enzyme. The low activity of the enzyme causes that a
      concentration considered normal of histamine from food cannot be metabolized and a
      transepithelial penetration of exogenous histamine occurs. In this way, histamine passes into
      the bloodstream, increasing its plasma concentration and once located freely in the blood, it
      is distributed throughout different parts of the body, producing adverse effects.

      One of the factors that causes DAO deficiency is genetics. The genetic sequence of DAO is
      found in a fragment located on chromosome 7 (7q34-q36) of the human genome. There are 85
      single nucleotide variants (SNPs) located and identified in the human DAO gene (AOC1). Seven
      of these SNPs produce amino acid substitution, being candidates to cause alterations in the
      metabolic capacity of the enzyme.

      Since histamine accumulation can trigger fibromyalgia, and the enzyme DAO has been shown to
      degrade histamine, oral supplementation with DAO food supplements, prepared from pig kidney,
      is suggested as a treatment for fibromyalgia.

      The objective of this study is to analyze whether DAO enzyme supplementation reduces the
      characteristic symptoms of fibromyalgia. In addition, the prevalence of DAO deficiency in
      women with fibromyalgia will be identified by genetic analysis of DAO deficiency from a
      saliva sample. It will also be evaluated if patients require a lower intake of analgesics
      after supplementation with the enzyme DAO.
    


Intervention name(s): fibroDAO®; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): One DAO enzyme capsule is taken with water 20 minutes before each meal, 3 times a day. DAO enzyme capsules contains 0.3 mg DAO enzyme divided into 2 white/beige tablets (each gastro-resistant tablet contains 0.15 mg DAO enzyme) and 80 mg magnesium divided into 2 lilac tablets (each immediate-release tablet contains 40 mg of Mg).; One placebo capsule is taken with water 20 minutes before each meal, 3 times a day. Placebo capsules consist of microcrystalline cellulose and gelatin capsules with the same shape, size and colour as the DAO enzyme.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Fibromyalgia; Diamine Oxidase; Supplementation; Genetics; Treatment