Quality of Life in Systemic Nickel Allergy Syndrome
Condition: Systemic Nickel Allergy Syndrome; Quality of Life
MeSH terms: Hypersensitivity; Syndrome
Study type: Observational

Summary: 
      This study evaluates the effects of Nickel oral hyposensitization treatment (NiOHT) on
      health-related quality of life (HRQoL) of patients suffered from Systemic Nickel Allergy
      Syndrome (SNAS).
    

Detailed description: 
      Nickel (Ni) is a nutritionally essential metal widely distributed in the environment, and it
      has been reported to be one of the most common causes of allergic contact dermatitis (ACD),
      affecting nearly 15-20% of the general population. As known, Ni-hypersensitivity can induce
      less frequently also respiratory allergy (RA) and in approximately 20% of Ni-ACD patients
      cause a more complex condition termed Systemic Nickel Allergy Syndrome (SNAS). It is
      characterized by a combination of cutaneous (in regions without direct nickel contact) and
      extracutaneous gastrointestinal symptoms, after the ingestion of Ni-rich foods, especially
      vegetables. Then, a low-Ni diet, following positive patch tests, represents a effective
      diagnostic and therapeutic tool in the control of systemic manifestations, determining a
      significant clinical improvement.

      It is known that Nickel oral hyposensitization treatment (NiOHT) is a effective approach for
      the management of Ni allergy, especially in a subset of patients with SNAS, inducing
      immunological and clinical tolerance to metal at the doses normally taken with the diet.

      Although a large number of clinical trials focused on the health-related quality of life
      (HRQoL) in allergic disease, the expectations, the needs and the psychosocial characteristics
      of patients affected by SNAS are limited and no data exist pre- and post-treatment and
      specifically with NiOHT. Given the high safety profile and beneficial effects of
      immunotherapy on HRQoL of patients with allergic rhinitis, we hypothesized similar positive
      results even after oral Ni desensitization.
    

Intervention name(s): Nickel oral hyposensitization treatment
Intervention type(s): Biological
Intervention description(s): Nickel oral hyposensitization treatment (NiOHT) was performed with hard gelatin capsules containing Nickel sulphate (NiSO4) at different dosages (0.1 ng, 1 ng, 10 ng, 0.1 μg, 0.5 μg) and microcrystalline cellulose as excipient (TIO Nickel, Lofarma SpA, Milan, Italy). Treatment was given 3 times a week increasing progressively the dose from 0.1 ng to 3 μg in 10 weeks with a maintenance phase of 1,5 μg a week for a period of 12 months. After 6 months, patients were allowed to gradually reintroduce nickel-rich foods, starting with those with a maximum of 100 mcg of nickel content. For all the treatment period, information on the appearance of side effects or more severe adverse reactions and the need for antiallergic drugs (corticosteroids, antihistamine drugs) were collected.
Other intervention name(s): NiOHT - TIO Nickel
Intervention MeSH terms: Nickel
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The Researchers enrol patients suffer from Systemic Nickel Allergy Syndrome (SNAS),
        condition characterised by a combination of cutaneous (in regions without direct nickel
        contact) and extracutaneous gastrointestinal symptoms, after the ingestion of Nickel-rich
        foods, especially vegetables.
      
Keywords: Nickel allergy; Systemic nickel allergy syndrome; Health-related quality of life; Nickel oral hyposensitizing treatment; Diet; Short-Form 36-Item Health Survey; Psychological General Well Being Index; Minnesota Multiphasic Personality Inventory