Fibromyalgia-like Joint/Muscle Pain and Synovitis in Non-celiac Wheat Sensitivity Patients
Fibromyalgia-like Joint/Muscle Pain and Synovitis in Non-celiac Wheat Sensitivity Patients
Recently it has been reported that a consistent percentage of the general population consider
 themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though
 they do not have CD or wheat allergy. This clinical condition has been named Non-Celiac
 Gluten Sensitivity' (NCGS). In a previous paper the investigators suggested the term
 'Non-Celiac Wheat Sensitivity' (NCWS), since it is not known what component of wheat causes
 the symptoms in NCGS patients, and the investigators also showed that these patients had a
 high frequency of coexistent multiple food hypersensitivity. The clinical picture of NCWS is
 characterized by combined gastrointestinal (bloating, abdominal pain, diarrhea and/or
 constipation, nausea, epigastric pain, gastroesophageal reflux, aphthous stomatitis) and
 extra-intestinal and/or systemic manifestations (headache, depression, anxiety, 'foggy mind,'
 tiredness, dermatitis or skin rash, fibromyalgia-like joint/muscle pain, leg or arm numbness,
 and anemia). Nowadays no data are available on the characteristic of 'rheumatologic' symptoms
 of NCWS patients. Therefore, the aims of the present study are: 1) to investigate the
 prevalence of fibromyalgia-like joint/muscle pain in NCWS patient, 2) to search for possible
 ultrasonographic alterations (i.e. synovitis) of hands and feet joints of NCWS patients, and
 3) to evaluate modification of fibromyalgia-like joint/muscle pain in NCWS patients after a
 gluten free diet period of almost 6 months.
Recently it has been reported that a consistent percentage of the general population consider
 themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though
 they do not have CD or wheat allergy. This clinical condition has been named Non-Celiac
 Gluten Sensitivity' (NCGS). In a previous paper the investigators suggested the term
 'Non-Celiac Wheat Sensitivity' (NCWS), since it is not known what component of wheat causes
 the symptoms in NCGS patients, and the investigators also showed that these patients had a
 high frequency of coexistent multiple food hypersensitivity. CD is an immunological disorder
 whose best-known manifestations are gastrointestinal symptoms. However, early joint
 manifestations are common and frequently overlooked features of the disease. Similarly, the
 clinical picture of NCWS is characterized by combined gastrointestinal (bloating, abdominal
 pain, diarrhea and/or constipation, nausea, epigastric pain, gastroesophageal reflux,
 aphthous stomatitis) and extra-intestinal and/or systemic manifestations (headache,
 depression, anxiety, 'foggy mind,' tiredness, dermatitis or skin rash, fibromyalgia-like
 joint/muscle pain, leg or arm numbness, and anemia). Nowadays no data are available on the
 characteristic of 'rheumatological' symptoms of NCWS patients. Therefore, the aims of the
 present study are: 1) to investigate the prevalence of fibromyalgia-like joint/muscle pain in
 NCWS patient, 2) to search for possible ultrasonographical alterations (i.e. synovitis) of
 hands and feet joints of NCWS patients, and 3) to evaluate modification of fibromyalgia-like
 joint/muscle pain in NCWS patients after a gluten free diet period of almost 6 months.
Inclusion Criteria:

 All the patients met the recently proposed criteria:

 -  negative serum anti-tissue transglutaminase and antiendomysium (EmA) immunoglobulin
 (Ig) A and IgG antibodies

 -  absence of intestinal villous atrophy

 -  IgE-mediated immunoallergic tests negative to wheat and cow's milk protein (skin prick
 tests and/or serum specific IgE detection).

 Adjunctive criteria adopted in our patients were:

 -  resolution of the gastrointestinal and extra-intestinal symptoms on a standard
 elimination diet, without wheat, cow's milk, egg, tomato, chocolate, or other food(s)
 causing self-reported symptoms

 -  symptom reappearance on double-blind placebo-controlled (DBPC) wheat challenge,
 performed as described previously. DBPC cow's milk protein challenge will be also
 performed to diagnose cow's milk protein allergy.

 Exclusion Criteria:

 Exclusion criteria will be:

 -  age <18 years

 -  positive EmA in the culture medium of the duodenal biopsies, even if the villi to
 crypts ratio in the duodenal mucosa was normal

 -  self-exclusion of wheat from the diet and refusal to reintroduce it before entering
 the study

 -  other organic gastrointestinal diseases

 -  previously diagnosed rheumatic diseases

 -  nervous system disease and/or major psychiatric disorder

 -  physical impairment limiting physical activity

 -  menopause; steroid and sex steroid therapy, hormone replacement therapy or
 ovariectomy.