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Notes: Twenty patients with irritable bowel syndrome due to food intolerance were randomized to either oral sodium cromoglycate or placebo in a double-blind cross-over trial. The study consisted of treatment with either sodium cromoglycate or placebo for 8 weeks, followed by the cross-over treatment for 8 further weeks. Patients were allowed to eat the offending foods during the study. Eighteen patients completed the study. Analysis of patients' diary card scores showed a statistically significant difference in favour of sodium cromoglycate. There was a long carry-over effect in the active-placebo order group. Therefore oral sodium cromoglycate seems to be a useful treatment in patients with irritable bowel syndrome and proven food intolerance.

Notes: Background Atopic dermatitis (AD) is a chronic allergic inflammatory disease, which manifests itself with eczematous skin lesions.Objective We compared the clinical efficacy of tacrolimus ointment (0.1%) given twice a day and oral cyclosporine (3 mg/kg) given once daily. Rescue medication for itching included cetirizine 10–20 mg (equal to one or two tables).Methods Thirty patients, aged 13–45 years (mean±SD 27.1±10.9), with a history of moderate-to-severe AD were randomized to treatments, 15 patients for each treatments. Assessment of efficacy was based on SCORAD, on scores of daily itching, erythema, interference with sleep, due to the skin condition and days without use of cetirizine tablets. SCORAD, measured on a scale (0–103), was evaluated before treatment (0) and at 7, 14, 21, 28, 35 and 42 days after treatment. Similarly, the means of daily symptoms, on a scale (0–3), were evaluated before the treatment (0) and at 7, 14, 21, 28, 35 and 42 days after treatment; finally, on day without use of cetirizine tablets. The safety of the study treatments was assessed through haematologic, biochemical and urinary testing and on systolic and diastolic blood pressures and heart rate measurements.Results SCORAD decreased in the two treatment groups 14 days after the beginning of the period study. However, the patients in tacrolimus ointment group reported significantly lower SCORAD than those treated with oral cyclosporine. Overall SCORAD, as assessed by the area under the curve (AUC) day0–42 (score/day), was significantly lower in the tacrolimus ointment group when compared with oral cyclosporine (P〈0.001). Similarly, AUC day0–42 (score/day) for itching, erythema and number of nights without interference with the sleep due to skin condition were significantly lower in the group of patients treated with tacrolimus compared with those treated with cyclosporine (P=0.003, 0.005 and 0.01, respectively). As regards the use of rescue medication, expressed by median of number of days without use of anti-H1, it was significantly lower in the group treated with tacrolimus (82.5) than in the cyclosporine group (76.5) (P=0.03). There were no appreciable changes in haematological and biochemical indices, in both treatments groups.Conclusion The results of this comparative study demonstrate that tacrolimus ointment twice daily and cyclosporine administered orally once daily are effective on SCORAD, daily symptoms and anti-H1 rescue. When we compared tacrolimus and cyclosporine there was a faster onset of action in the group treated with tacrolimus. The two drugs presented the same safety. However, these data support the preferential use of topical tacrolimus 0.1% in AD, because cyclosporine has potential side-effects.

Notes: Background Corticosteroids are considered to be particularly effective in reducing nasal congestion and are therefore recommended as first-line treatment in allergic rhinitis patients with moderate to severe and/or persistent symptoms.Objective We compared the clinical efficacy of fluticasone propionate aqueous nasal spray (FPANS) 200 μg given once daily, administered in mono-therapy or combined therapy with a H1 receptor antagonist (cetirizine, CTZ) or with a leukotriene antagonist (montelukast, MSK), and the combined therapy of CTZ plus MSK in the treatment of patients affected by allergic rhinitis to Parietaria during natural pollen exposure. In addition, we examined the effect of the treatment on eosinophil counts and eosinophil cationic protein (ECP) in nasal lavage performed at beginning of season, during season and at the end of the season.Methods One hundred patients aged 12–50 years (mean±SD 31.8±9.6) with a history of moderate to severe Parietaria pollen-induced seasonal allergic rhinitis were selected. A randomized, double-blind, double dummy, placebo (PLA)-controlled, parallel-group study design was used. Patients were treated FPANS 200 μg once daily (n=20) or with FPANS 200 μg once daily, plus CTZ (10 mg) in the morning (n=20), or with FPANS 200 μg once daily, plus MSK (10 mg) in the evening (n=20) or with CTZ (10 mg) in the morning plus MSK in the evening (n=20) or matched PLA (n=20). Assessment of efficacy was based on scores of daily nasal symptoms and on eosinophil counts and ECP in nasal lavage.Results All treatments showed significant differences (P〈0.001) compared with PLA in terms of total symptom, rhinorrhea, sneezing and nasal itching scores. Concerning nasal congestion on waking and daily only the groups treated with FPANS in mono-therapy or in combined therapy showed significant differences compared with PLA. Comparing the group treated with FPANS alone and the groups treated with FPANS plus CTZ, we found significant differences for total symptom score (P=0.04) and for nasal itching (P=0.003). The comparison between FPANS plus CTZ and FPANS plus MSK showed significant difference for nasal itching (P=0.003). Finally, there were significant differences between the group treated with FPANS and the group treated with CTZ plus MSK for total symptom score (P=0.009), for nasal congestion on waking (P〈0.001) and nasal congestion daily (P〈0.001). Also the comparisons between the group treated with FPANS plus CTZ and the group treated with CTZ plus MSK demonstrated significant differences (P〈0.001) for total symptom, for nasal congestion on waking and for nasal congestion on daily, for rhinorrhea (P=0.04) and for nasal itching (P=0.003) scores. Concerning the comparison between the group treated with FPANS plus MSK and the group treated with CTZ plus MSK we found significant differences for total symptom score (P=0.005), for nasal congestion on waking (P〈0.001) and for nasal congestion on daily (P〈0.001). No other differences were observed between the groups. Concerning blood eosinophil counts, significant differences were found between the treatments with FPANS in mono-therapy or in combined therapy with PLA group during and at the end of the season (P=0.0003 and P〈0.0001, respectively). Concerning eosinophils and ECP in nasal lavage, all treatments showed significant differences (P〈0.001) compared with PLA. Besides, there were significant differences (P〈0.001) between the groups treated with FPANS alone or in combined therapy and the group treated with CTZ plus MSK.Conclusion The results of this comparative study demonstrate that FPANS is highly effective for treating patients affected by allergic rhinitis, with efficacy exceeding that of CTZ plus MSK in combined therapy. In addition, the regular combined therapy of FPANS plus CTZ or plus MSK would not seem to offer substantial advantage with respect to FPANS in mono-therapy in patients affected by seasonal allergic rhinitis.

Notes: Background Adverse reactions to non-steroidal anti-inflammatory drugs (NSAID)s are frequent, and the need to identify a safe alternative drug is a common problem in clinical practice.Objective To assess the tolerability of rofecoxib, a drug that specifically inhibits COX-2, in a group of NSAID-sensitive patients.Methods One-hundred and four subjects (29 males and 75 females, mean age 35.6 ± 14.1) were enrolled. All subjects had experienced one or more episode characterized by cutaneous symptoms (erythema, and/or urticaria angioedema) following the assumption of NSAIDs; 92 subjects experienced reactions to only one NSAID (single intolerance: SI) and 12 subjects had reactions to multiple NSAIDs (multiple intolerance: MI). Rofecoxib was challenged at the following dosages: ¼ of 25 mg (6.25 mg), ¼ of 25 mg, and ½ of 25 mg (12.5 mg), at intervals of 1 h if no symptoms had developed with the previous administration, in order to reach a cumulative dose of 25 mg. All subjects underwent two double-blind, placebo-controlled challenges in two consecutive days.Results No reactions against placebo were observed. Similarly, no reactions were observed in all subjects both after the first and after the second challenge to rofecoxib.Conclusions The present study demonstrated that rofecoxib does not have cross-reactivity to NSAIDs. Rofecoxib is a safe alternative in subjects with previous adverse cutaneous reaction to NSAIDs.

Notes: Background The cause and pathogenesis of chronic urticaria are still poorly understood. IgE-independent reactions, are common in adult patients with chronic urticaria, who have daily spontaneous occurrence of weals. H1-receptor antagonists (antihistamines) are the major class of therapeutic agents used in the management of urticaria and angioedema. Nevertheless, chronic urticaria is often difficult to treat and may not be controlled by antihistamines alone. It has been postulated that mediators other than histamine, such as kinins, prostaglandin and leukotrienes, may be responsible for some of the symptoms in urticaria which are not controlled by antihistamines. In this study, which was randomized double-blind, placebo-controlled, we compare the clinical efficacy and safety of montelukast (MT) 10 mg given once a day and cetirizine (CET) 10 mg given once a day with placebo (PLA), in the treatment of patients with chronic urticaria who have positive challenge to acetylsalicylic acid (ASA) and/or food additives.Patients and methods A group of 51 patients, ranging in age from 15 to 71 years, with chronic urticaria and positive challenge to food additives and/or ASA, participated in this study for a period of 4 weeks, starting from a 3-day run-in. The assessment of the efficacy was based on scores of daily urticaria symptoms.Results MT significantly increased the percentage of symptom-free days for hive and itch. Analysis of frequency distribution of urticaria scores for each symptom gave similar results (MT vs. CET and MT vs. PLA, P 〈 0.001). The interference with sleep due to their skin condition was also lower in the group treated with MT (P 〈 0.001). In addition, the median number of days without the rescue medication was significantly higher in the MT group (24 days) than both the CET and the PLA groups (18 days, P 〈 0.001, and 20 days, P 〈 0.001, respectively). Finally, a low incidence of adverse events was observed in this study.Conclusion The results of this comparative study demonstrate that montelukast orally administered once a day is very effective for the treatment of cutaneous symptoms in patients with chronic urticaria due to food additives and/or ASA.

Notes: Background: The recovery of mediator metabolites from urine has the potential to provide a rapid, safe, and easily available index of release of mediators. We aimed to determine urinary metabolites of both histamine and leukotrienes (LTs) in patients affected by chronic urticaria (CU).Methods: Twenty patients with CU were studied. They were selected on the basis of double-blind placebo-controlled challenge (DBPC) with acetyl salicylic acid (ASA) and food additives. Ten patients (group B) were negative to both challenges. Ten patients (group C) presented urticaria and/or the appearance of angioedema during or 24 h after challenge, with reactions to ASA (five patients) or food additives (five patients). We recruited 15 healthy volunteers as controls (group A). During a second challenge, groups B and C were challenged double-blind with a single dose of ASA, or a specific food additive, or placebo. The healthy group was challenged only with a placebo (talc capsule). Patients in groups B and C were challenged twice: with placebo (as groups B1 and C1) and with ASA (groups B2 and C2) or food additives (C2). Four samples of urine were collected; one during the night before the specific or sham challenge (baseline), and three at 2, 6 and 24 h after the challenge. Urinary methylhistamine (N-MH) and LTE4 were analyzed and normalized for urinary creatinine.Results: For urinary N-MH at baseline, there was a significant difference only between group A and groups B1, B2, C1 and C2 (A vs. B1, P 〈 0.0001; A vs. B2, P 〈 0.0001; A vs. C1, P 〈 0.0001; A vs. C2, P 〈 0.0001). We detected a significant variation in urinary methylhistamine excretion only in group C2 after 2 h, 6 h and 24 h (P 〈 0.0001). However, no variations were observed in N-MH excretion rate in the other groups (A, B1, C1) after challenge with placebo, and in B2 after challenge with ASA 20 mg. For urinary LTE4 at baseline no differences were found between the mean values for the different groups. After specific challenge, only C2 patients showed significantly increased excretion rates of urinary LTE4 compared with the other groups challenged with placebo (A, B1, C1), or ASA (B2) (P 〈 0.0001). No significant correlation was seen between urinary LTE4 and methylhistamine excretion rate in any patients.Conclusion:  Our results show that urinary excretion of N-MH and LTE4 is different for CU patients without ASA or food hypersensitivity, compared to those with CU with ASA or food additive hypersensitivity after specific challenge.

Notes: Background:  Very few data are available from the literature on whether nonatopic subjects affected by persistent rhinitis may show the appearance of objective symptoms of rhinitis after the ingestion of food additives such as tartrazine (E102), erythrosine (E127), monosodium benzoate (E211), p-hydroxybenzoate (E218), sodium metabisulphite (E223), and monosodium glutamate (E620). It is still unclear whether the ingestion of food additive may cause, as well, a consensual reduction of nasal peak inspiratory flow (NPIFR). Therefore, we used a double-blind placebo-controlled (DBPC) study to evaluate this hypothesis.Patients and methods:  Two hundred and twenty-six consecutive patients (76 males and 150 females) aged 12–60 years (mean age 40.2 ± 16.3 years). After 1 month of an additive-free diet regimen, an open challenge was carried out (food additive-rich diet for 2 weeks). After this period, challenges were administered in a DBPC manner using the above-mentioned substances under investigation.Results:  Twenty of 226 subjects (8.8%) reported an improvement of the symptoms of rhinitis after additive-free diet. More precisely, six of 226 (2.6%) were symptom-free and 14 of 226 (6.2%) showed an improvement in their symptoms after an additive-free diet. As far as the results for DBPC are concerned, 20 challenges with monosodium benzoate induced both objective (i.e. sneezing and rhinorrhoea) and subjective symptoms (nasal blockage and nasal itching) of rhinitis with reduction of NPIFR ≥20%, 45 challenges induced subjective symptoms of rhinitis (i.e. nasal blockage and nasal itching), without reduction of NPIFR ≥20% of the basal value, two with tartrazine, seven with erythrosine, 19 with monosodium benzoate, three with p-hydroxybenzoate, six with sodium metabisulphite, and eight with monosodium glutamate, respectively.Conclusions:  The observation that nonatopic persistent rhinitis may be caused by the frequent, probably daily, ingestion of small doses of a nontolerated substance is intriguing and suggests that at least some patients with ‘chronic vasomotor rhinitis’ may be intolerant to a particular food additive. Therefore, food additives can be considered triggers or aggravating factors, rather than aetiological factors.

Notes: Abstract The authors describe the case of a 62-year-old woman affected by rheumatoid arthritis with severe lumbar spine involvement.