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Ten-year follow-up of early intensive self-management guidance in newly diagnosed patients with asthma
Kauppinen RS, Vilkka V, Hedman J, Sintonen H
The Journal of Asthma 2011;48(9):945-951
clinical trial
4/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: We assessed the 10-year effectiveness of self-management guidance in a prospective follow-up study of patients with asthma when inhaled corticosteroids were used from the beginning in the treatment. METHODS: Consecutive newly diagnosed asthmatics (n = 162) were randomized: 80 to an intervention group (IG) and 82 to a control group (CG). Lung function (LF), airway hyperresponsiveness (AHR), and health-related quality of life (HRQoL) were examined at 10 years. RESULTS: The advantages of intensive education with regards to LF measured by forced expiratory volume in 1 second and forced vital capacity were seen only after the first year. Later, there were no statistically significant differences in any parameters between the groups. However, during 10-year follow-up, peak expiratory flow, AHR, and HRQoL improved significantly in both groups (no differences as regards gender, smoking, or atopy). At 10 years, 68% of the IG and 75% of the CG patients still showed AHR after histamine challenge. Generic HRQoL scores in both groups equaled that of the age-standardized group a general population but only 50% in the IG and 55% in the CG had normal disease-specific HRQoL scores. According to Global Initiative for Asthma (GINA) criteria 23% of patients in the IG and 25% in the CG had asthma under control. CONCLUSIONS: The effectiveness of intensive self-management education could be shown only in the short term. The groups did not differ significantly in any of the parameters investigated, and showed nearly normal LF and HRQoL. AHR improved only partly and only a minority of the patients had asthma under good control according to GINA criteria. This study showed that evaluation of asthma using LF alone does not show the whole truth about asthma treatment results. HRQoL should be used in conjunction with GINA criteria, to assess asthma treatment outcomes. The value and importance of AHR for the evaluation of treatment remains obscure.

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