G Bronfort1, R L Evans, P Kubic, P Filkin. 1. Wolfe-Harris Center for Clinical Studies, Northwestern Health Sciences University, Bloomington, MN 55431, USA.
Abstract
OBJECTIVES: The first objective was to determine if chiropractic spinal manipulative therapy (SMT) in addition to optimal medical management resulted in clinically important changes in asthma-related outcomes in children. The second objective was to assess the feasibility of conducting a full-scale, randomized clinical trial in terms of recruitment, evaluation, treatment, and ability to deliver a sham SMT procedure. STUDY DESIGN: Prospective clinical case series combined with an observer-blinded, pilot randomized clinical trial with a 1-year follow-up period. SETTING:Primary contact, college outpatient clinic, and a pediatric hospital. PATIENTS: A total of 36 patients aged 6 to 17 years with mild and moderate persistent asthma were admitted to the study. OUTCOME MEASURES: Pulmonary function tests; patient- and parent- or guardian-rated asthma-specific quality of life, asthma severity, and improvement; am and pm peak expiratory flow rates; and diary-based day and nighttime symptoms. INTERVENTIONS: Twenty chiropractic treatment sessions were scheduled during the 3-month intervention phase. Patients were randomly assigned to receive either active SMT or sham SMT in addition to their standardized ongoing medical management. RESULTS: It is possible to blind the participants to the nature of the SMT intervention, and a full-scale trial with the described design is feasible to conduct. At the end of the 12-week intervention phase, objective lung function tests and patient-rated day and nighttime symptoms based on diary recordings showed little or no change. Of the patient-rated measures, a reduction of approximately 20% in beta(2) bronchodilator use was seen (P =.10). The quality of life scores improved by 10% to 28% (P <.01), with the activity scale showing the most change. Asthma severity ratings showed a reduction of 39% (P <.001), and there was an overall improvement rating corresponding to 50% to 75%. The pulmonologist-rated improvement was small. Similarly, the improvements in parent- or guardian-rated outcomes were mostly small and not statistically significant. The changes in patient-rated severity and the improvement rating remained unchanged at 12-month posttreatment follow-up as assessed by a brief postal questionnaire. CONCLUSION: After 3 months of combining chiropractic SMT with optimal medical management for pediatric asthma, the children rated their quality of life substantially higher and their asthma severity substantially lower. These improvements were maintained at the 1-year follow-up assessment. There were no important changes in lung function or hyperresponsiveness at any time. The observed improvements are unlikely as a result of the specific effects of chiropractic SMT alone, but other aspects of the clinical encounter that should not be dismissed readily. Further research is needed to assess which components of the chiropractic encounter are responsible for important improvements in patient-oriented outcomes so that they may be incorporated into the care of all patients with asthma.
RCT Entities:
OBJECTIVES: The first objective was to determine if chiropractic spinal manipulative therapy (SMT) in addition to optimal medical management resulted in clinically important changes in asthma-related outcomes in children. The second objective was to assess the feasibility of conducting a full-scale, randomized clinical trial in terms of recruitment, evaluation, treatment, and ability to deliver a sham SMT procedure. STUDY DESIGN: Prospective clinical case series combined with an observer-blinded, pilot randomized clinical trial with a 1-year follow-up period. SETTING: Primary contact, college outpatient clinic, and a pediatric hospital. PATIENTS: A total of 36 patients aged 6 to 17 years with mild and moderate persistent asthma were admitted to the study. OUTCOME MEASURES: Pulmonary function tests; patient- and parent- or guardian-rated asthma-specific quality of life, asthma severity, and improvement; am and pm peak expiratory flow rates; and diary-based day and nighttime symptoms. INTERVENTIONS: Twenty chiropractic treatment sessions were scheduled during the 3-month intervention phase. Patients were randomly assigned to receive either active SMT or sham SMT in addition to their standardized ongoing medical management. RESULTS: It is possible to blind the participants to the nature of the SMT intervention, and a full-scale trial with the described design is feasible to conduct. At the end of the 12-week intervention phase, objective lung function tests and patient-rated day and nighttime symptoms based on diary recordings showed little or no change. Of the patient-rated measures, a reduction of approximately 20% in beta(2) bronchodilator use was seen (P =.10). The quality of life scores improved by 10% to 28% (P <.01), with the activity scale showing the most change. Asthma severity ratings showed a reduction of 39% (P <.001), and there was an overall improvement rating corresponding to 50% to 75%. The pulmonologist-rated improvement was small. Similarly, the improvements in parent- or guardian-rated outcomes were mostly small and not statistically significant. The changes in patient-rated severity and the improvement rating remained unchanged at 12-month posttreatment follow-up as assessed by a brief postal questionnaire. CONCLUSION: After 3 months of combining chiropractic SMT with optimal medical management for pediatric asthma, the children rated their quality of life substantially higher and their asthma severity substantially lower. These improvements were maintained at the 1-year follow-up assessment. There were no important changes in lung function or hyperresponsiveness at any time. The observed improvements are unlikely as a result of the specific effects of chiropractic SMT alone, but other aspects of the clinical encounter that should not be dismissed readily. Further research is needed to assess which components of the chiropractic encounter are responsible for important improvements in patient-oriented outcomes so that they may be incorporated into the care of all patients with asthma.