Acupuncture and bronchial asthma:: A long-term randomized study of the effects of real versus sham acupuncture compared to controls in patients with bronchial asthma

Background: Acupuncture has traditionally been used in China in the treatment of bronchial asthma and is being increasingly applied in Western countries. Although there are many published studies on acupuncture and asthma, few meet the scientific criteria necessary to prove the effectiveness of acupuncture. Objective: To examine the short- and long-term effects of real versus sham or no acupuncture in patients with bronchial asthma. Design: Randomized partially blinded study with three parallel groups. Subjects: Sixty-six (66) patients of both genders (mean age, 39 years) with mild-to-moderate persistent bronchial asthma. Interventions: After 2 weeks of run-in, the patients with asthma were randomized to receive either real (23 patients) or sham acupuncture (23 patients) or no acupuncture (20 patients). Two acupuncture periods (each 4 weeks) within the first 4 months were followed by a 6-month observation. Measurements: Primary outcome was the change of peak expiratory flow (PEF) variability at the end of the two treatment periods. Secondary outcomes were changes in forced expiratory volume in 1 second (FEV1), airway responsiveness, symptoms of asthma, the use of asthma drugs, and patients' well-being. Moreover, the effect of the intervention on eosinophils and eosinophil cationic protein (ECP) in blood and sputum was assessed. Results: PEF variability decreased in all groups. In a subgroup of patients whose asthma medication remained fairly unchanged, PEF variability decreased significantly after needling of real as well as sham points at month 4 and 5 compared to controls (p less than or equal to 0.005). However, there was no difference in the decrease of PEF variability between patients who had the blinded treatment with real or sham acupuncture. Most of the other functional and clinical variables did not differ from those obtained in controls. Eosinophils and ECP in blood and sputum decreased in all groups, but the only significant differences were found in blood eosinophil count at 4 months between sham acupuncture and the control group (p < 0.05) and at 10 months between real and sham acupuncture (p < 0.05) suggesting a possible effect on eosinophilic inflammation. Conclusions: In view of the fact that the effects after real and sham acupuncture compared to controls who had no needling at all were small, in all likelihood clinically irrelevant, our data do not seem to support the use of acupuncture in the management of pharmacologically welltreated patients with mild-to-moderate persistent asthma.