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Can a standardized acupuncture technique palliate disabling breathlessness: a single-blind, placebo-controlled crossover study |
Lewith GT, Prescott P, Davis CL |
Chest 2004 May;125(5):1783-1790 |
clinical trial |
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; 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* |
STUDY OBJECTIVES: The management of disabling breathlessness is poor, and a standardized form of acupuncture has been reported as offering benefit. This study was designed to evaluate the efficacy of standardized acupuncture treatment. DESIGN: A single-blind, randomized, crossover study. SETTING: This study was carried out on a domiciliary basis in Southampton (UK). INTERVENTIONS: This study evaluated a standardized acupuncture technique versus an appropriately validated placebo/control (mock transcutaneous electrical nerve stimulation (TENS)) for disabling, nonmalignant breathlessness (largely COPD). The acupuncture was provided by an appropriately trained nurse acupuncturist. Each patient received six treatments in each phase of the study, with an intervening 2-week washout period. MEASUREMENTS AND RESULTS: The primary outcome was worst breathlessness (visual analog scale, 0 to 100 mm), with the sample size based on an 80% power to detect a 10-mm difference between treatment means. Secondary outcomes included the St George's respiratory questionnaire score and treatment credibility. RESULTS: Thirty-six patients were entered into the study (33 with COPD), and 24 patients completed both treatment phases. The primary outcome improved significantly during the course of the study, but there were no significant treatment differences between acupuncture and the placebo/control of mock TENS for either primary or secondary outcomes. The placebo was shown to be a credible control. There was no evidence of a carryover effect from the first to second phase of the study. CONCLUSION: This standardized acupuncture technique does not show specific efficacy in disabling nonmalignant breathlessness, but those entered into the study did experience clinically significant benefit from both treatments.
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