Rationale: Lung inflammation and injury is critical in cystic fibrosis. An ideal antiinflammatory agent has not been identified but inhaled corticosteroids are widely used despite lack of evidence. Objectives: To test the safety of withdrawal of inhaled corticosteroids with the hypothesis this would not be associated with an earlier onset of acute chest exacerbations. Methods: Multicenter randomized double-blind placebo-controlled trial in 18 pediatric and adult UK centers. Eligibility criteria included age Ͼ 6.0 yr, FEV 1 у 40% predicted, and corticosteroid use Ͼ 3 mo. During the 2-mo run-in period, all patients received fluticasone; they then took either fluticasone or placebo for 6 mo. Measurements and Main Results: Fluticasone group: n ϭ 84, median age 14.6 yr, mean (SD) FEV 1 76% (18); placebo group: n ϭ 87, median age 15.8 yr, mean (SD) FEV 1 76% (18). There was no difference in time to first exacerbation (primary outcome) with hazard ratio (95% confidence interval) of 1.07 (0.68 to 1.70) for fluticasone versus placebo. There was no effect of age, atopy, corticosteroid dose, FEV 1 , or Pseudomonas aeruginosa status. There was no change in lung function or differences in antibiotic or rescue bronchodilator use. Fewer patients in the fluticasone group withdrew from the study due to lung-related adverse events (9 vs. 15%); with a relative risk (95% confidence interval) of 0.59 (0.23-1.48) fluticasone versus placebo. Conclusions:In this study population (applicable to 40% of patients with cystic fibrosis in the UK), it appears safe to consider stopping inhaled corticosteroids. Potential advantages will be to reduce the drug burden on patients, reduce adverse effects, and make financial savings.

The head-downwards tipped position for physiotherapy has been claimed to exacerbate gastro-oesophageal reflux (GOR) in infants with cystic fibrosis (CF). This was investigated using lower oesophageal pH monitoring during physiotherapy. Twenty-one infants (age range 1-27 months) with respiratory disorders (CF=11), undergoing lower oesophageal pH monitoring were recruited. Subjects received two physiotherapy episodes in random order, A/B or B/A, 12 h apart. A began the gravity-assisted positioning head downward tip for: right lower lobe, middle lobe, left lower lobe and lingula; then supine with no tip for anterior segments of the upper lobes followed by apical segments of upper lobes in a sitting position. B was in the reverse order. Intermittent chest clapping was carried out for 4 min in each position by a physiotherapist blinded to the pH data. During episode A, the median change in pH from baseline was -0.32 (range -2.07 to +1.0) in non-CF subjects (NS) and -0.52 (range -2.7 to +0.52) in CF subjects (p<0.02). During episode B, the median change in non-CF subjects was -0.1 (NS; range - 1.7 to -0.15) and in CF subjects was -0.05 (NS; range -0.67 to +0.5). There was no order effect for positioning. In the CF subjects the sitting position was twice as likely to have the lowest pH measurement during physiotherapy than the other positions (p<0.04). In conclusion, the head-downward tipped positioning for physiotherapy treatment neither induces nor aggravates gastro-oesophageal reflux. There is no justification for routinely changing the way in which infant physiotherapy is carried out.

High-frequency chest compressions (HFCC) have been suggested as an alternative to conventional chest physiotherapy to aid sputum clearance in patients with cystic fibrosis (CF). We aimed to compare the active cycle of breathing techniques (ACBT) with the Hayek Oscillator Cuirass, performing HFCC on secretion clearance in children with CF during an exacerbation. Ten children (7 males; median age, 14 years; range, 9-16) received either two supervised sessions using HFCC or two self-treatment ACBT sessions in random order on successive days. Baseline pulmonary function was similar prior to treatments. Sputum weight increased significantly with ACBT compared with HFCC during treatment (5.2 g vs. 1.1 g, P < 0.005, morning; 4.1 g vs. 0.7 g, P < 0.01, afternoon). Pulmonary function improved significantly after morning ACBT (forced vital capacity (FVC): 2.67 l to 2.76 l, P < 0.03; forced expiratory volume in 1 sec (FEV1): 1.59 l to 1.62 l, P < 0.03). Following afternoon ACBT, there was a significant increase in FVC (2.64 to 2.79, P < 0.02), but no significant change in FEV1. Pulmonary function did not change at any time following HFCC. Compared with ACBT, HFCC by Hayek Cuirass is not an effective airway clearance treatment modality for children with CF during an infective exacerbation.

Background Traditionally, acupuncturists manipulate needles to enhance sensations referred to as de qi or 'acupuncture needle sensation'. Acupuncture needle sensations are complex and quantifying the experience has been diffi cult. The aim of this crossover study was to measure self-reported needle sensation during deep and bi-directional rotated needling in 15 healthy volunteers. Methods Each participant received an experimental intervention consisting of superfi cial needling followed by deep needling and then deep needling with bi-directional rotation. The control intervention consisted of superfi cial needling, followed by mock deep needling and then mock bi-directional rotation of the needle. The intensity of overall needle sensation was measured using a visual analogue scale (VAS). The subjective acupuncture sensation scale was used to capture component sensations. Results VAS scores were higher during 'deep' needle penetration when compared to superfi cial needling with mock deep insertion (p=0.0002). VAS scores were also higher during deep needling with bi-directional rotation compared to superfi cial needling with mock bi-directional rotation (p<0.0001). There were higher scores for total component sensation scores and for the sensation of throbbing during the deep needling with bi-directional rotation (p=0.001) when compared to superfi cial needling with mock bi-directional rotation. Tentative evidence that bi-directional needle rotation generated stabbing, tingling, heaviness, soreness and aching was also found. Conclusion Bi-directional rotation of a needle inserted into deep soft tissue produced higher acupuncture needle sensation intensities when compared to superfi cial needle insertion with mock deep penetration and bi-directional rotation. INTRODUCTIONManual manipulation of acupuncture needles is commonly used in clinical practice to increase the intensity of stimulation in order to improve therapeutic effects. Manipulation techniques include deep insertion of needles into deep soft tissue and/ or bi-directional rotation of needles. The relationship between manual needle technique and acupuncture needle sensation is poorly understood. 1There is some evidence that deep needling may be more effective than superfi cial needling for shoulder and low back pain 2 3 although a randomised controlled clinical trial involving 1162 low back pain patients found that deep acupuncture generated only 'marginally' superior pain relief than superficial acupuncture. 4 Manual manipulation of acupuncture needles can evoke 'de qi' in patients. 5 De qi is a term derived from traditional Chinese medicine to describe sensations experienced by the patient as a direct result of needling and to describe 'needle grasp' where the acupuncturist feels resistance to movement of a needle that has been inserted through the patient's skin. 6 More recently, the term 'acupuncture needle sensation' has been used to describe sensations experienced by the patient local to the inserted needle. 7 It is claimed that acupuncture n...

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