Treating obstructive sleep apnea with hypoglossal nerve stimulation.

BACKGROUND: Reduced upper airway muscle activity during sleep is fundamental to obstructive sleep apnea (OSA) pathogenesis. Hypoglossal nerve stimulation (HGNS) counteracts this problem, with potential to reduce OSA severity. STUDY OBJECTIVES: To examine safety and efficacy of a novel HGNS system (HGNS, Apnex Medical, Inc.) in treating OSA. PARTICIPANTS: Twenty-one patients, 67% male, age (mean ± SD) 53.6 ± 9.2 years, with moderate to severe OSA and unable to tolerate continuous positive airway pressure (CPAP). DESIGN: Each participant underwent surgical implantation of the HGNS system in a prospective single-arm interventional trial. OSA severity was defined by apnea-hypopnea index (AHI) during in-laboratory polysomnography (PSG) at baseline and 3 and 6 months post-implant. Therapy compliance was assessed by nightly hours of use. Symptoms were assessed using the Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ), Calgary Sleep Apnea Quality of Life Index (SAQLI), and the Beck Depression Inventory (BDI). RESULTS: HGNS was used on 89% ± 15% of nights (n = 21). On these nights, it was used for 5.8 ± 1.6 h per night. Nineteen of 21 participants had baseline and 6-month PSGs. There was a significant improvement (all P < 0.05) from baseline to 6 months in: AHI (43.1 ± 17.5 to 19.5 ± 16.7), ESS (12.1 ± 4.7 to 8.1 ± 4.4), FOSQ (14.4 ± 2.0 to 16.7 ± 2.2), SAQLI (3.2 ± 1.0 to 4.9 ± 1.3), and BDI (15.8 ± 9.0 to 9.7 ± 7.6). Two serious device-related adverse events occurred: an infection requiring device removal and a stimulation lead cuff dislodgement requiring replacement. CONCLUSIONS: HGNS demonstrated favorable safety, efficacy, and compliance. Participants experienced a significant decrease in OSA severity and OSA-associated symptoms. CLINICAL TRIAL INFORMATION: NAME: Australian Clinical Study of the Apnex Medical HGNS System to Treat Obstructive Sleep Apnea. REGISTRATION NUMBER: NCT01186926. URL: http://clinicaltrials.gov/ct2/show/NCT01186926.

Oral ginseng formulae for stable chronic obstructive pulmonary disease: a systematic review.

Ginseng alone or combined with other herbs has been increasingly used for chronic obstructive pulmonary disease (COPD). This review aims to evaluate the effectiveness and safety of oral Ginseng formulae for stable COPD. Four English databases and three Chinese databases were searched to identify randomized controlled trials. Methodological quality was assessed by Cochrane risk of bias and Jadad's scale. Data were analyzed using Review Manager 5.0. Twelve studies overall of low quality, involving 1560 participants were included. Results of three studies showed a mean difference (MD) of 0.30 (95%CI 0.02 to 0.58) for forced expiratory volume in 1 s (FEV(1)) improvement of Ginseng formulae versus placebo control. Findings of three studies revealed an MD of 9.43 (95%CI 3.64 to 15.21) of FEV(1) % predicted between Ginseng formulae and placebo control. Quality of life (Qol) measured by St. George's Respiratory Questionnaire was improved (MD -10.32, 95%CI -14.99 to -5.65) with Ginseng formulae plus pharmacotherapy versus pharmacotherapy alone in one study. There were no severe adverse events reported. Ginseng formulae for stable COPD patients show promising evidence of lung functions and Qol improvement. However, the degree of benefit is uncertain due to potential risk of bias of the included studies.

A randomized controlled trial of the effectiveness of topical amethocaine in reducing pain during arterial puncture.

OBJECTIVE: To determine if topical 4% amethocaine gel can reduce the pain associated with arterial punctures. DESIGN: Randomized, placebo-controlled, double-blinded trial with parallel groups. SETTING: Teaching hospital. PATIENTS: Adults requiring arterial punctures for blood gas estimation as part of routine care. INTERVENTIONS: Four percent amethocaine gel applied for 30 min prior to the radial arterial puncture, compared with a placebo gel. MAIN OUTCOME MEASURES: Pain scored on a visual analog scale from 0 to 100, and heart rate during the procedure. RESULTS: The mean pain score for the amethocaine group was 16.0 (SD, 23.3) and for the placebo group was 20.7 (SD, 18.5). The mean heart rates during arterial puncture were 84.1 beats/min (SD, 10.7) for the amethocaine group, and 83.8 beats/min (SD, 12.7) for the placebo group. These differences were not statistically significant. CONCLUSION: The topical use of 4% amethocaine gel does not reduce the pain associated with arterial puncture.