The impact of study type and sleep measurement on oxygen desaturation index calculation.

STUDY OBJECTIVES: The oxygen desaturation index (ODI) is an important measure of sleep-disordered breathing during polysomnography (PSG); however, the AASM Manual (V3) does not specify whether to include oxygen desaturations occurring during wake epochs. Additionally, an ODI obtained from PSG can differ from an ODI using home sleep apnea tests (HSATs) that do not measure sleep, hampering diagnostic and treatment decision reliability. This study aimed to (1) compare an ODI that included all desaturations with an ODI that excluded desaturations occurring during wake epochs in PSG and (2) compare ODIs obtained from PSG with HSAT. METHODS: 100 consecutive PSGs for investigation of obstructive sleep apnea were compared. ODIs were calculated including all desaturations (ODIall) and by excluding desaturations entirely during wake epochs (ODIsleep). Additionally, we compared ODIall with an ODI calculated using monitoring time as the denominator (ODIHSAT). RESULTS: The median (interquartile range) 3% ODI for ODIall was 22.8 (13.1, 44.1) events/h and ODIsleep was 17.6 (11.5, 35.2) events/h (median difference: -3.9 events/h [-8.2, -0.9]; 21.0% [8.7%, 33.2%]). This discrepancy was larger with increasing ODI and decreasing sleep efficiency. The ODIHSAT was 17.4 (11.3, 35.2) events/h and the median reduction in ODIHSAT vs ODIall was -4.5 (-10.9, -2.0) events/h (21.6%; 11.1%, 33.8). CONCLUSIONS: ODI was significantly reduced when desaturations in wake epochs were excluded, and when ODI was based on monitoring time rather than sleep time, with the potential for underestimation of disease severity. Results suggest that ODI can differ substantially depending on the calculation and study type used, and that there is a need for standardization to ensure consistent diagnosis and treatment outcomes. CITATION: Whenn CB, Wilson DL, Ruehland WR, Churchward TJ, Worsnop C, Tolson J. The impact of study type and sleep measurement on oxygen desaturation index calculation. J Clin Sleep Med. 2024;20(5):709-717.

Orally administered Chinese herbal therapy to assist post-surgical recovery for chronic rhinosinusitis-A systematic review and meta-analysis.

This systematic review and meta-analysis aims to: assess the effectiveness and safety of orally administered Chinese herbal medicines (CHMs) as adjuncts to the post-surgical management of chronic rhinosinusitis (CRS); inform clinicians of the current evidence; identify the best available evidence; and suggest directions for further research. Randomised controlled trials (RCTs) were identified from searches of nine databases plus clinical trial registries. Participants were adults and/or children diagnosed with sinusitis or rhinosinusitis, with or without nasal polyps, who had received surgery. Interventions were CHMs used orally following surgery for CRS as additions to conventional post-surgical management. Controls received conventional post-surgical management without CHMs. Studies reported results for Sino-Nasal Outcome Test (SNOT), visual analogue scales (VAS), Lund-Mackay computed tomography score (LM), Lund-Kennedy endoscopic score (LK), mucociliary transport time (MTT), mucociliary transport rate (MTR), mucociliary clearance (MC) or quality of life (QoL). Twenty-one RCTs were included. All used oral CHMs following functional endoscopic sinus surgery (FESS). The pooled results showed no significant difference between groups for SNOT-20 at the end of treatment (EoT) but there was a significant difference at follow up (FU) in favour of additional CHMs. The VAS for total nasal symptoms (VAS-TNS) showed greater improvements in the CHM groups at EoT and FU. Only FU data were reported for LM which showed greater improvement in the CHM groups. LK showed greater improvements at EoT and FU. The measures of mucociliary transport (MTT, MTR, and MC) each showed significantly greater improvement at EoT in the group that received additional CHMs. No study reported QoL. Adverse events were not serious, but reporting was incomplete. The meta-analyses suggested the addition of oral CHMs to conventional management following FESS may improve recovery. However, most studies were not blinded, and substantial heterogeneity was evident in some meta-analyses. Blinded studies are required to further investigate the roles of oral CHMs in post-surgical recovery. Systematic review registration number: The protocol was registered in PROSPERO (CRD42019119586).

Muscle energy technique for chronic obstructive pulmonary disease: A feasibility study.

OBJECTIVE: This study aimed to investigate the feasibility of implementing a manual therapy technique (muscle energy technique, MET) protocol in a hospital pulmonary rehabilitation (PR) program for patients with moderate to severe chronic obstructive pulmonary disease (COPD). Please cite this article as: Baxter DA, Coyle ME, Hill CJ, Worsnop C, Shergis JL. Muscle energy technique for chronic obstructive pulmonary disease: A feasibility study. J Integr Med. 2023; 21(3): 245-253. METHODS: Participants aged 40 years and over, with moderate to severe COPD, were recruited into this 12-week study. The primary outcome measures were feasibility (acceptability of the intervention and attendance/adherence to the trial) and safety (adverse events, AEs). All participants received the MET and PR therapies. Participants and assessors were unblinded. Semi-standardized MET was delivered on 6 occasions (a maximum of once per week) at the hospital directly before a PR session. Participants undertook PR sessions as per the hospital program at a frequency of two days per week for 8 weeks. Participants were contacted 4 weeks after their final MET treatment via a telephone call to assess acceptability of the intervention. RESULTS: Thirty-three participants were enrolled, with a median age of 74 years (range 45-89 years). The median number of MET sessions that participants attended was 5 (range 0-6) out of a possible 6 sessions (83% attendance). At follow-up, participants overwhelmingly enjoyed the MET treatment with some subjectively reporting improved breathing. There were no major AEs related to the intervention, with the majority of AEs classified as expected events related to COPD exacerbations. CONCLUSION: It is feasible to implement a manual therapy protocol using MET as an adjunct to PR in a hospital setting. Recruitment rates were satisfactory and there were no AEs related to the MET component of the intervention.

Chinese herbal therapy in the management of rhinosinusitis-A systematic review and meta-analysis.

This systematic review aims to assess the effects and safety of Chinese herbal medicines (CHMs) in the management of rhinosinusitis (RS); inform clinicians of the current state of the evidence; identify the best available evidence; and suggest further directions for research. Five English and four Chinese language databases, and four clinical trial registries were searched. Eligible studies were randomised controlled trials (RCTs). Participants were diagnosed with RS based on established criteria. Test interventions were CHMs administered orally and/or nasally, excluding injections and displacement techniques. Control interventions included placebos, no additional treatment, and conventional non-invasive treatments including pharmacotherapies and/or nasal irrigation, and/or inhalations. Polyposis and post-surgical recovery were excluded. Outcomes were Sino-Nasal Outcome Test (SNOT), visual analogue scales (VAS), Lund-Mackay computed tomography score (LM), Lund-Kennedy Endoscopic score (LK), Mucociliary transport time (MTT), Mucociliary transport rate (MTR), quality of life and adverse events (AEs). Risk of bias used the Cochrane tool. Meta-analysis in Review Manager 5.4.1 used random effects for mean difference (MD) or risk ratio (RR) with 95% confidence intervals. Heterogeneity was assessed as I2. Thirty-four RCTs were included, 30 of chronic RS (CRS) and four of acute RS (ARS). These enrolled 3,752 participants. Five RCTs blinded participants. For CRS, comparisons with placebo showed greater improvements in the CHM groups for SNOT-20 and VAS-TNS (total nasal symptoms). Blinded comparisons with pharmacotherapies showed no differences between groups in the degree of improvement for SNOT-20, VAS-TNS, and LM, suggesting these CHMs had similar effects, at least in the short term. In ARS, pooled results found improved scores on VAS-TNS and LK suggesting a benefit for combining these CHMs with pharmacotherapies. Limitations included inadequacies in study design and methodological reporting, and insufficient reporting of AEs. Heterogeneity in some pooled results precluded strong conclusions. Further well-designed studies are needed to test whether the results are replicable. Systematic review registration number: PROSPERO (CRD42019119586).

Filters Alter the Performance of Noninvasive Ventilators.

BACKGROUND: Noninvasive ventilation is recommended in hypercapnic respiratory failure secondary to ventilatory failure. Noninvasive ventilation may contribute to aerosol dispersion, which may increase the risk of transmission of COVID 2019. The addition of filters to the ventilator circuit has been recommended to reduce this risk. The aim of this benchtop study was to investigate the impact of adding filters to a ventilator circuit. METHODS: In this benchtop study, a breathing simulator was used with 4 commonly used ventilators. Ventilators were set to approximate the typical settings that are used for patients on long-term noninvasive ventilation. Ventilator performance was then evaluated with 3 circuit configurations in place: circuit A: no filter in situ; circuit B: 1 filter at the simulator end of the circuit; and circuit C: 1 filter at the simulator end of the circuit and a second filter at the ventilator end of the circuit. RESULTS: Ventilator variables were impacted by the addition of filters. Measurements of peak pressure (P < .001), tidal volume (P < .001), and peak flow (P < .001) decreased between circuit A and circuit C in all ventilators that were tested. Ventilator triggering was less sensitive in 3 of the 4 ventilators and the fourth ventilator did not trigger under the same simulator settings. CONCLUSIONS: This study demonstrated that ventilator settings established with filters in situ are not applicable if the ventilator is used without the filters. This is an important clinical consideration for patients who are hospitalized and require noninvasive ventilation in the COVID 2019 era.

Thunderstorm asthma in seasonal allergic rhinitis: The TAISAR study.

BACKGROUND: Asthma epidemics associated with thunderstorms have had catastrophic effects on individuals and emergency services. Seasonal allergic rhinitis (SAR) is present in the vast majority of people who develop thunderstorm asthma (TA), but there is little evidence regarding risk factors for TA among the SAR population. OBJECTIVE: We sought to identify risk factors for a history of TA and hospital presentation in a cohort of individuals with SAR. METHODS: This multicenter study recruited adults from Melbourne, Australia, with a past diagnosis of TA and/or self-reported SAR. Clinical information, spirometry results, white blood cell count, ryegrass pollen-specific (RGP-sp) IgE concentration, and fractional exhaled nitric oxide were measured to identify risk factors for a history of TA in individuals with SAR. RESULTS: From a total of 228 individuals with SAR, 35% (80 of 228) reported SAR only (the I-SAR group), 37% (84 of 228) reported TA symptoms but had not attended hospital for treatment (the O-TA group), and 28% (64 of 228) had presented to the hospital for TA (the H-TA group). All patients in the H-TA group reported a previous asthma diagnosis. Logistic regression analysis of factors associated with O-TA and H-TA indicated that lower FEV1 value and an Asthma Control Questionnaire score higher than 1.5 were associated with H-TA. Higher blood RGP-sp IgE concentration, eosinophil counts, and fractional exhaled nitric oxide level were significantly associated with both O-TA and H-TA. Receiver operating curve analysis showed an RGP-sp IgE concentration higher than 10.1 kU/L and a prebronchodilator FEV1 value of 90% or lower to be biomarkers of increased H-TA risk. CONCLUSION: Clinical tests can identify risk of a history of TA in individuals with SAR and thereby inform patient-specific treatment recommendations.

Perceptions and experiences of a manual therapy trial: a qualitative study of people with moderate to severe COPD.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) presents with physical, emotional and social difficulties that affect quality of life. Multimodal management includes both pharmacological and non-pharmacological strategies, and pulmonary rehabilitation (PR) plays an important role. Recent research has suggested that manual therapies may improve perceptions of dyspnea for people with COPD. METHODS: Focus group interviews were conducted as part of a mixed methods study to assess the feasibility of implementing a manual therapy technique-muscle energy technique (MET)-as an adjunct to PR for people with moderate to severe COPD. Focus group interviews were conducted to examine trial participants views of the intervention and the trial design. A thematic analysis was undertaken to explore the data. RESULTS: Twelve participants with moderate to severe COPD participated in three focus groups. Participants were motivated to participate in the trial to be proactive about their health. They perceived MET to be a gentle, comfortable form of stretching that allowed them to 'breathe easier' and prepared them for PR. A small number of participants reported mild muscular discomfort during MET, but this was short-lasting and was not bothersome. Participants enjoyed the one-on-one contact with researchers and learned more about their breathing while performing spirometric testing. Most participants wanted longer and more frequent MET sessions, and some requested 'homework' stretching exercises. CONCLUSIONS: The findings of this study show that a manual therapy intervention was received well by participants in a clinical trial setting. A small number of participants reported mild musculoskeletal discomfort in relation to the MET treatment. Participant preferences for additional and longer treatment sessions should be carefully considered against available resources in future clinical trials. TRIAL REGISTRATION: ANZCTR, ACTRN12618000801213. Registered 11 May 2018 - Retrospectively registered. http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374643&isReview=true.

Asthma self-management with regular support reduces health care use and improves QoL at 8 mo.

SOURCE CITATION: Hodkinson A, Bower P, Grigoroglou C, et al. Self-management interventions to reduce healthcare use and improve quality of life among patients with asthma: systematic review and network meta-analysis. BMJ. 2020;370:m2521. 32816816.

Effect of Panax Ginseng (G115) Capsules versus Placebo on Acute Exacerbations in Patients with Moderate to Very Severe COPD: A Randomized Controlled Trial.

Purpose: Herbal medicines are commonly used by people with chronic obstructive pulmonary disease (COPD) but high quality randomized controlled trials are limited. This study evaluated the therapeutic value of ginseng capsules in reducing acute exacerbations and improving the quality of life in people with COPD. Patients and Methods: This randomized, double-blind and placebo-controlled trial assessed ginseng's effects on 200 patients with moderate to very severe COPD. Ginseng capsules (200 mg, twice per day) were compared to placebo over 24 weeks. Patients were followed up for a further 24 weeks after the treatment period. The primary outcome measure was acute COPD exacerbation rate over 12 months. Secondary outcome measures were health-related quality of life, including the St George's Respiratory Questionnaire (SGRQ), COPD Assessment Test (CAT) and the Short Form 36 Health Survey (SF-36). We also assessed lung function, walking distance and use of relief medication. Results: Baseline characteristics were balanced between groups. The rate of COPD exacerbations was not statistically significant between groups after 1 year (62 participants in the ginseng group and 63 in the placebo group). Secondary outcome measures showed improvements after ginseng and placebo but results were not clinically significant. The incidence of adverse events in the two groups was similar and events were unrelated to the intervention. Conclusion: Compared with placebo, ginseng did not reduce the rate of acute COPD exacerbations over 12 months. It was safe and well tolerated by people with moderate to very severe COPD.

Hospitalised exacerbations of chronic obstructive pulmonary disease: adherence to guideline recommendations in an Australian teaching hospital.

BACKGROUND: Optimal management of exacerbations of chronic obstructive pulmonary disease (COPD) reduces patient morbidity and healthcare system burden. COPD guidelines, including the Global Initiative for Chronic Obstructive Lung Disease (GOLD) and the COPD-X Plan, provide evidence-based recommendations, but adherence in hospital practice is variable. AIMS: To examine current practice in management of COPD exacerbations at an Australian teaching hospital and to compare with COPD-X Plan recommendations. METHODS: Data were collected retrospectively from electronic medical records for admissions occurring during 1 May to 31 August 2016, and compared with recommendations from the COPD-X Plan. RESULTS: A total of 134 patients (n = 68 females) was admitted for a COPD exacerbation during the study period. Mean age was 75.4 ± 10.2 years and 33.6% were current smokers. Airflow obstruction on spirometry was confirmed in 67.2% (mean forced expiratory volume in 1 s was 53 ± 22% predicted (1.2 ± 0.5 L)). Excellent adherence to the COPD-X Plan was demonstrated in the ordering of chest radiographs (97%) and electrocardiograms (94%). Supplemental oxygen was appropriately provided to all patients with oxygen saturation of <88%. All patients with confirmed hypercapnic respiratory failure were managed with non-invasive ventilation. Corticosteroids and bronchodilators were prescribed for the majority of patients. Areas of suboptimal practice included inadequate usage of arterial blood gases, excess supplemental oxygen in the absence of hypoxaemia, over-prescription of intravenous antimicrobials, low referral rates to pulmonary rehabilitation and insufficient smoking cessation counselling. CONCLUSIONS: Level of adherence to guideline recommendations in the management of COPD exacerbations is inadequate and further strategies are required to elevate standards of practice.

Asymptomatic Carotid Stenosis Is Associated With Circadian and Other Variability in Embolus Detection.

Background and Purpose: Variability in transcranial Doppler (TCD) detection of embolic signals (ES) is important for risk stratification. We tested the effect of time of day on ES associated with 60-99% asymptomatic carotid stenosis. Materials and Methods: Subjects were from the Asymptomatic Carotid Stenosis Embolus Detection (ASED) Study such that half were previously ES-positive and half ES-negative with 6-monthly 60-min TCD monitoring. All underwent bilateral TCD monitoring for two 12-h sessions separated by 24 h. ES detection rates were calculated using 6 and 4-h intervals from midnight and effective TCD monitoring time. Results: Ten subjects (8 male, mean age 79.5 years) were monitored. Over 24 h, 5/10 study arteries with 60-99% asymptomatic carotid stenosis were ES-positive (range 1-28 ES/artery, 56 total ES from 177.9 total effective monitoring hours). The remaining five study arteries and all eight successfully monitored contralateral arteries were ES-negative. Using 6-h intervals the mean ES detection rate peaked at 0600-midday (0.64/h) and was lowest 1800-midnight (0.09/h) with an incidence rate ratio of 7.26 (95% CI 2.52-28.64, P ≤ 0.001). Using 4-h intervals the mean ES detection rate peaked at 0800-midday (0.64/h) and was lowest midnight-0400 (0.12/h) with an incidence rate ratio of 5.51 (95% CI 1.78-22.67, P = 0.001). Conclusions: Embolism associated with asymptomatic carotid stenosis shows circadian variation with highest rates 4-6 h before midday. This corresponds with peak circadian incidence of stroke and other vascular complications. These and ASED Study results show that monitoring frequency, duration, and time of day are important in ES detection.

12-month randomised controlled trial of ginseng extract for moderate COPD.

BACKGROUND: Panax ginseng (ginseng) is a therapeutic herb which might be beneficial in COPD. The study investigated if ginseng, compared with placebo, is effective and safe for people with moderate COPD. METHODS: This multicentre, randomised, double-blind, placebo-controlled trial compared 24 weeks of ginseng capsules (100 mg twice daily) with placebo. Participants were followed up for a further 24 weeks. Participants were aged 40 years and over and had airflow limitation in the moderate (Global Initiative for Chronic Obstructive Lung Disease 2) COPD range. The coprimary endpoints were the St George's Respiratory Questionnaire, the COPD Assessment Test and the Short Form Health Survey. Secondary outcomes included lung function, exacerbation rate and use of relief medication. FINDINGS: 168 participants were randomised 1:1 from five centres in Australia and China. Baseline characteristics were balanced between groups. There were no significant differences between ginseng and placebo, with overall results improving in both groups. Ginseng seemed safe for, and well tolerated by, people with COPD. INTERPRETATION: There was no significant difference in improvement in health-related quality of life (primary outcome) between the ginseng and placebo groups. TRIAL REGISTRATION NUMBER: ACTRN12610000768099.

Accuracy of Patient Perception of Supine Sleep.

STUDY OBJECTIVES: For clinicians involved in investigating and treating sleep disorders, understanding the accuracy of patient recall of supine sleep would allow informed comparisons between polysomnography (PSG) and patient-reported sleep in patients with supine-predominant obstructive sleep apnea. This study aims to assess the accuracy of patient perception of supine sleep. METHODS: Prospective observational cohort study, assessing patient perception of total sleep and supine sleep, including duration. Data were analyzed utilizing descriptive statistics, bias-plot (Bland-Altman) analysis, and Spearman correlation (rs) to analyze relationships among continuous data. RESULTS: Total number of patients who underwent PSG was 518, with data from 368 of these patients analyzed. Most of these patients underwent diagnostic PSG (49.2%). Patients were excluded because of missing or incomplete data (n = 133) or immobility (n = 17). Some patients (n = 97, 26%) did not perceive supine sleep, with 34 (35% of those with unperceived supine sleep or 9% of whole group) of these having more than 60 minutes of PSG supine sleep (range 0-305.5 minutes). All "unsure" patients (n = 8, 2.2%) had significant supine sleep recorded (31.5-257.5 minutes). For the presence of any PSG supine sleep, questioning had a sensitivity of 77.9%, specificity 72.7% with positive predictive value of 96.7% and negative predictive value of 24.5%. There was a significant correlation (rs = 0.63, P < .0001) between perceived and PSG supine sleep, but wide limits of agreement (-246.9 to 194.2 minutes). CONCLUSIONS: In patients undergoing in-laboratory PSG, the perception of supine sleep predicts the presence of PSG supine sleep. However, questioning patients has a poor negative predictive value and patient estimates of supine sleep duration are inaccurate.

An Ambulatory Polysomnography Study of the Post-traumatic Nightmares of Post-traumatic Stress Disorder.

Study Objectives: This study used ambulatory polysomnography (PSG) to investigate post-traumatic nightmares of post-traumatic stress disorder (PTSD). The key research question was whether post-traumatic nightmares occur in both rapid eye movement (REM) and non-REM sleep, and if so, whether nightmares in each sleep stage differed in content, phenomenology, and heart rate response. Underlying sleep disorders were investigated in an exploratory way. Methods: Thirty-five treatment-seeking veterans, current serving military members, and emergency service personnel undertook full PSG using the Compumedics (Melbourne, Australia) SomtePSG V1 system, during an inpatient psychiatric admission. The PSG recording included an event button to be pressed when a nightmare occurred, allowing us to determine the stage of sleep, changes in heart rate, and associated sleep events. The content and phenomenological features of participants' nightmares were recorded. Results: Of the 35 participants, 29 reported a nightmare during their sleep study, but only 21 pressed the event button and could recall the content of one or more nightmare. This yielded sleep and nightmare data for 24 nightmares. Of the 24, 10 nightmares arose from REM sleep and 14 from non-REM (stages N1 and N2). Seven were accurate trauma replays and 17 were non-replay or a mixture of replay and non-replay. Most nightmares were associated with respiratory or leg movement events and increase in heart rate on awakening. Conclusions: Post-traumatic nightmares of PTSD occur in both REM and non-REM sleep and are commonly associated with other sleep disturbances. These findings have important treatment implications.

Panax ginseng therapy for chronic obstructive pulmonary disease: a clinical trial protocol and pilot study.

BACKGROUND: Panax ginseng (Ren shen) has been used to treat chronic obstructive pulmonary disease (COPD). This article aims to present a study protocol and pilot trial comparing P. ginseng with placebo for treating moderate to very severe COPD. METHODS: COPD was diagnosed spirometrically, with participants having a forced expiratory volume in one second (FEV1) of between 20% and 79% and FEV1 to forced vital capacity (FVC) ratio of less than 70%. Outcome measures included exacerbation rate, St. Georges Respiratory Questionnaire, COPD Assessment Test and Short-form Health Survey (SF-36). Other outcome measures included the six-minute walk test, FEV1, FVC, relief medication use, use of COPD-specific medical resources, and adverse events. The study is a randomized, double-blind, placebo controlled clinical trial. The method of this pilot trial was based on a planned full-scale trial except that participants were enrolled for ten weeks compared to 52 weeks. In the pilot trial, 14 participants (57-73 years old) with moderate to very severe COPD were recruited from a community health program at a public Chinese medicine hospital in Guangdong Province, China. After a 2-week run-in period, 10 participants were eligible for the study and were randomly assigned to either P. ginseng group (n = 5) (200 mg twice daily for four weeks) or placebo group (n = 5), and then followed-up for an additional 4 weeks for a total of 10 weeks. RESULTS: Nine participants completed the trial and one dropped out. The exacerbation rate could not be evaluated because there were no exacerbations. One participant in P. ginseng group reported events of sore throat, cough and fever. Trial investigators did not consider these events as COPD exacerbations or adverse events. CONCLUSIONS: Participant recruitment, study design, data collection and outcome measurement have been tested in a pilot trial. A full-scale trial is warranted.

A meta-analysis of ear-acupuncture, ear-acupressure and auriculotherapy for cigarette smoking cessation.

BACKGROUND: This systematic review evaluated the effects of ear acupuncture, ear acupressure and auriculotherapy for cigarette smoking cessation (SC) at end-of-treatment (EoT), three, six and 12 months follow-up. METHODS: Searches of six English and Chinese databases located 25 randomized controlled trials (3735 participants). Methodological quality was assessed using Cochrane Risk of Bias. Meta-analyses were conducted in two pools: 1. SC-specific ear acupuncture/acupressure or auriculotherapy (EAP/R) vs. non-specific/inactive control; and 2. SC-specific EAP/R vs. other SC-specific treatment. Sensitivity analyses were conducted based on the validity of interventions as SC-specific treatments or non-specific/inactive interventions; and the use of biochemical SC confirmation. RESULTS: Pool 1: the 12 valid SC-specific EAP/R interventions were superior to inactive EAP/R controls at EoT (RR=1.77 [1.39, 2.25]), three months follow-up (RR=1.54 [1.14, 2.08]), and six months follow-up (RR=2.01, [1.23, 3.28]) but data were insufficient at 12 months. In Pool 2: there was no superiority or inferiority for EAP/R at EoT or at 3 and 6 month follow-ups compared to SC-specific behavioural therapy or SC-specific body acupuncture. CONCLUSIONS: Pool 1 data appeared most consistent for studies of ear acupressure (EAPR) vs. non-specific EAPR controls, with confirmed SC rates at 3 months post-treatment of 20.0% for test groups vs. 7.5% for controls. In Pool 2 the EAP/R interventions appeared neither inferior nor superior to the behavioural interventions at 3 and 6 month follow-ups. However, meta-analysis results derived from relatively small-sized trials with no biochemical validation of SC in Pool 2. Larger, well-controlled studies using biochemical confirmation of SC are needed.