scholarly journals Long-term benefits of airway clearance in bronchiectasis: a randomised placebo-controlled trial

2018 ◽  
Vol 51 (1) ◽  
pp. 1701926 ◽  
Author(s):  
Gerard Muñoz ◽  
Javier de Gracia ◽  
Maria Buxó ◽  
Antonio Alvarez ◽  
Montserrat Vendrell
Keyword(s):  
Quality Of Life ◽  
Placebo Group ◽  
Controlled Trial ◽  
Airway Clearance ◽  
Questionnaire Score ◽  
Sputum Volume ◽  
St George's Respiratory Questionnaire ◽  
Clinically Significant ◽  
Lateral Posture

Keeping airways clear of mucus by airway clearance techniques seems essential in bronchiectasis treatment, although no placebo-controlled trials or any studies lasting longer than 3 months have been conducted. We evaluate the efficacy of the ELTGOL (slow expiration with the glottis opened in the lateral posture) technique over a 1-year period in bronchiectasis patients with chronic expectoration in a randomised placebo-controlled trial.Patients were randomised to perform the ELTGOL technique (n=22) or placebo exercises (n=22) twice-daily (ClinicalTrials.gov,NCT01578681). The primary outcome was sputum volume during the first intervention and 24 h later. Secondary outcomes included sputum volume during the intervention and 24 h later at month 12, exacerbations, quality of life, sputum analyses, pulmonary function, exercise capacity, systemic inflammation, treatment adherence, and side effects.Sputum volume during intervention and 24 h later was higher in the ELTGOL group than in the placebo group both at the beginning and end of the study. Patients in the ELTGOL group had fewer exacerbations (p=0.042) and a clinically significant improvement in the St George's Respiratory Questionnaire score (p<0.001) and the Leicester Cough Questionnaire score compared with the placebo group (p<0.001).Twice-daily ELTGOL technique over 1 year in bronchiectasis patients facilitated secretion removal and was associated with fewer exacerbations, improved quality of life, and reduced cough impact.

scholarly journals Estimating the minimum important difference in the DEMQOL instrument in people with dementia

2021 ◽  
Author(s):  
Ellen C. Lee ◽  
Jessica Wright ◽  
Stephen J. Walters ◽  
Cindy L. Cooper ◽  
Gail A. Mountain
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Minimum Important Difference ◽  
Absolute Change ◽  
People With Dementia ◽  
Related Quality ◽  
Registration Number ◽  
Clinically Significant ◽  
Randomised Controlled

Abstract Purpose The Dementia-Related Quality of Life (DEMQOL) measure and the DEMQOL-Utility Score (DEMQOL-U) are validated tools for measuring quality of life (QOL) in people with dementia. What score changes translate to a clinically significant impact on patients’ lives was unknown. This study establishes the minimal important differences (MID) for these two instruments. Methods Anchor-based and distribution-based methods were used to estimate the MID scores from patients enrolled in a randomised controlled trial. For the anchor-based method, the global QOL (Q29) item from the DEMQOL was chosen as the anchor for DEMQOL and both Q29 and EQ-5D for DEMQOL-U. A one category difference in Q29, and a 0.07 point difference in EQ-5D score, were used to classify improvement and deterioration, and the MID scores were calculated for each category. These results were compared with scores obtained by the distribution-based methods. Results A total of 490 people with dementia had baseline DEMQOL data, of these 386 had 8-month data, and 344 had 12-month DEMQOL data. The absolute change in DEMQOL for a combined 1-point increase or decrease in the Q29 anchor was 5.2 at 8 months and 6.0 at 12 months. For the DEMQOL-U, the average absolute change at 8 and 12 months was 0.032 and 0.046 for the Q29 anchor and 0.020 and 0.024 for EQ-5D anchor. Conclusion We present MID scores for the DEMQOL and DEMQOL-U instruments obtained from a large cohort of patients with dementia. An anchored-based estimate of the MID for the DEMQOL is around 5 to 6 points; and 0.02 to 0.05 points for the DEMQOL-U. The results of this study can guide clinicians and researchers in the interpretation of these instruments comparisons between groups or within groups of people with dementia. Trial Registration Number and date of registration: ISRCTN17993825 on 11th October 2016.

Comparison of the effects of Buteyko and pranayama breathing techniques on quality of life in patients with asthma – a randomized controlled trial

2012 ◽  
Vol 27 (2) ◽  
pp. 133-141 ◽  
Author(s):  
Venkatesan Prem ◽  
Ramesh Chandra Sahoo ◽  
Prabha Adhikari
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Control Group ◽  
Life Questionnaire ◽  
Control Groups ◽  
Quality Of Life Questionnaire ◽  
Randomized Controlled ◽  
Questionnaire Score ◽  
And Control

Objective: To compare two breathing exercises (Buteyko and pranayama) with a control group in patients with asthma. Design: Randomized controlled trial. Subjects: One hundred and twenty subjects were randomized to three groups through block randomization. Subjects with an Asthma Quality of Life Questionnaire score <5.5 participated in the study. Setting: Outpatient pulmonary medicine department. Interventions: Subjects in the Buteyko and pranayama groups were trained for 3–5 days and instructed to practise the exercises for 15 minutes twice daily, and for three months duration. The control group underwent routine pharmacological management during the study period. Outcome measures: Asthma Quality of Life Questionnaire, Asthma Control Questionnaire and pulmonary function test. Results: The baseline characteristics were similar in all three groups. Post intervention, the Buteyko group showed better trends of improvement (mean (95% confidence interval), P-value) in total Asthma Quality of Life Questionnaire score than the pranayama (0.47 (–0.008–0.95), P = 0.056) and control groups (0.97 (0.48–1.46), P = 0.0001). In comparison between the pranayama and control groups, pranayama showed significant improvement (0.50 (0.01–0.98), P = 0.042) in total Asthma Quality of Life Questionnaire score. Conclusion: The Buteyko group showed better trends of improvement in quality of life and asthma control than the group performing the pranayama breathing exercise.

The Effect of Aromatherapy on Sleep and Quality of Life in Menopausal Women with Sleeping Problems: A Non-Randomized, Placebo-Controlled Trial

2020 ◽  
Vol 27 (6) ◽  
pp. 421-430
Author(s):  
Meryem Gürler ◽  
Aynur Kızılırmak ◽  
Mürüvvet Baser
Keyword(s):  
Quality Of Life ◽  
Placebo Group ◽  
Sleep Quality ◽  
Controlled Trial ◽  
Intervention Group ◽  
Placebo Control ◽  
Life Questionnaire ◽  
Menopausal Women ◽  
Sleeping Problems

<b><i>Introduction:</i></b> Menopause is the termination of menstruation and fertility. Women commonly experience sleeping problems during the menopausal period. Aromatherapy is among the complementary therapies used to remedy sleeping problems. <b><i>Methods:</i></b>This study aims to investigate the effects of lavender oil on sleep and quality of life of menopausal women through steam inhalation. This study was quasi-experimental with pre-test/post-test placebo control groups. It was conducted with 57 women, 27 of whom were subject to aromatherapy and 30 to a placebo. Data were collected using the Questionnaire Form, the Pittsburgh Sleep Quality Index (PSQI) and the Menopause-Specific Quality of Life Questionnaire (MENQOL). <b><i>Results:</i></b> For the intervention group, the PSQI median scores after the administration of aromatherapy were found to be significantly lower than those before the administration (<i>p</i> &#x3c; 0.001) and those of the placebo group (<i>p</i> &#x3c; 0.001). Similarly, for the intervention group, the total median MENQOL scores after the administration of the aromatherapy were found to be significantly lower than the scores prior to the administration (<i>p</i> &#x3c; 0.001) as well as the scores of the placebo group (<i>p</i> &#x3c; 0.001). <b><i>Conclusion:</i></b> It was found that aromatherapy involving lavender-scented steam inhalation increased sleep quality and quality of life in women with sleep deprivation problems during menopause.

scholarly journals Cannabis is associated with clinical but not endoscopic remission in ulcerative colitis: A randomized controlled trial

PLoS ONE ◽  
2021 ◽  
Vol 16 (2) ◽  
pp. e0246871
Author(s):  
Timna Naftali ◽  
Lihi Bar-Lev Schleider ◽  
Fabiana Scklerovsky Benjaminov ◽  
Fred Meir Konikoff ◽  
Shelly Tartakover Matalon ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Ulcerative Colitis ◽  
Placebo Group ◽  
Activity Index ◽  
Controlled Trial ◽  
Clinical Effects ◽  
Short Term Treatment ◽  
Double Blind ◽  
Endoscopic Score

Background Cannabis is often used by patients with ulcerative colitis, but controlled studies are few. We aimed to assess the effect of cannabis in improving clinical and inflammatory outcomes in ulcerative colitis patients. Methods In a double-blind, randomized, placebo-controlled trial, patients received either cigarettes containing 0.5 g of dried cannabis flowers with80mgTetrahydrocannabinol (THC)or placebo cigarettes for 8 weeks. Parameters of disease including Lichtiger disease activity index, C reactive protein (CRP), calprotectin, Mayo endoscopic score and quality of life (QOL) were assessed before, during and after treatment. Results The study included 32 patients. Mean age was 30 years, 14 (43%) females. Lichtiger index improved in the cannabis group from 10.9 (IQR 9–14) to5 (IQR 1–7), (p<0.000), and in the placebo group from 11 (IQR 9–13) to 8 (IQR 7–10)(p = 0.15, p between groups 0.001). QOL improved in the cannabis group from 77±4 to 98±20 (p = 0.000) but not in the placebo group (78±3 at week 0 and 78±17 at week 8;p = 0.459; p between groups 0.007). Mayo endoscopic score changed in the cannabis group from 2.13±1 to 1.25±2 (p = 0.015) and in the placebo group from 2.15±1to 1.69±1 (p = 0.367, p between groups 0.17). Conclusion Short term treatment with THC rich cannabis induced clinical remission and improved quality of life in patients with mild to moderately active ulcerative colitis. However, these beneficial clinical effects were not associated with significant anti-inflammatory improvement in the Mayo endoscopic score or laboratory markers for inflammation.(clinicaltrials.gov NCT01040910).

scholarly journals Effectiveness of chest physiotherapy and pulmonary rehabilitation in patients with non-cystic fibrosis bronchiectasis: a narrative review

2020 ◽  
Vol 90 (1) ◽  
Author(s):  
Sara Annoni ◽  
Angela Bellofiore ◽  
Elena Repossini ◽  
Marta Lazzeri ◽  
Antonello Nicolini ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cystic Fibrosis ◽  
Pulmonary Rehabilitation ◽  
Hypertonic Solution ◽  
Exacerbation Rate ◽  
Airway Clearance ◽  
Fatigue Exercise ◽  
Sputum Volume

Respiratory physiotherapy and rehabilitation are important therapeutic options in non-cystic fibrosis bronchiectasis (NCFB). The aims of this review of clinical trials were to evaluate the safety and the effects on physiologic and clinical outcomes of airway clearance techniques (ACTs) and rehabilitation in NCFB patients, in comparison to usual care. The search was performed on March 2018 by using PubMed and PeDro databases. 33 studies were selected. The use of ACTs for NCFB were effective in increasing sputum volume although no benefit in quality of life (QoL) or pulmonary exacerbations were observed. There were no differences in effectiveness between the several techniques used. Humidification and saline inhalation were able to aid airway clearance. Hypertonic solution (HS) was more effective than isotonic solutions (IS) in improving expectoration and sputum viscosity. Pulmonary rehabilitation (PR) was found to be associated with short term benefits in exercise capacity, dyspnea and fatigue. Exercise training seems to improve quality of life and lower exacerbation rate, but long-term data are not available. Further studies are necessary to identify the most feasible long-term outcomes such as QoL and exacerbation rate.

Quality of life evaluation of the effect of decapeptyl compared with zoladex preradiotherapy: Final results of randomised controlled trial.

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 62-62
Author(s):  
Amit Bahl ◽  
Amarnath Challapalli ◽  
Rosemary Greenwood ◽  
Katrina Hurley ◽  
Rajendra Persad
Keyword(s):  
Quality Of Life ◽  
Treatment Time ◽  
Controlled Trial ◽  
Block Design ◽  
Analysis Of Covariance ◽  
Radical Radiotherapy ◽  
Time Points ◽  
Significant Difference ◽  
Clinically Significant

62 Background: Hormone therapy in combination with radiotherapy is a curative treatment option for prostate cancer (CaP). There is paucity of data regarding quality of life (QoL) evaluation of neoadjuvant Decapeptyl. We reported on the equivalence of cytoreductive efficacy of neoadjuvant Decapeptyl and Zoladex previously. Here we present the final QoL evaluation of the effect of Decapeptyl compared with Zoladex preradiotherapy. Methods: Seventy-one patients with localised CaP who have chosen radical radiotherapy had been randomised by stratified block design, toreceive either Decapeptyl (D: n = 37) or Zoladex (Z: n = 34) with bicalutamide cover. All the patients had subsequent radical radiotherapy and followed up as per departmental protocol. The effect of Decapeptyl and Zoladex on QoL was assessed using EQ5D, QLQ-PR25, QLQ-C30 questionnaires, which were completed at baseline, 6, 10 & 14 weeks after start of therapy. QoL scores were analysed as mean scores over the 4 treatment time points for all domains, controlling for baseline scores using Analysis of Covariance. Results: There was no clinically significant difference or trend towards worsening QoL with either Z or D in the global (EQ5D) and cancer-specific (QLQ-C30) domains. The cancer-specific (QLQ-C30) symptom score also showed no trend towards worsening QoL with either Z or D. Symptom scores in the QLQ-PR25 questionnaire did not show a significant difference between Z and D arms with the exception of hormone symptoms. The hormone symptoms showed an increasing trend over the 4 treatment time points, with those in the Z arm significantly (p = 0.02) more affected (3 points higher on average) than patients in the D arm, despite equivalence in cytoreductive effect and achieving castrate levels of testosterone. Conclusions: There were no clinically significant differences in QoL domains between Zoladex and Decapeptyl, apart from hormones symptoms which were worse with Zoladex. Further validation is required with affect on hormone symptoms as the primary outcome measure. To our knowledge this is the first reported prospective randomised data demonstrating the effect of Zoladex and Decapeptyl, on QoL in the neoadjuvant setting. Clinical trial information: EduraCT: 2008-007028-25.

scholarly journals Measuring airway clearance outcomes in bronchiectasis: a review

2020 ◽  
Vol 29 (156) ◽  
pp. 190161
Author(s):  
Lisa J. Franks ◽  
James R. Walsh ◽  
Kathleen Hall ◽  
Norman R. Morris
Keyword(s):  
Quality Of Life ◽  
Lung Function ◽  
Outcome Measures ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Airway Clearance ◽  
Patient Reported ◽  
Related Quality ◽  
Sputum Volume

While airway clearance techniques (ACTs) are recommended for individuals with bronchiectasis, many trials have demonstrated inconsistent benefits or failed to reach their primary outcome. This review determined the most common clinical and patient-reported outcome measures used to evaluate the efficacy of ACTs in bronchiectasis. A literature search of five databases using relevant keywords and filtering for studies published in English, up until the end of August 2019, was completed. Studies included randomised controlled trials, using crossover or any other trial design, and abstracts. Studies were included where the control was placebo, no intervention, standard care, usual care or an active comparator. Adults with bronchiectasis not related to cystic fibrosis were included. Extracted data comprised study authors, design, duration, intervention, outcome measures and results. The search identified 27 published studies and one abstract. The most common clinical outcome measures were sputum volume (n=23), lung function (n=17) and pulse oximetry (n=9). The most common patient-reported outcomes were health-related quality of life (measured with St George's Respiratory Questionnaire, n=4), cough-related quality of life (measured with Leicester Cough Questionnaire, n=4) and dyspnoea (measured with Borg/modified Borg scale, n=8). Sputum volume, lung function, dyspnoea and health- and cough-related quality of life appear to be the most common clinical and patient-reported measures of airway clearance treatment efficacy.

scholarly journals The Addition of Salmeterol 50 µg Bid to Anticholinergenic Treatment in Patients with COPD: A Randomized Placebo Controlled Trial

2002 ◽  
Vol 9 (3) ◽  
pp. 178-185 ◽  
Author(s):  
Kenneth R Chapman ◽  
Peter Arvidsson ◽  
AG Chuchalin ◽  
DP Dhillon ◽  
Peter Faurschou ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Placebo Group ◽  
Controlled Trial ◽  
Airflow Obstruction ◽  
Chronic Obstructive ◽  
Anticholinergic Medication ◽  
Anticholinergic Therapy ◽  
Symptom Scores ◽  
Baseline Levels

BACKGROUND: In the past, the role of long-acting beta2-agonists in chronic obstructive pulmonary disease (COPD) relative to other agents has been unclear.OBJECTIVES: To compare the effect of adding salmeterol (50 µg bid) or placebo to concurrent anticholinergic therapy on symptom scores, quality of life, prebronchodilator lung function and exacerbations in patients with moderately severe COPD.METHODS: This was a double-blind, randomized, parallel-group study in patients aged 40 years or older receiving anticholinergic medication. Patients were randomly assigned to treatment with placebo (n=207) or salmeterol (n=201) via a Diskus/Accuhaler inhaler for 24 weeks.RESULTS: The morning trough (prestudy drug) forced expiratory volume in 1 s (FEV1) increased significantly above baseline levels among the salmeterol-treated patients. Improvement in FEV1was greater in the salmeterol group than in the placebo group at four weeks (difference 0.06 L, P <0.005), eight weeks (0.06 L, P <0.005) and 16 weeks (0.05 L, P <0.05) after the start of treatment. There was a nonsignificant trend in favour of salmeterol after 24 weeks of treatment (P=0.198). Improvements in morning peak flow were significantly greater in the salmeterol group over 24 weeks (P <0.01). Although symptom scores were numerically higher in the salmeterol group than in the placebo group and there was less requirement for rescue bronchodilator use, these differences were not statistically significant. In the salmeterol group, fewer patients had exacerbations of COPD, and there was a trend toward an improved quality of life. The safety profile of the two groups was similar.CONCLUSIONS: Salmeterol has a beneficial effect when added to existing anticholinergic therapy in patients with COPD. The regular use of salmeterol for six months was not associated with worsening of the underlying airflow obstruction; rather, there was a tendency for the trough FEV1to improve above the baseline levels over the treatment period.

scholarly journals Improvement of sulphur mustard-induced chronic pruritus, quality of life and antioxidant status by curcumin: results of a randomised, double-blind, placebo-controlled trial

2011 ◽  
Vol 108 (7) ◽  
pp. 1272-1279 ◽  
Author(s):  
Yunes Panahi ◽  
Amirhossein Sahebkar ◽  
Mojtaba Amiri ◽  
Seyyed Masoud Davoudi ◽  
Fatemeh Beiraghdar ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Placebo Group ◽  
Substance P ◽  
Controlled Trial ◽  
Life Quality ◽  
Serum Concentrations ◽  
Double Blind ◽  
Sulphur Mustard ◽  
Chronic Pruritus

Skin is among the first and most heavily damaged organs upon sulphur mustard (SM) exposure. Pruritus is the most common chronic skin complication of SM, which adversely affects the quality of life (QoL). However, current therapies for the management of SM-induced pruritus are very limited and associated with side effects. The present trial investigated the efficacy of curcumin in the alleviation of SM-induced chronic pruritic symptoms. A total of ninety-six male Iranian veterans (age 37–59 years) were randomised to receive either curcumin (1 g/d, n 46) or placebo (n 50) for 4 weeks. Serum concentrations of substance P and activities of antioxidant enzymes were measured at baseline and at the end of the trial. Assessment of pruritus severity was performed using the pruritus score, visual analogue scale (VAS) and scoring atopic dermatitis (SCORAD) index. QoL was evaluated using the Dermatology Life Quality Index (DLQI) questionnaire. Serum concentrations of substance P (P < 0·001) as well as activities of superoxide dismutase (P = 0·02), glutathione peroxidase (P = 0·006) and catalase (P < 0·001) were significantly reduced in the curcumin group, while no significant change was observed in the placebo group. Curcumin supplementation was also associated with significant reductions in measures of pruritus severity including the pruritus score (P < 0·001), VAS score (P < 0·001), overall (P < 0·001) and objective SCORAD (P = 0·009), and DLQI's first question (P < 0·001). None of these measures was significantly changed in the placebo group. As for the QoL, although DLQI scores decreased in both groups (P < 0·001 and P = 0·003 in the curcumin and placebo groups, respectively), the magnitude of reduction was significantly greater in the curcumin group (P < 0·001). In conclusion, curcumin may be regarded as a natural, safe, widely available and inexpensive treatment for the management of SM-induced chronic pruritus.

scholarly journals Four-week daily airway clearance using oscillating positive-end expiratory pressure versus autogenic drainage in bronchiectasis patients: a randomised controlled trial

2021 ◽  
pp. 00426-2021
Author(s):  
Galit Livnat ◽  
Naama Yaari ◽  
Nili Stein ◽  
Lea Bentur ◽  
Moneera Hanna ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Forced Expiratory Volume ◽  
Treatment Burden ◽  
Ventilation Inhomogeneity ◽  
Airway Clearance ◽  
Sputum Volume ◽  
Randomised Controlled

BackgroundAirway clearance (AC) is a fundamental component of bronchiectasis care. Lung clearance index (LCI) is a measurement of ventilation inhomogeneity. Its responsiveness to long-term AC is unknown. We aimed to compare two methods of daily AC over four weeks: autogenic drainage (AD) and oscillating positive airway pressure (oPEP), and to to determine effects of AC on LCI and clinical outcomes.MethodsAdults with bronchiectasis naive to airway clearance were randomised to daily AC with either AD or oPEP. Difference in LCI as primary outcome, spirometry, sputum volume and purulence, and quality of life were evaluated at randomisation and after four weeks of AC.ResultsFifty-one patients (32 women, 19 men, mean age 66.2±12.8 years) were randomised and 49 completed the study (25 AD, 24 oPEP). The LCI and forced expiratory volume in the first second (FEV1) did not change between visits between groups (difference between groups 0.02), nor between visits in either group. Sputum quantity decreased in 12/24 (50%) of the oPEP group, and in 6/25 (24%) of the AD group (p=0.044). The “treatment burden” worsened or was unchanged in 70% of participants randomised to AD and 55% randomised to oPEP (p=0.038).ConclusionSputum quantity decreased in more participants randomised to oPEP group after one month of daily AC, with a better treatment burden. The effects of four weeks of AC on LCI were not significant in either treatment group.

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