Borrill Z, Roy K, Kolsum U, et al. Seretide withdrawal increases airway inflammation in moderate COPD patients. Eur J Clin Pharmacol 2009;65:1165-66
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/19603154
Full text article: https://link.springer.com/article/10.1007%2Fs00228-009-0697-5
| Methods | Study design: Open-label randomized controlled study with a parallel-design
Number of groups: Two groups |
| Participants | Number of participants: 14 randomized, 10 completed
· Intervention deprescribing group: 9 randomized, 5 completed · Control group: 5 randomized, 5 completed Age: 65 years Sex: Not described Participants with dementia: No Inclusion criteria: · Post-bronchodilator forced expiratory volume in one second (FEV1) 50– 80% predicted and FEV1/forced vital capacity < 70% · Stable dose of fluticasone propionate 500–1,000 μcg per day and salmeterol 100 μcg per day · Current or ex-smokers with at least ten pack-years Exclusion criteria: · Patients with a history of more than one exacerbation of COPD during the past 12 months requiring treatment with oral corticosteroid · Any previous admission for exacerbation of COPD requiring non-invasive or endotracheal intubation or admission to the intensive care unit Country: England Setting: Not described |
| Interventions | Medicines: Inhaled fluticasone propionate (500 or 1,000 μcg) per day and salmeterol 100 μcg per day compared to continued medicine use
Withdrawal method: Not described Comparator: Usual treatment |
| Outcomes | Exacerbations causing drop-outs
Forced expiratory volume in one second Sputum neutrophil percentage |
| Dates | Dates: Not described
Follow-up duration: Six weeks |
| Funding sources | Not described |
| Notes | Limited detail – published as a letter to the editor
Additional information sought to find out FEV1 at the end of the study, but not received. |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | Unclear risk | Randomization method not described:
“Patients were randomized at a ratio of 3:2, stratified according to current smoking status, to either withdrawal or continuation of inhaled fluticasone propionate/salmeterol (SFC) for 6 weeks.” |
| Allocation concealment (selection bias) | Unclear risk | Concealment method not described. |
| Blinding of participants and personnel (performance bias) | High risk | The study is an open study. Patients and personnel could easily tell who was in which group. |
| Blinding of outcome assessment (detection bias) | Unclear risk | The study is an open study.
Insufficient information was given as to who were the assessors were. |
| Incomplete outcome data (attrition bias) | High risk | The incomplete data were those four patients who withdrew failed because of worsening of the primary outcomes. This datawere related to the intervention. Instead, they brought forward the last measured data from when they were in the trial.
“Four patients in the withdrawal group withdrew from the study due to exacerbation of COPD. Data from these patients are brought forward from the last observation obtained.” |
| Selective reporting (reporting bias) | Unclear risk | The protocol was described in limiteddetail, so it remains unclear if there was selective reporting. |
| Other bias | Unclear risk | Limited description of the methods, so the risk of bias cannot be adequately ascertained.
Conflicts of interest are not stated. 2 out of three references refer to work done by one of the authors (Vestbo). |
Bourgeois 201416
| Methods | Study design: Before-and-after study
Number of groups: One group |
| Participants | Number of participants: 38 enrolled, 37 completed
Age: 84.3 years Sex: 27 female, 11 male Participants with dementia: No (inclusion criteria was cognitively competent) Inclusion criteria: Established the chronic use of benzodiazepines or Z-drugs for insomnia (administered daily at bedtime for at least 3 months) Cognitively competent, which was confirmed with a Katz disorientation score of 1 or 2 (disorientation in time and place ranging from 1 = no disorientation to 4 = severe) Exclusion criteria: Critically ill Fatal diagnosis with short life expectancy Residents who used a benzodiazepine during the day (for the indication anxiety) Used a sedative antidepressant (trazodone, amitriptyline, mirtazapine) Phytotherapy as co-medication Country: Belgium Setting: Aged care facilities, five |
| Interventions | Medicines: Benzodiazepines and z-drugs
N05BA (anxiolytics) N05CD (hypnotics) N05CF (Z-drugs) Withdrawal method: Not strictly set as the general practitioner was responsible, but researchers suggested a 25 % reduction either every one week or everytwo weeks. “median duration of the discontinuation process was 21 days (range 7–88 days)” Comparator: Usual treatment |
| Outcomes | Use of hypnoticmedication
Total number of chronically used medications Functional characteristics were scored using the Katz scale (measures activities of daily living and disorientation) Depression (measuredwith Geriatric Depression Scale) Hospital admissions Falls Hearing and visual impairment Frequent pain Withdrawal symptoms (measured with the Benzodiazepine Withdrawal Symptom Questionnaire) Sleep quality (Pittsburgh Sleep Quality Index) Quality of Life (EuroQol-5D-3L) |
| Dates | Dates: September 2012 until July 2013
Follow-up duration: Eight months |
| Funding sources | Not described |
| Notes |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | High risk | Non-randomized study |
| Allocation concealment (selection bias) | High risk | Open study |
| Blinding of participants and personnel (performance bias) | 5 out of 5 | Open study |
| Blinding of outcome assessment (detection bias) | 5 out of 5 | Open study |
| Incomplete outcome data (attrition bias) | 1 out of 5 | All participants accounted for at 8 months. |
| Selective reporting (reporting bias) | 1 out of 5 | Use of hypnoticmedication – REPORTED
Total number of chronically used medications – REPORTED Functional characteristics were scored using the Katz scale (measures activities of daily living and disorientation) – REPORTED Depression measure with Geriatric Depression Scale – REPORTED Hospital admissions Falls – REPORTED Hearing and visual impairment – REPORTED Frequent pain – REPORTED Withdrawal symptoms (measured with the Benzodiazepine Withdrawal Symptom Questionnaire) – REPORTED Sleep quality (Pittsburgh Sleep Quality Index) – REPORTED Quality of Life (EuroQol-5D-3L) – REPORTED |
| Confounding (non-randomized) | 5 out of 5 | There is no concurrent control group |
| Other bias | High risk | Left to the general practitioner to initiate discontinuation in study, so not uniform and subject |
| Newcastle-Ottawa scale | ||
| Selection bias | Representativeness of the exposed cohort | Truly representative of the average person who is cognitively intact living in a residential aged care facility. |
| Selection of the non-exposedcohort | No concurrent control group | |
| Ascertainment of exposure | Secure record | |
| Demonstration that outcome of interest was not present at start of study | Yes | |
| Comparability bias | Comparability of cohorts on the basis of the design or analysis | The study controlled for general practitioner’s belief if a person could be withdrawn |
| Outcome bias | Assessment of outcome | Record linkage |
| Was follow-up long enough for outcomes to occur | Yes | |
| Adequacy of follow-up of cohorts | Complete follow-up – all participants accounted for | |
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