De Jonge JW, Knottnerus JA, Van Zutphen WM, et al. Short term effect of withdrawal of diuretic drugs prescribed for ankle oedema. British Medical Journal 1994;308:511-13
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/8136670
Full text article: https://www.bmj.com/content/308/6927/511
| Methods | Study design: Open-label randomized controlled study with a parallel-design
Number of groups: Two groups |
| Participants | Number of participants: 63 randomized, 55 completed
· Active deprescribing group: 34 randomized, 26 completed · Control group: 29 randomized, 29 completed Age given as age groups, not mean, median nor range · 65 to 74 years, n=34 · 75 to 84 years, n=23 · 85 years and over, n=6 Sex: 55 female, 8 male Participants with dementia: No Inclusion criteria: · Clinical examination since patients prescribed diuretics for heart failure could have reported taking them for ankle edema · Tried to include patients who had heart failure diagnosed on insufficient grounds Exclusion criteria: · Took less than one dose of diuretics a week · Edema caused by the nephritic syndrome or liver cirrhosis · Took diuretics for hypertension · Terminal illness · Hospitalized · Decreased mental functioning · Crural ulcer · Congestive heart failure · Increased risk of developing congestive heart failure after stopping diuretic drugs · Heart failure previously established by a cardiologist · History of severe dyspnea treated by the general practitioner as cardiac failure, atrial fibrillation, symptoms of right-sided heart failure, palpable right ventricular pulsations, or hepatomegaly Country: The Netherlands Setting: Community – 15 general practices |
| Interventions | Medicine: Diuretics (frusemide, frusemide plus triamterene, frusemide plus amiloride, frusemide plus hydrochlorothiazide-amiloride*, hydrochlorothiazide-amiloride*, hydrochlorothiazide-triamterene*, triamterene, epitizide-triamterene*, bumetanide, amiloride, hydrochlorothiazide, chlorthalidone, mefruside, spironolactone plus hydrochlorothiazide-triamterene)
Withdrawal schedule: Not stated Comparator: Usual care |
| Outcomes | Ankle edema
Successful deprescribing Determinants of edema after deprescribing |
| Dates | Dates: Not described
Follow-up duration: 6 weeks |
| Funding sources | Not described |
| Notes | Limited detail. Those who did not successfully deprescribe were reported as drop-outs.
Additional information sought to find mean age of participants, but not received. |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | Low risk | “Eligible patients were randomly assigned to an intervention group (stopping diuretic drugs) or a control group (containing diuretic drugs). Randomization was pre-stratified in each practice.” |
| Allocation concealment (selection bias) | Unclear risk | No method described. It was probably not done, as it is an open study. |
| Blinding of participants and personnel (performance bias) | High risk | Based on the described method, the interventions were either stopping the drugs or continuing drugs. No mention of placebo. |
| Blinding of outcome assessment (detection bias) | High risk | As above. |
| Incomplete outcome data (attrition bias) | High risk | Drop-outs were mostly due to symptoms directly related to the intervention. |
| Selective reporting (reporting bias) | High risk | Change in edema was the outcome method, and this was reported. The analysis uses some co-determinates that were not pre-specified. |
| Other bias | Low risk | No conflicts reported. |
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