Esselinckx W, Doherty SM, Dixon ASJ. Polymyalgia Rheumatica – Abrupt and Gradual Withdrawal of Prednisolone Treatment, Clinical and Laboratory Observations. Annals of the Rheumatic Diseases 1977;36(3):219-24
PubMed link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1006669/
Full text article: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1006669/pdf/annrheumd00040-0022.pdf
| Methods | Study design: Single-blinded before-and-after case series
Number of groups: Four groups based on biochemical response to intervention |
| Participants | Number of participants: 18 enrolled, 17 completed
Age: 69 years (range 47 to 91 years) Sex: 11 female, 7 male Participants with dementia: No Inclusion criteria: · Polymalgia rheumaticatreated with stable doses corticosteroids Exclusion criteria: · Presented with any of the clinical signs thatare known to correlate with histologically proven temporal arteritis Country: England Setting: Community |
| Interventions | Medicine: Prednisolone (corticosteroid treatment before the study varied from 9 to 96 months, mean 27 months).
Blinded deprescribing – the substitution of white tablets of ascorbic acid of identical appearance. Withdrawal schedule: Abrupt in the first stage, gradual in the second stage with a mean withdrawal rate of 1mg per month over a four- to five- month period |
| Outcomes | Successful deprescribing after abrupt discontinuation
Laboratory results after gradual discontinuation Laboratory outcomes after abrupt discontinuation Successful deprescribing after titrated withdrawal Adverse effects |
| Dates | Dates: Not described
Follow-up duration: · Abrupt discontinuation: up to 10 weeks · Gradual discontinuation: up to six months |
| Funding sources | Partly supported by a grant from the Arthritis and Rheumatism Council.
Author W.E. received a British Council Fellowship. |
| Notes |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | High risk | Not randomized |
| Allocation concealment (selection bias) | High risk | Single-arm |
| Blinding of participants and personnel (performance bias) | 1 out of 5 | The participants were blinded.
“…white tablets of ascorbic acid of identicalappearance…” |
| Blinding of outcome assessment (detection bias) | 5 out of 5 | Not done |
| Incomplete outcome data (attrition bias) | 1 out of 5 | Appears to be free of missing outcome data as the authors report cases as outcome data rather than performing statistical analysis. |
| Selective reporting (reporting bias) | 5 out of 5 | There is no evidence of a pre-specified protocol and analysis plan (nor evidence of approval from a Human Research Ethics Committee).
There were no pre-specified criteria. Data were measuredin some cases and subjectively assessed in other cases depending on the measure. Reporting was on a case by case basis i.e. no analysis of change or statistical significance |
| Confounding (non-randomized) | 5 out of 5 | There is no control group, so potential for a confounding factor to affect the outcomes exists.
Limited methodology was described to assess confounders. No mention of other medicines/treatments was made, and I am unsure whether these were in use at the time of the paper. |
| Other bias | Unclear risk | Limitedmethodology was described and in a non-standard format due to the age of the paper, therefore,difficult to establish if the study is free of other problems that could put it at a high risk of bias.
The study does not state follow-upduration. e.g., note that it is unclear if participants gave informed consent (no evidence of approval from a Human Research Ethics Committee), nor is it entirely clear participants were aware they were participating in a study. Other drugs were not reported. There was no timeframe in the method apart from the intermediate step. Patients were told they should try the new tablet for a week and report back at the next interview. They were allowed to revert to the prednisolone tablets if they became veryuncomfortable. The timing of the changes in therapy seems to have been based on the response of the patient. “Patients were observed and confirmed to be symptom-free on this dose (period B) for at least one week before prednisolone withdrawal. The latter was achievedby substitution of white tablets of ascorbic acid of identical appearance. Patients were toldsimply that they should try the new tablet for a week and report back at the next interview.” |
| Newcastle-Ottawa scale | ||
| Selection bias | Representativeness of the exposed cohort | Limited description of the derivation of the cohort. |
| Selection of the non-exposed cohort | No description of the derivation of the non-exposed cohort.
|
|
| Ascertainment of exposure | Ascertainment of exposure by structured interview
|
|
| Demonstration that outcome of interest was not present at start of study | The authors did not demonstrate that the outcome of interest was not present at the start of the study. | |
| Comparability bias | Comparability of cohorts on the basis of the design or analysis | The study controls for the deprescribing of prednisolone. |
| Outcome bias | Assessment of outcome | Assessment of outcomes by self-report. |
| Was follow-up long enough for outcomes to occur
|
The follow-up was probably adequate for long enough for outcomes to occur.
|
|
| Adequacy of follow-up of cohorts | Complete follow-up – all subjects accounted for | |
Leave a Reply