Randomised controlled trialindependent cross-checkabstract checked★ key study I-AUTO-101 in-depth review
Stopping hydroxychloroquine in lupus
A randomized study of the effect of withdrawing hydroxychloroquine sulfate in systemic lupus erythematosus.
Overview
Canadian Hydroxychloroquine Study Group. N Engl J Med 1991 · PMID 1984192 · DOI 10.1056/NEJM199101173240303
In stable lupus, people switched to placebo had far more flares (73%) than those who kept taking hydroxychloroquine (36%).
Does the study support the specific claim? No · Methodological quality: high
Plain-language summary
Study explained simply
- What did the researchers want to find out?
Test whether HCQ can be stopped in stable lupus.
- How was the study done?
Double-blind RCT, 24 weeks.
- How many people, animals or samples were studied?
47 Canadian patients with stable SLE.
- What was actually found?
More and earlier flares after withdrawal.
- How large was the observed effect?
RR 2.5 (1.08-5.58).
- What do the results mean in everyday life?
Stopping lupus medicine leads to flares; diet should not replace it.
- What are the study's limitations?
Small, short.
- What does it say about Elawady's specific claim?
Contradicts 'lupus is treated by following the system' as a replacement for medicine.
- Do the results apply to Germany and Europe?
Applies; same physiology.
- What can explicitly not be concluded from this study?
Effects of adding a diet to HCQ.
Scientific in-depth review
1. Full reference
- Authors
- Canadian Hydroxychloroquine Study Group
- Journal
- N Engl J Med
- Year
- 1991
- Identifier
- PMID 1984192 DOI 10.1056/NEJM199101173240303
- Verification
- verified – PubMed efetch 2026-10-26; Crossref update-to/updated-by check
- Retracted
- no
- Corrections
- none
- Extent checked
- abstract only
- Conflicts of interest and funding
not stated in abstract
2. Research question
Does stopping hydroxychloroquine in clinically stable SLE increase flares?
3. Study design and population
- Study design
- Randomised controlled trial – Randomised, double-blind, placebo-controlled withdrawal trial (24 weeks)
- Population
Patients with clinically stable SLE taking HCQ
- Country
Canada
- Period
not stated in abstract
- Sample size
47 (25 continued HCQ, 22 placebo)
- Inclusion and exclusion criteria
not stated in abstract
4. Methods and endpoints
- Exposure / intervention
Withdrawal of HCQ (placebo)
- Comparator
Continued HCQ
- Endpoints
Clinical flare; severe exacerbation; time to flare
- Statistical methods
Relative risk with 95% CI
5. Actual results
- Results
Flare: 16/22 placebo vs 9/25 HCQ; RR 2.5 (95% CI 1.08-5.58); shorter time to flare (P=0.02). Severe exacerbation: 5/22 vs 1/25; RR 6.1 (0.72-52.44).
- Absolute risks
Flare risk 72.7% vs 36.0% (risk difference 36.7 percentage points; NNH about 3 for withdrawal) - calculated from reported counts.
- Authors' conclusion
Patients with quiescent SLE who take HCQ are less likely to have a clinical flare if maintained on the drug.
6. Strengths
- Double-blind placebo-controlled withdrawal design
- Clinically relevant question
7. Weaknesses
- Small; 24 weeks
- Severe exacerbation estimate imprecise
8. Risk of bias
- Orienting tool
- RoB 2
- Type of assessment
- simplified assessment (abstract only)
- Full formal assessment
- no
- Overall risk of bias
- low
- Rationale
Double-blind randomised design.
9. Assessment of the statistical interpretation
Crude RR from counts 2.02 vs reported 2.5 (probably time-based); CI log-consistent. See stats/I-AUTO-101_hcq_withdrawal.py.
10. Relevance to the specific claim
Direct randomised evidence that stopping standard lupus medication causes flares - the concrete harm of replacing drug treatment with a diet.
11. Independent contrary findings
No trial shows diet alone controls SLE.
12. Transferability to Germany and Europe
Universal biology; applies in Europe and Egypt.
13. Overall methodological judgement
High-quality evidence underpinning the safety note.
| Multidimensional assessment | |
|---|---|
| Authenticity of the source | verified |
| Methodological quality | high |
| Risk of bias | low |
| Precision of results | low |
| Directness | direct |
| Reproducibility | replicated |
| Consistency with the overall evidence | consistent |
| Regional transferability | high |
| Adequacy of the interpretation (by the archive) | not applicable |