ArticleCureus2025
A Phase-II Investigator-Initiated Randomized, Double-Blind, Parallel-Group Clinical Trial of 5-Aminolevulinic Acid Hydrochloride/Sodium Ferrous Citrate (5-ALA-HCl/SFC) for Patients With Adult-Onset Still's Disease (AOSD) Refractory to Corticosteroids.
Article in Cureus, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo evaluate the efficacy and safety of 5-aminolevulinic acid hydrochloride/sodium ferrous citrate (5-ALA-HCl/SFC) in patients with adult-onset Still's disease (AOSD) refractory to corticosteroids. METHODS/
designThis multicenter, investigator-initiated, randomized, double-blind, placebo-controlled, parallel-group phase II trial was designed to enroll 30 participants but was prematurely terminated after enrolling four participants because of slow recruitment. Participants were randomized to receive 5-ALA-HCl/SFC (100 or 300 mg/day) or placebo for 8 weeks. The primary endpoint was the achievement of adapted ACR 30 at week 4.
resultsAll four enrolled participants achieved adapted ACR 30 at week 4. Adapted ACR 50/ 70/ 90 responses and improvements in systemic feature score, serum ferritin, and quality of life varied among individuals. No serious adverse events were observed.
conclusionEfficacy signals were observed, especially in the high-dose group; however, the small sample size precludes definitive conclusions. Further research is required to confirm this.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.