Rumalon versus placebo in five-year knee and hip osteoarthritis follow-up
Five-year knee joint-space loss
0.37 mm with Rumalon versus 0.42 mm with placebo (p=0.68).
Five-year hip joint-space loss
0.21 mm with Rumalon versus 0.22 mm with placebo (p=0.53).
Function, pain and anti-inflammatory drug use
No statistically significant between-group differences in the Lequesne index, pain during passive movement or NSAID use.
0.37 mm with Rumalon versus 0.42 mm with placebo (p=0.68).
More reported outcomes
Reported adverse effects
14.5% with Rumalon and 15% with placebo.
Study notes · methods, sources and limitations
Participants or model 400 adults randomized across three Czech clinical centers. Knee osteoarthritis: 140 Rumalon and 140 placebo. Hip osteoarthritis: 60 and 60.
Design Double-blind, block-randomized comparison with identical saline placebo. Each course consisted of fifteen 2 mL intramuscular injections given twice weekly. Two courses per year for five years. The radiographic analysis included 394 participants with follow-up imaging.
Important limitations
The trial found no measurable structure-modifying benefit. Joint-space loss was slower than anticipated in both arms.
Osteoarthritis and Cartilage 8(5), 335–342 · Publication record
GLADIOLUS observational study of Rumalon in osteoarthritis
Pain with movement at 12 weeks
Median 6 to 2 on a 0–10 scale. Pain at rest fell from 4 to 1, and functional impairment fell from 5 to 1.
NSAID use
68.1% reportedly stopped taking NSAIDs.
Reported adverse events
Skin allergic reactions in 0.3% and moderate injection-site pain in 0.37%. Gastrointestinal and cardiovascular events were reported in 8% and 6%, respectively.
Median 6 to 2 on a 0–10 scale. Pain at rest fell from 4 to 1, and functional impairment fell from 5 to 1.
Study notes · methods, sources and limitations
Participants or model 2,955 adults with osteoarthritis, including 414 who also received diacerein.
Design Russian multicenter retrospective analysis of routine care over 12 weeks. The Russian protocols used 25 intramuscular injections, starting with 0.3 and 0.5 mL, then 1 mL per injection. Maintenance injections were given three times per week. Diacerein was 100 mg/day in the combination subgroup. Clinicians could use additional care.
Important limitations
All patients received Rumalon. Treatment selection and concurrent care can explain some of the change from baseline.
Modern Rheumatology Journal 14(2), 76–83 · Publication record
Three-year Russian comparison of Rumalon in workers with knee osteoarthritis
Pain with walking
At the start of year two, the paper reports 0.69 versus 1.41 points with Rumalon and control (p<0.01).
Joint function
The Lequesne index differed at 18 months (p<0.05). Knee range of motion favored the treated group (p<0.04).
Radiographic progression
The authors found no statistically significant group difference.
At the start of year two, the paper reports 0.69 versus 1.41 points with Rumalon and control (p<0.01).
More reported outcomes
Allergic reaction
One participant discontinued Rumalon during the third course after an allergic reaction.
Study notes · methods, sources and limitations
Participants or model 100 workers from two Russian factories with knee osteoarthritis. 80 received Rumalon and 20 served as controls.
Design Open prospective comparison. Rumalon was given as 2 mL intramuscularly twice weekly for 15 injections per course, two courses per year for three years. Both groups could receive ibuprofen and physiotherapy. Ten treated participants and five controls withdrew.
Important limitations
Open treatment, unequal group sizes, withdrawals and concurrent care limit the symptom comparison.
Terapevticheskii Arkhiv, issue 5, pp. 64–66 · Publication record
Rumalon is an injectable glycosaminoglycan–peptide mixture derived from calf rib cartilage and bone marrow. Russian cohorts reported less osteoarthritis pain during follow-up. A five-year placebo-controlled trial found no significant difference in knee or hip joint-space loss.
Research background
Rumalon is an injectable glycosaminoglycan–peptide mixture derived from calf rib cartilage and bone marrow. Russian cohorts reported less osteoarthritis pain during follow-up. A five-year placebo-controlled trial found no significant difference in knee or hip joint-space loss.
Compound class
Cartilage and bone marrow extract
Research collection
Peptide bioregulation · editorial grouping
Research institutions
No institutional affiliation recorded
Source review
Review dates and the material assessed are listed with each publication below.
02 / HOW TO READ THE RESEARCH
Understanding the evidence
Human research
Osteoarthritis trials, open comparisons and Russian observational cohorts.
Study methods
Five-year placebo-controlled radiographs, symptom assessments and laboratory cartilage assays.
Independent replication
Early symptom findings varied across comparisons. The largest long-term randomized trial found no significant difference from placebo in joint-space loss or measured symptoms.
Source access
Original articles and indexed abstracts are linked with each study.
Safety evidence
Studies report adverse events including allergic reactions and injection-site pain. The five-year study reported adverse effects in 14.5% with Rumalon and 15% with placebo.
Open a topic for the evidence assessment.
More findings, background and history
What remains unclear
Group assignment, comparators, planned outcomes, effect estimates, adverse events and possible participant overlap are key limits to interpreting the studies.
Human reports are linked; their presence does not establish effectiveness. Several publications can describe the same participants.
2000 · Rumalon versus placebo in five-year knee and hip osteoarthritis follow-upFive-year knee joint-space loss: 0.37 mm with Rumalon versus 0.42 mm with placebo (p=0.68).
K. Pavelká, J. Gatterová, V. Gollerova, Z. Urbanová, M. Sedlácková, R. D. Altman · Osteoarthritis and Cartilage 8(5), 335–342
0.37 mm with Rumalon versus 0.42 mm with placebo (p=0.68).
Results and tables
Reported findings and study design
Reported findings
Double-blind, block-randomized comparison with identical saline placebo. Each course consisted of fifteen 2 mL intramuscular injections given twice weekly. Two courses per year for five years. The radiographic analysis included 394 participants with follow-up imaging.
Dose, route and schedule
Double-blind, block-randomized comparison with identical saline placebo. Each course consisted of fifteen 2 mL intramuscular injections given twice weekly. Two courses per year for five years. The radiographic analysis included 394 participants with follow-up imaging.
Protocol source ↗ · Original article, Figure 1 and joint-space tables
Results · Original article, Figure 1 and joint-space tables
Measure
Result
Comparison, timing and statistics
Five-year knee joint-space loss
0.37 mm with Rumalon versus 0.42 mm with placebo (p=0.68).
Five-year hip joint-space loss
0.21 mm with Rumalon versus 0.22 mm with placebo (p=0.53).
Function, pain and anti-inflammatory drug use
No statistically significant between-group differences in the Lequesne index, pain during passive movement or NSAID use.
Reported adverse effects
14.5% with Rumalon and 15% with placebo.
Participant flow and five-year joint-space loss
Participant flow and five-year joint-space loss
Joint
Randomized, Rumalon / placebo
Analyzed, Rumalon / placebo
Rumalon
Placebo
p
Knee
140 / 140
138 / 139
0.37 mm
0.42 mm
0.68
Hip
60 / 60
58 / 59
0.21 mm
0.22 mm
0.53
The trial found no measurable structure-modifying benefit. Joint-space loss was slower than anticipated in both arms.
400 adults randomized across three Czech clinical centers. Knee osteoarthritis: 140 Rumalon and 140 placebo. Hip osteoarthritis: 60 and 60.
Source reviewed
Original article, Figure 1 and joint-space tables
Study limitations
The trial found no measurable structure-modifying benefit. Joint-space loss was slower than anticipated in both arms.
Reviewed 2026-11-12.
Read the source ↗2020 · GLADIOLUS observational study of Rumalon in osteoarthritisPain with movement at 12 weeks: Median 6 to 2 on a 0–10 scale. Pain at rest fell from 4 to 1, and functional impairment fell from 5 to 1.
L. I. Alekseeva, A. E. Karateev, E. Yu. Pogozheva, V. N. Amirdzhanova, E. S. Filatova, V. A. Nesterenko · Modern Rheumatology Journal 14(2), 76–83
Median 6 to 2 on a 0–10 scale. Pain at rest fell from 4 to 1, and functional impairment fell from 5 to 1.
Results and tables
Reported findings and study design
Reported findings
Russian multicenter retrospective analysis of routine care over 12 weeks. The Russian protocols used 25 intramuscular injections, starting with 0.3 and 0.5 mL, then 1 mL per injection. Maintenance injections were given three times per week. Diacerein was 100 mg/day in the combination subgroup. Clinicians could use additional care.
Dose, route and schedule
Russian multicenter retrospective analysis of routine care over 12 weeks. The Russian protocols used 25 intramuscular injections, starting with 0.3 and 0.5 mL, then 1 mL per injection. Maintenance injections were given three times per week. Diacerein was 100 mg/day in the combination subgroup. Clinicians could use additional care.
Median 6 to 2 on a 0–10 scale. Pain at rest fell from 4 to 1, and functional impairment fell from 5 to 1.
NSAID use
68.1% reportedly stopped taking NSAIDs.
Reported adverse events
Skin allergic reactions in 0.3% and moderate injection-site pain in 0.37%. Gastrointestinal and cardiovascular events were reported in 8% and 6%, respectively.
All patients received Rumalon. Treatment selection and concurrent care can explain some of the change from baseline.
2,955 adults with osteoarthritis, including 414 who also received diacerein.
Source reviewed
Original Russian article
Study limitations
All patients received Rumalon. Treatment selection and concurrent care can explain some of the change from baseline.
Reviewed 2026-11-12.
Read the source ↗1997 · Three-year Russian comparison of Rumalon in workers with knee osteoarthritisPain with walking: At the start of year two, the paper reports 0.69 versus 1.41 points with Rumalon and control (p<0.01).
L. I. Alekseeva, A. N. Karyakin, A. V. Smirnov, L. I. Benevolenskaya · Terapevticheskii Arkhiv, issue 5, pp. 64–66
At the start of year two, the paper reports 0.69 versus 1.41 points with Rumalon and control (p<0.01).
Results and tables
Reported findings and study design
Reported findings
Open prospective comparison. Rumalon was given as 2 mL intramuscularly twice weekly for 15 injections per course, two courses per year for three years. Both groups could receive ibuprofen and physiotherapy. Ten treated participants and five controls withdrew.
Dose, route and schedule
Open prospective comparison. Rumalon was given as 2 mL intramuscularly twice weekly for 15 injections per course, two courses per year for three years. Both groups could receive ibuprofen and physiotherapy. Ten treated participants and five controls withdrew.
100 workers from two Russian factories with knee osteoarthritis. 80 received Rumalon and 20 served as controls.
Source reviewed
Original Russian article, pp. 64–66
Study limitations
Open treatment, unequal group sizes, withdrawals and concurrent care limit the symptom comparison.
Reviewed 2026-11-12.
Read the source ↗2018 · PRIMULA: Rumalon in persistent knee osteoarthritis painPain at 12 weeks: Visual analog pain score fell 34.6% and WOMAC pain fell 37.2% from baseline (both p<0.001).
A. E. Karateev, L. I. Alekseeva, A. M. Lila, et al. · Consilium Medicum 20(9), 51–57
Visual analog pain score fell 34.6% and WOMAC pain fell 37.2% from baseline (both p<0.001).
Results and tables
Reported findings and study design
Reported findings
Open-label series with assessments at weeks 8 and 12. The Russian protocols used 25 intramuscular injections, starting with 0.3 and 0.5 mL, then 1 mL per injection. The main text specifies three maintenance injections per week.
Dose, route and schedule
Open-label series with assessments at weeks 8 and 12. The Russian protocols used 25 intramuscular injections, starting with 0.3 and 0.5 mL, then 1 mL per injection. The main text specifies three maintenance injections per week.
Protocol source ↗ · Original Russian article, full methods and results
Results · Original Russian article, full methods and results
Measure
Result
Comparison, timing and statistics
Pain at 12 weeks
Visual analog pain score fell 34.6% and WOMAC pain fell 37.2% from baseline (both p<0.001).
Function and stiffness at 12 weeks
WOMAC functional impairment fell 30.0%, stiffness 30.4% and the total score 32.4% from baseline.
Medication use and adverse events
31.7% stopped NSAIDs. Adverse events were reported in 1.8%, with no resulting interruptions of Rumalon.
The study had no comparison arm. Changes from baseline include the effects of concurrent care and time.
115 patients with persistent knee osteoarthritis pain and prior oral treatment.
Source reviewed
Original Russian article, full methods and results
Study limitations
The study had no comparison arm. Changes from baseline include the effects of concurrent care and time.
Reviewed 2026-11-12.
Read the source ↗2022 · Rumalon with or without diacerein in a Russian multicenter knee osteoarthritis trialWOMAC pain at the end of treatment: Median scores fell from 198 to 110 mm with combination therapy and from 209 to 112 mm with Rumalon alone.
L. I. Alekseeva, A. M. Lila, E. P. Sharapova, E. A. Taskina, et al. · Therapy, issue 2, pp. 6–18
Median scores fell from 198 to 110 mm with combination therapy and from 209 to 112 mm with Rumalon alone.
Results and tables
Reported findings and study design
Reported findings
The authors report random assignment, eight months of treatment and two months of follow-up. The Russian protocols used 25 intramuscular injections, starting with 0.3 and 0.5 mL, then 1 mL per injection. The 1 mL injections were given on alternate days and the course was repeated at six months. The combination group received diacerein 50 mg daily for one month, then 50 mg twice daily for seven months.
Dose, route and schedule
The authors report random assignment, eight months of treatment and two months of follow-up. The Russian protocols used 25 intramuscular injections, starting with 0.3 and 0.5 mL, then 1 mL per injection. The 1 mL injections were given on alternate days and the course was repeated at six months. The combination group received diacerein 50 mg daily for one month, then 50 mg twice daily for seven months.
Results · Original Russian article, methods and results
Measure
Result
Comparison, timing and statistics
WOMAC pain at the end of treatment
Median scores fell from 198 to 110 mm with combination therapy and from 209 to 112 mm with Rumalon alone.
Pain on movement
Both groups improved on the visual analog scale. The authors found no between-group difference on this measure.
Ultrasound-detected synovitis
Relative risk 0.51 with combination therapy versus Rumalon alone at the end of treatment (95% CI 0.28–0.92, p=0.04).
Adverse events
Four combination participants and one Rumalon-only participant reported an event. One combination participant withdrew after hand-joint swelling.
Both arms received Rumalon. The trial compares adding diacerein with continuing Rumalon alone. Baseline visual analog pain was higher in the combination group.
78 adults from six Russian regions with knee osteoarthritis. 45 received Rumalon plus diacerein and 33 received Rumalon alone.
Source reviewed
Original Russian article, methods and results
Study limitations
Both arms received Rumalon. The trial compares adding diacerein with continuing Rumalon alone. Baseline visual analog pain was higher in the combination group.
Reviewed 2026-11-12.
Read the source ↗1987 · Double-blind Rumalon trial in bilateral knee osteoarthritisAuthor-rated favorable response: 64% with Rumalon versus 29% with placebo (p<0.05).
106 participants with bilateral knee osteoarthritis.
Source reviewed
Original indexed abstract
Study limitations
The abstract omits arm sizes, injection schedule, the exact response definition and adverse-event counts.
Reviewed 2026-11-12.
Read the source ↗1990 · Rumalon and cartilage-degrading enzymes in human osteoarthritic cartilageCartilage enzyme activity: The authors reported dose-dependent inhibition of collagenolytic and proteoglycanase activity, with no change in phospholipase A2 activity.
This was an assay of excised tissue. The abstract does not quantify an effect on cartilage in treated patients.
Reviewed 2026-11-12.
Read the source ↗1987 · Rumalon in a rat model of dexamethasone-induced cartilage injuryCartilage metabolism and cell structure: The authors reported that coadministration countered dexamethasone-associated suppression of sulfur-35 incorporation and changes in chondrocyte survival and organelles.
M. Annefeld, B. Erne · Clinical Rheumatology 6(3), 340–349
The authors reported that coadministration countered dexamethasone-associated suppression of sulfur-35 incorporation and changes in chondrocyte survival and organelles.
Dexamethasone exposure with or without the glycosaminoglycan–peptide complex. Investigators measured radiolabeled sulfur incorporation and cartilage cell structure.
Dose, route and schedule
Dexamethasone exposure with or without the glycosaminoglycan–peptide complex. Investigators measured radiolabeled sulfur incorporation and cartilage cell structure.
The authors reported that coadministration countered dexamethasone-associated suppression of sulfur-35 incorporation and changes in chondrocyte survival and organelles.
The experiment models drug-induced cartilage injury in rats. Numerical treatment effects were unavailable in the abstract.