Skip to main content

Table 2 Clinical studies on hpCS in Hip, Knee and Hand OA, on formulation 1200 mg/die and on pharmacoeconomic impact

From: Highly purified chondroitin sulfate: a literature review on clinical efficacy and pharmacoeconomic aspects in osteoarthritis treatment

Condition/topic
First author [Ref.]
Design
Patients Treatment/dose
Control/dose
Follow-up
Summary of results, primary efficacy parameters
Hip OA    
Conrozier 1992 [33]
RCT
56 hpCS 3 × 400 mg/day
PLB
6 months
Pain (VAS); LI; analgesic consumption; patient’s assessment, hpCS better than PLB
Knee OA    
Uebelhart 1998 [34]
RCT pilot
42 hpCS 800 mg/day
PLB
1 year
Pain and overall mobility (VAS) at 3 (p < 0.05) and 12 (p < 0.01) months hpCS better than PLB
Uebelhart 2004 [35]
RCT
120 hpCS 800 mg/day
PLB
2 × 3 months during 1 year
hpCS: more LI decrease (36% hpCS vs 23% PLB; p = 0.001); less JSW reduction (0.44 vs 0.46 mm p < 0.05) than PLB
Michel 2005 [36]
RCT
300 hpCS 800 mg/day
PLB
2 years
JWS at 2 years: hpCS no change; PLB − 0.14 mm, (p < 0.001 vs. baseline)
Radrigàn 2007 [37]
Open, non-controlled
61 hpCS 800 mg/day for 3 months
follow-up: 6 months
Improvement of 44.4% in the LI (p < 0.0001) and of 56.8% (right) and 61.7% (left) in the knee pain measured by VAS
Kahan 2009 [38]
RCT
622 hpCS 800 mg/day
PLB
2 years
Reduction in JSW loss with hpCS (p < 0.0001 vs. PLB); less patients with radiographic progression in hpCS (p < 0.0005)
Möller 2010 [39]
RCT
129 hpCS 800 mg/day
PLB
3 months
hpCS better than PLB in pain at VAS (p < 0.01), LI (p < 0.05) reduction of use of analgesics (p < 0.05)
Wildi 2011 [40]
RCT
69 hpCS 800 mg/day
PLB
6 months double- blind
hpCS 800 mg/ day
6 months open-label
Less cartilage volume loss in hpCS than in PLB group (p = 0.03). Lower subchondral BML scores in hpCS group at 12 months (lateral compartment p = 0.035; lateral condyle p = 0.044)
Montfort 2012 [41]
RCT
45 hpCS 800 mg/day
paracetamol 4000 mg/day
6 months
hpCS significantly reduced synovitis compared to paracetamol (p < 0.01)
hpCS effectively reduced functional incapacity (p < 0.01)
Reginster 2017 [42]
RCT
604 hpCS 800 mg/day
celecoxib 200 mg/day
PLB
6 months
At day 182 pain (VAS) reduced (p = 0.001 hpCS; p = 0.009 celecoxib) and LI reduced (p = 0.023 hpCS; p = 0.015 celecoxib) vs. PLB
Hand OA    
Wang 1992 [43]
RCT
34 hpCS 3 × 400/day
PLB
18 months
hpCS reduced pain (VAS) and improved hand function
Verbruggen 1998 [44]
RCT
119 hpCS 3 × 400 mg/day
PLB
3 years
Patients with new joints with lesions: hpCS 5.9%; PLB 22.4%
Rovetta 2002 [45]
RCT
24 hpCS 800 mg/day + naproxen 500 mg/day
naproxen 500 mg/day
24 months
hpCS + naproxen lower increase in number of joints with erosions (p < 0.05)
Rovetta 2004 [46]
RCT
24 hpCS 800 mg/day + naproxen 500 mg/day
naproxen 500 mg/day
24 months
hpCS + naproxen better than naproxen in Heberden (p < 0.001) and Dreiser (p < 0.001) scores, in patient’s (p < 0.001) and clinician’s (p < 0.001) judgement
Gabay 2011 [47]
RCT
162 hpCS 800 mg/day
PLB
6 months
Significant decrease in the patient’s global assessment of hand pain (difference VAS scores − 8.7 mm; p = 0.016) and significant improvement in FIHOA score (− 2.14; p = 0.008) in hpCS group vs placebo
Condrosulf 1200 mg
Knee OA
   
Morreale 1996 [48]
RCT
146 hpCS 3 × 400 mg/day
diclofenac 3 × 50 mg/day;
3 months + 3 months follow-up
LI hpCS − 64.4%; diclofenac vs − 29.7% vs baseline; paracetamol consumption hpCs − 88%; diclofenac − 37.8% (p < 0.01)
Bourgeois 1998 [49]
RCT
127 hpCS gel 1 × 1200 mg/day
hpCS 3 × 400 mg/day
PLB
3 months
hpCS 1 × 1200 and 3 × 400 lower than PLB in LI (p < 0.0001 at day 91) and pain (VAS) (hpCS 1 × 1200 p < 0.01 from day 14; hpCS 3 × 400 p < 0.005 from day 42)
Pavelka 1998 [50]
RCT
140 hpCS 200 mg/die
2 × 400 mg/die
3 × 400 mg/die
PLB
3 months
hpCS 2 × 400 and 3 × 400 mg/die more effective than 200 mg/die and PLB on LI (p < 0.01); pain at VAS (p < 0.01). No difference between 2 × 400 and 3 × 400 mg/day
Clegg 2006 [51]
RCT
1583 hpCS 3 × 400 mg/day
GlcN 3 × 500 mg/day
GlcN + hpCS
celecoxib 200 mg/day
PLB
2 years
Response rate, percent difference from PLB
GlcN + 3.9% (p = 0.30),
hpCS: + 5.3% (p = 0.17),
GlcN + hpCS: % 6.5% (p = 0.09)
celecoxib: + 10.0% (p = 0.008)
Zegels 2013 [52]
RCT
353 hpCS 1 × 1200 mg/day
3 × 400 mg/day
PLB
hpCS 1200 mg or hpCS 3 × 400 mg/day significantly improved compared to PLB in terms of LI (p < 0.001) and VAS for spontaneous pain (p < 0.01)
Pelletier 2016 [53]
RCT
114 hpCS 3 × 400 mg/day
celecoxib 200 mg/day
2 years
hpCS showed less cartilage loss than celecoxib in medial compartment (p = 0.018) and medial condyle (p = 0.008)
IBSA 2019
RCT
246 hpCS 1 × 1200 mg/day
hpCS 3 × 400 mg/day
91 days
hpCS 1200 mg once daily not inferior to hpCS 3 × 400 mg/day in LI (− 2.9 ± 0.3; − 2.6 ± 0.3, respectively; p < 0.0001). No significant difference regarding pain, NSAIDs consumption
IBSA 2019
RCT
94 hpCS 1 × 1200 mg/day
hpCS 3 × 400 mg/day
PLB
91 days
Mean (± SD) decrease of LI from baseline to day 91: − 4.3 (3.3) in the hpCS 1200 mg group, − 4.1 (2.9) in the hpCS 400 mg group and − 1.0 (2.0) in the PLB group
Pharmacoeconomy    
Bruyère 2009 [58]
Knee OA
RCT
622 hpCS 800 mg/die
PLB
2 years
Health Utility Index better for hpCS than PLB at 6 months (p < 0.03)
Lagnaoui 2006 [59]
OA
Prospective observational
844 hpCS 800–1200 mg/day
Long-term (≥ 3 months)
Recent (< 3 months) users
Lower consumption of NSAIDs (p < 0.05) and analgesics (p < 0.01) by long-term users
Rubio-Terres 2010 [4]
OA
Observational retrospective
530 CS
NSAIDs
CS + NSAIDs
6-months
Treatment cost 6-month: CS €141; NSAIDs €182. Concomitant CS could reduce use of NSAIDs