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Bioavailable turmeric extract for knee osteoarthritis: a randomized, non-inferiority trial versus paracetamol.
Singhal, S, Hasan, N, Nirmal, K, Chawla, R, Chawla, S, Kalra, BS, Dhal, A
Trials. 2021;(1):105
Abstract
BACKGROUND To compare the efficacy and safety of bioavailable turmeric extract versus paracetamol in patients with knee osteoarthritis (OA). METHODS In this randomized, non-inferiority, controlled clinical study, patients of knee OA were randomized to receive bioavailable turmeric extract (BCM-95®) 500 mg capsule two times daily or paracetamol 650 mg tablet three times daily for 6 weeks. The primary outcome measure was Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale. The secondary outcome measures were WOMAC total, WOMAC stiffness, and WOMAC physical function scores. Responder analysis of individual patients at different levels (≥ 20%, ≥ 50%, and ≥ 70%) for WOMAC score was calculated. TNF alpha and CRP levels were evaluated and adverse events (AE) were also recorded. RESULTS Seventy-one and seventy-three knee OA patients, respectively in bioavailable turmeric extract and paracetamol groups, completed the study. Non-inferiority (equivalence) test showed that WOMAC scores were equivalent in both the groups (p value < 0.05) in all the domains within the equivalence limit defined by effect size (Cohen's d) of 0.5 whereas CRP and TNF-α were better reduced with turmeric extract than paracetamol. After 6 weeks of treatment, WOMAC total score, pain, stiffness, and function scores got a significant improvement of 23.59, 32.09, 28.5, and 20.25% respectively with turmeric extract. In the turmeric extract group, 18% of patients got more than 50% improvement and 3% of patients got more than 70% improvement in WOMAC pain and function/stiffness score and none of the patients in the paracetamol group met the criteria. CRP and TNF-α got significantly reduced (37.21 and 74.81% respectively) in the turmeric extract group. Adverse events reported were mild and comparatively less in the turmeric extract group (5.48%) than in the paracetamol group (12.68%). CONCLUSION The results of the study suggest that bioavailable turmeric extract is as effective as paracetamol in reducing pain and other symptoms of knee osteoarthritis and found to be safe and more effective in reducing CRP and TNF-α. TRIAL REGISTRATION Clinical Trials Registry - India CTRI/2017/02/007962 . Registered on 27 February 2017.
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Efficacy and safety of combination of curcuminoid complex and diclofenac versus diclofenac in knee osteoarthritis: A randomized trial.
Shep, D, Khanwelkar, C, Gade, P, Karad, S
Medicine. 2020;(16):e19723
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Abstract
BACKGROUND To compare the efficacy and safety of combination of curcuminoid complex and diclofenac vs diclofenac alone in the treatment of knee osteoarthritis (OA). METHODS In this randomized trial, 140 patients of knee OA received either curcuminoid complex 500 mg (BCM-95) with diclofenac 50 mg 2 times daily or diclofenac 50 mg alone 2 times daily for 28 days. Patients were assessed at baseline, day 14 and day 28. Primary efficacy measures were Knee injury and OA outcome score (KOOS) subscale at day 14 and day 28. Anti-ulcer effect and patient-physician's global assessment of therapy at day 28 were included as secondary endpoints. Safety after treatment was evaluated by recording adverse events and laboratory investigations. RESULTS Both treatment groups showed improvement in primary endpoints at each evaluation visit. Patients receiving curcuminoid complex plus diclofenac showed significantly superior improvement in KOOS subscales, viz. pain and quality of life at each study visit (P < .001) when compared to diclofenac. Less number of patients required rescue analgesics in curcuminoid complex plus diclofenac group (3%) compared to diclofenac group (17%). The number of patients who required histamine 2 (H2) blockers was significantly less in curcuminoid complex plus diclofenac group compared to diclofenac group (6% vs 28%, respectively; P < .001). Adverse effects were significantly less in curcuminoid complex plus diclofenac group (13% vs 38% in diclofenac group; P < .001). Patient's and physician's global assessment of therapy favored curcuminoid complex plus diclofenac than diclofenac. CONCLUSION Combination of curcuminoid complex and diclofenac showed a greater improvement in pain and functional capacity with better tolerability and could be a better alternative treatment option in symptomatic management of knee OA. TRIAL REGISTRATION ISRCTN, ISRCTN10074826.
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Mineral rich algae with pine bark improved pain, physical function and analgesic use in mild-knee joint osteoarthritis, compared to Glucosamine: A randomized controlled pilot trial.
Heffernan, SM, McCarthy, C, Eustace, S, FitzPatrick, RE, Delahunt, E, De Vito, G
Complementary therapies in medicine. 2020;:102349
Abstract
INTRODUCTION Osteoarthritis (OA) is characterised by synovial joint pain, functional disability and affects ∼13 % of people worldwide, of which ∼16-27 % report Knee-OA (KOA). Glucosamine (Glu) is the most widely used nutraceutical treatment for OA despite a lack of scientific consensus, therefore alternative nutraceutical treatments are required. The aim of this study was to investigate the effect of Lithothamnion species, seawater-derived magnesium and pine bark (Aq+) on pain, symptoms and improve physical function in symptomatic (sKOA), compared to Glu. METHODS 358 participants were screened. In a double-blinded crossover pilot-trial, sKOA participant (n = 30) were randomly assigned to either the Glu group (2000 mg day-1) or Aq+ (3056 mg day-1) for 12 weeks (clinicaltrials.gov:NCT03106584). The Knee Injury and Osteoarthritis Outcome Score was used to assess subjective pain and symptoms. Timed-up-and-Go (TuG) and Six minute walking distance were used to assess functional change and analgesic use was recorded. RESULTS Aq+ improved pain, with a large effect (P < 0.01, d' = 0.73, 95 %CI 0.201-1.265) and no change for Glu (d' = 0.38, P = 0.06). Only Aq+ improved pain (P < 0.05) for males (d' = 0.91, 95 %CI 0.162-1.667) and females (d' = 0.55, 95 %CI 0.210-1.299). In females, Aq+ improved TuG by -7.02 % (d' = 0.92, 95 %CI 1.699-0.141) while Glu worsened performance by 4.18 % (P = 0.04). Aq+ reduced analgesia by 71.6 %, compared to Glu (P = 0.02; d' = 0.82, 95 %CI 1.524-0.123). Aq+ was superior to Glu at improving pain, KOOS subscales, physical function and analgesia use in mild-sKOA. Given these data, Aq+ should be considered as a supplementary treatment for early-stage-KOA and may have the potential to reduce use of pain medication, although larger replication studies are required.
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Comparative efficacy and safety of Verbascox® - a proprietary herbal extract capable of inhibiting human cyclooxygenase-2 - and celecoxib for knee osteoarthritis.
Nannoni, G, Volterrani, G, Mattarocci, A, Minoretti, P, Emanuele, E
Drug discoveries & therapeutics. 2020;(3):129-134
Abstract
The aim of this randomized, single-blind, active-controlled pilot study was to investigate the clinical efficacy of oral supplementation with Verbascox®, a proprietary herbal extract capable of inhibiting human cyclooxygenase-2 (COX-2), in patients with mild-to-moderate osteoarthritis (OA) of the knee. Patients in the control group (n = 50) did not undergo any treatment (watchful waiting). Patients in the Verbascox® group (n = 50) received oral supplementation (800 mg/day) with the herbal extract for 2 weeks. The final study group consisted of patients (n = 50) who received celecoxib, a known pharmacological inhibitor of COX-2, 200 mg/day for 2 weeks. Examining physicians and laboratory personnel were blinded to group assignment, whereas patients were unblinded. All participants were evaluated using standard measures of pain relief and improvement in functional capacity at baseline, after 1 week, and at the end of the 2-week treatment course. Moreover, serum levels of substance P (SP), a member of the tachykinin family of neuropeptides involved in pain perception, were measured at the three time points. Both Verbascox® and celecoxib reduced pain, improved functional capacity, and lowered serum SP levels at 2 weeks compared with baseline, without significant inter-arm differences. Both Verbascox® and celecoxib showed a limited number of treatment-emergent adverse events. In summary, oral supplementation with Verbascox® (800 mg/day) in patients with mild-to-moderate OA of the knee is as effective and safe as a standard therapeutic dose of celecoxib in terms of pain relief and improvement in functional capacity after a 2-week treatment course.
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Timing of periarticular injection has no effect on postoperative pain and functional recovery in simultaneous bilateral total knee arthroplasty: a prospective randomized, double-blinded trial.
Laoruengthana, A, Jarusriwanna, A, Rattanaprichavej, P, Rasamimongkol, S, Varakornpipat, P, Pongpirul, K
BMC musculoskeletal disorders. 2019;(1):162
Abstract
BACKGROUND Given no consensus on optimal timeframe of periarticular multimodal drug injection (PMDI) in knee osteoarthritis patients undergoing total knee arthroplasty (TKA), this study was aimed to compare the postoperative pain and the functional recovery in patients who underwent simultaneous bilateral TKA (SBTKA) and received PMDI at the different intraoperative time points. METHODS This prospective, randomized, double-blinded controlled trial study included 48 patients who underwent SBTKA and received PMDI mixture, either before prosthetic implantation (late PMDI), or just after knee arthrotomy (early PMDI). Each subject's knees were randomly selected to different PMDI administration time points. The outcome parameters were postoperative pain assessed by using a visual analog scale (VAS), the maximal angle of knee flexion, and quadriceps function from day 1 to 6 weeks after surgery. RESULTS Late PMDI revealed slightly higher VAS at 6 and 12 h after the operation than early PMDI administration. Afterward, the VAS tended to be lower in the late than early PMDI administration until the end of the study, but without statistical significance. The time difference between early and late PMDI had no effect on postoperative VAS, while older age resulted in significantly less pain. No statistical differences between the two groups in all other outcome parameters were observed. CONCLUSIONS Postoperative pain reduction and functional recovery of SBTKA with early and late PMDI administration were not significantly different. The time interval of PMDI between knees did not confound the comparison of postoperative pain and functional recovery in SBTKA. TRIAL REGISTRATION The protocol of this study was retrospectively registered in the Thai Clinical Trials Registry database No. TCTR20170617001 on 16 June 2017.
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Safety and efficacy of curcumin versus diclofenac in knee osteoarthritis: a randomized open-label parallel-arm study.
Shep, D, Khanwelkar, C, Gade, P, Karad, S
Trials. 2019;(1):214
Abstract
BACKGROUND The purpose of this study was to compare the efficacy and safety of curcumin with those of diclofenac in the treatment of knee osteoarthritis (OA). METHODS In this randomized, open-label, parallel, active controlled clinical study, 139 patients with knee OA were randomly assigned to receive either a curcumin 500-mg (BCM-95®) capsule three times daily or a diclofenac 50-mg tablet two times daily for 28 days. Patients underwent assessment at baseline and days 7, 14, and 28. The main outcome measure was severity of pain using visual analogue scale score at days 14 and 28. Knee Injury and Osteoarthritis Outcome Score (KOOS) (at days 14 and 28), anti-flatulent effect (at day 7), anti-ulcer effect, weight-lowering effect, and patient's and physician's global assessment of therapy at day 28 were included as secondary outcome measures. Safety after treatment was evaluated by recording adverse events and laboratory investigation. RESULTS At days 14 and 28, patients receiving curcumin showed similar improvement in severity of pain and KOOS scale when compared with diclofenac, and the difference was not statistically significant. At day 7, the patients who received curcumin experienced a significantly greater reduction in the number of episodes of flatulence compared with diclofenac (P <0.01). At day 28, a weight-lowering effect (P <0.01) and anti-ulcer effect (P <0.01) of curcumin were observed. None of the patients required H2 blockers in the curcumin group, and 19 patients required H2 blockers in the diclofenac group (0% versus 28%, respectively; P <0.01). Adverse effects were significantly less in the curcumin group (13% versus 38% in the diclofenac group; P <0.01). Patient's and physician's global assessment of therapy was similar in the two treatment groups. CONCLUSION Curcumin has similar efficacy to diclofenac but demonstrated better tolerance among patients with knee OA. Curcumin can be an alternative treatment option in the patients with knee OA who are intolerant to the side effects of non-steroidal anti-inflammatory drugs. TRIAL REGISTRATION ISRCTN, ISRCTN10074826 . Registered 21 November 2017 - Retrospectively registered.
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The effects of two different water exercise trainings on pain, functional status and balance in patients with knee osteoarthritis.
Kunduracilar, Z, Guvenir Sahin, H, Sonmezer, E, Sozay, S
Complementary therapies in clinical practice. 2018;:374-378
Abstract
METHODS Eighty-nine female patients who had been diagnosed with knee osteoarthritis were divided into three groups as two experimental and a control group. All groups have received the standard therapy (hotpack, ultrasound, TENS). Both experimental groups underwent water exercise program. While Group 1 performed lower extremity exercise training, Group 2 performed upper extremity exercises as well as trunk exercises in addition to the lower extremity exercises used in the Group 1. The third group was control group who did not receive water exercise treatment. The pain severity was measured with the Visual Analog Scale (VAS). Functional status was assessed by using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Balance was evaluated by using the single leg stance test. RESULTS The change in VAS scores from pre-to post-treatment was highest in Group 1 (p < 0.001). On the other hand, the change in WOMAC pain, stiffness and physical function values from pre-to post-treatment was highest in Group 2 (p < 0.001). DISCUSSION Water exercise training was found to be beneficial in the treatment of knee osteoarthritis in both groups. Moreover, adding upper extremity and trunk exercises to the lower extremity exercises was found to be more effective for improving the function.
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Efficacy and safety of loxoprofen hydrogel patch versus loxoprofen tablet in patients with knee osteoarthritis: a randomized controlled non-inferiority trial.
Mu, R, Bao, CD, Chen, ZW, Zheng, Y, Wang, GC, Zhao, DB, Hu, SX, Li, YJ, Shao, ZW, Zhang, ZY, et al
Clinical rheumatology. 2016;(1):165-73
Abstract
This study is aimed at comparing the efficacy and safety of loxoprofen sodium hydrogel patch (LX-P) with loxoprofen sodium tablet (LX-T) in patients with knee osteoarthritis (OA). One hundred sixty-nine patients were enrolled in a randomized, controlled, double-blind, double-dummy, multicenter, non-inferiority trial of LX-P. Patients were randomly assigned to either LX-P or LX-T groups for a 4-week treatment. The primary efficacy endpoint was the proportion of patients with an overall improvement of ≥50%, and the secondary efficacy endpoint was the proportion of patients with an improvement of ≥25% from baseline in each of the seven main symptoms. The non-inferiority trial was based on a power of 80% and significance level of 2.5% with a non-inferiority margin of -10%. In both intention-to-treat (ITT) and per-protocol (PP) analyses, LX-P was as effective as LX-T in regard to the primary endpoint. In the ITT analysis, the difference between the two groups was 12.6% [95% confidence interval, -1.7 to 26.9%]. No significant differences were found between the two groups in any of the secondary efficacy outcomes. A lower incidence of adverse events was observed in LX-P group; however, the difference was not statistically significant. No serious adverse events were reported in the LX-P group, whereas one case was reported in LX-T group. Based on the present study, topical loxoprofen patch was non-inferior to oral loxoprofen in patients with knee osteoarthritis.
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[With herbal wraps for knee pain control].
MMW Fortschritte der Medizin. 2016;(5):9
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Prospective, randomized, double-blinded, double-dummy and multicenter phase IV clinical study comparing the efficacy and safety of PG201 (Layla) and SKI306X in patients with osteoarthritis.
Ha, CW, Park, YB, Min, BW, Han, SB, Lee, JH, Won, YY, Park, YS
Journal of ethnopharmacology. 2016;:1-7
Abstract
ETHNOPHARMACOLOGICAL RELEVANCE This prospective, randomized, double-blinded, double-dummy, multicenter study compared the efficacy and safety of PG201 (Layla®), a new product from extracts of 12 plant sources and SKI306X (Joins®) which have been well investigated and in relatively wide usage among herbal medicine, for the treatment of patients with knee osteoarthritis. AIM OF THE STUDY To compare the efficacy and safety of PG201 and SKI306X in patients with knee osteoarthritis. MATERIALS AND METHODS A prospective, double-blinded multicenter study was conducted in 124 patients with Kellgren and Lawrence grade 2-3 knee osteoarthritis. Patients were randomly assigned to receive 600mg of PG201 (300mg, twice daily) and 600mg of SKI306X placebo (200mg, thrice daily) or 600mg of SKI306X (200mg, thrice daily) and PG201 placebo (300mg, twice daily) for 12 weeks. The primary outcome was the improvement of pain by week 8 as assessed by the 100-mm pain visual analog scale (VAS). Secondary outcomes included pain VAS improvement level at week 12, pain VAS improvement rate at weeks 8 and 12, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) improvement level at weeks 8 and 12, the improvement of the quality of life (EQ-5D), overall symptom self-assessment score, and rescue medication consumption. RESULTS The pain VAS improvement at 8 weeks was 14.2±16.2 in the experimental group and 11.9±13.1 in control group (p=0.557), confirming that the experimental group was not inferior to the control group as lower limit (-8.38) of 95% CI of the difference of VAS improvement between two groups was well above the allowed limit (-10 mm). There was no significant difference in all secondary outcomes including pain VAS, WOMAC, EQ-5D, overall symptom self-assessment score, and rescue medication consumption. Adverse events were low and similar between the two groups. CONCLUSIONS The results of this study showed that PG201 significantly reduced knee pain and improved knee function and were comparable to SKI306X. PG201 can be suggested as an effective treatment of knee osteoarthritis. Trial registration ClinicalTrials.gov:NCT01768468.