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Clinical Efficacy and Safety of Yellow Oil Formulations 3 and 4 versus Indomethacin Solution in Patients with Symptomatic Osteoarthritis of the Knee: A Randomized Controlled Trial.

ABSTRACT: Background:Topical nonsteroidal anti-inflammatory drugs (NSAIDs) are widely prescribed for the treatment of symptomatic osteoarthritis (OA) of the knee. However, searching for alternatives such as locally available medicinal herbs to manage OA knee pain remains of clinical value. The objective of the present study was to evaluate the efficacy and safety of two yellow oil formulations in patients with OA of the knee. Methods:This prospective, randomized, single-blind, active-controlled, noninferiority study enrolled 102 patients with OA of the knee. Eligible patients were randomly assigned to apply either yellow oil formulation 3 (YOF3), yellow oil formulation 4 (YOF4), or indomethacin solution (INDO) topically four times daily for four weeks. Outcomes were assessed on a biweekly basis. The primary efficacy outcome measure was a 100?mm visual analog scale (VAS) of pain, while secondary endpoints included knee function, physical performance assessments, and safety parameters. Modified intention-to-treat and per-protocol analyses were applied. Assessment of noninferiority was done with a prespecified margin of 10?mm for VAS pain. Results:Of 102 patients enrolled, 86 completed the study: 29/34 in the YOF3 group, 25/34 in the YOF4 group, and 32/34 in the INDO group. The absolute reduction in VAS pain at the final evaluation was -25.06?±?13.91, -18.50?±?16.06, and -23.38?±?10.05?mm in the YOF3, YOF4, and INDO groups, respectively (p=0.169). Only YOF3 was found to be noninferior to INDO. Other efficacy outcomes were significantly improved in all three groups. All the interventions were well tolerated; no skin rash was observed in any of the three groups. Conclusions:YOF3 was shown to be noninferior to INDO in relieving knee pain and should be considered an alternative for the treatment of symptomatic OA of the knee. Further research into the mechanism of action of YOF3 and its long-term efficacy and safety is required.

SUBMITTER: Koonrungsesomboon N

PROVIDER: S-EPMC7397436 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Clinical Efficacy and Safety of Yellow Oil Formulations 3 and 4 versus Indomethacin Solution in Patients with Symptomatic Osteoarthritis of the Knee: A Randomized Controlled Trial.

Koonrungsesomboon Nut N Teekachunhatean Supanimit S Chansakaow Sunee S Hanprasertpong Nutthiya N

Evidence-based complementary and alternative medicine : eCAM 20200725

<h4>Background</h4>Topical nonsteroidal anti-inflammatory drugs (NSAIDs) are widely prescribed for the treatment of symptomatic osteoarthritis (OA) of the knee. However, searching for alternatives such as locally available medicinal herbs to manage OA knee pain remains of clinical value. The objective of the present study was to evaluate the efficacy and safety of two yellow oil formulations in patients with OA of the knee.<h4>Methods</h4>This prospective, randomized, single-blind, active-contro ...[more]

PMID: 32774422

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Project description:BackgroundThere are no proven therapies that modify the structural changes associated with osteoarthritis (OA). Preclinical data suggests that intra-articular recombinant human BMP-7 (bone morphogenetic protein-7) has reparative effects on cartilage, as well as on symptoms of joint pain. The objective of this study was to determine the safety and tolerability as well as dose-limiting toxicity and maximal tolerated dose of intra-articular BMP-7. The secondary objectives were to determine the effect on symptomatic responses through 24 weeks.MethodsThis was a Phase 1, double-blind, randomized, multi-center, placebo-controlled, single-dose escalation safety study consisting of 4 dosing cohorts in participants with knee OA. Each cohort was to consist of 8 treated participants, with treatment allocation in a 3:1 active (intra-articular BMP-7) to placebo ratio. Eligible participants were persons with symptomatic radiographic knee OA over the age of 40. The primary objective of this study was to determine the safety and tolerability of BMP-7 including laboratory assessments, immunogenicity data and radiographic assessments. Secondary objectives were to determine the proportion of participants with a 20%, 50%, and 70% improvement in the WOMAC pain and function subscales at 4, 8, 12, and 24 weeks. Other secondary outcomes included the change from baseline to 4, 8, 12, and 24 weeks for the OARSI responder criteria.ResultsThe mean age of participants was 60 years and 73% were female. All 33 participants who were enrolled completed the study and most adverse events were mild or moderate and were similar in placebo and BMP-7 groups. The 1 mg BMP-7 group showed a higher frequency of injection site pain and there was no ectopic bone formation seen on plain x-rays. By week 12, most participants in both the BMP-7 and placebo groups experienced a 20% improvement in pain and overall the BMP-7 group was similar to placebo with regard to this measurement. In the participants who received 0.1 mg and 0.3 mg BMP-7, there was a trend toward greater symptomatic improvement than placebo. The other secondary endpoints showed similar trends including the OARSI responder criteria for which the BMP-7 groups had more responders than placebo.ConclusionsThere was no dose limiting toxicity identified in this study. The suggestion of a symptom response, together with the lack of dose limiting toxicity provide further support for the continued development of this product for the treatment of osteoarthritis.

Project description:BackgroundExperimental and clinical evidence support a link between body representations and pain. This proof-of-concept study in people with painful knee osteoarthritis (OA) aimed to determine if: (i) visuotactile illusions that manipulate perceived knee size are analgesic; (ii) cumulative analgesic effects occur with sustained or repeated illusions.MethodsParticipants with knee OA underwent eight conditions (order randomised): stretch and shrink visuotactile (congruent) illusions and corresponding visual, tactile and incongruent control conditions. Knee pain intensity (0-100 numerical rating scale; 0 = no pain at all and 100 = worst pain imaginable) was assessed pre- and post-condition. Condition (visuotactile illusion vs control) × Time (pre-/post-condition) repeated measure ANOVAs evaluated the effect on pain. In each participant, the most beneficial illusion was sustained for 3 min and was repeated 10 times (each during two sessions); paired t-tests compared pain at time 0 and 180s (sustained) and between illusion 1 and illusion 10 (repeated).ResultsVisuotactile illusions decreased pain by an average of 7.8 points (95% CI [2.0-13.5]) which corresponds to a 25% reduction in pain, but the tactile only and visual only control conditions did not (Condition × Time interaction: p = 0.028). Visuotactile illusions did not differ from incongruent control conditions where the same visual manipulation occurred, but did differ when only the same tactile input was applied. Sustained illusions prolonged analgesia, but did not increase it. Repeated illusions increased the analgesic effect with an average pain decrease of 20 points (95% CI [6.9-33.1])-corresponding to a 40% pain reduction.DiscussionVisuotactile illusions are analgesic in people with knee OA. Our results suggest that visual input plays a critical role in pain relief, but that analgesia requires multisensory input. That visual and tactile input is needed for analgesia, supports multisensory modulation processes as a possible explanatory mechanism. Further research exploring the neural underpinnings of these visuotactile illusions is needed. For potential clinical applications, future research using a greater dosage in larger samples is warranted.

Project description:Genicular artery embolization (GAE) is a novel therapy to treat patients with symptomatic knee osteoarthritis (OA) by reducing synovial arterial hypervascularity. This study evaluates the safety and efficacy of GAE for the treatment of symptomatic knee OA. A prospective, single-center, open-label U.S. Food and Drug Administration-approved investigational device exemption study was conducted. Patients enrolled in the study were 40 to 80 years old, with moderate or severe knee OA (Kellgren-Lawrence grade 2, 3, or 4), who previously had failure of conservative therapy. Baseline pain (visual analog scale [VAS]) and symptom scores (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]) were assessed. After femoral arterial access was achieved, GAE of 1, 2, or 3 genicular arteries supplying the location of the subject's pain, as determined by digital subtraction angiography and cone-beam computed tomography, was performed using 100-μm particles. Adverse events and symptoms scores were assessed at 1 week, 1 month, 3 months, 6 months, and 1 year after GAE. Over a 10-month period, 40 subjects were enrolled. The median age was 69 years (range, 49 to 80 years). The median body mass index was 29 kg/m2 (range, 19 to 44 kg/m2). Knee OA severity was grade 2 in 18% of the patients, grade 3 in 43%, and grade 4 in 40%. Technical success was achieved in 100% of the subjects. Transient skin discoloration and transient mild knee pain after the procedure were common and expected. Treatment-related adverse events included a groin hematoma requiring overnight observation in 1 subject, self-resolving focal skin ulceration in 7 subjects, and an asymptomatic small bone infarct on magnetic resonance imaging at 3 months in 2 subjects. The WOMAC total and VAS pain scores decreased by 61% and 67% at 12 months from a median baseline of 52 (of 96) and 8 (of 10), respectively. Twenty-seven patients (68%) had a reduction of ≥50% in both WOMAC total and VAS pain scores. This prospective trial demonstrates that GAE is effective and durable in reducing pain symptoms from moderate or severe knee OA that is refractory to other conservative therapy, with an acceptable safety profile. Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Project description:BACKGROUND:Knee osteoarthritis (OA) is a common and important cause of pain and disability, but interventions aimed at modifying structures visible on imaging have been disappointing. While OA affects the whole joint, synovitis and effusion have been recognised as having a role in the pathogenesis of OA. Krill oil reduces knee pain and systemic inflammation and could be used for targeting inflammatory mechanisms of OA. METHODS/DESIGN:We will recruit 260 patients with clinical knee OA, significant knee pain and effusion-synovitis present on MRI in five Australian cities (Hobart, Melbourne, Sydney, Adelaide and Perth). These patients will be randomly allocated to the two arms of the study, receiving 2?g/day krill oil or inert placebo daily for 6?months. MRI of the study knee will be performed at screening and after 6?months. Knee symptoms, function and MRI structural abnormalities will be assessed using validated methods. Safety data will be recorded. Primary outcomes are absolute change in knee pain (assessed by visual analog score) and change in size of knee effusion-synovitis over 24?weeks. Secondary outcomes include improvement in knee pain over 4, 8, 12, 16 and 20?weeks. The primary analyses will be intention-to-treat analyses of primary and secondary outcomes. Per protocol analyses adjusting for missing data and for treatment compliance will be performed as the secondary analyses. DISCUSSION:This study will provide high-quality evidence to assess whether krill oil 2?g/day reduces pain and effusion-synovitis size in older adults with clinical knee OA and knee effusion-synovitis. If krill oil is effective and confirmed to be safe, we will provide compelling evidence that krill oil improves pain and function, changes disease trajectory and slows disease progression in OA. Given the lack of approved therapies for slowing disease progression in OA, and moderate cost of krill oil, these findings will be readily translated into clinical practice. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry, ACTRN12616000726459. Registered on 02 June 2016. Universal Trial Number (UTN) U1111-1181-7087.

Dataset Information

Clinical Efficacy and Safety of Yellow Oil Formulations 3 and 4 versus Indomethacin Solution in Patients with Symptomatic Osteoarthritis of the Knee: A Randomized Controlled Trial.

Publications

Clinical Efficacy and Safety of Yellow Oil Formulations 3 and 4 versus Indomethacin Solution in Patients with Symptomatic Osteoarthritis of the Knee: A Randomized Controlled Trial.

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