Effect of glucosamine sulphate on joint space narrowing, pain and function in patients with hip osteoarthritis; subgroup analyses of a randomized controlled trial

Department of General Practice, Erasmus MC, University Medical Center Rotterdam, The Netherlands.
Osteoarthritis and Cartilage (Impact Factor: 4.17). 10/2008; 17(4):427-32. DOI: 10.1016/j.joca.2008.05.022
Source: PubMed


Recently we reported that glucosamine sulphate (GS) did not have an effect on the symptoms and progression of primary care patients with hip osteoarthritis (OA). The aim of this present study was to investigate whether there are subgroups of patients with hip OA for whom GS might be an effective therapy.
We randomized 222 patients with hip OA that met one of the American College of Rheumatology criteria to either 1500 mg of oral GS or placebo once daily for 2 years. Subgroup analyses were predefined for radiographic severity (Kellgren & Lawrence (KL)=1 vs >or=2) and for type of OA (localised vs generalised). Additional exploratory subgroup analyses focused on groups based on pain level, pain medication use, baseline joint space width (JSW), and concomitant knee OA at baseline. Primary outcome measures were Western Ontario MacMaster Universities (WOMAC) pain and function scores over 24 months, and joint space narrowing (JSN) after 24 months.
In the predefined subgroups based on radiographic severity and type of OA, the outcomes WOMAC pain, function and JSN were similar for the GS and placebo group.
GS was not significantly better than placebo in reducing symptoms and progression of hip OA in subgroups of patients.

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    • "The study population consisted of primary care patients diagnosed with hip OA (N = 222) who participated in a prospective, randomized , controlled trial that assessed the effect of glucosamine sulphate (the GOAL trial: glucosamine sulphate in hip osteoarthritis)161718. The Medical Ethics Committee of the Erasmus MC approved the study design, and all patients provided written informed consent. "
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    ABSTRACT: The goal was to assess whether there is an association between ambient weather conditions and patients' clinical symptoms in patients with hip osteoarthritis (OA). The design was a cohort study with a 2-year follow-up and 3-monthly measurements and prospectively collected data of weather variables. The study population consisted of 222 primary care patients with hip OA. Weather variables included temperature, wind speed, total amount of sun hours, precipitation, barometric pressure, and relative humidity. The primary outcomes were severity of hip pain and hip disability measured with the Western Ontario and McMasters University Osteoarthritis Index (WOMAC) pain and function subscales. Associations between hip pain and hip disability and the weather variables were assessed using crude and multivariate adjusted linear mixed-model analysis for repeated measurements. On the day of questionnaire completion, mean relative humidity was associated with WOMAC pain (estimate 0.1; 95%CI 0.0-0.2; p 0.02). Relative humidity contributed ⩽1% to the explained within-patient variance and between-patient variance of the WOMAC pain score. Mean barometric pressure was associated with WOMAC function (estimate 0.1; 95%CI 0.0-0.1; p 0.02). Barometric pressure contributed ⩽1% to the explained within-patient variance and between-patient variance of the WOMAC function score. The other weather variables were not associated with the WOMAC pain or function score. Our results support the general opinion of OA patients that barometric pressure and relative humidity influences perceived OA symptoms. However, the contribution of these weather variables (⩽1%) to the severity of OA symptoms is not considered to be clinically relevant.
    No preview · Article · Jan 2014 · Pain
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    • "When considering only high quality trials, the ES for glucosamine sulfate decreased to 0.29 (0.003 to 0.57), with no publication bias but still heterogeneity outcomes of trials. The same analysis revealed a small but significant ES (0.24 (0.04 to 0.43)) for glucosamine sulfate for reduction of joint space loss in the medial compartment of knee OA patients, as reported by two sponsored RCTs [55,56], but a non-significant effect on joint space narrowing in hip OA patients after a 24-month treatment either when considering the whole study group [66] or when analyzing predefined subgroups for OA severity [64]. The same conclusion was reached by the Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT), with a ES of 0.15 (-0.07 to 0.38) [61]. "
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    ABSTRACT: Glucosamine in its acetylated form is a natural constituent of some glycosaminoglycans (for example, hyaluronic acid and keratan sulfate) in the proteoglycans found in articular cartilage, intervertebral disc and synovial fluid. Glucosamine can be extracted and stabilized by chemical modification and used as a drug or a nutraceutical. It has been approved for the treatment of osteoarthritis (OA) in Europe to promote cartilage and joint health and is sold over the counter as a dietary supplement in the United States. Various formulations of glucosamine have been tested, including glucosamine sulfate and glucosamine hydrochloride. In vitro and in vivo studies have uncovered glucosamine's mechanisms of action on articular tissues (cartilage, synovial membrane and subchondral bone) and justified its efficacy by demonstrating structure-modifying and anti-inflammatory effects at high concentrations. However, results from clinical trials have raised many concerns. Pharmacokinetic studies have shown that glucosamine is easily absorbed, but the current treatment doses (for example, 1,500 mg/day) barely reach the required therapeutic concentration in plasma and tissue. The symptomatic effect size of glucosamine varies greatly depending on the formulation used and the quality of clinical trials. Importantly, the effect size reduces when evidence is accumulated chronologically and evidence for the structure-modifying effects of glucosamine are sparse. Hence, glucosamine was at first recommended by EULAR and OARSI for the management of knee pain and structure improvement in OA patients, but not in the most recent NICE guidelines. Consequently, the published recommendations for the management of OA require revision. Glucosamine is generally safe and although there are concerns about potential allergic and salt-related side effects of some formulations, no major adverse events have been reported so far. This paper examines all the in vitro and in vivo evidence for the mechanism of action of glucosamine as well as reviews the results of clinical trials. The pharmacokinetics, side effects and differences observed with different formulations of glucosamine and combination therapies are also considered. Finally, the importance of study design and criteria of evaluation are highlighted as new compounds represent new interesting options for the management of OA.
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    • "This showed they had a mean VAS score of 56.4 with an SD of 19.3, a mean WOMAC pain score of 51.2 with a SD of 16.4; these data are very similar to the SDs in the study of Qvistgaard et al. Therefore, in the planned trial, we will include 135 patients, anticipating only 5% loss to follow-up based on the relatively short follow-up and earlier experience with loss to follow-up [22,23]. "
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    ABSTRACT: Recent international guidelines recommend intra-articular corticosteroid injections for patients with hip osteoarthritis who have moderate to severe pain and do not respond satisfactorily to oral analgesic/anti-inflammatory agents. Of the five available randomized controlled trials, four showed positive effects with respect to pain reduction. However, intra-articular injection in the hip is complex because the joint is adjacent to important neurovascular structures and cannot be palpated. Therefore fluoroscopic or ultrasound guidance is needed.The systemic effect of corticosteroids has been studied in patients with impingement shoulder pain. Gluteal corticosteroid injection was almost as effective as ultrasound-guided subacromial corticosteroid injection. Such a clinically relevant effect of a systemic corticosteroid injection offers a less complex alternative for treatment of patients with hip osteoarthritis not responsive to oral pain medication. This is a double-blinded, randomized controlled trial. A total of 135 patients (aged > 40 years) with hip osteoarthritis and persistent pain despite oral analgesics visiting a general practitioner or orthopaedic surgeon will be included. They will be randomized to a gluteal intramuscular corticosteroid injection or a gluteal intramuscular placebo (saline) injection. The randomization will be stratified for setting (general practitioner and outpatient clinics of department of orthopaedics). Treatment effect will be evaluated by questionnaires at 2, 4, 6, and 12 weeks follow-up and a physical examination at 12 weeks. Primary outcome is severity of hip pain reported by the patients at 2-week follow-up. Statistical analyses will be based on the intention-to-treat principle. This study will evaluate the effectiveness of an intramuscular corticosteroid injection on pain in patients with hip osteoarthritis. Patient recruitment has started. This trial is registered in the Dutch Trial Registry: number NTR2966.
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