Primary studies included in this systematic review

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Primary study

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Glucosamine and chondroitin for knee osteoarthritis: a double-blind randomised placebo-controlled clinical trial evaluating single and combination regimens.

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Journal Annals of the rheumatic diseases
Year 2015
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This article is included in 11 Systematic reviews Systematic reviews (11 references)

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<b>OBJECTIVE: </b>To determine if the dietary supplements, glucosamine and/or chondroitin, result in reduced joint space narrowing (JSN) and pain among people with symptomatic knee osteoarthritis. <b>METHODS: </b>A double-blind randomised placebo-controlled clinical trial with 2-year follow-up. 605 participants, aged 45-75 years, reporting chronic knee pain and with evidence of medial tibio-femoral compartment narrowing (but retaining &gt;2 mm medial joint space width) were randomised to once daily: glucosamine sulfate 1500 mg (n=152), chondroitin sulfate 800 mg (n=151), both dietary supplements (n=151) or matching placebo capsules (n=151). JSN (mm) over 2 years was measured from digitised knee radiographs. Maximum knee pain (0-10) was self-reported in a participant diary for 7 days every 2 months over 1 year. <b>RESULTS: </b>After adjusting for factors associated with structural disease progression (gender, body mass index (BMI), baseline structural disease severity and Heberden's nodes), allocation to the dietary supplement combination (glucosamine-chondroitin) resulted in a statistically significant (p=0.046) reduction of 2-year JSN compared to placebo: mean difference 0.10 mm (95% CI 0.002 mm to 0.20 mm); no significant structural effect for the single treatment allocations was detected. All four allocation groups demonstrated reduced knee pain over the first year, but no significant between-group differences (p=0.93) were detected. 34 (6%) participants reported possibly-related adverse medical events over the 2-year follow-up period. <b>CONCLUSIONS: </b>Allocation to the glucosamine-chondroitin combination resulted in a statistically significant reduction in JSN at 2 years. While all allocation groups demonstrated reduced knee pain over the study period, none of the treatment allocation groups demonstrated significant symptomatic benefit above placebo. <b>Trial Registration Clinicaltrialsgov Identifier: </b>NCT00513422; http://www.clinicaltrials.gov.

Primary study

Unclassified

No effect of glucosamine sulfate on osteoarthritis in the temporomandibular joints--a randomized, controlled, short-term study.

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Authors Cahlin BJ , Dahlström L
Journal Oral surgery, oral medicine, oral pathology, oral radiology, and endodontics
Year 2011
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This article is included in 5 Systematic reviews Systematic reviews (5 references)

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OBJECTIVE: The aim of this study was to evaluate the clinical effects of oral glucosamine sulfate, compared with placebo, on osteoarthritis in the temporomandibular joints (TMJs). STUDY DESIGN: Fifty-nine patients, consecutive referrals fulfilling the research diagnostic criteria for temporomandibular disorder for TMJ osteoarthritis, confirmed roentgenographically, were randomized to the daily intake of 1,200 mg glucosamine sulfate or identical placebo capsules in this double-blind trial. Pain on visual and verbal rating scales and opening capacity were registered before and after 6 weeks of medication. RESULTS: The signs and symptoms were similar in the groups initially and they were ameliorated over time. No differences in improvement between groups after treatment were indicated. Eight patients in the glucosamine group and 2 in the placebo group stopped the medication prematurely. Gastrointestinal side effects were reported by a total of 10 and 3 patients, respectively. CONCLUSIONS: Oral glucosamine sulfate was not superior to placebo in reducing signs and symptoms of osteoarthritis in the TMJs in this short-term trial.

Primary study

Unclassified

A randomized controlled exploratory evaluation of standardized ayurvedic formulations in symptomatic osteoarthritis knees: A Government of India NMITLI project

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Journal Evidence-based complementary and alternative medicine : eCAM
Year 2011
Links Pubmed DOI PubMed Central

This article is included in 5 Systematic reviews Systematic reviews (5 references)

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The multidisciplinary "New Millennium Indian Technology Leadership Initiative" Arthritis Project was undertaken to validate Ayurvedic medicines. Herbal formulations in popular use were selected by expert consensus and standardized using modern tools. Our clinical strategy evolved from simple exploratory evaluations to better powered statistically designed drug trials. The results of the first drug trial are presented here. Five oral formulations (coded A, B, C, D and E), with a common base of Zingiber officinale and Tinospora cordifolia with a maximum of four plant extracts, were evaluated; with placebo and glucosamine as controls. 245 patients suffering from symptomatic OA knees were randomized into seven arms (35 patients per arm) of a double blind, parallel efficacy, multicentric trial of sixteen weeks duration. The groups matched well at baseline. There were no differences for patient withdrawals (17.5%) or adverse events (AE) of mild nature. Intention-to-treat efficacy analysis, demonstrated no significant differences (P < .05) for pain (weight bearing) and WOMAC questionnaire (knee function); placebo response was high. Based on better pain relief, significant (P < .05) least analgesic consumption and improved knee status, "C" formulation was selected for further development. Controlled exploratory drug trials with multiple treatment arms may be used to economically evaluate several candidate standardized formulations.

Primary study

Unclassified

The efficacy and tolerability of glucosamine sulfate in the treatment of knee osteoarthritis: a randomized, double-blind, placebo-controlled trial.

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Journal Current therapeutic research, clinical and experimental
Year 2009
Links Pubmed DOI PubMed Central

This article is included in 6 Systematic reviews Systematic reviews (6 references) 1 Broad synthesis Broad syntheses (1 reference)

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BACKGROUND: Osteoarthritis (OA) is the most common form of arthritis and is often associated with disability and impaired quality of life. OBJECTIVE: The aim of the study was to assess the efficacy and tolerability of glucosamine sulfate (GS) in the treatment of knee OA. METHODS: Consecutive outpatients affected by primary monolateral or bilateral knee OA were enrolled in this double-blind, double-dummy, prospective, randomized, placebo-controlled trial. One group received GS 1500 mg QD for 12 weeks, and the other group received placebo QD for 12 weeks. The treatment period was followed by a 12-week treatment-free observation phase. Each patient was examined at baseline and at weeks 4, 8, 12, 16, 20, and 24. The primary efficacy criteria were pain at rest and during movement, assessed on a visual analog scale (VAS) of 0 to 100 mm. The secondary criteria included the Western Ontario and McMaster Universities (WOMAC) index for total pain score (W-TPS), total stiffness score (W-TSS), and total physical function score (W-TPFS). VAS, W-TPS, W-TSS, and W-TPFS were evaluated at baseline and at weeks 4, 8, 12, 16, 20, and 24. Analgesic drug consumption (ie, acetaminophen or NSAIDs) was also assessed. RESULTS: Patient demographics were similar in the GS and placebo groups. Of 60 randomized patients (30 per group), 56 completed the study (28 treated with GS and 28 who received placebo). Statistically significant improvements in symptomatic knee OA were observed, as measured by differences in resting pain at weeks 8, 12, and 16 (all, P &lt; 0.05 vs placebo) and in pain during movement at weeks 12 and 16 (both, P &lt; 0.05). W-TPS was lower with GS than placebo at weeks 8, 12, and 16 (all, P &lt; 0.01), and at week 20 (P &lt; 0.05). W-TSS was also lower with GS than placebo at weeks 8, 12, 16, and 20 (all, P &lt; 0.05). W-TPFS was lower with GS than placebo at weeks 8 (P &lt; 0.05), 12 (P &lt; 0.01), 16 (P &lt; 0.05), and 20 (P &lt; 0.05). Drug consumption was lower in the GS group than the placebo group at weeks 8, 12, 16, and 20 (all, P &lt; 0.05). The incidence of adverse events was 36.7% with GS and 40.0% with placebo. CONCLUSIONS: GS 1500 mg QD PO for 12 weeks was associated with statistically significant reductions in pain and improvements in functioning, with decreased analgesic consumption, compared with baseline and placebo in these patients with knee OA. A carryover effect was detected after treatment ended.

Primary study

Unclassified

Effect of glucosamine sulfate on hip osteoarthritis: a randomized trial.

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Journal Annals of internal medicine
Year 2008
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This article is included in 10 Systematic reviews Systematic reviews (10 references) 2 Broad syntheses Broad syntheses (2 references)

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<b>BACKGROUND: </b>The effectiveness of glucosamine sulfate as a symptom and disease modifier for osteoarthritis is still under debate.<b>OBJECTIVE: </b>To assess whether glucosamine sulfate has an effect on the symptoms and structural progression of hip osteoarthritis during 2 years of treatment.<b>DESIGN: </b>Randomized, controlled trial.<b>SETTING: </b>Primary care in the Netherlands.<b>PATIENTS: </b>222 patients with hip osteoarthritis who were recruited by their general practitioner. Patients were eligible if they met the American College of Rheumatology clinical criteria for hip osteoarthritis.<b>Intervention: </b>2 years of treatment with 1500 mg of oral glucosamine sulfate or placebo once daily.<b>Measurements: </b>Primary outcome measures were Western Ontario and McMaster Universities (WOMAC) pain and function subscales over 24 months and joint space narrowing after 24 months. The main secondary outcome measures were WOMAC pain, function, and stiffness after 3, 12, and 24 months.<b>RESULTS: </b>At baseline, both groups were similar in demographic and clinical variables. Overall, WOMAC pain did not differ (mean difference [glucosamine sulfate minus placebo], -1.54 [95% CI, -5.43 to 2.36]), nor did WOMAC function (mean difference, -2.01 [CI, -5.38 to 1.36]). Joint space narrowing also did not differ after 24 months (mean difference, -0.029 [CI, -0.122 to 0.064]). Only 1 of the sensitivity analyses, based on extreme assumptions regarding missing assessments due to total hip replacement, provided results consistent with a glucosamine effect.<b>Limitations: </b>Twenty patients had total hip replacement during the trial. Half of the patients had a Kellgren and Lawrence score of 1.<b>CONCLUSION: </b>Glucosamine sulfate was no better than placebo in reducing symptoms and progression of hip osteoarthritis. International Standard Randomised Controlled Trial Number: ISRCTN54513166.

Primary study

Unclassified

A natural mineral supplement provides relief from knee osteoarthritis symptoms: a randomized controlled pilot trial.

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Journal Nutrition journal
Year 2008
Links Pubmed DOI PubMed Central

This article is included in 6 Systematic reviews Systematic reviews (6 references) 1 Broad synthesis Broad syntheses (1 reference)

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<b>BACKGROUND: </b>This small, pilot study evaluated the impact of treatment with a natural multi-mineral supplement from seaweed (Aquamin) on walking distance, pain and joint mobility in subjects with moderate to severe osteoarthritis of the knee.<b>METHODS: </b>Subjects (n = 70) with moderate to severe osteoarthritis of the knee were randomized to four double-blinded treatments for 12 weeks: (a) Glucosamine sulfate (1500 mg/d); (b) Aquamin (2400 mg/d); (c) Combined treatment composed of Glucosamine sulfate (1500 mg/d) plus Aquamin (2400 mg/d) and (d) Placebo. Primary outcome measures were WOMAC scores and 6 Minute Walking Distances (6 MWD). Laboratory based blood tests were used as safety measures.<b>RESULTS: </b>Fifty subjects completed the study and analysis of the data showed significant differences between the groups for changes in WOMAC pain scores over time (p = 0.009 ANCOVA); however, these data must be reviewed with caution since significant differences were found between the groups at baseline for WOMAC pain and stiffness scores (p = 0.0039 and p = 0.013, respectively, ANOVA). Only the Aquamin and Glucosamine groups demonstrated significant improvements in symptoms over the course of the study. The combination group (like the placebo group) did not show any significant improvements in OA symptoms in this trial. Within group analysis demonstrated significant improvements over time on treatment for the WOMAC pain, activity, composite and stiffness (Aquamin only) scores as well as the 6 minute walking distances for subjects in the Aquamin and Glucosamine treatment groups. The Aquamin and Glucosamine groups walked 101 feet (+7%) and 56 feet (+3.5%) extra respectively. All treatments were well tolerated and the adverse events profiles were not significantly different between the groups.<b>CONCLUSION: </b>This small preliminary study suggested that a multi mineral supplement (Aquamin) may reduce the pain and stiffness of osteoarthritis of the knee over 12 weeks of treatment and warrants further study.<b>Trial Registration: </b>ClinicalTrials.gov number: NCT00452101.

Primary study

Unclassified

Glucosamine sulfate in the treatment of knee osteoarthritis symptoms: a randomized, double-blind, placebo-controlled study using acetaminophen as a side comparator.

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Journal Arthritis and rheumatism
Year 2007
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This article is included in 22 Systematic reviews Systematic reviews (22 references) 3 Broad syntheses Broad syntheses (3 references)

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OBJECTIVE: To assess the effects of the prescription formulation of glucosamine sulfate (1,500 mg administered once daily) on the symptoms of knee osteoarthritis (OA) during a 6-month treatment course. METHODS: Three hundred eighteen patients were enrolled in this randomized, placebo-controlled, double-blind trial in which acetaminophen, the currently preferred medication for symptomatic treatment of OA, was used as a side comparator. Patients were randomly assigned to receive oral glucosamine sulfate 1,500 mg once daily (n = 106), acetaminophen 3 gm/day (n = 108), or placebo (n = 104). The primary efficacy outcome measure was the change in the Lequesne index after 6 months. Secondary parameters included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and response according to the Osteoarthritis Research Society International criteria. These outcome measures were assessed using an intent-to-treat analysis. RESULTS: At baseline, the study patients had moderately severe OA symptoms (mean Lequesne index approximately 11 points). Glucosamine sulfate was more effective than placebo in improving the Lequesne score, with a final decrease of 3.1 points, versus 1.9 with placebo (difference between glucosamine sulfate and placebo -1.2 [95% confidence interval -2.3, -0.8]) (P = 0.032). The 2.7-point decrease with acetaminophen was not significantly different from that with placebo (difference -0.8 [95% confidence interval -1.9, 0.3]) (P = 0.18). Similar results were observed for the WOMAC. There were more responders to glucosamine sulfate (39.6%) and acetaminophen (33.3%) than to placebo (21.2%) (P = 0.004 and P = 0.047, respectively, versus placebo). Safety was good, and was comparable among groups. CONCLUSION: The findings of this study indicate that glucosamine sulfate at the oral once-daily dosage of 1,500 mg is more effective than placebo in treating knee OA symptoms. Although acetaminophen also had a higher responder rate compared with placebo, it failed to show significant effects on the algofunctional indexes.

Primary study

Unclassified

Effectiveness of glucosamine for symptoms of knee osteoarthritis: results from an internet-based randomized double-blind controlled trial.

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Journal The American journal of medicine
Year 2004
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This article is included in 14 Systematic reviews Systematic reviews (14 references) 1 Broad synthesis Broad syntheses (1 reference)

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PURPOSE: To present the safety and effectiveness results of a prototypical 12-week, double-blind, randomized placebo-controlled trial of glucosamine among subjects with knee osteoarthritis who were recruited and followed entirely over the Internet. METHODS: The study comprised 205 subjects aged 45 years or older with symptomatic knee osteoarthritis who were recruited over the Internet; eligibility was authenticated through medical record review. Participants were assigned randomly to 1.5 g/d of glucosamine (n = 101) or placebo (n = 104), of whom 108 completed the intervention (93 in each arm). The primary outcome measure was the pain subscale of the Western Ontario and McMaster Universities Osteoarthritis Index (Likert version). Additional outcome measures included the physical function and stiffness subscales and overall score of the questionnaire, and analgesic use. RESULTS: There was no difference between treatment and control groups in terms of change in pain score (2.0 +/- 3.4 vs. 2.5 +/- 3.8, P = 0.41), stiffness (0.7 +/- 1.6 vs. 0.8 +/- 1.5, P = 0.52), physical function (5.2 +/- 9.5 vs. 4.6 +/- 9.6, P = 0.49), overall score (7.8 +/- 13.1 vs. 7.8 +/- 13.5, P = 0.81), and analgesic use (133 +/- 553 vs. -88 +/- 755, P = 0.12). Stratification by osteoarthritis severity, glucosamine product, and use of a nonsteroidal anti-inflammatory drug, as well as exclusion of opiate users, did not alter the results. The number and type of adverse events reported was similar between the groups. CONCLUSION: Our results suggest that although glucosamine appears to be safe, it is no more effective than placebo in treating the symptoms of knee osteoarthritis.

Primary study

Unclassified

Randomised, Double-Blind, Parallel, Placebo-Controlled Study of Oral Glucosamine, Methylsulfonylmethane and their Combination in Osteoarthritis.

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Authors Usha PR , Naidu MU
Journal Clinical drug investigation
Year 2004
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This article is included in 13 Systematic reviews Systematic reviews (13 references) 2 Broad syntheses Broad syntheses (2 references)

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OBJECTIVE: Glucosamine, classified as a slow-acting drug in osteoarthritis (SADOA), is an efficacious chondroprotective agent. Methylsulfonylmethane (MSM), the isoxidised form of dimethyl-sulfoxide (DSMO), is an effective natural analgesic and anti-inflammatory agent. The aim of this study was to compare the efficacy and safety of oral glucosamine (Glu), methylsulfonylmethane (MSM), their combination and placebo in osteoarthritis of the knee. PATIENTS AND DESIGN: A total of 118 patients of either sex with mild to moderate osteoarthritis were included in the study and randomised to receive either Glu 500mg, MSM 500mg, Glu and MSM or placebo capsules three times daily for 12 weeks. Patients were evaluated at 0 (before drug administration), 2, 4, 8 and 12 weeks post-treatment for efficacy and safety. The efficacy parameters studied were the pain index, the swelling index, visual analogue scale pain intensity, 15m walking time, the Lequesne index, and consumption of rescue medicine. RESULTS: Glu, MSM and their combination significantly improved signs and symptoms of osteoarthritis compared with placebo. There was a statistically significant decrease in mean (+/- SD) pain index from 1.74 +/- 0.47 at baseline to 0.65 +/- 0.71 at week 12 with Glu (p < 0.001). MSM significantly decreased the mean pain index from 1.53 +/- 0.51 to 0.74 +/- 0.65, and combination treatment resulted in a more significant decrease in the mean pain index (1.7 +/- 0.47 to 0.36 +/- 0.33; p < 0.001). After 12 weeks, the mean swelling index significantly decreased with Glu and MSM, while the decrease in swelling index with combination therapy was greater (1.43 +/- 0.63 to 0.14 +/- 0.35; p < 0.05) after 12 weeks. The combination produced a statistically significant decrease in the Lequesne index. All treatments were well tolerated. CONCLUSION: Glu, MSM and their combination produced an analgesic and anti-inflammatory effect in osteoarthritis. Combination therapy showed better efficacy in reducing pain and swelling and in improving the functional ability of joints than the individual agents. All the treatments were well tolerated. The onset of analgesic and anti-inflammatory activity was found to be more rapid with the combination than with Glu. It can be concluded that the combination of MSM with Glu provides better and more rapid improvement in patients with osteoarthritis.

Primary study

Unclassified

Glucosamine Sulfate Use and Delay of Progression of Knee Osteoarthritis: A 3-Year, Randomized, Placebo-Controlled, Double-blind Study

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Journal Archives of internal medicine
Year 2002
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This article is included in 1 Systematic review Systematic reviews (1 reference)

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