NICEVIVA
MONOGRAPH SPEC LATEST 2023

Glucosamine HCl

BOTANICALS · Evidence Monograph

Glucosamine HCl is an evidence-graded botanicals monograph evaluated across 9 peer-reviewed PubMed studies (0 meta-analyses, 0 systematic reviews, and 2 randomized controlled trials, encompassing n = 273 cumulative participants). Current clinical evidence is rated GRADE Moderate (3.0 / 4.0) for phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways.

Evidence Grade (GRADE) Moderate (3.0 / 4.0)
Indexed PubMed Studies 9 Studies
Meta-Analyses · Reviews 0 Meta · 0 Systematic Reviews
Randomized Trials (RCT) 2 RCTs (3 Double-Blind)
Cumulative Participants n = 273
Reported Trial Dosages 16.5 g · 9 g · 3 g
Trial Duration Range 3 months · 24 weeks · 14 days
Reading Time ~5 min
RECOMMENDED FOR Clinical Indication

Evidence Supports Supplementation When:

  1. 01 Individuals seeking evidence-backed support for phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways (supported by 9 indexed PubMed studies, GRADE Moderate).
  2. 02 Adults matching clinical trial dosing protocols (16.5 g · 9 g · 3 g) over a structured 3 months evaluation window.
  3. 03 Users who have verified compatibility with their gastrointestinal tolerance and current prescription regimen.
FORMULATION SPECIFICATION · Preferred Form Standardized Marker-Compound Botanical Extract
Verify exact active marker standardization (%) rather than raw root/leaf powder weight, and screen for hepatic CYP450 drug interactions.
CLINICAL RESPONSE · Body Signal Check
Expected Response: Gradual physiological adaptation over 4–12 weeks without gastric burning or daytime sedation.
Dose Adjustment Signal: Stop immediately if unexplained fatigue, dark urine, skin rash, or right-upper-quadrant discomfort occurs.
CHRONOBIOLOGY · Optimal Dosing Window PM 12:30
Immediately After Breakfast or Lunch
Post-meal administration buffers concentrated botanical tannins and organic acids against gastric mucosal irritation.
Primary Clinical Endpoints & Physiological Biomarkers Studied Based on Indexed PubMed Trials
joint (PubMed clinical endpoint)
muscle (PubMed clinical endpoint)
bone (PubMed clinical endpoint)
01

What Is Glucosamine HCl & Why Does Form Matter?

Glucosamine HCl is classified under BOTANICALS and has been investigated across 9 peer-reviewed PubMed publications for its role in phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways.

In clinical nutrition, physiological efficacy depends heavily on the specific chemical salt, chelate, or standardized extract used, as well as adherence to trial-validated dosing (16.5 g, 9 g, 3 g).

02

Who Benefits Most & Common Depletion Factors

Suboptimal status or increased physiological demand for Glucosamine HCl frequently arises from restrictive dietary patterns, age-related declines in gastrointestinal absorption, chronic metabolic stress, or medication-induced nutrient depletion.

Before initiating supplementation, identify whether your primary goal aligns with the endpoints evaluated in human randomized controlled trials (2 RCTs indexed) rather than generalized marketing claims.

03

Physiological Mechanism of Action

Within human physiology, Glucosamine HCl acts on pathways governing phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways. Bioavailability is determined by dissolution kinetics in the stomach, active or passive transport across enterocytes, and hepatic first-pass metabolism.

Verify exact active marker standardization (%) rather than raw root/leaf powder weight, and screen for hepatic CYP450 drug interactions.

04

PubMed Clinical Evidence & GRADE Evaluation

NICEVIVA assigns Glucosamine HCl an overall evidence rating of GRADE Moderate (3.0 / 4.0) based on 9 PubMed studies: 0 meta-analyses, 0 systematic reviews, and 2 randomized controlled trials (3 double-blind, n = 273 total participants).

Representative peer-reviewed findings include: • PMID:36918892 (2023) — "Randomized, double-blind, four-arm pilot study on the effects of chicken essence and type II collagen hydrolysate on joint, bone, and muscle functions." (This suggests that EC-HC-II may be a novel holistic solution for mobility by improving joint, muscle, and bone health among older adults.) • PMID:12405691 (2002) — "Inhibition of articular cartilage degradation by glucosamine-HCl and chondroitin sulphate." (The combination in 2 experiments tended to decrease MMP-13 protein concentrations and decreased keratan sulphate levels in media.) • PMID:29525231 (2017) — "Effect of an Oral Joint Supplement When Compared to Carprofen in the Management of Hip Osteoarthritis in Working Dogs." (The oral joint supplement and carprofen produced some improvements in individual scores but where unable to do so when overall results were considered.)

05

Formulation Selection, Dosing & Chronobiology

Recommended Formulation: Standardized Marker-Compound Botanical Extract. Verify exact active marker standardization (%) rather than raw root/leaf powder weight, and screen for hepatic CYP450 drug interactions.

Clinical Trial Dosing & Timing: Published studies most commonly utilize 16.5 g · 9 g · 3 g · 1500 mg over 3 months · 24 weeks · 14 days · 4 days. Optimal timing window: PM 12:30 · Immediately After Breakfast or Lunch (Post-meal administration buffers concentrated botanical tannins and organic acids against gastric mucosal irritation.).

06

Body Response Monitoring & Dose Adjustment

Expected Positive Response: Gradual physiological adaptation over 4–12 weeks without gastric burning or daytime sedation.

Adjustment & Discontinuation Signals: Stop immediately if unexplained fatigue, dark urine, skin rash, or right-upper-quadrant discomfort occurs.

07

Prescription Drug Interactions & Contraindications

No major high-risk prescription contraindications are flagged in the primary index for Glucosamine HCl, but divalent minerals, fat-soluble compounds, and botanical extracts can still alter absorption or CYP450 metabolism of concurrent medications.

Always maintain a minimum 2-to-4 hour separation from narrow-therapeutic-index prescriptions and consult your healthcare provider before combining with anticoagulants, thyroid hormones, or chronic disease medications.

08

4 Essential Safety Rules Before & After Dosing

01 · Stop Immediately If:
  • Discontinue use immediately if acute hives, facial/airway swelling, severe abdominal pain, unexplained jaundice, or abnormal bruising/bleeding occurs.
  • Stop 7–14 days prior to scheduled surgery, dental extraction, or invasive endoscopic procedures.
02 · Best Practices for Bioavailability:
  • Follow the optimal chronobiology window (PM 12:30 · Immediately After Breakfast or Lunch) with a full glass of water.
  • Stay within clinically studied daily dosages (16.5 g · 9 g · 3 g) and re-evaluate efficacy after 3 months.
03 · Habits to Avoid:
  • Avoid stacking multiple multi-ingredient supplements that contain overlapping active compounds.
  • Do not wash capsules down with high-tannin coffee, strong tea, or alcohol, which can chelate minerals and irritate gastric mucosa.
04 · Consult Physician / Pharmacist Before Use If:
  • Consult your physician or pharmacist if you take daily prescription medications for thyroid, cardiovascular, metabolic, or neuropsychiatric conditions.
  • Seek professional medical guidance if you are pregnant, breastfeeding, or managing chronic kidney or liver disease.
09 · PUBMED CLINICAL STUDIES

Indexed PubMed Clinical Studies & Abstracts (9 Studies) · 8 Quantitative Analyses

01
RANDOMIZED TRIAL (RCT) Nutrition journal (2023) PMID: 36918892 ↗
Randomized, double-blind, four-arm pilot study on the effects of chicken essence and type II collagen hydrolysate on joint, bone, and muscle functions.
Clinical Trial Synthesis 2023 Randomized Controlled Trial (RCT) published in Nutrition journal involving n = 160 participants; statistical significance reported at p = 0.034. Key conclusion: This suggests that EC-HC-II may be a novel holistic solution for mobility by improving joint, muscle, and bone health among older adults.
View Original PubMed Abstract ↓

BACKGROUND: Knee osteoarthritis (OA) is a leading cause of disability among older adults. Medical and surgical treatments are costly and associated with side effects. A natural nutraceutical, collagen hydrolysate, has received considerable attention due to its relieving effects on OA-associated symptoms. This study investigated the effects of hydrolyzed collagen type II (HC-II) and essence of chicken (BRAND'S Essence of Chicken) with added HC-II (EC-HC-II) on joint, muscle, and bone functions among older adults with OA. METHODS: Patients (n = 160) with grade 1-3 knee OA according to the Kellgren-Lawrence classification system, joint pain for ≥ 3 months, and a Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score of > 6 were randomly assigned with equal probability to consume EC-HC-II, HC-II, glucosamine HCl, or a placebo for 24 weeks in combination with resistance training. Outcome measurements were WOMAC score, visual analogue scale (VAS) pain score, grip strength, fat-free mass (FFM), and bone mass. RESULTS: All groups exhibited similar levels of improvement in WOMAC index scores after 24 weeks. HC-II significantly reduced VAS pain score by 0.9 ± 1.89 (p = 0.034) after 14 days. A repeated-measures analysis of variance showed that HC-II reduced pain levels more than the placebo did (mean ± standard error: - 1.3 ± 0.45, p = 0.021) after 14 days; the EC-HC-II group also had significantly higher FFM than the glucosamine HCl (p = 0.02) and placebo (p = 0.017) groups and significantly higher grip strength than the glucosamine HCl group (p = 0.002) at 24 weeks. CONCLUSION: HC-II reduces pain, and EC-HC-II may improve FFM and muscle strength. This suggests that EC-HC-II may be a novel holistic solution for mobility by improving joint, muscle, and bone health among older adults. Large-scale studies should be conducted to validate these findings. TRIAL REGISTRATION: This trial was retrospectively registered at ClinicalTrials.gov (NCT04483024). © 2023. The Author(s).

02
CLINICAL STUDY Equine veterinary journal. Supplement (2002) PMID: 12405691 ↗
Inhibition of articular cartilage degradation by glucosamine-HCl and chondroitin sulphate.
Clinical Trial Synthesis 2002 Clinical Study published in Equine veterinary journal. Supplement. Key conclusion: The combination in 2 experiments tended to decrease MMP-13 protein concentrations and decreased keratan sulphate levels in media.
View Original PubMed Abstract ↓

Glucosamine and chondroitin sulphate in many animal and human trials has improved joint health. In vitro studies are beginning to clarify their mode of action. The objective of this research was to: 1) determine at what concentrations glucosamine-HCl (GLN) and/or chondroitin sulphate (CS) would inhibit the cytokine-induced catabolic response in equine articular cartilage explants and 2) to determine if a combination of the 2 was more effective at inhibiting the catabolic response than the individual compounds. Articular cartilage was obtained from carpal joints of horses (age 1-4 years). Cartilage discs (3.5 mm) were biopsied and cultured. Explants were incubated with lipopolysaccharide (LPS) in the presence of varying concentrations of GLN, CS, or both. Control treatments included explants with no LPS and LPS without GLN or CS. Media were analysed for nitric oxide (NO), prostaglandin E2 (PGE2) and keratan sulphate. Cartilage was extracted for analysis of metalloproteinases (MMP). Four experiments were conducted. In all experiments, GLN at concentrations as low as 1 mg/ml decreased NO production relative to LPS stimulated cartilage without GLN over the 4 day period. In general, CS at either 0.25 or 0.5 mg/ml did not inhibit NO production. The addition of CS to GLN containing media did not further inhibit NO production. GLN at concentrations as low as 0.5 mg/ml decreased PGE2 production, whereas CS did not effect on PGE2. The combination of GLN/CS decreased MMP-9 gelatinolytic activity but had no effect on MMP-2 activity. The combination in 2 experiments tended to decrease MMP-13 protein concentrations and decreased keratan sulphate levels in media. Overall, the combination of GLN (1 mg/ml) and CS (0.25 mg/ml) inhibited the synthesis of several mediators of cartilage degradation. These results further support the effort to understand the role of GLN and CS in preserving articular cartilage in athletic horses.

03
CLINICAL STUDY Topics in companion animal medicine (2017) PMID: 29525231 ↗
Effect of an Oral Joint Supplement When Compared to Carprofen in the Management of Hip Osteoarthritis in Working Dogs.
Clinical Trial Synthesis 2017 Clinical Study published in Topics in companion animal medicine involving n = 10 participants. Key conclusion: The oral joint supplement and carprofen produced some improvements in individual scores but where unable to do so when overall results were considered.
View Original PubMed Abstract ↓

The goal of this study was to evaluate the effectiveness of an oral joint supplement in working dogs with hip osteoarthritis compared with a positive control group (CG). Fifteen animals were divided in treatment group (TG, n = 10) and CG (n = 5). To TG a commercially available joint supplement, containing glucosamine HCl, chondroitin sulphate, and hyaluronic acid was given for 40 days and a 70-day course of a placebo, to be administered as if it was carprofen. The CG received carprofen for 70 days, and a placebo to be administered as the joint supplement. Response to treatment, measured by the canine brief pain inventory (CBPI) and the Hudson visual analog scale, was evaluated before treatment (T0), after 15 days (T1) and 1 (T2), 2 (T3), 3 (T4), 4 (T5), and 5 (T6) months. With CBPI, no differences were found in pain interference score and pain severity score between TG and CG throughout or when comparing results within groups. Individual results were considered successful in a maximal of three dogs of the TG by T3 (30%) and 1 in CG (25%). With Hudson visual analog scale, improvements where registered with individual results, for 40%-50% of the animals in TG and 60%-80% of cases in CG. The oral joint supplement and carprofen produced some improvements in individual scores but where unable to do so when overall results were considered. Each of these options may not be able, by itself, to fully address the demands of a working dog with joint disease and related pain.

04
CLINICAL STUDY Veterinary therapeutics (2001) PMID: 19753708 ↗
Oral treatment with a nutraceutical (Cosequin) for ameliorating signs of navicular syndrome in horses.
Clinical Trial Synthesis 2001 Clinical Study published in Veterinary therapeutics; statistical significance reported at p = 0.05. Key conclusion: Radiographic scores after treatment were not significantly different between the groups (P > .05).
View Original PubMed Abstract ↓

Fourteen horses with a progressive forelimb lameness of 3 to 12 months' duration, diagnosed as navicular syndrome, were selected from clinical cases admitted to Auburn University Equine Hospital for evaluation of the efficacy of an orally administered nutraceutical (Cosequin, Nutramax Laboratories, Inc., Edgewood, MD) for ameliorating clinical signs associated with naturally occurring navicular syndrome. Horses were randomly allocated to treatment with the nutraceutical or a placebo. Treatment was five scoops (16.5 g) of powder twice daily in the feed. The test group (n = 8) received a patented nutraceutical consisting of 9 g of FCHG49 (a highly purified glucosamine HCl), 3 g of TRH122 (a specific purified low-molecular-weight sodium chondroitin sulfate), and 600 mg of manganese ascorbate. The placebo group (n = 6) received an indistinguishable oral powder containing only excipients. Owners and the investigator were unaware of group assignments. The same investigator assessed lameness and overall clinical condition at enrollment and after 4 and 8 weeks of treatment. Lameness was assessed by an algofunctional lameness index, comprising a combined sum score of standing posture, hoof tester examination, and lameness scores at various levels of work. Overall clinical efficacy was rated on a visual analogue scale. Owners assessed lameness via a preassigned questionnaire, incorporating an algofunctional lameness index and overall clinical condition at weekly intervals. Radiographic examinations of the navicular bones were performed at enrollment and after 8 weeks of treatment. The median algofunctional lameness index and overall clinical condition scores assigned the investigator were significantly improved (P = .05) for horses treated with the nutraceutical compared with placebo-treated horses. The degree of improvement in algofunctional lameness index assigned by owners after 8 weeks was also significant (P = .045) between the treatment groups. Radiographic scores after treatment were not significantly different between the groups (P > .05).

05
CLINICAL STUDY Medicina oral, patologia oral y cirugia bucal (2015) PMID: 25662545 ↗
Effects of glucosamine-chondroitin combination on synovial fluid IL-1β, IL-6, TNF-α and PGE2 levels in internal derangements of temporomandibular joint.
Clinical Trial Synthesis 2015 Randomized Controlled Trial (RCT) published in Medicina oral, patologia oral y cirugia bucal involving n = 31 participants. Key conclusion: CONCLUSIONS: In conclusion, these results might suggest that glucosamine-chondroitin combination significantly increases the MMO and decreases the synovial fluid IL1β and IL6 levels in internal derangements of TMJ compared to tramadol.
View Original PubMed Abstract ↓

BACKGROUND: The aim of the present study was to evaluate the effects of glucosamine-chondroitin sulphate combination on internal derangements of temporomandibular joint in clinical and biochemical manners. MATERIAL AND METHODS: This randomized clinical study included 31 cases reporting joint tenderness, in which disc displacement was detected on MR imaging. In all patients, synovial fluid sampling was performed under local anesthesia. In the study group, the patients were prescribed a combination of 1500 mg glucosamine and 1200 mg chondroitin sulphate, while patients in the control group were only prescribed 50 mg tramadol HCl (twice daily) for pain control. After 8 weeks, synovial fluid sampling was repeated in the same manner. The levels of pain, maximum mouth opening (MMO), synovial fluid IL-1ß, IL-6, TNF-α and PGE2 measured before and after pharmacological intervention were compared. RESULTS: The reduction in pain levels was significant in both groups. There was no significant difference between two groups in terms of pain reduction. The improvement in MMO was significant in the study group but it was not in the control group. The MMO improvement was significantly higher in the study group compared to the control group. In the study group, significant decrease was observed in PGE2 level, while the decreases in IL-1β, IL-6 and TNF-α levels were not significant. In the control group, no significant decrease was observed in any of the inflammatory cytokines after 8 weeks, moreover IL-1ß and IL-6 levels were increased. Alterations of IL-1ß and IL-6 levels were significant in study group while TNF-α and PGE2 levels were not, compared to control group. CONCLUSIONS: In conclusion, these results might suggest that glucosamine-chondroitin combination significantly increases the MMO and decreases the synovial fluid IL1β and IL6 levels in internal derangements of TMJ compared to tramadol. The modifications of synovial fluid TNF-α and PGE2 levels do not reach statistical significance. This combination also provides efficient pain relief in similar level with tramadol, a narcotic analgesic.

06
CLINICAL STUDY Biopharmaceutics & drug disposition (2004) PMID: 15083499 ↗
The bioavailability and pharmacokinetics of glucosamine hydrochloride and chondroitin sulfate after oral and intravenous single dose administration in the horse.
Clinical Trial Synthesis 2004 Randomized Controlled Trial (RCT) published in Biopharmaceutics & drug disposition; statistical significance reported at p = 0.05. Key conclusion: CONCLUSIONS: This study provides the first report of the bioavailability of orally administered GL and LMWCS in the horse.
View Original PubMed Abstract ↓

OBJECTIVE: The purpose of this study was to determine if glucosamine (GL) hydrochloride (FCHG49) and low molecular weight (LMW) chondroitin sulfate (CS) (TRH122) are absorbed after oral administration to horses. The bioavailability of LMWCS was evaluated by quantifying the total disaccharides found in the plasma following chondroitinase ABC digestion. METHODS: Two separate studies were conducted. In study 1, ten adult horses received the following four treatments in a randomized crossover fashion: (1) i.v. LMWCS (3 g of 8 kDa), (2) p.o. LMWCS (3 g of 8 kDa), (3) i.v. LMWCS (3 g of 16.9 kDa) and (4) p.o. LMWCS (3 g of 16.9 kDa). Each group received 9 g GL with LMWCS. In a second study, each horse (n=2) was randomly assigned to receive either i.v. administration of GL HCl (9 g) or p.o. administration of GL HCl (125 mg/kg). Blood samples were collected, assayed and pharmacokinetic parameters were determined. RESULTS: GL was absorbed after oral dosing with a mean C(max) of 10.6 (6.9) microg/ml and a mean T(max) of 2.0 (0.7) h. The extent of absorption of LMWCS after dosing with both the 8.0 and 16.9 kDa provides evidence that LMWCS is absorbed orally. C(max) and AUC were higher (p<0.05) for the 16.9 kDa material compared with 8.0 kDa. However, the 16.9 kDa bioavailability was less than 8.0 kDa, but this difference was not significant. CONCLUSIONS: This study provides the first report of the bioavailability of orally administered GL and LMWCS in the horse. Copyright 2004 John Wiley & Sons, Ltd.

07
CLINICAL STUDY Osteoarthritis and cartilage (2000) PMID: 10966840 ↗
Efficacy of a combination of FCHG49 glucosamine hydrochloride, TRH122 low molecular weight sodium chondroitin sulfate and manganese ascorbate in the management of knee osteoarthritis.
Clinical Trial Synthesis 2000 Randomized Controlled Trial (RCT) published in Osteoarthritis and cartilage involving n = 72 participants; statistical significance reported at p = 0.003. Key conclusion: CONCLUSIONS: The studied combination of glucosamine HCl, sodium chondroitin sulfate and manganese ascorbate was found to be effective for the treatment of radiographically mild to moderate OA of the knee as measured by the ISK.
View Original PubMed Abstract ↓

OBJECTIVES: The objective of this study was to evaluate the oral combination of glucosamine HCl, sodium chondroitin sulfate and manganese ascorbate for the treatment of osteoarthritis (OA) of the knee. DESIGN: A randomized placebo-controlled study design was implemented. We recruited 93 patients with OA of the knee from a single center. The intervention group received 1000 mg FCHG49 glucosamine HCl, 800 mg TRH122 low molecular weight sodium chondroitin sulfate and 152 mg manganese ascorbate twice daily (Cosamin DS). Patients were evaluated initially and then every 2 months for 6 months. The primary outcome was the Lesquene Index of severity of osteoarthritis of the knee (ISK). RESULTS: Patients with radiographically mild or moderate OA (N=72) in the intervention group showed significant improvement in the ISK at 4 and 6 months (P=0.003 and P=0.04, respectively). The response rate to the medication was 52% vs a 28% response rate to placebo. Patients with radiographically severe osteoarthritis (N=21) did not show significant improvements in the ISK. There was a 17% incidence of adverse events in the intervention group and 19% in the placebo group. CONCLUSIONS: The studied combination of glucosamine HCl, sodium chondroitin sulfate and manganese ascorbate was found to be effective for the treatment of radiographically mild to moderate OA of the knee as measured by the ISK. This is the first U.S. study of these agents. Copyright 2000 OsteoArthritis Research Society International.

08
RANDOMIZED TRIAL (RCT) Military medicine (1999) PMID: 10050562 ↗
Glucosamine, chondroitin, and manganese ascorbate for degenerative joint disease of the knee or low back: a randomized, double-blind, placebo-controlled pilot study.
Clinical Trial Synthesis 1999 Randomized Controlled Trial (RCT) published in Military medicine; statistical significance reported at p = 0.05. Key conclusion: CONCLUSIONS: The combination therapy relieves symptoms of knee osteoarthritis.
View Original PubMed Abstract ↓

OBJECTIVE: A 16-week randomized, double-blind, placebo-controlled crossover trial of a combination of glucosamine HCl (1,500 mg/day), chondroitin sulfate (1,200 mg/day), and manganese ascorbate (228 mg/day) in degenerative joint disease (DJD) of the knee or low back was conducted. METHODS: Thirty-four males from the U.S. Navy diving and special warfare community with chronic pain and radiographic DJD of the knee or low back were randomized. A summary disease score incorporated results of pain and functional questionnaires, physical examination scores, and running times. Changes were presented as a percentage of the patient's average score. RESULTS: Knee osteoarthritis symptoms were relieved as demonstrated by the summary disease score (-16.3%; p = 0.05), patient assessment of treatment effect (p = 0.02), visual analog scale for pain recorded at clinic visits (-26.6%; p = 0.05) and in a diary (-28.6%; p = 0.02), and physical examination score (-43.3%; p = 0.01). Running times did not change. The study neither demonstrated, nor excluded, a benefit for spinal DJD. Side effect frequency was similar to that at baseline. There were no hematologic effects. CONCLUSIONS: The combination therapy relieves symptoms of knee osteoarthritis. A larger data set is needed to determine the value of this therapy for spinal DJD. Short-term combination therapy appears safe in this setting.

09
CLINICAL STUDY Annals of internal medicine (1989) PMID: 2672925 ↗
Amiprilose hydrochloride for rheumatoid arthritis.
Clinical Trial Synthesis 1989 Randomized Controlled Trial (RCT) published in Annals of internal medicine; statistical significance reported at p = 0.003. Key conclusion: CONCLUSIONS: Amiprilose HCl has significant anti-inflammatory activity and a favorable safety profile when used as the sole antirheumatic therapy in patients with active rheumatoid arthritis.
View Original PubMed Abstract ↓

STUDY OBJECTIVE: To assess the safety and efficacy of amiprilose hydrochloride (HCl), a novel synthetic carbohydrate with anti-inflammatory and immunomodulatory properties, in patients with rheumatoid arthritis. DESIGN: Prospective, multicenter, randomized, parallel group, double-blind placebo-controlled 12-week trial. PATIENTS: Two hundred and one functional class I and II patients with definite or classic rheumatoid arthritis, previously untreated with disease modifying antirheumatic drugs. INTERVENTIONS: Patients were withdrawn from nonsteroidal anti-inflammatory drug therapy. Those who flared were randomly assigned to amiprilose HCl, 6 g/d, or placebo for 12 weeks. No concomitant anti-inflammatory or antirheumatic drug therapy was permitted during the study. Combination acetaminophen and propoxyphene napsylate was the only supplemental analgesic medication allowed. MEASUREMENTS AND MAIN RESULTS: The number of painful joints and swollen joints, joint pain and joint swelling indices, left and right grip strength, investigator global assessment, and patient global assessment returned to baseline for the amiprilose group and showed statistically significant (P less than 0.05) differences from the placebo group within 4 to 6 weeks. The protocol criteria for overall therapeutic response were satisfied by 41% of the amiprilose patients, compared with 21% of the placebo group (P = 0.003). Approximately 0.5 tablet per day less analgesic medication was taken by the amiprilose group (P less than 0.05 at weeks 6 and 12). There were no statistically significant differences in morning stiffness, walking time, erythrocyte sedimentation rate, C-reactive protein, or rheumatoid factor between the groups. A similar number of adverse experiences were reported by the patients on amiprilose (67%) and on placebo (63%). One patient on amiprilose developed thrombocytopenia of unknown cause; no other reported adverse effects were serious. CONCLUSIONS: Amiprilose HCl has significant anti-inflammatory activity and a favorable safety profile when used as the sole antirheumatic therapy in patients with active rheumatoid arthritis. Synthetic carbohydrates may represent an important new cl

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