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Randomized controlled trial of diclofenac sodium gel in knee osteoarthritis.
Semin Arthritis Rheum. 2009 Dec; 39(3):203-12.SA

Abstract

OBJECTIVES

Nonsteroidal anti-inflammatory drugs have dose-related adverse effects. Topical nonsteroidal anti-inflammatory drugs may offer local efficacy with low systemic drug levels. This study assessed the efficacy and safety of topical diclofenac sodium 1% gel (DSG) in mild to moderate symptomatic knee osteoarthritis.

METHODS

In a randomized, double-blind, vehicle-controlled trial, 492 adults aged >or=35 years with symptomatic knee osteoarthritis of >or=6 months' duration were randomized to DSG 4 g (n = 254) or vehicle (n = 238) 4 times daily for 12 weeks. Primary efficacy outcomes at week 12 were the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale, WOMAC physical function subscale, and global rating of disease. Secondary outcomes included these outcomes assessed after 1, 4, and 8 weeks, and pain on movement assessed using a 100-mm visual analog scale. All adverse events were recorded.

RESULTS

At week 12, the DSG group had significant decreases versus the vehicle group in mean WOMAC pain (P = 0.01), mean WOMAC physical function (P = 0.001), and mean global rating of disease (P < 0.001). Efficacy outcomes significantly favored DSG versus vehicle beginning at week 1. Application site reactions occurred in 5.1% and 2.5% of patients in the DSG and vehicle groups, respectively. The incidence of gastrointestinal disorders was 5.9% with DSG and 5.0% with vehicle.

CONCLUSIONS

Over a 3-month treatment period, topical treatment with DSG achieved statistically and clinically significant improvements of pain and measures of physical function in patients with knee osteoarthritis.

Authors+Show Affiliations

hrbarthel@earthlink.netNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19932833

Citation

Barthel, H Richard, et al. "Randomized Controlled Trial of Diclofenac Sodium Gel in Knee Osteoarthritis." Seminars in Arthritis and Rheumatism, vol. 39, no. 3, 2009, pp. 203-12.
Barthel HR, Haselwood D, Longley S, et al. Randomized controlled trial of diclofenac sodium gel in knee osteoarthritis. Semin Arthritis Rheum. 2009;39(3):203-12.
Barthel, H. R., Haselwood, D., Longley, S., Gold, M. S., & Altman, R. D. (2009). Randomized controlled trial of diclofenac sodium gel in knee osteoarthritis. Seminars in Arthritis and Rheumatism, 39(3), 203-12. https://doi.org/10.1016/j.semarthrit.2009.09.002
Barthel HR, et al. Randomized Controlled Trial of Diclofenac Sodium Gel in Knee Osteoarthritis. Semin Arthritis Rheum. 2009;39(3):203-12. PubMed PMID: 19932833.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized controlled trial of diclofenac sodium gel in knee osteoarthritis. AU - Barthel,H Richard, AU - Haselwood,Douglas, AU - Longley,Selden,3rd AU - Gold,Morris S, AU - Altman,Roy D, PY - 2009/05/20/received PY - 2009/09/01/revised PY - 2009/09/17/accepted PY - 2009/11/26/entrez PY - 2009/11/26/pubmed PY - 2010/2/3/medline SP - 203 EP - 12 JF - Seminars in arthritis and rheumatism JO - Semin Arthritis Rheum VL - 39 IS - 3 N2 - OBJECTIVES: Nonsteroidal anti-inflammatory drugs have dose-related adverse effects. Topical nonsteroidal anti-inflammatory drugs may offer local efficacy with low systemic drug levels. This study assessed the efficacy and safety of topical diclofenac sodium 1% gel (DSG) in mild to moderate symptomatic knee osteoarthritis. METHODS: In a randomized, double-blind, vehicle-controlled trial, 492 adults aged >or=35 years with symptomatic knee osteoarthritis of >or=6 months' duration were randomized to DSG 4 g (n = 254) or vehicle (n = 238) 4 times daily for 12 weeks. Primary efficacy outcomes at week 12 were the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale, WOMAC physical function subscale, and global rating of disease. Secondary outcomes included these outcomes assessed after 1, 4, and 8 weeks, and pain on movement assessed using a 100-mm visual analog scale. All adverse events were recorded. RESULTS: At week 12, the DSG group had significant decreases versus the vehicle group in mean WOMAC pain (P = 0.01), mean WOMAC physical function (P = 0.001), and mean global rating of disease (P < 0.001). Efficacy outcomes significantly favored DSG versus vehicle beginning at week 1. Application site reactions occurred in 5.1% and 2.5% of patients in the DSG and vehicle groups, respectively. The incidence of gastrointestinal disorders was 5.9% with DSG and 5.0% with vehicle. CONCLUSIONS: Over a 3-month treatment period, topical treatment with DSG achieved statistically and clinically significant improvements of pain and measures of physical function in patients with knee osteoarthritis. SN - 1532-866X UR - https://www.unboundmedicine.com/medline/citation/19932833/Randomized_controlled_trial_of_diclofenac_sodium_gel_in_knee_osteoarthritis_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0049-0172(09)00116-4 DB - PRIME DP - Unbound Medicine ER -