A single-blind, randomized, controlled trial to assess the efficacy and tolerability of rofecoxib, diclofenac sodium, and meloxicam in patients with acute gouty arthritis

doi:10.1016/S0149-2918(04)90035-5

Clinical Therapeutics

Volume 26, Issue 3, 2004, Pages 399-406

https://doi.org/10.1016/S0149-2918(04)90035-5 Get rights and content

Abstract

Background: Acute attacks of gouty arthritis are characterized by the rapid onset of severe pain, swelling, and erythema of the affected joint. Nonsteroidal anti-inflammatory drugs are considered the drugs of first choice for treating acute gout. Rofecoxib is a specific cyclooxygenase-2 inhibitor, which has demonstrated analgesic efficacy in the setting of acute pain. Whether it is effective in the treatment of acute gouty arthritis remains to be evaluated.

Objective: The aim of this study was to assess the efficacy and tolerability of rofecoxib compared with diclofenac sodium sustained release (SR) and meloxicam in the treatment of acute gouty arthritis.

Methods: In this single-blind, randomized, controlled, parallel-group study, patients aged ≥18 years with acute gout within 48 hours of onset were randomized to receive oral treatment with 2 tablets of rofecoxib (25 mg), diclofenac (75 mg), or meloxicam (7.5 mg) once daily for 7 days. The primary outcome measures were patients global assessment of response to therapy and investigator assessment of response to therapy on days 3 and 8. Other efficacy measurements included investigator assessment of total inflammatory scores on days 3 and 8 and patient assessment of pain intensity during the first 12 hours of treatment.

Results: Sixty-two patients (53 men, 9 women; mean [SD] age, 51.1 [12.1] years) were assigned to receive rofexocib (n = 20), diclofenac (n = 21), or meloxicam (n = 21). For patient global response to therapy on days 3 and 8, rofecoxib was associated with analgesic efficacy in significantly more patients compared with meloxicam (84.2% vs 40.0% of patients [P = 0.005] and 94.7% vs 60.0% of patients [P = 0.02], respectively); no significant differences versus diclofenac were found. Similarly, for investigator global assessment of response to therapy, a greater percentage of responders was found in the rofecoxib group compared with the meloxicam group on day 3 (88.9% vs 40.0% of patients [P = 0.02]), but the difference was not significant on day 8. A greater percentage of responders was found in the rofecoxib group compared with the diclofenac group on day 3 (88.9% vs 47.3% [P = 0.007]), but the difference was not significant on day 8. Compared with baseline, all regimens showed significant improvement in total inflammatory scores on days 3 and 8 (all P < 0.01). During the first 12 hours after dosing, pain intensity score was significantly reduced with rofecoxib starting at 0.5 hours (P < 0.05), but not with diclofenac or meloxicam. Clinical adverse events (AEs) were reported in 4 (20.0%), 7 (33.3%), and 6 (28.6%) patients in the rofecoxib, diclofenac, and meloxicam groups, respectively; the most common AEs reported were edema in 1 patient each in the rofecoxib (5.0%) and meloxicam (4.8%) groups and 2 patients (9.5%) in the diclofenac group and abdominal (1 [5.0%], 1 [4.8%], and 2 [9.5%], respectively). No significant differences in tolerability were found among the 3 treatment groups.

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From 8,522 records identified in the database search, 134 full text papers were reviewed, and 71 trials were included, of which 36 were acute and 35 were chronic. Only 3 of 36 (8%) acute trials reported all five core domains and none of the 35 included chronic trials reported all 7 core domains. In the acute trials, twenty-seven unique measurement instruments across the 5 core domains were identified. For chronic trials there were 31 unique measurement instruments used across the 7 core domains. Serum urate was reported in 100% of the chronic trials and gout flares in 80%. However, other core domains were reported in <30% of chronic trials. In particular the patient-important domains such as HR-QOL, patient global assessment and activity limitations were rarely reported. A broad variety of different measurement instruments were used to assess each endorsed core domain, a minority of trials used the OMERACT endorsed instruments. For acute trials, the number reporting on all core domains was consistently low and no change was detected before and after the endorsement of the core domains in 2009. None of the included chronic trials reported on all 7 endorsed core domains at any time.
In this study we found a low adherence with the intended endorsed (i.e., core) outcome domains for acute and chronic gout studies which represents a poor uptake of the global OMERACT efforts for the minimum of what should be measured in clinical trials. In addition, there is a significant variation in how the OMERACT endorsed outcome domains have been measured. This systematic review demonstrates the need for continuous encouragement among gout researchers to adhere to OMERACT core domains as well as further guidance on outcome measurements reporting.
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Bloodletting therapy (BLT) is widely used to relieve acute gouty arthritis (AGA). However, limited evidence-based reports exist on the effectiveness and safety of BLT. This systematic review aims to evaluate the feasibility and safety of BLT in treating AGA.
Seven databases were exhaustively screened from the date of establishment to July 31, 2020, irrespective of the publication source and language. The included articles were evaluated for bias risk by using the Cochrane risk of bias assessment tool. All statistical analyses were done with Review Manager 5.3.
Twelve studies involving 894 participants were included for the final analysis. Our meta-analysis revealed that BLT was highly effective in relieving pain (MD = −1.13, 95% CI [-1.60, −0.66], P < 0.00001), with marked alterations in the total effective (RR = 1.09, 95% [1.05, 1.14], P < 0.0001) and curative rates (RR = 1.37, 95%CI [1.17, 1.59], P < 0.0001). In addition, BLT could dramatically reduce serum C-reactive protein (CRP) level (MD = −3.64, 95%CI [-6.72, −0.55], P = 0.02). Both BLT and Western medicine (WM) produced comparable decreases in uric acid (MD = −18.72, 95%CI [-38.24, 0.81], P = 0.06) and erythrocyte sedimentation rate (ESR) levels (MD = −3.01, 95%CI [-6.89, 0.86], P = 0.13). Lastly, we demonstrated that BLT was safer than WM in treating AGA (RR = 0.36, 95%CI [0.13, 0.97], P = 0.04).
BLT is effective in alleviating pain and decreasing CRP level in AGA patients with a lower risk of evoking adverse reactions.
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Namely, to ascertain the injury degree of articular cartilage, GAG and Hyp content regarded as the degradation indicators of proteoglycan and collagen can be examined. Patients often suffer the rapid onset of severe pain, swelling, warmth, erythema, and decreased range of motion in the affected joint during acute phase (Cheng et al., 2004; Neogi, 2011; So et al., 2010), leading to joint destruction when become chronic. Generally, effective treatment of acute gouty arthritis must target both the pain and the underlying inflammation.
Xiaofeng Granules (XF) is a kind of granules prepared by the famous traditional Chinese medicine formula for its efficiency in treating gouty diseases.
We investigated the relevance between XF that made from Modified simiaowan (MSW) as the anti-gouty arthritis drugs and protective mechanisms for cartilage matrix in order to provide the evidence for new drug application.
In the present study, we evaluated the anti-gouty arthritis activity of XF in rats and rabbits models induced by MSU together with chondrocytes focusing on the link to proteoglycan degradation in vitro studies.
The results demonstrated that XF significantly reduced the swelling rate and attenuated the pathological changes in joints. The XF-containing serum were used medicated serum in cellular experiments. The in vitro data were in accordance with the in vivo results, showing that the constituents in XF-containing serum had obvious inhibitory effects on the activation of pro-inflammatory mediators in chondrocytes. Moreover, XF-containing serum substantially inhibited MSU-induced expression of glycosaminoglycans(GAG) and hydroxyproline(Hyp), and up regulated proteoglycan, which might be associated with the regulation of the balance of MMP-3/TIMP-1and ADAMTS-4/TIMP-3 inchondrocytes.
In conclusion, XF that made from MSW showed obvious effects on acute gouty arthritis, which also provided an effective protection on cartilage matrix degradation.
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Although pain is the primary symptom, effective treatment of acute gouty arthritis must target both the pain and underlying inflammation. Acute gout is frequently treated with non-steroidal anti-inflammatory agents (NSAIDs), colchicine, or corticosteroids [1,4,7]. A systematic review of the literature was originally performed in 2010 as part of the initiative funded by the American College of Rheumatology to develop recommendations for the management of gout (including but not limited to management of acute attacks of gouty arthritis).
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A single-blind, randomized, controlled trial to assess the efficacy and tolerability of rofecoxib, diclofenac sodium, and meloxicam in patients with acute gouty arthritis

Abstract

Rheum Dis Clin North Am.

Clin Ther.

Ann Emerg Med.

Blood

Clin Ther.

Obstet Gynecol.

Diagnosis and management of gout

Am Fam Physician

A survey of current prescribing practices of antiinflammatory and urate-lowering drugs in gouty arthritis

N Z Med J.

A survey of current prescribing practices of antiinflammatory and urate lowering drugs in gouty arthritis in the province of Ontario

J Rheumatol.

Ketoprofen versus indomethacin in patients with acute gouty arthritis: A multicenter, double blind comparative study

J Rheumatol.