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1.
Karel Pavelka Tom Tr
Karel Karpa Petr Vtek Marie Sedl
kov Vra Vlaskov Jana Bhmov Jozef Rovenský 《Arthritis \u0026amp; Rheumatology》2007,56(12):4055-4064
Objective
To determine whether the efficacy of diacerein persists at 2 months after the end of a 3‐month treatment period, compared with placebo, in patients with painful knee osteoarthritis (OA).Methods
After a 1‐week nonsteroidal antiinflammatory drug washout period, patients received either diacerein or placebo for 3 months, followed by an off‐treatment period of 3 months to determine the carryover effects of the drug. Although patients were followed up through month 6, the primary efficacy end point was the percent change from baseline in pain (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC] A) at month 5 (i.e., 2 months after the end of treatment) compared with placebo. The co–primary efficacy end point was the percent change from baseline in the total WOMAC score, also at month 5 versus placebo.Results
Two hundred three patients were screened, and 168 patients with painful knee OA were randomized. One hundred sixty‐five patients were analyzed in an intent‐to‐treat analysis. At month 5, diacerein showed statistically significant superiority versus placebo as assessed with both the WOMAC A (P < 0.0001) and the total WOMAC (P < 0.0001), demonstrating the carryover effect of the drug. This superiority was already evident from month 2 for pain (P = 0.001) and month 1 for total WOMAC (P = 0.0021). Diacerein was safe and well tolerated. No serious or previously undocumented adverse events were observed during the study.Conclusion
This is the first published study of a symptomatic slow‐acting OA drug in which the time of assessment of the primary outcome end points was 2 months after the end of a 3‐month treatment period. The results show that diacerein is safe and effective for the treatment of knee OA and has a long carryover effect.2.
Anna‐K. Nilsdotter Ewa M. Roos Jonas P. Westerlund Harald P. Roos L. Stefan Lohmander 《Arthritis care & research》2001,45(3):258-262
Objective
To compare the responsiveness of the Functional Assessment System (FAS), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the Medical Outcomes Study 36‐item Short Form (SF‐36) in patients with osteoarthritis (OA) scheduled for total hip replacement.Method
Twenty patients with a mean age at surgery of 72.6 years, with primary OA of the hip, were investigated preoperatively and at 3, 6, and 12 months postoperatively with the FAS, WOMAC, and SF‐36. The responsiveness was calculated as standardized response mean, effect size, and relative efficiency.Results
The pain and function scores of WOMAC and SF‐36 showed greater responsiveness than FAS at 3 months. These differences remained at 6 and 12 months postoperatively. The differences between these 3 outcome measures were found to be similar using several methods for calculating responsiveness.Conclusion
Self‐administered questionnaires like WOMAC and SF‐36 are more responsive measures of pain and function than range of motion, performance tests, and observer‐administered questions (FAS) following total hip replacement.3.
Robert G. W. Lambert Edna J. Hutchings Michael G. A. Grace Gian S. Jhangri Barbara Conner‐Spady Walter P. Maksymowych 《Arthritis \u0026amp; Rheumatology》2007,56(7):2278-2287
Objective
To determine the efficacy of fluoroscopically guided corticosteroid injection for hip osteoarthritis (OA) in a randomized, double‐blind, placebo‐controlled trial.Methods
Fifty‐two patients with symptomatic hip OA were randomly allocated to receive placebo (10 mg bipuvicaine, 2 ml saline) (n = 21) or corticosteroid treatment (10 mg bipuvicaine, 40 mg triamcinolone hexacetonide) (n = 31). Patients were followed up for 1, 2, 3, and 6 months. The primary outcome measure was the pain improvement response, defined as a 20% decrease in the Western Ontario and McMaster Universities OA Index (WOMAC) pain score (on 5 100‐mm visual analog scales [VAS]) (WOMAC20) from baseline to 2 months postinjection. Secondary outcomes were a 50% decrease in the WOMAC pain score (WOMAC50), changes in other WOMAC subscale scores, patient's global assessment of health (on a 100‐mm VAS), and Short Form 36 (SF‐36) quality of life indices. Analyses were based on the intent‐to‐treat principle.Results
The mean WOMAC pain score fell 49.2% (decreasing from 310.1 mm to 157.4 mm) at 2 months postinjection in patients receiving corticosteroid, compared with a decrease of 2.5% (from 314.3 mm to 306.5 mm) in the placebo group (P < 0.0001). The proportion of WOMAC20 responders at 2 months' followup was significantly higher in the corticosteroid group (67.7%) compared with the placebo group (23.8%) (P = 0.004); similar proportions of WOMAC50 responders were observed between groups (61.3% in the corticosteroid group versus 14.3% in the placebo group; P = 0.001). Response differences were maintained at 3 months' followup (58.1% responders in the corticosteroid group versus 9.5% responders in the placebo group; P = 0.004). Significant differences in the WOMAC stiffness and physical function scores (P < 0.0001), patient's global health scores (P = 0.005), and SF‐36 physical component scores (P = 0.04) were observed, with patients in the corticosteroid group showing greater improvements. There were no differences in the frequency of adverse events between groups.Conclusion
This placebo‐controlled trial confirms that corticosteroid injection can be an effective treatment of pain in hip OA, with benefits lasting up to 3 months in many cases. Future studies should address questions related to the benefits of repeated steroid injection and the effects of this treatment on disease modification.4.
X. Chevalier P. Goupille A. D. Beaulieu F. X. Burch W. G. Bensen T. Conrozier D. Loeuille A. J. Kivitz D. Silver B. E. Appleton 《Arthritis care & research》2009,61(3):344-352
Objective
To evaluate the clinical response, safety, and tolerability of a single intraarticular injection of anakinra in patients with symptomatic osteoarthritis (OA) of the knee.Methods
Patients with OA of the knee were enrolled in a multicenter, double‐blind, placebo‐controlled study and randomized 2:1:2 to receive a single intraarticular injection of placebo, anakinra 50 mg, or anakinra 150 mg in their symptomatic knee. Patients were evaluated for 12 weeks postinjection. The primary end point was the change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score from baseline to week 4. Safety assessments included the evaluation of adverse events (AEs), laboratory tests, and vital signs. Pharmacokinetic parameters were assessed in a subset of patients.Results
Of 170 patients who enrolled, 160 (94%) completed the study. The mean improvements from baseline to week 4 in the WOMAC score were not statistically different between the placebo group and the patients who received 50 mg of anakinra (P = 0.67) or 150 mg of anakinra (P = 0.77). Anakinra was well tolerated. No withdrawals due to AEs or serious AEs, and no serious infections or deaths were reported. No clinically significant trends were noted in laboratory values or vital signs. Pharmacokinetic parameters demonstrated that the mean terminal half‐life of anakinra in serum after intraarticular injection was ∼4 hours.Conclusion
Anakinra was well tolerated as a single 50‐mg or 150‐mg intraarticular injection in patients with OA of the knee. However, anakinra was not associated with improvements in OA symptoms compared with placebo.5.
John D. Bradley Douglas K. Heilman Barry P. Katz Patricia G'Sell Janine E. Wallick Kenneth D. Brandt 《Arthritis \u0026amp; Rheumatology》2002,46(1):100-108
Objective
To evaluate the effectiveness of tidal irrigation (TI) in comparison with a well‐matched sham irrigation (SI) procedure as a treatment for knee osteoarthritis (OA).Methods
One hundred eighty subjects with knee OA were randomized to receive TI or SI, with clinical followup over the ensuing 12 months. The primary outcomes of interest were change in pain and function, as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Subjects and the nurse assessor were blinded, and success of blinding was assessed.Results
Although the study groups were otherwise comparable, the baseline WOMAC pain and physical functioning scores were higher (worse) in the SI group. After adjustment for baseline, there were no differences between the effects of SI and TI. Blinding was successful, with ∼90% of SI and TI subjects stating that they had received the TI procedure.Conclusion
Most, if not all, of the effect of TI appears to be attributable to a “placebo response.”6.
Robyn E. Fary Graeme J. Carroll Tom G. Briffa N. K. Briffa 《Arthritis \u0026amp; Rheumatology》2011,63(5):1333-1342
Objective
To determine the effectiveness of subsensory, pulsed electrical stimulation (PES) in the symptomatic management of osteoarthritis (OA) of the knee.Methods
This was a double‐blind, randomized, placebo‐controlled, repeated‐measures trial in 70 participants with clinical and radiographically diagnosed OA of the knee who were randomized to either PES or placebo. The primary outcome was change in pain score over 26 weeks measured on a 100‐mm visual analog scale (VAS). Other measures included pain on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), function on the WOMAC, patient's global assessment of disease activity (on a 100‐mm VAS), joint stiffness on the WOMAC, quality of life on the Medical Outcomes Study Short‐Form 36 (SF‐36) health survey, physical activity (using the Human Activity Profile and an accelerometer), and global perceived effect (on an 11‐point scale).Results
Thirty‐four participants were randomized to PES and 36 to placebo. Intent‐to‐treat analysis showed a statistically significant improvement in VAS pain score over 26 weeks in both groups, but no difference between groups (mean change difference 0.9 mm [95% confidence interval −11.7, 13.4]). Similarly, there were no differences between groups for changes in WOMAC pain, function, and stiffness scores (−5.6 [95% confidence interval −14.9, 3.6], −1.9 [95% confidence interval −9.7, 5.9], and 3.7 [95% confidence interval −6.0, 13.5], respectively), SF‐36 physical and mental component summary scores (1.7 [95% confidence interval −1.5, 4.8] and 1.2 [95% confidence interval −2.9, 5.4], respectively), patient's global assessment of disease activity (−2.8 [95% confidence interval −13.9, 8.4]), or activity measures. Fifty‐six percent of the PES‐treated group achieved a clinically relevant 20‐mm improvement in VAS pain score at 26 weeks compared with 44% of controls (12% [95% confidence interval −11%, 33%]).Conclusion
In this sample of subjects with mild‐to‐moderate symptoms and moderate‐to‐severe radiographic OA of the knee, 26 weeks of PES was no more effective than placebo.7.
Clifton O. Bingham J. Chris Buckland‐Wright Patrick Garnero Stanley B. Cohen Maxime Dougados Silvano Adami Daniel J. Clauw Timothy D. Spector Jean‐Pierre Pelletier Jean‐Pierre Raynauld Vibeke Strand Lee S. Simon Joan M. Meyer Gary A. Cline John F. Beary 《Arthritis \u0026amp; Rheumatology》2006,54(11):3494-3507
Objective
Bisphosphonates have slowed the progression of osteoarthritis (OA) in animal models and have decreased pain in states of high bone turnover. The Knee OA Structural Arthritis (KOSTAR) study, which is the largest study to date investigating a potential structure‐modifying OA drug, tested the efficacy of risedronate in providing symptom relief and slowing disease progression in patients with knee OA.Methods
The study group comprised 2,483 patients with medial compartment knee OA and 2–4 mm of joint space width (JSW), as determined using fluoroscopically positioned, semiflexed‐view radiography. Patients were enrolled in 2 parallel 2‐year studies in North America and the European Union. These studies evaluated the efficacy of risedronate at dosages of 5 mg/day, 15 mg/day, 35 mg/week (in Europe), and 50 mg/week (in North America) compared with placebo in reducing signs and symptoms, as measured by the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index and patient global assessment (PGA) scores, and in slowing radiographic progression.Results
A reduction of ∼20% in signs and symptoms, as measured by WOMAC subscales and PGA scores, was observed in all groups, with no treatment effect of risedronate demonstrated. Risedronate did not significantly reduce radiographic progression as measured by decreased JSW or using a dichotomous definition of progression (joint space loss of ≥0.6 mm). Thirteen percent of patients receiving placebo demonstrated significant disease progression over 2 years. A dose‐dependent reduction in the level of C‐terminal crosslinking telopeptide of type II collagen, a cartilage degradation marker associated with progressive OA, was seen in patients who received risedronate. No increase in the number of adverse events was demonstrated for risedronate compared with placebo.Conclusion
Although risedronate (compared with placebo) did not improve signs or symptoms of OA, nor did it alter progression of OA, a reduction in the level of a marker of cartilage degradation was observed. A sustained clinically relevant improvement in signs and symptoms was observed in all treatment and placebo groups.8.
Steven A. Mazzuca Mark C. Page Russell D. Meldrum Kenneth D. Brandt Satham Petty‐Saphon 《Arthritis care & research》2004,51(5):716-721
Objective
To identify changes in joint pain, stiffness, and functional ability in patients with knee osteoarthritis (OA) after use of a knee sleeve that prevents loss of body heat by the joint.Methods
Subjects with symptomatic knee OA (n = 52) were randomized to 2 treatment groups: verum sleeve (specially fabricated to retain body heat) or placebo sleeve (standard cotton/elastane sleeve). Subjects wore the sleeve over the more painful OA knee for at least 12 hours daily for 4 weeks. Pain, stiffness, and functional impairment (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]) in the index knee were measured at baseline and after 4 weeks of wear, after which sleeve use was discontinued. Telephone followup interviews were conducted 2 and 4 weeks later.Results
After 4 weeks of sleeve wear, subjects in the active treatment group reported a 16% decrease in mean WOMAC pain score relative to baseline (P = 0.001). Those who wore the placebo sleeve reported a 9.7% decrease from baseline (P = 0.002). The difference between treatment groups was not statistically significant (P = 0.12). However, it was found that the 12 subjects who believed correctly that they had received the verum sleeve reported a highly significant decrease in WOMAC pain score (?27.5% relative to baseline, P = 0.0001). In comparison, subjects who received the verum sleeve but believed they had received the placebo sleeve exhibited only a marginally significant improvement in pain (?13.0% relative to baseline, P = 0.07). In the placebo group, the modest improvement in pain scores appeared unrelated to the subject's impression of the type of sleeve worn.Conclusion
This pilot study was insufficiently powered to be a definitive trial of the heat‐retaining sleeve. Given the magnitude of changes in knee pain in the active treatment group, heat retention merits further scientific investigation as a treatment modality for patients with knee OA.9.
Helen M. Lapsley Lyn M. March Kate L. Tribe Marita J. Cross Peter M. Brooks 《Arthritis care & research》2001,45(3):301-306
Objective
To determine “out‐of‐pocket” expenditures related to osteoarthritis (OA) and to explore whether demographic details, health status scores (Medical Outcomes Study 36‐item Short Form [SF‐36] and Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]), or perception of social effect were expenditure determinants.Methods
A prospective cohort study of community‐dwelling subjects with OA completed 4 consecutive 3‐month cost diaries. In addition, subjects completed the SF‐36 and WOMAC at baseline and at 12 months. Social impact at baseline was collected. Four groups categorized by age and sex were compared. Patients undergoing joint replacement were excluded.Results
Differences in health status were defined more by age than by sex, especially for physical function. The costs to the patients were high, particularly for women, who spent more on medications and special equipment. Women also reported receiving more assistance from family and friends. Higher disease‐related expenditures were associated with greater pain levels, poorer social function and mental health, and longer duration of disease. Significant independent predictors of total patient expenditures related to OA were being female and having joint stiffness.Conclusion
Despite having heavily subsidized health care and access to the Pharmaceutical Benefits Scheme, out‐of‐pocket costs for patients with OA in Australia are considerable. Higher expenditures for patients with OA are related to more advanced disease, especially for women.10.
Thomas J. Schnitzer Jannie Beier Piet Geusens Paul Hasler Sanjay K. Patel Ingo Senftleber Xavier Gitton Alan Moore Victor S. Sloan Gyula Por 《Arthritis care & research》2004,51(4):549-557
Objective
To compare the efficacy and tolerability of the novel cyclooxygenase 2‐selective inhibitor lumiracoxib with placebo and diclofenac in osteoarthritis (OA).Methods
Adults (n = 583) with knee or hip OA were randomized to receive for 4 weeks lumiracoxib 50, 100, or 200 mg twice daily or 400 mg once daily; placebo; or diclofenac 75 mg twice daily. Efficacy assessments included overall joint pain intensity and Western Ontario and McMaster Universities Osteoarthritis Index subscales; tolerability was evaluated by adverse event and physician reporting.Results
All lumiracoxib doses were superior to placebo in relieving pain, improving stiffness, and improving physical function after 4 weeks. At study endpoint, pain relief was comparable among all lumiracoxib dosages and similar to diclofenac. Lumiracoxib tolerability was superior to diclofenac and comparable to placebo.Conclusion
Lumiracoxib provides predictable and sustained relief from pain, stiffness, and impaired physical function in OA. Lumiracoxib shows clinically comparable efficacy and superior tolerability to diclofenac.11.
Jean‐Pierre Raynauld Chris Buckland‐Wright Rupert Ward Denis Choquette Boulos Haraoui Johanne Martel‐Pelletier Imad Uthman Visithan Khy Jean‐Luc Tremblay Carole Bertrand Jean‐Pierre Pelletier 《Arthritis \u0026amp; Rheumatology》2003,48(2):370-377
Objective
To evaluate the safety and efficacy of long‐term intraarticular (IA) steroid injections for knee pain related to osteoarthritis (OA).Methods
In a randomized, double‐blind trial, 68 patients with OA of the knee received IA injections of triamcinolone acetonide 40 mg (34 patients) or saline (34 patients) into the study knee every 3 months for up to 2 years. The primary outcome variable was radiologic progression of joint space narrowing of the injected knee after 2 years. Measurements of minimum joint space width were performed by an automated computerized method on standardized fluoroscopically guided radiographs taken with the patient standing and with the knee in a semiflexed position. The clinical efficacy measure of primary interest was the pain subscale from the Western Ontario and McMaster Universities OA Index (WOMAC). Efficacy measures of secondary interest were the total score on the WOMAC, physician's global assessment, patient's global assessment, patient's assessment of pain, range of motion (ROM) of the affected knee, and 50‐foot walking time. Clinical symptoms were assessed just before each injection.Results
At the 1‐year and 2‐year followup evaluations, no difference was noted between the two treatment groups with respect to loss of joint space over time. The steroid‐injected knees showed a trend toward greater symptom improvement, especially at 1 year, for the WOMAC pain subscale, night pain, and ROM values (P = 0.05) compared with the saline‐injected knees. Using area under the curve analyses, knee pain and stiffness were significantly improved throughout the 2‐year study by repeated injections of triamcinolone acetonide, but not saline (P < 0.05).Conclusion
Our findings support the long‐term safety of IA steroid injections for patients with symptomatic knee OA. No deleterious effects of the long‐term administration of IA steroids on the anatomical structure of the knee were noted. Moreover, long‐term treatment of knee OA with repeated steroid injections appears to be clinically effective for the relief of symptoms of the disease.12.
Objective
To determine if a dose‐response relationship exists between percentage changes in body weight in persons with symptomatic knee osteoarthritis (OA) and self‐reported pain and function.Methods
Data from persons in the Osteoarthritis Initiative (OAI) and the Multicenter Osteoarthritis (MOST) study data sets (n = 1,410) with symptomatic function‐limiting knee OA were studied. For the OAI, we used baseline and 3‐year followup data, while for the MOST study, baseline and 30‐month data were used. Key outcome variables were Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function and pain change scores. In addition to covariates, the predictor variable of interest was the extent of weight change over the study period divided into 5 categories representing different percentages of body weight change.Results
A significant dose‐response relationship (P < 0.003) was found between the extent of percentage change in body weight and the extent of change in WOMAC physical function and WOMAC pain scores. For example, persons who gained ≥10% of body weight had WOMAC physical function score changes of ?5.4 (95% confidence interval ?8.7, ?2.00) points, indicating worsening physical function relative to the reference group of persons with weight changes between <5% weight gain and <5% weight reduction.Conclusion
Our data suggest a dose‐response relationship exists between changes in body weight and corresponding changes in pain and function. The threshold for this response gradient appears to be body weight shifts of ≥10%. Weight changes of ≥10% have the potential to lead to important changes in pain and function for patient groups as well as individual patients.13.
Siddharth K. Das S. Ramakrishnan Kavita Mishra Ragini Srivastava G. G. Agarwal Ragini Singh A. R. Sircar 《Arthritis care & research》2002,47(3):280-284
Objective
To determine if colchicine added to nimesulide may have a beneficial effect on osteoarthritis (OA) of the knee.Methods
Colchicine 0.5 mg twice daily or placebo was added to nimesulide (a nonsteroidal antiinflammatory drug) in 36 patients with OA of the knee in a randomized, double‐blind, placebo‐controlled trial over a 5‐month period.Results
The 30% improvement rate at 20 weeks was higher in the colchicine group than in the control group receiving placebo, as measured by total Western Ontario and McMaster University Osteoarthritis scores (57.9% versus 23.5%) and visual analog scale for index knee pain (52.6% versus 17.6%) (primary measures of response). The significance persisted on combined analysis by Mantel‐Haenszel test (P = 0.062). Comparison of means also showed significant improvement in the colchicine group versus the control group in a multivariate analysis performed using T2 test (P = 0.0115).Conclusion
Among patients with OA of the knee, the group receiving colchicine plus nimesulide exhibited significantly greater symptomatic benefit at 20 weeks than did the control group receiving nimesulide plus placebo.14.
15.
Michael C. Nevitt David T. Felson Elizabeth N. Williams Deborah Grady 《Arthritis \u0026amp; Rheumatology》2001,44(4):811-818
Objective
Most observational studies suggest that postmenopausal women taking hormone replacement therapy have a reduced risk of radiographic knee and hip osteoarthritis (OA). There are no randomized trial data on the association of hormone treatment with knee or hip OA, and no studies have been published regarding the relationship of hormone treatment to knee or hip symptoms. This study examined the association of hormone treatment with prevalent knee symptoms and disability related to knee pain as assessed at the final visit of the Heart and Estrogen/Progestin Replacement Study (HERS).Methods
The HERS was a 4‐year randomized, double‐blind, placebo‐controlled trial of estrogen plus medroxy progesterone acetate for prevention of coronary heart disease in postmenopausal women with documented coronary disease. Participants in this substudy on knee pain were 969 postmenopausal women, with a mean age of 66 years and mean body mass index of 28.6 kg/m2, attending the final visit at 9 clinical centers. Frequent knee symptoms were assessed by interview and the severity of knee pain and disability related to knee pain were determined using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Knee symptoms and disability were compared between women assigned to receive hormones and those assigned to receive placebo.Results
Frequent knee pain was reported in 24.1% of women assigned to receive hormone therapy versus 26.1% of those assigned to the placebo group, a difference of −2.0% (95% confidence interval [95% CI] −7.4% to 3.5%). Among women with knee pain, there were no differences in the severity of pain (score difference −0.2, 95% CI −1.2 to 0.8) or disability (score difference −0.7, 95% CI −3.8 to 2.4) as assessed on the WOMAC. All results were similar for women whose body mass index was either above or below the median.Conclusion
In a group of older, postmenopausal women with cardiac disease, we found no significant effect of 4 years of estrogen plus progestin therapy compared with placebo on knee pain and related disability. Our findings may not apply to other groups of women or to the effect of hormone therapy on the structural changes of knee OA.16.
Allan Gibofsky Gary W. Williams Frank McKenna John G. Fort 《Arthritis \u0026amp; Rheumatology》2003,48(11):3102-3111
Objective
To compare the efficacy of the cyclooxygenase 2 (COX‐2)–specific inhibitors celecoxib and rofecoxib in treating the signs and symptoms of osteoarthritis (OA).Methods
In this randomized, placebo‐controlled, double‐blind, multicenter study, 475 patients with OA of the knee received either celecoxib 200 mg/day (n = 189), rofecoxib 25 mg/day (n = 190), or placebo (n = 96) for 6 weeks. Arthritis assessments were performed at baseline, week 3, and week 6 (or at the time of early termination).Results
In primary measures of efficacy (OA pain score on a 100‐mm visual analog scale [VAS] and total domain score on the Western Ontario and McMaster Universities Osteoarthritis Index), celecoxib 200 mg/day and rofecoxib 25 mg/day demonstrated similar efficacy. At week 6, celecoxib was associated with a 34‐mm mean improvement on the VAS for OA pain, compared with 31.6 mm for rofecoxib and 21.2 mm for placebo. The difference between celecoxib and rofecoxib was −2.5 mm, with an upper limit of the 95% confidence interval of 2.7 mm and within the prespecified definition of noninferiority. Secondary measures of efficacy showed similar results. All differences in primary and secondary measures of efficacy between the 2 active treatments and placebo were statistically significant (P < 0.02), whereas all of the comparisons of efficacy between celecoxib and rofecoxib met the predefined criteria for noninferiority. All treatments were well tolerated throughout the study, with similar proportions of patients withdrawing due to adverse events.Conclusion
Celecoxib 200 mg/day and rofecoxib 25 mg/day are equally efficacious in treating the signs and symptoms of OA.17.
18.
Cem Gabay Carole Medinger‐Sadowski Danielle Gascon Frank Kolo Axel Finckh 《Arthritis \u0026amp; Rheumatology》2011,63(11):3383-3391
Objective
To evaluate the symptomatic effects of highly purified chondroitin 4 and chondroitin 6 sulfate (CS) therapy in patients with osteoarthritis (OA) of the hand.Methods
This investigator‐initiated, single‐center, randomized, double‐blind, placebo‐controlled clinical trial included 162 symptomatic patients with radiographic evidence of hand OA (American College of Rheumatology criteria). Inclusion criteria included patient's assessment of global spontaneous hand pain of at least 40 mm on a 0–100‐mm visual analog scale (VAS) and functional impairment of at least 6 (0–30 scale) on the Functional Index for Hand OA (FIHOA) in the most symptomatic hand. Patients received either 800 mg of CS (n = 80 patients) or placebo (n = 82 patients) once daily for 6 months and were analyzed in an intent‐to‐treat approach. The two primary outcomes were the change in the patient's assessment of global spontaneous hand pain and in hand function (by FIHOA score) from baseline to month 6. Secondary outcomes were improvement in grip strength, duration of morning stiffness, acetaminophen consumption, and the investigator's global impression of treatment efficacy.Results
There was a significantly more pronounced decrease in the patient's global assessment of hand pain in the CS group than in the placebo group (difference VAS scores −8.7 mm; P = 0.016). Hand function improved significantly more in the CS group than in the placebo group (difference in FIHOA scores −2.14; P = 0.008). There was a statistically significant between‐group difference in favor of CS for the duration of morning stiffness and for the investigator's global impression of treatment efficacy. Changes in grip strength, acetaminophen consumption, and safety end points were not significantly different between the two groups.Conclusion
This study demonstrates that CS improves hand pain and function in patients with symptomatic OA of the hand and shows a good safety profile.19.
Chenchen Wang Christopher H. Schmid Patricia L. Hibberd Robert Kalish Ronenn Roubenoff Ramel Rones Timothy McAlindon 《Arthritis care & research》2009,61(11):1545-1553
Objective
To evaluate the effectiveness of Tai Chi in the treatment of knee osteoarthritis (OA) symptoms.Methods
We conducted a prospective, single‐blind, randomized controlled trial of 40 individuals with symptomatic tibiofemoral OA. Patients were randomly assigned to 60 minutes of Tai Chi (10 modified forms from classic Yang style) or attention control (wellness education and stretching) twice weekly for 12 weeks. The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score at 12 weeks. Secondary outcomes included WOMAC function, patient and physician global assessments, timed chair stand, depression index, self‐efficacy scale, and quality of life. We repeated these assessments at 24 and 48 weeks. Analyses were compared by intent‐to‐treat principles.Results
The 40 patients had a mean age of 65 years and a mean body mass index of 30.0 kg/m2. Compared with the controls, patients assigned to Tai Chi exhibited significantly greater improvement in WOMAC pain (mean difference at 12 weeks ?118.80 mm [95% confidence interval (95% CI) ?183.66, ?53.94; P = 0.0005]), WOMAC physical function (?324.60 mm [95% CI ?513.98, ?135.22; P = 0.001]), patient global visual analog scale (VAS; ?2.15 cm [95% CI ?3.82, ?0.49; P = 0.01]), physician global VAS (?1.71 cm [95% CI ?2.75, ?0.66; P = 0.002]), chair stand time (?10.88 seconds [95% CI ?15.91, ?5.84; P = 0.00005]), Center for Epidemiologic Studies Depression Scale (?6.70 [95% CI ?11.63, ?1.77; P = 0.009]), self‐efficacy score (0.71 [95% CI 0.03, 1.39; P = 0.04]), and Short Form 36 physical component summary (7.43 [95% CI 2.50, 12.36; P = 0.004]). No severe adverse events were observed.Conclusion
Tai Chi reduces pain and improves physical function, self‐efficacy, depression, and health‐related quality of life for knee OA.20.
Jolanda Cibere Jacek A. Kopec Anona Thorne Joel Singer Janice Canvin David B. Robinson Janet Pope Paul Hong Eric Grant John M. Esdaile 《Arthritis care & research》2004,51(5):738-745