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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. 相似文献
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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
Objective
To assess the efficacy of glucosamine sulfate in knee osteoarthritis (OA).Methods
A 4‐center, 6‐month, randomized, double‐blind, placebo‐controlled glucosamine discontinuation trial was conducted in 137 current users of glucosamine with knee OA who had experienced at least moderate improvement in knee pain after starting glucosamine. Study medication dosage was equivalent to the dosage of glucosamine taken prior to the study (maximum 1,500 mg/day). Followup continued for 6 months or until disease flare, whichever occurred first. The primary outcome was the proportion of disease flares in the glucosamine and placebo groups using an intent‐to‐treat analysis. Secondary outcomes included time to disease flare; analgesic medication use; severity of disease flare; and change in pain, stiffness, function and quality of life in the glucosamine and placebo groups.Results
Disease flare was seen in 28 (42%) of 66 placebo patients and 32 (45%) of 71 glucosamine patients (difference ?3%; 95% confidence interval [95% CI] ?19, 14; P = 0.76). In the Cox regression analysis, after adjustment for sex, study site, and OA radiographic severity, time to disease flare was not significantly different in the glucosamine compared with placebo group (hazard ratio of flare = 0.8; 95% CI 0.5, 1.4; P = 0.45). At final study visit, acetaminophen was used in 27% and 21% of placebo and glucosamine patients, respectively (P = 0.40), nonsteroidal antiinflammatory drugs were used in 29% and 30% (P = 0.92), and both were used in 20% and 21% (P = 0.84). No differences were found in severity of disease flare or other secondary outcomes between placebo and glucosamine patients.Conclusion
In patients with knee OA with at least moderate subjective improvement with prior glucosamine use, this study provides no evidence of symptomatic benefit from continued use of glucosamine sulfate.3.
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Francesco Zulian Giorgia Martini Cristina Vallongo Fabio Vittadello Fernanda Falcini Annalisa Patrizi Maria Alessio Francesco La Torre Rosa A. Podda Valeria Gerloni Mario Cutrone Anna Belloni‐Fortina Mauro Paradisi Silvana Martino Giorgio Perilongo 《Arthritis \u0026amp; Rheumatology》2011,63(7):1998-2006
Objective
Juvenile localized scleroderma is a chronic progressive fibrotic disorder of the skin that causes permanent disability and aesthetic damage. This study was undertaken to assess the safety and efficacy of methotrexate (MTX) in the treatment of juvenile localized scleroderma.Methods
In this double‐blind study, patients with active juvenile localized scleroderma were randomized (2:1) to receive oral MTX (15 mg/m2, maximum 20 mg) or placebo once weekly, for 12 months or until treatment failure. Both groups received oral prednisone (1 mg/kg/day, maximum 50 mg) for the first 3 months. A target lesion was evaluated clinically, with infrared thermography and using a computerized scoring system with skin score rate (SSR) evaluation. Response to treatment was defined as the absence of new lesions, SSR ≤1, and a decrease in lesion temperature of at least 10% compared to baseline. Treatment failure was defined as the occurrence of new lesions, SSR >1, or increased lesion temperature. All analyses were done on the intent‐to‐treat population.Results
Of the 85 patients screened, 70 (ages 6–17 years) were randomized (46 to the MTX group, 24 to the placebo group). The mean disease duration was 2.3 years. After an initial response in all patients, disease relapsed in 15 MTX‐treated patients (32.6%) and 17 placebo‐treated patients (70.8%) (P < 0.005). New lesions appeared in 3 MTX‐treated patients (6.5%) versus 4 placebo‐treated patients (16.7%). The mean SSR decreased from 1 to 0.79 in the MTX group and increased from 1 to 1.1 in the placebo group, and the mean target lesion temperature decreased by 44.4% in the MTX group versus 12.1% in the placebo group. Twenty‐six patients in the MTX group (56.5%) and 11 patients in the placebo group (45.8%) developed mild side effects related to treatment. None of the side effects were severe enough to necessitate treatment discontinuation.Conclusion
Our findings indicate that MTX is efficacious in the treatment of juvenile localized scleroderma and is well tolerated.5.
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Stphane Genevay Sebastien Viatte Axel Finckh Pascal Zufferey Federico Balagu Cem Gabay 《Arthritis \u0026amp; Rheumatology》2010,62(8):2339-2346
Objective
Based on several experimental results and on a preliminary study, a trial was undertaken to assess the efficacy of adalimumab, a tumor necrosis factor α inhibitor, in patients with radicular pain due to lumbar disc herniation.Methods
A multicenter, double‐blind, randomized controlled trial was conducted between May 2005 and December 2007 in Switzerland. Patients with acute (duration of <12 weeks) and severe (Oswestry Disability Index score of >50) radicular leg pain and imaging‐confirmed lumbar disc herniation were randomized to receive as adjuvant therapy either 2 subcutaneous injections of adalimumab (40 mg) at 7‐day intervals or matching placebo. The primary outcome was the score for leg pain, based on a visual analog scale (0–100 mm), which was recorded every day for 10 days and at 6 weeks and 6 months.Results
Of the 265 patients screened, 61 were enrolled; 31 patients were assigned to receive adalimumab, and 4 patients in the placebo group were lost to followup. Over time, the course of leg pain was more favorable in the adalimumab group than in the placebo group (P = 0.002). However, the effect size was relatively small, and at the last followup visit the difference was 13.8 (95% confidence interval −11.5, 39.0). Compared with patients in the placebo group, approximately twice as many patients in the adalimumab group fulfilled the criteria for “responders” and for “low residual disease impact” (P < 0.05), and fewer surgical discectomies were performed (6 versus 13 in the placebo group; P = 0.04).Conclusion
The addition of a short course of adalimumab to the treatment regimen of patients experiencing acute and severe sciatica resulted in a small decrease in leg pain and in significantly fewer surgical procedures.7.
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.8.
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Randomized double‐blind placebo‐controlled multicenter trial of Yokukansan for neuropsychiatric symptoms in Alzheimer's disease 下载免费PDF全文
Katsutoshi Furukawa Naoki Tomita Daisuke Uematsu Kazunori Okahara Hiroyuki Shimada Masaki Ikeda Toshifumi Matsui Koichi Kozaki Masahiko Fujii Tatsuji Ogawa Hiroyuki Umegaki Katsuya Urakami Hiroshi Nomura Naoto Kobayashi Aki Nakanishi Yukihiro Washimi Hisashi Yonezawa Satoshi Takahashi Masaharu Kubota Yosuke Wakutani Daisuke Ito Takahiro Sasaki Etsuro Matsubara Kaori Une Aiko Ishiki Yukie Yahagi Mikio Shoji Hiroyasu Sato Yasuo Terayama Masafumi Kuzuya Nobuo Araki Manabu Kodama Takuhiro Yamaguchi Hiroyuki Arai 《Geriatrics & Gerontology International》2017,17(2):211-218
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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.13.
E. William St.Clair William E. Wilkinson David S. Pisetsky Daniel J. Sexton Richard Drew Virginia B. Kraus Robert A. Greenwald 《Arthritis \u0026amp; Rheumatology》2001,44(5):1043-1047
Objective
To determine the feasibility, safety, and potential clinical efficacy of intravenous (IV) doxycycline therapy for rheumatoid arthritis (RA), as well as its possible effects on serum and urinary markers of collagen breakdown.Methods
The exploratory trial was designed as a 16‐week, single‐center, randomized, double‐blind, placebo‐controlled trial. Eligible subjects with active seropositive or erosive RA were randomly allocated into 3 treatment groups: doxycycline 200 mg IV, azithromycin 250 mg orally, or placebo. The blinded IV study drug was administered once daily for the first 3 weeks by home self‐infusion and then weekly for the next 8 weeks, concurrent with the blinded oral study drug at the prescribed doses. The primary end points were the change between baseline and week 4 in the tender joint count, erythrocyte sedimentation rate, and urinary excretion of pyridinoline.Results
The trial was stopped prematurely after enrollment of 31 patients. Three subjects were withdrawn because of worsening arthritis, and 1 patient was withdrawn when newly diagnosed with breast cancer. Infusion‐related events occurred in 13 (42%) of 31 patients, but none were serious. There were 4 serious adverse events unrelated to the study drug, including a new diagnosis of breast cancer in 3 cases and hospitalization for abdominal pain in 1 case. No significant differences were observed across treatment groups in any of the 3 primary clinical end points.Conclusion
Although IV doxycycline therapy was generally well‐tolerated by patients in this trial, it did not show any evidence of reducing disease activity or collagen crosslink production.14.
Lesley M. Arnold Don L. Goldenberg Sharon B. Stanford Justine K. Lalonde H. S. Sandhu Paul E. Keck Jeffrey A. Welge Fred Bishop Kevin E. Stanford Evelyn V. Hess James I. Hudson 《Arthritis \u0026amp; Rheumatology》2007,56(4):1336-1344
Objective
To assess the efficacy and safety of gabapentin in patients with fibromyalgia.Methods
A 12‐week, randomized, double‐blind study was designed to compare gabapentin (1,200–2,400 mg/day) (n = 75 patients) with placebo (n = 75 patients) for efficacy and safety in treating pain associated with fibromyalgia. The primary outcome measure was the Brief Pain Inventory (BPI) average pain severity score (range 0–10, where 0 = no pain and 10 = pain as bad as you can imagine). Response to treatment was defined as a reduction of ≥30% in this score. The primary analysis of efficacy for continuous variables was a longitudinal analysis of the intent‐to‐treat sample, with treatment‐by‐time interaction as the measure of effect.Results
Gabapentin‐treated patients displayed a significantly greater improvement in the BPI average pain severity score (P = 0.015; estimated difference between groups at week 12 = −0.92 [95% confidence interval −1.75, −0.71]). A significantly greater proportion of gabapentin‐treated patients compared with placebo‐treated patients achieved response at end point (51% versus 31%; P = 0.014). Gabapentin compared with placebo also significantly improved the BPI average pain interference score, the Fibromyalgia Impact Questionnaire total score, the Clinical Global Impression of Severity, the Patient Global Impression of Improvement, the Medical Outcomes Study (MOS) Sleep Problems Index, and the MOS Short Form 36 vitality score, but not the mean tender point pain threshold or the Montgomery Asberg Depression Rating Scale. Gabapentin was generally well tolerated.Conclusion
Gabapentin (1,200–2,400 mg/day) is safe and efficacious for the treatment of pain and other symptoms associated with fibromyalgia.15.
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Michelle A. Petri Robert G. Lahita Ronald F. Van Vollenhoven Joan T. Merrill Michael Schiff Ellen M. Ginzler Vibeke Strand Arlene Kunz Kenneth J. Gorelick Kenneth E. Schwartz 《Arthritis \u0026amp; Rheumatology》2002,46(7):1820-1829
Objective
To evaluate whether treatment with prasterone (dehydroepiandrosterone [DHEA]) would allow the dosage of prednisone (or an equivalent corticosteroid) to be reduced to ≤7.5 mg/day for 2 months or longer while maintaining stable or reduced disease activity in steroid‐dependent women with systemic lupus erythematosus (SLE).Methods
In a double‐blind, randomized trial, 191 female SLE patients receiving prednisone (10–30 mg/day) were treated daily with either placebo, 100 mg of oral prasterone (an adrenal androgen), or 200 mg of oral prasterone for 7–9‐months. At monthly intervals, corticosteroid dosages were reduced by algorithm in patients whose SLE Disease Activity Index (SLEDAI) score was stable or improved. Patients for whom a sustained reduction in the dosage of prednisone (≤7.5 mg/day) was achieved for at least the last 2 months of the 7–9‐month treatment period were classified as responders.Results
Response rates were 41% in the placebo group, 44% in the 100‐mg prasterone group, and 55% in the 200‐mg group (P = 0.110, 200 mg versus placebo). Among the 137 subjects (45 in the placebo group, 47 in the 100‐mg group, and 45 in the 200‐mg group) who had active disease at baseline (defined as SLEDAI score >2), 29%, 38%, and 51%, respectively, were responders (P = 0.031 for 200 mg prasterone versus placebo). Acne was the most common adverse event but was generally mild. Clinical and laboratory changes primarily reflected androgenic effects of prasterone.Conclusion
Among women with lupus disease activity, reducing the dosage of prednisone to ≤7.5 mg/day for a sustained period of time while maintaining stabilization or a reduction of disease activity was possible in a significantly greater proportion of patients treated with oral prasterone, 200 mg once daily, compared with patients treated with placebo.17.
S. Wayne Miles Janie Sheridan Bruce Russell Rob Kydd Amanda Wheeler Carina Walters Greg Gamble Peta Hardley Maree Jensen Kimmo Kuoppasalmi Pekka Tuomola Jaana Föhr Outi Kuikanmäki Helena Vorma Raimo Salokangas Antti Mikkonen Mika Kallio Jussi Kauhanen Vesa Kiviniemi Jari Tiihonen 《Addiction (Abingdon, England)》2013,108(7):1279-1286
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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