Food intolerance in rheumatoid arthritis. I. A double blind, controlled trial of the clinical effects of elimination of milk allergens and azo dyes.

ObjectivesPersons at high risk of rheumatoid arthritis (RA) might benefit from a low-risk pharmacological intervention aimed at primary prevention. Previous studies demonstrated disease-modifying effects of statins in patients with RA as well as an association between statin use and a decreased risk of RA development. A randomised, double-blind, placebo-controlled trial investigated whether atorvastatin could prevent arthritis development in high-risk individuals.MethodsArthralgia patients with anticitrullinated protein antibody (ACPA) >3 xULN or ACPA and rheumatoid factor, without (a history of) arthritis, were randomised to receive atorvastatin 40 mg daily or placebo for 3 years. The calculated sample size was 220 participants. The primary endpoint was clinical arthritis. Cox regression analysis was used to determine the effect of atorvastatin on arthritis development.ResultsDue to a low inclusion rate, mainly because of an unwillingness to participate, the trial was prematurely stopped. Data of the 62 randomised individuals were analysed. Median follow-up was 14 (inner quartiles 6–35) months. Fifteen individuals (24%) developed arthritis: 9/31 (29%) in the atorvastatin group; 6/31 (19%) in the placebo group: HR 1.40, 95% CI 0.50 to 3.95.ConclusionsIn this small set of randomised high-risk individuals, we did not demonstrate a protective effect of atorvastatin on arthritis development. The main reason for the low inclusion was unwillingness to participate; this may also impede other RA prevention trials. Further research to investigate and solve barriers for prevention trial participation is needed.

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Su.106. Clinical Effects of Intraarticular Injection of Polymerized-Type I Collagen: a Double-Blind, Randomized, Placebo-Controlled Trial

Clinical Immunology ◽

10.1016/j.clim.2006.04.533 ◽

2006 ◽

Vol 119 ◽

pp. S196

Author(s):

Janette Furuzawa-Carballeda ◽

Andres Agualimpia-Janning ◽

Olga Munoz-Chable ◽

Salvador Macias-Hernandez

Keyword(s):

Type I Collagen ◽

Controlled Trial ◽

Intraarticular Injection ◽

Type I ◽

Clinical Effects ◽

Double Blind

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Cyclosporin A monotherapy versus cyclosporin A and methotrexate combination therapy in patients with early rheumatoid arthritis: a double blind randomised placebo controlled trial

Annals of the Rheumatic Diseases ◽

10.1136/ard.62.4.291 ◽

2003 ◽

Vol 62 (4) ◽

pp. 291-296 ◽

Cited By ~ 59

Author(s):

A H Gerards

Keyword(s):

Rheumatoid Arthritis ◽

Combination Therapy ◽

Cyclosporin A ◽

Early Rheumatoid Arthritis ◽

Controlled Trial ◽

Double Blind

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Randomised Double-Blind Trial of Combination Antibiotic Therapy in Rheumatoid Arthritis

International Journal of Rheumatology ◽

10.1155/2011/585497 ◽

2011 ◽

Vol 2011 ◽

pp. 1-6 ◽

Cited By ~ 2

Author(s):

Angela Smith ◽

Caroline Doré ◽

Peter Charles ◽

Alena Vallance ◽

Tara Potier ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Placebo Group ◽

Active Treatment ◽

Active Rheumatoid Arthritis ◽

Controlled Trial ◽

Primary Outcome Measure ◽

Good Evidence ◽

Double Blind ◽

Acr20 Response ◽

Significant Difference

Objective. A combination of intravenous clindamycin and oral tetracycline has been used for many years as a treatment for active rheumatoid arthritis (RA), despite the absence of good evidence for its efficacy. A single-blind pilot study of this therapy suggested that a double-blind placebo-controlled trial was warranted.Methods. Patients with active RA were randomised in a 2 : 1 ratio to receive active treatment or placebo for 25 weeks. The active treatment consisted of intravenous clindamycin in a reducing regime, and oral tetracycline twice daily three times a week. 50 patients were to be recruited. The primary outcome measure was the proportion of patients achieving an ACR20 response.Results. An interim statistical analysis was performed after 20 patients had completed the study. Two patients in the active group achieved an ACR20 response, with none in the placebo group (NS). There was a better ESR20 response in the placebo group (P=.02). There were no other significant differences between the groups. The results indicated that it was unlikely that a significant difference in ACR20 response would emerge if the remaining 30 patients were recruited. The trial was therefore halted.Conclusion. This antibiotic regime is unlikely to be a valuable therapy for active rheumatoid arthritis.

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Methotrexate in resistant juvenile rheumatoid arthritis: Results of the USA–USSR double-blind, placebo-controlled trial

Classic Papers in Rheumatology ◽

10.3109/9780203214237-61 ◽

2001 ◽

pp. 122-123

Keyword(s):

Rheumatoid Arthritis ◽

Juvenile Rheumatoid Arthritis ◽

Controlled Trial ◽

Double Blind ◽

Double Blind Placebo ◽

The Usa

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The research evidence base for homeopathy: a fresh assessment of the literature

Homeopathy ◽

10.1016/s1475-4916-03-00006-7 ◽

2003 ◽

Vol 92 (02) ◽

pp. 84-91

Author(s):

RT Mathie

Keyword(s):

Clinical Trials ◽

Research Evidence ◽

Controlled Trial ◽

Relative Number ◽

Evidence Base ◽

Weight Of Evidence ◽

Clinical Effects ◽

Upper Respiratory Tract ◽

Medical Conditions ◽

Double Blind

Abstract Background. The claims made for the clinical effects of homeopathy are controversial. The results of several meta-analyses of clinical trials are positive, but they fail in general to highlight specific medical conditions that respond well to homeopathy. Aims. This review examines the cumulative research from randomised and/or double-blind clinical trials (RCTs) in homeopathy for individual medical conditions reported since 1975, and asks the question: What is the weight of the original evidence from published RCTs that homeopathy has an effect that is statistically significantly different from that in a comparative group? Method. Analysis of the 93 substantive RCTs that compare homeopathy either with placebo or another treatment. Results. 50 papers report a significant benefit of homeopathy in at least one clinical outcome measure, 41 that fail to discern any inter-group differences, and two that describe an inferior response with homeopathy. Considering the relative number of research articles on the 35 different medical conditions in which such research has been carried out, the weight of evidence currently favours a positive treatment effect in eight: childhood diarrhoea, fibrositis, hayfever, influenza, pain (miscellaneous), side-effects of radio- or chemotherapy, sprains and upper respiratory tract infection. Based on published research to date, it seems unlikely that homeopathy is efficacious for headache, stroke or warts. Insufficient research prevents conclusions from being drawn about any other medical conditions. Conclusions. The available research evidence emphasises the need for much more and better-directed research in homeopathy. A fresh agenda of enquiry should consider beyond (but include) the placebo-controlled trial. Each study should adopt research methods and outcome measurements linked to a question addressing the clinical significance of homeopathy's effects.

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