[Long-term therapy of progressive chronic polyarthritis with naproxen]. 1975

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The efficacy of d-2-(6'-methoxy-2'-naphthyl)-propionic acid (naproxen) in the treatment of patients with rheumatoid arthritis as well as its good tolerance has been established in double-blind studies which have been conducted in 34 centers in the U.S.A. Since the value of a new antirheumatic drug can only be assessed after years of clinical experience, provision was made in the protocols of the double-blind studies that the patients completing the controlled studies could continue naproxen treatment. Our experience is based on 603 patients, of whom 337 came from controlled, and 266 from previous open studies. The longest treatment with naproxen lasted four years. 16% of the patients discontinued therapy because of a exacerbation of their symptoms, and 8% because of side-effects, the latter being described in detail. Follow-up examinations of the patients were performed 4841 times at bi-monthly intervals. The statistical analysis of the objective disease symptoms showed a significant decrease of the rheumatic manifestations. In order to exclude the possibility of a long-term placebo effect, and as a proof of continuing efficacy, 73 patients received double-blind placebo instead of naproxen (placebo pulse) for two weeks, whereas the others continued on naproxen. Statistical analysis of the objective symptoms during the two treatment phases of the study showed naproxen significantly superior to placebo in all disease manifestations. Symptoms of those patients receiving placebo aggravated rapidly. They improved again after naproxen was resumed. The situation was reverse in those patients who received placebo during the second phase of the study. Side-effects were observed 13 times under placebo, but only two times under naproxen. The integration of a 2-week-placebo-pulse during long-term naproxen therapy of patients with rheumatoid arthritis is a sensitive method to prove the continuing therapeutic efficacy of this drug.

UI MeSH Term Description Entries
D008134 Long-Term Care Care over an extended period, usually for a chronic condition or disability, requiring periodic, intermittent, or continuous care. Care, Long-Term,Long Term Care
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D009280 Naphthaleneacetic Acids Naphthalene derivatives containing the -CH2CCO2H radical at the 1-position, the 2-position, or both. Compounds are used as plant growth regulators to delay sprouting, exert weed control, thin fruit, etc. Acids, Naphthaleneacetic
D009288 Naproxen An anti-inflammatory agent with analgesic and antipyretic properties. Both the acid and its sodium salt are used in the treatment of rheumatoid arthritis and other rheumatic or musculoskeletal disorders, dysmenorrhea, and acute gout. Aleve,Anaprox,Methoxypropiocin,Naprosin,Naprosyn,Naproxen Sodium,Proxen,Sodium Naproxenate,Synflex,Naproxenate, Sodium,Sodium, Naproxen
D010919 Placebos Any dummy medication or treatment. Although placebos originally were medicinal preparations having no specific pharmacological activity against a targeted condition, the concept has been extended to include treatments or procedures, especially those administered to control groups in clinical trials in order to provide baseline measurements for the experimental protocol. Sham Treatment
D002908 Chronic Disease Diseases which have one or more of the following characteristics: they are permanent, leave residual disability, are caused by nonreversible pathological alteration, require special training of the patient for rehabilitation, or may be expected to require a long period of supervision, observation, or care (Dictionary of Health Services Management, 2d ed). For epidemiological studies chronic disease often includes HEART DISEASES; STROKE; CANCER; and diabetes (DIABETES MELLITUS, TYPE 2). Chronic Condition,Chronic Illness,Chronically Ill,Chronic Conditions,Chronic Diseases,Chronic Illnesses,Condition, Chronic,Disease, Chronic,Illness, Chronic
D002986 Clinical Trials as Topic Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries. Clinical Trial as Topic
D005500 Follow-Up Studies Studies in which individuals or populations are followed to assess the outcome of exposures, procedures, or effects of a characteristic, e.g., occurrence of disease. Followup Studies,Follow Up Studies,Follow-Up Study,Followup Study,Studies, Follow-Up,Studies, Followup,Study, Follow-Up,Study, Followup
D005767 Gastrointestinal Diseases Diseases in any segment of the GASTROINTESTINAL TRACT from ESOPHAGUS to RECTUM. Cholera Infantum,Gastrointestinal Disorders,Functional Gastrointestinal Disorders,Gastrointestinal Disorders, Functional,Disease, Gastrointestinal,Diseases, Gastrointestinal,Functional Gastrointestinal Disorder,Gastrointestinal Disease,Gastrointestinal Disorder,Gastrointestinal Disorder, Functional

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