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A Randomized, Double-blind, Placebo Controlled Study of Oral Adenosine Triphosphate in Subacute Low Back Pain
BERNARD BANNWARTH, FRANÇOIS-ANDRE ALLAERT, BERNARD AVOUAC, MICHEL ROSSIGNOL, SYLVIE ROZENBERG, and JEAN-PIERRE VALAT
ABSTRACT.
Objective. To assess the efficacy and safety of oral adenosine triphosphate (ATP) in subacute low back pain. Methods. This was a randomized, double-blind, parallel group, placebo controlled clinical trial. The patients were given either ATP 90 mg once daily (n = 81) or placebo (n = 80) for one month. The patients were assessed 3 times during the study period, at days 0, 7, and 30. The primary outcome measure was the Roland-Morris Disability Questionnaire (RDQ) at day 30. Secondary measures of efficacy included visual analog scale (VAS) pain, overall assessments of efficacy by both patient and investigator, and number of dextropropoxyphene and acetaminophen combination tablets used as rescue analgesic. Results. Regarding the RDQ, the mean values dropped from 10.3 ± 2.8 at baseline to 7.5 ± 3.8 (day 7) and 5.2 ± 5.2 (day 30) in the ATP group, and from 11.0 ± 3.5 to 9.1 ± 4.2 (day 7) and 6.1 ± 4.3 (day 30) in the placebo group. The difference between the 2 groups was statistically significant at day 7 (p = 0.02) but not at day 30 (p = 0.2). In other words, the mean changes from baseline were 2.8 ± 3.1 and 2.0 ± 2.6 at day 7 (p = 0.06), and 5.1 ± 3.9 and 5.0 ± 4.2 at day 30 (p = 0.78) in the ATP group and the placebo group, respectively. There were no statistically significant differences in the VAS pain and overall assessments of efficacy between groups at any time point during the study. Conversely, there was a significant difference in the use of the rescue analgesic between groups, in favor of ATP (p = 0.04). Oral ATP was well tolerated. Conclusion. Oral ATP might have an early acting effect in subacute low back pain. (J Rheumatol 2005;32:1114-7) Key Indexing Terms:
ADENOSINE TRIPHOSPHATE
From the Department of Rheumatology, Groupe Hospitalier Pellegrin and Division of Therapeutics, EA 525, Victor Segalen University, Bordeaux; Department of Medical Information, Teaching Hospital, Dijon; Department of Rheumatology, Henri Mondor Teaching Hospital, Créteil; Department of Rheumatology, Pitié-Salpétrière Teaching Hospital, Paris; Department of Rheumatology, Trousseau Teaching Hospital, Tours, France; and Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Canada. Supported by Laboratoires Mayoly-Spindler, France. B. Bannwarth, MD, Professor, Department of Rheumatology, Groupe Hospitalier Pellegrin and Division of Therapeutics, Victor Segalen University; F.A. Allaert, MD, PhD, Professor, Department of Medical Information, Teaching Hospital; B. Avouac, MD, Department of Rheumatology, Henri Mondor Teaching Hospital; M. Rossignol, MD, MSc, Department of Epidemiology, Biostatistics and Occupational Health, McGill University; S. Rozenberg, MD, Department of Rheumatology, Pitié-Salpétrière Teaching Hospital; J.P. Valat, MD, Professor, Trousseau Teaching Hospital. Address reprint requests to Pr. B. Bannwarth, Department of Rheumatology, Groupe Hospitalier Pellegrin, CHU de Bordeaux, 33076 Bordeaux Cedex, France. E-mail: bernard.bannwarth@u-bordeaux2.fr Accepted for publication January 29, 2005. |