A randomized, double-blind, placebo controlled triphosphate in study of oral adenosine subacute low back pain.
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.


CONCLUSIONS
Oral ATP might have an early acting effect in subacute low back pain.
Bannwarth
Bernard
B
Department of Rheumatology, Groupe Hospitalier Pellegrin and Division of Therapeutics, EA 525, Victor Segalen University, Bordeaux, France. bernard.bannwarth@u-bordeaux2.fr
Allaert
François-Andre
FA
Avouac
Bernard
B
Rossignol
Michel
M
Rozenberg
Sylvie
S
Valat
Jean-Pierre
JP
D000255:Adenosine Triphosphate / Q000627:therapeutic use*; D000284:Administration, Oral; D000328:Adult; D000700:Analgesics / Q000627:therapeutic use*; D004185:Disability Evaluation; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000188:drug therapy*; D008297:Male; D010147:Pain Measurement; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D000700:Analgesics; D000255:Adenosine Triphosphate