[Otorhinolaryngologic pain in the adult. A comparison of the analgesic efficacy of lysine acetylsalicylate and paracetamol].
OBJECTIVE
Unlike paracetamol, aspinin has anti-inflammatory properties which may be helpful in relieving pain associated with inflammation. To confirm this hypothesis, we performed a randomized, double-blind, double-dummy study to compare the relative analgesic efficacy of lysine acetylsalicylate (LAS) and paracetamol (PAR) in ENT pain in adults.


METHODS
After initiation of the treatment by a placebo (PLA), both drugs were given at the same dose (1 g twice daily on D1 and 1 g three times daily on D2) for two days. From the third day to the seventh day, the patients could freely take the same drug if necessary. The analgesic effect was assessed by measuring the area under the curve (AUC) of pain severity as scored by patients on a visual analogue scale. The secondary efficacy criteria were the difference relative to the basal pain score of the scores at each evaluation time (PID), the sum of these differences (SPID), and the proportion of patients responding to the treatment (i.e. experiencing a decrease of at least 50% in the pain score).


RESULTS
A total of 312 patients, included by 30 French centres, were treated by LAS (n = 156) or PAR (n = 156). Pain was related to an infection in 98% of the cases. Nine percent of patients in each treatment group were responders to the PLA and were consequently not included in the per protocol (PP) analysis but in the intent-to-treat (ITT) analysis. During days 1 and 2, patients in the LAS group had less pain than those of the PAR group, the difference becoming significant at Day 2 whatever the population analysed, PP (p = 0.01) or ITT (p = 0.01). LAS also showed better analgesic efficacy than PAR as assessed by measures of PID and SPID, the difference being significant at several times of evaluation for PID, and on Day 2 for SPID evaluation in the PP (p = 0.01) and ITT analysis (p = 0.007). The proportion of responders was significantly higher in the LAS group than in the PAR group (70% versus 56%, p = 0.01). Safety was comparable between the treatment groups. The overall efficacy judgement of investigators and patients was significantly better for LAS than for PAR (p = 0.01 and p = 0.006 respectively, at the Day 2 evaluation).


CONCLUSIONS
In this study, LAS proved to be more effective than PAR in the treatment of ENT-associated pain in adults. This is probably related to the anti-inflammatory activity of LAS.
Cabane
J
J
Service de Médecine interne, Hôpital Saint-Antoine, 184, rue du Faubourg Saint-Antoine, F75571 Paris. jean.cabane@sat.ap-hop-paris.fr
Bernard-Fernier
M F
MF
D000082:Acetaminophen / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use*; D001241:Aspirin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008239:Lysine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010038:Otorhinolaryngologic Diseases / Q000188:drug therapy*; D010146:Pain / Q000188:drug therapy* / Q000209:etiology; D010147:Pain Measurement; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D000082:Acetaminophen; D008239:Lysine; D001241:Aspirin; C010395:acetylsalicylic acid lysinate