Double-blind evaluation of analgesic efficacy of orally administered diclofenac, nefopam, and acetylsalicylic acid (ASA) plus codeine in chronic cancer pain.
The analgesic efficacy and toxicity of oral diclofenac sodium 50 mg (q.i.d.) vs. nefopam 60 mg (q.i.d.) and a combination of 640 mg ASA and 40 mg codeine (q.i.d.) in cancer patients with moderate to severe chronic pain has been evaluated in a randomized double-blind study. Planned duration of treatment was 10 days. Pain intensity was evaluated by a visual analog scale. The length of patient participation in the trial, the patient's final global evaluation and the incidence of side effects were also evaluated. Ninety-nine patients were enrolled in the study. All treatments produced a statistically significant pain relief (P less than 0.01) without differences among groups but only 26 of 99 patients (26.3%) completed the planned treatment period. Mean time in the study was 4.65 days. Inefficacy and side effects were the main reasons for premature treatment interruption. Patients treated with nefopam had a significantly shorter period in the study than patients treated with the other 2 treatments. Adverse effects were slightly more frequent with the nefopam and ASA + codeine regimens. The 3 therapeutic regimens appear to be similar as to analgesic efficacy, but diclofenac presents the advantage of a slightly better safety profile than nefopam and the ASA + codeine combination.
Minotti
Vincenzo
V
Division of Medical Oncology, Policlinico, 06100 PerugiaItaly Institute of Internal Medicine I, University of Perugia, 06100 PerugiaItaly Institute of Anesthesiology, University of Perugia, 06100 PerugiaItaly Medical Department Ciba-Geigy, Origgio, 21040 VareseItaly.
Patoia
Lucio
L
Roila
Fausto
F
Basurto
Carlo
C
Tonato
Maurizio
M
Pasqualucci
Vittorio
V
Maresca
Vincenzo
V
Del Favero
Albano
A
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000700:Analgesics / Q000627:therapeutic use*; D001241:Aspirin / Q000009:adverse effects / Q000627:therapeutic use; D002908:Chronic Disease; D002986:Clinical Trials as Topic; D003061:Codeine / Q000009:adverse effects / Q000627:therapeutic use; D004008:Diclofenac / Q000009:adverse effects / Q000627:therapeutic use; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009340:Nefopam / Q000009:adverse effects / Q000627:therapeutic use; D009369:Neoplasms / Q000188:drug therapy; D010146:Pain / Q000188:drug therapy*; D010352:Patient Dropouts
D000700:Analgesics; D004338:Drug Combinations; D004008:Diclofenac; D009340:Nefopam; D001241:Aspirin; D003061:Codeine