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Titolo:
COMPARATIVE EFFICACY OF DICLOFENAC DISPERSIBLE 50 MG AND IBUPROFEN 400 MG IN PATIENTS WITH PRIMARY DYSMENORRHEA - A RANDOMIZED, DOUBLE-BLIND, WITHIN-PATIENT, PLACEBO-CONTROLLED STUDY
Autore:
MARCHINI M; TOZZI L; BAKSHI R; PISATI R; FEDELE L;
Indirizzi:
UNIV MILAN,DEPT OBSTET & GYNECOL L MANGIAGALLI MILAN ITALY CIBA GEIGY AG,DEPT MED CH-4002 BASEL SWITZERLAND CIBA GEIGY SPA,DEPT MED ORIGGIO ITALY
Titolo Testata:
International journal of clinical pharmacology and therapeutics
fascicolo: 9, volume: 33, anno: 1995,
pagine: 491 - 497
SICI:
0946-1965(1995)33:9<491:CEODD5>2.0.ZU;2-R
Fonte:
ISI
Lingua:
ENG
Keywords:
DYSMENORRHEA; DICLOFENAC; IBUPROFEN; ANALGESIA;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Citazioni:
12
Recensione:
Indirizzi per estratti:
Citazione:
M. Marchini et al., "COMPARATIVE EFFICACY OF DICLOFENAC DISPERSIBLE 50 MG AND IBUPROFEN 400 MG IN PATIENTS WITH PRIMARY DYSMENORRHEA - A RANDOMIZED, DOUBLE-BLIND, WITHIN-PATIENT, PLACEBO-CONTROLLED STUDY", International journal of clinical pharmacology and therapeutics, 33(9), 1995, pp. 491-497

Abstract

Sixty female out-patients suffering from moderate to severe primary dysmenorrhea, aged 14-40 years (mean 27 years), entered this randomized, double-blind, 3-period, within-patient study, evaluating the efficacy and tolerability of diclofenac dispersible 46.5 mg (equivalent to 50mg of diclofenac sodium), ibuprofen 400 mg and placebo taken up to 4 times daily for a maximum of 3 days. Pain relief was evaluated on a verbal rating scale (0 = none, 1 = slight, 2 = moderate, 3 = considerable, 4 = complete) at 0.5, 1, 2, 3, 4, 5 and 6 hours after the first dose; the weighted sum of pain relief scores over the 6-hour observation period was also investigated (TOTPAR-6). Pain intensity was assessed on a verbal rating scale (0 = nil, 1 = mild, 2 = moderate, 3 = severe) at baseline and at the above mentioned time points; the weighted sum of pain intensity differences at each time point was also analyzed (SPID-6). A rescue medication was permitted 1 hour or more after the intake of the test drug: in such cases the last value of pain intensity/relief scores was carried forward and used for the analysis. A global evaluation of efficacy and of trial medication as compared to her usual medication was performed by the patient at the end of each treatment period. Finally, adverse experiences were recorded throughout the study period. Analysis of covariance and Koch's adaptation of the Wilcoxon-Mann-Whitney rank sum test were used, where appropriate, for statistical analysis. Mean TOTPAR-6 values for diclofenac dispersible, ibuprofenand placebo were 16.5, 17.8 and 14.7, respectively. Diclofenac dispersible showed a statistically significant superiority over placebo for this main efficacy variable (p < 0.05), whereas ibuprofen showed only a trend of superiority over placebo (p = 0.076). Mean SPID-6 values for diclofenac dispersible, ibuprofen and placebo were 9, 10.2 and 7.9, respectively. The contrast between diclofenac dispersible and placebo did not quite achieve statistical significance (p = 0.08). Ibuprofen differentiated statistically from placebo on this measure (p < 0.05). Overall efficacy at the end of the treatment period (after multiple doses) was rated as ''excellent'' or ''good'' by 66% of patients after diclofenac dispersible, 59% after ibuprofen and 54% after placebo. Diclofenac dispersible was rated superior to the usual treatment by 44.4%, ibuprofen by 42.6% and placebo by 34.5% of patients. Eight patients complained of adverse experiences which were predominantly gastrointestinal, i.e. nausea, abdominal pain, dyspepsia and diarrhea. In 5 patients adverse experiences occurred only during 1 treatment period (4 on diclofenac dispersible, one on ibuprofen), whereas 3 patients reported adverse experiences during 2 treatment periods (2 on diclofenac dispersible and placebo, 1 on diclofenac dispersible and ibuprofen). The tolerability was assessed as excellent or good by the investigator for 85.7% of the patients when on diclofenac dispersible, 92.8% when on ibuprofen and 96.5% when on placebo. No significant differences between treatments were found for the investigator's assessment of overall tolerability. Both diclofenac dispersible and ibuprofen have been shown to be effective and well tolerated analgesics for the treatment of moderate to severe primary dysmenorrhea. Additionally, the assay sensitivity of the trial has been demonstrated (significantly better efficacy of areference drug, namely ibuprofen, over placebo) with no major differences being noted between diclofenac dispersible and ibuprofen with respect to the analgesic effect.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 03/07/20 alle ore 16:28:23