Diclofenac versus pethidine in the treatment of pain after hysterectomy.

A double-blind study was performed in 63 patients to compare diclofenac (a non-steroidal anti-inflammatory drug), pethidine and placebo with regard to efficacy and tolerability in the treatment of pain after abdominal hysterectomy. The compounds were injected post-operatively and the duration of pain relief was chosen as the parameter of efficacy. Pain intensity was measured on a visual analogue scale by the patient and according to a six-point scale by the investigator. Diclofenac gave significantly longer pain relief than pethidine or placebo. Few side-effects were reported after diclofenac and placebo, and post-operative bowel paralysis tended to be shorter with diclofenac.

Cyproterone acetate versus levonorgestrel combined with ethinyl estradiol in the treatment of acne. Results of a multicenter study.

In spite of an abundant literature on antiandrogen treatment with cyproterone acetate (CA) there have been no objectively measured results to prove statistically the possible superiority of CA over combined oral contraceptive pills in the treatment of acne vulgaris. A multicenter study was therefore done, in which two preparations containing CA in combination with ethinylestradiol (EE) were compared with a marketed combined oral contraceptive pill. The preparations studied were: CA 2 mg + EE 50 micrograms (Diane), CA 2 mg + EE 35 micrograms (Diane mite), Levonorgestrel 150 micrograms + EE 30 micrograms (Neovletta). A woman was eligible for the study if she was found by a dermatologist to have at least eight acne lesions (sum of papules, pustules, cysts and nodules) on her face, was otherwise healthy and without medication. After a primary assessment of the number of acne lesions by the dermatologist the woman was referred to a gynecologist and given one of the three test preparations double-blind and at random. The treatment was to continue for 6 months. 133 women were recruited at eight different centers. The groups thus constituted were of similar size and comparable with regard to age, degree of acne, and menstrual and contraceptive histories. As the number of acne lesions varied considerably between patients all data were converted into percentage change during treatment before they were processed in a computer. After only 4 months of treatment the patients on Diane and Diane mite had a significantly greater reduction in the number of acne lesions compared with those on Neovletta.(ABSTRACT TRUNCATED AT 250 WORDS)

Comparison of contraceptive acceptability of levonorgestrel and ethinyl oestradiol administered in one three-phasic (Trionetta) and one monophasic (Neovletta) version.

In a Swedish multicenter study, a total number of 835 women completed a total of 6472 treatment cycles. Half of them were allotted at random to use the monophasic oral contraceptive Neovletta, also known as Microgynon 30 (30 micrograms ethinyl oestradiol + 150 micrograms levonorgestrel in each tablet). The second half was allotted to Trionetta, also known as Triquilar, Trigynon and Logynon (6 tablets with 30 micrograms ethinyl oestradiol + 50 micrograms levonorgestrel, 5 tablets with 40 micrograms ethinyl oestradiol + 75 micrograms levonorgestrel and 10 tablets with 30 micrograms ethinyl oestradiol + 125 micrograms levonorgestrel). The latter version was also present in a 28-day version containing in addition 7 "placebo" tablets to be used in the otherwise tablet-free interval. The contraceptive reliability was excellent although one pregnancy occurred in the three-phase version. It could be attributed to patient failure. In all aspects of bleeding control, the three-phasic pill proved to be superior to the reference monophasic preparation. The extreme low incidence of missed withdrawal bleeding and stability already during the first months of use are noteworthy features. For both preparations, continuation rate was at six months of use about 85% and at 12 months it was a similar figure. The most common reason for withdrawal was bleeding, about 5% each for both preparation. No serious side-effects were reported. The study clearly indicates that the three-phasic version is a major improvement in spite of a considerably decreased total dose of the gestagen.

PIP: A total of 835 women in a Swedish multicenter study completed a total of 6472 oral contraceptive (OC) treatment cycles; half of the women were allotted at random to use the monophasic OC Neovletta, also known as Microgynon 30 (30 mcg ethinyl estradiol + 150 mcg levonorgestrel in each tablet) and the 2nd half was allotted to Trionetta, also known as Triquilar, Trigynon, and Logynon (6 tablets with 30 mcg ethinyl estradiol + 50 mcg levonorgestrel, 5 tablets with 40 mcg ethinyl estradiol + 75 mcg levonorgestrel and 10 tablets with 30 mcg ethinyl estradiol + 125 mcg levonorgestrel). The latter version was also present in a 28-day version containing in addition 7 placebo tablets to be used in the otherwise tablet-free interval. There was a comparatively high number of missed tablets. Tablets were omitted in 8.1% of the total number of cycles in the triphasic group and the corresponding figure for the monophasic group was 9.4%. Despite this fact, only 1 pregnancy occurred during the observation period and during treatment with Trionetta 21. This pregnancy was classified by the attending physician as clearly due to patient failure (3 consecutively missed tablets). Both formulations exerted a normalizing effect on cycle length, being more pronounced with the triphasic formulation. The 2 combinations reduced to the same extent previously prolonged bleeding periods, i.e., greater than 7 days. The percentage of women with bleeding periods longer than 7 days in the 6th and 12th treatment cycle was 1.4% and 0.6%, respectively, for Neovletta and 0.9% and 0.6%, respectively for Trionetta. The 2 combinations reduced to the same extent previously profuse bleedings. In the last untreated cycle, the percentage of women with profuse bleeding was 6.7% in the Neovletta group and 9.1% in the Trionetta group. Failure of getting withdrawal bleeding was rare in both treatment groups, but the triphasic formulation was found to be superior to the fixed dose combination. In the Neovletta group 85.9% completed the 1st trial period of 6 cycles. The corresponding figure for Trionetta was 83.9%. Acne and headache were, for both formulations, reported less frequently during treatment than in the last untreated cycle. 1 case of thrombophlebitis was reported during treatment with Neovletta. There was no statistically significant increase of the mean blood pressure or the mean body weight during treatment.