[Otorhinolaryngologic pain in the adult. A comparison of the analgesic efficacy of lysine acetylsalicylate and paracetamol]. / Douleurs oto-rhino-laryngologiques chez l'adulte. Comparaison de l'efficacité antalgique de l'acétylsalicylate de lysine et du paracétamol.

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. PATIENTS AND 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). CONCLUSION: 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.

[Antihypertensive efficacy and tolerability of diltiazem and enalapril, alone or in combination. DESG. Diltiazem Enalapril Study Group]. / Efficacité antihypertensive et tolérance du diltiazem et de l'énalapril, en monothérapie et lors de leur association. DESG. Diltiazem Enalapril Study Group.

OBJECTIVES: Since conversion enzyme inhibitors and calcium inhibitors may have synergic actions, we evaluated the antihypertensive effect and tolerance of prolonged-release diltiazem (300 mg/d) and enalapril (20 mg/d). METHODS: A double blind study included 176 patients with mild to moderate hypertension. Diltiazem was given to 89 (44 males, 45 females, mean age 49.91 +/- 10.50 years, mean resting diastolic arterial pressure 103 +/- 5 mmHg) and 87 (49 males, 38 females, mean age 51.37 +/- 12.13 years, mean resting diastolic arterial pressure 103 +/- 5 mmHg) received enalapril. Single drug therapy was given for 6 weeks and then continued for another 8 weeks in responders. At the end of the first 6-week period non-responders were given a combination regimen (diltiazem 300 mg and enalapril 20 mg). RESULTS: After 6 weeks of single drug therapy, 48 patients in the diltiazem group (61.5%) and 53 in the enalapril group (65.4%) had normal blood pressures which remained normal at the end of the trial 8 weeks later in 36 (76%) and 42 (82%) respectively. After 8 weeks of combined regimen 15 of the 24 non-responders (68%) to single drug diltiazem therapy had normal blood pressures as did 18 of the 23 non-responders (78%) to enalapril alone. Tolerance evaluated clinically, biologically and electrocardiographically was comparable to reports in the literature. CONCLUSION: Delayed prolonged-release diltiazem 300 mg and enalapril 20 mg thus had equivalent antihypertensive effects and were equally well tolerated. Combination therapy increased effectiveness without inducing any additional side effects.

[Ambulatory measurement of blood pressure and efficacy of diltiazem. Influence of the timing of drug ingestion and initial blood pressure level]. / Mesure ambulatoire de la pression artérielle et efficacité du diltiazem. Influence de l'horaire de prise du médicament et du niveau de pression artérielle initiale.

Clinical and 24-hour ambulatory measurements were made in 46 patients with mild to moderate essential hypertension in order to confirm that the efficacy and safety of sustained-release diltiazem LP 300 mg were the same regardless of the time of day at which it was taken. After two weeks of placebo, patients were randomly assigned double-blind to take diltiazem LP 300 mg either morning or evening for four weeks. Diltiazem LP 300 mg significantly lowered diastolic and systolic blood pressure in both groups by clinical or 24-hour ambulatory measurement, and without any difference according to whether diltiazem LP 300 mg was administered morning or evening. A lesser fall in blood pressure during the night in both groups led to study of the effect of diltiazem LP 300 mg according to initial ambulatory diastolic blood pressure level. Diltiazem brought about a greater fall in blood pressure when patients had an ambulatory diastolic pressure of 90 mmHg or more. Clinical, laboratory and electrocardiographic parameters were all satisfactory, regardless of the time at which the drug was taken.

[Evaluation of the efficacy of a venotonic capillary protector in the treatment of metrorrhagia due to IUD or micropill contraception]. / Appreciation de l'efficacite d'une association veinotonique protecteur capillaire comme traitement des metrorragies de la contraception par D.I.U. ou par micropilule.

PIP: Results are presented of a double blind trial of a venotonic capillary protector for treatment of metrorrhagia due to IUD or progestin micropill contraception. 20 randomly selected patients each with Gravigarde IUDs or using the low-dose oral contraceptive (OC) Milligynon containing norethindrone acetate received the venotonic while 20 others using each method received a placebo. The venotonic and placebo were to be taken in 4 daily capsules during 3 20-day treatment periods interrupted by the menstrual periods. Assessment criteria for the drug included subjective reports of improvement and objective reports of the number of days of bleeding intermenstrually, duration of bleeding, and number of sanitary napkins needed. The 2 groups of IUD users and the 2 groups of OC users were comparable in age, weight, and height. The duration of use of the IUD averaged about 7 months in both study and control groups. The pretreatment duration of intermenstrual bleeding averaged 8.5 days in the IUD treatment group, 6.8 in the IUD placebo group, 7.5 in the OC treatment group, and 6.6 in the OC placebo group. In all groups about 3 sanitary napkins were required for each episode. After 3 treatment cycles, 70% of patients in the 2 treatment groups but only 10% in the placebo groups reported that discomfort due to bleeding was absent or slight. Both treatment groups experienced highly significant reductions in the duration of intermenstrual bleeding, but the frequency of bleeding was very significantly lowered only after 3 treatment cycles. Tolerance of treatment was good or very good throughout the study for both the treatment and placebo groups.^ieng