Efficacy of St. John's wort extract WS 5570 in major depression: a double-blind, placebo-controlled trial.

OBJECTIVE: In a double-blind, randomized, placebo-controlled trial with 375 patients the authors investigated the antidepressant efficacy and safety of 300 mg t.i.d. of hydroalcoholic Hypericum perforatum extract WS 5570. METHOD: The study participants were male and female adult outpatients with mild to moderate major depression (single or recurrent episode, DSM-IV criteria). After a single-blind placebo run-in phase, the patients were randomly assigned, 186 to WS 5570 and 189 to placebo, after which they received double-blind treatment for 6 weeks. Follow-up visits were held after 1, 2, 4, and 6 weeks. The primary outcome measure was the change from baseline in the total score on the 17-item Hamilton Depression Rating Scale. In addition, analyses of responders (patients with at least a 50% reduction in Hamilton total score) and patients with remissions (patients with a total score of 6 or less on the Hamilton scale at treatment end) were carried out, and subscale/subgroup analyses were conducted. The design included an adaptive interim analysis performed after random assignment of 169 patients with options for group size adjustment or early termination. RESULTS: Compared to placebo, WS 5570 produced a significantly greater reduction in total score on the Hamilton depression scale and significantly more patients with treatment response or remission. It was more effective in patients with higher baseline Hamilton scores and led to global reduction of depression-related core symptoms, assessed with the melancholia subscale of the Hamilton scale. The placebo and WS 5570 groups had comparable adverse events. CONCLUSIONS: H. perforatum extract WS 5570 was found to be safe and more effective than placebo for the treatment of mild to moderate depression.

Antidepressant efficacy and tolerability of milnacipran, a dual serotonin and noradrenaline reuptake inhibitor: a comparison with fluvoxamine.

The antidepressant efficacy and tolerability of milnacipran, a dual action serotonin-noradrenaline reuptake inhibitor, were compared with those of the selective serotonin reuptake inhibitor, fluvoxamine, in 113 patients with moderate to severe major depression. Treatment with milnacipran, 50 mg b.d. for 6 weeks, produced a significantly greater reduction in Montgomery-Asberg Depression Rating Scale (MADRS) scores than fluvoxamine, 100 mg b.d. (P = 0.007; 65.4% versus 49.9%, respectively); significantly greater decreases were also seen on days 7 (P = 0.04) and 28 (P = 0.03). The response rate (the proportion of patients showing a decrease in MADRS scores of at least 50%) was 78.9% in patients receiving milnacipran, compared with 60.7% in fluvoxamine-treated patients (P = 0.04). Milnacipran also produced greater improvements in 24-item Hamilton Depression Rating Scale scores (P = 0.05). On the Clinical Global Impression Improvement scale, 77.2% of milnacipran-treated patients were rated as considerably or markedly improved, compared with 60.7% of patients receiving fluvoxamine (P = 0.06 chi-squared). Both treatments were well tolerated; the only significant difference between the two groups was a higher incidence of tremor and drowsiness in patients treated with fluvoxamine. It is concluded that milnacipran may offer some advantages over selective serotonin reuptake inhibitors, such as fluvoxamine, in the treatment of moderate to severe major depression.

A double-blind comparison of venlafaxine and fluoxetine in patients hospitalized for major depression and melancholia. The Venlafaxine French Inpatient Study Group.

The antidepressant efficacy and short-term safety of venlafaxine and fluoxetine were compared in 68 patients hospitalized with major depression and melancholia. Venlafaxine was superior in efficacy to fluoxetine; total scores for both the MADRS and the HAM-D were significantly (p < or = 0.05) lower in the venlafaxine group than in the fluoxetine group at Weeks 4 and 6. Overall tolerance was similar for the two treatments.

Citalopram versus fluoxetine: a double-blind, controlled, multicentre, phase III trial in patients with unipolar major depression treated in general practice.

Two selective serotonin reuptake inhibitors (SSRIs), citalopram and fluoxetine, both at a daily dose of 20 mg, were compared in patients with unipolar major depression treated in general practice. This was a multicentre, double-blind, randomized trial carried out in France. The duration of treatment was 8 weeks. Patients were assessed by means of the Montgomery-Asberg Depression Rating Scale (MADRS), the 17 items Hamilton Depression Rating Scale (HAMD) and the investigator's Clinical Global Impressions (CGI), Observed and spontaneously reported adverse events were also recorded. A total of 357 patients of both sexes, aged between 21 and 73 years, entered the double-blind phase of the trial. A clear reduction of both the MADRS and the HAMD mean total scores was observed in both treatment groups with no statistically significant differences between treatments. Apart from back pain recorded more frequently in the citalopram group, no significant difference was found between the two treatment groups with regard to adverse events, and both citalopram and fluoxetine were considered to be well tolerated. It was concluded that citalopram was as effective as fluoxetine in the treatment of unipolar major depression. Citalopram showed an earlier onset of recovery than fluoxetine.

Atherosclerosis as an immune disease?

Immunology has many effects on atherogenesis. In addition to their usual action risk factors for atherosclerosis have an immunomodulating effect and immunomodulation may be a new treatment of atherosclerosis.

Ecology and arteriosclerosis.

An ecological theory of arteriosclerosis invokes antirisk factors dependent on infections and parasitic infestations through the medium of immunoglobulins. Dysglobulinemia modifies blood cholesterol, platelet function, hemostasis, and biophysics of the blood in the vessels. This could explain the differences in epidemiology of arteriosclerosis between northern developed countries and tropical countries, and the present frequency of coronary heart disease in developed countries. Arteriosclerosis is conditioned by environmental factors other than diet.

[Study of 20 cases of apparently primary pulmonary arterial hypertension]. / Etude de 20 cas d'hypertension artérielle pulmonaire apparemment primitive

The authors have studied the clinical, electrocardiographic, radiological, phonomechanographic and haemodynamic features of 20 cases of apparently primary pulmonary hypertension of fairly severe degree. An attempt has been made to correlate on the one hand the haemodynamic values, and on the other the clinical findings, ECG signs of right-sided preponderance, the size of the artery to the right lower lobe on X ray, and the phonomechanographic results. Particular importance is given to a discussion on the aetiology. It is recalled that syphilis can be excluded, that it is possible the operate on thromboses, and that bilharzia and the haemoglobinopathies may play a part which is yet to be defined.

[Difficulties in the echocardiographic diagnosis of false aneurysm of the left ventricle. Apropos of 2 cases]. / Difficultés du diagnostic échocardiographique des faux anévrysmes ventriculaires gauches. A propos de deux cas.

The echocardiographic diagnostic criteria of left ventricular pseudo-aneurysm are well established: the demonstration of a narrow-necked communication between the left ventricular cavity and the aneurysm and endocardial discontinuity at the site of myocardial rupture. The authors report two cases in which these criteria were fulfilled, leading to an echocardiographic diagnosis of pseudo-aneurysm which was erroneous as the operative findings were those of true left ventricular aneurysms.

[M monoclonal macroglobulinemia induced in BALB/C mice. Effect on blood cholesterol and its significance]. / Macroglobulinémie M monoclonale provoquée chez la souris BALB/C. Incidence sur la cholestérolémie et intérêt.

BALB/C mice have been inoculated with a monoclonal IgM secreting hybridoma and have developed an hypocholesterolemia strongly dependent of the hypermacroglobulinemia M obtained (P less than 0.001). Cholesterolegram shows cholesterol is carried on the monoclonal IgM fraction. This result has been established in comparison with a lot of mice treated with the same no secreting hybridoma and a lot of untreated-mice, in these cases cholesterolemia is not modified. The whole aminoacids sequence of this IgM being nearly achieved, it is thinked of check the hypocholesterolemic activity of several parts of this immunoglobulin.

[Haloperidol decanoate. Results of an open-ended multicentric study in chronic psychotic states]. / Décanoate d'halopéridol. Résultats d'une étude ouverte multicentrique dans les états psychotiques chroniques.

UNLABELLED: An open multicentric study of 196 in-patients was carried out in 9 centres. After an initial stabilization (min. 15 days) with oral haloperidol, patients received haloperidol decanoate IM for at least 24 weeks (or a minimum of 9 injections). RESULTS: - esterification of haloperidol increased the duration of its efficacy (interval between 2 injections: average 4 weeks) without interfering with its therapeutic activity (global appreciation scale, BPRS at each injection and at the end of the treatment); - equivalent quantities of haloperidol injected at a time were 15 to 20 times those administered daily during the initial stabilisation period; - side-effects were not different with haloperidol decanoate as compared to those of the previous period (haloperidol).

[Nomifensine: clinical data (author's transl)]. / La nomifensine. Données cliniques.

Open studies with nomifensine the placebo, and double-blind controlled comparisons of nomifensine with placebo, imipramine, amitriptyline, nortriptyline... have been carried out in various parts of the world. Daily dosage varied (50-225 mg), lenght of treatment also (226 weeks). These trials showed considerable effectiveness of nomifensine in neurotic and reactive depressions, it counteracts inhibition and restores drive. Nomifensine caused no significant cardiovascular or anticholinergic side-effects. It does not potentiate the effect of alcohol.

[Apple peel small bowel. Report of two cases of a peculiar type of small bowel atresia (author's transl)]. / Le syndrome "apple peel small bowel" ou syndrome du grêle en colimaçon a propos de deux cas d'atrésie intestinale d'un type particulier.

The authors report two personal cases of a peculiar type of small bowel atresia called "Apple peel small bowel", they give proheminence on the unusualiness of the lesion, the non specific clinical picture, and the relatively bad prognosis. The physiopathologic hypothesis which were proposed for this disease are reviewed.

Comparative study of azithromycin and amoxicillin/clavulanic acid in the treatment of lower respiratory tract infections.

Forty-eight patients with acute bronchitis and four with pneumonia were randomly assigned to receive five doses (500 mg on day 1, plus 250 mg/day on days 2-5) of azithromycin; 54 patients with acute bronchitis and four with pneumonia were assigned 30 doses (625 mg every eight hours for ten days) of amoxicillin/clavulanic acid (CA). The two regimens were equally effective, with clinical improvement or cure in 92% and 87% of patients respectively, bacteriological cure in 89% and 86%, with 91% and 89% of pathogens eliminated. Minor side effects occurred in 6% and 12% of patients in the two groups, respectively. No major abnormalities in laboratory safety parameters were seen in either group.