Relative importance of sexuality and quality of life in patients with prostatic symptoms. Results of an international study.

OBJECTIVE: Benign prostatic hyperplasia (BPH) and its treatment can impair the quality of life (QoL) of patients with the condition. Among the BPH-specific instruments available for assessing QoL, no consensus has emerged on the concepts that should be measured, particularly for aspects of sexual life. The objective of this study was to determine which aspects of QoL were most affected by prostatic symptoms and which patients considered the most important. METHOD: After an extensive literature review, we drew up a self-administered questionnaire composed of an exhaustive list of concepts found in the available QoL/BPH measures. In a cross-sectional study, 73 French and 44 English patients with an International Prostate Score (I-PSS) > 7 were asked to fill in this 89-item questionnaire. The level of interference of the symptoms with each aspect of QoL and the importance of the problem were reported by the patients. RESULTS: The aspects reported to be most affected and to be the most important were sleep, anxiety and worry about the disease, mobility, leisure, daily activities, sexual activities and satisfaction with sexual relationships. French patients considered all sexual aspects of life more important than English patients. CONCLUSION: This study confirms that QoL is an important outcome in BPH. The major concepts identified by the patients to be important include sexual ones. These results suggest the importance of including the assessment of sexual functioning and behavior in any further evaluations of BPH treatments effects on QoL.

Comparison of phytotherapy (Permixon) with finasteride in the treatment of benign prostate hyperplasia: a randomized international study of 1,098 patients.

BACKGROUND: Controversy regarding the relative efficacy of treatments for the relief of the symptoms of benign prostatic hyperplasia (BPH). METHODS: This was a 6-month double-blind randomized equivalence study that compared the effects of a plant extract (320 mg Permixon) with those of a 5 alpha-reductase inhibitor (5 mg finasteride) in 1,098 men with moderate BPH using the International Prostate Symptom Score (IPSS) as the primary end-point. RESULTS: Both Permixon and finasteride decreased the IPSS (-37% and -39%, respectively), improved quality of life (by 38 and 41%), and increased peak urinary flow rate (+25% and +30%, P = 0.035), with no statistical difference in the percent of responders with a 3 ml/sec improvement. Finasteride markedly decreased prostate volume (-18%) and serum PSA levels (-41%); Permixon improved symptoms with little effect on volume (-6%) and no change in PSA levels. Permixon fared better than finasteride in a sexual function questionnaire and gave rise to less complaints of decreased libido and impotence. CONCLUSIONS: Both treatments relieve the symptoms of BPH in about two-thirds of patients but, unlike finasteride, Permixon has little effect on so-called androgen-dependent parameters. This suggests that other pathways might also be involved in the symptomatology of BPH.

How to collect, check, and analyze data from clinical trials and be proud of it!

Many software programs have been developed to help in the Clinical Research field of the pharmaceutical industry. Few or none were able to do everything easily and interactively. The present paper tells the story of happy users in love with their clinical trial software.

[Monitoring of clinical trials and interim analysis. 1. Monitoring committee]. / Surveillance d'essais cliniques et analyses intermédiaires. 1. Les comités de surveillance.

In order to fulfil the ethical principles linked to the protection of patients randomized in a controlled clinical trial, monitoring procedures need to be set up. In this context, a committee of experts, called the data monitoring committee is in charge of reviewing regularly unblinded data to assess the quality and the relevance of the trial, to evaluate the evidence of an emerging treatment difference and to control the rate of occurrence of serious adverse events. After each meeting, the monitoring committee reports to the steering committee its recommendation to continue or to stop the trial prematurely. Protocol modifications might be proposed as well. Illustrated with several examples, this article reviews different situations a monitoring committee might have to tackle with.

[Monitoring of clinical trials and interim analysis. 2. Statistic methods]. / Surveillance d'essais cliniques et analyses intermédiaires. 2. Méthodes statistiques.

Although the decision to continue or to stop prematurely a clinical trial is not solely based on statistical tests, they bring useful objective arguments to the data monitoring board. However, the multiple use of statistical tests leads to increase the risk of false positive conclusions in favor of one of the treatments, and several methods have been developed to address this problem. This article presents the four major strategies that are being used for monitoring clinical trials, as well as the rationale for planning and using such statistical monitoring procedures.

Effect of an in vivo immunostimulant treatment on PMN functions: interaction with antibiotics in vitro.

The in vivo effect of immunostimulant treatment, bacterial ribosomes together with membranal proteoglycans (three tablets and three sprays daily during 4 days) in combination or not with in vitro amoxicillin or josamycin (range 5-50 micrograms/ml), has been studied on three related functions of polymorphonuclear cells (PMN) isolated from human blood: adhesion, spontaneous and oriented migration. The immunostimulant treatment always induces an increase of the three parameters. A positive effect of high concentrations of amoxicillin could be also observed on adhesion and gives rise to a great additional impact by associating it with immunostimulant treatment (control: 8.26 PMN/field; assay: 51.55 PMN/field). Spontaneous and oriented migration are not very altered by in vitro antibiotics. A very significant decrease of chemotaxis has been only observed with 50 microgram/ml of josamycin. However, the immunostimulant treatment compensates for this negative effect. The real increase in PMN activation produced by the immunostimulant treatment might extend its indications beyond prevention during antibiotherapy, for example in the acute phase of respiratory infections.

[Documentation and maintenance of "intra-muros" developed software]. / Documentation et maintenance d'un logiciel développé "intra-muros".

In a Pharmaceutical Industry Research Center requirements in statistics and data processing are: data acquisition and management, clinical trials management, clinical trials accomplishment, computation and statistics. Authors explain the choice they have made to develop softwares by themselves. They review software functions and insist on maintenance and documentation and also on internal education procedures necessary for their implementation and using.

Prevention of migraine attacks through the use of dihydroergotamine.

A strictly controlled clinical trial on a group of 20 patients treated with a time-release preparation of dihydroergotamine compared with 20 on a placebo for the prevention of migraine attacks confirmed that dihydroergotamine was very effective and considered satisfactory by 65% of the patients treated.

[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

[Medical treatment of prostatic adenoma. Controlled trial: PA 109 vs placebo in 110 patients]. / Traitement médical de l'adénome prostatique. Essai contrôlé: PA 109 vs placebo chez cent dix patients.

110 patients presenting with a prostatic adenoma sufficiently symptomatic to be treated medically, but not requiring surgical management, were included in a controlled test whose effectiveness was assessed after one month on the basis of objective criteria (nocturnal pollakiuria, urinary output, postmictional residue) and subjective criteria (dysuria, patients' opinions). PA 109 appeared significantly more effective than a placebo, especially in the objective criteria (p less than 10(-9]. Perfectly tolerated, clinically and biologically, this efficacy was again found in a supplementary study of forty seven patients, with a mean follow-up of 14.6 months, and over 2 1/2 years in some cases. Under the study conditions, and on the basis of the study criteria, PA 109 seems a good treatment for mictional disorders associated with non-surgical adenomas of the prostate.

Pharmacological study of the antitussive and respiratory-analeptic properties of N-(2'-ethylpyrrolidino)diphenylacetamide hydrochloride (F 1459).

The antitussive and respiratory stimulant properties of N-(2'-ethylpyrrolidino)diphenylacetamide hydrochloride (F 1459) in animals are reported. In the mechanical stimulation of the trachea in guinea pigs and after intraperitoneal administration of the product, F 1459 showed a better antitussive action as compared to oxeladin, zipeprol, codeine and clobutinol. Low intraduodenal doses of F 1459 also reduced in cats the cough induced by the electrical stimulation of the superior laryngeal nerve. In anesthetized dogs whose respiratory functions had been depressed by morphine, F 1459 significantly increased the volume inspired per minute, an effect not due to any uncoupling effect on oxidative phosphorylation. F 1459 has local anesthetic and broncholytic properties that may play a role in the mechanism of its antitussive action. Contrarily to codeine, the test compound did not induce a decrease in the intestinal transit.