A pilot double-blind, randomized, placebo-controlled trial of the efficacy of trace elements in the treatment of endometriosis-related pain: study design and methodology

Endometriosis is one of the most common benign gynecological disorders, affecting almost 10%–15% of all women of reproductive age and .30% of infertile women. The pathology is associated with various distressing symptoms, particularly pelvic pain, which adversely affect patients’ quality of life. It is an estrogen-dependent disease. There is evidence both in animals and in humans that metal ions can activate the estrogen receptors. They are defined as a variety of xenoestrogens, called metalloestrogens, which could act as endocrine disruptors. Therefore, it could be considered to act on this gynecological disorder using food supplements containing trace elements (ie, nutripuncture). The assumption is that they could modulate estrogen receptors and thus influence the tropism and the survival of cells involved in endometriosis. By a modulation of the antioxidant system, they might also interact with various parameters influencing tissue biochemistry. The objective of this article is to describe and discuss the design and methodology of an ongoing double-blind, randomized, placebo-controlled study aiming to evaluate the efficacy of metal trace elements on the reduction of pain and improvement of quality of life, in patients with a revised American Fertility Society Score Stages II–IV endometriosis, combined or not with adenomyosis, during a treatment period of 4 months. Trace elements or placebo is proposed in the absence of any other treatment or as an add-on to current therapies, such as sexual hormones, nonsteroidal anti-inflammatory drugs, and surgery. A placebo run-in period of one menstrual cycle or 30 days for women in amenorrhea has been scheduled to eliminate the patients who are responding too much to the placebo. After a 1:1 ratio randomization on Day 0, the treatment with trace elements or placebo will last for 4 monts (120 days)

Fasciite nécrosante de la paroi abdominale post-césarienne

Necrotizing fasciitis (NF) is a rare infection (0,2 to 0,4/100,000 adults) of the dermis and hypodermis extending along muscular fascia1. The absence of pathognomonic symptoms makes its diagnosis difficult. Rapidly progressive, it is a life-threatening emergency whose prognosis is letal in 30 % of cases. Treatment of necrotizing fasciitis is mixed and involves aggressive surgical debridement and medical treatment with antibiotics and supportive agents. This article is presenting the case of a young woman who developed abdominal necrotizing fasciitis following a caesarean section. In forty-eight hours, the patient developed septic shock with an extensive and rapid destruction of her abdominal wall. After hysterectomy and multiple surgical debridements, evolution was favorable. After one month, a reconstruction of the abdominal wall could be performed.SCOPUS: ar.jinfo:eu-repo/semantics/publishe

Management of pelvic organ prolapse in French-speaking Belgium: the EPILAPSUS study

Management of pelvic organ prolapse (POP) may be conducted by abdominal (laparotomy or laparoscopy) or vaginal approach, with or without mesh repair, mainly depending on the surgeon’s expertise. The aim of this study was to determine the trends in surgical management of POP in French-speaking Belgium. The GGOLFB Gynecologic surgery working group initiated a registry of the patients surgically treated for POP from eight centers in French-speaking Belgium. In this prospective multicentric study, conducted between June 2010 and January 2013, we analyzed the clinical and surgical data, the postoperative results at 4 months, the intra and postoperative complications, and reoperation rates. A total of 394 patients were registered in the database. Surgical POP repair was performed vaginally in 83.5 % of the patients, with prosthetic material in 70.2 % of the cases. In case of abdominal procedure, surgery was mainly (93.5 %) performed by laparoscopic sacrocolpopexy. The most common intraoperative complications were severe bleeding (2.3 %), bladder (2 %), and bowel (0.2 %) injuries. At 4 months, the total reoperation rate was 11.3 %. The anatomical success rate (POP-Q < 2) was 87.5 % with 2.1 % of reoperation for recurrence. Mesh exposure was observed in 9.8 % of the cases. Surgery for stress urinary incontinence (SUI) was reported in 5.1 % of the patients. The analysis of the current urogynecological practice in French-speaking Belgium shows that vaginal mesh repair is the preferential approach used for management of POP in the participating centers. The creation of a national database will help to evaluate the global trends in prolapse surgery and the potential impact of the FDA notification in the management of POP in Belgium

Effects of raloxifene treatment on the phenotype of blood monocytes.

Raloxifene (RLX), a selective oestrogen receptor modulator, has oestrogen-agonist effects on bone, lipoproteins, and homocysteine and oestrogen-antagonist activity in the breast and uterus, positioning it as a potential drug for long-term prevention of coronary heart disease in postmenopausal women. To further evaluate its influence on cardiovascular risk factors, we studied the effects of 60 mg/day RLX on serum lipid levels, inflammatory (high-sensitivity C-reactive protein, and coagulation (fibrinogen) markers, monocytes, and fibrinolysis in 15 healthy postmenopausal women. Markers were measured at baseline, after 1 month without treatment, and after 3 months of treatment. Fibrinolysis was evaluated using the euglobulin clot lysis time (ECLT) determined with a new semiautomatic optical method. Monocyte phenotype was determined by measurement of the expression of the antigens CD14, HLA-DR, and CD62-L using flow cytometry. After 3 months of RLX treatment, we observed a decrease in total cholesterol (p = 0.002), in low-density lipoprotein cholesterol (p <0.001), and in lipoprotein A (p = 0.01). Fibrinogen (p = 0.002) decreased significantly, and high-sensitivity C-reactive protein had a tendency to decrease, but this did not reach statistical significance (p = 0.06). RLX treatment had no effect on ECLT (p = 0.223) or on white blood cell, lymphocyte, and total monocyte counts (p = 0.313). Monocyte expression of HLA-DR, CD14, and CD62-L was not modified by the treatment. In conclusion, we confirm that RLX has beneficial short-term effects on levels of lipids and inflammatory markers, with no effect on fibrinolysis or monocyte phenotype.Clinical TrialJournal ArticleResearch Support, Non-U.S. Gov'tSCOPUS: ar.jinfo:eu-repo/semantics/publishe