Efficacy of a repair cream containing Rhealba oat plantlets extract l-ALA-l-GLU dipeptide, and hyaluronic acid in wound healing following dermatological acts: a meta-analysis of >2,000 patients in eight countries corroborated by a dermatopediatric clinical case.

Background: The frequency of dermatological acts is increasing. These procedures often cause injuries and traumatic alterations in specific skin layers, slowing down wound healing. Patients and methods: An open observational study lasting 1 month was conducted on 2,363 patients who had undergone various dermatological procedures. This study was conducted in eight European countries and an Asian country during which the tolerance and efficacy of a cosmetic cream based on Rhealba oat plantlets' extract, l-ALA-l-GLU dipeptide, and hyaluronic acid were assessed on patients' wounds. Results: Efficacy was observed 5' after the first application, which leads to an immediate relief, confirmed by the overall efficacy judged by the doctors as good or very good in 96.8% of the cases. In Germany, the efficacy of the same cream was assessed on children suffering from first- or second-degree burns. In this dermatopediatric case, the aim was to support the regeneration process and prevent scarring by using a topical cream rather than a silicon bandage or corticosteroids. A positive effect on skin regeneration and prevention of scaring could already be observed after 4 weeks of application without any undesired complication. Conclusion: This clinical focus complements the previous meta-analysis by demonstrating that the tested cream containing Rhealba oat plantlets' extracts, l-ALA-l-GLU dipeptide, and hyaluronic acid could also be used with a great efficacy in children after thermal burns to prevent scaring.

A multicenter, randomized, open-label, controlled study comparing the efficacy, safety and cost-effectiveness of a sequential therapy with RV4104A ointment, ciclopiroxolamine cream and ciclopirox film-forming solution with amorolfine nail lacquer alone in dermatophytic onychomycosis.

BACKGROUND: The efficacy of topical antifungals is controversial. OBJECTIVE: To compare the efficacy and safety of a sequential(SEQ) treatment with chemical nail avulsion and topical antifungals to amorolfine nail lacquer in dermatophytic onychomycosis. METHODS: This was a randomized,parallel-group, controlled study comparing a 36-week SEQ treatment with chemical nail avulsion with RV4104A ointment(class I medical device containing 40% urea) followed by ciclopirox cream for 8 weeks and ciclopirox nail lacquer for 25 weeks (SEQ group) to amorolfine nail lacquer for 36 weeks (AMO group). Patients had to have a big toenail onychomycosis,sparing the matrix. The primary efficacy criterion was complete cure at week 48. A cost-effectiveness analysis was performed. RESULTS: A total of 142 patients were randomized. The complete cure rate at week 48 was significantly higher in the SEQ group than in the AMO group (36.6 vs. 12.7%, p = 0.001). Clinical cure at week 48 was observed in 53.5% of patients in the SEQ group versus 17% in the AMO group (p < 0.01). The cost of cure per patient was 50% lower with SEQ treatment (EUR 33) compared with amorolfine(EUR 76). CONCLUSION: A treatment of onychomycosis comprising chemical avulsion of the pathological nail, ciclopirox cream and nail lacquer is significantly more effective than amorolfine nail lacquer.

The cumulative effect of small dietary changes may significantly improve nutritional intakes in free-living children and adults.

BACKGROUND/OBJECTIVES: The ELPAS (Etude Longitudinale Prospective Alimentation et Santé) study was an 8-month randomized controlled dietary modification trial designed to test the hypothesis that family dietary coaching would improve nutritional intakes and weight control in 2026 free-living children and parents. It resulted in significant nutritional changes, with beneficial effects on body mass index in adults. In these ancillary analyses, we investigated dietary changes throughout the intervention. SUBJECTS/METHODS: Before the study, modeling analyses were carried out on the French Association Sucre Produits Sucrés Consommation et Communication (ASPCC) food-consumption database to identify the most efficient dietary intervention strategy. During the study, all participants performed monthly three nonconsecutive 24-h dietary recalls: this allowed for measuring changes in the number of servings per day and serving size for each targeted food category throughout the intervention. RESULTS: Modeling analyses showed that targeting only the 10 main foods contributing to fat and carbohydrate intakes did not allow for reaching the ELPAS nutritional goals. As a result, it was decided to target more foods and to propose several types of dietary advice (such as change in serving size, change in cooking method, food substitution). This strategy led to many appropriate dietary changes during the intervention, but only a few of them reached significance. The mean number of servings per day was indeed significantly modified for only 7% of the targeted food categories in children and 17% in parents. The mean serving size was modified for only 12% of targeted food categories in children and 9% in parents. CONCLUSIONS: The cumulative effect of small dietary changes may induce significant nutritional improvements, with limited burden for populations.

[Analgesic effect of transcutaneous cranial electrostimulation in patients treated by Nd:YAG laser for cancer of the rectum. A double-blind randomized trial]. / Efficacité de l'électrostimulation transcutanéo-crânienne dans l'analgésie de patients traités par le laser Nd:YAG pour cancer du rectum. Essai randomisé en double insu.

The aim of this double blind cross-over randomized trial was to assess if transcutaneous cranial electrical stimulation by Limoge current could decrease the dose of fentanyl required in patients with rectal cancer treated by Nd:YAG laser. Fifty patients, 29 women, 21 men, 78 +/- 10 years old (range: 53-96 years), were treated by 2 laser sessions with an interval of 48 hours between each session. Active and sham electrostimulation were given in random order for the 2 laser sessions. The major end point was the quantity of fentanyl injected when the score of pain was greater than or equal to 5 according to a visual analgesic scale. Age, sex, body weight, tumor location and length, tumor circumferential extent and luminal patency, duration of laser session, amount of energy delivered per session (watt-seconds), and number of patients with deep sedation did not differ between the 2 groups. There was no interaction between the order of treatments and the treatments. The mean quantity of fentanyl was 29 micrograms and 42 micrograms when sham electrostimulation was given. There was a decrease of 31 percent in the quantity of fentanyl with active electrostimulation (P less than 0.05). Results were not affected either by the treatment order nor by tumor location. There were no side effects in either group.

Endoscopic laser therapy for duodenal villous adenoma.

A 72-year-old woman had a 20-mm supraampullary villoglandular adenoma with a focal carcinoma in situ. The neurological status of the patient did not allow any major surgical procedure. Therefore laser therapy was performed using the Nd:YAG laser. Six laser sessions were necessary to destroy the whole adenoma. After 30 months of follow-up, there was neither endoscopic nor histologic recurrence. The laser therapy should be therefore considered in treating large sessile duodenal villous adenoma occurring in inoperable patients. However, a repeated endoscopic surveillance must be performed.

A randomized study of a coaxial fiber versus a naked fiber for endoscopic Nd:YAG laser therapy of esophageal and rectal tumors.

The aim of the study was to determine whether the number of Nd:YAG laser sessions necessary to produce the maximal endoscopic effect was different with the noncontact method using the coaxial fiber than with the contact method using the naked fiber inserted into the tumor. Over a 6-month period, 40 consecutive patients were treated for esophageal and rectal cancers or for benign tumors too large to be removed with a diathermy snare. All of the patients who were offered this treatment had been assessed as unsuitable for surgery and radiotherapy. Twenty patients were randomly assigned to the coaxial fiber group and 20 patients to the naked fiber group. Before treatment, patients in the two groups were not different with respect to age, sex, kind of tumor, contraindication for surgery and radiotherapy, luminal patency, and tumor circumferential extent. At the end of the treatment, the endoscopic score, the transit score, and the evolution of rectal hemorrhage and mucous secretions were not different between the two groups. The number of treatments required to achieve the maximal endoscopic benefit was 6.7 +/- 4.9 (range, 2 to 20) (median = 5) in the coaxial fiber group and 3.4 +/- 1 (range, 2 to 5) (median = 3) in the naked fiber group (p = 0.01). Treatment tolerance and complications were not different between the two groups, but the financial cost related to the fiber was lower in the naked fiber group than in the coaxial fiber group. Therefore, we recommend the contact method using the naked fiber inserted into the tumor in endoscopic Nd:YAG laser therapy for gastrointestinal tumors.

[Nd:YAG laser treatment of colorectal villous tumors]. / Traitement par le laser Nd:YAG des tumeurs villeuses colo-rectales.

Fifty-eight patients, 23 men, 35 women (mean age 76 +/- 10 yrs), with colorectal villous adenomas underwent endoscopic neodymium Yag laser therapy. In 50 patients with interpretable results, tumor ablation was complete in 45 p. 100 of extensive adenomas involving at least two thirds of the circumference and extending longitudinally for at least 4 cm, in 92 p. 100 of intermediate adenomas between 1 and 4 cm in diameter and in 100 p. 100 of small adenomas with diameter less than or equal to 1 cm. These patients had a mean follow up of 72 weeks (range 13-182 wks). Twelve adenomatous tissue recurrences occurred in 9 patients. In 10 of these recurrences, laser ablation was effective. Age, sex, dysplasia grade, macroscopic appearance, or tumor location did not influence the results which were related to the size of the villous adenomas. Four complications occurred: a symptomatic stenosis, an asymptomatic stenosis, an ileocaecal fistula and a rectal fistula near a colorectal anastomosis.

[Palliative treatment of cancers of the esophagus and cardia with neodymium YAG laser: short-term results and multidimensional analysis of factors related to functional improvement and tumor destruction]. / Traitement palliatif des cancers de l'oesophage et du cardia par le laser YAG néodyme: Résultats à court terme et analyse multidimensionnelle des facteurs liés à l'amélioration fonctionnelle et à la destruction tumorale.

The aim of this study was to report initial results of endoscopic Nd YAG laser therapy in palliative treatment of esophageal and cardial carcinoma and to define parameters that could predict initial outcome. Of 116 patients, 95 men and 21 women (mean age 68 years, range 33-94 years), 6 patients presented with inaccessible, completely obstructing squamous cell carcinoma. Of these 6 tumors, 5 were located in the cervical esophagus. Seventy-two patients with squamous cell carcinoma and 38 patients with adenocarcinoma were treated. Improvement of dysphagia was achieved in 90 of 110 patients (82 p. 100) after 2.8 sessions (range 2-7 sessions). Total destruction of the intraluminal tumor was achieved in 66 patients (60 p. 100) after 3.3 sessions, partial destruction in 36 patients (33 p. 100) after 4.3 sessions and treatment had no effect in 8 patients (7 p. 100) after 3.8 sessions. Forty-four of the 52 impassable stenoses with the Olympus GIFP3 endoscope were passed through with the Olympus GIFQ endoscope after 3.7 sessions. Six complications occurred: 1 esophageal perforation and 5 esobronchotracheal fistulas. Improvement of dysphagia and tumoral destruction were analyzed in two manners. Of 13 selected variables, 3 were significantly related with improvement of dysphagia after stepwise logistic regression: destruction of intraluminal tumor (p = 0.003), endoscopic fungating appearance (p = 0.03) and the age related type of surgical contraindication (p less than 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)

[Palliative treatment of adenocarcinoma of the rectum by Nd-YAG laser. Immediate and long-term results. Study of factors related to the initial destruction of the tumor]. / Traitement palliatif des adénocarcinomes du rectum par le laser YAG néodyme. Résultats immédiats et à long terme. Etude des facteurs liés à la destruction tumorale initiale.

Fourty-five patients, 28 men, 17 women (mean age 73 +/- 18 yrs) with rectal carcinoma underwent palliative endoscopic neodymium YAG laser therapy. Rectal hemorrhage ceased in 89 p. 100 of affected patients after 3 +/- 2 sessions and a normal rectal transit was restored in 80 p. 100 of affected patients after 3 +/- 1 sessions. Total destruction of intraluminal tumor was achieved in 40 p. 100 of patients after 4 +/- 1 sessions. Symptomatic improvement was more frequent in patients in whom total destruction of intraluminal tumor was achieved (p less than 0.01). Stepwise logistic regression selected 2 independent variables capable of predicting tumoral destruction: the kind of surgical contraindication, more often related to cancer extension (p less than 0.001) and a greater tumor length (p less than 0.03) in patients in whom destruction of intraluminal tumor was incomplete. Twenty-eight patients were subsequently treated after palliation was achieved. Cumulative probability of remaining improved at 6 months when treatment was not stopped was 40 p. 100 (confidence limits to 95 p. 100: 23 p. 100-59 p. 100). Five complications occurred, 3 rectovaginal fistulas and 2 stenosis.

[Multidimensional analysis by Cox's model of the survival of patients with alcoholic cirrhosis]. / Analyse multidimensionnelle selon le modèle de Cox de la survie de patients atteints de cirrhose alcoolique.

A group of 249 patients with alcoholic cirrhosis was prospectively studied in order to assess the prognostic value of 23 clinical and biochemical factors. Methods included the Cox model completed with validation by assessing the proportionality and by comparing the estimated and observed results, a study of the influence on the results of the truncated data and the factors with non normal distribution, and an expression of the results using predictive values. Results showed that encephalopathy, age, serum albumin and total bilirubin concentrations and serum gamma glutamyl transpeptidase activity had an independent prognostic value. The Cox model was validated and results showed that taking into account the truncated data and the non normal distribution modified the results. An index using the five independent prognostic factors had a good negative predictive value, permitting to predict, in one third of the patients, survival i. e. which patient had a probability to be alive at two years greater than 90 p. 100.

Prognostic value of serum fibronectin concentration in alcoholic cirrhotic patients.

The aim of this study was to assess prospectively the prognostic value of serum fibronectin in 114 alcoholic cirrhotic patients and to compare serum fibronectin with other prognostic variables. The Cox model and log-rank test were used to compare survival rates at 1 year. Considered alone, serum fibronectin, age, serum albumin, total serum bilirubin, gamma-glutamyl transpeptidase, prothrombin time, presence of encephalopathy and ascites were associated with survival to 1 year. The estimated survival rate at the end of 1 year was, for patients with serum fibronectin greater than 165 mg per liter: 84 +/- 5%, and for patients with serum fibronectin less than or equal to 165 mg per liter: 53 +/- 7% (p less than 0.001). With the step-wise multidimensional analysis using the Cox model to assess the combined effect of several prognostic variables, serum fibronectin was the first variable selected followed by age, encephalopathy and serum albumin which entered the model by virtue of their independent prognostic value. Multivariate regression and partial correlation analysis showed that fibronectin was independently correlated with serum albumin, gamma-glutamyl transpeptidase and total serum bilirubin explaining that the prognostic value of albumin diminished and that the prognostic value of total serum bilirubin and gamma-glutamyl transpeptidase disappeared when combined with serum fibronectin.

Prognostic value of total serum bilirubin/gamma-glutamyl transpeptidase ratio in cirrhotic patients.

The aim of this study was to assess the prognostic value of total serum bilirubin (TSB), gamma-glutamyl transpeptidase (GGT) and the TSB/GGT ratio in 129 consecutive cirrhotic patients, and to determine how seven other clinical and biochemical variables affect the prognostic value of these measurements. The Cox model and log rank test were used to compare survival rates at 1 year. Considered alone, encephalopathy, ascites, TSB, prothrombin time, serum albumin, GGT and the TSB/GGT ratio (TSB expressed in mumoles per liter and GGT in IU per liter were associated to the 1-year survival (p less than 0.10). The estimated per cent surviving at the end of 1 year was 20% for those with encephalopathy and 59% for those without, 46% and 62% for those with and without ascites, 28% for those with TSB greater than 3.0 mg per dl, 68% for those with TSB less than or equal to 3.0 mg per dl, 44% for those with GGT less than or equal to 100 IU per liter, 60% for those with GGT greater than 100 IU per liter, and 12% for those with TSB/GGT greater than 1, 66% for those with TSB/GGT less than or equal to 1. With the Cox model, which was used to assess the combined effect of several prognostic variables, GGT was the only biochemical variable which added significant prognostic value to TSB. The combination of TSB and GGT added significant prognostic value to encephalopathy and ascites.