Visually induced nausea causes characteristic changes in cerebral, autonomic and endocrine function in humans.

An integrated understanding of the physiological mechanisms involved in the genesis of nausea remains lacking. We aimed to describe the psychophysiological changes accompanying visually induced motion sickness, using a motion video, hypothesizing that differences would be evident between subjects who developed nausea in comparison to those who did not. A motion, or a control, stimulus was presented to 98 healthy subjects in a randomized crossover design. Validated questionnaires and a visual analogue scale (VAS) were used for the assessment of anxiety and nausea. Autonomic and electrogastrographic activity were measured at baseline and continuously thereafter. Plasma vasopressin and ghrelin were measured in response to the motion video. Subjects were stratified into quartiles based on VAS nausea scores, with the upper and lower quartiles considered to be nausea sensitive and resistant, respectively. Twenty-eight subjects were exposed to the motion video during functional neuroimaging. During the motion video, nausea-sensitive subjects had lower normogastria/tachygastria ratio and cardiac vagal tone but higher cardiac sympathetic index in comparison to the control video. Furthermore, nausea-sensitive subjects had decreased plasma ghrelin and demonstrated increased activity of the left anterior cingulate cortex. Nausea VAS scores correlated positively with plasma vasopressin and left inferior frontal and middle occipital gyri activity and correlated negatively with plasma ghrelin and brain activity in the right cerebellar tonsil, declive, culmen, lingual gyrus and cuneus. This study demonstrates that the subjective sensation of nausea is associated with objective changes in autonomic, endocrine and brain networks, and thus identifies potential objective biomarkers and targets for therapeutic interventions.

Phase 2 study of a new Hydrofiber dressing for superficial chronic or acute wounds.

OBJECTIVE: To evaluate the safety and performance of MedicelTulle Dressing (MTD) in subjects with chronic or acute wounds left to heal by secondary intention. METHOD: This 28-day, multi-centre, single-arm clinical study was conducted at seven sites in France. Thirty patients with a chronic (n = 20) or acute wound (n = 10) were treated with MTD and gauze as a secondary dressing. Study treatment lasted 28 days or until healing. RESULTS: Mean baseline wound area was 14.8cm2. There were 103 clinic dressing changes and 220 home dressing changes. Seven adverse events were reported in five subjects, including one treatment-related adverse event of dry scab. No adherence was reported for 66% of clinic dressing changes and 53% of home dressing changes. No trauma was reported for 96% of clinic dressing changes. Mean reduction in wound size was 7.0cm2. CONCLUSION: In this study, MTD demonstrated good safety results. Additional study is warranted to confirm the clinical utility of MTD in the management of chronic or acute wounds left to heal by secondary intention.

Efficacy, safety and acceptability of a new two-layer bandage system for venous leg ulcers.

OBJECTIVE: To evaluate the efficacy, tolerability and acceptability of a new two-bandage compression system in the local management of venous or mixed aetiology ulcers predominantly of venous origin. METHOD: This was a prospective non-comparative open label phase III clinical study. Forty-two patients were recruited from 12 centres. Inclusion criteria included ulcers with at least 50% granulation tissue, a surface area of 2-20 cm2, an ulcer duration of 1-24 months, an ankle circumference of less than 28 cm, and no history of deep vein thrombosis in the three months before enrolment. The primary endpoint was reduction in ulcer surface area, and secondary endpoints were the evolution of leg oedema and patient comfort. During the six-week follow-up, patients underwent weekly clinical assessments and their ulcer surface area was measured by planimetry and photography every alternate week. RESULTS: The mean ulcer surface area at inclusion was 7 +/- 6 cm2. The mean surface reduction after six weeks was 58.5%, with 24% of the treated wounds healing in a mean time of 25.9 +/- 9.46 days. The patients considered that the new compression system had a better effect on quality of life, evaluated by parameters such as pain, heat, itching and general comfort, than the system worn before entry into the study. Patient concordance with the new system was excellent and 86% of leg ulcers improved or healed after six weeks. Local tolerance was considered very good. CONCLUSION: This new two-bandage compression system is effective and well accepted by patients.

A prospective study on the use of a non-adhesive gelling foam dressing on exuding leg ulcers.

OBJECTIVE: This non-comparative phase II study aimed to evaluate the safety and performance of a non-adhesive gelling foam dressing (GFD-N) in leg ulcer management. METHOD: Forty-six subjects with moderately to heavily exuding leg ulcers were treated with a regimen including GFD-N. Dressings were changed at least every seven days for four weeks or until healing. RESULTS: Mean GFD-N wear time was 3.2 days per subject. Mean wound area decreased from 10.1 cm2 at baseline to 5.1 cm2 at four weeks (p<0.001) and healed in five subjects (11%). The surrounding skin improved or remained stable in all but one subject. When compared with pre-study dressings, ulcer pain decreased for GFD-N, both with the dressing in place (p<0.001) and on dressing removal (p<0.001). Of final investigator ratings for 45 subjects, most were 'excellent' for ease of application (89%), ease of removal (96%), conformability (67%) and overall performance (58%). Five subjects experienced adverse events; none were serious or dressing-related. CONCLUSION: This small study demonstrates that GFD-N was safe, effective and convenient for wound healing, exudate management, pain/comfort and ease of use.

Compression and peri-ulcer skin in outpatients' venous leg ulcers: results of a French survey.

OBJECTIVE: To evaluate concordance with compression therapy in ambulatory patients with venous leg ulcers. METHOD: This was a prospective observational survey conducted in general practice. Consecutive patients with venous leg ulcers about to receive a non-adherent primary dressing and with no contraindication to compression bandaging were selected. At the inclusion visit, size, local aspect of the ulcer and the peri-ulcer skin were scored. Patients were asked about concordance with compression and were given a questionnaire to be completed at home. If patients were seen at a three-week follow-up visit, ulcer and peri-ulcer characteristics and concordance were reassessed. RESULTS: A total of 2842 patients were included, of whom 2532 were re-evaluated at three weeks and 1397 (49%) returned their questionnaire. A compression bandage was already available for 62.9% of these patients, and 62.7% said they used it on a daily basis, 23.3% wore it one or two days per week and 13.7% wore it irregularly or never. There was a statistically significant correlation between concordance with compression and ulcer and peri-ulcer skin severity scores (p < 0.001 and p = 0.042 respectively). At the follow-up visit, concordance with compression therapy improved (80.1% were wearing it regularly). Ulcer, peri-ulcer skin severity scores and ulcer size were significantly lower (p < 0.001) when concordance with compression therapy was good. However, 65.6% of patients considered applying compression very difficult; 45% considered it very unaesthetic and 23% judge wearing it to be very painful, while 9% thought it may worsen their ulcer. CONCLUSION: On a short-term basis, concordance with compression can be substantially improved by simple measures with a clear favourable consequence on both ulcer status and peri-ulcer skin aspect when a non-adherent primary dressing is used. However, the acceptability of compression to patients is poor, and continuous effort is required to convince them of its importance.

Leg ulcers and the Urgocell Non-Adhesive wound dressing.

The objectives of this clinical trial were to evaluate the efficacy and tolerance of the Urgocell Non-Adhesive (NA) dressing in the local management of venous or mixed leg ulcers. The study was a non-comparative, prospective, multicentre (15 centres) phase III, clinical trial. The studied population was composed of non-immunodepressed adults presenting a venous or mixed leg ulcer, uninfected, non-cancerous, present for less than 18 months. Patients were followed up for 6 weeks with a weekly visit, including a clinical examination, area tracings and photographs. Evaluation by nursing staff and patients was performed at each dressing changed. Forty-three patients were included, presenting a leg ulcer with a mean surface area of 10.7 cm2. The surface area was reduced by a mean of 38% after 6 weeks of treatment. Four local adverse events were deemed to be related to the tested treatment and acceptability was noted very good for patients and nursing staff. The Urgocell NA dressing, combined with compression therapy, promoted the healing of the chronic wounds under study. The good tolerance and acceptability of the tested dressing were greatly appreciated.

Prognostic factors for venous ulcer healing in a non-selected population of ambulatory patients.

OBJECTIVE: To identify wound prognostic indicators in a non-selected patient population with leg ulcers. METHOD: This was a prospective observational survey involving 151 physicians. Ambulatory patients with venous leg ulcers were treated with a non-adherent foam dressing and usual leg ulcer management. At follow-up after three to six weeks, ulcer healing parameters and local treatment tolerability were recorded and concordance with compression therapy was validated. RESULTS: A > or = 40% reduction in the largest wound length was selected as an indicator of a favourable healing outcome. A total of 330 patients were included and seen at follow-up. The mean largest wound length was 4.9 +/- 3.6 cm. A > or = 40% decrease in this parameter was noted in 178 patients. Dressing acceptability and tolerability were excellent. Compression therapy, while heterogeneous among physicians, was used regularly and applied correctly (by patients and practitioners) in 81.2% of patients. Predictors for not reaching the main outcome were the presence of an arterial lower limb disease, an ulcer duration of more than three months and an initial ulcer length of 10 cm or more. Linear regression showed that old age and a high body mass index were independent predictors of a poor outcome. CONCLUSION: Clinical indicators such as simple ulcer length measurement and ulcer duration may help physicians to detect patients with a prognosis of poor healing.

Efficacy of Class 1 elastic compression stockings in the early stages of chronic venous disease. A comparative study.

AIM: The aim of this study was to compare the efficacy of Class 1 (10-15 mmHg at the ankle) compression stockings with that of reference stockings of identical appearance during the early stages of chronic venous disease (CVD). METHODS: A prospective multi-center randomized double blind crossover study was conducted on 2 groups of female patients presenting with CVD with a CEAP classification of C1-3SEp As1-5. The efficacy of Class 1 compression stockings was evaluated with respect to global painful discomfort (visual analog scale), each symptom of CVD, the daily behavior of the patient, changes in the volume of the legs, and the functioning of the venous pump (D-PPG). The compliance level of each patient was measured by the number of days that she wore the stockings for at least 6 hours, and tolerance was measured by the reporting of ensuing undesirable events. RESULTS: A total of 125 patients were included in the study and were analyzed for intent to treat. Highly significant differences favoring Class 1 compression stockings were noted with respect to both global painful discomfort and each symptom of CVD with the exception of paresthesia. The relief of symptoms that resulted from the use of the Class 1 compression stockings was twice that which resulted from the use of the reference stockings. Differences that favored the Class 1 compression stockings were also observed with respect to 2 quality-of-life factors (mood and daily work activity). Good compliance in the use of the stockings was reported for 95% of the patients, and tolerance was higher for the Class 1 compression stockings group than for the reference group. CONCLUSION: The regular wearing of Class 1 graduated elastic compression stockings during a 15-day period results in a significant improvement in the symptomatology of early-stage chronic venous disease, i.e., in the relief of global painful discomfort as well as in quality-of-life criteria. A high level of patient compliance in the wearing of the stockings was achieved in this study.

The healing properties of Promogran in venous leg ulcers.

OBJECTIVE: To evaluate the healing rate of venous leg ulcers treated with Promogran. METHOD: Patients with stagnating venous leg ulcers were recruited. Target wounds were > or = 2 cm but < or = 10 cm in any one dimension. Subjects were randomly allocated to receive either Promogran or a non-adherent dressing (Adaptic) with a secondary dressing of gauze followed by short-stress compression (Biflex). Weekly wound assessments occurred over 12 weeks and dressings were changed twice weekly by the investigator and/or nurse team. Planimetry tracings and photographs were blindly reviewed and assessed by two independent investigators. An intent-to-treat analysis was performed. RESULTS: Seventy-three patients were included. Thirty-seven were randomly allocated Promogran and 36 Adaptic. Twenty-nine patients completed the 12-week follow-up visit, 25 healed before week 12 and 19 stopped follow-up before week 12 for reasons unrelated to healing. Significantly more patients in the Adaptic group than in the Promogran group switched to another dressing (22.2% versus 5.4%; p = 0.035). Eleven venous leg ulcers healed in the control group (31%) and 15 in the Promogran group (41%) (p = 0.373). Overall, 15 venous leg ulcers healed or improved in the control group (42%) and 23 in the Promogran group (62%) (p = 0.079). Surface area decreased, on average, by 36.5 +/- 11.4% (median decrease: 44.6%) in the Adaptic group and by 54.4 +/- 10.9% (median decrease: 82.4%) in the Promogran group (p < 0.001). A < or = 20% surface area reduction was observed in 15 patients in the Adaptic group and in seven in the Promogran group (42% versus 19%; p = 0.034). No severe local adverse events were noted in either group, although poor tolerability caused a dressing switch in five patients in the control group and three in the Promogran group. Dressing acceptability was good or excellent in more than 60% of subjects in both groups. CONCLUSION: The results suggest that Promogran may accelerate healing in venous leg ulcers and was well tolerated compared with the current standard of care.

[Ultrasonography of postoperatively recurrent varicose veins in the area of the short saphenous vein]. / Aspect échographique des récidives variqueuses postopératoires du territoire de la veine petite saphène.

STUDY AIM: The aim of this retrospective study was to classify postoperative recurrent varicose veins in the area of the short saphenous vein. PATIENTS AND METHOD: This retrospective ultrasound Doppler exploration was performed in 60 patients (77 limbs) who had been operated with crossectomy, isolated or associated with a stripping of the short saphenous vein, after a mean 9.2-year interval. RESULTS: Recurrences were classified in five categories: 14.8% of the patients had a recurrence in relation to a venous stump at the level of the crossectomy; 32.1% had a saphenous vein in its anatomical location, 21% had reflux due to incompetence; in 28.4%, recurrence was not correlated with the short saphenous vein; and in only 3.8%, there was a pseudo-angiomatosis appearance. In half of these patients, recurrence was related to an incomplete stripping of the short saphenous vein. CONCLUSION: In order to avoid incomplete and inefficient treatments leading to recurrent varicose veins, an ultrasound Doppler exploration is necessary before and after crossectomy and stripping of the short saphenous vein.

[Esthetic treatment of varicosities]. / Traitement esthétique des varicosités.

Telangiectasia is dilatation of the subpapillary venous plexus of the epidermis of the lower limbs, which can lead to aesthetic embarrassment. Before treating telangiectasia, patient history and clinical examination help establishing its origin. It can be with isolated, associated reticular drainage veins, or be part of superficial venous insufficiency. Several types of treatment have been proposed. Microsclerotherapy is the most effective and least costly. Muller's phlebectomy can be performed when telangiectasia is fed by large reticular veins, either afferent or efferent. Treatment by laser and pulsed light appear best reserved to treatment of finer venous dilatations, either complementary or after failure of sclerotherapy.

[Echo Doppler classification of postoperative recurrence of varicose veins in the region of the internal saphenous vein]. / Classification écho-Doppler des récidives variqueuses post-opératoires du territoire saphène interne.

OBJECTIVES: Surgical treatment of varicose veins of the lower limbs is frequently complicated by recurrence. Although recurrence was long thought to result from technical errors, certain patients have progressive disease. METHODS: We used duplex-Doppler to assess 102 patients (160 limbs) with recurrence after resection of the saphene-femoral junction with stripping of the internal saphenous vein and the varicose network on the medial aspect of the leg. A vein map was established to classify recurrences. RESULTS: Type I, junctional stump with incontinent collateral, was observed in 22.5% of the cases. Type II, sapheno-femoral junction in an anatomic position, was found in 18.1%. Type III, backward flow from a perforating vein or a collateral of the common femoral was found in 13.1% and type IV, cavemomous aspect, in 7.5%. In 45% of the cases, the patient had a progressive condition with backward flow from collateral branches in the perineal or inguinal area unconnected to the common femoral. DISCUSSION: The cause of recurrent varicose veins is a question of debate: inadequate or incomplete treatment versus disease progression. Due to the chronic and evolutive nature of varicose veins, duplex Doppler exploration is essential for the preoperative work-up. Follow-up examinations should also be performed every year when the clinical examination suggests recurrence.

[Sclerotherapy section of incompetent short saphenous veins: indications, technique, results]. / Section sclérothérapie des saphènes internes incontinentes. Indications, technique, résultats.

UNLABELLED: Sclerotherapy section of the long consists of a combination of ligations, with section and injection of the proximal and distal segment of the long saphenous vein. This technique is performed under local anesthesia 10 centimeters from the saphenofemoral junction and can be performed as an outpatient procedure. MATERIALS AND METHODS: Inclusion criteria are incompetent long saphenous vein diameter over 9 millimeters in older patients whose Duplex-scan examination eliminated other leaking points such as anterior or posterior tributaries or the junction, reflux coming from superficial iliac circonflex veins or from vulvo-pudendal varicose veins. Our study concerned 75 patients. 78 limbs were operated, 72 were reviewed after 1 year and 65 after 3 years. RESULTS: 66 of the 72 limbs (91.6%) had an incompressibility without flux or reflux at the sapheno-femoral junction level after 1 year and 59 of the 65 limbs (90.8%) after 3 years. Sclerosis with incompressibility without flux or reflux was observed in the lower third of the thigh in 51 of the 72 limbs (70.8%) after 1 year and in 40 of the 65 limbs (61.5%) after 3 years, without any clinically detectable underlying varicose recurrence. DISCUSSION: This technique is ambulatory and economic and ensures control of sapheno-femoral junction reflux. In the majority of reflux cases, the reflux observed in the lower third of the thigh is related to a Hunter perforanting vein that can feed an underlying varicose network. They were treated by ultrasound-guided ossifying injection. CONCLUSION: The indications for this technique are incompetence of the sapheno-femoral junction in older patients with trophic disorders, allowing effective treatment of the source of the reflux with rapid healing of underlying trophic disorders.

An ambulatory treatment of varicose veins associating surgical section and sclerotherapy of large saphenous veins (3S technique). Preliminary study with results at one year.

BACKGROUND: The 3S technique enables treatment of large incontinent greater saphenous veins in patients who, for medical or social reasons, refuse traditional surgical methods. It associates phlebectomy with section-ligation and injection of a sclerosing solution in the proximal and distal segments. The 3S technique is merely one stage in the treatment of the saphenous vein, aimed at suppressing reflux, and associated with sclerosis of the junction. It must always be combined with later sclerotherapy sessions. METHODS: One hundred and eight patients were operated on by the 3S technique, of which 100 had 1-year follow-up. Each patient was checked by duplex scan examination before treatment, and 1 month and 1 year after. RESULTS: We obtained good results without reflux in 96% at the sapheno-femoral junction at 1 year. CONCLUSIONS: Superficial venous insufficiency is a chronic disease with evolution or recurrences. To appreciate the efficiency of 3S technique, it will be better to have 5 years worth of follow-up. This is a preliminary study with a short follow-up.

Influence of estrogens and progesterone on the venous system of the lower limbs in women.

Treatments with estrogens and progestogens are suspected of causing vascular complications either directly or by metabolic consequences. Although many studies have demonstrated an increased incidence of arterial and deep venous thrombosis, since 1970 the dose of estrogens and progesterones have been lowered with a proportional lowering of side effects. After classification of estrogens and progestogens, we studied their peripheral vascular effects. In our study, we demonstrated that the effects of estroprogestogen treatment on the superficial venous system depend on the dose of estrogen and progestogen.

PIP: Physicians examined the charts of 2295 21-40 year old oral contraceptive (OC) users who presented at 2 hospitals in France with venous disorders to determine the effect of various OCs on the functional symptomatology of venous disorders. The hospitals are the Hospital Notre Dame du Bon Secours in Paris and the Hospital Beaujon in Clichy. The various symptoms have existed between more than 1 year and greater than 3 years. The women used OCs with either a monophsic, biphasic, or triphasic minimal dose (304-40 mcg estrogen and 0.15-1 mg progestogen) or a monophasic normal dose (50 mcg estrogen and 500 mg progestogen). Over the course of OC use, the normal dose OC caused more significant intensity of heaviness, pain, and abnormal sensation (e.g., burning, prickling, or formication) than the minimal dose OCs. Other symptoms examined but not significantly affected by estrogen and progestogen dose are cramps and edema. These results and the fact that functional symptomatology appears several years before dilatation with or without reflux of the saphenous veins and other varices indicate that estrogens, progestogens, or their associative action facilitate varicose vein development in individuals with factors which predispose them to vascular disorders (familial history, prolonged standing, obesity, and sedentary). They also aggravate the superficial venous state in these patients.

[Comparative study of the effectiveness of continuous or intermittent courses of a phlebotonic drug on venous disorders disclosed or aggravated by oral, estrogen-progesterone contraceptives]. / Etude comparative de l'efficacité des cures continues ou discontinues d'un phlébotonique sur les troubles veineux révélés ou aggravés par la contraception orale estroprogestative.

In patients with venous disorders related to oral contraceptives, venotonic treatment should be prescribed for as long as contraception is maintained. 2,295 patients between the ages of 20 and 40 years with venous insufficiency revealed or aggravated by oral contraceptives were randomised to receive venotonic treatment for one month either continuously or in parallel with active contraceptive treatment, from the 10th to the 28th day. The results demonstrated the values of prolonged treatment of venous disease, as its effects persisted and were reinforced with time. The possibility of intermittent prescription would appear to improve compliance and lower the cost of treatment while ensuring comparable long-term efficacy.

PIP: Throughout France, physicians randomly assigned 2295 women with vein insufficiency, which was either disclosed or aggravated by use of a combined oral contraceptive (OC), to the group treated by two doses of the extract of Ribes nigrum every day for 24 weeks or to the group treated with the same dose of the phlebotonic drug only during days 10-28 of the cycle (i.e., parallel with OC use). There were 968 women in the first group and 1023 in the second group. Continuous treatment significantly reduced signs and symptoms of vein insufficiency (p 0.001). In fact, after 24 weeks of treatment, pain and edema were absent in 89.1% and 79.6% of women, respectively. Treatment only during days 10-28 of the cycle also significantly reduced signs and symptoms (p 0.001). The disappearance rate of the various signs and symptoms among women in the second group were comparable with the rate of women in the first group. After 24 weeks of treatment parallel with OC use, the disappearance rate ranged from 61% to 96%, depending on the sign or symptom. The effects of both treatments continued and improved with time. These findings show that intermittent use of the phlebotonic drug equals that of daily use. It appears that intermittent use will improve compliance and reduce drug costs while maintaining long-term efficacy.