Prevention of diffuse, minimal lymphatic "retention" with Robuvit®: a concept, supplement registry study.

BACKGROUND: The aim of this study was to evaluate the effects of the standardized supplement Robuvit® (oak wood extract) in defined diffuse, minimal lymphatic "retention" (DMLR). METHODS: Robuvit® has already been investigated in both primary and secondary (post-surgical, post chemo-radiotherapy) lymphatic insufficiency. This registry included subjects with diffuse, minimal lymphatic "retention" (DMLR). The registry management groups included women with mild-moderate limb swelling using standard management (SM) as controls. A second, comparable group used prevention with Robuvit® at the dosage of 3 cp/day (300 mg/day) for 4 weeks. RESULTS: No tolerability problems or side effects were observed with the preventive supplementation. The management groups (34 women in total), including 18 women in Robuvit® and 16 in SM were comparable in age and baseline evaluations. After 4 weeks, in the Robuvit® group, edema scale values derived from ultrasound observations decreased significantly (P<0.05) at all measurement's sites, from the proximal (inguinal) level to the more distal (ankle-foot) level. No significant changes in edema were observed in control subjects. Generally, in areas with higher level of edema (distal areas at the foot and ankle), the edema decrease was larger than in more proximal, ultrasound measurement sites. CONCLUSIONS: Preventive Robuvit® supplementation appears to be safe and effective in controlling DMLR in subjects without significant or apparent clinical conditions. This preventive, concept study should be extended to a larger population for more meaningful observations.

Supplementary management with Pycnogenol® in Parkinson's disease to prevent cognitive impairment.

BACKGROUND: The aim of this registry study in patients with Parkinson's Disease (PD) in treatment, was to evaluate the effects of Pycnogenol® supplementation on some accessory symptoms and cognitive functions (COFU). METHODS: The registry included 43 PD patients who had been diagnosed at least one year before the start of the study. The PD condition was considered mild, with minimal progression. The management for these patients was a monotherapy using carbidopa/levodopa (standard management; SM). Supplementary Pycnogenol® was used at 150 mg/day for 4 weeks. The neurological management was not affected. RESULTS: Tolerability and safety were very good; the two registry groups were comparable with comparable symptoms at baseline. The most disabling symptoms were considered tremor, bradychinesia, alterations in COFU, rigidity and speech changes. All symptoms were rated as mild-to-moderate. After 4 weeks, these target symptoms were significantly attenuated with the supplement in comparison with the SM only (P<0.05). Particularly the COFU score was significantly higher (P<0.05) with the supplement. No interference between the main neurological management and the supplement was observed. Oxidative stress (plasma free radicals), high in both registry groups at inclusion, was significantly lower in the supplement group at 4 weeks (P<0.05). The main PD-associated items (cognitive aspects, motory and postural aspects) considered the most common and disturbing problems were evaluated and scored (0 to 4) with a visual scale line. At 4 weeks, the scores for all items were lower in the supplement group in comparison with the control, SM group. Peripheral edema was present in all patients at inclusion. The edema was minimal at inclusion (at the ankle-foot level with pretibial extension) and present in all subjects. It changed in two SM subjects and was still present at 4 weeks in 19 out 22 of the SM patients. In the supplemented patients, edema (present at inclusion in all subjects), was visible in 4 subjects out of 21 (19%) at 4 weeks. CONCLUSIONS: Pycnogenol® supplementation may help in selected patients with PD - under stable neurological treatment - to improve some signs and symptoms and some aspects associated with COFU. Studies are in progress on a larger population sample and with new evaluation methods.