Supplementation with a new food grade delivery system of Boswellia and Centella in the intervertebral discs registry: the Sager study.

BACKGROUND: The aim of this registry study was to investigate the potential of a new food-grade formulation of the association of Boswellia serrata and Centella asiatica extracts (Boswellia/Centella Phytosome, [BCP]) in combination with standard management (SM) to produce a faster re-expansion of the intervertebral disks in symptomatic subjects with "flattened" disks in the lower spine, due to wrong posture and compression after repeated trauma. METHODS: The study was designed as a 3-6 months pilot registry. Three groups of subjects were comparable for characteristics and symptoms at baseline: SM+BCP; SM; SM+glucosamine. RESULTS: No side effects were observed. Regarding target measurements at 3 and 6 months, height increased in the BCP group vs. the other two groups. The total spine length improved in the BCP group (P<0.05); in particular at 6 months the increase was doubled with BCP. SM was effective in producing elongation but the association with BCP made spinal elongation faster, more effective, with a better expansion of the intervertebral disks. Regarding ultrasound measurements, BCP was able to significantly ameliorate the posterior disk space (P<0.05) and decreased disk density more than the other groups of the study. Signs/symptoms and mobility were improved with BCP (P<0.05), while rescue medications decreased. The loss of working days was reduced with all managements (significantly more in BCP group than in the other two). CONCLUSIONS: The relative effects on spinal elongation, disk space, signs/symptoms of BCP appeared to double the efficacy of SM, improving symptoms associated to a very good tolerability of BCP.

A sport cream (Harpago-Boswellia-ginger-escin) for localized neck/shoulder pain.

BACKGROUND: Neck/shoulder, sudden pain, or muscular pain (not associated to structural or bone/joints components), due to fascial or muscular strain is common in active subjects, in non-professional athletes and sports performers. The aim of this supplement registry was the evaluation of a cream based on natural, active ingredients for topical application in supporting the improvement of pain and improving head/neck mobility, possibly minimizing the use of systemic drugs. METHODS: The cream includes standardized active ingredients of natural origin as an extract of Harpagophytum procumbes, an extract from Boswellia serrata, a CO2 extract of ginger and escin. Subjects were divided into three groups, all using the standard management (SM) in combination with the Sport Cream or in addition to Flector (diclofenac) patch. RESULTS: The groups were comparable and homogeneous at the baseline. No side effects or skin tolerability issues were observed with the Sport Cream nor with the SM or diclofenac patches. Subjects receiving sport cream + SM reported a significant improvement in pain, stiffness, altered mobility and altered working capacity, with a reduced need for rescue medication (diclofenac) compared to subjects in the other two groups. CONCLUSIONS: Finally, subjects receiving sport cream + SM reported a more remarkable decrease in skin temperature in the affected area associated to an improvement in clinical symptoms.

Exploring the concept of vigor and dys-vigor in men of 50-65 years: effects of Robuvit®.

BACKGROUND: The aim of this registry study was to evaluate the effects of Robuvit® (extract from oak wood), in otherwise healthy subjects (aged 50 to 65 years) who complained of decreased general vigor. Robuvit® has been shown to be effective in convalescence, chronic fatigue syndrome and post-traumatic stress disorder. METHODS: The standard management (SM) for this condition included diet, regular daily routines and regular exercise. All subjects had increased oxidative stress (>350 Carr Units) at inclusion. Two groups, SM and SM+Robuvit® supplementation, were formed. Robuvit® was supplemented at a dose of 300 mg/day for 4 weeks. A visual analogue scale line or vigor visual analogue line score of the most common problems associated with a decrease in vigor was used by all included subjects. RESULTS: Forty subjects were included in the study. 20 in the SM group and 20 in the SM + Robuvit® supplement group. All subjects completed the 4-week study; both groups improved with the health program and under SM. No drop-outs and no side effects were recorded; a very good tolerability for the supplement was reported. At 4 weeks, the scores in Robuvit®-supplemented subjects, were significantly higher for all vigor-related items in comparison with the scores of subjects managed with the SM only (P<0.05). In parallel, oxidative stress (plasma free radicals expressed in Carr units) was statistically lower (P<0.05) in Robuvit®-supplemented subjects than in SM only after 4 weeks. CONCLUSIONS: The concept of vigor, partially associated with premature aging, decreased level of activity and exercise, a sedentary lifestyle, appears to be a quantifiable entity. Robuvit® supplementation - previously shown to be effective in chronic fatigue syndrome, convalescence, post-mononucleosis, PTSD or in liver failure - improves vigor; further evaluations need to be planned according to the concept of this pilot registry.

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.

Central cardiovascular calcifications: supplementation with Pycnogenol® and Centellicum®: variations over 12 months.

BACKGROUND: This 'concept' registry study evaluated the efficacy of Pycnogenol® and the combination Pycnogenol® and Centella Asiatica (Centellicum®) in controlling over 12 months the increasing number of arterial/cardiac calcifications in subjects with asymptomatic atherosclerosis. METHODS: The study included 3 groups of 30 males with asymptomatic coronary calcifications. Group one was followed with standard management (SM); group 2 used SM and Pycnogenol® (150 mg/day); group 3 used the combination Pycnogenol® (150 mg/day) + Centellicum® (450 mg/day). All subjects took cardioaspirin (Bayer, 100 mg/day). RESULTS: No dropouts, no clinical events were observed in 12 months. The 3 groups had comparable demographic and medical characteristics at baseline. No tolerability problems and no side effects from supplementation were reported. After 12 months, oxidative stress was significantly decreased (P<0.05) in both groups taking Pycnogenol®. The evaluation of the number of calcifications >1 mm indicated a trend in controls using SM towards a progressive increase in calcifications. At 12 months the decrease in the number of calcifications with the combined supplements (Pycnogenol® and Centellicum®) (group 3) was -9.952% and thus significantly better that in the other two groups (P<0.05). Pycnogenol® alone was more effective than SM alone in controlling the variation in calcifications (P<0.05). Considering a 34.88% increase in SM subjects, the total absolute difference between SM (34.8%) and the decrease observed in group 3 (-9.95%) was 44.75% (P<0.02). This indicates that supplementation with the combined supplements blocks the increase in calcified areas and, possibly, in time may decrease the number of calcified spots. CONCLUSIONS: This study shows that there is a significant activity of the complex Pycnogenol®+ Centellicum® in reducing the progressive diffusion of central cardiovascular calcifications-associated with advanced plaques - in a relatively short period of time. Longer studies - focusing also on events - may better evaluate the efficacy of these standardized supplements combination on the evolution of atherosclerosis.

Pycnogenol®+Centellicum®, post-stent evaluation: prevention of neointima and plaque re-growth.

BACKGROUND: The aim of this study was to evaluate the regrowth and progression of within-stent neointima after stenting as a model of accelerated atherosclerosis and the potential effects of the combination Pycnogenol® and Centellicum® in 12 months' follow-up. METHODS: Progression was defined as the passage from one arterial risk class to next, more advanced risk class in 12 months of follow-up. Each class corresponds to a different risk of cardiovascular events and progression. Three management groups were formed, treated with either standard management (SM), Pycnogenol® 150 mg/day, or a combination of Pycnogenol® 150 mg/day and Centellicum® 450 mg/day. RESULTS: No side effects or tolerability problems were observed. 82 subjects with stented arteries in class 2 were evaluated for the passage into class 3 over 12 months. This group included 82 subjects; there were no dropouts. The management subgroups were comparable at baseline. At 12 months 66.7% of subjects in the SM subgroup progressed to class 3, versus 10.7% in the Pycnogenol® group; progression was seen in 6.7% (P<0.05) of subjects supplemented with the combination. In the second section of the registry study (78 subjects with stented arteries in class 3) we evaluated the percentage of patients passing into class 4. At 12 months 53.6% of subjects using the SM progressed versus 26.9% in the subgroup using Pycnogenol® (P<0.05) and 11.5% in the Pycnogenol®+Centellicum® group (P<0.05). Across all 160 subjects in the three management groups, progression of the stented artery at 12 months was seen in 59.6% of subjects in the SM group versus 18.5% (P<0.05) in the group managed with Pycnogenol® only. The Pycnogenol®+Centellicum® combination further decreased progression down to 8.9% (P<0.05). Oxidative stress was significantly reduced (P<0.05) in the two supplement groups. CONCLUSIONS: In conclusion, the combination Pycnogenol®+Centellicum® appears to reduce the rate of progression of the neointima after stenting.

Chronic venous insufficiency and venous microangiopathy: management with compression and Pycnogenol®.

BACKGROUND: The aim of this prospective supplement summer registry study was to evaluate the efficacy of Pycnogenol® in controlling symptoms of chronic venous insufficiency (CVI) and microcirculatory parameters: venous hypertension and microangiopathy. Pycnogenol® (Horphag Research) is the standardized extract of the bark of Pinus Pinaster. METHODS: During the summer period between June and August 142 patients were split into three groups: 1) Pycnogenol® 150 mg/day; 2) compression stockings; 3) and compression + Pycnogenol®. RESULTS: Venous pressure (ambulatory venous pressure, AVP) and refilling time (RT), microcirculatory and clinical measurements were comparable at inclusion. At 8 weeks variations in skin flux (RF), rate of ankle swelling (RAS), skin PO2-PCO2, Analogue Symptomatic Score (ASLS), Venous Disability and severity Scores and local oxidative stress (OS) indicated a statistically significant improvement by Pycnogenol® both as a single supplement and in association with compression in comparison with baseline. Pycnogenol® significantly improved the microcirculation in comparison with compression (P<0.05). The combined effects of Pycnogenol+compression produced the best results in most measurements. The summer study penalized compression - in a very hot summer - with many drops out. No side effects due to supplementation were observed; tolerability was optimal. The tolerability to stocking was less than optimal (70% of compression not correctly used). Pycnogenol® alone was more effective than compression alone. The increase (P<0.05) in skin O2 and the decrease in PCO2 were associated with the decrease in skin flux. The variations in capillary filtration (RAS) were the most important microcirculation changes. RAS is directly associated with swelling, the hallmark of CVI. Pycnogenol® in both Pycnogenol groups significantly improved RAS in comparison with compression only (P<0.05). The decrease in OS in both Pycnogenol® groups was significant in comparison with compression only (P<0.05). A lower OS is an important micro-metabolic indication of a better capillary bed with better nutritional, perfusional exchanges. The clinical measurements followed the patterns of the microcirculation with the supplement groups performing statistically better (P<0.002) than the compression-only. CONCLUSIONS: This "summer registry" study confirms the clinical and microcirculatory efficacy of Pycnogenol in CVI and venous microangiopathy. The study indicates the significant clinical role of Pycnogenol® (both as a single treatment and in association with compression) in the management, treatment and control of this common clinical problem.

Xerostomia: prevention with Pycnogenol® supplementation: a pilot study.

BACKGROUND: The aim of this pilot study was the evaluation of primary, idiopathic mucosal dryness (xerostomia or dry mouth) in subjects without cancer. METHODS: A group of non-diabetic subjects and a group of diabetics were managed with standard management (SM) or with SM+Pycnogenol® (150 mg/day) for 2 weeks. RESULTS: In total, 48 subjects were included in the study; 24 diabetics and 24 non-diabetics. 12 diabetics and 12 non-diabetics took Pycnogenol® and 12 diabetics and 12 non-diabetics were followed up with standard management only and served as controls. No side effects and no tolerability problems were observed with Pycnogenol®. The registry groups were comparable for characteristics and symptoms at baseline. All otherwise healthy subjects had a BMI<26 kg/m2. In 2 weeks, salivary flow and oxidative stress improved significantly in both groups of subjects (non-diabetics and diabetics) with 150 mg/day Pycnogenol® (P<0.05), while minimal improvements in salivary flow were seen with SM. The subjective score and the number of mucosal breaks and ulcerations, all minimal (<1 mm in length or diameter), were significantly decreased with Pycnogenol® supplementation (P<0.05) with minimal variations in the SM controls. Finally, the mean lysozyme level in parotid saliva samples was significantly increased in the Pycnogenol® group (P<0.05) both in diabetics and non-diabetics. CONCLUSIONS: Based on these preliminary results, Pycnogenol® could be a new, valid option for the treatment of xerostomia.

A controlled study of a lecithinized delivery system of curcumin (Meriva®) to alleviate the adverse effects of cancer treatment.

A proprietary lecithin delivery system of curcumin (Meriva) was evaluated in a controlled study to assess its efficacy in alleviating the side effects of cancer chemo- and radiotherapy in 160 patients undergoing these treatments. In both cases, a semi-quantitative evaluation of the side effects was carried out using a visual analogue scale, assessing also the plasma free radical status in all patients. Results showed that lecithinized curcumin might alleviate the burden of side effects associated to chemo- and radiotherapy, suggesting that the anecdotal use of various preparations of curcumin as a supportive agent for cancer treatment is well worth a systematic investigation in larger scale clinical trials. The capacity of curcumin to upregulate anti-oxidative responses and downregulate inflammatory pathways could explain its beneficial effect in tempering the prolonged and systemic oxidative and inflammatory effects of cancer treatment, and the beneficial effects observed in the plasma oxidative status in all patients of the treatment group support this view.