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The article presents information on the variations in plasma free radicals in patients with venous hypertension with HR (Paroven, Venoruton; 0-(β-hydroxyethyl)-rutosides). Macro and microcircuIatory methods now assess the microcirculatory changes seen in chronic venous hypertension. Treatment of chronic venous hypertension is usually surgery and sclerotherapy and other conservative measures such as compression. The high levels of PFRs in the distal blood, higher than at the systemic level, may be associated with a significant deterioration of the microcirculation in venous microangiopathy.

Background: Centellicum ® , a standardized Centella Asiatica extract, has been used orally for fibrosis and scar prevention. The main aim of this 2-month registry pilot study was the reduction of visible, significant scars and keloids after suturing traumatic wounds with irregular edges (lacerations), using Centellicum ® ., Methods: The effects of oral Centellicum ® (450 mg/day; 2 capsules) and a standard management (SM) on wound healing were compared with the effects of a control group that used only the standard management., Results: Forty-eight otherwise healthy male subjects with lacerations requiring suturing were included in the study. 25 took Centellicum ® in addition to the standard management and 24 followed the standard management only. No side effects were observed with the supplement. Centellicum ® supplementation showed very good tolerability and compliance with 98% of the capsules correctly used. The two groups of otherwise healthy male subjects with lacerations were considered comparable at inclusion and there were no dropouts. No infections were observed. At 60 days, the scar dimensions were significantly smaller in the supplemented group (P<0.05). The elevation of the scar above the surrounding, non-affected skin, was also significantly reduced in the Centellicum ® group compared to controls (P<0.05). Local pain levels were significantly lower (P<0.05) in the supplement group at 60 days. Additionally, the scar redness score was significantly lower in the supplement group compared to controls (P<0.05) by the end of the study. The incidence of initial keloid formation was significantly lower in the supplemented subjects at 60 days, as determined by finger-point pressure palpation and high-resolution ultrasound (P<0.05). Skin flux, as measured by laser Doppler flowmetry (indicating hypervascularization due to local inflammation) was lower (P<0.05) with Centellicum ® at the end of the study. Inflammation, assessed via thermography (hot spots on the healing skin) was less visible and reduced in most areas in the supplement group (P<0.05) in comparison with the control group. Plasma oxidative stress was significantly lower in the Centellicum ® group at the end of the study (P<0.05)., Conclusions: Oral Centellicum ® intake over 2 months improved healing of lacerations and reduced scarring, fibrosis and keloids at the level of the lesions. A larger study setup with more patients and with a prolonged study duration is needed to confirm these initial results.

Background: The aim of this registry study was to evaluate the effects of Pycnogenol ® and Centellicum ® (PYCE) on skin perfusion and skin elasticity in healthy women over a period of 4 weeks., Methods: The supplemented women used 150 mg of Pycnogenol ® and 450 mg of Centellicum ® daily. The supplemented group used the combination PYCE daily for 4 weeks and followed the standard management (SM) in addition. A control group used only the SM. SM for all subjects included a healthy diet (low levels of NaCl, low sugar, low calories), vitamin supplementation (C, E, B), daily mild outdoors exercise, regular washing with neutral soap; the same non-clinical, non-specific hydrating cream (Nivea) was used once daily., Results: Sixty-three women completed the registry study. Thirty women using the PYCE combination and 33 women in the control group. The groups were comparable at baseline. No clinical condition was observed during the registry; no drug was used. There were no side effects or tolerability problems with the supplements. After 4 weeks, ultrasound elastosonography showed that skin elasticity significantly improved with the PYCE combination (P<0.05) without significant changes in the control group. In parallel, transcutaneous skin PO2 increased significantly with PYCE compared to controls and transcutaneous skin PCO2 decreased significantly compared to controls (P<0.05). This showed that skin oxygenation and nutrition improved with PYCE. Skin hydration also significantly improved with PYCE (P<0.05) in comparison with controls. Skin flow, indicating skin blood perfusion (thermoregulatory flow), assessed by laser Doppler flowmetry significantly improved over 4 weeks compared to controls (P<0.05). More specifically, the most superficial part of the flow, in the most superficial layer of the skin, corresponding to the nutritional blood flow, significantly improved with the combination PYCE compared to controls (P<0.05). Skin and tissue elasticity are crucial in surgery for healing, scarring, and wound closure. Reduced elasticity can lead to irregular or delayed healing. This preliminary concept study suggests that PYCE supplementation enhances skin elasticity, perfusion, and nutrition, with visible effects seen in just 4 weeks., Conclusions: This preliminary, concept study indicates that skin elasticity, skin perfusion, and skin nutrition improved with the supplementation of PYCE and the effects of PYCE were visible after only 4 weeks. A longer observation period should be considered in future studies. In conclusion, this pilot concept study shows a significant activity of the combination Pycnogenol ® and Centellicum ® on skin elasticity over a short period of supplementation.

Background: The aim of this 4-week pilot registry, supplement study was to assess the effects of Pycnogenol ® compared to a standard management on hand osteoarthritis associated with pain. As Pycnogenol ® decreases inflammation and pain, chronic use of drugs, causing side effects may be reduced., Methods: The registry patients included suffered finger pain associated with hand osteoarthritis All subjects used a standard management (SM). A supplementary group additionally used 150 mg Pycnogenol ® per day. In addition, a retrospective group with 40 comparable subjects using oral diclofenac was used for comparison. Forty-two subjects with hand osteoarthritis completed the study. The registry patients were former sport professionals, fishermen and subjects working with their hands in a common manual activity. 22 subjects took Pycnogenol ® in addition to standard management and 20 subjects followed the standard management only and served as controls., Results: The two groups were comparable at inclusion. No subject had to stop supplementation or the SM. No side effects were observed. After 4 weeks, spontaneous pain in the morning and pain after work were significantly reduced with Pycnogenol ® supplementation compared to controls (P<0.05). Residual pain at rest in the evening was significantly improved after 4 weeks with the supplement compared to controls (P<0.05). The number of subjects requiring pain medication during the 4-week study period was significantly lower in the supplement group (2/22) compared to controls (8/20) (P<0.05). Hand dynamometry results show significant improvement in hand-finger strength (due to decreased pain and stiffness) with the supplement compared to controls (P<0.05). At inclusion, all subjects presented hyperthermic joints, 2°C higher than the surrounding tissues as shown by thermography. After 4 weeks, the number of subjects with hyperthermic joints was lower in the Pycnogenol ® group than in controls (P<0.05). Both nonspecific markers of inflammation (ESR and C-reactive protein levels in blood) were significantly lower after 4 weeks in the Pycnogenol ® group than in controls (P<0.05). Other routine blood tests were normal at inclusion and at the end of the study. Within 4 weeks, plasma oxidative stress decreased by 14.4% (P<0.05) in the Pycnogenol ® group vs. 5.5% in the control group. The retrospective comparison with a group of 40 comparable subjects using oral diclofenac showed that after 4 weeks, the efficacy of Pycnogenol ® on improving pain in the morning, after work and in the evening, on hand-finger strength and on decreasing C-reactive protein was significantly higher (P<0.05) than in the diclofenac group (comparable, non-parallel group, CNPG)., Conclusions: In conclusion, supplementation with Pycnogenol ® was well tolerated and effectively controlled pain while improving grip strength in patients with hand osteoarthritis. All supplement subjects showed an improved operativity.

Background: The aim of this supplement registry study was to evaluate the efficacy of Pycnogenol ® in controlling signs and symptoms of chronic venous insufficiency (CVI), diabetic microangiopathy and microcirculatory parameters - in diabetic patients with CVI and microangiopathy. These CVI patients are eligible for medical procedures as their incompetent superficial veins can be treated with repeated sclerotherapy and or local surgery according to needs., Methods: During this registry study, only non-interventional managements were used. The effects of the use of elastic compression with standard management (SM) was compared to Pycnogenol ® intake (150 mg/day) and SM, without using elastic compression for 8 weeks., Results: Fifty-eight diabetic patients with CVI completed the study with 28 subjects supplemented with Pycnogenol ® and 30 in the control group. The two groups completing 8 weeks were comparable at baseline. After 8 weeks, no side effects were observed; the compliance was optimal with >98.5% of the supplement capsules correctly used. The tolerability to stockings was lower (73% of stockings were not fully used for the whole day). There were no dropouts. Venous pressures were comparable in the two groups at baseline. Microcirculatory and clinical measurements of the patients were comparable at inclusion. After 8 weeks, the differences between Pycnogenol ® and elastic compression were statistically significant for skin resting flux (RF), rate of ankle swelling (RAS), transcutaneous PO2 and PCO2 indicating a significant improvement in microcirculatory perfusion with Pycnogenol ® in comparison with elastic compression. In parallel, clinical symptoms assessed by the Composite Symptom Score (CSS), the venous Clinical severity Score (VCSS) and the Venous Disability Score (VDS), were significantly lower in the Pycnogenol ® group than in the compression group, indicating a significant clinical effect of Pycnogenol ® compared to elastic compression (P<0.05). Pycnogenol ® showed important antioxidant properties and lowered oxidative stress as seen also in previous studies., Conclusions: This registry study confirms the clinical and microcirculatory efficacy of Pycnogenol ® in CVI in diabetics. The study indicates the significant supplementary, clinical role of Pycnogenol ® in the management of this common clinical condition over a short period of time, possibly preventing ulcerations.

Background: Chronic venous insufficiency (CVI) is the consequence of venous valve reflux and/or venous flow obstruction and resulting venous hypertension in the lower extremities. The aim of this prospective supplement registry study was to evaluate the efficacy of compression stockings or Pycnogenol ® in controlling symptoms and edema in CVI and their efficacy on microcirculatory parameters., Methods: Two comparable groups of 30 subjects with CVI were observed for 4 months., Results: Elastic compression was less tolerated than Pycnogenol ® with 12 subjects being unable to follow the compression routine. No side effects due to supplementation were observed; tolerability of the supplementation was optimal. Ambulatory venous pressure (AVP) and refilling time (RT) at inclusion indicated a significant increase in venous pressure and reflux (refilling time <16 seconds). AVP and RT did not change after 4 months. Microcirculatory and clinical measurements were comparable at inclusion between the 2 groups. After 4 months, skin resting flux (RF) and skin PO2-PCO2 were significantly improved with Pycnogenol ® compared to compression (P<0.05). The significant increase in skin PO2 and the decrease in PCO2 after Pycnogenol ® intake were ascribed to the decrease in the abnormally high skin resting flux, a sign of better perfusion and skin nutritional supply. Pycnogenol ® reduced leg volume, on average by 18.3% in the evening compared to 4.4% of reduction with compression (P<0.05) showing an important effect on edema. The venous Clinical Severity Score (VCSS) and the composite symptom score (CSS) decreased significantly in the Pycnogenol ® group compared to compression, indicating a better improvement in microcirculatory perfusion and nutritional supply produced by the supplementation of Pycnogenol ® in comparison with compression. Pycnogenol ® significantly improved microcirculation and clinical symptoms in comparison with compression. The decrease in local oxidative stress (OS) at the distal perimalleolar region with Pycnogenol ® was significant in comparison with compression (P<0.05). A lower local OS is an important metabolic indication of a better capillary perfusion with better nutritional exchanges. At the end of the registry study, four small ulcerations and skin breaks in four limbs (between 3 and 5 mm of maximum diameters) were observed in the compression group. No ulcerations or skin breaks were observed in the Pycnogenol ® group., Conclusions: Pycnogenol ® relieved edema, improved microcirculation in CVI patients and reduced stationary, interstitial fluid in comparison with compression. Most symptoms of CVI are associated with interstitial water retention; the presence of extra fluid in limb tissues alters perfusion and nutrient supply. Pycnogenol ® supplementation reduced water and fluid accumulation in CVI limbs and improved microcirculation and local oxidative stress thus showing important anti-edema effects.

Background: Hemorrhoids are a common problem associated with symptoms, like swelling, local thrombosis and generally with a decreased quality of life, often in otherwise healthy subjects. Hemorrhoids can be classified by grades (I to IV) according to their severity. In this registry study subjects treated with excisional hemorrhoidectomy (EH) for the first time, were included. After surgery, edema tends to complicate surgical areas causing relevant symptoms. Most hemorrhoids symptoms are related to alterations in bowel habits. Increase in diet fibers to avoid constipation, exercise, and limiting straining reduce recurrence after surgery., Methods: The aim of the registry study was to evaluate the effects of Pycnogenol ® (Horphag Research, Geneva, Switzerland) on relieving postoperative symptoms following hemorrhoidectomy. Pycnogenol ® 150 mg/day was used between one month before surgery up to one month after surgery. The main postoperative symptoms were scored., Results: Thirty-eight subjects completed the 60-day supplement registry study. Eighteen subjects were supplemented with Pycnogenol ® in addition to the standard management (SM) and 20 subjects only received SM and were considered as controls. The two groups were comparable for age, sex and main symptoms distribution and for their clinical characteristics at inclusion. No other disease was present. The scores for pain, discomfort, and constipation were significantly lower with the supplement compared to controls (P<0.05) 10 and 30 days after surgery. In addition, the quality-of-life score was higher with Pycnogenol ® (P<0.05) while bleeding (minimal, not clinically evaluable) and a possible residual anal stenosis (requiring a longer period of observation) were barely observed. A satisfactory return to activity was observed 30 days after surgery in the 18 subjects using Pycnogenol ® , and in only 15 out of 20 patients (75%) in the control group (P<0.05). All Pycnogenol ® subjects were able to drive and perform daily tasks in comparison with 14 out of 20 subjects in the control group. The proportion of patients that took pain medication from day 10 to 30 post-surgery was significantly lower in the Pycnogenol ® group than in controls (P<0.05)., Conclusions: In this post-surgical pilot, registry study, Pycnogenol ® was effective in preventing and controlling postoperative symptoms after hemorrhoidectomy. To confirm the results, more cases are needed, including different surgical methods and clinical conditions. Mucosal and cutaneous edema and perianal swelling - generally seen after surgery - seem to be clearly reduced with Pycnogenol ® and the supplement intake was associated with a more regular and pain-controlled convalescence and healing.

Background: The aim of this registry supplement study was to evaluate the effects of the oral supplement Pycnogenol ® on possible skin discolorations or other minor skin changes after varicose vein sclerotherapy in comparison with a standard management (SM)., Methods: One hundred sixty-one subjects completed the study. 84 took Pycnogenol ® from the day before sclerotherapy for 12 weeks and followed SM. 77 followed SM only and served as controls. 420 injection sites were followed-up in the Pycnogenol ® group and 431 in the control group. The number of injected veins (using only Aetoxysklerol) was on average 4-8 veins/patient. No side effects were observed for the SM or for supplementation. Pycnogenol ® supplementation showed a good tolerability. The two management groups were comparable for age, sex and veins distribution at inclusion., Results: After 12 weeks, skin discoloration assessed by a skin staining score was generally significantly lower and less frequent (P<0.05) with Pycnogenol ® with a score of 0.4±0.2 compared to controls (with a score of 2.1±0.4). In addition, the number of stains per treated vein was significantly lower in the Pycnogenol ® group than the control group., Conclusions: Varicose vein sclerotherapy is a minimally invasive procedure almost without complications. Pycnogenol ® intake appears to improve healing and prevent skin discolorations after injection of the sclerosing agent. To verify this effect of Pycnogenol ® , more studies for a longer period are needed.

Background: The aim of this registry study was to evaluate the efficacy of Pycnogenol ® in controlling signs/symptoms and temporary impairment of cognitive function (COFU) associated with jet lag. Previous flight studies have shown a decrease in the level of jet lag symptoms with Pycnogenol ® . The control of jet lag signs/symptoms appeared to be correlated with flight-related microangiopathy and peripheral edema. Pycnogenol ® - a standardized extract from the bark of French maritime pine - has significant antiedema, anti-inflammatory and antioxidant properties., Methods: A group of subjects flying east in economy class for 10-12 hours used Pycnogenol ® 150 mg/day and a similar group without supplementation served as controls. A subgroup of mild hypertensive subjects using a single ACE inhibitor was also included., Results: One hundred twenty-seven subjects completed the study. Of the participants, 48 were aviation professionals like pilots, flight attendants or air company staff - 24 of them took Pycnogenol ® and 24 served as controls. Forty-seven study participants were frequent flyers and non-staff professionals, 25 of which took Pycnogenol ® and 22 served as controls. In addition, a group of 32 subjects with mild hypertension was included, 16 took Pycnogenol ® and 16 served as controls. No side effects and a good tolerability were observed. The registry groups were comparable for baseline characteristics. Eastbound flights' duration was 11.22±0.4 hours in supplemented subjects and 11.14±0.32 in controls. Dropouts were due to logistical problems. Post flight Visual Analogue Scale (VAS) scores were significantly lower in all Pycnogenol ® groups, including hypertensives for all signs and symptoms of jet lag compared to controls, showing prevention and improvement of jet lag symptoms. The duration of any sign/symptom of jet lag with Pycnogenol ® intake was significantly shorter (P<0.05) post-flight compared to controls (P<0.05). The number of nights of altered/disturbed sleep was also lower in the Pycnogenol ® groups compared to controls. Leg edema was present in almost all subjects with different degrees especially in the hypertensive group. The increase in ankle circumference before and after flight was significantly lower with Pycnogenol ® compared to controls (P<0.05). After the flight, average scores of the single COFU tasks were significantly higher in the Pycnogenol ® groups compared to controls, showing preserved cognitive function., Conclusions: In conclusion, in this registry study Pycnogenol ® was effective in preventing jet lag-related symptoms and preserving cognitive functions without tolerability problems. These observations should be tested in a larger group of subjects including complex individuals prone to edema (i.e. diabetics, hypertensive or older patients).

Background: The aim of this pilot, efficacy supplement registry was to use a supplementary management with berberine to control hyperlipidemia. The supplement Berberine (Berbevis™ as Sophy ® tablets) was used to control lipids and to evaluate (as a natural, preventive management) the early evolution of subclinical atherosclerosis in subjects (otherwise healthy, not using drugs) with borderline hyperlipidemia., Methods: The registry involved two groups of subjects not using drugs for a total of 50 subjects and three months of supplementation., Results: The registry groups using standard management (SM) or SM and supplement were resulted comparable. No side effects were observed during the three months of berberine supplementation. No tolerability problems were reported. All subjects managed with berberine completed the three-month registry. Compliance was >97% (% of correctly used tablets). Total cholesterol was significantly decreased with berberine (P<0.05) and HDL was significantly improved (P<0.5) with supplementation. Triglycerides decreased in the berberine groups (P<0.05) and the levels of CoQ10 remained within normal values in supplemented subjects. Oxidative stress - measured in Carr units - was significantly decreased with berberine (P<0.05). Routine blood tests remained within normal values during the registry. Body weight was significantly more decreased (P<0.05) with berberine in comparison with standard management. The fat proportion also decreased (P<0.05) with berberine supplementation and the abdominal fat thickness (in the peri-umbilical area) was significantly decreased after berberine supplementation (P<0.05)., Conclusions: This pilot registry indicates that berberine administration is effective in reducing lipids (decreasing weight, fat percentage and abdominal fat) in otherwise healthy subjects not using drugs. A longer study, with more advanced hyperlipidemic subjects is suggested. Predictive analytics according to Siegel suggests that a six-month study with 60 patients, in more advanced hyperlipidemic, also evaluating the intima-media thickness for the analysis of vascular benefits, may produce a stronger evaluation for this product.

Background: The aim of this pilot, supplement study was the evaluation of primary, idiopathic mucosal mouth dryness (xerostomia or dry mouth) in subjects without systemic diseases., Methods: Subjects with xerostomia were managed either with standard management (SM) or with SM and a Pycnogenol ® mouth spray (Hankintatukku Oy, Karkkila, Finland), at the dosage of 60 mg/day in 30 spurts, for 2 weeks., Results: A total of 50 subjects were included in the study: 25 controls using only standard management (SM) and 25 subjects using the Pycnogenol ® mouth spray. No side effects and no tolerability problems were observed with the Pycnogenol ® mouth spray. The groups were comparable for characteristics and symptoms at baseline. These otherwise healthy subjects had a BMI<26. After 2 weeks, salivary flow and salivary oxidative stress (in Carr Units) were improved significantly with Pycnogenol ® mouth spray as compared to controls (P<0.05), whereas minimal improvements in salivary flow were seen with SM. The subjective symptomatic dry mouth score and the number of mucosal breaks and ulcerations (all minimal, <1 mm in length or diameter) were significantly decreased with the Pycnogenol ® mouth spray supplement compared to SM controls (P<0.05). The Pycnogenol ® mouth spray led to significant improvement in salivary lysozyme levels, compared to controls (P<0.05)., Conclusions: Based on these preliminary results, Pycnogenol ® mouth spray could be a new supplementary option for the management of primary xerostomia.

Background: Atherosclerosis progression is possible in subjects with limited alteration of body weight, lipid profile, and oxidative stress. The ultrasound carotid thickness (IMT) and arterial wall modification (granulation and bubbles) are evident signs of the disease. Intestinal fats absorption shifting (IFAS) is expected to prevent or reduce the arterial damage. The aim of the registry was to evaluate the effects of a mild diet in association with lifestyle modifications (standard management [SM]) and SM+ a polyglucosamine biopolymer (BP) shifting the intestinal absorption of dietary fats., Methods: The present is a two-year registry comparing two groups of otherwise healthy subjects, respectively 150 (SM) and 144 (SM+BP). BP was administered at the dosage of 3g/day. IMT and relative arterial damages were measured together with lipid profile, oxidative stress, anthropometric and vital measures., Results: The two groups at the baseline were comparable for all variables: 8 cases of drop out were found limited to SM. Compliance with BP was optimal (>97%) and no side effect were observed. IMT showed a significant decrease in thickness (P<0.05) using BP+SM, while increased in SM group. Intimal granulations and lipid wall bubbles were also significantly decreased with BP in comparison to SM only (P<0.05). BMI significantly decreased with BP (P<0.05) as well as BW, fat mass, lipid profile and oxidative stress in comparison to SM only. A positive variation in blood pressure and heart rate (P<0.05) was also observed., Conclusions: BP allows IFAS to improve early subclinical arterial lesions that tend to progress to plaques and clinical events. The long-term and safe treatment of BP is effective on IMT, lipids, BW, and early lesions of the arterial wall structure in subjects with subclinical conditions. BP also reduces oxidative stress which contributes to lipid oxidation and deposition into the arterial wall layer in areas of high dynamic stress (arterial bifurcations).

Background: This pilot study in post-stroke patients evaluated the effects of supplementation with Pycnogenol ® on alterations in cognitive functions (COFU) over a period of 6 months, starting 4 weeks after the stroke., Methods: The effects of supplementation - possibly acting on residual brain edema, on global cognitive function, attention and on mental performance - were studied. A control group used standard management (SM) and the other group added Pycnogenol ® , 150 mg daily to SM., Results: 38 post-stroke patients completed the 6-month-study, 20 in the Pycnogenol ® group and 18 in the control group. No side effects were observed with the supplement. The tolerability was very good. The patients included into the two groups were comparable for age, sex and clinical distribution. There were 2 dropouts in the control group, due to non-medical problems. Main COFU parameters (assessed by a cognitive questionnaire) were significantly improved (all single items) with the supplement compared to controls (P<0.05). Additional observations indicate that Pycnogenol ® patients experienced significantly less mini-accidents (including falls) than controls (P<0.05). The incidences of (minor) psychotic episodes or conflicts and distress and other problems including rare occurrence of minor hallucinations, were lower with the supplementation than in controls (P<0.05). Single observations concerning daily tasks indicated a better effect of Pycnogenol ® compared to controls (P<0.05). Plasma free radicals also decreased significantly with the supplement in comparison to controls (P<0.05). Globally, supplemented subjects had a better recovery than controls., Conclusions: In post-stroke subjects, Pycnogenol ® supplementation resulted in better recovery outcome and faster COFU 'normalization' after the stroke in comparison with SM; it can be considered a safe, manageable post-stroke, adjuvant management possibly reducing local brain edema. Nevertheless, more patients and a longer period of evaluation are needed to confirm these results.

Background: The aim of this registry study was to evaluate the progress of osteoarthrosis (OA) symptoms after the intake of a new standardized supplement combination (Pycnogenol ® + Centellicum ® , both Horphag Research) in a group of subjects with OA., Methods: Supplemented subjects took daily 150 mg Pycnogenol ® + 450 mg Centellicum ® for 6 months. Another comparable group of subjects using only standard management (SM) was included as a reference., Results: Forty-five subjects with a mean age of 42 years completed the study, 25 in the supplemented group and 20 in the SM group. There were no safety problems or tolerability issues with the supplements. The two groups, SM and SM + Pycnogenol ® + Centellicum ® were comparable for age and clinical characteristics at inclusion. The two main ultrasound characteristics of cartilage, its thickness and surface-irregularity were more improved with the supplements. Pain scores, C reactive protein, the level of fitness and the use of extra pain killers (as rescue medication) were all significantly improved at 6 months with the supplement combination compared to SM (P<0.05). Plasma free radicals, pain-free walking distance on treadmill and erythrocyte sedimentation rate (ESR) were significantly improved with the supplements compared to SM., Conclusions: The morphological improvement - visible with ultrasound - correlates with a decrease in clinical symptoms and with a more efficient ambulation without pain. SM along with the Pycnogenol ® Centellicum ® combination are useful to avoid drug treatments that may expose patients to some side effects over time.

This article was published in Volume 69, issue 1 of publishing year 2023, with a mistake in Table I. The correct Table I is the one included in this erratum.

Background: The aim of this ex-vivo study was to evaluate the efficacy of Pycnogenol ® -Centellicum ® oral supplementation on vein segments, retrieved from graft harvesting or from vein surgery. The parameters assessed were elasticity and recovery after dynamic tests: 1) an enlargement stress; 2) an elongation stress; and 3) elasticity after torsion. The tests were made in standardized conditions, less than 3 hours after explant, at 22 °C by the same operator with surgical and microsurgical experience., Methods: Veins of 59 subjects were included in the study: 17 subjects with normal veins with a planned bypass graft and 42 subjects with varicose veins. Of the subjects with normal veins, 8 subjects followed standard management (group 1) and 9 took Pycnogenol ® -Centellicum ® for 4 weeks before surgery (group 2). In the group with varicose veins, 22 subjects served as controls (group 3) and 20 were supplemented with Pycnogenol ® -Centellicum ® for 4 weeks before surgery (group 4). No side effects or tolerability problems were observed in the supplementation period before surgery and veins harvesting. The full return to initial shape/sizes after dynamic stress was evaluated in 1 min after removing the stress., Results: In group 1, 4 out of 8 vein segments recovered their size after forced enlargement vs. 7/9 in the Pycnogenol ® -Centellicum ® group 2 (P<0.05). In the elongation test, 3/8 normal control vein segments recovered their length (group 1) vs. 7/9 in the supplement group (group 2) (P<0.05). In the torsion test, 4/8 (group 1) veins recovered their shape after torsion vs. 9/9 veins in Pycnogenol ® -Centellicum ® -pretreated segments (group 2) (P<0.05). Only 45.8% of normal, control vein segments (group 1) recovered their shape/size in comparison with 85.2% of normal vein segments in the supplement group (group 2) (P<0.05). In group 3 and 4 (segments of varicose veins), the proportion of vein segments with enlargements, elongation and torsion were significantly lower at the end of the test (P<0.05) in the Pycnogenol ® -Centellicum ® group 4 with 51.7% of the vein segments recovering their shape in the Pycnogenol ® -Centellicum ® vs. 16.6% of the vein segments recovering their shape in control segments (P<0.05). Results show that Pycnogenol ® -Centellicum ® supplementation allows vein segments to better return to their original shape/size after a morphological alteration of shape (in different directions). This could be an expression of an improved wall tone and elasticity of the veins. No vein was teared or damaged during the 59 tests indicating that all stresses were well within the normal wall tensile characteristics of the veins., Conclusions: In this study, Pycnogenol ® -Centellicum ® improved vein elasticity in subjects with normal and varicose veins as vein segments were more elastic (able to recover length and shape) and less passively dilated by high pressure or dynamic stresses. This study indicates that the protective effects of Pycnogenol ® -Centellicum ® may partially stop passive dilatation of veins to varicose veins over time by improving vein elasticity. Pycnogenol ® -Centellicum ® managed vein segments return more rapidly back to the initial dimensions, shapes and diameters after a dynamic stress.

Background: The aim of this pilot registry study was to evaluate the efficacy of Robuvit ® (oak wood extract) on residual fatigue due to convalescence in otherwise healthy subjects within one month after surgery and chemotherapy for colon cancer. Robuvit ® has been clinically tested in subjects with fatigue (chronic fatigue syndrome), post-traumatic stress disorder, convalescence and burnout., Methods: One group of patients followed the standard management (SM) and was designated as control group while the supplementation group followed the SM and additionally took two Robuvit ® capsules daily for six weeks (200 mg/day).The main study endpoints were the Karnofsky performance scale index, handgrip strength in kg, fitness test score on a treadmill, self-assessed work ability, fatigue score, oxidative stress and carcinoembryonic antigen (CEA) plasma levels. In addition, the mood of the patients was assessed using the 'brief mood introspection scale', BMIS., Results: Fifty-one subjects with fatigue linked to convalescence within 1 month after chemotherapy for colon cancer completed the study, 29 in the Robuvit ® group and 22 as controls. The two management groups were comparable for age and sex distribution. The main investigation parameters were also comparable at inclusion. No side effects or tolerability problems were observed in the six weeks of follow-up. Occasional use of painkillers, antinausea medication or anti-inflammatory agents was accepted. After six weeks, Robuvit ® supplementation significantly improved the Karnofsky performance scale index compared to controls. Hand grip strength (dynamometry), treadmill fitness test score and the self-assessed work ability were significantly improved with Robuvit ® as well. The fatigue score after six weeks was significantly improved with Robuvit ® (P<0.05) in comparison with SM controls. Mood was significantly improved after 6 weeks in the Robuvit ® patients compared to the control group. The examined study parameters improved in the patients of the control group as well, during a normal postchemotherapy convalescence, but in a lesser extend when compared to the supplementation group. Oxidative stress was high at inclusion in both groups. The decrease in oxidative stress - as plasma free radicals - was significantly higher with the supplementation (P<0.05). CEA values were within the normal values from inclusion and in the 6 weeks of the registry in all subjects., Conclusions: In conclusion, Robuvit ® helps to reduce fatigue after chemotherapy and improves strength, performance, fitness, work ability and mood in these patients, without exposing them to the risk of side effects.

Background: Intestinal fat absorption shifting (IFAS) can be obtained in hyperlipidemic subjects with polyglucosamine biopolymer (BP) able to segregate most metabolic fats in the gut, making them unavailable for intestinal interaction (shift). The aim of this study was to evaluate the effects of a SM (standard management) for hyperlipidemia in asymptomatic subjects for primary cardiovascular prevention focusing on arterial wall morphology (IMT thickness) in comparison to SM associated to the administration of the BP., Methods: Two groups of comparable subjects (SM and SM+oral BP, 3 g/day) were considered; subjects were managed - in a supplement, pilot registry - for a year. Weight, fat mass, lipid profile, oxidative stress, IMT (carotids), the presence of granulations at the internal arterial layers and "near wall low density 'bubbles' were observed and compared at 1 year of management. A non-parallel, comparable group of subjects (102) using a statin for the same conditions was used as a reference population., Results: Two hundred eighty-four subjects completed one year (140 in the SM group and 144 in the SM+BP group). Compliance was optimal with (96.3% of the table correctly used) with no side effects. BMI, fat mass and oxidative stress decreased more in the SM+BP group (P<0.05). Cholesterol and triglycerides levels were significantly improved with BP (P<0.05). IMT measurements were significantly decreased (P<0.05) in the SM+BP group (as for the intimal granulation/bubbles) with minimal variations in the comparative SM group. In the statin group, the lipid profile was modified (P<0.05) but not the IMT and the rate of drop outs was higher (15.7%); these patients stopped the management; in 23% of these subjects muscular pain not seen with BP, was observed., Conclusions: These results indicate positive effects of IFAS due to BP on IMT and arterial wall morphology and weight after 12 months. Fat shifting at intestinal level and the reduction of oxidative stress limit lipid oxidation/deposition into the arterial wall.

In this preliminary pilot registry study, we investigated the effects of the oral supplementation of a standardized cranberry extract (Anthocran® Phytosome®, Indena) delivered by a lecithin-based system, for the prophylactic management of recurrent-urinary tract infections (R-UTIs). We included 64 otherwise healthy subjects who underwent a surgical procedure and required post-surgical urinary catheterization for high-risk UTIs or a previous history of R-UTIs. Patients were given supplementation with the standardized cranberry extract at the dose of either 120 mg/day ( n  = 12) or 240 mg/day ( n  = 12) or assigned to a control group consisting of standard management (SM; n  = 18) or nitrofurantoin administration ( n  = 22) for 4 weeks. After 4 weeks, patients receiving the standardized cranberry supplementation reported to have a more effective reduction in UTI symptoms, as assessed on the visual analogue scale, compared with patients in the SM or nitrofurantoin groups. The occurrence of hematuria and urine bacterial contamination were decreased among patients treated with the supplement compared with controls ( p  < 0.05). The cranberry extract was also superior to the control management in terms of recurrence of signs/symptoms, with none of the patients in this group suffering from a R-UTI in the 3 months following the study end ( p  < 0.05). The supplementation showed an optimal safety profile, with no significant adverse events and no drop-outs in the supplement group. This registry shows that this cranberry extract is effective as a supplementary, preventive management in preventing post-operative, post-catheter UTIs; the product has a good tolerability profile.

Background: The aim of this study was to evaluate the effects of Robuvit ® in preventing the progression of chronic hepatitis (CH) in non-alcoholic fatty liver disease (NAFLD) which encompasses the entire spectrum of fatty liver disease, from isolated steatosis to non-alcoholic steatohepatitis (NASH)., Methods: One group of patients followed the Standard management (SM) and were assigned as controls while the supplementation group followed the SM and additionally took 2 Robuvit® capsules daily for 3 months (200 mg/day)., Results: 34 subjects with NAFLD were included in the study. The two groups completing 90 days were comparable at baseline with 18 being supplemented with Robuvit ® and 16 in the control group. The tolerability was very good, and no side effects were observed with the supplement. Fasting glucose levels were significantly lower after 3 months with Robuvit ® (P<0.05) compared to controls. The increased serum aspartate aminotransferase levels (AST), considered the key metabolic value in these patients, decreased significantly with Robuvit® (P<0.05) compared to controls. Serum alanine aminotransferase levels (ALT) also decreased significantly with the supplement compared to controls (P<0.05). Platelet count and albumin levels improved significantly with Robuvit® (P<0.05) in comparison to standard management. No other significant changes were observed. The APRI score (the AST/platelet ratio index) was also decreased with the supplementation compared to controls (P<0.05). A high APRI score provides an estimate of the possibility of the liver to develop fibrosis and eventually cirrhosis. After Robuvit® supplementation, the ultrasound characterization showed a significant decrease in the size of the liver in association with a lower echogenicity, which represents less fibrotic changes due to collagen accumulation., Conclusions: Robuvit® improved liver function in NAFLD and prevented progression to liver fibrosis by improving hepatic metabolism in a relatively short period of time. Numerous people are affected by NAFLD, many of them with subclinical symptoms. But to date, there are no specific, definite treatment options. Prolonged evaluations of Robuvit® in a larger group of subjects is suggested.

Background: The aim of this pilot registry study was to assess the preventive effect of an 8-week Pycnogenol ® (French maritime pine bark extract) supplementation on symptoms, such as cognitive and motor aspects, in subjects with Parkinson's disease (PD)., Methods: The study was based on five types of observations: a. Karnofsky performance scale index; b. oxidative stress markers in plasma (plasma free radicals, PFR); c. the main signs and symptoms, evaluated by a physician; d. face motion and expressions and their symmetry, recorded with a high-speed video camera., Results: A total of 79 patients were included in the study: 39 controls using only standard management (SM) and 40 subjects supplemented with Pycnogenol ® 150 mg/day. At inclusion, the two groups (SM and SM+Pycnogenol ® ) were comparable for age, symptoms, Karnofsky performance scale rating and for the management of PD. Likewise, oxidative stress and the presence of peripheral edema were also comparable between the two groups. No side effects of supplementation were observed. There were no tolerability problems. At the end of the study after 8 weeks, the Karnofsky performance index was significantly (P<0.05) higher with Pycnogenol ® compared to controls. Also, the proportion of patients with a clinically visible peripheral edema decreased significantly over 8 weeks with Pycnogenol ® compared to controls (P<0.05). Plasma oxidative stress was significantly lower with Pycnogenol ® (P<0.05). The scores of PD main signs/symptoms like tremor, bradykinesia, alterations in cognitive functions, rigidity and speech impairment were significantly lower in the Pycnogenol ® group compared to controls (P<0.05). Face expression evaluation showed a marked asymmetry at inclusion. Over 8-week supplementation, facial expression scores for visible and subliminal asymmetry, altered facial responses, altered shoulder motion and altered emotional pattern improved significantly in the Pycnogenol ® group compared to controls (P<0.05) where the scores did not change significantly., Conclusions: In conclusion, according to this pilot registry study, Pycnogenol ® supplementation helps patients with moderate, well-controlled PD - under stable treatment - to attenuate most signs and symptoms and life-relational aspects associated with Parkinson-related cognitive impairment.

Background: The aim of this open, pilot supplement registry study was to evaluate the protective, preventive effects of Robuvit ® on professional-related fatigue symptoms and on aspects of cognitive functions, professional attitudes and decision-making in healthy nurses under professional stress and with increased oxidative stress., Methods: In total, 40 subjects, aged 30-37, completed the 4-week registry study. A control group of 20 subjects used only the standard management (SM) and one group of 20 subjects took 300 mg Robuvit ® in addition. Safety and tolerability of Robuvit ® were optimal. The two registry groups were comparable at inclusion., Results: The overall scores of the real daily life and tasks questionnaire after 4 weeks were significantly higher in the Robuvit ® group (P<0.05) as compared to controls. It increased from 4.3±0.4 at baseline to 6.78±0.8 after 4 weeks of Robuvit ® intake and from 4.2±0.5 to 5.12±1.0 in the control group. The supplementation significantly improved the subjective perception of fatigue in comparison with controls (P<0.05). A practical professional score evaluation provided an indication of professional attitude and stamina, in difficult, stressful working conditions under continuous pressure. The results showed that after 4-week supplementation, all assessed parameters improved significantly and the difference with controls was statistically significant (P<0.05). Furthermore, oxidative stress as plasma free radicals decreased significantly in the Robuvit ® group (P<0.05) but not in the control group., Conclusions: Robuvit ® supplementation appears to improve most symptoms related to work-induced fatigue, stress and cognitive function and supports stamina. Further evaluations need to be planned according to the concept of this pilot registry in a field that requires more attention.

Background: Intestinal fat absorption shifting (IFAS) can be achieved with a polyglucosamine biopolymer (BP) able to retain most fats in the gut so that they are available to the intestinal microbiota (shift). The aim of this study was to evaluate the effects of the standard management (SM) of asymptomatic cardiovascular disease prevention on intima-media thickness (IMT) in comparison with SM combined with BP., Methods: Two groups (SM and SM+3 g BP/day) were compared. They consisted of 86 and 81 subjects respectively treated for 6 months. Anthropometric variables, vital signs, fat mass, lipid profile, oxidative stress, carotid IMT, granulations at the IM layer and near-wall low density bubbles were measured., Results: Seventy-eight cases in the SM group and 81 in the SM+BP group completed the management period. Compliance was optimal (>97%) with no side effects. The anthropometric variables, vital signs, fat mass and oxidative stress were significantly lower only in the SM+BP group (P<0.05). Cholesterol and triglyceride levels improved with BP use (P<0.05). The changes in IMT were reduced significantly (P<0.05) in the SM+BP group only. The same was true for intimal granulation/bubbles., Conclusions: The preliminary results suggest that the IFAS caused by BP has a positive effect on IMT and arterial wall structure (thickness and low-density bubbles) even during a short period of management. The intestinal fat shifting and reduction in oxidative stress seem to limit lipid oxidation and deposition on the arterial wall.

Background: The aim of this registry study was to evaluate the preventive efficacy of Pycnogenol ® (French maritime pine bark, standardized extract), an anti-inflammatory and antioxidant supplement, previously used for muscular pain and cramps, in otherwise healthy subjects with restless legs syndrome (RLS)., Methods: Two management groups were formed: one using the standard management (SM) and one using SM and Pycnogenol ® 150 mg/day for 4 weeks., Results: Forty-five subjects were included in the study, 21 took Pycnogenol ® and 24 were in the SM group. After 4 weeks no side effects or tolerability problems were observed. Compliance was optimal. The two groups were comparable at baseline. Limb sensations were assessed with a Visual Analogue Scale Line (0 to 4). There was a statistically non-significant improvement with SM in all subjects. Improvement with Pycnogenol ® supplementation was significant (P<0.05) for all assessed parameters with important clinical meanings as 19 out of 21 supplemented subjects reported a clear benefit from supplementation. Resting flux - slightly elevated at inclusion - was normalized in the supplemented group (P<0.05) as seen by a decrease in flux. The venoarteriolar response - affected at inclusion in all subjects with RLS - was improved with the supplement, indicating a better axon-axon reflex response and a lower level of subclinical neural alteration. The need for pain managements was significantly reduced (P<0.05) with supplementation after 4 weeks, as only 4/21 supplemented subjects vs. 16/24 in the SM-only group had to use analgesics. Thermography of the leg did not reveal any significant asymmetry of perfusion. Oxidative stress as plasma free radicals (PFR) was significantly improved (reduced) (P<0.05) in subjects using Pycnogenol ® . Likewise, minimal edema, measured with the edema tester, was significantly decreased with Pycnogenol ® ., Conclusions: Pycnogenol ® prevents or relieves symptoms associated with restless leg syndrome and positively affects the venoarteriolar response. Future studies in this condition, including more complex subjects may indicate the role of Pycnogenol ® in this common and still obscure syndrome and in subclinical muscular and neurological alterations.

Background: The aim of this open supplement study was to evaluate the effects of Pycnogenol ® in comparison with controls on symptoms of post-COVID-19 syndrome and in improving endothelial function, microcirculation, inflammatory markers and oxidative stress over 3 months in symptomatic subjects recovering from COVID-19., Methods: Sixty subjects recovering from symptomatic COVID-19 were included. One group of 30 followed a standard recovery management while 30 comparable subjects received a supplement of 150 mg Pycnogenol ® daily (in 3 doses of 50 mg) in addition to standard management., Results: Two groups of selected subjects were comparable at baseline. The groups progressively improved both with the SM (standard management) and with the SM in combination with the supplement. Patients, supplemented with Pycnogenol ® showed significantly better improvement compared to the control group patients. No side effects from the supplementation were observed; tolerability was optimal. The progressive evolution over time was visible in all target measurements. Physiological tests: endothelial function, low in all subjects at inclusion was assessed by flow mediated dilation (FMD) and finger reactive hyperemia in the microcirculation (laser Doppler measurements) after the release of an occluding suprasystolic cuff. It was significantly improved in the Pycnogenol ® group after one month and after 3 months (P<0.05 vs. controls). The rate of ankle swelling (RAS) by strain gauge decreased significantly in the supplemented group (P<0.05) in comparison with controls showing an improvement of the capillary filtration rate. At inclusion, the kidney cortical flow velocity indicated a decrease in perfusion (lower systolic and diastolic flow velocity) in all patients. Kidney cortical flow velocity increased significantly with the supplement (P<0.05) in comparison with controls with improvement in systolic velocity and in diastolic component. High sensitivity CRP (hs-CRP) and Il-6 plasma levels decreased progressively over 3 months with a significant more pronounced decrease in the supplement group (P<0.05). The number of patients with normal plasma IL-6 levels at the end of the study was higher (P<0.05) with the supplement. ESR followed the same pattern with a progressive and a more significant decrease in the supplemented subjects (P<0.02). Oxidative stress decreased significantly in the supplemented group (P<0.05) compared with the control group. Systolic blood pressure was significantly lower in the supplemented group (P<0.05) at the end of the study. Finally, the scores of Quality-of-life, mood and fatigue questionnaire and the Karnofsky Scale Performance Index significantly improved in the supplement group (P<0.05) compared to controls after 1 and 3 months. All other blood parameters (including platelets and clotting factors) were within normal values at the end of the study., Conclusions: In conclusion, Pycnogenol ® may offer a significant option for managing some of the signs and symptoms associated with post-COVID-19 syndrome. This pilot evaluation offers some potential rationale for the use of Pycnogenol ® in this condition that will have significant importance in the coming years.

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.

Background: The aim of this study was to evaluate the combination of Pycnogenol ® (150 mg/day) (Horphag Research, London, UK) and Centella asiatica (Centellicum ® 3×225 mg/day; Horphag Research) (PY-CE) for 8 months in subjects with sequelae of idiopathic interstitial pneumonia (IIP). Recently, post-COVID-19 lung disease is emerging with large numbers of patients left with chronic lung conditions. Considering the antifibrotic activity of the combination PY-CE, we also tested this supplementary management in post-COVID-19 lung patients., Methods: Nineteen subjects with idiopathic interstitial pneumonia (IIP) were included in the study. High Resolution CT scans at inclusion confirmed the presence of lung fibrosis: 10 patients were treated with the Pycnogenol ® Centellicum ® combination and 9 subjects with standard management (SM) served as controls. Oxidative stress that was very high in all subjects at inclusion, decreased significantly in the supplement group (P<0.05). The Karnofsky Performance Scale Index significantly improved in the supplement group in comparison with controls (P<0.05). The symptoms (fatigue, muscular pain, dyspnea) were significantly lower after 8 months in supplemented patients (P<0.05) as compared with controls., Results: At the end of the study, the small cystic lesions (honeycombing) and traction bronchiectasis were stable or in partial regression in 4 subjects in the supplemented group (vs. none in the control group) with a significant improvement in tissue edema in the supplemented subjects. On ultrasound lung scans the white (more echogenic) fibrotic component at inclusion was 18.5±2.2% in the images in controls vs. 19.4±2.7% in the supplement group. At the end of the study, there was no improvement in controls (18.9±2.5%) vs. a significant improvement in supplemented subjects (16.2±2.1%; P<0.05). In addition, 18 subjects with post-COVID-19 lung disease were included in the study; 10 patients were treated with the Pycnogenol ® Centellicum ® combination and evaluated after 4 weeks; 8 patients served as controls. Preliminary results show that symptoms associated with post-COVID-19 lung disease after 4 weeks were significantly improved with the supplement combination (P<0.05). Oxidative stress and the Karnofsky Performance Scale Index were significantly improved in the supplements group as compared with controls (P<0.05)., Conclusions: According to these observations, Pycnogenol ® controls and decreases edema and Centellicum ® by modulating the apposition of collagen, slows down the development of irregular cicatrization, the keloidal scarring and fibrosis. More time is needed to evaluate this effect in a larger number of post-COVID-19 patients with lung disease. This disease has affected millions of subjects worldwide, leaving severe consequences. Pycnogenol ® and Centellicum ® may improve the residual clinical picture in post-COVID-19 lung disease (PCL) patients and may reduce the number of subjects evolving into lung fibrosis. The evolution from edema to fibrosis seems to be slower or attenuated with this supplement combination both in Idiopathic pulmonary fibrosis (IPF) and in PCL patients.

Background: Back pain (BP) is one of the most common problems seen by general practitioners. The aim of this pilot registry study was to evaluate the effects of Pycnogenol ® (French Maritime Pine Bark extract) on pain, mobility and muscle spasm in patients with recurring episodes of back pain without any other clinical condition., Methods: The registry follow-up lasted 3 weeks. Subjects used either SM (standard management), including mild exercise and 3 days of resting or immobilization - or SM+Pycnogenol ® 200 mg/day (4 cps/day)., Results: Eighty-two subjects were included in the study, 23 took Pycnogenol ® and 59 were in the SM group. No safety problems or tolerability problems were observed with Pycnogenol ® or with the SM. The two groups, SM and SM+Pycnogenol ® , were comparable at inclusion. A prevalent localization to the lower part of the back/spine was observed in all patients of both groups. The improvement in Karnofsky performance status Scale - expressing the global physical capacity of the individuals - during the 3 weeks of follow-up was significantly higher and faster in the Pycnogenol ® group (P<0.05) compared to SM. Patients were able to restart physical training in 3 weeks with Pycnogenol ® (in comparison with 4.5 weeks with SM only). The decrease in back pain score (VASL score) was faster and more pronounced with Pycnogenol ® (P<0.05) compared to SM. Oxidative stress was significantly reduced in subjects using Pycnogenol ® (P<0.05) while it remained elevated in the control group. The use of the rescue medication doses (ibuprofen) was significantly higher in the SM only (P<0.05) in comparison with SM+Pycnogenol ® ., Conclusions: Pycnogenol ® appears to be an effective and safe supplementary management in healthy subjects with idiopathic BP. Mobility, pain, general physical capacity and oxidative stress improved in only a week with further improvements up to 4 weeks in most patients; results appear to be better and faster with Pycnogenol ® supplementation than with SM alone.

Background: The aim of this pilot, registry study was to evaluate the prophylactic effects of oral supplementation with Pycnogenol ® (150 mg/day) in subjects with previous history of recurrent (urinary tract infections (UTI) in a 2-month open follow-up., Methods: subjects with recurrent-UTIs, defined by: 1) at least three symptomatic UTIs over the past year; 2) two episodes of UTI's in the past six months; 3) symptoms of UTIs with urinalysis without bacterial presence, were included in the study. Pycnogenol ® was supplemented at the dose of 150 mg/day for 2 months., Results: The two groups of subjects (supplement and controls, each including 25 subjects) were demographically and clinically comparable at baseline. No side effects or tolerability problems were observed. The registry evaluated the number of recurrent UTIs in two months; there was a limited decrease in the rate of recurrent UTIs, in comparison with the period before inclusion of 9.93% in the standard management group in comparison with a more important decrease in the Pycnogenol ® group (-50.1%; P<0.05). The number of episodes decreased from 3.22±0.4 to 2.9±0.3 in the control group in 2 months versus a decrease from 3.1±0.5 to 1.6±0.6 in the Pycnogenol ® group. The number of infection-free subjects at the end of the two-month registry study was significantly higher with the supplement (P<0.05) than in controls. Oxidative stress measured as plasma free radicals at inclusion was 388±22 Carr units in the control group and resulted unchanged (not significant) at the end of the study (379±21 Carr units). In the supplement group, there was a significant decrease in oxidative stress from 389±24 to 227±14 Carr units at the end of the study (P<0.05)., Conclusions: This pilot registry indicates that prophylaxis with Pycnogenol ® decreases the occurrence of UTIs both in men and women without side effects and with a good tolerability. The effects of Pycnogenol ® in these patients - including the control of oxidative stress - may be very important, particularly when a predominantly inflammatory component (UTI without infection or with a minimal bacterial component due to bacterial fragments) is present and maintains the inflammatory process.

This open pilot registry study aimed to evaluate and compare the prophylactic effects of Pycnogenol® or cranberry extract in subjects with previous, recurrent urinary tract infections (UTI) or interstitial cystitis (IC). Methods . Inclusion criteria were recurrent UTI or IC. One subject group was supplemented with 150 mg/day Pycnogenol®, another with 400 mg/day cranberry extract, and a group served as a control in a 2-month open follow-up. Results . 64 subjects with recurrent UTI/IC completed the study. The 3 groups of subjects were comparable at baseline. All subjects had significant symptoms (minor pain, stranguria, repeated need for urination, and lower, anterior abdominal pain) at inclusion. In the course of the study, the subjects reported no tolerability problems or side effects. The incidence of UTI symptoms, in comparison with the period before inclusion in the standard management (SM) group, decreased significantly; there was a more pronounced decrease in the rate of recurrent infections in the Pycnogenol® group ( p < 0.05). The improvement in patients supplemented with Pycnogenol® was significantly superior to the effects of cranberry. At the end of the study, all subjects in the Pycnogenol® group were infection-free ( p < 0.05vs. cranberry). Significantly, more subjects were completely symptom-free after 2 months of management with Pycnogenol® (20/22) than with SM (18/22) and cranberry (16/20). Conclusions . This pilot registry suggests that 60 days of Pycnogenol® supplementation possibly decrease the occurrence of UTIs and IC without side effects and with an efficacy superior to cranberry., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2021 A. Ledda et al.)

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.

Background: The aim of this registry study was the prospective evaluation of the efficacy of Pycnogenol ® in idiopathic fibromyalgia (FM), over 4 weeks in comparison with the standard management (SM)., Methods: A SM and a Pycnogenol ® +SM group were formed. Pycnogenol ® supplementation was used at the dose of 150 mg/day (4 weeks). The study considered the most important/frequent symptoms of FM., Results: Fifty patients with idiopathic fibromyalgia were included: 26 in the Pycnogenol ® group and 24 served as controls. The two groups were comparable at inclusion. No other disease or condition was present. All subjects were otherwise healthy women (BMI<26), not using any drug. All subjects had an elevated level of oxidative stress (OS) at inclusion. All routine blood tests - and all inflammatory and rheumatic tests - were within the normal range at inclusion and at the end of the study. No safety or tolerability problems were observed. The percentage of patients using NSAIDs (non-steroidal anti-inflammatory drugs) as rescue medications in the observation period was significantly higher in the SM management group (P<0.05) in comparison with the supplement group. The percentage of patients using corticosteroids as rescue medication was significantly higher in the SM group (P<0.05). The percentage of subjects with the symptoms/complaints decreased significantly, considering each symptom, with Pycnogenol ® after 4 weeks in comparison with the SM (P<0.05)., Conclusions: Pycnogenol ® supplementation appears to control and reduce the intensity of common symptoms and complaints - especially pain-related - associated with FM. Pycnogenol ® could be a 'soft', safe supplementation and prevention method to manage the symptoms of most of these patients, even for longer periods, reducing the need for drugs.

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.