Pycnogenol® Supplementation Prevents Recurrent Urinary Tract Infections/Inflammation and Interstitial Cystitis.

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.

Structured reporting of chest CT in COVID-19 pneumonia: a consensus proposal.

OBJECTIVES: The need of a standardized reporting scheme and language, in imaging of COVID-19 pneumonia, has been welcomed by major scientific societies. The aim of the study was to build the reporting scheme of chest CT in COVID-19 pneumonia. METHODS: A team of experts, of the Italian Society of Medical and Interventional Radiology (SIRM), has been recruited to compose a consensus panel. They used a modified Delphi process to build a reporting scheme and expressed a level of agreement for each section of the report. To measure the internal consistency of the panelist ratings for each section of the report, a quality analysis based on the average inter-item correlation was performed with Cronbach's alpha (Cα) correlation coefficient. RESULTS: The overall mean score of the experts and the sum of score were 3.1 (std.dev. ± 0.11) and 122 in the second round, and improved to 3.75 (std.dev. ± 0.40) and 154 in the third round. The Cronbach's alpha (Cα) correlation coefficient was 0.741 (acceptable) in the second round and improved to 0.789 in the third round. The final report was built in the management of radiology report template (MRRT) and includes n = 4 items in the procedure information, n = 5 items in the clinical information, n = 16 in the findings, and n = 3 in the impression, with overall 28 items. CONCLUSIONS: The proposed structured report could be of help both for expert radiologists and for the less experienced who are faced with the management of these patients. The structured report is conceived as a guideline, to recommend the key items/findings of chest CT in COVID-19 pneumonia.

Effectiveness of a novel boswellic acids delivery form (Casperome®) in the management of grade II ankle sprains due to sport trauma - a registry study.

OBJECTIVE: In this study, we evaluated a novel delivery form of boswellic acids (Casperome®) in the management of signs and symptoms associated with ankle sprain grade II due to sport trauma. PATIENTS AND METHODS: In this supplement registry study, 72 otherwise healthy subjects with grade II ankle sprain induced by sport activities were advised to either follow a standard management (SM, 37 subjects) for the condition or the SM with the additional daily intake of 1 tablet containing 250 mg Casperome® (35 subjects). Subjects were allowed to use rescue medications (ketoprofen tablets, 25 mg/tablet), and their intake was measured at the end of the management period of 7 days. Each individual was subjected to several non-invasive examinations (self-reported pain at rest and under moderate exercise, range of active and passive movement, presence of local hematomas by ultrasonography) at the following time periods: at inclusion, to evaluate the basal conditions of the subject before the beginning of the study, at day 3 and at the end of the week to evaluate the response differences between the two groups. Additionally, a blood sample from the Casperome® treated subjects (34 out of 35 subjects) was taken at day 7 and analyzed for the systemic concentration of boswellic acids. RESULTS: The 72 individuals recruited in this study spontaneously decided which management to follow, either SM (n=37) or SM+Casperome® (n=35). Supplementation with Casperome® 250 mg/day showed beneficial effects in the reduction of signs and symptoms of ankle sprains evaluated at day 3 and day 7, and was shown to induce measurable plasma level of boswellic acids. Moreover, the supplementary use of Casperome® was well-tolerated and devoid of side effects. CONCLUSIONS: Our pilot registry study showed the effectiveness of Casperome® supplementation in improving recovery after ankle sprain of mild severity (grade II), suggesting a potentially beneficial role in relieving the trauma associated with sport activities and in decreasing the use of rescue drugs.

Mirtogenol® supplementation in association with dorzolamide-timolol or latanoprost improves the retinal microcirculation in asymptomatic patients with increased ocular pressure.

OBJECTIVE: Supplementation with Mirtogenol® improves the retinal microcirculation and reduces intraocular pressure (IOP) in ocular hypertension, when administrated either alone or in association with an ophthalmic solution (latanoprost). In this study, microcirculatory parameters (perfusion of the circle of Zinn-Haller and retinal circulation) and oxidative stress were tested to assess the effects of Mirtogenol® plus traditional antihypertensive drugs in patients with elevated IOP. PATIENTS AND METHODS: 88 otherwise healthy patients with increased IOP were followed-up in a supplement registry for 12 weeks. Three groups received; (a) dorzolamide-timolol plus Mirtogenol®; (b) latanoprost drops plus Mirtogenol® or (c) latanoprost only. Oral supplementation consisted of two tablets/day of Mirtogenol® (80 mg of bilberry extract, Mirtoselect® plus 40 mg of Pycnogenol®). IOP, retinal blood flow, perfusion of the circle of Zinn-Haller, and oxidative stress were measured during the registry period. RESULTS: The three study groups were comparable; IOP and ocular blood flow velocity at inclusion were also comparable. Over the study period the decrease in IOP and the improvements in retinal microcirculation were statistically significant for all management groups, with a marginally more evident benefit in Mirtogenol®+latanosprost-treated patients. At 12 weeks, the altered perfusion at the circle of Zinn-Haller was improved in all groups; patients using Mirtogenol® showed a better perfusional pattern compared with subjects using only latanoprost. A reduction in oxidative stress was observed in supplemented subjects at the end of the study period; no significant change was seen in non-supplemented patients. All managements were well-tolerated without side effects. CONCLUSIONS: Supplementation with Mirtogenol®, in addition to local ophthalmic treatments, is safe and may contribute as a supplementary management to reach a normal IOP and ocular microcirculatory parameters.

A natural pharma standard supplement formulation to control treatment-related toxicity and oxidative stress in genitourinary cancer: a preliminary study.

OBJECTIVE: Oncological treatments are associated with toxicities that may decrease compliance to treatment in most genitourinary cancer patients. Supplementation with pharmaceutical-standardized supplement may be a supplementary method to control the side effects after chemo- and radiotherapy and the increased oxidative stress associated to treatments. This registry study evaluated a natural combination of supplements containing curcumin, cordyceps, and astaxanthin (Oncotris™) used as supplementary management in genitourinary cancer patients who had undergone oncological therapy. PATIENTS AND METHODS: Patients with genitourinary cancers (prostate or bladder malignancies) who had undergone and completed cancer treatments (radiotherapy, chemotherapy or intravesical immunotherapy with increased oxidative stress and residual symptoms) were recruited in this registry, supplement study. Registry subjects (n = 61) freely decided to follow either a standard management (SM) (control group = 35) or SM plus oral daily supplementation (supplement group = 26). Evaluation of severity of treatment-related residual side effects, blood count test, prostate-specific antigen (PSA) test and plasma free radicals (oxidative stress) were performed at inclusion and at the end of the observational period (6 weeks). RESULTS: Two patients dropped out during the registry. Therefore, the analysis included 59 participants: 26 individuals in the supplementation group and 33 in the control group. In the supplement group, the intensity of signs and symptoms (treatment-related) and residual side effects significantly decreased at 6 weeks: minimal changes were observed in controls. Supplementation with Oncotris™ was associated with a significant improvement in blood cell count and with a decreased level of plasmatic PSA and oxidative stress. CONCLUSIONS: Naturally-derived supplements, specifically Oncotris™ (patent pending), could support the body to overcome the treatment-related toxicities - and the relative oxidative stress in cancer patients.

Management of Varicose Veins and Chronic Venous Insufficiency in a Comparative Registry with Nine Venoactive Products in Comparison with Stockings.

The aim of this registry study was to compare products used to control symptoms of CVI. Endpoints of the study were microcirculation, effects on volume changes, and symptoms (analogue scale). Pycnogenol, venoruton, troxerutin, the complex diosmin-hesperidin, Antistax, Mirtoselect (bilberry), escin, and the combination Venoruton-Pycnogenol (VE-PY) were compared with compressions. No safety or tolerability problems were observed. At inclusion, measurements in the groups were comparable: 1,051 patients completed the registry. Best performers : Venoruton, Pycnogenol, and the combination VE-PY produced the best effects on skin flux. These products and the combination VE-PY better improved PO 2 and PCO 2 . The edema score was decreased more effectively with the combination and with Pycnogenol. Venoruton; Antistax also had good results. Considering volumetry, the best performers were the combination PY-VE and the two single products Venoruton and Pycnogenol. Antistax results for edema were also good. The best improvement in symptoms score were obtained with Pycnogenol and compression. A larger decrease in oxidative stress was observed with Pycnogenol, Venoruton, and with the VE-PY combination. Good effects of Antistax were also observed. Parestesias were lower with Pycnogenol and with Antistax. Considering the need for interventions, the best performers were Pycnogenol, VE-PY, and compression. The efficacy of Pycnogenol and the combination are competitive with stockings that do not have the same tolerability in warmer climates. A larger and more prolonged evaluation is suggested to evaluate cost-efficacy (and non-interference with drugs) of these products in the management of CVI. The registry is in progress; other products are in evaluation.

Supplementation with a lecithin-based delivery form of Boswellia serrata extract (Casperome®) controls symptoms of mild irritable bowel syndrome.

OBJECTIVE: Irritable Bowel Syndrome (IBS) is a chronic, gastrointestinal disorder in which abdominal pain or discomfort is associated with defecation or changes in bowel habits. Its multifactorial pathophysiology leads to a variety of available treatments, mainly aimed at controlling symptoms. The management of IBS patients could be optimized by individualized strategies, including non-pharmaceutical approaches. In this study, we evaluated the efficacy and safety of a novel delivery form of Boswellia serrata extracts (BSE) (Casperome®) in patients with IBS. PATIENTS AND METHODS: 71 otherwise healthy subjects with idiopathic IBS were recruited. Participants were assigned to the following management strategies: hyoscine butylbromide; papaverine hydrochloride + A. belladonna extract; supplementation with Casperome®. Predominant IBS symptoms were evaluated at inclusion and at the end of the observational period (4 weeks). The numbers of subjects who needed rescue medication or medical attention/hospital admission were recorded. Adverse events were also evaluated. RESULTS: In all groups, the IBS symptoms investigated, namely abdominal pain, altered bowel movements, meteorism and cramps improved during the observational period. Of note, the number of subjects who needed medical attention significantly decreased only in Casperome®-supplemented group. In addition, Casperome® supplementation was related to a lower incidence of side effects (mainly stypsis). CONCLUSIONS: This preliminary study suggests that Casperome® supplementation could represent a promising alternative approach to manage symptoms associated with IBS in otherwise healthy subjects.

Effects of a curcumin-based supplementation in asymptomatic subjects with low bone density: a preliminary 24-week supplement study.

OBJECTIVE: Osteopenia is a chronic bone condition characterized by decreased calcification, density, or bone mass that, if untreated, can lead to osteoporosis and bone fractures. Although its increasing prevalence, nowadays osteopenia is not adequately prevented and managed. In this study, we evaluated the efficacy, in term of changes in bone density, and safety of an oral formulation based on turmeric phytosome (Meriva®), in subjects suffering from low bone density. PATIENTS AND METHODS: 57 otherwise healthy subjects with low bone density were enrolled in this pilot, supplement study. Informed participants freely decided to follow either a standard management (SM) to control low bone density (control group=28) or SM associated with a curcumin-based oral supplementation (supplement group=29). The bone densities of heel, small finger and upper jaw were evaluated at inclusion and at different time points during the observational period (4, 12 and 24 weeks), in all subjects. RESULTS: The bone density of the heel measured by the Sahara densitometer remarkably improved in the Meriva®-supplemented group, with a significant decrease of ultrasounds transmission values at week 12 (-18.4%) and at week 24 (-21.0%), compared with baseline values. The bone densities of small finger and upper jaw also significantly increased during the study in supplemented subjects, reaching +7.1% and +4.8%, respectively, at week 24, with respect to values at inclusion. Noteworthy, no significant changes of heel, small finger and upper jaw densities were observed in the control group. Last, no safety and tolerability issues were reported during the observational period. CONCLUSIONS: This preliminary study suggests that a curcumin-based supplementation in combination with an appropriate lifestyle could be beneficial in the prevention and management of osteopenia.

Managing ulcerative colitis in remission phase: usefulness of Casperome®, an innovative lecithin-based delivery system of Boswellia serrata extract.

OBJECTIVE: Boswellia serrata extracts (BSE) have been traditionally used for the treatment of several inflammatory diseases. The aim of this study was to evaluate the efficacy of a novel delivery form of BSE (Casperome®) in Ulcerative Colitis (UC) during minimally symptomatic remission phase. PATIENTS AND METHODS: In this open-label, observational, registry study, informed participants with UC in remission phase (n = 43) freely decided to receive the oral daily Casperome® supplementation (n = 22) or no supplementation (n = 21) for 4 weeks. Several parameters associated with minimally symptomatic UC in remission were evaluated at the inclusion and the end of the study. RESULTS: A significant beneficial effect of Casperome® was observed for all the parameters evaluated, namely: diffuse intestinal pain, evident and occult blood in stools, bowel movements and cramps, watery stools, malaise, anemia, rectal involvement, number of white blood cells as well as need for concomitant drugs and medical attention. Faecal concentration of calprotectin, a marker of bowel inflammation, resulted ameliorated in Casperome® supplemented patients. CONCLUSIONS: Our study showed that Casperome® supplementation attenuates symptoms associated with mild UC in remission, reducing the use of drugs and medical consultations. Therefore, our study suggests that Casperome® supplementation could represent a promising alternative approach to manage minimally symptomatic UC and maintain the remission phase.

Bilberry extracts are not created equal: the role of non anthocyanin fraction. Discovering the "dark side of the force" in a preliminary study.

OBJECTIVE: Several experimental studies and clinical trials support the potential of bilberry (Vaccinium myrtillus L) extracts in promoting eye health and circulation. Many active ingredients have been isolated from the berries and leaves of the bilberry plant. However, anthocyanins represent the most widely studied bioactive compounds in this plant. PATIENTS AND METHODS: The aim of this registry, supplement study was to evaluate the effects of Mirtoselect® (standardized in 36% anthocyanins and obtained by an industrial extraction process that preserves the full range of the non-anthocyanin components, mainly natural sugars and polyphenols) in different types of retinal vasculopathies. In total, 140 patients with different types of retinopathy spontaneously decided to join one of the following groups: standard management (SM) only (n=38); SM associated with Mirtoselect® supplementation (n=47); SM associated with a generic bilberry extract supplementation (n=55). Retinal circulatory parameters and flow measurements of the retinal vessels were evaluated at the inclusion and after 6-months supplementation. RESULTS: Overall, significant improvements in several retinal circulatory parameters such as retinal blood flow velocity, with respect to the values at inclusion, were observed in both supplementation groups, especially in Mirtoselect® supplementation group. However, at 6 months, inter-group comparison revealed a statistical advantage in all tested parameters for Mirtoselect® supplementation groups. No side effects or tolerability concerns were reported. CONCLUSIONS: Our registry study suggests that Mirtoselect® supplementation could represent an effective and safe integrated approach for the treatment of different retinopathies.

Supplementation with high titer cranberry extract (Anthocran®) for the prevention of recurrent urinary tract infections in elderly men suffering from moderate prostatic hyperplasia: a pilot study.

OBJECTIVE: Recently, cranberry extracts have been tested as a nutritional supplementation in the prevention of lower urinary tract symptoms (LUTS) as well as recurrent urinary tract infections (UTIs) in subjects at risk, with mixed results. However, evidence of efficacy should be considered only for well-characterized and standardized products in a more selected study population. Moreover, the efficacy of these interventions in elderly must be further investigated. The aim of this pilot, registry study was to evaluate the prophylactic effects of an oral supplementation containing a highly concentrated and standardized cranberry extract reproducing the natural total profile of cranberry fruits, in elderly men with benign prostatic hyperplasia (BPH), suffering from recurrent UTIs, over a 2-months follow-up. PATIENTS AND METHODS: 43 men (age > 65 years) enrolled in this study freely decided to receive either a standard management (SM) only (n = 21) or SM associated with an oral supplementation (n = 23). Supplementation consisted in a daily administration of one capsule containing cranberry extract (Anthocran®) for 60 consecutive days. The clinical effectiveness in the prevention of UTIs was determined by the number of UTIs in the two months before the inclusion in the registry and during the supplementation period, and the number of symptom-free subjects during the registry period. Safety considerations were also performed. RESULTS: In the supplemented group, the mean number of UTI episodes reported during the registry (0.8 ± 0.5) significantly decreased compared with inclusion time (3.2 ± 1.3), p-value = 0.0001. No significant changes were observed in control, SM-only group. Importantly, the cranberry oral supplementation was superior over SM at reducing the mean number of UTIs (p-value = 0.0062). CONCLUSIONS: These results suggest that cranberry supplementation could be an effective and safe approach, within an SM program, for the prevention of recurrent UTIs in elderly men suffering from BPH avoiding some antibiotic treatments.

Movardol® (N-acetylglucosamine, Boswellia serrata, ginger) supplementation in the management of knee osteoarthritis: preliminary results from a 6-month registry study.

OBJECTIVE: Knee Osteoarthritis (OA) is a chronic disease caused by the deterioration of cartilage in joints, which results in activation of the inflammatory response, pain, and impaired movement. Complementary therapies, particularly supplementation, in the management of moderate/severe knee OA have been gaining attention. This registry study aimed at evaluating the synergistic effect of Movardol®, a supplementation containing active ingredients with recognized anti-inflammatory activities on symptoms and levels of circulating biomarkers of knee OA. PATIENTS AND METHODS: 54 subjects with symptomatic, moderate knee OA freely decided to follow either a standard management (SM) (n = 26) or SM plus oral supplementation with Movardol® (n = 28). Movardol® supplementation containing N-acetyl-D-glucosamine, ginger, and Boswellia Serrata extract was taken at the following dosage: 3 tablets/day for one week and then 2 tablets/day. Several parameters were assessed at inclusion and after 1, 3 and 6 months: functional impairment by the Karnofsky Performance Scale Index; pain, stiffness, physical, social and emotional functions by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC); total and pain-free walking distance; circulating biomarkers of inflammation and oxidative stress. RESULTS: Significant improvements in the functional outcomes and pain-free walking distance were observed after 1, 3 and 6 months in OA patients supplemented with Movardol®. Moreover, all the signs/symptoms of disease assessed by the WOMAC tended to regress over a 6-month period in patients following SM+supplementation. Inflammatory markers and plasmatic content of reactive oxygen species decreased over 6 months, in supplemented patients. Movardol® supplementation resulted to be safe and well tolerated, also showing the beneficial effect in term of a decrease in pharmacological and non-pharmacological treatments and, consequently, reduction in management costs. CONCLUSIONS: These preliminary results indicate the efficacy and safety of Movardol® supplementation in the management of moderate knee OA.

The COFU3 Study. Improvement in cognitive function, attention, mental performance with Pycnogenol® in healthy subjects (55-70) with high oxidative stress.

AIM: This 12-month product registry study evaluated the effects of supplementation with French pine bark extract (Pycnogenol(®)) on cognitive function, attention, and mental performance in healthy subjects with high oxidative stress. METHODS: Healthy subjects (age range 55-70) were screened - within a cardiovascular screening program - for oxidative stress. Out of 150 subjects, high oxidative stress was present in 44; the use of the supplement Pycnogenol(®) was suggested (100 mg/day). These subjects decided to use Pycnogenol(®) and accepted to be evaluated by assessing cognitive functions. A group of subjects with comparable oxidative stress was followed as a reference. IQ Code (Informant Questionnaire on Cognitive Decline in the Elderly), daily tasks, cognitive function, oxidative stress and the short Blessed tests (SBT) were used (in defined scales) to evaluate cognitive functions (COFU). RESULTS: As for the IQ Code, at 12 months there was a significantlty total lower score in Pycnogenol(®) patients and also a lower value (P<0.05) for 14 out of 16 items in the questionnaire. Daily tasks: all items were improved (P<0.05) with supplementation in comparison with controls. The improvement was seen for all 12 items (P<0.05) with the supplement. Cognitive function values (visual scale line) indicated a significant improvement (P<0.05) in all elements present in the questionnaire with the 12-month supplementation (no significant variations in controls). Oxidative stress was comparable in both groups at inclusion. It was significantly decreased with Pycnogenol(®) (-28.07%; P<0.05) at 12 months; there was no decrease in controls. The short blessed test (SBT) value was significantly increased in controls (P<0.05); but significantly decreased in the Pycnogenol(®) group (P<0.05). Values for supplemented patients at 12 months were almost within the normal range (21 out or 38 were below the normal value of 4). Tolerability and compliance for Pycnogenol(®) were optimal with >97% of the doses of the supplement correctly used. No side effects were observed, recorded or described. CONCLUSION: Pycnogenol(®) supplementation for 12 months appears to improve cognitive function and oxidative stress in normal subjects between 55 and 70 years of age.

Management of functional, hepatic damage after chemotherapy with Liverubin (pharma-standard silymarin).

Mild, temporary hepatic failure (MTHF) after chemotherapy is a common clinical problem; in case of repeated episodes MTHF may cause chronic impairment. This registry has evaluated post- chemotherapy (PC)-MTHF in subjects using Liverubin (standardized Silymarin) for 8 weeks (3 capsules/day). METHODS: PC-MTHF was evaluated in a registry study. Hepatitis markers were negative at inclusion and at end-registry. In the final registry there were results concerning 18 Liverubin-supplemented patients and 19 controls completing the 8-week period. Signs/symptoms. The distribution of the most common symptoms and signs with ultrasound scans were comparable. Symptoms were mostly minimal or subclinical. Most symptoms observed at inclusion were completely disappeared or greatly attenuated after 8 weeks. The improvement produced by Liverubin induced a better and faster disappearance of symptoms. The results of the blood tests (at inclusion and at 8 weeks showed the increase in albumin, significantly (P<0.05) faster with the final values higher in the supplement group. Total bilirubin was reduced with the supplement better than in controls (P<0.05). Direct bilirubin values improved more in the supplement (P<0.05) group. The decrease in SGPT and AST-ASAT was more evident with the supplement (P<0.05). Improvement in controls was more limited. Alkaline phosphatase was significantly lower (than in controls) with Liverubin at 8 weeks (p<0.05). Gamma GT also decreased more and faster with the supplement. The ESR (erythrocytes sedimentation rate) was decreased in both groups, more in the Liverubin group (P<0.05). There was a more limited decrease in controls with persisting higher values at 8 weeks. The white cell count was also better at 3 months (with a larger decrease with the supplement; P<0.05). Oxidative stress. Plasma free radicals (PFR) were elevated in both groups at inclusion. A more significant decrease in the supplement group was observed at 8 weeks. Persisting elevation in values was seen in controls (P<0.05). Platelets values improved better with Liverubin (P<0.05). Safety and tolerability were optimal (no side effect was registered). In conclusion, results from this pilot registry indicate a significant activity of Liverubin associated with a very good safety profile, in patients with post-chemotherapy hepatic failure. The recovery of hepatic function is faster and more effective with Liverubin in comparison with the best "standard" management.

Phyto-relief CC: prevention of cold episodes. Control of signs/symptoms and complications.

The aim of this supplement, registry study was to evaluate the effects of the use of standardized, oral supplement (Phyto-Relief CC, Alchem). Phyto-Relief CC includes anti-inflammatory, anti-oxidant and anti- edema natural compounds. Increased salivation produced by ginger is useful in the prevention of cold episodes and on signs and symptoms associated to the episodes by increasing saliva and its content (i.e. lysozyme). Main targets of the study were the evaluation of the occurrence of episodes and the reduction of signs/symptoms, the reduction of days of disease, the reduction in the use of other treatments and the control of cold-related complications. RESULTS: The two resulting registry groups were comparable. There were 5 full episodes (lasting at least 3 days) of cold in 61 registry subjects (8.1%) in comparison with 17 cases in 63 subjects (26.98%) in controls. Phyto-Relief CC subjects - even in this time-limited and small study population registry - had 30.1% of the episodes of the control group with a reduction of 69.88% of the cold episodes (p<0.0221). Also in the following, continuation, third week only 3 episodes of cold were recorded in the Phyto- Relief CC group vs 6 (50% reduction) observed in controls. All the other chosen parameters were better in the supplement group (p<0.05). Affected days (2.9;1.1 vs 4.6; 1.2 in controls), lost working days (0.58;0.5 vs 1.02;0.43 in controls. The use of any other OTC product, nasal drops, aspirin, Vit C, antihistamines, aerosols, the number of complications after 4 days were better in the Phyto-Relief CC group. Disease 'extension' (to >4 days), particularly tracheal and bronchial extension were significantly less frequent (p<0.05) with the supplement. No safety or tolerability problem was observed. In conclusion this preliminary study shows that Phyto-Relief CC may help the evolution of cold if used early, when initial symptoms could be identified. More specific evaluations and larger prevention studies are needed.

Miraqule-C and mild heart failure: an 8-week registry.

The aim of this registry study was the evaluation of possible benefits of a supplement including CoenzymeQ10 and a grape seed combination (MiraQule C, Alchem) in stable, moderate, heart failure patients. RESULTS: The mean age of the 18 supplemented patients was 60.1;2 years (the age of the 22 controls was 61.1;2.2). The two groups were comparable. There were no dropouts in the two groups. In the 8 weeks of the registry, all supplemented patients remained in the NYHA class while 7 out of 22 in controls increased the level of heart failure passing into Class III. Systolic- diastolic pressure, heart rate, respiratory rate were minimally (non significantly lowered) with the supplement without differences controls. Ultrasound-derived ejection fraction was increased by supplementation (median of 2.7%) in the CoQ10 group (p<0.05) while there were minimal, non- significant differences in controls. Walking distance on treadmill was also significantly increased with the supplement (p<0.05) and only marginally in controls. The microcirculation (laser Doppler parameters and transcutaneous PO2, PCO2) improved significantly in the MQ-C group (p<0.05) and only marginally in controls. Oxidative stress was significantly decreased (p<0.05) with the CoQ10 preparation while there were minimal. Non-significant changes were observed in in controls. Tolerability and compliance were optimal (with more than 95% of the capsules correctly used). In conclusion in this supplement registry Miraqule-C seem to help patients with moderate heart failure and should be considered for larger studies.

Hand 'stress' arthritis in young subjects: effects of Flexiqule (pharma-standard Boswellia extract). A preliminary case report.

This case report (supplement registry study) evaluated subjects with painful 'stress' arthritis of the hand mainly localized at the joints. The patients received a suggestion to follow a rehabilitation plan (standard management; SM). A second group also used the same SM in association with the oral, pharma-standard supplement FlexiQule (Alchem) a new standardized, phytosomal preparation manufactured from the Boswellia plant, which can be used for self-management in inflammatory conditions (150 mg / 3 times daily). The two resulting registry groups included 12 subjects using SM+Flexiqule and and 11 controls (SM only). The groups were comparable. Serology showed no significant alterations: only ESR was slightly elevated (minimal elevation). After 2 weeks, the ESR was normal in the supplement group and mildly elevated in controls (p<0.05%). The decrease in hypertermic areas was greater/faster (p<0.05) in the supplement group. The identification of a working stress and the localization to the dominant hand was comparable in both groups. At 2 weeks, the decrease in pain was significantly faster and more important with the supplement (p<0.05). The hand became more usable in time and the score was better with the supplement (p<0.05). No supplemented patient had to use other drugs, while in the control group 3 subjects eventually used NSAIDs to control pain and stiffness and one used corticosteroids. In conclusion, the natural extract Flexiqule was effective in controlling work-related stress arthritis (without inflammaìtory signs) over a 2 weeks period, better than only Standard Management. More prolonged and larger studies are needed.

Supplementary management of functional, hepatic damage with Liverubin (pharma-standard Silymarin). A 3-month registry.

Mild, temporary hepatic failure (MTHF) is a common clinical problem; in case of repeated episodes MTHF may cause chronic liver impairment. This registry has evaluated MTHF in subjects using Liverubin (standardized Silymarin) for 8 weeks. METHODS: MTHF was evaluated in a registry study. In all subjects viral hepatitis markers were negative at inclusion. Different possible causes of MTHF had been considered. In these subjects alcohol was not a main factor. The registry included MTHF patients with decreased albumin levels, increased total bilirubin, altered hepatic function enzymes, increased oxidative stress. Two management groups were created: a standard management (SM) group and a SM+Liverubin group; 32 Liverubin patients and 33 SM subjects completed the registry. Liverubin was used at the dosage of two tablets (each equivalent to 140 mg) daily. RESULTS: Distribution of symptoms, blood test values and ultrasound results were comparable. Symptoms observed at inclusion disappeared at 3 months in both groups. The increase in albumin levels was significantly (P<0.05 at 4 weeks) faster and the final blood tests improved more with Liverubin. Total bilirubin was reduced with the supplement (better than in controls; P<0.05). Direct bilirubin values improved more in the supplement group at 3 months (P<0.05). The decrease of SGPT and AST- ASAT was more evident in the supplement group (P<0.05). Alkaline phosphatase value was normalized at in Liverubin patients; values decreased less in controls (P<0.05). Gamma GT decreased more with Liverubin. ESR was decreased in both groups (significantly more with Liverubin: P<0.05). There was a less important decrease in controls at 3 months. The white cell count was also better with the supplement group; P<0.05). Plasma free radicals - significantly elevated in both groups at inclusion - decreased more with the supplement at 3 months. All other blood tests (including hematocrit, renal function tests) were within the normal range at inclusion and at 3 months in both groups. Hepatitis markers were negative at inclusion and at end-registry. Safety and tolerability were optimal (no side effect was registered). CONCLUSION: In conclusion, data from this pilot, registry study indicate a significant activity of Liverubin associated with a very good safety profile, in patients with temporary hepatic failure. The recovery of hepatic function is faster and more effective with Liverubin compared to the best "standard" management.

Recurrence of retinal vein thrombosis with Pycnogenol® or Aspirin® supplementation: a registry study.

AIM: The aim of this study was to use Pycnogenol® to reduce the recurrence of retinal vein thrombosis (RVT) after a first episode. Pycnogenol® is an anti-inflammatory, anti-edema and an antiplatelet agent with a "mild" antithrombotic activity. The registry, using Pycnogenol® was aimed at reducing the number of repeated episodes of RVT. METHODS: Possible management options--chosen by patients--were: standard management; standard management + oral Aspirin® 100 mg once/day (if there were no tolerability problems before admission); standard management + Pycnogenol® two 50 mg capsules per day (for a total of 100 mg/day). Number of subjects, age, sex, distribution, percentage of smokers, and vision were comparable. RESULTS: Recurrent RVT was seen in 17.39% of controls and in 3.56% of subjects supplemented with Pycnogenol® (P<0.05 vs. controls). There was RVT in 15.38% of the subjects using Aspirin®. The incidence of RVT was 4.88 times higher with standard management in comparison with the supplement group and 4.32 lower with Pycnogenol® supplementation in comparison with Aspirin®. Vision level was better with Pycnogenol® (20/25 at nine months; P<0.05). With Pycnogenol®, edema at the retinal level was also significantly reduced compared to the other groups. Pycnogenol® has a very good safety profile. In the Aspirin® group 26 completed 9 months and 6 subjects dropped out for tolerability problems. In the Aspirin® group, 2 minor, subclinical, retinal, hemorrhagic episodes during the follow-up were observed (2 subjects out of 26, equivalent to 7.69%). This pilot registry indicates that Pycnogenol® seems to reduce the recurrence of RVT without side effects. It does not induce new hemorrhagic episodes that may be theoretically linked to the use of Aspirin® (or other antiplatelets). CONCLUSION: Larger studies should be planned involving a wider range of conditions, diseases and risk factors associated to RVT and to its recurrence.

Effects of Pycnogenol® on endothelial dysfunction in borderline hypertensive, hyperlipidemic, and hyperglycemic individuals: the borderline study.

AIM: This registry study aimed to evaluate the effects of supplementation with pycnogenol on altered endothelial function (EF) in borderline hypertensive, hyperlipidemic and hyperglycemic subjects without atherosclerotic changes in their main arteries and no coronary artery disease. METHODS: Flow mediated dilatation (FMD) and endothelium-independent (EID) dilatation were measured with brachial ultrasound after occlusion. Also, after occlusion, laser Doppler (LDF) flux and distal straingauge flow were measured. Oxidative stress (oxstress) was evaluated at 8 and 12 weeks. 93 subjects with borderline symptoms were enrolled into the study: 32 hypertensives, 31 hyperlipidemics, 30 hyperglycemics. All participants were instructed to follow the best available management to control their symptoms. In addition to best management, half of the subjects in each group used 150 mg/day Pycnogenol(®). 31 normal subjects were included as control. RESULTS: After 12 weeks metabolic values and blood pressure were back to normal in all subjects. Values were slightly better under Pycnogenol(®). FMD increased after 8 weeks from an average 5.3;3.4% to 8.2;2.2% with a further increase to 8.8;3.1% (P<0.05) at 12 weeks. No effects were found in controls and normal subjects. EID of normal subjects was consistently higher with 26%. LDF skin flux increased with Pycnogenol(®) at 8 weeks and 12 weeks. The final flux increase was not different from normal values. In controls flux after occlusion was not improved at 8 weeks; there was a significant but minor increase at 12 weeks. Flux increases were superior in all Pycnogenol(®) subjects. In Pycnogenol(®) subjects, limb flow after occlusion increased at 8 weeks with a further increase at 12 weeks. In controls inclusion flow after occlusion was comparable at 8 and 12 weeks. Oxidative stress was significantly decreased in Pycnogenol(®) subjects at 8 and 12 weeks. Minor differences were observed in controls. CONCLUSION: This open registry study indicates that Pycnogenol(®) improves EF in preclinical, borderline subjects in a macro-microcirculatory model. This observation may suggest an important preventive possibility for borderline hypertensive, hyperglycemic and hyperlipidemic subjects.