Pycnogenol® supplementation to relieve symptoms after hemorrhoidectomy.

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.

Positive effects of Pycnogenol®-Centellicum® on venous elasticity: an ex-vivo concept study.

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.

Centella asiatica (Centellicum®) facilitates the regular healing of surgical scars in subjects at high risk of keloids.

BACKGROUND: Formation of scars after surgical incisions requires the proper appositions of elements contributing to the scarring process. The structural rebuilding of damaged tissues is essential in producing a linear scar. The excess of blood, foreign particles, exuberant sutures, necrotic tissue, possible infective agents, as well as the ongoing inflammatory process may produce a non-linear, sometimes painful keloidal scar. Centella asiatica (CA) extracts have been used topically since ancient times for preventing keloids (i.e. after extensive burns) and for other applications including ulcer healing. The aim of this registry study was to evaluate the effect of supplementation with Centellicum® (Horphag Research Ltd.) on the healing of surgical wounds in subjects with previous hypertrophic or keloid scars, and to identify with ultrasound the collagen components of the scar in order to assess the quality (or linearity) of surgical wounds. METHODS: Subjects with history of hypertrophic scars or keloid following previous surgery were included in this registry. Short term antibiotic prophylaxis was used as per surgical standards with cephalosporins for three days maximum after surgery. Only patients receiving abdominal or knee surgery were included. A total of 129 patients were included: 64 in the control group treated only with standard management, and 65 in the active treatment group where CA supplementation with Centellicum® was used at the dose of two 225 mg capsules/day from the 2nd to 6th week after surgery. RESULTS: A total of 64 scars were analyzed within the control group and 65 in the supplement group. The tolerability to Centellicum® was overall good, and no side effects were reported. Compliance to treatment was optimal, with >98% of the CA capsules correctly used. The ultrasound-assessed scar tissue regularity was on average lower in controls than in supplemented subjects (P<0.05). Scars also appeared to be significantly more homogeneous in CA patients than in controls. CONCLUSIONS: Supplementation with Centellicum® is safe and does not interfere with other concomitant treatments. It is well tolerated and compliance to treatment is optimal.

Postpartum Varicose Veins: Supplementation with Pycnogenol or Elastic Compression-A 12-Month Follow-Up.

This open registry aimed to evaluate the clinical evolution of postpartum varicose veins (VVs), in healthy women after the second pregnancy, how these veins regain shape and competence, and possible treatments. The registry included two groups of women: (1) those who used elastic compression stockings, and (2) who used an oral venotonic agent (Pycnogenol, 100 mg/d). A total of 12 evaluation targets were established. Minor symptoms were scored in an analogue scale line. A visual analogue scale line evaluated the overall satisfaction relative to elastic compression or Pycnogenol. Overall 133 women completed the registry evaluation with at least 3 months of follow-up. The resulting two registry groups were comparable. At 3 and 6 months in the Pycnogenol group the number of veins and incompetent sites were lower. At 6 months there were 13.3% of patients with edema in controls versus 3.2% in the Pycnogenol group. Spider veins decreased in Pycnogenol patients. Cramps and other minor symptoms were less common in the Pycnogenol group. In both groups there was a significant improvement at 6 months with better results in the Pycnogenol group. The need for treatment was limited with a decreased need for sclerotherapy, surgery, and conservative treatments in the Pycnogenol group. The overall satisfaction was higher among Pycnogenol patients, and compliance was optimal. Re-evaluation at 12 months indicated that the variations in VVs and spider vein clusters and the associated symptoms did not change. Most remodeling appeared to happen within 6 months after the pregnancy. It was concluded that the use of Pycnogenol improves signs/symptoms of postpartum VVs, and venous function and shape seem to return faster to prepartum, physiological pattern with its use.

Superficial venous incompetence: low-cost outpatient minisurgery, sclerotherapy and combined procedure as a management plan. Costs and efficacy. A 20-year, follow-up registry.

BACKGROUND: This registry study evaluated low-cost outpatient surgery (mini-S) for venous insufficiency as an alternative to stripping. METHODS: This 20-year follow-up is focused on the recurrence of varices and on the long-term efficacy of the mini-S (group 1) in comparison with controls (2, stripping), sclerotherapy (3) or a combination of mini-S+sclerotherapy (4). Costs were compared. RESULTS: At 20-years of follow-up, considering recurrence/development of new varicose veins, 24.05% of the limbs treated with mini-S developed new varices in comparison with 64.4% in group 2, 24.1% in group 3 and 15.4% in group 4 (P<0.05). New surgical procedures were needed in 18.9% of mini-S patients vs. 58.5% in group 2, 21.9% in group 3 and 19.7% in group 4 (P<0.05 between group 2 and the other groups). Sclerotherapy (in the years following the initial treatment) was used in 37.9% of mini-S patients in comparison with 67.7% of subjects in group 2 patients, 33.1% in group 3 and 22.8% in group 4 (P<0.05 between outpatient treatment and group 2). The superficial venous system was incompetent in 21% of mini-S patients in comparison with 38.8% in group 2 (P<0.05), 20.7% in group 3 and 17.9% of group 4. At 20 years edema was present in 10.5% of limbs in group 2 in comparison with a <3% (range 2.2-2.1%) in the other groups. Edema was more significant after stripping. Ambulatory venous pressure measurements in subgroups was lower in groups 1, 3 and 4 with a lower refilling time (P<0.05). The cost of in-hospital, daily surgical treatments were €1978 (covered by the heathcare provider). The cost of mini-S was on average €488 per limb (covered by patients). CONCLUSIONS: Outpatients procedures, in particular the mini-S management plan, were cheaper than stripping and more effective at 20-years follow-up. They could be a model for emerging contries with restricted budgets for vein surgery. Also being cheaper more people may have benefits from treatment when/where hospital procedures are not covered by an healthcare provider.

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

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

Lymphatic tissue transplant in lymphedema--a minimally invasive, outpatient, surgical method: a 10-year follow-up pilot study.

Lymphedema is mainly characterized by swelling, fibrosis, and non-pitting edema. The aim of this study was evaluation of the long-term (10 years) effects of autologous lymphatic tissue implant in lymphedema. Lymphatic tissue from 9 patients (harvested form the same patient in areas not affected by lymphedema) was reimplanted into the affected limb, and these patients were followed for 10 years. Lymph nodes were harvested at the neck, axillary, or inguinal space (contralateral limb). Results showed that limb volume was decreased in the treatment group vs. controls. In ultrasound, black, low density, lymphatic spaces were visible in 100% of patients at inclusion but in only 23% of these subjects at 10 years. Thus, this early report proposes a new, minimally invasive method to improve lymphedema. Studies in progress will indicate the role of lymphatic transplant in the management of lymphedema and the best indications for this method.