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Three-Arm Randomized Trial of Sodium Alginate for Preventing Radiation-Induced Esophagitis in Locally Advanced Non-Small Cell Lung Cancer Receiving Concurrent Chemoradiotherapy: The OLCSG1401 Study Protocol.
Ninomiya, K, Ichihara, E, Hotta, K, Sone, N, Murakami, T, Harada, D, Oze, I, Kubo, T, Tanaka, H, Kuyama, S, et al
Clinical lung cancer. 2017;(2):245-249
Abstract
Concurrent chemoradiotherapy (CRT) is the standard of care for locally advanced non-small cell lung cancer (LA-NSCLC). However, this intensive therapy often causes severe esophagitis, which could deteriorate a patient's quality of life (QOL), leading to poor treatment compliance. Sodium alginate, approved in Japan for gastritis, is sufficiently highly viscous to remain in the esophageal mucosa, providing a protective effect in the esophagus. To investigate whether this compound has a preventive effect against severe esophagitis in patients receiving concurrent CRT, we plan a 3-arm randomized trial of sodium alginate with 2 different schedules versus water. The primary endpoint is set as the proportion of patients with grade ≥ 3 esophagitis using the Common Terminology Criteria for Adverse Events, version 4.0. With stratification by institute, performance status, and percentage of the esophageal volume receiving >35 Gy, the patients will be randomly assigned to 1 of the following groups: sodium alginate initiated concomitantly with CRT (group A), sodium alginate initiated soon after the development of extremely mild esophagitis during CRT (group B), or water administered throughout CRT (group C). Assuming that the proportion of grade ≥ 3 esophagitis would be 8% in groups A and B and 27% in group C, the required sample size would be 200 patients, with 70% power and 5% α. The secondary endpoints include QOL, the frequency of additional prescriptions of analgesics, treatment response, and survival. The results of the present study will clarify whether sodium alginate can prevent esophagitis in patients with LA-NSCLC undergoing CRT.
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Oligosaccharide nanomedicine of alginate sodium improves therapeutic results of posterior lumbar interbody fusion with cages for degenerative lumbar disease in osteoporosis patients by downregulating serum miR-155.
Qu, Y, Wang, Z, Zhou, H, Kang, M, Dong, R, Zhao, J
International journal of nanomedicine. 2017;:8459-8469
Abstract
Degenerative lumbar disease (DLD) is a significant issue for public health. Posterior lumbar intervertebral fusion with cages (PLIFC) has high-level fusion rate and realignment on DLD. However, there are some complications following the surgery. Alginate oligosaccharides (AOS) have antioxidant and anti-inflammatory activities and may be suitable for infection therapy. MiR-155 is a biomarker associated with inflammatory and oxidative stress. AOS may promote PLIFC therapy by regulating miR-155. Pluronic nanoparticles and oligosaccharide nanomedicine of alginate sodium (ONAS) were prepared with ampicillin at size <200 nm. Ninety-six DLD osteoporosis patients received PLIFC and were evenly assigned into ONAS group (OG, oral administration of 100 mg ONAS daily) and control group (PG, 100 mg pluronic nanoparticles). Serum miR-155 level was measured by real-time quantitative PCR. The levels of superoxide dismutase (SOD), glutathione (GSH), aspartate aminotransaminase (AST), alanine aminotransferase (ALT), interleukin-1β (IL-1β), and interleukin-1 receptor antagonist (IL-1ra) were measured. Weighted mean difference (WMD), relative risk (RR), complications, surgery infection rate, fusion rate, and Japanese Orthopaedic Association (JOA) scores were used to evaluate therapeutic efficacy. After 1-month therapy, infection rates and side effects were lower in OG than those in PG (RR =0.64, 95% confidence interval [CI] [0.48, 0.84], P=0.001). The fusion rates were higher in OG than in PG (WMD =21.96, 95% CI [-0.24, 37.62], P=0.021). The JOA scores were higher in OG than in PG (RR =0.52, 95% CI [0.33, 0.84], P=0.007), and no significant difference was found for the visual analog scale and Oswestry Disability Index. Serum levels of miR-155, ALT, AST, and IL-1β were lower while SOD, GSH, and IL-1ra were higher in OG than in PG. MiR-155 mimic increased the levels of ALT, AST, and IL-1β and reduced the levels of SOD, GSH, and IL-1ra. In contrast, miR-155 inhibitor had reverse results. Therefore, ONAS has better improvement in complications and therapeutic effects on DLD by regulating serum miR-155.
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Treatment of pressure sores in spina bifida patients with calcium alginate and foam dressings.
Ausili, E, Paolucci, V, Triarico, S, Maestrini, C, Murolo, D, Focarelli, B, Rendeli, C
European review for medical and pharmacological sciences. 2013;(12):1642-7
Abstract
STUDY DESIGN Prospective study on local treatment of pressure sores using calcium alginate and foam dressings in spina bifida patients. OBJECTIVE Investigate if this sequential approach is valid and safe for selected patients with neurological impairments. MATERIALS AND METHODS Using European Pressure Ulcer Grading System, after clinical evaluation of local sore, selected patients of Spina Bifida Center of Rome were treated with sequential calcium alginate and foam dressings for 12 weeks. Pressure ulcere surfaces were measured monthly by ulcer tracing. The endpoints were the mean absolute areas surface reduction during every month and number of patients achieving a 50% or more during study. RESULTS 14 patients (7 males aged 12-24 years) with spina bifida and pressure sores were treated. Mean and standard deviation of mean surface area reduction were 12.5 ± 7.5 cm 2 at start of the study versus 3.7 ± 5.2 cm 2 after 12 weeks, p < 0.001. 75% of the patients reached mean surface area reduction of 50% during trial. Dressing tolerance was good in every patient. CONCLUSIONS Calcium alginate and foam dressings are valid and safe approach in the treatment of pressure sores in selected patients with spina bifida. In fact, they protect the wound and create an environment favorable to healing.
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Dose-dependent suppression of hunger by a specific alginate in a low-viscosity drink formulation.
Peters, HP, Koppert, RJ, Boers, HM, Ström, A, Melnikov, SM, Haddeman, E, Schuring, EA, Mela, DJ, Wiseman, SA
Obesity (Silver Spring, Md.). 2011;(6):1171-6
Abstract
Addition of specific types of alginates to drinks can enhance postmeal suppression of hunger, by forming strong gastric gels in the presence of calcium. However, some recent studies have not demonstrated an effect of alginate/calcium on appetite, perhaps because the selected alginates do not produce sufficiently strong gels or because the alginates were not sufficiently hydrated when consumed. Therefore, the objective of the study was to test effects on appetite of a strongly gelling and fully hydrated alginate in an acceptable, low-viscosity drink formulation. In a balanced order crossover design, 23 volunteers consumed a meal replacement drink containing protein and calcium and either 0 (control), 0.6, or 0.8% of a specific high-guluronate alginate. Appetite (six self-report scales) was measured for 5 h postconsumption. Relevant physicochemical properties of the drinks were measured, i.e., product viscosity and strength of gel formed under simulated gastric conditions. Hunger was robustly reduced (20-30% lower area under the curve) with 0.8% alginate (P < 0.001, analysis of covariance), an effect consistent across all appetite scales. Most effects were also significant with 0.6% alginate, and a clear dose-response observed. Gastric gel strength was 1.8 and 3.8 N for the 0.6 and 0.8% alginate drinks, respectively, while product viscosity was acceptable (<0.5 Pa.s at 10 s(-1)). We conclude that strongly gastric-gelling alginates at relatively low concentrations in a low-viscosity drink formulation produced a robust reduction in hunger responses. This and other related studies indicate that the specific alginate source and product matrix critically impacts upon apparent efficacy.
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Sodium Alginate (Gaviscon®) does not reduce apnoeas related to gastro-oesophageal reflux in preterm infants.
Corvaglia, L, Spizzichino, M, Zama, D, Aceti, A, Mariani, E, Legnani, E, Faldella, G
Early human development. 2011;(12):775-8
Abstract
BACKGROUND Apnoea of prematurity (AOP) frequently recurs in preterm infants. We have previously shown that a significant but variable proportion of AOP is induced by gastro-oesophageal reflux (GOR). AIM: The aim of this study is to evaluate the efficacy of sodium alginate in reducing the frequency of GOR-related AOP. SUBJECTS Twenty-eight preterm infants with AOP were studied by a six-hour recording of combined multichannel intraluminal impedance and pH monitoring and polysomnography, including two three-hour postprandial periods: sodium alginate was given after one single meal named as drug-given (DG) meal, while the other as drug-free (DF). RESULTS During 165h of registration, 715 apnoeas were recorded, 368 after-DG and 347 after-DF (p=.99); furthermore, 851 GOR episodes were detected, 315 after-DG and 536 after-DF (p=.001). No differences in the number of AOP were found between DG and DF. A significant reduction in the number of acid GORs and in acid exposure was found during DG, while the administration of sodium alginate didn't influence non-acid GOR indexes. The frequency of GOR-related apnoeas didn't differ between DG and DF. DISCUSSION Sodium alginate doesn't reduce the total number of AOP nor GOR-related apnoeas. On the other hand, it reduces acid GOR features, while it had no effect on non-acid GOR indexes.
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[Preventive effect of polaprezinc suspension dispersed in sodium alginate solution (P-AG) for stomatitis induced by Docetaxel/Cisplatin/Fluorouracil (DCF) chemotherapy in patients with head and neck cancer].
Sugisaki, T, Kawakami, K, Nemoto, M, Kawata, K, Ishibashi, M, Fujiki, Y, Mishima, Y, Yokoyama, M, Takahashi, S, Hatake, K, et al
Gan to kagaku ryoho. Cancer & chemotherapy. 2011;(5):783-7
Abstract
We measured the effectiveness of the prophylactic administration of a polaprezinc suspension dispersed in sodium alginate solution (P-AG) by dividing it into two courses in the same patients, and measured the stomatitis induced by Docetaxel/Cisplatin/Fluorouracil (DCF) chemotherapy. We then evaluated the results. We defined the therapeutic course as the course where P-AG was given therapeutically for stomatitis induced after DCF chemotherapy. We defined the prophylactic course as when P-AG was prophylactically given before any incidences of stomatitis after the therapeutic course. We compared the incidences of stomatitis in the prophylactic courses with those of the therapeutic courses. The incidences of stomatitis that were higher than Grade 1 were 17 out of 17 patients (100%) in the therapeutic course. On the other hand, they were 15 out of 17 patients (88. 2%) in the prophylactic course. Compared with the mean of the Grade of Stomatitis by the Common Terminology Criteria for Adverse Events version 3. 0 (CTCAE v. 3. 0), the maximal Grade of stomatitis significantly decreased in the prophylactic courses compared to those of the therapeutic courses(p<0. 05). Therefore, these results suggested that we were able to decrease the severity of stomatitis by using P-AG prophylactically, as opposed to using P-AG therapeutically.
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In vivo imaging of intragastric gelation and its effect on satiety in humans.
Hoad, CL, Rayment, P, Spiller, RC, Marciani, L, Alonso, Bde C, Traynor, C, Mela, DJ, Peters, HP, Gowland, PA
The Journal of nutrition. 2004;(9):2293-300
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Abstract
Previous studies indicated that physical characteristics of food influence satiety, but the relative importance of the oral, gastric, and intestinal behaviors of the food is unclear. The aim of this study was to investigate the satiating effects of 2 types of alginates, which gel weakly or strongly on exposure to acid, compared with guar gum whose viscosity is unaffected by acid. Subjects (n = 12; 3 men, 9 women) ingested a 325-mL sweetened, milk-based meal replacer beverage on 4 separate occasions, either alone as a control or including 1% by weight alginate or guar gum. Intragastric gelling, gastric emptying, and meal dilution were assessed by serial MRI while satiety was recorded for 4 h. MR images showed that all of the meals became heterogeneous in the stomach except for guar, which remained homogeneous. The alginate meals formed lumps in the stomach, with the strong-gelling alginate producing the largest volume. Although gastric emptying was similar for all 4 meals, the sense of fullness at the same gastric volume was significantly greater for all 3 viscous meals than for the control. Compared with the control meal, the strong-gelling alginate (P = 0.031) and guar (P = 0.041) meals increased fullness at 115 min, and the strong-gelling alginate decreased hunger by the 115-min (P = 0.041) and 240-min (P = 0.041) time points. Agents that gel on contact with acid may be useful additions to weight-reducing diets. We hypothesize that this effect is due to distension in the gastric antrum and/or altered transport of nutrients to the small intestine in the lumps.
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Evaluation of two calcium alginate dressings in the management of venous ulcers.
Limová, M
Ostomy/wound management. 2003;(9):26-33
Abstract
Calcium alginate dressings facilitate the management of highly exudating wounds such as venous ulcers. To evaluate and compare the performance of two calcium alginate dressings in the management of venous ulcers, a prospective, randomized, controlled clinical study was conducted among 19 outpatients at two wound clinics in California. Ten patients (53%) were treated with Alginate A and nine patients (47%) with Alginate B. Dressings were changed weekly and patients were followed for a maximum of 6 weeks or until the venous ulcer no longer required the use of an alginate dressing. At each dressing change, the wound was assessed and dressing performance evaluated. Absorbency of exudate, patient comfort during wear, ease of removal, adherence to wound bed, dressing residue following initial irrigation, patient comfort during removal, ease of application, and conformability were assessed. Patients using Alginate A experienced significantly less foul odor (P = 0.02) and less denuded skin (P = 0.04) than Alginate B at follow-up wound assessments. With the exception of conformability, Alginate A was rated significantly better than Alginate B (P less than or equal to 0.05) in all dressing performance assessments. No significant healing differences were observed. As the different performance characteristics of various calcium alginate dressings become more obvious in clinical practice, further study is warranted to determine their optimal effectiveness.
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Efficacy and tolerance of calcium alginate versus vaseline gauze dressings in the treatment of diabetic foot lesions.
Lalau, JD, Bresson, R, Charpentier, P, Coliche, V, Erlher, S, Ha Van, G, Magalon, G, Martini, J, Moreau, Y, Pradines, S, et al
Diabetes & metabolism. 2002;(3):223-9
Abstract
BACKGROUND The study aimed at comparing the efficacy and tolerance of an alginate wound dressing with a vaseline gauze dressing in the treatment of diabetic foot lesions. METHODS This open-label randomized multicenter controlled study was designed to assess the effect of an up to 6-week treatment with either calcium alginate or vaseline gauze dressings. Lesions were either acute or chronic, under cleansing, and with a surface area of 1-50 cm(2); osteomyelitis and severe hypovascularization were non-inclusion criteria. Dressings were changed every day then, once granulation had occurred, every 2 to 3 days. Primary outcome was the proportion of patients with granulation tissue over 75% of the wound area and having a 40% decrease in wound surface area; secondary outcomes were pain on dressing changes, the number of dressing changes, and adverse events. RESULTS Seventy-seven patients were enrolled. Due to the premature cessation of treatment in 13 patients, it was decided to reduce the period of the efficacy analysis to 4 weeks (without revising the criteria of efficacy). The success rate was of 42.8% in the calcium alginate group and of 28.5% in the vaseline gauze group (not significant difference). A subsequent analysis of granulation tissue surfaces covering the wounds at week 4 (all surfaces taken together) showed a superiority of calcium alginate (p=0.04). Pain on dressing change was lower in the calcium alginate group (p=0.047) and the total number of dressing changes tended also to be lower (p=0.07). Adverse events, which occurred 4 times in the calcium alginate group and 6 times in the other, were judged independent of the treatments. CONCLUSIONS As compared with vaseline gauze, calcium alginate appears to be more appropriate for topical treatment of diabetic foot lesions in terms of both healing and tolerance.