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Double-blind, randomised controlled trial on the efficacy of saline nasal irrigation with sodium hyaluronate after endoscopic sinus surgery.
Mozzanica, F, Preti, A, Gera, R, Bulgheroni, C, Cardella, A, Albera, A, Collurà, F, Mevio, N, Dragonetti, A, Schindler, A, et al
The Journal of laryngology and otology. 2019;(4):300-308
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Abstract
OBJECTIVE There is a growing interest in sodium hyaluronate for the clinical management of patients who undergo functional endoscopic sinus surgery for chronic rhinosinusitis, because of the mucosal regenerative properties of this macromolecule. However, its role in post-operative care is still debated. This study aimed to evaluate the effect of sodium hyaluronate administered via nasal irrigation with saline, in the post-operative period, after functional endoscopic sinus surgery. METHODS A multicentric, prospective, randomised, double-blind, parallel group study was conducted on 56 consecutive patients who underwent functional endoscopic sinus surgery for chronic rhinosinusitis without polyps. Group 1 received the standard therapy of normal saline; group 2 received saline plus sodium hyaluronate. RESULTS Both objective and subjective measurements, in terms of endoscopic appearance and patient-reported satisfaction, were significantly better in group 2 compared to group 1. CONCLUSION Sodium hyaluronate may be a useful adjunct to nasal saline irrigation in the early post-operative period following functional endoscopic sinus surgery.
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Effectiveness of intra-articular injections of sodium hyaluronate-chondroitin sulfate in knee osteoarthritis: a multicenter prospective study.
Rivera, F, Bertignone, L, Grandi, G, Camisassa, R, Comaschi, G, Trentini, D, Zanone, M, Teppex, G, Vasario, G, Fortina, G
Journal of orthopaedics and traumatology : official journal of the Italian Society of Orthopaedics and Traumatology. 2016;(1):27-33
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Abstract
BACKGROUND Intra-articular injection of hyaluronic acid is a well-established therapy for the treatment of knee osteoarthritis. The aim of the study was to assess the effectiveness and safety of the use of Arthrum HCS(®) (40 mg hyaluronic acid and 40 mg chondroitin sulfate in 2 mL). MATERIALS AND METHODS This was an open, multicenter, prospective study. Men or women over 40 years of age with documented knee osteoarthritis and WOMAC subscore A (severity of pain) ≥25 were enrolled. They received three weekly intra-articular injections of sodium hyaluronate 2 % and chondroitin sulfate 2 % in combination. WOMAC subscore A was assessed at 1, 3 and 6 months after the last injection. RESULTS One hundred and twelve patients were included (women, 66 %). The mean (SD) WOMAC subscore A decreased from 52.1 (15.2) at inclusion to 20.5 (19.7) at month 6 (P < 0.0001). The mean subscore was already significantly decreased 1 month after the last injection at 25.7 (P < 0.0001). Pain relief and consumption of analgesic drugs, both assessed with visual analogic scale (VAS), consistently decreased. The investigators were satisfied/very satisfied as regards the therapeutic effectiveness of sodium hyaluronate-chondroitin sulfate in reducing pain (77 %), improving mobility (78 %) and reducing the consumption of analgesics (74 %). Only one adverse effect was reported by one patient (knee tumefaction). CONCLUSION These results suggest that intra-articular injections of Arthrum HCS(®) (sodium hyaluronate plus chondroitin sulfate) in patients with knee osteoarthritis are efficient and safe. These results should be confirmed in a randomized controlled study. LEVEL OF EVIDENCE IV.
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Effect of a hyaluronic acid and carboxymethylcellulose ophthalmic solution on ocular comfort and tear-film instability after cataract surgery.
Mencucci, R, Boccalini, C, Caputo, R, Favuzza, E
Journal of cataract and refractive surgery. 2015;(8):1699-704
Abstract
PURPOSE To evaluate the efficacy and safety of using sodium hyaluronate 0.1% and carboxymethylcellulose 0.5% artificial tears for ocular discomfort and tear-film stability in eyes after cataract surgery. SETTING Twenty ophthalmic centers in Italy. DESIGN Prospective randomized case series. METHODS This study enrolled patients scheduled for unilateral cataract surgery. After surgery, patients received artificial tears and a topical steroid-antibiotic (study group) or topical steroid-antibiotic alone (control group) and were assessed postoperatively at 1 and 5 weeks. Outcome measures were tear breakup time (TBUT), ocular surface disease index (OSDI), frequency of dry-eye symptoms evaluated using a visual analog scale (VAS), and corneal fluorescein staining. RESULTS The study comprised 282 patients. At 5 weeks, the mean TBUT was statistically significantly higher in the study group than in the control group (P = .0003). The mean OSDI score statistically significantly improved in both groups from 1 to 5 weeks (P < .0001 for both groups); however, there was no statistically significant difference between the groups at these timepoints. The artificial tears statistically significantly improved VAS-assessed dry-eye symptoms in the study group compared with the control group at 5 weeks (P < .001). The mean corneal fluorescein staining was significantly reduced in the study group compared with the control group at 5 weeks (P = .002 versus P = .05, respectively). No treatment-related adverse events were reported. CONCLUSION Sodium hyaluronate 0.1% and carboxymethylcellulose 0.5% ophthalmic solution was effective and well tolerated in reducing dry-eye disease symptoms and improving the clinical outcome after cataract surgery. FINANCIAL DISCLOSURE No author has a financial or proprietary interest in any material or method mentioned.
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Is intravesical instillation of hyaluronic acid and chondroitin sulfate useful in preventing recurrent bacterial cystitis? A multicenter case control analysis.
Gugliotta, G, Calagna, G, Adile, G, Polito, S, Saitta, S, Speciale, P, Palomba, S, Perino, A, Granese, R, Adile, B
Taiwanese journal of obstetrics & gynecology. 2015;(5):537-40
Abstract
OBJECTIVE Urinary tract infections (UTIs) are common in the female population and, over a lifetime, about half of women have at least one episode of UTI requiring antibiotic therapy. The aim of the current study was to compare two different strategies for preventing recurrent bacterial cystitis: intravesical instillation of hyaluronic acid (HA) plus chondroitin sulfate (CS), and antibiotic prophylaxis with sulfamethoxazole plus trimethoprim. MATERIALS AND METHODS This was a retrospective review of two different cohorts of women affected by recurrent bacterial cystitis. Cases (experimental group) were women who received intravesical instillations of a sterile solution of high concentration of HA + CS in 50 mL water with calcium chloride every week during the 1(st) month and then once monthly for 4 months. The control group included women who received traditional therapy for recurrent cystitis based on daily antibiotic prophylaxis using sulfamethoxazole 200 mg plus trimethoprim 40 mg for 6 weeks. RESULTS Ninety-eight and 76 patients were treated with experimental and control treatments, respectively. At 12 months after treatment, 69 and 109 UTIs were detected in the experimental and control groups, respectively. The proportion of patients free from UTIs was significantly higher in the experimental than in the control group (36.7% vs. 21.0%; p = 0.03). Experimental treatment was well tolerated and none of the patients stopped it. CONCLUSION The intravesical instillation of HA + CS is more effective than long-term antibiotic prophylaxis for preventing recurrent bacterial cystitis.
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PXL01 in sodium hyaluronate for improvement of hand recovery after flexor tendon repair surgery: randomized controlled trial.
Wiig, ME, Dahlin, LB, Fridén, J, Hagberg, L, Larsen, SE, Wiklund, K, Mahlapuu, M
PloS one. 2014;(10):e110735
Abstract
BACKGROUND Postoperative adhesions constitute a substantial clinical problem in hand surgery. Fexor tendon injury and repair result in adhesion formation around the tendon, which restricts the gliding function of the tendon, leading to decreased digit mobility and impaired hand recovery. This study evaluated the efficacy and safety of the peptide PXL01 in preventing adhesions, and correspondingly improving hand function, in flexor tendon repair surgery. METHODS This prospective, randomised, double-blind trial included 138 patients admitted for flexor tendon repair surgery. PXL01 in carrier sodium hyaluronate or placebo was administered around the repaired tendon. Efficacy was assessed by total active motion of the injured finger, tip-to-crease distance, sensory function, tenolysis rate and grip strength, and safety parameters were followed, for 12 months post-surgery. RESULTS The most pronounced difference between the treatment groups was observed at 6 months post-surgery. At this timepoint, the total active motion of the distal finger joint was improved in the PXL01 group (60 vs. 41 degrees for PXL01 vs. placebo group, p = 0.016 in PPAS). The proportion of patients with excellent/good digit mobility was higher in the PXL01 group (61% vs. 38%, p = 0.0499 in PPAS). Consistently, the PXL01 group presented improved tip-to-crease distance (5.0 vs. 15.5 mm for PXL01 vs. placebo group, p = 0.048 in PPAS). Sensory evaluation showed that more patients in the PXL01 group felt the thinnest monofilaments (FAS: 74% vs. 35%, p = 0.021; PPAS 76% vs. 35%, p = 0.016). At 12 months post-surgery, more patients in the placebo group were considered to benefit from tenolysis (30% vs. 12%, p = 0.086 in PPAS). The treatment was safe, well tolerated, and did not increase the rate of tendon rupture. CONCLUSIONS Treatment with PXL01 in sodium hyaluronate improves hand recovery after flexor tendon repair surgery. Further clinical trials are warranted to determine the most efficient dose and health economic benefits. TRIAL REGISTRATION ClinicalTrials.gov NCT01022242; EU Clinical Trials 2009-012703-25.
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Sodium hyaluronate for the treatment of chronic shoulder pain associated with glenohumeral osteoarthritis: a multicenter, randomized, double-blind, placebo-controlled trial.
Kwon, YW, Eisenberg, G, Zuckerman, JD
Journal of shoulder and elbow surgery. 2013;(5):584-94
Abstract
BACKGROUND Nonoperative treatments for glenohumeral osteoarthritis (GH-OA) are limited. Intra-articular therapy with sodium hyaluronate (HA) has been effective in treating OA of the knee. Therefore, we sought to evaluate the efficacy and safety of HA in treating chronic pain associated with GH-OA. METHODS This double-blind, randomized, controlled multicenter trial enrolled 300 patients with GH-OA: 150 received HA and 150 received phosphate-buffered saline (PBS) in 3 weekly injections and were evaluated over 26 weeks. Primary and secondary outcome measurements were visual analog scale (VAS) for pain and the percentage of Outcome Measures in Rheumatoid Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) high responders. RESULTS In HA and PBS intent-to-treat (ITT) patients, there was a mean improvement from baseline in VAS of 19.88 mm and 16.29 mm at week 26, respectively. Similarly, the percentage of OMERACT-OARSI high responders in the HA group was higher (40.8% vs 34.9%); however, neither difference was statistically significant (P = .1121 and P = .0690, respectively). In a subset of patients without concomitant shoulder pathologies, the differences of VAS and OMERACT-OARSI high-responder rates between groups were 4.0 mm and 8.37%, respectively, which reached statistical significance. Safety analyses showed comparable rates of adverse events between groups, and neither group reported serious treatment-related adverse events. CONCLUSIONS A numeric advantage, but without statistical significance, was found for HA ITT patients with GH-OA. Although data for a subset of HA patients without concomitant pathologies reached statistical significance, additional randomized trials are needed to confirm the clinical implication of this outcome.
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Multicenter clinical trial on the performance and tolerability of the Hyaluronic acid-collagenase ointment for the treatment of chronic venous ulcers: a preliminary pilot study.
Gravante, G, Sorge, R, Giordan, N, Georgescu, SR, Morariu, SH, Stoicescu, I, Clatici, V
European review for medical and pharmacological sciences. 2013;(20):2721-7
Abstract
BACKGROUND Bed debridement is important to treat chronic wounds. Effective agents should remove the necrosis but protect the granulation tissue. We evaluated the performance and tolerability of a new composite ointment containing collagenase and hyaluronic acid for chronic venous ulcers. PATIENTS AND METHODS Subjects with class 6 venous ulcers (CEAP classification) of at least 6 months duration were prospectively recruited. The ointment was administered daily and follow-up visits were conducted on the fifth, 10th, 15th and 20th days. On each visit the necrotic area was measured with a grid. The moisture balance, odour, viability of non-necrotic areas and the presence of erythema were also assessed. Primary outcome was the percentage of subjects with complete debridement, secondary outcomes the time to complete healing, reduction of the lesion area, absence of necrotic tissue, presence of odor, erythema, hydration, any adverse events. RESULTS One hundred subjects were enrolled in four centres. All patients achieved complete debridement of the necrotic area and a significant reduction of the total ulcer area by day 20, while other parameters improved significantly over time. Only two patients experienced a transient leg oedema. CONCLUSIONS The combination of collagenase and hyaluronic acid is safe and effective for chronic venous ulcers.
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Dextranomer in stabilized sodium hyaluronate (Solesta®): in adults with faecal incontinence.
Hoy, SM
Drugs. 2012;(12):1671-8
Abstract
Dextranomer in stabilized sodium hyaluronate, hereafter referred to as dextranomer/hyaluronic acid, is a biocompatible bulking agent administered by submucosal injection. It is hypothesized to expand the submucosal layer of the proximal anal canal, thereby augmenting bowel control. Treatment with dextranomer/hyaluronic acid was associated with symptomatic improvements in adult patients with faecal incontinence participating in a randomized, double-blind, sham-controlled, multinational study and a noncomparative, multinational study. In the double-blind study, patients in the dextranomer/hyaluronic acid group met the primary efficacy objective in that a significantly higher proportion of patients responded to treatment (≥50% reduction from baseline in the number of incontinence episodes) at the 6-month post-treatment timepoint than in the sham group (two of three primary response criteria), with the durability of the treatment response (≥25% reduction from baseline in the number of incontinence episodes) confirmed at the 12-month post-treatment timepoint (third primary response criterion). For the most part, dextranomer/hyaluronic acid did not significantly differ from the sham treatment in terms of quality of life and various other symptomatic endpoints at 6 months post-treatment in the double-blind study, although there were significant improvements from baseline in various parameters, such as the mean number of incontinence-free days, the median number of incontinence episodes and mean Faecal Incontinence Quality of Life domain scores, at 12 months post-treatment. In general, dextranomer/hyaluronic acid was well tolerated for up to 18 months post-treatment, with the majority of treatment-related adverse events considered mild or moderate in intensity.
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Gynecologic use of Sepraspray Adhesion Barrier for reduction of adhesion development after laparoscopic myomectomy: a pilot study.
Fossum, GT, Silverberg, KM, Miller, CE, Diamond, MP, Holmdahl, L
Fertility and sterility. 2011;(2):487-91
Abstract
OBJECTIVE To assess the safety and efficacy of Sepraspray Adhesion Barrier (a modified hyaluronic acid and carboxymethylcellulose powder) after laparoscopic surgery, in view of both the high efficacy of Seprafilm Adhesion Barrier in reducing postoperative adhesions after open surgical procedures and the difficulty with laparoscopic delivery. DESIGN Multicenter, randomized, reviewer-blinded trial. SETTING Reproductive endocrinology and infertility clinics. PATIENT(S): Women undergoing laparoscopic myomectomy for indications including infertility. INTERVENTION(S): Randomization to treatment with (n = 21) or without (n = 20) Sepraspray Adhesion Barrier. MAIN OUTCOME MEASURE(S): Postoperative adhesions development was assessed at early second-look laparoscopy. Adhesions were scored using the modified American Fertility Society scoring system. RESULT(S): Surgical procedure duration length was 99 versus 102 minutes in the control versus Sepraspray Adhesion Barrier groups, respectively, with the median number of fibroids removed being two in each group and corresponding fibroid weights of 134 ± 103 versus 113 ± 161 g, respectively. Adhesions scores increased in both the control and Sepraspray Adhesion Barrier groups, with larger although nonstatistically significant increases noted in control subjects when evaluating for the anterior uterus, the posterior uterus, and the entire uterus. CONCLUSION(S): Laparoscopic application of Sepraspray Adhesion Barrier after myomectomy in this pilot study was associated with a trend toward a reduction in postoperative adhesion development, as well as an encouraging safety profile. Further evaluation is warranted. CLINICAL TRIAL NUMBER Sepraspray Adhesion Barrier #NCT00624930.
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The design and protocol of heat-sensitive moxibustion for knee osteoarthritis: a multicenter randomized controlled trial on the rules of selecting moxibustion location.
Chen, R, Chen, M, Kang, M, Xiong, J, Chi, Z, Zhang, B, Fu, Y
BMC complementary and alternative medicine. 2010;:32
Abstract
BACKGROUND Knee osteoarthritis is a major cause of pain and functional limitation. Complementary and alternative medical approaches have been employed to relieve symptoms and to avoid the side effects of conventional medication. Moxibustion has been widely used to treat patients with knee osteoarthritis. Our past researches suggested heat-sensitive moxibustion might be superior to the conventional moxibustion. Our objective is to investigate the effectiveness of heat-sensitive moxibustion compared with conventional moxibustion or conventional drug treatment. METHODS This study consists of a multi-centre (four centers in China), randomised, controlled trial with three parallel arms (A: heat-sensitive moxibustion; B: conventional moxibustion; C: conventional drug group). The moxibustion locations are different from A and B. Group A selects heat-sensitization acupoint from the region consisting of Yin Lingquan(SP9), Yang Lingquan(GB34), Liang Qiu(ST34), and Xue Hai (SP10). Meanwhile, fixed acupoints are used in group B, that is Xi Yan (EX-LE5) and He Ding (EX-LE2). The conventional drug group treats with intra-articular Sodium Hyaluronate injection. The outcome measures above will be assessed before the treatment, the 30 days of the last moxibustion session and 6 months after the last moxibustion session. DISCUSSION This trial will utilize high quality trial methodologies in accordance with CONSORT guidelines. It will provide evidence for the effectiveness of moxibustion as a treatment for moderate and severe knee osteoarthritis. Moreover, the result will clarify the rules of heat-sensitive moxibustion location to improve the therapeutic effect with suspended moxibustion, and propose a new concept and a new theory of moxibustion to guide clinical practices. TRIAL REGISTRATION The trial is registered at Controlled Clinical Trials: ChiCTR-TRC-00000600.