Types of biomaterials useful in brain repair.

Biomaterials is an emerging field in the study of brain tissue engineering and repair or neurogenesis. The fabrication of biomaterials that can replicate the mechanical and viscoelastic features required by the brain, including the poroviscoelastic responses, force dissipation, and solute diffusivity are essential to be mapped from the macro to the nanoscale level under physiological conditions in order for us to gain an effective treatment for neurodegenerative diseases. This research topic has identified a critical study gap that must be addressed, and that is to source suitable biomaterials and/or create reliable brain-tissue-like biomaterials. This chapter will define and discuss the various types of biomaterials, their structures, and their function-properties features which would enable the development of next-generation biomaterials useful in brain repair.

Subjective Evaluation of the Results of Injectable Hyaluronic Acid Fillers for the Face.

BACKGROUND: Skin ageing is a physiological process, progressive and irreversible. Hyaluronic acid injection treatments are used to correct the signs of skin ageing. MATERIAL AND METHODS: Hyaluronic acid was implanted in the area of the cheek and the forehead aesthetic units in 57 women, aged 35-55 years. Apart from the clinical observation, self-assessment of the therapeutic results was conducted. The "My skin" questionnaire was used for subjective evaluation of the treatment results. RESULTS: Mean wrinkle score in the pre-menopausal group changed after the treatment, from 3.2±0.6 to 1.1±0.3 and from 3.2±0.6 to 0.8±0.6 for the forehead and the cheek esthetic units, respectively. In the post-menopausal group, the score decreased from 3.8±0.4 to 1.7± 0.7 and from 3.2±0.617 to 0.8± 0.6 for the forehead and the cheek esthetic units, respectively. The changes were age-dependent. Improved appearance of the facial skin - higher satisfaction with skin tone and scent - was reported after hyaluronic acid injections. Higher subjective perception of improvement corresponded to older age, irrespectively of the menopausal status. Correlations between age and the effect of the treatment on maintaining proper skin hydration as well as between improved appearance of the forehead area and feelings of autonomy and well-being were found. CONCLUSION: Hyaluronic acid injections significantly improved the subjective perception and overall assessment of the scent and appearance of the facial skin.

Efficient weapon for protracted warfare to malaria: A chondroitin sulfate derivates-containing injectable, ultra-long-lasting meshy-gel system.

Progress at elimination of malaria is limited by the challenges of reaching large rural population and ensuring patient adherence to adequate pharmacologic treatment. In the present study, a novel material (octadecylamine modified chondroitin sulfate) was synthesized, to fabricate a long acting release meshy gel system as an efficient weapon for protracted warfare to malaria. Ivermectin loaded meshy gels (IVM-MG) composed of different amount of phospholipids, triglyceride and modified chondroitin sulfate were formulated. They were in aqueous state with low viscosity before injection, but rapidly turned into gel state with significantly increased viscosity upon exposure to an aqueous environment after injection. In vitro study proved a sustained released effect in different releasing media. In vivo study showed no irritation at injection site and slowly drug release over a 30-day release period in rat model. Among the three IVM-MG formulations, IVM-MG-3 with the highest amount of octadecylamine modified chondroitin sulfate presented the highest viscosity increase after solution-gel transition, the least initial burst release, and the longest sustained release effect over 30 days in rat model. Furthermore, by using mathematical models, IVM-MG system could boost the efficacy of mass drug administration toward malaria elimination goals. Meshy gel systems for long-acting drug delivery have the potential to revolutionize treatment options for malaria and other diseases of which treatment adherence is essential for their efficacy.

New technology and practice of dust pollution control with foam jet in underground mines.

Foam is used as an efficient means of dust suppression in underground coal mines. The poor performance of conventional adding device of foaming agent restricts its wide application. The objective of this study is to propose and investigate a new parallel jet adding device (PJAD). Experimental results show that PJAD requires a greater water flow to produce negative pressure than the single stage jet adding device (SJAD) and is harder to generate cavitation. PJAD consumes a less pressure loss than SJAD and realizes any adding proportion below 1%, which is especially suitable for precision addition of foaming agent. A foaming system used for dust suppression is put forward with PJAD adding foaming agent. Field application indicates that foam achieves a far better dust suppression effect than the roadheader water spraying, and the foam cost is significantly reduced due to the low adding proportion of foaming agent. The marked dust suppression effect makes us believe that the proposed PJAD will greatly promote the large-scale application of foam technology used for dust suppression in underground coal mines.

Rheology of hyaluronic acid and dynamic facial rejuvenation: Topographical specificities.

Sound knowledge of the rheology of hyaluronic acids is fundamental for facial rejuvenation procedures. Hyaluronic acid implants are subjected to complex mechanical forces within the facial tissues that vary depending on the anatomical region. Analysis of these forces is important to establish the rheological specifications of hyaluronic acid implants in each specific zone. This approach will optimize the correction of age-related loss of volume, since the filler will be chosen as a function of the mechanics of the anatomical zone, with the objective to respect facial dynamics.

Using a New Photo Scale to Compare Product Integration of Different Hyaluronan-Based Fillers After Injection in Human Ex Vivo Skin.

BACKGROUND: The rheological properties of HA products have been investigated thoroughly, and these properties have been used to predict the clinical performance of HA fillers. It has been suggested that firm gels have a better ability to withstand deformation, and softer gels have been claimed to integrate and spread more into the tissue since they are perceived to deform more easily. However, the scientific published data regarding product integration of filler products with different physicochemical properties is limited. Thus, there is a need to improve the understanding regarding links between rheological properties of the gel material and the clinical performance. OBJECTIVE: The objectives of this study were: to develop and validate a photo scale for assessment of product distribution after intradermal injection, and to evaluate if product differences, such as overall rheological properties, gel particle size, swelling factor, and cohesivity effect the product distribution into the tissue after intradermal injections. MATERIAL AND METHODS: Intradermal injections of HA fillers were performed in ex vivo human abdominal skin samples. The skin samples were processed for histological evaluation. In order to evaluate the product integration after intradermal injection and compare the results between different products a 5-grade product integration scale (from 0 to 4) was developed based on representative microphotographs. The scale was validated and used for the evaluation of integration of the different products used in the study. The results were correlated with the rheological properties of the different products. RESULTS: G', the elastic modulus, is one important rheological parameter. Strong and firm gels have higher G' than weak and soft gels. When plotting the G' to mean product integration score in human skin obtained in the study, there was a statistically significant correlation with products with lowest G' having the highest integration score and products with high G' having the lowest integration scores. No statistical correlation could be seen when analyzing the score versus particle size, swelling factor, and cohesivity. CONCLUSION: The degree of product integration can be assessed and scored according to a 5-grade visual scale based on representative microphotographs. Products with different rheological properties distribute differently when injected into the skin. Firmer gel texture resulted in more targeted product integration whiles softer gel texture resulted in distributed product integration. J Drugs Dermatol. 2018;17(9):982-986.

A Single Site, Open Label Clinical Trial, Evaluating the Duration, Efficacy, and Safety of a Novel Lip Plumper.

INTRODUCTION: Lip plumpers are topical agents that offer immediate, but temporary, volumization of the lips. While these products are becoming increasingly popular and are available at multiple retailers, there is a lack of clinical studies to evaluate the efficacy, longevity, and safety of the lip plumping products. METHODS: This is a prospective, single center, clinical trial to evaluate the duration, efficacy, and safety of a lip plumping agent in two clinical visits. Lip volume and adverse event were assessed by two clinicians at various time points: 15 minutes, 1 hour, 2 hours, 3 hours, and 4 hours. RESULTS: Twenty-two subjects were enrolled in the study, and eighteen completed the study. Investigator assessments of global improvement 15 minutes after application of the lip plumping product demonstrated improvement in lip fullness in 100% of the subjects (18/18), and 1 hour post-application 67% (12/18) showed an improvement in lip fullness that was statistically significant compared to the 2-hour assessment (P less than 0.05). Subject evaluations noted improvement in lip fullness 15 minutes post-application in 94.4% (17/18) of subjects, and 1 hour post-application, 89% (16/18) of the subjects who completed the trial noted some improvement in the volume of their lips that was statistically significant compared to the 2-hour post-application time point (P less than 0.0001). Subjects noted that they did experience a tingling and heat sensation, but a majority noted that that this sensation lasted less than 15 minutes. DISCUSSION: Our study demonstrated that the lip plumping product increased lip volume in almost all patients 15 minutes post-application and showed a continued improvement in lip fullness per investigator assessments 1 hour after application. Adverse events of a tingling or heat sensation were expected and observed as the topical product contained capsaicin, cinnamon, and menthol, all of which can induce this sensation by the release of substance P. J Drugs Dermatol. 2018;17(9):999-1004.

Facial Volumetric Structural Rejuvenation: A Natural Approach to Restoring Youthfulness and Preventing Aging.

When rejuvenating the face with soft tissue fillers, one must consider its structural framework, and patient specific goals/needs holistically to achieve natural results.

Descemet membrane endothelial keratoplasty using ophthalmic viscoelastic devices for eyes with laser iridotomy-induced corneal endothelial decompensation: Analysis of 11 eyes.

Graft insertion into the anterior chamber is one of the most important procedures for successful Descemet membrane endothelial keratoplasty (DMEK). Especially in eyes with fragile zonular fibers and a shallow anterior chamber, smooth graft insertion tends to become more difficult. Ophthalmic viscoelastic devices (OVDs) can usually help to retain the space in the anterior chamber and to improve the safety of manipulations during various ophthalmic surgeries. Therefore, we postulated that graft insertion into the anterior chamber could be improved by their use. The purpose of this study is to investigate the availability and efficacy of OVDs during graft insertion in DMEK surgery.A total of 11 eyes of 9 patients with bullous keratopathy who underwent DMEK were retrospectively analyzed. The cause of bullous keratopathy was corneal endothelial decompensation following laser iridotomy in all eyes. We used low viscous dispersive OVD (Opegan) to maintain the anterior chamber depth during graft insertion in all of the eyes.The graft insertion was uneventful in all of the eyes. The inserted graft was attached to the back surface of the cornea. However, 2 eyes needed rebubbling, and after rebubbling, all of the 2 grafts completely attached to the back surface of the cornea. The best spectacle-corrected visual acuity significantly improved 6 months after surgery (P < .001) and the central corneal thickness significantly decreased (P < .001).The use of OVD facilitates safer graft insertion during DMEK, and subsequently prevents endothelial cell loss, which leads to a successful procedure.

Outcomes of viscocanalostomy and phaco-viscocanalostomy in patients with advanced glaucoma.

PURPOSE: To determine the medium-term outcomes for patients with advanced glaucoma undergoing viscocanalostomy. METHODS: All patients with advanced glaucoma (mean deviation (MD) - 12.00 dB or above) and patients with poor visual acuity secondary to advanced glaucoma which precluded formal visual field assessment undergoing viscocanalostomy (VC) and phaco-viscocanalostomy between 2010 and 2014 under the care of a single surgical team were included. Intraocular pressure (IOP), visual acuity (VA) and visual field outcomes were assessed from data prospectively collected into a surgical outcome database. Success was defined at two IOP cut-off points: IOP ≤ 21 and ≤ 16 mmHg with (qualified) or without (complete) medications. RESULTS: One hundred thirty-five patients were included. Mean IOP changed from 23.6 ± 6.4 mmHg pre-operatively to 15.3, 15.8 and 14.8 mmHg at 1, 2 and 3 years, a change of 35, 33.5 and 39% respectively. Qualified success for an IOP ≤ 21 mmHg was achieved in 95.66, 90.6 and 80% and complete success in 52.5, 48.6 and 30.6% at year 1, 2 and 3. Qualified success for an IOP ≤ 16 mmHg was achieved in 66.6, 66.05 and 60% and complete success in 44.8, 37.6 and 30.6% at year 1, 2 and 3. The cumulative probability for achieving an IOP ≤ 21 mmHg with or without drops was 86.1, 81.4 and 81.4% at 12, 24 and 36 months. Eleven patients (8.1%) failed to achieve adequate IOP control and needed further surgical intervention. Eleven (8.1%) patients needed an intervention (Yag goniopuncture) following VC. Four patients (2.9%) had some post-operative complications, which resolved within 2 weeks following surgery. Nine patients (6.7%) lost more than 2 Snellen lines. There was no significant change in the MD across time points. CONCLUSION: Viscocanalostomy and viscocanalostomy combined with phacoemulsification is a safe and effective method of controlling IOP in the medium term in patients with advanced glaucoma.

The efficacy of Viscocanalostomies and combined phacoemulsification with Viscocanalostomies in the treatment of patients with glaucoma: a non-randomised observational study.

BACKGROUND: To evaluate the outcomes of Viscocanalostomy (VC) and Phacoviscocanalostomy (PV) in controlling primary and secondary glaucoma in a large cohort of patients from a single eye unit and performed by a single surgeon. METHODS: This non-randomised, retrospective study was conducted on 620 eyes of 458 patients. All patients who had either viscocanalostomy (VC) or combined phacoemulsification and viscocanalostomy (PV) over a three-year period were included. Intraocular pressures (IOP), number of anti-glaucoma medications used, and any complications were recorded over a 3-year follow up period. Paired T-Test was used to compare preoperative and post-operative IOP at specified time points. Kaplan-Meier survival models were used to determine success rates over the study period. RESULTS: Six hundred twenty procedures were performed during the 3-year study period, of which 427 were PV and 193 VC. The mean follow-up was 31.8 months. Overall complete success (IOP ≤ 21 mmHg, without medication) at 3 years was achieved in 65.7% of patients, with qualified success (IOP ≤21 mmHg with or without medication) achieved in 96.0%. Subgroup analysis showed complete success rate of 76.0% for PV and 63.1% for VC (p = 0.005), with qualified success 95.9% for PV and 94.0% for VC (p = 0.668). Mean pre-operative IOP (mmHg) for all procedures was 23.02 ± 5.6, with PV and VC subgroups at 22.54 ± 5.10 and 24.06 ± 6.45. Post-operatively IOP at month 12 and 36 was 14.74 ± 3.57 and 14.40 ± 3.17 respectively for all procedures, 14.62 ± 3.26 and 14.44 ± 3.10 for PV, and 15.03 ± 4.18 and 14.31 ± 3.33 for VC. Across all procedures, pre-operatively an average of 3.05 ± 0.96 anti-glaucoma medications were used. This reduced to 0.13 ± 0.39 in 12 months and 0.38 + 0.71 by 36 months. Sixty-five cases had complications due to trabeculo-Descemet window perforation during viscocanalostomy with 7 cases developing complications from the cataract element. In the 12.9% of patients who had complications there were no differences of IOP noted at 3 years. CONCLUSION: VC and PV have good IOP lowering capacity and are both effective at sustaining a reduction in IOP at 3 years. PV achieved a higher success rate without medication. The low complication profile with reduced post-operative care means these procedures may be a preferred option for early surgical intervention.

Viscoelastic Tamponade Applied to the Ocular Surface for Enhanced Control of Gaseous Egress From the Anterior Chamber During Final Bubble Titration in DMEK Surgery: The "Polite" Burp.

PURPOSE: To present a novel technique for enhancing the surgeon's control over the volume of air or gas that is "burped" from the anterior chamber during final bubble and intraocular pressure (IOP) titration in Descemet membrane endothelial keratoplasty. METHODS: After ascertaining that the intracameral bubble is either too large and/or has rendered IOP too high, a bead of ophthalmic viscoelastic is applied to the ocular surface over a paracentesis incision, which is then depressed in the usual fashion to burp gas from the anterior chamber. RESULTS: The weight and viscosity of the viscoelastic create a tamponade that slows the egress of gas from the anterior chamber, thereby making it more controllable. CONCLUSIONS: If the bubble size or IOP needs to be reduced at the conclusion of the Descemet membrane endothelial keratoplasty procedure, application of ophthalmic viscoelastic over the paracentesis can enhance the surgeon's control over the volume of gas burped from the anterior chamber, thereby reducing the tendency to swing between a bubble that is too large or too small.

Severe Intraocular Pressure Elevation After Intracameral Healon 5 Viscoelastic Support for Postoperative Hypotony After XEN Gel Stent Insertion.

PURPOSE: The purpose of this article was to describe (i) a novel case of severe intraocular pressure (IOP) elevation due to intracameral Healon 5 for management of early postoperative (post-op) hypotony following XEN Gel Stent insertion and (ii) the management of this complication. MATERIALS AND METHODS: A case report. RESULTS: A 52-year-old man, with primary open-angle glaucoma and suboptimal left IOP control on maximally tolerated medical therapy, was managed with XEN Gel Stent insertion at another tertiary eye unit. Post-op, the IOP was 2 mm Hg with a shallow anterior chamber (AC) and choroidal effusions. Intracameral injections of Provisc on post-op days 1 and 3 failed to reverse hypotony. At 1 week post-op, persistent clinically significant hypotony was managed with Healon 5 injection into the AC. Twelve hours later, the patient experienced significant pain and reduced vision and presented to a different tertiary eye unit, where left visual acuity was hand movements, IOP was 70 mm Hg with a deep AC (complete ophthalmic viscosurgical device fill with Healon 5) and a flat drainage bleb with no external drainage. Emergency AC washout of the Healon 5 was performed with resolution of symptoms, visual acuity, and IOP control. CONCLUSIONS: We caution against the use of intracameral Healon 5 in the management of post-op hypotony following XEN Gel Stent insertion, given the potential risk for extreme IOP elevation and sight loss.

Hydroimplantation versus viscoimplantation: comparison of intraocular lens implantation with and without ophthalmic viscoelastic device in phacoemulsification.

Purpose: To compare the efficacy and safety of intraocular lens implantation with and without ophthalmic viscoelastic device in phacoemulsification. Methods: A randomized prospective study was conducted on 84 eyes of 84 patients who underwent uneventful phacoemulsification by the same surgeon. Patients were divided into two groups after the completion of lens cortex removal. Intraocular lens implantation was performed with balanced salt solution irrigation in group H (n=42, hydroimplantation) and with ophthalmic viscoelastic device in group V (n=42, viscoimplantation). The main outcomes measured were postoperative changes of intraocular pressure (IOP), central corneal thickness (CCT), mean absolute refractive error, time of surgery, and the frequency of complications. Patients were evaluated 1 day, 1 week, and 1 month postoperatively. Results: There was no significant difference in mean age, gender, preoperative IOP and preoperative CCT between the two groups. IOP and CCT were not significantly different 1 day, 1 week, and 1 month postoperatively between the two groups. Mean absolute refractive error was also not significantly different between the two groups. Time of surgery was significantly lower in group H than in group V (953.81 ± 88.33 seconds, 1072.33 ± 172.16 seconds, respectively, p<0.001). No other complications were observed during the intraocular lens implantation in the two groups. Conclusions: Hydroimplantation technique is safe and effective in phacoemulsification. Furthermore, reduced time of surgery and reduced cost of ophthalmic viscoelastic devices are the advantages of this technique. Abbreviations: OVDs = ophthalmic viscosurgical devices; IOP = intraocular pressure; MARE = mean absolute refractive error; CCT = central corneal thickness; CDE = cumulative dissipated energy; AL = axial length; ACD = anterior chamber depth; ACM = anterior chamber maintainer; ECCE = extracapsular cataract extraction.

Dynamic mechanical behaviour of nanoparticle loaded biodegradable PVA films for vaginal drug delivery.

In this study, we investigated the viscoelastic and mechanical behaviour of polyvinyl alcohol films formulated along with carrageenan, plasticizing agents (polyethylene glycol and glycerol), and when loaded with nanoparticles as a model for potential applications as microbicides. The storage modulus, loss modulus and glass transition temperature were determined using a dynamic mechanical analyzer. Films fabricated from 2% to 5% polyvinyl alcohol containing 3 mg or 5 mg of fluorescently labeled nanoparticles were evaluated. The storage modulus and loss modulus values of blank films were shown to be higher than the nanoparticle-loaded films. Glass transition temperature determined using the storage modulus, and loss modulus was between 40-50℃ and 35-40℃, respectively. The tensile properties evaluated showed that 2% polyvinyl alcohol films were more elastic but less resistant to breaking compared to 5% polyvinyl alcohol films (2% films break around 1 N load and 5% films break around 7 N load). To our knowledge, this is the first study to evaluate the influence of nanoparticle and film composition on the physico-mechanical properties of polymeric films for vaginal drug delivery.

Remnant extraction by using an intraocular lens injector with essential flow.

PURPOSE: To describe a new technique for remnant removal in cases of posterior capsular rupture during cataract surgery and Soemmering ring extraction during intraocular lens (IOL) removal. METHODS: An IOL injector, inserted into the anterior chamber, provides a new exit for residual lens fragments. Passive fluid flow, supplied by an anterior chamber maintainer or some ocular viscoelastic device (OVD) injection, delivers the residual fragments into a lumen of the injector in assistance with a second device such as a phaco-chopper and vitreous cutter. RESULTS: Soemmering rings can be removed safely through small incisions even when under the iris. Nucleus fragments in anterior chamber can be removed safely. Fragments that fall into the vitreous cavity can float up for removal by passive flow. CONCLUSIONS: This new technique, remnant extraction through lens injector with essential flow, has several practical advantages over existing methods including reduced OVD injection and smaller incision size. It may offer an alternative to existing methods of remnant removal in cases of posterior capsular rupture during cataract surgery and Soemmering ring extraction.

VISCOELASTIC ASSISTED DRAINAGE OF SUPRACHOROIDAL HEMORRHAGE ASSOCIATED WITH SETON DEVICE IN GLAUCOMA FILTERING SURGERY.

PURPOSE: The purpose of this article is to describe a novel surgical technique for the management of large suprachoroidal hemorrhages associated with the insertion of glaucoma seton devices. METHODS: In this interventional case series, the authors describe six eyes of six patients who had management of suprachoroidal hemorrhage with pars plana choroidal drainage along with simultaneous insertion of viscoelastic into the posterior segment. All patients had a median of 8-month postoperative follow-up. RESULTS: Five of the 6 patients had useful final vision ranging from 20/40 to 20/200. In all cases, the postoperative intraocular pressures did not increase beyond 28 mmHg and responded to aqueous humor suppressants. CONCLUSION: As suprachoroidal hemorrhage can be a devastating complication of glaucoma surgery, the authors report a relatively straightforward surgical technique that can restore ambulatory vision in a high proportion of patients.

Informe técnico de evaluación de tecnologías para el dispositivo médico de implante de Hilano GF-20 / Technology evaluation technical report for the HF-20 implant medical device

INTRODUCCIÓN: El presente informe está referido al Requerimiento de la Red Asistencial Arequipa de Especificaciones Técnicas de Implante de Hilano GF 20 y desbloqueo de Código SAP. ANTECEDENTES: -Resolución de Presidencia Ejecutiva Nº 152-PE-ESSALUD-2015, de fecha 23 de febrero del 2015, el Reglamento de Organización y Funciones del Instituto de Evaluación de Tecnologías en Salud e Investigación (IETSI); -Con Carta Nº 1028-G-RAAR-ESSALUD-2016, de fecha 11 de Abril del 2016, el Gerente Red Asistencial Arequipa - EsSalud, solicita a IETSI (Instituto de Evaluación de Tecnologías en Salud e Investigación), Especificaciones Técnicas de Implante de Hilano y desbloqueo de Código SAP. METODOLOGIA: Fuente Primaria: Los usuarios (Jefes del Servicio de Ortopedia y traumatología), han remitido su requerimiento para solicitar las especificaciones técnicas del implante Hilano GF20, por medio de carta Nº 1028-G-RAAR-ESSALUD-2016, de fecha 11 de Abril del 2016, por cuanto indican: Que en viscosuplementación está recomendada en las guías de tratamiento de Osteoartritis de las principales instituciones internacionales; Que el viscosuplemento de mayor similitud al líquido sinovial normal; Ha demostrado ser eficaz en diversos grados de steoartritis; Ha demostrado disminuir el dolor y mejorar la función articular en pacientes con osteoartritis Grado II y III; Ha demostrado retrasar la necesidad de reemplazo total de rodilla en una mediana de 2,1 años; En tratamiento de osteoartritis significó un ahorro de costos por paciente de 33% en el primer año, 10% y 9% en el segundo y tercer año. Asimismo se menciona como sustento técnico del requerimiento las Guías de Instituciones internacionales: OARSI (Osteoarthritis Research Society International), Guías de consenso de expertos basados en la evidencia del año 2007,y guías mexicanas de tratamiento de osteoartritis Rev. 2013, en las cuales se detalla que el uso de Hilano se encuentra en controversia. Búsqueda de Información: Se realizó una revisión sistemática de la evidencia científica sobre la eficacia, seguridad, efectividad relacionado al implante de Hilano. Se consultaron las siguientes bases de datos electrónicas: MEDLINE y PreMedline (1950-abril 2013), EMBASE (1980-abril 2013), PsycInfo (1887- abril 2013), CINAHL (1982- abril 2013), Cochrane Library (1982- abril 2013) y Centre for Reviews & Dissemination (1973- abril 2013). El análisis bibliográfico se complementó con consultas manuales, web de organizaciones y agencias de evaluaciones nacionales e internacionales. CONCLUSIONES: Una intervención debe primero mostrar tener un beneficio clínico, y el mejor comparador para mostrar esto sería el placebo, con el fin de identificar la magnitud del efecto sobre la respuesta al placebo. Solo si se prueba un efecto sobre placebo, se deben considerar la evidencia de sus comparaciones con otros tratamientos activos Los estudios que han evaluado la eficacia de Hilano GF20 relativo a placebo o suero salino, sugieren que Hilano GF20 reduce el dolor medido con las escalas de WOMAC hasta los tres meses, pero es semejante al placebo cuando el dolor es medido con la escala VAS a los tres y 6 meses. Además, después de tres meses, las reducciones importantes en el dolor se mostraron cuando se utilizaron múltiples inyecciones, pero este efecto no fue demostrado para inyecciones únicas y siempre que el dolor fuera medido con las escalas de WOMAC. Nuevamente, tras un periodo de tres meses, Hilano GF 20 y placebo fueron similares en su efecto en el dolor medido con la escala VAS. El probable efecto de Hilano GF 20 sobre el dolor no es consistente en función a la escala utilizada para medir el dolor de la articulación. La calidad de la evidencia que respalda estos probables efectos de beneficio de Hilano GF20 es de calidad baja o muy baja, lo cual implica que la confianza en los resultados es baja. El verdadero valor del efecto puede ser sustancialmente diferente al presentado, de realizarse estudios de adecuado diseño y conducción. El bloqueo de este Dispositivo se realiza hasta que se demuestre el costo-beneficio y beneficio clínico que representa a la Institución.