«Hyalgel» – a new and effective way to treat osteoarthrosis

Osteoarthrosis – a heterogeneous group of diseases of various etiology, characterized by degeneration of the articular cartilage and following changes of subchondral bone, synovial fluid and synovial membrane, ligaments, capsule and periarticular muscles. Additional terms being used are:  osteoarthritis, arthrosis, arthritis, degenerative joint disease. They all mean the same condition.

Actuality of developing new pharmaceutical drugs for an effective treatment of osteoarthritis is caused by the fact that this pathology is the most wide-spread form of articular pathology. Besides that osteoarthritis becomes one of the most wide-spread diseases in the present-day society. Late diagnostics and ineffective therapy deteriorates the well-being of patients, rising of the temporary unemployment and early disability of the people of capable age.

Today the combined use of antiphlogistic medicine, chondroprotectors and intra-articular injections of Sodium Hyaluronate is counted to be the most effective. Non-steroidal, antiphlogistic and analgesic medicine treatment is administered during the period of intensification of illness. It is directed on pain relief and amyctic of articular and tissues around it. In these cases doctors usually administer non-steroidal antiphlogistic medicine like Diclofenac, Ibuprofen, Indometacin, etc. It is necessary to mention the possibility of strong negative side-effects of such drugs on the organism as well as their low effect on treating osteoarthrosis.

Chondroprotectors represent the medical drugs, which improve the structure of cartilage. Intake of those drugs slows down the progress of osteoarthrosis, strengthens the cartilage tissue. The most effective of those are chondroitin sulfate and glucosamine. Long usage of those drugs improves the condition of musculoskeletal system as a whole.

Use of intra-articular injections of hyaluronate-based drugs such as Ostenil, Synocrom and Durolane is called to fill up the lack of Sodium Hyaluronate in synovial fluid. That can slow down the evolution of osteoarthrosis and remove the pain syndrome. But just for one course there are about 3-6 injections needed and the patient needs to undergo 1-3 courses per one year. We must mention that those injections (as it is counted by most specialists) almost do not have any anti-inflammatory properties. Besides that, there are a lot of articulations which are not so easy to hit directly. In case of any mistake, it will not make any harm but will result in wasting an expensive medicine, taking into account that each injection costs about one hundred USD.

It is not difficult to understand that all the above-mentioned drugs have a number of deficiencies as side-effects, incompatibility of medicine, high price, low therapeutic effect, etc. Russian scientists considered the whole experience of treating osteoarthrosis and achievements of modern pharmacology and developed a fundamentally new medicine for an effective treatment of osteoarthrosis. This innovative medicine is produced in a gel form to be used externally. Its trade name is “Hyalgel”, gel 4 g №4, manufactured by: LLC Research and Production Company “AS-KOM”, Moscow.

 “Ostenil” and “Synocrom” are very similar to “Hyalgel” in terms of action and effect.  However, unlike them, “Hyalgel” does not require intra-articular injections, has no side-effects, and possesses pronounced anti-inflammatory and regenerative properties. Besides that, “Hyalgel” is significantly cheaper than these drugs.

“Hyalgel” consists of biologically active substances of herbal and animal origin: Sodium Hyaluronate, Chondroitin sulphate, Boswellia extract. These active substances are widely known to have been successfully used in the treatment of arthrotropic diseases. Gel based “Hyalgel” consists of an aquacomplex of titanium glycerol-solvate (“Tisolium”).  As a metal-complex compound, “Tisolium” possesses anti-inflammatory properties. The presence of glycerin bonded molecules and of a titanium atom provide protective, anti-edematous and locally acting analgesic action, as well as having a positive effect on synovial fluid composition. However, the unique key property of “Tisolium” is the ability to penetrate through the skin, mucous membrane and even bone tissue at a depth of 7cm.  “Tisolium” delivers its drug substance to the abnormal focus avoiding destruction of the substance and fully releasing it. It forms stable complexes along with the other active components of “Hyalgel”, retaining all their medical properties. Since transcutaneous conduction exceeds 4cm, about 70% of “Hyalgel” active substances are able to penetrate through the joint capsule into the cavity of any synovial articulation. Therefore, they saturate the joints tissue and synovial fluid.

When “Hyalgel” is applied externally on the sore joint, within the next few hours it penetrates into the joint through subcutaneous tissue where, step by step, it starts to release active substances from complexes, formed by “Tisolium”. Sodium Hyaluronate, released inside the joint cavity, fully improves synovial fluid, restoring its lubricity and impact absorption function.  “Hyalgel” also causes a positive effect on cartilage tissues, restoring their normal structure and composition.  The fundamental point is the fact that “Hyalgel” contains pharmaceutical high-molecular Sodium Hyaluronate with normalized molecular weight of 1100 kDa.

Boswellia extract, introduced into adjacent tissue and the joint itself, provides massive anti-inflammatory and sedative effect in the joint and its surrounding tissues. Chondroitin sulfate starts to implement its chondroprotective and regenerative functions in cartilage tissue.   In addition to that “Tisolium” also provides anti-inflammatory, anti-edematous and local analgesic action. It should be particularly emphasized that the gradually released active substances almost do not possess transcutaneous conduction properties. These substances continuously remain in the abnormal focus, providing the desired therapeutic effect for various arthrotropic diseases. Just 2-3 hours after external application of “Hyalgel” on the sore joint - a complex process starts not only to eliminate manifestations of osteoarthrosis, but also its causes such as inflammatory conditions, cartilage tissue degradation, and the loss of normal synovial fluid properties. The gel form of “Hyalgel” precludes accumulation of fluid in tissues and, unlike lipids of fatty ointments and emulsions, protects the tissue from desiccation and edema, and enhances its oxygenation.

None of the existing drugs on the pharmaceutical market have such comprehensive therapeutic effect as the “Hyalgel” when applied with minimum amount at the simplest method.

 “Hyalgel” is a unique new generation Sodium Hyaluronate-based medicinal drug which has no equals. Optimally selected ratio of active substances is making “Hyalgel” effective and safe for the treatment of osteoarthrosis and other arthrotropic related diseases when applied externally without using injections or undergoing special physiotherapeutic procedures. One tube of 4g of “Hyalgel” is sufficient enough for the complete treatment of the large synovial joint.

Let us briefly present the results of stage II knee-joint osteoarthrosis treatment.

Material and methods

About 65 patients aged from 39 to 68, who had verified stage II knee-joint osteoarthrosis, had been tested during the clinical efficacy research of “Hyalgel” application. “Hyalgel” treatment regimen consisted of 2 courses of 4 tubes each with 12 days interval between courses. Each course consisted of 4 single application treatments of “Hyalgel”, with each treatment being administered in intervals of 36-48 hour and applied direct to the skin around the area of the knee joint. One “Hyalgel” tube of 4g was evenly applied in a thin layer (of no more than 0.2mm) on the skin surface around the knee-joint area. Prior to the gel application, the knee-joint area of the skin was cleaned and moistened with the 10% water-alcohol solution.  After the application, the “Hyalgel” had lasted on the skin no less than 12 hours. The treatment was administered as a monotherapy on an outpatient basis.

Results and discussion

One of the therapy evaluations of using “Hyalgel” as a knee-joint osteoarthrosis treatment was carried out in accordance with VAS (visual analogue scale) immediately after the completion of the 2nd course of the therapy (after 1 and 6 months respectively).

Pain evaluation scale by VAS (mean values) during “Hyalgel” application

Index	Initially before treatment	After 2 days	After 1 month	After 6 months
VAS day (mm)	61.7	28.1	27.6	31.8

Overall treatment efficacy evaluation of using “Hyalgel” was the following: in 38.5% of cases the therapy effect was evaluated by a physician as “significantly better”; in 58.4% - as “better”; in 3.1% - as “no change”; “deterioration” – none. In 42.5% of cases the result of the gel application was evaluated by patients as “significantly better”; in 56.0% - as “better”; in 1.5% - as “no effect”; as “deterioration” – none.

Obtained results have shown the high potency of “Hyalgel” in the treatment of osteoarthrosis in the knee-joint. It also reduces the intensity of the pain syndrome, improves joint function, reverses secondary synovitis, reduces the need for NSAIDs, and improves the well-being of patients. “Hyalgel” has proven to have an anti-inflammatory effect and to normalize the composition of the synovial fluid. According to the arthrosonography data, “Hyalgel” significantly inhibits the rate of joint space narrowing, and the destruction process of the articulate cartilage. No side effects have been revealed during the administration of “Hyalgel”. 

Conclusions

The simplicity of administration, high potency, therapeutic effect complexity, drug safety and low cost - compared to Sodium Hyaluronate-based synovial fluid implants, conclude that “Hyalgel” is the new modern treatment for osteoarthrosis. “Hyalgel” is recommended to be widely used in treatment practice of osteoarthrosis (stages I – III), as well as other joint related diseases. 

General Distributor on the territory of the Russian Federation and the CIS: Group of Companies “MedVeyv”