Study of the effectiveness of the drug Chondroguard (chondroitin sulfate) in patients with osteoarthritis

Introduction

Osteoarthritis (OA) is a degenerative-dystrophic disease of the joints, the cause of which is damage to the cartilage tissue of the articular surfaces with the subsequent addition of an inflammatory reaction [1].
OA occurs in more than 70% of patients aged 60–65 years [2]. The pathological process primarily affects the knee and hip joints, which significantly worsens the quality of life and leads to disability, especially in the elderly. Representing a serious socio-economic problem, the disease is one of the main causes of permanent disability. According to EULAR (The European League Against Rheumatism) (2003), the risk of disability due to knee OA is equal to the risk associated with heart disease. OA is in 4th place among the main causes of disability in women and in 8th place in men [3]. OA is based on an imbalance between anabolic and catabolic processes in joint tissues and hyaline cartilage. The slowly progressive course of the disease leads to a gradual decrease in the volume of hyaline cartilage until it is completely lost. Inflammation of the synovial membrane, bone remodeling and the formation of subchondral sclerosis, the formation of osteophytes and subchondral cysts, and fibrosis of the joint capsule appear. Inflammation is of paramount importance in the development and progression of OA. Inflammation results in pain [4].

Treatment of OA involves influencing all possible stages of pathogenesis. The complex of measures taken depends on the severity of the pain syndrome, the nature of the inflammatory phenomena, functional failure and concomitant pathology. To influence the symptoms of OA during periods of exacerbation, non-steroidal anti-inflammatory drugs (NSAIDs) are used [6, 7]. However, the use of this group of drugs is limited due to the negative impact on the gastrointestinal tract. The generally accepted treatment regimen is the minimum effective dose of NSAIDs [7, 8]. The main goals of OA therapy are pain relief, slowing the progression of the degenerative-dystrophic process, preventing damage to intact joints, reducing the risk of exacerbation and preventing side effects of pharmacotherapy.

For the symptomatic treatment of OA, a group of the most studied, evidence-based slow-acting drugs has been identified, containing natural components of the cartilaginous intercellular substance - glucosamine and chondroitin sulfate (CS) [3, 5]. CS refers to specific drugs that are characterized by a slow development of symptom-modifying action, a pronounced aftereffect within 4–8 weeks. and more and have potential structure-modifying (chondroprotective) properties. The high-molecular mucopolysaccharide CS affects metabolic processes in hyaline cartilage, helps reduce degenerative changes in joint cartilage, accelerates regeneration processes, and stimulates the synthesis of proteoglycans. CS accumulates mainly in the cartilage tissue of joints. The synovial membrane is not an obstacle to the penetration of the drug into the joint cavity [9]. The maximum effect of cholesterol occurs with the initial signs of damage to the articular apparatus, however, the drug also acts during the development of the clinical picture of OA, slowing down the progression of the process. The inclusion of cholesterol in complex therapy allows you to reduce the dose of NSAIDs and shorten the duration of taking analgesics [5]. The release form of most CS drugs is intended for oral use, but their bioavailability is significantly lower than the bioavailability of drugs for intramuscular administration.

Materials and research methods

Of the 422 patients included in the study since 2012, 276 women and 146 men aged 45–78 years with primary knee OA of Kellgren–Lawrence stages II (79%) and III (21%) required treatment. NSAIDs. The duration of the disease was from 3 months. up to 20 years. The average is 6 years. The duration of the last exacerbation is from 1 to 12 weeks. The average is 5 weeks. In 40% of patients, the most severe symptoms of damage to the left knee joint were observed, in 60% of patients - to the right.

Before the start and during the subsequent study, 295 patients (70%) took NSAIDs, 127 (30%) did not.

The study did not include patients with operations on the knee joints, those who had undergone intra-articular administration of various drugs over the past 6 months, those receiving glucocorticoids, or physiotherapeutic treatment. The use of NSAIDs that the patient was taking at the start of the study was allowed.

The drug Chondrogard was prescribed in a dose of 1 ml (100 mg) after 1 day (the first 3 injections), the 4th and subsequent injections - 2 ml (200 mg). A total of 30 intramuscular injections were performed over 2 months.

The study to study the effectiveness of the drug Chondrogard included 4 visits: V1 – screening and initiation of therapy, V2 – 2 weeks. from the start of therapy, V3 (telephone contact with the patient) – 1 month. from the start of therapy, V4 – 2 months. (end of therapy). During the 1st visit, compliance with the criteria for inclusion in the study program was assessed, and exclusion criteria were identified. The patient's card was filled out and 1 dose of the drug Chondrogard was administered. Patients who took chondroprotectors and stopped taking them for at least 6 months were allowed to participate in the study. before inclusion in the program. During the 2nd and 4th visits, adverse events were recorded and the patient's chart was filled out. During the period between the 2nd and 4th visits, telephone contact was made, adverse events were identified, drug tolerability was assessed, and patient compliance with the study protocol was confirmed.

Selection criteria for the research program:

men and women aged 45 to 70 years;
established diagnosis of primary tibiofemoral OA according to the criteria of the American Rheumatological Association;
pain when walking a distance of 40 m on a visual analogue scale (VAS);
OA stage II or III according to Kellgren – Lawrence;
need to take NSAIDs (taken within 30 days over the last 3 months).

Criteria for exclusion from the research program:

secondary gonarthrosis, infectious arthritis, systemic inflammatory diseases of the joints, gout, pseudogout, Paget's disease, intra-articular fractures, ochronosis, acromegaly, hemochromatosis, Wilson's disease, primary chondromatosis;
intra-articular administration of any drugs for 6 weeks. before the start of the study;
chondrocalcinosis;
aseptic necrosis of the condyles of the femur and tibia;
surgery on the knee joint;
known hypersensitivity to cholesterol;
severe concomitant cardiovascular and endocrine diseases;
peptic ulcer of the stomach and duodenum during the last month;
bleeding and tendency to bleed;
history of thrombophlebitis;
pregnancy;
lactation period.

Performance indicators:

dynamics of the WOMAC index (pain, stiffness and functional impairment) in % relative to the initial visit;
walking time at a distance of 15 m;
need for NSAIDs.

The effectiveness of therapy was assessed by the doctor and the patient.

Criteria for excluding patients from the study:

ineffectiveness of therapy for the underlying disease;
persistence or intensification of pain requiring changes in therapy;
serious adverse events;
patient refusal to participate in the study;
violations of the research protocol.

Pain syndrome was assessed using the VAS scale. Assessment of pain syndrome using this scale is convenient in outpatient settings. Moderate pain (2 points) was experienced by 103 (24.4%) patients, severe pain (3 points) – by 79 (18.7%) patients.

All patients were prescribed standard drug therapy, which included NSAIDs, B vitamins, and an optimal motor regimen was recommended.

Results and discussion

The study established good tolerability of the drug Chondroguard. No adverse reactions, either general or local (at injection sites), were noted. The criteria for the effectiveness of the drug in the treatment of OA were the absence of pain and changes in its intensity.

Taking into account the distinctive features of chondroprotective drugs (the time for the onset of effect is 2–8 weeks after the start of use), the analysis of the study was carried out within the appropriate time frame. The use of the drug Chondrogard led to a significant improvement in the patients’ condition: on the 14th day, pain was relieved in 50% of cases, on the 60th day – in 68.7% (Table 1).

To assess the effectiveness of the treatment, the WOMAC index and VAS scale were studied. It should be noted that the study of the material using surveys was partly subjective. When studying the indicators of the WOMAC index, slightly different data were obtained than when analyzing the indicators of the VAS scale. The WOMAC index reflects the physical condition, in contrast to the VAS index, which characterizes the physical and mental health of patients.

The total severity of pain in all observed patients on the VAS scale at the beginning of the study was estimated at 364 mm, after 1 week. after the start of the study - 344 mm (decrease relative to the initial visit - 5.5%), after 1 month. – 260 mm (28.6%), at the end of the study – 178 mm (51.1%).

The total amount of morning stiffness at the beginning of the study was 234 mm, after 1 week. – 230 mm (decrease relative to the initial visit – 1.7%), after 1 month. – 198 mm (15.4%), at the end of the study – 142 mm (39.3%).

The average time to travel a distance of 15 m at the beginning of the study was 11.6 s, after 1 week. – 11.6 s (no changes compared to primary indicators), after 1 month. – 11.2 (decrease relative to the initial visit – 3.4%), at the end of the study – 10.1 s (12.9%).

Total assessment of the degree of functional impairment: at the beginning of the study – 1680 mm, after 1 week. – 1626 mm (decrease compared to the 1st visit – 3.2%), after 1 month. – 1390 mm (17.3%), at the end of the study – 1034 mm (38.5%).

Dynamics of WOMAC index indicators: at the beginning of the study – 2282 mm, after 1 week. – 2116 mm (positive dynamics – 7.28%), after 1 month. – 1848 mm (19.02%), at the end of the study – 1354 mm (40.67%) (Fig. 1).

In all cases of NSAID use, the duration of their use was no more than 14 days. Adverse events were observed in the form of hyperemia at the injection site - 24 cases (5.7% of the total number of patients). This condition was quickly relieved after local treatment and was due to the specific administration of the drug. Heartburn, noted in 6 cases (1.4% of the total number of patients), was temporary and was relieved after diet correction. Nausea, detected in 4 cases (1% of the total number of patients), was relieved without the use of medications. All patients who took part in the study program successfully completed the full course of treatment.

Subjective assessment of the effectiveness of the drug Chondrogard (CS) by patients is as follows: “satisfactory” - in 146 cases (34.6%), “good” - in 277 cases (65.7%).

Conclusion

The study revealed the clinical effectiveness of the drug Chondrogard (CH), which has a symptom-modifying effect in patients with OA, as evidenced by the indicators of pain relief, reduction of stiffness, improvement of the function of the affected joints and the total WOMAC index. It was noted that the severity of the effect increased throughout the entire study period, reaching a maximum at the end of 2 months. after starting to use the drug.

When studying the effectiveness of therapy, the high safety indicator of the drug and the absence of serious side effects were confirmed. Detected adverse events in most cases were caused by the method of administration of the drug and were stopped without consequences.

These studies allow us to recommend Chondroguard (CH) as a reliably effective drug in everyday clinical practice for the treatment of patients with OA in a day hospital and outpatient setting.

HONDROGUARD (solution)

remember yourself more and more often.
I could raise my left arm every other day. Not long ago, my dad was hospitalized with pneumonia. In order to exclude the possibility of infection, and the deadline for the next study was approaching, I underwent FOG. They didn’t give me the FOG results, but sent me for further examination. It turned out that the doctor discovered problems with the clavicular-humeral joint. They were so serious that it became noticeable on fluorography. They diagnosed arthrosis. The neurologist prescribed Amelotex for muscle relaxation and pain relief, and also recommended taking chondroprotectors. I know from myself that now I would definitely forget to take the pills on time, so I asked to be prescribed chondroprotectors in the form of injections. She prescribed me a solution in the form of injections "Chondroguard".

On the box you can find information about the composition. The main component here is sodium chondroitin sulfate. This is the substance that restores cartilage tissue. The drug should be stored at room temperature; I carried it in my bag.

The expiration date is stamped on the box. It's hard to see. Advice to the manufacturer is to print this information. The shelf life of Chondrogard is 2 years. Not very big. However, the entire package is used at once.

The box contains 2 blisters of 5 ampoules. Each blister is sealed. It's convenient, the ampoules don't fall out.

The drug "Chondroguard" has small but clear instructions. This drug is prescribed for osteochondrosis to improve joint mobility and restore cartilage tissue.

The drug has no major contraindications. The only thing is that you should not use it during the growth of the body (children), as well as pregnant and lactating women. Then, through breast milk and the mother’s bloodstream, excess substances can reach the baby, which will lead to improper formation of the skeleton and cartilage tissue.

Take Chondrogard in a course of up to 30 injections. I was prescribed 10 intramuscular injections. The drug is effective for 48 hours, which is why it is prescribed every other day.

Chondroguard is produced in Russia. It's average in price. A package of 10 2 ml ampoules cost me 1383 rubles. A 1ml package costs 799 rubles.

If we compare drugs in tablets, then Chondrogard is somewhat more profitable. The same Teraflex costs about 2,200 rubles for 100 tablets. As I already said, you need to drink it in a course of at least 3 months. And this is at least 2 packages.

Chondroguard is placed intramuscularly in the butt while lying down. I was given injections at the clinic, so I didn’t feel any pain, although I don’t like injections. One of the nurses advised me to warm up the ampoule in my hands before the injection so that the drug would be better absorbed. Unfortunately, I didn't have time for this. But even so, I didn’t feel any particular pain or bumps at the injection site.

Today I gave my last injection. What can I say about the effect: like most similar chondroprotectors, the result cannot be verified, that is, I cannot see whether my cartilage tissue has become stronger or not. The only thing is that the clavicular-humeral joint practically stopped hurting. I hope this is the result of Chondrogard.

The neurologist warned me that osteochondrosis cannot be cured. I will have to support my cartilage tissue with similar chondroprotectors all my life. Doctors advise taking courses of treatment with such drugs 1-2 times a year.

Most likely next time I will also choose an injectable chondroprotector!