A report of the results of clinical study of the biologically Active peptide bioregulator of cartilage origin:
The biologically active food additive Sigumir® contains a complex of low-molecular peptides with molecular weight up to 5000 Da, isolated from cartilaginous tissue of young animals - calves aged up to 12 months.
Sigumir® is manufactured in the form of capsules with a content of active substances 10 mg.
Experimental studies have shown that the peptides possess tissue-specific action on the cells of the tissues from which they were isolated. They improve trophism of the cartilaginous tissue cells and regulate metabolic processes in it, thus reducing a risk of various joint and spine diseases. Thus it is possible to extrapolate an efficiency of Sigumir® in restoration of cartilaginous tissue function in patients with inflammatory and dystrophic-degenerate disease of musculoskeletal system.
The clinical studies of Sigumir® were carried out at the Medical Center of the Saint Petersburg Institute of Bioregulation and Gerontology in patients with osteoarthritis of joints, osteochondrosis of spine and osteoporosis during the period from November 2005 till February 2006.
Sigumir® was administered per os 10-15 minutes before meal 1-2 capsules 2-3 times a day for 30-45 days depending on severity of the pathological process.
Treatment and rehabilitation of patients with degenerate-dystrophic diseases of the joints and spine, accompanied with irreversible progressive changes, is a complex problem, most urgent in geriatric patients (2, 3).
Drug therapy of degenerate-dystrophic diseases of the joints and spine includes various symptomatic and pathogenic medicines (1):
1. Analgesics and anti-inflammatory agents (analgin, Novocain blockades, rheopyrine, indomethacin, brufen)
2. Antihistamine drugs (dimedrol, pipolphen)
3. Drugs, which improve peripheral circulation (pachycarpine, platyphyllin)
4. Bio-stimulators (rumalon, aloe, vitreous body, ATP)
5. Enzymatic preparations (lidasa, ronidasa)
6. Anabolic steroids (nerabol, retabolil)
Clinical characteristic of the patients
Sigumir® treatment was carried out in 33 patients with the following diagnoses: ‘Osteoarthritis of knee joints’ (10 patients, including 7 men and 3 women), ‘spinal osteochondrosis’ (15 patients, including 6 men and 9 women), ‘Osteoporosis’ (8 women). The age of patients has made from 45 up to 78 years.
There were 31 patients in the control group; all of them had similar diagnoses, sex and age. Distribution of the patients by diagnoses, sex and age is shown in the table 1.
Patients with osteochondrosis of knee joints were complaining of pain and restricted flexion and extension of the joints while walking. In the patients of senior age group the typical signs were deformation of joints, atrophy of femoral muscles and weakening of the ligamentous apparatus of the joints.
The patients from the second group have been often experiencing pain in lower back with irradiation along the sciatic nerve, which were more intense at changing of the body position, walking and physical load.
The patients with osteoporosis complain of frequent bone fractures, which take place at insignificant injury or even with no apparent cause.
The disease period has made from 5 to 20 years old; there was a progressive dynamics of the pathological process development.
In patients of basic and control group the disease period has made from 5 to 20 years and the progressive pathological process was noticed.
All the patients have been taking analgesics and ant inflammation drugs for a long time, these drugs have resulted in short-term therapeutic effect, which required increase in a dose of the drugs per treatment course and duration of their administration.
The patients of the control group have been taking general purpose medicines. The patients of the main group have been taking Sigumir® in addition to the general purpose medicines – 1-2 capsules, 2-3 times a day before meal for 30-45 days.
Distribution of the patients by diagnosis, sex and age
Osteoarthrosis of knee joints
Sigumir® efficiency assessment was carried out by the way of analysis of the patient complaints progression, and by the way of analysis of objective parameters: general clinical analysis of blood and urine, biochemical blood analysis, X-ray examination.
It is important to note that X-ray symptoms of degenerate and dystrophic diseases of joints and spine are not only objective diagnostic criteria of pathological process development stage, but are of high prognostic importance for the drug therapy carried out.
It was established that administration of Sigumir® in patients with knee joint osteoarthritis resulted in decrease in the pain syndrome and increase in mobility of the joints in 68.5% of cases. And the pain symptoms were stopped mostly in radiologically identifiable initial stages of the disease: joint space narrowing between patella and femur, lateral osteophytes of patella and femoral condyle. There were no considerable dynamics of roentgenological symptoms during this period.
In patients with developed arthritis there was similar, but less intense dynamics of subjective parameters. This stage of disease was diagnosed in elderly patients, so such subjective signs were characterized as very advantageous.
In patients with osteochondrosis of lumbar spine administration of Sigumir® in parallel with complex therapy has resulted in a decrease in the pain syndrome in 53,7% of cases. Such changes were most typical for the patients of middle age. Age-related progression of the disease, accompanied by typical radiological symptoms (narrowing of the space between adjacent vertebral bodies due to flattening degenerate intervertebral disks; anterior and posterior osteophytes of the vertebral bodies, arthritic changes of posterior and lateral intervertebral joints in the form of narrowing of the spaces, irregularity of the contours, osteophytes at the margins of the joint ends; changes of configuration of intervertebral foramens), resulted in development of spondylosis and spondylarthrosis and formation of neurodystrophic and neurovascular syndromes. In these cases long-term (not less than 45-60 days) administration of Sigumir® has resulted in decrease in the pain symptoms, caused by a load on vertebral column and extremities, and resulted in increase in the vertebral column movement range.
The patients with osteoporosis after long-term administration of the drug have shown a stabilization of metabolic processes in the bone tissue: reduction in the number of typical fractures, considerable acceleration of restoration of the function of the musculoskeletal system and decrease in the time of stay in the hospital.
All the patients had considerable relief of the main symptoms of these groups of diseases, characterized by considerable persistence.
Sigumir® does not result in side effects, complications and drug dependence.
Thus the results of the study carried out testify treatment efficiency of Sigumir® and expediency of its use for complex treatment and prophylaxis of degenerate and dystrophic diseases of the joints and vertebral column in combination with any means os symptomatic and pathogenic therapy, used for treatment of this group of diseases (analgesics, anti-inflammatory, antihistamine and vascular preparations, bio-stimulators, enzyme preparations, anabolic steroids, vitamins etc.).
The biologically active peptide bioregulator Sigumir® promotes normalization of metabolic processes in cartilaginous tissue and slows down its involute changes.
Sigumir® can be used as medical and preventive mean in the form of biologically active food additive in the form of adjunct in combination with any means of symptomatic and pathogenic therapy, used for treatment of degenerate-dystrophic diseases of joints and vertebral column - osteoarthritis, osteochondrosis, osteoporosis etc.
Sigumir® is well tolerated by patients at oral administration, it does not result in any side effects and can be widely used as a treatment and prophylactic biologically active food additive.
Recommended Sigumir® dosage
· For osteoarthritis patients - per os 10-15 minutes before meals 2 capsules, 3 times a day for 45 days.
· For osteochondrosis patients - per os 10-15 minutes before meals 2 capsules, 3 times a day for 45 days.
· For osteoporosis patients - per os 10-15 minutes before meals, 2 capsules, 2 times a day for 30 days.
· It is recommended to carry out another treatment course in 3-6 months.
· It is expedient to recommend Sigumir® for treatment and prophylaxis.
1. Mashkovsky M.D. Medicines: Pharmacotherapy for doctors, manual: 2 parts. - Vilnius: ZAO “Gamta”, 1993.
2. Nasonova V.A., Astapenko M.G. Clinical rheumatology: Manual for doctors. - M.: Medicine, 1989. - 592 pages
3. Geriatry manual / Edited by D.F. Chebotarev, N.B. Mankovsky. - M.: Medicine, 1982. - 544 pages