Results of the use of the paraffin-containing Vesicure-Fizomed device in the treatment of chronic diseases of the hepatobiliary system
Highest Category Physician V. D. Pavlov
5th Central Polyclinic of the Ministry of Defence of the Russian Federation
Study aim. Assessment of the efficacy and tolerability of the paraffin-containing therapeutic Vesicure-Fizomed device in patients with chronic cholecystitis.
Material and methods. The study included 24 patients with various clinical manifestations of cholelithiasis. In the course of the study (at 3 and 6 months), changes in subjective and objective clinical parameters were assessed, including evaluation of clinical-laboratory values and ultrasonography data.
Results. The use of the paraffin-containing therapeutic Vesicure-Fizomed device resulted in reduced severity of manifestations of inflammation in the gallbladder wall and decreased concrement dimensions in the majority of subjects.
Conclusion. The paraffin-containing therapeutic Vesicure-Fizomed device is an efficient and safe means applicable in the treatment of cholelithiasis.
Numerous clinical observations reported in recent years have demonstrated that, as human life tends to last longer, the probability of simultaneous development of diseases in several organs and systems gets much higher.
In clinical practice, both of a general practitioner and of specialist physicians, many patients present with complaints that require analysis in every particular case and development of a comprehensive plan of clinical evaluation. Therefore, differential diagnosis, for instance, in patients complaining of abdominal pain necessitates, as a rule, obligatory ultrasonic examination of the abdominal cavity organs.
Observations lasting for many years have shown that this diagnostic approach is highly informative and absolutely rational, in particular in verification of diseases of the liver and biliary tracts.
There is currently no doubt that diseases of the liver and biliary tracts present a serious medicosocial and economic problem, which is the result of their significant prevalence, the ongoing tendency to higher incidence rates, and the considerable frequency of complications.
Notwithstanding the fact that numerous literature sources point out that surgery is the “golden standard” in the treatment of such hepatobiliary system abnormality as calculous cholecystitis. This treatment modality has a wide range of contraindications, postoperative complications, and, what is most important, it leads to considerable reduction of the patient’s quality of life.
Because of this, it is extremely important for practitioners that the search for new, less traumatic generally, and highly efficient conservative therapies affecting the pathogenetic elements of this disease continues.
The aim of this study was to evaluate the clinical efficacy of the paraffin-containing therapeutic Vesicure-Fizomed device in patients with chronic calculous cholecystitis.
The paraffin-containing therapeutic Vesicure-Fizomed device was developed by the domestic company Fizomed Ltd.
This patented appliance (Patent for Medical Invention №2103958) is based on the specific technology that is used to treat medicinal paraffin; thanks to this technology, the paraffin, which is present in this device as a set of paraffin-containing elements, exerts physiological biostimulating and system-forming effects on tissue structures in the projections of the gallbladder and the right liver lobe, without employing external warmth.
The paraffin-containing therapeutic Vesicure-Fizomed device is a product made of elastic tape; it is equipped with a fixative pocket in which paraffin-containing inserts treated in a special manner are placed. To put the paraffin-containing inserts into use, they have to be fixated on the right hypochondrium, which ensures direct biostimulating effects on the areas where the gallbladder and the right liver lobe are projected.
MATERIAL AND METHODS OF THE STUDY
We monitored 24 patients who visited a urologist complaining of various types of genitourinary system dysfunction. The study subjects included 15 females and 9 males aged between 37 and 75 years. Along with detected clinical manifestations of chronic pyelonephritis in 12 of them, urolithiasis in 8 patients, and chronic cystitis in 4 patients, all subjects were shown ultrasonographically to have concrements in the gallbladder and diffuse changes of varying degree in the hepatic parenchyma.
Duration of disease ranged between 2 and 25 years.
Diagnosis was made using the patient’s complaints (pain, dyspepsia, and asthenovegetative system symptoms), medical history (improper nutrition, excessive alcohol consumption, concurrent abnormalities in the endocrine system), physical examination (painful palpation, liver dimensions), data of clinical-laboratory evaluations (complete blood counts and blood chemistry), and ultrasonography of the abdominal cavity organs.
All subjects were administered a monotherapy course with the paraffin-containing Vesicure-Fizomed device. Patients used the device on their own, at home, in accordance with its Instructions for Use, over a period of 6 months. In the course of treatment, all subjects underwent repeated follow-up evaluations, at 3 months and 6 months.
The tolerability and efficacy of the paraffin-containing therapeutic device were estimated in the course of treatment using the combination of subjective signs and objective clinical data. Therapeutic efficacy was assessed considering the degree and velocity of symptom regression. Treatment results were graded as good, satisfactory or unsatisfactory. The “good” gradation corresponded with pronounced positive changes in all symptoms, the “satisfactory” mark denoted regression of less than half of the mentioned symptoms, and the “no result” grade was assigned to cases with absent or insignificant positive changes.
RESULTS AND DISCUSSION
At baseline, all 24 patients reported episodes (as frequent as once or twice a year) of clear manifestations of pain, dyspeptic, and asthenoneurotic syndromes, which were associated, as a rule, with deviations in the nutrition regimen and psychoemotional or physical stress.
Over half of subjects, namely 15 out of 24, already knew about the presence of concrements in their gallbladders and had been treated with periodical pharmacotherapy courses, which had resulted in temporary subjective improvements not accompanied by positive changes in the ultrasonographic picture.
Clinical-laboratory studies revealed moderate leukocytosis and shifts in peripheral blood chemistry values in these 15 patients. In particular, insignificant elevations were seen in cholesterol, transaminase, alkaline phosphatase, and bilirubin levels, and mercuric chloride and thymol tests produced excessive results in 9 subjects.
On ultrasonic examination, all 24 patients had elevated density and thickness of the gallbladder wall, increased gallbladder volume, and deteriorated contractility. Solitary or multiple (up to three) gallbladder concrements measuring 10-30 mm in diameter and diffuse alterations in the hepatic parenchyma were detected in 13 patients; the rest of the subjects had multiple fine concrements measuring 8-10 mm in diameter, and free bile was observed in all of these cases.
At the follow-up visit, in 3 months, all patients receiving monotherapy with the paraffin-containing Vesicure-Fizomed device pointed out significant alleviation of the heaviness and painful sensations in the right hypochondrium, better appetite, and improved general condition, enhanced working capacity, and improved psychoemotional status. Seven out of 15 subjects (47%) had their clinical-laboratory test values back into normal ranges.
Follow-up ultrasonography revealed reduced density and thickness of the gallbladder wall in 12 patients, three of whom had decreased density of the hepatic parenchyma.
In 4 out of 13 subjects with solitary concrements, concrement diameter reductions from 1 to 3 mm were demonstrable in the gallbladder lumen.
The final evaluation carried out at 6 months demonstrated significant improvements in the general condition and no complaints in all study patients. The clinical-laboratory test values were within normal ranges in 13 out of 15 patients (86%).
There were no abnormalities on liver and gallbladder ultrasonography in 13 subjects. The other 11 subjects had insignificant positive changes in the visual picture, or the changes corresponded to those detected at the previous follow-up evaluation.
Assessment of treatment results in the study subjects is shown in Table 1
Therefore, the undertaken study has clearly demonstrated that treatment with the paraffin-containing therapeutic Vesicure-Fizomed device results in pronounced enough and demonstrable positive changes in the course of cholelithiasis, which were evidenced by considerable improvements in the subjects’ general condition, normalization of clinical-laboratory test values, and positive changes on imaging of the bile-excreting organs.
Considering all of the above, we would like to emphasize that, in order to achieve more successful treatment results, therapeutic courses have to be conducted over a period of 6 months or longer and always be taken under a physician’s control and accompanied by repeated follow-up ultrasonic examinations of the liver and the gallbladder.
Based on the analysis of obtained clinical results, we can claim that the therapy in question is an absolutely novel and highly promising treatment modality applicable in diseases of the hepatobiliary system. The paraffin-containing Vesicure-Fizomed device is efficient in the treatment of this patient category and can be recommended for further treatment after discharge from GI or therapeutic hospitals, as well as in the settings of ambulatory out-patient care.
Prolonged and (preferably) continuous use of this therapeutic modality involves penetrative impact on tissue processes, which helps enhance tissue trophism, metabolism, and oxygenation. All of these effects in their turn pave the way for improvements in the functions of the liver and the bile-excreting system and elimination of biliary concrements. Because of these findings, the paraffin-containing therapeutic Vesicure-Fizomed device not just exerts efficient therapeutic activities, but it can also be used for prevention of disease relapses.
We also believe that further studies are necessary that would be aimed at evaluation of the clinical efficacy of the paraffin-containing therapeutic Vesicure-Fizomed device in the settings of specialized hospitals and departments of scientific-research institutes in the Russian Federation, which will greatly help to introduce this treatment modality into the clinical practice of ambulatory out-patient practitioners and improve considerably the quality of life in this patient category.