PHYSIOLOGICAL REGULATING MEDICINE 2012 CLINICAL TRIAL ON PRM PREPARATIONS IN THE TREATMENT OF PATIENTS SUFFERING FROM URINARY APPARATUS INFECTIONS SUMMARY I. Dudar CLINICAL ETHIC ISSUE This clinical study was conducted according to the “Law of Ukraine On Medications” and the Helsinki Declaration last review. All patients were provided with the information about the study aim “Informative Patient Letter”, and agreed. During the research process neither conflicts nor participation refusal appeared. INTRODUCTION Urinary system infections play a consid- erable role in the structure of diseases. This term means the contamination of the Urinary Tract without clarification point of the Urinary Apparatus affected level. In such infections the microorganisms range varies according to the age, gender, way of infection spread, and disease form. The highest incidence is shown for Gram-negative flora in 60-70% - E.coli; less often – pathogenic Streptococcus and Staphylococcus; high incidence not only of mono-flora but of associat- ed microorganisms. Clinical strategy herein is aimed primari- ly to reduce the microbial-inflammatory process and must be implemented in ac- cordance with toxic preparation proper- ties, efficiency in relation to the most fre- quent agents of disease, as well as with the preparation ability to create therapeutic concentration in tissues, patient’s age, lev- el of renal dysfunction, urinal pH, etc. – The prominent role in renal and Urinary Apparatus infections treatment provide the medicines of wide action range able to inhibit both Gram- positive and Gram-negative flora. As a rule, frequently recurrent infections of the Urinary Tract requires the supportive antibacterial therapy. Constant is the aim on finding the way to rise the efficiency of Urinary Apparatus infection treatment. Physiological Regulating medicine (PRM) preparations produced by GUNA Laboratories (Italy) – present the innovative conception of low dose medicine development. These preparations are innovative in low dose medicine, comprising potentiated hormones, neuropeptides, RESEARCH PERIOD: 07.2010 – 12.2010 – Topic: high incidence of Urinary Apparatus infections requires a very efficient treatment. However, the administration of antibac- terial drugs does not solve all these problems, allowing the recurrent way of diseases, not reaching irritator eradica- tion which requires prevention with antimicrobial and other drugs not matching clinical needs. – Research methods: clinical. – Patients: 10 in the Main Group (research); 10 in the Experimental Group. – Diagnosis and main inclusion criteria: Urinary Apparatus infections, patients aged 18-65 years. – Examined preparations, dosage and administration: GUNA-Kidney – prescribed for 1 week, 10 drops 5 times a day; 2nd-8th week 10 drops 3 times a day. Eubioflor and GUNA-Diur were prescribed at the same posology. – Duration of treatment: 8 weeks. – Research criteria: microbial inflam- mation signs. Efficiency: treatment efficiency in the Main Group should be higher than in the Experimental Group. – Safety: if any side effect appears (adverse effects) the research is stopped. – Statistical methods: analysis of variance (Student). – Conclusions: limited clinical study on GUNA-Diur, GUNA-Kidney, Eubioflor proved the absence of side effects, good tolerance, efficiency of named preparations for cases with Urinary Apparatus infections. Efficiency result: 70%. Safety result: no side effects detected. URINARY APPARA- TUS INFECTIONS, GUNA-KIDNEY, EUBIOFLOR, GUNA-DIUR, PHYSIOLOGI- CAL REGULATING MEDICINE, LOW DOSE KEY WORDS 9
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PHYSIOLOGICAL REGULATING MEDIC INE 2012
CLINICAL TRIAL ON PRMPREPARATIONS IN THETREATMENT OF PATIENTSSUFFERING FROM URINARYAPPARATUS INFECTIONS
SUMMARY
I. Dudar
CL
INIC
AL
ETHIC ISSUE
This clinical study was conductedaccording to the “Law of Ukraine OnMedications” and the HelsinkiDeclaration last review. All patients were provided with theinformation about the study aim“Informative Patient Letter”, andagreed. During the research process neitherconflicts nor participation refusalappeared.
INTRODUCTION
Urinary system infections play a consid-erable role in the structure of diseases.
This term means the contamination of theUrinary Tract without clarification point ofthe Urinary Apparatus affected level. In such infections the microorganismsrange varies according to the age, gender,way of infection spread, and disease form.
The highest incidence is shown forGram-negative flora in 60-70% - E.coli;less often – pathogenic Streptococcusand Staphylococcus; high incidence
not only of mono-flora but of associat-ed microorganisms. Clinical strategy herein is aimed primari-ly to reduce the microbial-inflammatoryprocess and must be implemented in ac-cordance with toxic preparation proper-ties, efficiency in relation to the most fre-quent agents of disease, as well as with thepreparation ability to create therapeuticconcentration in tissues, patient’s age, lev-el of renal dysfunction, urinal pH, etc.
– The prominent role in renal andUrinary Apparatus infections treatmentprovide the medicines of wide actionrange able to inhibit both Gram-positive and Gram-negative flora.
As a rule, frequently recurrentinfections of the Urinary Tract requiresthe supportive antibacterial therapy.Constant is the aim on finding the wayto rise the efficiency of UrinaryApparatus infection treatment. Physiological Regulating medicine(PRM) preparations produced byGUNA Laboratories (Italy) – presentthe innovative conception of low dosemedicine development. These preparations are innovative inlow dose medicine, comprisingpotentiated hormones, neuropeptides,
RESEARCH PERIOD: 07.2010 – 12.2010– Topic: high incidence of UrinaryApparatus infections requires a veryefficient treatment. However, the administration of antibac-terial drugs does not solve all theseproblems, allowing the recurrent way ofdiseases, not reaching irritator eradica-tion which requires prevention withantimicrobial and other drugs notmatching clinical needs. – Research methods: clinical.– Patients: 10 in the Main Group(research); 10 in the Experimental Group.– Diagnosis and main inclusion criteria:Urinary Apparatus infections, patientsaged 18-65 years.– Examined preparations, dosage and administration: GUNA-Kidney –prescribed for 1 week, 10 drops 5 timesa day; 2nd-8th week 10 drops 3 times aday. Eubioflor and GUNA-Diur wereprescribed at the same posology.
– Duration of treatment: 8 weeks.– Research criteria: microbial inflam-mation signs.Efficiency: treatment efficiency in theMain Group should be higher than inthe Experimental Group. – Safety: if any side effect appears(adverse effects) the research isstopped.– Statistical methods: analysis ofvariance (Student).– Conclusions: limited clinical study onGUNA-Diur, GUNA-Kidney, Eubioflorproved the absence of side effects,good tolerance, efficiency of namedpreparations for cases with UrinaryApparatus infections.Efficiency result: 70%.Safety result: no side effects detected.
It was suggested for the complextherapy to use: Guna-Kidney – basicremedy for renal diseases treatmentpossessing also neuroprotective effect;Eubioflor – preparation applied forintestinal microflora; PilosellaCompositum (Guna-Diur) – preparationof emictory, anti-inflammatory, andantiseptical effects.
Taking into account the high incidence of
Urinary System infections (2nd place afteracute respiratory viral infection), the de-velopment of rising the treatment efficien-cy strategy is of immediate interest.
TRIAL PLAN
GENERAL PLAN
Open, randomized clinical trial.Guna-Kidney – a basic preparation for re-nal diseases treatment, was prescribed for1 week, 10 drops 5 times a day; 2nd-8thweek – 10 drops 3 times a day; sameposology for Eubioflor, and Guna-Diur.– This trial included 20 patients, dividedinto 2 Groups: 1st Group – patients treat-
(chronic aggravations) infection-inflammation renal and Urinary Systemdiseases: primary and secondarypielonephritis, cystitis, urethritis.
Patients inclusion was possible with thepatient’s written agreement to be errolledin the clinical study. Patients were included in Groups by ran-dom selection. Each patient was allowed to participate inthe clinical study 1 time only. All the iden-tification information about the patient(name, birth-date, case report, etc.) wasregistered in the “Personal patient card”.
– Exclusion criteriaContraindications for patient’s inclusion inthe trial are the following: high sensibilityto the preparation components, heavy liv-er and kidney disorders, pregnancy, heavycirculatory decompensation, pulmonaryinsufficiency of II-III level, decompensat-ed diabetes, mental disorders, drug and al-cohol addiction, other conditions consid-ered as inappropriate,
– Patient’s refusalPatients elimination from the trial or testing.Elimination was provided due to patient’srefusal, treatment compliance violation,diagnosis change, other necessary treat-ments.
THERAPY
Treatment was indicated after diagnosis bymeans of physical and instrumental ex-aminations, bacterial test on the first day,taking into account Urinary System infec-tions in patients. – Inclusion was made by random selection.
1гр. 2гр. 1 гр. 2гр. 1гр. 2гр. 1гр. 2гр. 1гр. 2гр.к 1гр. 2гр. 1 гр. 2гр. 1гр. 2гр.Lumbalgia Edema Dysuria Headache, weaknessAppetite Body temperature Leucocytosis AlbuminsUrine leucocytes Albuminuria Cylindruria Urinary bacterial testFecal path. flora Blood pressure Ultrasound resultRelapse Side effects Treatment tolerability
*difference between main and experimental Group is apocryphal.
pathology type, which is enough to eval-uate the efficiency.
POPULATION SELECTION
– Inclusion criteriaFor the preparations efficiency evaluation,both genders were included from 18 to 65years old. These patients were suffering from acute
TAB. 1
Systematic plan of the clinical trial.
TAB. 2
Groups of
patients.
ed by complex administration of antibac-terial medicines + GUNA low dose prepa-rations; 2nd Group – patients treated withantibacterial medicines only (fluoro-quinolones, penicillin family antibiotics,nitrofurantoin).
Patients of both Groups were randomizedaccording to age, gender, nosological dis-ease form, level of disease intensity.– The trial was conducted during 8 weeksin accordance to the patient’s state and
When arrived to the hospital, all patientswere examined for evaluation of possibleinclusion into the clinical trial, with indi-cating the anamnesis (allergy in particu-lar), preliminary antibiotics therapy data(for chronic diseases), and its efficiency.
The following data were evaluated andput in documentation: birth-date, gender,body mass, and • anamnesis data
• anamnesis morbi• associated disease and associated
therapies • disease at the beginning• preliminary treatments• patient’s complains: lumbalgia,
dysuria, headache, high temperature, • objective examination data: pulse,
• laboratory examination data: generalblood and urine tests, urine
Nechiporenko’s test (in case of lightleukocyturia), day’s albuminuria, urinebacterial inoculation and antibiogramresults, dysbiosis fecal examination re-sults, biochemical blood test (BUN,creatinine, liver tests: GPT, GOT, biliru-bin, thymol test); kidney X-ray and ul-trasound (studied for diagnosis verifi-cation), ECG.
Stated indexes were evaluated before andafter treatment (every week) (TAB. 1).
PATIENTS
From July to December 2010, were ex-amined 20 patients aged 18-65 years, 3men, 17 women (TAB. 2). Every patient suffered from Urinary Sys-tem infections (acute cystitis, recurrent cys-titis, acute pyelonephritis, chronicpyelonephritis aggravation (TAB. 3). All patients were divided into 2 Groups:10 patients were given antibacterial prepa-ration + PRM therapy (Main Group); 10patients of Experimental Group receivedonly antibacterial preparations: 1 for cys-titis lasting 3-5 days, 2 and more – forpyelonephritis lasting 10-14 days de-pending on the clinical picture. Among all the included patients in 15 cas-es the GFR was >60ml/min, correspon-ding to the normal renal function, and 5cases with the CRD of 3rd stage with re-duced GFR intensity <60ml/min.
EFFICIENCY
General clinic efficiency was evaluatedaccording to objective and subjective in-dexes dynamics for each patient.
Evaluation of particular symptoms was per-formed with the help of verbal scale: 0 –not indicated; 1 – low rate; 2 – mediumrate; 3 – high rate of medicine efficiency.
Stated data demonstrated that such pa-tients’ complains as lumbalgia, dysuria,low/no appetite, asthenia after 2 weeks oftreatment were diminished, with furtherdynamics (TAB. 4).
Diagnosis
Acute pyelonephritis
Chronic pyelonephritis,
aggravation
Acute cystitis
Recurrent cystitis in course with
recurrent slice
Main Group*
2(20%)
4(40%)
3(30%)
1(10%)
Experimental Group*
3(30%)
4(40%)
1(10%)
2(20%)
Symptom
Unwellness
Lumbalgia
Headache
Dysuria
Appetite
Beforetreatment
0 1 2 3
0 1 2 3
0 1 2 3
0 1 2 3
0 1 2 3
On 10-14 day
of treatment
0 1 2 3
0 1 2 3
0 1 2 3
0 1 2 3
0 1 2 3
After 8 weeks
0 1 2 3
0 1 2 3
0 1 2 3
0 1 2 3
0 1 2 3
*difference between main and experimental Group is apocryphal.
Particularly interesting are the GFR dy-namics in patients of both the Main andthe Experimental Group, marking the im-provement in CRD (TAB. 5).
Stated datademonstrate that such patients’complains as lumbalgia, dysuria, low/noappetite, asthenia after 2 weeks of treat-ment were diminished, with further dy-namics (TAB. 6).
Treatment efficiency evaluation was per-formed by every patient based on the fol-lowing criteria: «good», «medium» or«bad» (TAB. 7).
It is important to consider that the bacter-ial inoculation with sensibility define pe-riod takes 5 days that is why antibioticswere prescribed before getting the result.The most frequent (50% cases) were path-ogenic Escherichia coli (30% cases), path-ogenic Streptococcus haemolyticus, Strep-tococcus faecalis, less frequent, Proteusmirabilis, Klebsiella, Staphylococcus au-reus, Citrobacter, and others (20%).
Attention should be paid also to the factthat irritator eradication appeared in 8 pa-tients of the Main Group and in 6 patientsof the Experimental Group.
– Positive is the absence of recurrent cas-es in the Main Group, while in the Exper-imental Group it has been recorded 1 caseof aggravation.
GUNA low dose preparations per-formed the considerable positive im-pact on renal functional indexes.
Even if these changes are statistically apoc-ryphal as well as in comparison with theExperimental Group – the improvementof such indexes as creatinine, urea andGFR are greatly considerable in the courseof CRD.
Not a single patient in the Main Groupcomplained on dysbiosis, meanwhile in40% of the Experimental Group the ad-ministration of fluconazole, for 5 patients- probiotics were needed.
Great attention was paid to patients with-out gaining the desirable therapeutic ef-fect. These were 2 patients of the Main Groupand 4 patients of the Experimental Group.In fact they all were suffering from the ag-gravated pyelonephritis in the course ofcholecystolithiasis (2 patients), 2 patients– after Urinary Tract surgery, 2 patients hadpyelonephritis aggravation in course withcystic disease. For 1 patient of the Experimental Groupnegative GFR changes were indicated.
TOLERABILITY AND SAFETY
Tolerability of PRM preparations Guna-Kidney, Eubioflor and Guna-Diur ap-peared to be good.
During the preparations administrationand after the treatment end, patients hadno complains about after-taste, feces dis-order or other undesirable effects; objec-tively while conducting clinical, instru-mental and laboratory tests no data onpathological rate, pulse, blood pressure,ECG changes, as well as changes in gen-eral and biochemical blood and urine testswere indicated.
– No case of allergic and other undesir-able or negative effects were recorded.
General efficiencyevaluation
GoodMedium
Bad
MainGroup
7(70%)3(30%)
ExperimentalGroup
6(60%)3(30%)1(10%)
Criteria
Improvement
Partial positive dynamics
Worsening
MainGroup
8(80%)
2(20%)
0
ExperimentalGroup
6(60%)
3(30%)
1(10%)
Clinical-laboratory efficiency rate wasbased on the following criteria: improve-ment, partial positive dynamics, worsen-ing (TAB. 8).
TAB. 7
General clinical efficiency evaluation
(patient) based on the dynamics of his/her
clinical complains.
TAB. 8
General clinical-laboratory efficiency rate.
1gr. 2 gr. 1 gr. 2 gr. 1 gr. 2 gr. 1gr. 2 gr. 1 gr. 2 gr.Lumbalgia in grades 21 22 14 12 7 10 6 9 3 7
On the basis of this limited clinical trialon the administration of GUNA PRMpreparations Guna-Kidney, Eubioflor andGuna-Diur vs antimicrobial treatment on-ly – we can provide the following con-clusions:– GUNA preparations under this trial bythe effect and absence of negative side ef-fects can be prescribed for patients suffer-ing from Urinary System infection to beadded to the therapy with antimicrobialdrugs. �
Author
Dr. I. Dudar, MD– Medical Sciences Academy of Ukraine. Nephrology Institute Efferent Technology Department
26, Petra Zaporozhtsia str.Kyiv - Ukraine.
HOMEOPATHIC MEDICINE
For the temporary relief of symptoms related to intestinal dysbiosis such as �atulence after meals, diarrhea or constipation, poor digestion.
Uses
Take 15 minutes before meals.
Directions
Stop use and ask doctor if symptoms of diarrhea or constipa-tion, �atulence, bloating or poor digestion persist for more than 5 days or worsen. If pregnant or breast-feeding ask a doctor before use. Keep this and all medicines out of reach of children.
1 U.S. Food and Drug Administration Sec. 400.400 Conditions Under Which Homeo-pathic Drugs May be Marketed (CPG7132.15).
These statements have not been evaluated by the Food and Drug Administration. They are not intended to diagnose, treat, cure, or prevent any disease. They are not a substitute for individual medical attention.
