THE THERAPEUTIC EFFICACY OF PRM MEDICINE GUNA-BOWEL

PHYSIOLOGICAL REGULATING MEDIC INE 1/2010

THE THERAPEUTIC EFFICACY OF PRM MEDICINE GUNA-BOWEL IN PAEDIATRIC CYCLIC VOMITING SYNDROME

SUMMARY

L. Cerempei, I. Cucos, O. Cirstea, E. Cerempei, L. Gritco, L. Bocearova

CLINICAL

INTRODUCTION

The cyclic vomiting syndrome (CVS)diagnosis is based on the Rome IIIdiagnostic criteria (Los Angeles, 2006)that include the following:1. Two or more periods of intense nau-

sea and unremitting vomiting orretching, lasting from several hoursto several days.

2. Return to usual state of health thatlasts from several weeks to severalmonths.

The data by Li and Balin (2000) andScarcia (2000) estimate that in 68% ofthe cases the most frequent trigger fac-tors include:• Infectious diseases in 41% , espe-cially chronic sinusitis

• Mental stress (34% )• Food, including chocolate, cheese,and other

• Physical exhaustion or sleep depri-vation (18% )

• Atopy (13% )• Menstrual periods (13% ) and other.

The pathophysiology in CVS isunknown. Two different functional struc-tures in the brain are responsible for theact of vomiting: the vomiting centre situ-ated in the lateral reticular formationand a chemoreceptor trigger zone on thefloor of the IV ventricle, known as area

postrema. The main role is played by the vomitingcentre which represents a collector ofafferent impulses. The chemoreceptor trigger zone initiatesthe act of vomiting by sending theimpulses to the vomiting centre.

- Two mechanisms of vomiting andeructation are known: the first mecha-nism is related to the initial activationof the vomiting centre. Afferent vagal and sympathic nervessend impulses to the vomiting centrefrom the biliary tract and digestiveorgans, larynx, peritoneum, coronaryarteries, the vestibular apparatus, thal-amus, hypothalamus, and cortex. The motor impulses are transmitted tothe vomiting centre from thediaphragm through the diaphragmaticnerves, to intercostal and abdominalmuscles through the spinal nerves, andto the pharynx, larynx, oesophagusand stomach through the vagal nerve. The second mechanism is based on thechemoreceptor trigger zone stimula-tion, in which impulses are directed toactivate the vomiting centre. The triggerfactors of the chemoreceptor zone are:serotonin, angiotensin, neurotensin,VIP, gastrin, substance P, dopamine,drugs, uremia, hypoxia, diabeticketoacidosis, endotoxin Gram-positivebacteria, radiations, and others.

The cyclic vomiting syndrome (CVS)diagnosis is based on the Rome III diag-nostic criteria (Los Angeles, 2006).The data by Li and Balin (2000) andScarcia (2000) estimate that in 68% ofthe cases the most frequent triggerfactors include:• Infectious diseases in 41%, espe-

cially chronic sinusitis;• Mental stress (34%);• Food, including chocolate, cheese

and other;• Physical exhaustion or sleep depri-

vation (18%);• Atopy (13%);• Menstrual periods (13%) and other.- Patients with CVS aged from 2 up to 7years old were divided into 2 studygroups: the control group included 16children who received standard thera-py; the second group included patientswith CVS (35 children) who receivedstandard therapy and Guna Bowel for aperiod of 10 days.All the examined patients were hospi-talized immediately: in 52% of cases itwas the second episode in the diseasehistory, 48% of children had relapsingcourse. The supplementation of the basic treat-ment with the PRM preparation GunaBowel markedly improved the clinicalpicture in children with CVS: during thefirst three days all children reporteddecrease of pain syndrome (in the con-trol group this was noticed in 87%),toxic syndrome reduced in 86% of thepatients and 67% of the controls, vom-iting episodes in the first two daysended in 87% of the children whoreceived Guna Bowel and in 74% of thecontrols.

CYCLIC VOMIT-ING SYNDROME, PAEDIATRICS, GUNA-BOWEL

KEY WORDS

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Cerempei:Art. Del Giudice 05/11/10 15.04 Pagina 17

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The CVS involves disturbances of thehypothalamic-pituitary-adrenal axis(with secretion increase of theCorticotropin-Releasing Factor) as wellas vegetative dysregulation (sympa-thicotonia).

It is known that the stress activation ofthe hypothalamic-pituitary-adrenalaxis causes bouts of vomiting. The core nucleus in the central nerv-ous system that takes part in the regu-lation of the hypothalamic-pituitary-adrenal axis is the paraventricularnucleus (PVN) of hypothalamus. The PVN is the source of the corti-cotropin-releasing factor which is themain physiological regulator of thepituitary adrenocorticotropic hormone(Tache and Bonaz, 2007).

The following conditions play animportant role in the development andcourse of the CVS:• Disorders of the autonomous nerv-ous system;

• Excessive production of IL-6 whichis a marked activator of the hypo-thalamic-pituitary-adrenal axis.

The CVS is considered as a mitochondr-ial disease because of the DNA muta-tions in the mitochondria which are the“electric power suppliers” of the cell. Any mitochondrial enzyme defect(there are around 80 active enzymesoperating in the mitochondria) disturbsthe proper functioning of the “energystation”, which affects, first of all, theenergy-dependent tissues and organs –the Central Nervous System, cardiacand skeletal muscles, kidney, liver, andendocrine glands.

Three phases are distinguished in theevolution of the CVS:I. Nausea-free interval between

episodes when the child feels well;II. A prodrome starting when the

patient begins to feel the symp-toms signalling the approach of anepisode of headache, nausea andgeneral weakness; it may be pre-vented by taking the necessarytreatment. If it develops, it may

last from several minutes to sever-al days, but in 25% of the childrenit may not occur at all;

III. A vomiting phase is characterizedby intense nausea and vomitingand is manifested in all childrenwith CVS.

CVS prophylaxis treatment is adminis-tered in the 1st and 2nd phase of thedisease, and monotherapy or bitherapyis used: • Antihistamines: cyproheptadine and

pizotifen (cyproheptadine 0.25–0.5mg/kg/day); pizotifen 0.5-1.0 mg

once at night• b-Blockers: propranolol 0.25–1.0mg/kg/day

• Tricyclic antidepressants: amitripty-line 0.25-0.5 mg/kg, phenobarbital2 mg/kg

• Alternatives: topiramate, valproicacid, gabapentin, levetiracetam, L-carnitine 50–100 mg/kg/day,Coenzyme Q10 10 mg/kg/day.

Acute management is performed inhospital settings and includes the fol-lowing medications: • 10% glucose concentration, 4%

Cholecalciferol 2X* Skatolum 6/10X**

Carduus mar. 2X Chelidonium majus 2X

Collinsonia can. 2X Taraxacum off. 2X

Kali carb. 6/8/12X Natrum carb. 6/8/12X

Alumina 6/8XBryonia 6/8X

Rectum 6/12/30XColon 6/12/30XNux vomica 6/8X Thiaminum hydr. 2X

Niacin 2XPantothenic ac. 2X

Alumina 6/8X

Stimulation of intestinal function in general.

Stimulation of peristalsis. Decrease of rectal

atony episodes.

ChC

Regulation of constitutional proneness to drainage insufficiency

of the digestive tract.

Aloe 2X Rhamnus 2X Rheum 2X

Laxative action to treat irritation episodes of

intestinal mucosa.

Protection of epithelia*. Anti-putrefaction and

anti-dysbiosis action **.

INTESTINAL STIMULATION

ANTIDEGENERATIVE ACTION

CONSTITUTIONAL REBALANCE

HEPATIC STIMULATION

LAXATIVE ACTION

Reduction of portal stasis.Choleretic and cholagogue action.

Mechanisms of action of Guna Bowel.

FIG. 1


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potassium chloride, 10% NaCl • Ondansetron 0.3-0.4 mg/kg/hourand in a second stage 0,1mg/kg/hour

• Omeprazol 1 mg/kg/day two times aday or Lorazepam 0.05-0.1 mg/kg

• Chlorpromazine 0.15–0.3 mg/kgtwo or three times a day.

Based on the properties of thePhysiological Regulating Medicine(PRM) drug Guna Bowel (FIG. 1) (detoxi-fication, decreased flatulence andincrease of the intestinal motility), wehave included it in the therapeuticscheme during the 3rd phase – the peri-od of acute manifestations.

- The aim of this study was to evaluateGuna Bowel therapeutic effectiveness inchildren with CVS.

PATIENTS AND METHODS

Patients with CVS aged from 2 up to 7years old were divided into 2 study groups:the control group included 16 childrenwho received standard therapy; the sec-ond group included patients with CVS (35children) who received standard therapyand Guna Bowel for a period of 10 days.

In both groups the following main symp-toms were observed: pain, vomiting, de-hydration, and toxicity.

All the patients underwent comprehen-sive clinical, biological and instrumen-tal examinations: electrocardiography, ultrasonography, esophagogastro-duo-denoscopy and chest radiography whenit was necessary. General analysis of theblood and urine, biochemical and en-zyme immunoassay tests to assessserum amylase, ALT, AST, general biliru-bin and its fractions, total protein, urea,glucose, and cholesterol were per-formed. Ionogram and anion balance(Gas Easy Blood device - Medica) werealso performed. Ketones in urine wereassessed by using the biochemicalmethod with sodium nitroprusside.

Children were examined by the followingspecialists: neurologist, gastroenterologist,nephrologist, and others. - Biological tests have been collected toassess biochemical indicators in bothgroups (lactate, sodium, potassium, HPL,SAO, metabolic molecules, ketones,necrotic substances in serum, amylaseconcentration in serum and urine).

RESULTS AND DISCUSSION

All the examined patients were hospital-ized immediately: in 52% of cases it wasthe second episode in the disease history,48% of children had relapsing course. A seasonal character was noticed with ahigher prevalence of the episodes in springand summer; this can be explained withan increased risk caused by food trigger-ing the disease. It is necessary to mention that in 45.8%of patients there was a positive history ofchronic ENT disorders (pharyngitis, si-nusitis), and in 73% of the children neu-rological disorders were found (residualencephalopathy and epilepsy syndrome).

The general condition was considered se-vere in 82.3% of the cases and very se-vere in 17.7% of the patients. Nausea, re-peated vomiting (six and more episodes),sometimes with undigested food, biliousemesis in 14%, acetone halitosis, severeabdominal pain were the major com-plaints. Moderate dehydration syndrome(6-9% of weight loss) was assessed in92.7%of the children, severe dehydration(acute weight loss up to more than 10%)in 7.3% of the cases. Signs of airways disorders included a most-ly mild compensatory metabolic tachyp-nea in children. Acute bronchitis was no-ticed in 5.6% of the cases and in 1.2% ofthe patients acute focal bronchopneumo-nia was diagnosed. Ketoacidosis levels in children with CVS(assessed by acetone concentration inurine) increased markedly in 85.72% ofthe children and moderately in 14.28%.In 64.32% of the patients metabolic aci-dosis was determined and mixed acid-

base disorder in 35.68% of the cases. In 43.6% of the children hypoglycemiawas revealed, in 10.9% - hyperglycemiathus pancreatic lesions being confirmedin 53.7% of the patients with CVS. Therapeutic management was focused onthe toxic syndrome and dehydration, andincluded measures for rehydration, elec-trolyte and acid-base re-balancing, restora-tion of peripheral circulation disorders,treatment of the main disease which trig-gered CVS development. To correct he-modynamic and metabolic crisis an infu-sional 5% dextrose solution was initiallyapplied, 0.9% NaCl and Ringer, but theinfusion volume varied depending on the severity of the dehydration and toxicsyndrome. When an improvement of the clinical con-dition was obtained and the vomitingepisodes had become less frequent, thetherapy continued with oral rehydration(5% dextrose, oral rehydration solutions).

The supplementation of the basic treat-ment with the PRM preparation GunaBowel markedly improved the clinical pic-ture in children with CVS: during the firstthree days all children reported decreaseof pain syndrome (in the control group thiswas noticed in 87%), toxic syndrome re-duced in 86% of the patients and 67%of the controls, vomiting episodes in thefirst two days ended in 87% of the chil-dren who received Guna Bowel and in74% of the controls. Metabolic acidosis was corrected in the firstday of treatment in 68% of the patients inthe study group and in 45%of the childrenwho received only the basic treatment.

Therefore, the use of Guna Bowel in ad-dition to the therapeutic scheme hascontributed to the clinical improvementin children with CVS, with a twofold de-crease of the pain and 1.3 fold of toxicsyndrome, a decrease of vomitingepisodes frequency, a 1.5 fold recoveryrate of fluid and electrolyte balancecompared with the control group.

The administration of Guna Bowel to chil-dren with CVS reduced the duration ofepisodes by one day (24 hours). �


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Literature1. Boles R, Le S, Maslim A, Adams K, Li B, Hi-

gashimoto T, Ito M: Mitochondrial DNA controlregion sequence variations in cyclic vomitingsyndrome with neuromuscular disease. 2002.(submitted).

2. Brown J, Li B: Recurrent vomiting in children.Clinical Perspect�/�es in Gastroenterology 5:2002, 35-39.

3. Dignan F, Symon D, AbuArafeh I, Russell G: Theprognosis of cyclical vomiting syndrome. ArchDis Child 84.-2000, 55-57.

4. Issenman R: Cyclic vomiting syndrome. DigestHealth in Children, International Foundation forFunctional Gastrointestinal Disorders 2(2) 2002.1-2 .

5. Kenny P.: Sindrome de vomitos cicliocos: unenigma pediatricio vigente [Spanish]. Arch ar-gent pediatr 98(1).- 2000, 34-40.

First author’s address

L. Cerempei, MD– Chair of Paediatrics and Neonato-logy, State University of Medicineand Pharmacy, Nicolae Testemitanu.

Chisinau, Republic of Moldova

FDA l isted and regulated 1

GUNA®-DERMO

HOMEOPATHIC MEDICINE

For the temporary relief of symptoms of general skin irritation and rashes such as itching, dryness, hypersensitivity.

Uses

Store at 20°-25° C (68°-77° F).

Other Information

Ethyl alcohol 30%

Inactive Ingredient

[email protected], tel. (484) 223 3500www.gunainc.com

Contacts

Take 15 minutes before meals.

Directions

Drug Facts

Package30 ml / 1.0 ". oz. bottle

Stop use and ask doctor if symptoms of itching, dryness or hypersensitivity worsen or persist more than 5 days. 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 Homeopathic 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.

Warnings

Adults and children 12 years and older

Children between 12 years and 6 years of age

Children under 6 years

20 drops in a little water, 2 times per day

10 drops ina little water, 2 times per day

5 drops in a glass of water, 2 times per day

Active IngredientsArsenicum albumBelladonnaDulcamaraEchinacea angustifoliaGraphitesInterleukin 1 beta Interleukin 2MelatoninPlantago majorSulphur 6C

6C6C6C6C6C7C4C4C4C6C

PurposeSkin BlistersSwellingMuscle SorenessAnti-infectionSkin In"ammationImmune StrengtheningImmune StrengtheningHormonal SupportDetoxi#cationSensitive Skin


THE THERAPEUTIC EFFICACY OF PRM MEDICINE GUNA-BOWEL

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