"INFORMATION FOR PROFESSIONALS"

Following Clinical Results are shown as examples of the valuable biological activity exhibited by the unique ingredients of NaturOzone products. They were achieved in past recent years, under a Multicentric Clinical Program, with the use of formulations adequate for Ozone Therapy Procedures, applied by qualified professionals. They include data about sample selection and distribution, initial diagnostics, tabulated results and conclusions. More extensive clinical and laboratory experimentation data are available through More Info Links.

 

BEFORE	AFTER
BEFORE	AFTER

MATERIALS AND METHODS:

20 patients with diagnostic of juvenile acne were at random selected from the cosmetology service. Mean age was 20,4 years, 12 patients were men and 8 women.

The degree of acne in patients was classified as to:

DEGREE I: Itch with low or no flogistic reaction.

DEGREE II: As DEGREE I + inflammed pustulous wounds.

DEGREE III: As DEGREE II + deeper wounds.

DEGREE IV: As DEGREE III + cystic follicular wounds with intense secondary infection, fistulae and deforming scars.

Ozone cream was prescribed for application twice a day, after soap and water washing, during 30 days.

Patients were visited 15 and 30 days after initiation of treatment, for evaluation of evolution.

Evaluation criteria:

SATISFACTORY: In case of itch, pustulous superficial, so as inflammatory follicular wounds and infection, disappearance of them.

UNSATISFACTORY: In case of persistence of described wounds.

COMPLICATIONS: It was also evaluated any complication presented during the treatment period.

Data were collected in records and were processed automatically, applying statistical tests to the results achieved. (P=0.05)

Table I shows composition of sample as to patients acne degree. Half of them (50 %) corresponded to degree II, but also 40 % corresponded to the most severe degrees III and IV.

ACNE: PATIENTS EVOLUTION

CONCLUSIONS:

Ozone Cream is very useful in the treatment of polimorphic acne, even for the most severe degrees of it.

No significant complications were observed in any patient.

BEFORE

AFTER

MATERIALS AND METHODS:

Patients sample comprised 120 children with ages up to 15 years, with clinical diagnostic of aphtouse gingivostomatitis & no previous medical treatment. They were at random distributed among two groups.

Usual laboratory blood examinations were performed, so as wounds cultures. Corporal weight was measured before and after the treatment.

Treatment:

Local cures twice a day up to 20 days, by means of topical application of the medication on every one of the wounds. No meals or drinks were allowed until 2 hours after every application.

Control group: Comprising 60 patients, receiving Iodoxuridine as local medication.

Ozone oil group: Comprising 60 patients, receiving ozonised oil as local medication.

Clinical remission of symptoms:

Fever regression.
Disappearance of gingival pain.
Acceptance of meals.
Improvement of general conditions.

Healing:

Disappearance of wounds.
Normalisation of blood tests.

Most frequent ages were between 1 to 5 years. No significant differences were between groups in regard to age and sex.

Initial wound cultures showed the following germs:

Herpes simplex
Staphylococcus aureus
Streptococcus haemoliticus
Candida albicans
Fuso spirilus

70 % of patients in each group did not change their weights. In the ozone oil group, 19 % diminished it and 11 % increased it. In the control group, 25 % diminished it and only 5 % increased it.

As to clinical remission of symptoms, showed in Table I, significant differences were noticeable in regard to the time needed to achieve them. 95 % of ozone oil group patients improved within 3 days while Iodoxuridine group patients needed up to 10 days for similar level of improvement.

Table II shows the behaviour of wounds healing. Most of ozone oil group patients healed within 7 days and all of them were healed on the 10^th day. Iodoxuridine patients instead, needed up to 20 days for total healing.

Neither adverse reactions to medication nor complications were observed in any of the patients, despite some of them had previously suffered allergic episodes.

CONCLUSIONS:

Ozone oil efficacy was demonstrated for the treatment of this disease in children.

Ozone oil was more effective as medication than Iodoxuridine

Hospitalisation was much shorter in patients treated with ozone oil.

No secondary adverse reactions were present in patients under treatment.

 

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GASTRODUODENAL ULCERS. OZONISED CAPSULES APPLICATION.

INTRODUCTION:

Gastroduodenal ulcers treatment has been subject of many therapeutic tests, been a world health problem with great social-economical repercussions. Many surveys performed demonstrate a relatively high mortality among ulcerous patients, due to frequent complications as bleeding and perforations of potential fatal evolution.

With the appearance of H2 histamine blockers, as cimetidine, and combinations with other drugs, higher healing indexes have been achieved, nevertheless many patients refer side effects as: discomfort, mental confusion, gynecomasties, libido inhibition, sexual impotency, etc. Nowadays it is recognised the infection by Helycobacter pylori, an anaerobic bacteria that impedes the ulcerous crater cicatrisation, as one of main factors involved in the appearance of gastroduodenal ulcers. It has been also published that high proportion of world population is, with no conscience, infected by this bacteria, and for that reason antibiotics have been also introduced in combined treatments for this disease.

Ozone Therapy has been applied from this early century in different pathologies, been nowadays more widespread in Europe. It is known the germicidal properties of ozone and certain of its derivatives, and in particular it was demonstrated their effectivity against Helycobacter pylori in in vitro cultures. In addition, some of these products have already satisfactorily passed preclinical tests of toxicity, dermal and ophthalmic irritation, mutagenicity, teratogenicity, etc.

As known, any treatment for gastroduodenal ulcers can be intended to reduce the acid secretion rate, neutralise the secreted acid, inhibit peptic activity, keep mucouse integrity, so as also to eliminate Helycobacter pylori. It is basically in these last aspects that beneficial actions of certain ozonised derivatives are expectable, first of all due to their metabolic regulation effect, citoprotecting and tissue regenerating action, so as the improvement of oxygenation levels, as it has been proved in the treatment of lower limbs ulcers by chronic venous insufficiency and other skin diseases. No less important, by their potent germicidal effect, for the elimination of Helycobacter pylori. As precedents, Mattassi already reported the anti-inflammatory and cicatrising effect of Ozone Therapy in the Idiopathic Ulcerative Colitis.

Based on the ozonised derivatives therapeutic properties, it was decided to perform a study on their oral administration in gastric and/or duodenal ulcer patients, because of its prevalence and importance affecting individuals in full labour activity, and limiting, in many of them, their productive and social capacities.

MATERIALS & METHODS:

20 adult patients bearing gastroduodenal ulcers were studied. Endoscopies were performed before treatment to evaluate their lesions, and after it as clinic evaluation criterion.

Criteria for Admittance to the Study:

- Ulcer dimension of 1 cm or more.
- Not any surgical intervention over the higher digestive tract of patient performed.
- No complications as digestive bleeding or pyloric syndrome present at the admittance.

Patients were ambulatory treated with ozone derivative capsules (2 every day), during a month. One cap at morning, when getting up (minimum half hour before breakfast) and another one when going to bed (minimum two hours after last meal.

Evaluation Criteria:

By Direct Endoscopic Observation of the Ulcer:

Healed:                    disappeared ulcerous niche, with cicatrise or not.
Partially healed:      reduced to less than 30 % of original dimension, lower depth.
Diminished:              reduced to between 30 & 60 % of original dimension.

To all patients an intended questionnaire was applied and a form was supplied to record their symptoms and interesting data which could respond to secondary reactions.
The endoscopy specialist did not know the treatment applied to patients. Endoscopies were performed with an Olympus GIF-K Panendoscope. They were performed by a Gastroenterology Spec. and a specialised Tech.

RESULTS & DISCUSSION:

Table 1 shows the results achieved on the gastroduodenal ulcers under study in the Gastroenterology Service of the Univ. Hospital.

TABLE I

GASTRODUODENAL ULCERS: EFFECTIVITY OF ONE MONTH TREATMENT.

 

PATIENTS TOTAL	HEALED	PARTIALLY HEALED	DIMINISHED
20	12 (60 %)	4 (20 %)	4 (20 %)

No secondary adverse reactions attributable to treatment were observed.

CONCLUSIONS:

Ozonised capsules showed very effective for gastroduodenal ulcers treatment.

No secondary adverse reactions were observed during treatment evaluation.

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RELAPSING GASTRODUODENAL GIARDIASIS. APPLICATION OF OZONISED CAPSULES. MULTICENTRIC STUDY.

INTRODUCTION:

Giardia lamblia is a kind of cosmopolitan protozoa, today still cause of severe health problems due to the potentially abundant symptoms accompanying their infections. It prevails in tropical countries, in depressed economic regions; however, in past few years a world-wide alarming augment has been noticed. According to WHO in Europe it affects approximately 2 % of population. Clinical symptoms of this infection passes from asymptomatic excretion of cysts to severe persistent diarrhoea, arriving even to malabsorption syndrome. Occasionally it has been reported colecystitis, urticaria, granulomatous hepatitis, pancreatitis, multiform erythema, etc. One of the difficulties to combat giardiasis is the variable response of patients to nitroimidazols, in many cases not arriving to definitive healing, that is why new drugs are been searched.

It has been reported that ozone and certain derivatives kill Giardia cysts in vitro. Ozone is been used from the beginning of XXth century, been nowadays widespread preferentially in Europe. In addition, some of these products have already satisfactorily passed preclinical tests of toxicity, dermal and ophthalmic irritation, mutagenicity, teratogenicity, etc. Based on the difficulties for the treatment of giardiasis and frequent relapses, so as the high germicidal potential and stability of certain ozone derivatives, it was decided to perform present therapeutic test to evaluate their effectivity for treatment of this pathology.

MATERIALS AND METHODS:

55 adult patients suffering from relapsing Giardia lamblia were studied. They had previously received conventional treatments twice or more. Before treatment, duodenal frotis were performed to asses the presence of Giardia lamblia in patients under study. It was repeated after treatment as healing criterion.

Treatment:

SCHEME 1 - At the Gastroenterology Service of the Univ. Hospital it was ambulatory prescribed to 35 patients ozone capsules (2 every day), during 10 days. One cap at morning, when getting up (minimum half hour before breakfast) and another one when going to bed (minimum two hours after last meal. After it, one week period of interruption was followed by repetition of same treatment during 10 days again.

SCHEME 2 - At the Parasitology Dpt. of "IPK" 20 patients were treated under admission, with only one 10 days cycle of administration of 2 daily ozone capsules, in the same way as SCHEME 1, but with low fat diet and absence of milk and derivatives.

- Absence of Giardia lamblia trofozoites in duodena, assessed by direct observation of duodenal frotis.
- To all patients an intended questionnaire was applied and a form was supplied to record their symptoms and interesting data which could respond to secondary reactions.
- The endoscopy specialist did not know the treatment applied to patients. Endoscopies were performed with an Olympus GIF-K Gastrofibroscope. During this procedure, one specimen punch of duodena was taken for the performance of the corresponding frotis. They were fixed in alcohol-ether solution and coloured with Giemsa.

Table 1 shows the results achieved in the treatment of relapsing symptomatic giardiasis under the studies performed in both Gastroenterology Services.

TABLE I

RELAPSING GIARDIASIS: EFFECTIVITY OF TREATMENT

 

SCHEME	TOTAL PATIENTS	HEALED	NOT HEALED
SCHEME I	35	33 (94 %)	2 (6 %)
SCHEME II	20	14 (70 %)	6 (30 %)

CONCLUSIONS:

Ozonised capsules showed very effective for relapsing giardiasis treatment.

No secondary adverse reactions were observed during treatment evaluation.

Performed in: "LOUIS PASTEUR" POLICLINIC & NATIONAL CENTRE FOR SCIENTIFIC RESEARCH.

MATERIALS AND METHODS:

The sample was composed of 120 patients with lower limb ulcers (post traumatic or due to chronic venous insufficiency) of 1 to 4 centimetres diameter, at random distributed among two groups: Ozone Oil group and Control Group. Ulcers were of recent origin or up to 3 years old, even some were suffered torpid evolution.

Treatment:

The treatment for this study was recommended to patients for 30 days at home.

Control group: 60 patients, treated as:

- Venous repose.
- Hyposodic diet.
- Oral analgesics, if needed.
- Cures twice a day as follows:
    - Mechanical cleaning of the area with benzalconium chloride 1/5000 and drying.
    - Local application of antibiotics.

Ozone Oil Group: 60 patients, treated with the same procedures but with ozone oil, instead of antibiotics.

Evaluation Criteria:

Evolution: as to the behaviour of patients signs and symptoms.

Healing: as to the cicatrisation of wounds. After the period of the study, in cases not healed, remission to hospital was considered.

Table I shows distribution of ulcers between groups according to ethiology. Most of them were of venous insufficiency origin, as usual, and their distribution was homogeneous. Also homogeneous were the distributions of sex and age between groups.

On the other hand, in control group patients the evolution was significantly slower in all aspects. Inflammation and, in lesser extension, pain remained present in many patients for more than 15 days.

Regarding healing of ulcers, it was very remarkable the fact that most of patients with ozone oil treatment (95 %) healed within the first 15 days (Table III) and the remaining three patients within the following 5 days. In control group instead, only a few patients healed in the first 15 days. Most of them healed from the day 16 to 20, and 8 patients did not heal up to the end of the 30 days period and had to be submitted for hospital treatment.

CONCLUSIONS:

Ozone oil resulted much more effective than conventional treatments for healing of lower limb ulcers of venous or traumatic origin.

Patients symptoms disappeared faster and completely in those treated with ozone oil, as compared with control group.

Lower limb ulcers in ozone oil group healed within less than 15 days in 95% of patients, while in control group this was achieved in only 11,6% of patients.

Performed in: C.G. CENTRAL CLINIC & NATIONAL CENTRE FOR SCIENTIFIC RESEARCH.

MATERIALS AND METHODS:

The sample was composed of 240 patients with diagnostic of vulvovaginitis and positive vaginal cultures, at random distributed among two groups: Ozone Group and Control Group.

Treatment:

Control Group: 140 patients, treated daily at home with the most suitable antibiotics or/and antimycotics, according to the antibiograms performed in the corresponding cultures.

Ozone Group: 140 patients, treated in the same manner, but solely with ozone oil.

Evaluation Criteria:

Evolution: as to the behaviour of symptoms.

Healing: as to the negativisation of vaginal cultures.

Table I shows patients distribution among groups, according to the germs found in cultures. This distribution was satisfactorily homogeneous, so as age distribution.

Pruritus was very frequently referred, similarly in both groups (Table II). It was very significant the disappearance of this symptom within 24 hours in all patients receiving ozonised ovules, while the corresponding period was not less than 72 hours for control group.

Only 2 over 110 mycosis patients did not heal.
E. Coli persisted in 4 over 21 patients within cases of mixed infections. Also C. Albicans in one of them.
Only 1 over 9 of bacterial leucorrea patients persisted positive.

5 over 108 mycosis patients did not heal.
4 over 22 patients within cases of mixed infections persisted positive.
3 over 10 bacterial leucorrea patients persisted positive.

Healing results with ozonised ovules treatment were better and disappearance of symptoms faster than those with conventional drugs, specially in cases of bacterial infections.

Candida Albicans showed very high incidence in vaginal cultures.

The application of ozonised ovules treatment, being effective over all kinds of germs, does not require the results of pre treatment cultures neither antibiograms for the selection of the drugs to be applied. So time is saved, and success improved.

Performed in: UNIVERSITY POLICLINIC & NATIONAL CENTRE FOR SCIENTIFIC RESEARCH.

MATERIALS AND METHODS:

The universe of study were 200 patients with the following diagnostic:

Periapical radio lucid rarefacted region, with the presence or not of fistulae, in monoradicular teeth.
They were at random distributed among two groups: ozone oil and control.

The common initial treatment procedure for all patients was as follows:

- Absolute isolation of operating field.
- Aseptization of the field with surgical tincture and alcohol.
- Access to pulpar chamber in the longitudinal axis direction looking for the conduit entrance.
- Extraction of radicular pulp with suitable extractors.
- Rinsing of the conduit with the antiseptic conductosol.
- Determination of conductimetry.
- Widening of the conduit to reach the healthy dentine.
- Rinsing of the conduit with sodium hypochlorite.
- Drying of the conduit with sterile absorbent paper cones.

Control group: 100 patients, treated with Cresophene impregnated in sterile cotton ball in the chamber, at the conduit gate.

Ozone oil group: 100 patients, treated with ozonised Oil impregnated in sterile cotton ball in the chamber, at the conduit gate.

The study comprised a 16 days period, with 8 visits, for every patient.

Evaluation Criteria: The patients were considered as follows:

Healed, when concurred:         Pain absence and dry conduit.

Improved, when concurred:      Only pain at percussion and/or wet conduit.

No change, when concurred:    Sustained pain and/or wet conduit.

Pain absence was: No pain referred by the patient neither spontaneous nor at any action of palpation or percussion on the tooth.

Pain at percussion was: That momentaneous pain referred by the patient when knocking is effected in the longitudinal axis of the tooth.

Sustained pain was: That pain referred by the patient without external influences, even after the application of the treatment.

Age and sex were homogeneously distributed among both groups under study.

The distribution of pain occurrence and fistulae were also similar (Table I)

The remarkable higher effectivity of ozone oil in this entity could be due, in addition to its known therapeutic properties, to the fact that being a low surface tension vehicle, it makes easier the penetration in the collateral microchannels hardly accessible with instruments and other germicides.

CONCLUSIONS:

Higher proportion of patients treated with ozone oil healed (91 %), compared to those treated with Cresophene (55%).

88 % of patients recovered with ozone oil needed only up to 3 visits. With Cresophene only 5 % healed in this period.

98 % of patients treated with ozone oil healed or improved, while only 87 % of those treated with Cresophene.

No adverse reactions were observed in any patient.

Performed in: UNIVERSITY POLICLINIC & NATIONAL CENTRE FOR SCIENTIFIC RESEARCH.

MATERIALS AND METHODS:

The universe of study comprised 100 patients with diagnostic of dental hyperstesia, at random distributed among two groups.

Treatment:

It was administered as daily topical applications of the medication on the sensitive teeth and the surrounding region up to three weeks. The first application was performed in the initial visit and the patients were instructed to perform it themselves daily at home.

Ozone oil group: Comprised 50 patients receiving ozone oil as topical medication.

Placebo group: Comprised 50 patients receiving common vegetable oil as topical medication.

Patients were visited weekly for evaluation.

Improvement: attenuation of the sensitivity to changes of temperature or mechanical manipulations.

Healing: disappearance of the referred sensitivity.

Table I shows the results achieved along the treatment period. More than half of ozone oil patients were relieved in their symptoms already in the first evaluation (7 days), but none of the placebo patients. Healing was progressively achieved in ozone oil patients up to 91 % at the end of treatment. Improvement was achieved in the remaining 9 % of patients. This results are statistically very significantly different from those of the placebo group.

In placebo patients, at the end of the treatment some effect was observed, which, apart from the placebo effect, could be attributed to some protective effect of vegetal oil on dentine.

Ozone oil proved to be effective for the local treatment of dental hyperstesia.

No complications were observed during the evaluation of treatment.