WO2017086899A1

WO2017086899A1 - An aromatherapeutic oil mixture for relieving itching in the treatment of uremic pruritus

Info

Publication number: WO2017086899A1
Application number: PCT/TR2016/050448
Authority: WO
Inventors: Mehtap KAVURMACI; Mehtap TAN
Original assignee: Ataturk Universitesi Bilimsel Arastirma Projeleri Birimi
Priority date: 2015-11-17
Filing date: 2016-11-16
Publication date: 2017-05-26

Abstract

The invention relates to an aromatherapeutic mixture consisting of lavender oil, tea tree oil, and at least one carrier oil, to be used for relieving uremic itching in hemodialysis therapy.

Description

An Aromatherapeutic Oil Mixture for Relieving Itching in the Treatment of Uremic

Pruritus

DESCRIPTION

Technical Field

The invention relates to the use of the combination of aromatherapeutic oil mixture consisting of lavender, tea tree, and at least one carrier oil, in the treatment of uremic pruritus. The invention particularly relates to a combination which relieves uremic pruritus encountered in patients receiving hemodialysis therapy.

State of the Art

End-Stage Renal Disease (ESRD) is defined as an irreversible deterioration of the regulation of fluid-electrolyte balance and metabolic and endocrine functions of the kidney.^{1 2} In Turkey, where the number of patients with ESRD has increased dramatically, out of 66,71 1 patients with ESRD, 52,675 receive hemodialysis therapy according to the records of the Society of Nephrology dated 2013.³ The most common way of treating the patients with ESRD is the procedure in which the blood drawn from the patient is re-given to the patient after being freed of liquid and metabolic wastes by means of hemodialysis machine.^{1 2} Hemodialysis is a life-saving treatment for patients with ESRD. However, despite the developments in hemodialysis, it is a treatment method causing complications in a non-negligible frequency. The most important of these complications is itching, affecting approximately 75-85% of the cases undergoing hemodialysis.^{4 5}

The itching in ESRD is known as uremic pruritis. Although the causes of uremic pruritis are not completely understood today, the following are emphasized: uremia, accumulation of various harmful micro particles affecting peripheral nerves on the surface of the skin, medicaments, changes in skin pH level, skin dryness, increase in plasma histamine level, as well as the susceptibility to the tools used during hemodialysis, dialysate, and the agents used for sterilization.⁶⁷ The severity of itching varies from one patient to another, being typically the most severe during and immediately after hemodialysis. Uremic pruritus is an important problem that lowers the patients' quality of life and negatively affects sleeping- resting, social life, body image, and emotional health of the patients, with the accompanying risks of impairing skin complexion and causing infection due to scrubbing, scratching, and scarring.⁸ The treatments used for uremic pruritis until today are as follows; antihistaminic drugs, increasing the frequency of hemodialysis, heparin, active carbon, cholestyramine, sodium, lidocaine, nicergoline, ketotifen, naloxone, neurotrophin, magnesium-free dialysis, hemoperfusion, parathyroidectomy and erythropoietin treatment.⁶

Among these, the most frequently used treatment method in uremic pruritis is the administration of antihistaminic drugs via oral route. Antihistaminic drugs are only effective in mild and moderate uremic pruritis cases. They are, however, less effective in persistent and severe cases.¹⁰

Another method for itching treatment is increasing the frequency of hemodialysis, which increases uremic pruritis in some patients while leading to no changes in the others.⁶

On the other hand, in heparin therapy, itching may be increased in patients with uremic pruritus undergoing hemodialysis due to the allergic reaction against bovine and swine heparin.¹¹

Uremic pruritis has a poor image because of its complex etiology and ineffective treatment options, in addition to the possibility of causing side effects, the cost and complexity thereof, and the limitations in human life. Therefore, the patients seek alternative methods for treating itching.

As a result, due to the aforementioned drawbacks and insufficiency of the existing solutions with regard to the subject matter, a development in the aromatherapeutic oil mixture has deemed necessary in the related technical field.

Objects of the Invention

The present invention relates to an aromatherapeutic oil mixture for relieving uremic pruritis, which will meet the needs mentioned above, eliminate all the disadvantages, and provide some other advantages.

The primary object of the invention is to apply the aromatherapeutic combination consisting of lavender, tea tree, and carrier oils to the patients receiving hemodialysis therapy due to End Stage Renal Disease and suffering from uremic itching, by means of applying to the areas of the patient's skin with itching problems. Hence, the itching of the patients is relieved. An object of the invention is to obtain the lavender, tea tree, and carrier oils, which together form the present combination, from essential oils that are both herbal and have the least toxic effect. It is thus aimed that said combination does not cause side effects. Another object of the invention is that said oil combination makes the patient relieved and refreshed owing to the pleasant aromatic scents thereof.

Yet another object of the invention is that the cost of the treatment method with the combination consisting of lavender, tea tree, and carrier oils is considerably lower than the other treatment methods used in the state of the art.

A similar object of the invention is to assist in preserving skin complexion and preventing infections since said oils are not only antiseptic, but they nourish and moisturize the skin as well.

In order to achieve the aforementioned objects, the invention is an aromatherapeutic mixture which relieves uremic pruritus, characterized by comprising lavender oil, tea tree oil, and at least one carrier oil. The structural and characteristic features and all advantages of the invention will be understood more clearly by referring to the following figures and the detailed description written with reference to these figures; therefore, the evaluation needs to be done by taking these figures and the detailed description into consideration. Figures for a Better Understanding of the Invention

Fig. 1 : The graphical view representing the results of the comparison between pretest- posttest itching scores of experimental and control groups, to which the combination according to the invention is applied. The drawings do not necessarily need to be scaled and the details that are not required for understanding the invention may have been omitted. Apart from that, the elements that are at least substantially identical or have at least substantially identical functions are referred with the same reference number. Detailed description of the invention

In this detailed description, the preferred embodiments of the aromatherapeutic oil mixture relieving uremic pruritis according to the invention will only be described in order for the subject matter to be better understood, without any limitations.

In order to alleviate uremic pruritis, the invention provides the combination of an aromatherapeutic oil mixture that consists of the essential oils of lavender and tea tree, as well as at least one carrier oil. A characteristic of the invention is that it is a combination that relieves uremic pruritis in patients undergoing hemodialysis therapy.

The ingredients and their ratios (%) in the combination according to the invention:

Raw Materials and their Properties:

Essential oil:

• Lavender Oil: It is an essential oil which has the least toxic and allergic effect of all the essential oils and which is used in various dermatological problems.

Lavender oil is used by being diluted with sweet almond oil in dermatological problems including bug bites, cuts, wounds, burns, bruises, spots, allergies, eczema, etc. due to its wound healing and antiseptic characteristic.¹³'¹⁴ There exist many studies in literature reporting that lavender oil is effective against bacteria and fungi species.^{15 16}

It is preferred in the combination according to the invention due to the anti-allergic and antiseptic effect thereof.

• Tea Tree Oil: It is known as a refreshing, immune system supporting, and a very potent antiseptic.

It is used for cleaning infected wounds and cuts by being mixed with jojoba oil and assists in healing the scars in the tissues, helping the skin to heal.^{13 14} The dermatological studies conducted using tea tree oil found better results and less side effects compared to conventional therapies in acne, dandruff, head lice, and recurrent herpes labialis. It is preferred in the combination according to the invention due to the refreshing and antiseptic effects thereof.

Carrier Oil: It includes almond oil, jojoba oil, olive oil, hazelnut oil, walnut oil, or sunflower seed oil individually or in combination.

• Almond Oil: It has softening, nourishing, and renewing effects on the skin.^{13 14}

It is preferred in the combination according to the invention as it nourishes and moisturizes the skin.

• Jojoba Oil: It protects the skin against detrimental effects of the environment since it serves as a pH stabilizer.

It has cell renewing and anti-allergic features.^{13 14} It is preferred in the combination according to the invention due to these properties thereof.

• Olive Oil : It is an oil rich in vitamin E, has antiseptic characteristic, nourishes and renews the skin.^{13 14} It is preferred in the combination according to the invention due to these properties thereof. · Hazelnut Oil: It easily penetrates into the skin, nourishing it deeply.^{13 14} It is preferred in the combination according to the invention due to these properties thereof.

• Walnut Oil: It has skin-nourishing property, refreshes and soothes the skin.^{13 14} It is preferred in the combination according to the invention due to these properties thereof.

• Sunflower Seed Oil: it nourishes the skin, prevents infections, at the same time it is rich in vitamin E.^13/14 It is preferred in the combination according to the invention due to these properties thereof.

The use of aromatherapy in dermatology is developing rapidly around the world. It has been found in many studies that aromatherapy oils have beneficial effects in various dermatological diseases including itching, psoriasis, eczema, head lice, hair loss, and so on.^18"20

Nevertheless, the combination according to the invention is used for relieving uremic itching in terms of both the raw materials comprises therein and the ratios (%) of these raw materials. The oils used in the aromatherapeutic mixture according to the invention are less allergic in terms of effects and shows its action at a shorter time. As the mixture is made homogeneous by means of vibration method, it is possible to benefit from the effects of the oils to the desired extent.

Production method of the combination according to the invention:

• Mixing the lavender and tea tree oil at a ratio of 1 :1 ,

• To the resulting lavender and tea tree oil mixture, adding carrier oil at a ratio of 4:1 , thereby diluting and preparing the mixture, and

• Agitating the prepared oil mixture well enough until obtaining an homogeneous mixture.

In the preferred embodiment of the invention, vibration system is used for allowing the oils with different densities within the prepared oil mixture to be mixed homogeneously.

A pH meter is used for determining whether the pH of the resulting oil mixture is suitable for the skin or not. pH is adjusted as 5.5-6.5 and a mixture suitable for skin pH level is prepared. The combination according to the invention, subsequent to being produced at room temperature, is stored in light proof glass bottles at room temperature in order that the oils inside the mixture will not decompose and that the oils will be prevented against such factors as heat, light. It is important that the invention is tested, prior to use, by applying a small amount on a small area of the patient's forearm against the likelihood of developing any possible allergic reaction. The areas of application need to be gently wiped and cleaned with warm water using cotton or pad prior to application so as to clean the skin surface and allow an easy absorption of essential oils before applying the invention.

The invention should be applied the itching areas (except the arm with fistula) of hemodialysis patients suffering from itching for 7-15 mins for each area with 3-4 mL of oil by massage, and this application should continue for at least 6 weeks. For facilitating the application of the prepared mixture onto the skin, it is required to use spray glass bottles.

Experimental Study and Results:

An experimental study was performed with pretest-posttest control groups in order to better evaluate the effect of the invention on itching and to increase the reliability of research results. The combination according to the invention was applied to the itching areas (without applying on the arm with fistula) of the patients in the experimental group for three times a week during 6 weeks, simultaneously with the dialysis session by the investigator. The patients in the control group continued their routine care in the clinic, with no intervention in these patients by the investigator to apply the combination. At the end of the research period, it was found that the itching scores, mean posttest scores, of the patients in the experimental group to whom the oil mixture according to the invention was applied were much lower than the mean posttest scores of the patients in the control group and the difference between the groups was statistically significant. Said result is also graphically shown in Fig. 1 .

REFERENCE LIST

1 . Eng N, Uysal H (2014) Diyaliz Tedavisi ve Hemsirelik Bakimi: ig Hastahklari Hemsireligi.

N Eng (Ed), Istanbul, Nobel Tip Kitabevleri, p. 248-250.

2. Karaca A, Yesiltepe G (2013) Llriner Sistem Hastahklari ve Bakim: ig Hastahklari Hemsireligi. Z Durna (Ed), Istanbul, Akademi Basin, p. 441 -496.

3. Registry of The Nephrology, Dialysis and Transplantation in Turkey. Registry (2013) http://www.tsn.org.tr/folders/file/tsn_registry_2012.pdf (access: March 1 1 , 2015)

4. Kavurmaci M (2015). Prevalence of uremic itching in patients undergoing hemodialysis.

Hemodialysis International DOI:10.1 1 1 1 /hdi.12301 5. Mettang T, Kremer AE (2014). Uremic pruritus. Kidney Int doi: 10.1038/ki.2013.454.

6. Asicioglu E, Kahveci A, Kog M, Ozener C (201 1 ) Uremic pruritus: Stil itching. Turk Neph Dial Transpl, 20(1 )7-13. 7. Buddenkottel J, Steinhoff M. Pathophysiology and therapy of pruritus in allergic and atopic diseases. Allergy 2010; 65: 805-821 .

8. Akar A, Gur AR. Llremik kasmti. Turkderm 2000; 34: 21 1 -215. 9. Aygeman N. Aromaterapi. Konya: inci Ofset;2008.p.1 1 -131 .

10. Nasrollahi AR, Miladipour A, Ghanei E, Yavari P, Haqhverdi F. Montelukast for treatment of refractory pruritus in patients on hemodialysis. Iran J Kidney Dis, 2007; 1 (2): 73-77. 1 1 . Zucker I, Yosipovitch G, David M, Gafter U, Boner G. Prevalence and characterization of uremic pruritus in patients undergoing hemodialysis: Uremic pruritus is still a major problem for patients with end-stage renal disease. J Am Acad Dermatol, 2003; 49 (5) :842-846 12. Zeynalov Y. Nag bitkiler. Aden Yayincihk. 2001

13. Ozata N. Fitoterapi ve Aromaterapi. First Edition. Istanbul: Aritan Yaymevi. 2006. Ebecioglu N. Saghgimiz igin yararh bitkiler. Istanbul: Remzi Kitabevi. 2001 Lis-Balchin M, Hart S. Studies on the mode of action of the essential oil of lavender (Lavandula angustifolia P. Miller). Phytother Res 1999; 13: 540-542. Hammer KA, Carson CF, Riley TV. Antimicrobial activity of essential oils and other plant extracts. Journal of Applied Microbiology 1999; 86: 985-990. Carson CF, Ashton L, Dry L, Smith DW, Riley TV. Melaleuca alternifolia (tea tree) oil gel (6%) for the treatment of recurrent herpes labialis. J Antimicrob Chemother 2001 ; 48:

450-451 . Anderson C, Lis-Balchin M, Kirk-Smith M. Evaluation of massage with essentialoils on childhood atopic eczema. Phytother Res 2000;14(6):452-6. Ro YJ, Ha HC & Kim CG (2002) The effects of aromatherapy on pruritus in patients undergoing hemodialysis. Dermatology Nursing 14, 231 -56. Herro E, Jacob SE. Mentha piperita (peppermint). Dermatitis 2010; 21 : 327-329.

Claims

1. An aromatherapeutic mixture for relieving uremic itching, characterized by comprising lavender oil, tea tree oil, and at least one carrier oil.

2. An aromatherapeutic mixture as in Claim 1 , characterized by comprising lavender oil 10- 20% by weight, tea tree oil 10-20% by weight, and carrier oil 60-80% by weight.

3. An aromatherapeutic mixture as in Claim 1 , characterized in that said carrier oil is selected, individually or in combination, from the group comprising almond oil, jojoba oil, olive oil, hazelnut oil, walnut oil, or sunflower seed oil.

4. The production method of an aromatherapeutic mixture for relieving uremic itching, characterized by comprising the process steps of: a) mixing lavender oil and tea tree oil, and

b) adding, to the thus mixed and prepared lavender oil and tea tree oil mixture, at least one carrier oil, and obtaining a homogeneous mixture.

5. An aromatherapeutic mixture as in Claim 4, characterized in that said mixture of step a) has a ratio of 1 :1 .

6. An aromatherapeutic mixture as in Claim 4, characterized in that said mixture of step b) has a ratio of 4:1 .

7. The production method of an aromatherapeutic mixture as in Claim 4, characterized by comprising lavender oil 10-20% by weight, tea tree oil 10-20% by weight, and carrier oil 60- 80% by weight.

8. The production method of an aromatherapeutic mixture as in Claim 4, characterized in that said carrier oil of step b) is selected, individually or in combination, from the group comprising almond oil, jojoba oil, olive oil, hazelnut oil, walnut oil, or sunflower seed oil.

9. The production method of an aromatherapeutic mixture as in Claim 4, characterized in that said mixture is mixed homogeneously by means of a vibration system.

10. The use of the mixture consisting of lavender oil, tea tree oil, and at least one carrier oil for relieving uremic itching.