INTRODUCTION AND BACKGROUND
ON SPELEOTHERAPY AND HALOTHERAPY

Nowadays powerful development of pharmacology and industrial production of medicines encouraged growth of treatment by medication. Simplicity of application, availability and rapid effect provided priority of pharmacotherapy. However, together with therapeutic effect, medicines can cause pathologic conditions that are connected with side effects.

Many allergic conditions and autoimmunal processes are caused by medicines. Furthermore treatment by medication does not restore the own defense mechanisms of the body. This point of view makes physicians turn back to the experience of natural healing factors and carry out investigations in order to find medication-free treatment methods.

Halotherapy ("halos" in Greek means salt) is one of such methods. Halotherapy is the mode of treatments in a controlled air medium that simulates a natural salt cave microclimate.

Treatment in natural salt cave (speleotherapy) has been known for a long time. The efficacy of speleotherapy is associated with the unique cave microclimate. The natural dry sodium chloride aerosol is the major curative factor of the cave microclimate. It is formed by the convective diffusion from salt walls. Other factors such as comfortable temperature and humidity regime, the hypobacterial and allergen-free air environment saturated with aero ions enhance the therapeutic effect.

A suggestion that it is the air saturated with saline dust that causes the main curative effect in the speleotherapy of patients with respiratory diseases was first formulated by a Polish physician F.Bochkowsky in 1843. Salt mines are known to be used for therapeutic purposes in many countries, such as Austria (Solzbad-Salzeman), Rumania (Sieged), Poland (Wieliczka), Azerbaijan (Nakhichevan), Kirgizia (Chon-Tous), the Ukraine: Solotvino, (Carpathians); Artiomovsk (Donietsk region) and others.

Speleotherapy has been acknowledged as a highly effective medication-free treatment method. It is assumed that during the treatment, the organism adapts to the specific features of the microclimate and alters all its functional systems.

However adaptation of the patients who came from different climate areas, travel and transport problems, and limited number of beds kept back its wide spreading. So HT has been worked out.

HT is the method of natural therapy, which takes from Speleotherapy the main healing factor - aero dispersed environment saturated with dry sodium chloride aerosol.

Halotherapy (HT) is a mode of treatment in a controlled air medium that simulates the natural salt cave microclimate. HT is performed in a special room with salt-coated walls and floor - the Halochamber.
Dry sodium chloride aerosol containing particles of 1-5um in size is produced by a special nebulizer and released into the Halochamber. The effect of HT was evaluated in 124 patients with various types of respiratory diseases (bronchial asthma, chronic obstructive and non-obstructive bronchitis, bronchiectasis, cystic fibrosis) in a placebo-controlled clinical trial.
HT resulted in significant clinical improvements as measured by various lung function tests (flow-volume loop parameters, body plethysmography, bronchial resistance) compared to placebo(1). Other studies have reported similar benefits in patients with chronic pulmonary disease(2)(3)(4).
The Russian Ministry of Health approved the Halocomplex Chamber as a medical device in 1995. Most of the published work on Halotherapy has appeared in Russian journals and publications. Summaries and abstracts in English are contained in the additional information package.

(1) Chervinskaya AV, Zilber NA. Halotherapy for treatment of respiratory diseases. J Aerosol Med 1995 Fall;8(3):221-232.
(2) P.P.Gorbenko, Adamova IV, Sinitsyna TM. Bronchial hyperreactivity to the inhalation of hypo and hypersomolar aerosols and its correction by Halotherapy. Ministry of Public Health of the Russian Federation, Russian Pneumological Scientific Society Pulmonology, 1993;3(2).
(3) E.N.Semochkin, V.P. Silvestrov, V.N. Surovikov. Halotherapy: Complex treatment in out-patients with breathing (respiratory tract) pathologies. Kremlin Medicine. Clinical Herald 1999;3.
(4) G.A.Norvaisa, D.Noreikiene.Halotherapy in management of endogenial bronchial asthma. Center of Halotherapy, Pulmonology Department, Hospital Red Cross, Klaipeda, Lithuania. Annual meeting, Interasthma, Palanga, Lithuania, May 28-30, 1999.

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THE TECHNOLOGY

 The Halocomplex consists of a speleoclimatic chamber (walls and floor are covered by rock salt) with the addition of a halogenerator. The special salt covering on the walls acts as a buffer for air moisture and helps maintain the environmental aseptic properties.

Dry sodium chloride aerosol containing particles of 1-5 um in size is produced in this room by a special nebulizer, the halogenerator, the device which pushes air containing this aerosol into the chamber.

The halogenerator has a microprocessor that monitors and maintains the temperature, relative humidity and mass concentration of aerosol in the chamber. In contrast to Speleotherapy, that relies only on the natural salt provided on the walls of the chamber, Halotherapy provides a specified concentration of dry salt aerosol under controlled conditions of temperature and relative humidity, while regulating the size and speed of the dry sodium aerosol particles.
The halocomplex controls and maintains the concentration of highly dispersed aerosol at four pre-set levels (level I to IV), providing a concentration of dry sodium chloride between 1 to 16 mg/m³

Fractions of dry sodium chloride aerosol in the Halochamber
(according to the data of optical devices)

The halogenerator is situated in the interconnecting room and brings a flow of clean, dry air, saturated with highly dispersed particles of sodium chloride into the therapeutic room.

Recommended composition of rock salt for Halotherapy:

This environment has stable humidity (relative air humidity 40-60%) and stable air temperature (18-24°C). These parameters create comfortable conditions for patients and promote a stable aerosol environment.

A stable hypoallergenic, hypobacterial environment is maintained in the therapeutic room. The assessment of the microbial contamination during a session of Halotherapy proves that 1m3 contains from 90 to 130-200 saprophytic microorganisms (according to WHO standards on air sterility, 1m3 should contain less than 300 microbial bodies). Microflora content returns to its initial level 10-20 minutes after the session is completed.

Generic Name
Dry saline aerosol inhalation in a microclimate chamber

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INDICATION FOR USE

To relieve the symptoms of the following conditions:

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MECHANISMS OF ACTION

 The main effective factor is a curative breathing environment, which is saturated with dry sodium chloride aerosol at a mass concentration varying from 1-16 mg/m3 with a particle size of 1-5 um. Particle size is optimal for penetration in all sections of the respiratory tract. Dry sodium chloride aerosol has a considerable level of negative charge of the particles (6-10 nK/m3). The inner surfaces of airways have a slight positive charge. Negatively charged particles of dry sodium chloride aerosol move in the lumen of respiratory tract and settle more intensively compared to neutral particles. In addition, the negative charge increases aerosol stability. Thus dry aerosol action is much more effective than one that is moist.

 The use of dry aerosol allows the creation of the optimal temperature and humidity parameters in the curative chamber, thus avoiding respiratory tract mucus edema and bronchial spasm - common reactions in patients when moist aerosols are used. Furthermore, the dose of sodium chloride received by the patient within a 1-hour Halotherapy session is less than the dose received while inhaling moist sodium chloride aerosol.

 The positive effect of Halotherapy could be explained in the following way:
 One of the pathogenesis mechanisms of obstructive lung diseases is the mucocellular clearance disturbance. Sodium chloride aerosol improves reological properties of the airway's content and normalizes mucocellular clearance. Sodium chloride is necessary for normal functioning of the bronchial ciliated epithelium, whereas the sodium chloride content in the bronchial secretion of patients with chronic lung diseases decreases. Due to the aerosol's curative influence, the beneficial effects in improving respiratory tract drainage function are evident during Halotherapy: relief of sputum expectoration, reduction of sputum viscosity, relief of coughing and positive changes in the auscultator picture of the lungs.

 Sodium chloride aerosol provides bactericidal and bacteriostatic effect on respiratory tract micro flora and stimulates alveolar macrophage reactivity, facilitating the increase of phagocyte elements and their activity.

Cytobacteriological research of bronchial and nasopharyngeal content of patients with asthma, chronic obstructive bronchitis and cystic fibrosis demonstrate the fact that Halotherapy promotes the reduction of neutrophils and pathogenic microorganisms and increases alveolar macrophages. Its inhibitory effect on growth and vital capability of microorganisms is accompanied by loss of their pathogenic properties and by adaptation to changed conditions.

This adaptation, due to the loss of fluid, leads to the enhancement of their hydrophobic properties, facilitating attachment to epithelial cells. However, the activation of microbial adhesion does not occur due to the increase of epithelial cell's electrophysiological functional activity. Moreover, the colonization resistance of epithelial cells is enhanced under the effect of dry sodium chloride aerosol.
This indicates its favorable action on the protective properties of respiratory tract cells and activation of non-specific body defense.
Superficial skin autoflora of most of the patients normalizes after Halotherapy sessions. Halotherapy effects positively on humoral and cellular immunity of the patients with chronic lung diseases. The reduction of IgE levels after Halotherapy in patients with asthma is especially important.

Optimal temperature and humidity, hypoallergenic and hypobacterial air medium are maintained in the Halochamber. Breaking patient contact with pathogenic external air factors has an additional positive influence on the organism.

The mechanisms of action of Halotherapy are many-fold:
• mucolytic
• antibacteriologic
• antiinflammatory
• immunomodulating
• hyposensibilizing

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EFFICACY

Annual meeting, "Interastma", Palanga, Lithuania, May 28-30, 1999

Abstract

HALOAEROSOL THERAPY IN THE REHABILITATION OF ASTHMA PATIENTS

A.V.Chervinskaya, S.l.Konovalov
Clinical Research Respiratory Center, St. Petersburg, Russia

The use of natural physical factors has a great significance in asthma patients' rehabilitation. The atmosphere of salt cave is the main curative factor of the haloaerosol therapy (HT) method.
The controlled air medium with the respirable particles of dry salt aerosol is created in an ordinary room with special equipment. Density of aerosol depends on nosology, clinical features and FEV1 (0,5-1; 1-2; 3-5; 7-9 mg/m3). Other factors are comfortable temperature and humidity, and hypobacterial and allergen-free air medium.

The HT method was sanctioned by the Russian Ministry of Public Health in 1990. To study the efficiency of HT, the data were collected from 15 Russian hospitals (during 1991-1994). We have evaluated the results of HT in 4780 adults and children with various types of pulmonary diseases. HT course consisted of 10-20 daily procedures of 1 hour.

The HT results were assessed by physicians on the basis of clinical symptoms, functional parameters and the dosage of medication dynamics with the use of standard questionnaires.
HT resulted in improvement of clinical state in 85% of mild and moderate asthma cases, 75% of severe asthma cases and 97% of chronic bronchitis and bronchiectasis cases. Long-term examination of patients (for one or more years) demonstrated the effect of HT on reduction in the frequency of exacerbations and reduction in chronic symptoms.

Clinical trial published in the Journal of Aerosol Medicine (1995) is attached.

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SAFETY

Rare side effects
Slight skin itch and skin irritation appearing as a small punctate skin rash are observed in some patients after Halotherapy sessions. These effects usually disappear after 3-5 sessions. In cases where a throat tickle occurs, gargling with boiled water is recommended. Conjunctivitis may occur due to irritation of the mucous tunic of the eye during Halotherapy sessions. It is recommended to instill eye drops (sulfacetamide solution) for 5-7 days in order to stop inflammatory process and have the patient keep their eyes closed during Halotherapy sessions.

Drug interactions
Not known.

CONTRAINDICATIONS

The following are the primary contraindications:

COMPLIANCE

Factors that increase compliance:

 - This is a gentle treatment with rare temporary minor side effects (e.g. itchy skin, throat tickle).
 - Treatment benefits usually last up to 6-12 months, sometimes longer.
 - There is a very pleasant environment during the treatment - client sits in a comfortable armchair, in a cave-like room, inhaling air saturated with salt aerosol. The treatment is accompanied by relaxation music.
 - No additional costs are involved (e.g. supplements, etc.).
 - Treatment cost is reasonable, sometimes insurable.
 - The clinic has health care professionals on staff to recommend the appropriate course of treatment and monitor the client throughout.
 - Spirometry measurements are done to compare the lung function before and after the treatment.

Factors that might decrease the compliance:

 - Frequency of the treatments - it is generally recommended to have one treatment per day for 2 weeks, although number of clients who must have them less often still benefit from the treatments.

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