Clinical Study on Salt Therapy as a Respiratory Remedy
Chervinskaya, A. & Zilber N.(1995) Halotherapy for the Treatment of Respiratory Diseases. Journal of Aerosol Medicine 8(3): 221-232
Salt Therapy was administrated in a group of 124 patients (54 males and 70 females) aged from 16 to 62 years with various types of chronic nonspecific pulmonary diseases. In all of the patients (pts), the disease was in the stage of a prolonged exacerbation. Before the treatments 95% of the pts of the main group had been coughing, half of them (47%) had severe attacks of coughing with scanty viscous sputum. Most of the pts (81%) suffered from attacks of asthma so that one third of them used combined medication to control it. Auscultation revealed harsh and weakened breathing, and dry rales in 58% of the patients.
60% of the pts received a base therapy (beta-agonists, theophyllines, chromoglycate natrii, corticosteroids, etc.), the effect of which was insufficient and did not allow to achieve a complete remission. The pts had not taken any antibacterial medicine.
The control group was represented by 15 pts (7 females and 8 males) aged from 18 to 56 years. Placebo course consisted only of 10 procedures of musical psychosuggestive program with slides demonstration in an ordinary room.
The pts’ condition was assessed by daily medical supervision, with functional and laboratory tests made before and after Salt Therapy, as well as every 7th day during the treatments. Series of examinations in the control group consisted of the tests similar to those for the main group of pts.
Disease # Patients
Bronchial asthma 87
Chronic bronchitis 26
Cystic fibrosis 5
Total patients 124
After 3-5 sessions of Salt Therapy 70-80% of the pts (according to nosology) presented some improvements: expectoration of good amount of sputum- it was less tenacious and easier to discharge, better auscultator pattern of the lungs, less frequent occurrence of cough attacks or respiratory discomfort. Some pts with severe and moderate bronchial asthma (BA) (35 patients – 27% of the total number) experienced difficulty in brining up the phlegm and worsening of cough during 3-4 days after 3-4 sessions. These manifestations seem to be due to the temporal bad bronchial drainage resulting from hyper secretion of mucus and discharge of old clots of secretion from bronchi of smaller diameter. Expiratory dyspnea appeared or became more pronounced in 18 patients (15% or cases) at different periods of Salt Therapy. Those were mainly the patients with exercise-induced asthma and aspirin-induced asthma. None of the pts complained of bad condition during the Salt Therapy procedures.
By the end of the course of Salt Therapy all the pts felt better they slept well, had no fatigue or weakness, and their nervous system stabilized. Clinical symptoms analysis demonstrated that the number of asthma attacks and respiratory discomfort cases decreased significantly as compared to the initial ones (81% and 52%, respectively, p<0.001). The number of asthma attacks controlled by combined medication also decreased (32% and 2%, respectively, p<0.001).
The cases of coughing occurred more rarely (95% and 70%, respectively, p<0.001), coughing became easier and more productive, the amount of sputum reduced, it became mucousal. The number of the patients with signs of vasomotor rhinitis decreased (61% and 24%, respectively p<0.001).
Corticosteroids were discontinued in 50 % (11 pts) of the pts with corticosteroid therapy (22 pts). Those were the cases when inhaled corticosteroids were prescribed as anti-inflammatory agents. In 7 patients it was possible to reduce the dose, 41 patients (60% of pts who inhaled beta- agonists) were able to discontinue beta-agonists or reduce the dose. Reduction (or cancellation) in bronchodilator and inhaled corticosteroid consumption was an indicator of clinical benefit.
The clinical state of 85% of the patients with mild and moderate BA, 75 % with severe BA, 98%- with chronic bronchitis, bronchiectasis and cystic fibrosis improved after Salt Therapy. The patients were examined 6 and 12 months after the first Salt Therapy course. No aggravations of the disease were seen from the 3rd to the 12th month. The average duration of the remission was 7.6-0.9 m. Most of the patients (60%) used no medication and sought no medical advice.
New England Journal of Medicine and Cystic Fibrosis
According to the n engl j med 354;3 http://www.nejm.org january 19, 2006, in an article titled A Controlled Trial of Long-Term Inhaled Hypertonic Saline in Patients with Cystic Fibrosis, persons who utilized hypertonic saline missed fewer days of school and work than those in the control group, had improved symptoms. Additionally, quoted from their study:
The primary outcome measure, the rate of change (slope) in lung function (reflected by the forced vital capacity [FVC], forced expiratory volume in one second [FEV 1],and forced expiratory flow at 25 to 75 percent of FVC [FEF 25–75]) during the 48 weeks of treatment, did not differ significantly between groups (P = 0.79). However, the absolute difference in lung function between groups was significant (P = 0.03) when averaged across all post-randomization visits in the 48-week treatment period. As compared with the control group, the hypertonic-saline group had significantly higher FVC (by 82 ml; 95 percent confidence interval, 12 to 153) and FEV 1 (by 68 ml; 95 percent confidence interval, 3 to 132) values, but similar FEF 25–75 values. The hypertonic-saline group also had significantly fewer pulmonary exacerbations (relative
reduction, 56 percent; P = 0.02) and a significantly higher percentage of patients without exacerbations (76 percent, as compared with 62 percent in the control group; P = 0.03). Hypertonic saline was not associated with worsening bacterial infection or inflammation.
Hypertonic saline preceded by a bronchodilator is an inexpensive, safe, and effective additional therapy for patients with cystic fibrosis. (ClinicalTrials.gov number, NCT00271310.)
Effects of Halotherapy on free radical oxidation in patients with chronic bronchitis[Article in Russian]
Farkhutdinov UR, Abdrakhmanova LM, Farkhutdinov RR.
Registration of luminol-dependent chemoluminescence of blood cells and iron-induced chemoluminescence of the serum was used to study generation of active oxygen forms and lipid peroxidation in patients with chronic bronchitis (CB). 49 patients with lingering CB showed inhibition of blood cell function and enhancement of lipid peroxidation. The addition of halotherapy to combined treatment of these patients promoted correction of the disorders and improvement of CB course.
Selected Studies from Dr. Alina Chervinskaya – a leading Halotherapy expert
Chervinskaya A., Ponikowska I. Halotherapy for treatment of patients with chronic obstructive pulmonary diseases// Acta Balneologica. – 2011. – LIII, N3 (125). – P.190. Aim of the study: The main objective was to estimate the efficacy of inhaled dry sodium chloride aerosol (DSCA) in rehabilitation therapy (RT) of patients with COPD. Objects and methods: It was double-blind placebo study. 72 patients (pts) with moderate and mild stage of COPD were recruited. They were randomized in 2 groups – interventional group (IG) (21 m, 18 f, 60.3±10.8 yrs) and control group (CG) (22 m, 11 f, 58.5±8.9 yrs). All patients received RT: daily procedures of chest massage, light radiation, physical exercises. Pts of IG were treated with the DSCA (45 min twice a day for 14 days). DSCA containing particles with size of 1-5 µm and level of mass concentration in the room of 10-15 mg/m3 was produced by halogenerator GDA-01.17 (Halomed UAB, Lithuania). CG received placebo (inhalations with room air) instead of DSCA. Clinical, functional parameters and measures of health-related quality of life (HRQL) by SF-16 and LCQ (10 items) were estimated after RT procedures and in 3 months. Results: Improvements of clinical symptom scores were observed in the both groups after the course of RT (p<0.05), but in 3 months positive effect was noticed only in IG (before – 13.8±5.4, after RT – 9.1±4.9, in 3 months – 9.6±4.3, p<0.05). Measures of LCQ were changed significantly after RT only in pts of IG, received DSCA (35.2±5.2 and 52.4±6.3, p<0.05). Positive changes of physical functioning measures were observed (SF-16) in IG and CG groups after RT, but they have been kept till 3 month only in IG. Conclusions: Application of inhalations of DSCA on the background of the RT in pts with COPD renders to positive effect.
Chervinskaya A. V. Effect of dry sodium chloride aerosol on the respiratory tract of tobacco smokers // The Europ. Respir. Journ.-Abstracts 16th ERS Annual Congress, Munich, Germany, September 2-6, 2006. – P. 106s-107s. The aim was to study influence of dry sodium chloride aerosol (DSCA) on the respiratory tract of tobacco smokers. 47 males were examined. They had the productive cough associated with smoking. The test group (TG) (24 male, 49.9±1.2 yrs; 27.0±1.7 pack/years) was treated with the DSCA (14 procedures). 20 procedures (10 min daily) were given using inhaler Haloneb®, producing DSCA with particles size of 1-5 μm and 0.5 mg/min density. The placebo group (PG) (23 male, 49.5±1.5 yrs; 27.9±2.3 pack/years) received inhalations with plain air. 88% of smokers of TG by the end of inhalation course reported easier and/or decreased cough, changes in the character of sputum, which became lighter and clearer. Improvement in the character of sputum was noted only 22% volunteers of PG (p<0.001). Cytobacteriologic study of brush bioptates taken from pharyngeal mucosa was carried out before and after procedures in the both groups. It was determined that the infection index (II – % of epitheliocytes with adhered cells of S. pneumoniae) and adhesion index (AI – the mean number of microbial cells per one epitheliocyte) decreased significantly in the TG (II before – 28.1±5.8 and after – 7.8±2.7%, p<0.01; IA before – 45.4±11.3 and after – 13.9±6.3 microbe cells, p<0.01). The amount of IgA in epithelial cells of the oropharyngeal micosa (estimated by indirect method of fluorescent antibodies) increased significantly in the TG (before – 1.5±0.9 and after – 2.0±0.5, p<0.05). There were no significant changes at these indexes in the PG. Conclusion: DSCA relieves the main symptoms (character of cough and sputum), improves local defense mechanisms and resistance of mucous membranes of tobacco smokers owing to decreased colonization activity of pathogenic microgerm.
Chervinskaya A.V., Alexandrov A.N., Konovalov S.I. Application of dry rock salt aerosol in case of common cold // XYI Congress of the European Rhinologic Society. VII Congress of the International Rhinologic Society. Week of the Nose: Abstract Book.- 1996. – P. 104. 17 patients with common cold underwent dry rock salt aerosol (DRSA) therapy. DRSA with particles size of 1-5 mkm and high negative charge is the main curative factor of Halotherapy (HT). Density of aerosol depends on nosology, clinical features and FEV1 (0.5-1; 1-2; 3-5; 7-9 mg/m3). HT is drug-free method, which simulates natural salt cave microclimate. There were two ways of DRSA administration: in the room with the controlled air medium which is created with special equipment; the inhalation through nasal mask of individual inhalator. The method of HT was sanctioned by the Russian Ministry of Public Health in 1990. It has been known that DRSA improves rheological properties of the airways contents, decreases edema of bronchial and nasal mucosa, it has a bactericidal action, enhances functioning of alveolar macrophages. Other factors are comfortable temperature and humidity, hypo bacterial and allergen free air medium. The common cold patients’ condition was assessed by daily clinical observation, functional and citobacteriological tests. In all cases we registered cold clinical symptoms disappear faster than in control group. The improvement in clinical state was accompanied by positive dynamics of laboratory tests.
Chervinskaya A., Alexandrov A., Strashnova O. Effect of dry sodium chloride aerosol in patients with bronchial asthma // Allergy & Immunology (abstr. Interasma 95). – 1995. – V. 27, N. 7.- P. 221. The effect of dry sodium chloride aerosol (DSCA) was evaluated in 125 patients (pts) with bronchial asthma (44 M,81 F, mean age 34.3+2.5 years). 60% of pts received a base medication without full effect. The control group of15 pts(8M,7F, mean age 38.4+1.5 years) received placebo. Treatment was performed in a special room with salt coated walls. The pts breathed quietly while reclining in chairs. DSCA containing the dominating amount of 2 to 5 mkm particles was produced by special nebulizer. The aerosol mass concentration (from 0.5 to 5 mg/m3) was prescribed according to the type of the disease. The DSCA course comprised 10-20 daily one hour procedures. Clinical symptoms analysis demonstrated that the number of asthma attacks decreased significantly. The cases with cough occurred more rarely, cough became easier and more productive. Reduction in bronchodilators and inhaled corticosteroid consumption was an indicator of clinical benefit. The pts showed significant increase of FVC, FEV1, PEF, FEF50 and decrease of Raw by the end of the treatment. The changes in control group parameters after placebo were not statistically significant. The pts were examined 6 and 12 months after the DSCA course. The average duration of remission was 7.6+0.9 months.
Chervinskaya A.V., Silber N.A., Alexandrov A.N. Halotherapy for treatment of bronchial asthma (abstract) // XIV World congress of asthmology – Interasma 93, Israel. – 1993. – P. 59. Halotherapy (HT) is a method of treatment under conditions of artificial salt cave microclimate. Therapeutic effect is stipulated by air-dispersed medium saturated with dry sodium chloride aerosol containing the dominating amount of 2 to 5 micron particles. Particle density (1-5 mg/m3) varies depending on the type and stage of the disease. The other factors – comfortable humidified temperature regime, the hypo bacterial and allergen free environment saturated with air-ions enhance the therapeutic effect. Seventy-one patients (25M, 46F, average 39.1±2.4 years) with various types of asthma were treated by HT. The drug treatment of 60% patients did not give full effect. A control group of 15 patients (8M, 7F, average 38.4±1.5 years) received placebo. The HT course comprised of 10-20 daily one hour procedures. Treatment was conducted in a special room. No side effects were observed during the course of HT. The clinical state of 85% patients with mild and moderate and 75% patients with severe asthma improved after HT. Forty seven percent of patients required fewer doses of drugs. The improvement in clinical state of patients was accompanied by positive dynamics in lung function tests. The changes in control group parameters after HT were not statistically significant. Thus, the results of HT application demonstrated its efficacy.
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