Research on the effectiveness of the Alfa OXY Spa capsule’s application in complex rehabilitation programs for addict patients (alcoholics and heroin addicts)
Preliminary results Glazachev Oleg, PhD., MD; Grigoriev Igor, PhD, MD; Dudnik Helena, MD; Yartzeva Ludmila
ALFA SPA Company P.K.Anokhin Research Institute of Normal Physiology Moscow, Russia, August 2004 – April 2005
Principal idea: The use of complex rehabilitation technologies applied in Alfa OXI SPA Capsule for the activation of detoxification processes, natural healing, recreational processes which in cooperative individually combined regimens may bring very tremendous health effects for drug and alcohol dependent patients in the stage of abstinence.
The use of Alfa OXI SPA Capsule may be rather relevant to be included in complex rehabilitation
program for addicts, alcohol abusers for the increase of the treatment efficiency.
Set of physiotherapeutic methods – infrared hyperthermia (to 800C), vibrational massage,
aromatherapy,monochromic light therapy, music-therapy, oxygen therapy general and local.
DESIGN OF THE STUDY
Number and general characteristics of the patients to be involved randomly to the study:
Two test groups, 15 patients in each:
1-st group — alcoholics (age 25 — 50 years)
2-nd group — heroin addicts (age 18 – 35 years)
For comparison studies – “control group” (2 groups. 10 persons in each are volunteered in random with the same disorders as in the test groups) were undergo basic treatment and rehabilitation without the usage of the Alfa capsule.
Scheme of the usage of Alpha Oxy Spa capsule:
- Acute stage — abstinent syndrome treatment — 4-5 sessions, 1 time per day every day cdetox” – program),
- Stage of post-abstinent disorders — 4-5 sessions 1 time per two days (every other day).
- Rehabilitation period — 7-9 sessions, one per day, 2 times in a week.
Total amount of the sessions — 15-18
Main stages of the complex medical and physiological examinations:
4 rnah, dates for examination:
* on the day when the patient gives his/her formal approval to participate in the studies (before treatment in Oxy SPA capsule)
* on the 4-5 day of treatment (after removal of the acute symptoms of abstinence, in the very beginning of post-abstinent disorders treatment);
* on the 2Dth day of treatment (after removal of post-abstinent disorders, in the beginning of rehabilitation program)
* on the 60-70th day of the treatment-rehabilitation process with the Oxy SPA capsule (at the end of the rehabilitation program),
– clinical observation and testing with the use of narcological scales, – psychological (internationally verified and valid scales),
- Studies of the personality:
- a) methods of evaluation of anxiety, anger, depression as personal characteristics (Ch.Spielberger) — before and after the course of
- Testing of verbal & logical thinking, memory, concentration. “10 words”, colour Luesher test – 4 times, once in each stage during the course of treatment.
- Examination of the emotional status:
*methods for evaluation of anxiety, anger, depression as a current state — before & after the sessions, 4 days, 8 times
scale of differential emotions, “Well-being scale” — 4 times once.
- Study of the peculiarities of the autonomic blood circulation:
- measurement of ABP, heart rate, registration of pneumo- and cardiorhythmograms (5min epoch) with the analysis of the heart rate variability parameters (HRV-analysis), calculation of stress indexes
- Psycho-physiological testing with the use of the device “Health Certificate”:
– Determination of static tremor parameters,
– Determination of complex sensori-motoric test parameters
- Psycho-motoric tempo test
Examination is done before and after session in the capsule at the mentioned stages — 4 days, 8 times.
Blood test — 4 times during the course of rehabilitation:
1. Anti-oxidant effect – Indexes: Ascorbic acid, Catalase, Tocopheroli acetate,
Uric acid salts, Malonic aldegid, —groups of proteins
2.Immunologic effect – Indexes: White blood cells, Leukocyte count, B,T- leukocytes, Subpopulations of T-leukocytes, Natural killers Automatic electrophoresis of saliva samples with determination of the protein spectrum (marker of the emotional tension) — saliva samples 8 times (4 days, before and after the session)
Pic.1. Dynamics of autonomic parameters (HRV indices) in addict patients before and right after the session in Alfa OXY SPA capsule on the 1-st, 7-th and 20th days of rehabilitation.
Pic.4. Dynamics of Stress Index in addict patients on the 1-st, 7-th and 20th days of rehabilitation. Presented data — before the session in Alfa OXY SPA capsule in appropriate days. Blue —experimental group, rose — controls.
Preliminary results (patient’s control during 3 weeks):
1. Decrease in duration of the rehabilitation course for elimination of acute symptoms of addiction.
2. Increase of detoxification effectiveness in abstinent period for alcohol and drug abusers.
3. Significant decrease of state psychological correlates of emotional anxiety, depression.
4. Improvement of psychomotoric coordination parameters, tendency to increase accuracy and rate of sensomotoric reactions.
5. Elimination of autonomic disorders, decrease in activation of sympathetic regulatory activity (SI, LF/HF decrease).
6. Most prominent difference in psychological and psychophysiological parameters is observed on 7th day of rehabilitation when patients who underwent Alfa capsule’s session differ from
Problems which we have to try to solve in the Project “Narcology”
1. Difficulties in providing of clinical research from the point of evidence based medicine (formation of the control group, the use of the same rehabilitation program for all the participants, comparison of the effects for separate procedures)
2. The need to find the clear criterion for the assessment of detoxification efficiency.
3. Compiling of the set of most typical patient’s states (individual peculiarities) which will be relevant to compose most effective individual rehabilitation program.
4. Not to forget placebo-problem and to find more relevant explanation why we can exclude placebo effect as a significant influence.
Prospects for the promotion of Alfa-capsules in narcological medical practice (for complex treatment of addiction):
1. Preparation of methodical papers for the implementation of Alfa capsules in medical rehabilitation of addictive patients — September-October 2005.
2. Elaboration of a new specialized program for the use of the device in narcology (on the base of scientific research) — September 2005.
3. Publication of the research results in 2-3 Russian journals specialized in narcology and restorative (regenerative) medicine — October (November) 2005. Preparation of the article to publish in European (American) Journal.
4. Participation with scientific reports based on conducted studies in 3 profiled conferences (June, September, November 2005)
Proposals for the extension of the use of Alfa SPA capsules in clinical, preventive and regenerative medicine
1. Development of a new model (modification) of Alfa Oxy Spa capsule adding method of interval hypoxic-hyperoxic training:
– Presentation of the method’s principle for the personal of Sybaritic Company.
– Getting the Patent for the method in Russia.
– Cooperation with the personal of SC in elaboration of medical and technical papers for the hypoxic-hyperoxic method.
2. Implementation of some physiological devices to Alfa capsules to use them for the control of patient’s current state during rehabilitation procedures (before and after the session):
– Choosing the optimal set of parameters which allow to estimate patient’s state.
– Study of the sensitivity, validity and specificity of the parameters in special observations of different group of patients.
– Preparation of medical and technical papers for the diagnostic device.