Hyperbaric Oxygenation in Treatment of Alcohol Dependence Syndrome
Condition: Alcohol Withdrawal Symptoms; Delirium Tremens (DTs)
MeSH terms: Alcohol Withdrawal Delirium; Alcoholism; Substance Withdrawal Syndrome
Study type: Interventional

Summary: 
      A 30 alcohol dependent patients were divided into A: Treatment group and B: Placebo group
      using simple randomization technique. (Liver function tests) GGT, ALT and AST levels and MCV
      (Mean corpuscular volume) at admission and 2 weeks later were estimated. Daily withdrawal
      symptoms were assessed using the Clinical Institute Withdrawal Assessment scale (CIWA-Ar) and
      DTs by Delirium Observation Screening (DOS) Scale (version 0 - 1). The data collected from
      the two groups were compared.
    

Detailed description: 
      This is a prospective randomized study conducted in the de-addiction ward of department of
      Psychiatry, Jubilee Mission Medical College, Thrissur, Kerala. The study period was from
      16/11/2014 to 30/04/2016 (17 months and 14 days). This study was approved by the
      Institutional Review Board. Male patients aged between 20-60 years with alcohol dependence as
      per ICD-10 criteria, who presented with AWS and DTs on admission or during the course in our
      ward were recruited to the study. Those patients suffering from severe physical illness
      incapacitating for psychiatric evaluation, who are mentally retarded, who have primary
      psychiatric disorders like psychosis, mood disorder and those with neurodegenerative
      disorders like Dementia, Cerebrovascular accidents were excluded. In each case the patient
      and relatives were explained about the purpose of the study, its nature and the possible
      advantages and disadvantages of taking part in the study. An informed consent for the study
      was obtained from the patient as well as the relatives. Each subject was evaluated by a
      proper history, general examination, systemic examination, detailed mental status
      examination, laboratory investigations and psychometric evaluation (if needed) at the time of
      admission. The intended laboratory investigations were γ-glutamyl transferase (GGT), Alanine
      aminotranferease (ALT), aspartate aminotransferase (AST) and MCV (mean corpuscular volume of
      RBCs). These were done at time of recruitment. The severity of withdrawal symptoms was
      assessed using the Clinical Institute Withdrawal Assessment scale (CIWA-Ar) and that for
      delirium was rated using the Delirium Observation Screening (DOS) Scale (version 0 - 1). All
      patients had an ECG and a baseline echocardiography to assess their cardiac status. The
      echocardiography was repeated at the end of 2 weeks. Parameters to be studied included
      ejection fraction, and end systolic residual volume. All the patients had an ENT consultation
      to rule out any tympanic membrane pathologies.

      The total of 30 patients divided to A: Treatment group and B: Control using Simple
      randomization technique using random number generating software (ver. 1). A, received the
      Hyperbaric Oxygen therapy treatment at 2.4 ATA for 90 minutes each day. B were also taken
      inside the Hyperbaric Chamber, but received only normobaric oxygen therapy for the same
      period of time at 1 ATA. All of the cases received all standard medications. Hyperbaric
      oxygenation was done at our hospital in a monoplace chamber (Oxicab,HyperbaricSAC, Peru). The
      entire session was carried out in presence of the Hyperbaric Physician and technician. Prior
      to this therapy the documentation of pulse rate, Blood Pressure and Blood sugar were done as
      standard procedure. The Hyperbaric sessions were done for 10 days in a row one time daily.
      Daily general examination, systemic examination, detailed mental status examination and
      administration of CIWA scale and DOS scale were carried out till the day of discharge.

      Laboratory investigations were repeated after two weeks. The patients were discharged when
      the biological functions were adequate, physical and mental conditions were stable and when
      they were motivated to remain abstinent from alcohol. Parameters assessed in two groups were
      compared.
    

Intervention name(s): Hyperbaric Oxygenation Therapy; Normobaric Oxygenation therapy
Intervention type(s): Device; Device
Intervention description(s): Received the Hyperbaric Oxygen therapy treatment at 2.4 ATA for 90 minutes each day.; Received the Normobaric Oxygen therapy treatment at 1 ATA for 90 minutes each day.
Other intervention name(s): Treatment group; Placebo group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 30 alcohol dependent patients were divided into A: Treatment group and B: Placebo group using simple randomization technique.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Health Services Research