Alcohol Withdrawal Symptoms Clinical Trial
Official title:
Hyperbaric Oxygenation in Treatment of Alcohol Dependence Syndrome
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.
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.
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