IVIG Versus Plasmapheresis in the Treatment of Guillian Barrie Syndrome Patients
Condition: Guillain-Barre Syndrome
MeSH terms: Guillain-Barre Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      In this study, the investigators address the question: whether treatment with IVIG is
      superior to treatment using plasmapheresis for functional recovery of patients with GBS?
      Recovery was quantified using: The changes in the A-Clinical grading scale MRC ( medial
      research council sum score ) and B-overall neuropathy limitations scale as the primary
      outcome and the changes in Neurophysiological study 3 months after treatment as a secondary
      outcome.

      This information will be used to evaluate which treatment is more beneficial to GBS patients.
    

Detailed description: 
      Guillain-Barré syndrome (GBS) is an inflammatory disease of the PNS and is the most common
      cause of acute flaccid paralysis, with an annual global incidence of approximately 1-2 per
      100,000 person-years. Patients with GBS typically present with weakness and sensory signs in
      the legs that progress to the arms and cranial muscles, although the clinical presentation of
      the disease is heterogeneous and several distinct clinical variants exist. Diagnosis of GBS
      is based on the patient's history and neurological, electrophysiological, and cerebrospinal
      fluid (CSF) examinations. Electrophysiological studies: provide evidence of peripheral
      nervous system (PNS) dysfunction and can distinguish between the subtypes of GBS: acute
      inflammatory demyelinating polyradiculoneuropathy (AIDP), acute motor axonal neuropathy
      (AMAN), and acute motor-sensory axonal neuropathy (AMSAN). Disease progression can be rapid,
      and most patients with GBS reach their maximum disability within 2 weeks. About 20% of
      patients with GBS develop respiratory failure and require mechanical ventilation. Cardiac
      arrhythmias and blood pressure instability can occur owing to the involvement of the
      autonomic nervous system. Immunomodulatory therapy should be started if patients are unable
      to walk independently for 10 m. Evidence on treatment efficacy in patients who can still walk
      independently is limited, but treatment should be considered, especially if these patients
      display rapidly progressive weakness or other severe symptoms such as autonomic dysfunction,
      bulbar failure, or respiratory insufficiency. Clinical trials have demonstrated a treatment
      effect for intravenous immunoglobulin (IVIg) when started within 2 weeks of the onset of
      weakness and for plasma exchange when started within 4 weeks.
    

Intervention name(s): plasmapheresis device; Intravenous immunoglobulin
Intervention type(s): Device; Drug
Intervention description(s): Group 1: 54 patients of Guillian Barrie syndrome undergo plasma exchange (5 sessions); group 2: 27 patients undergo intravenous injection of immunoglobulin for 5 consecutive days of IVIG 0.4gm/kg/day.
Other intervention name(s): plasma exchange device; IVIG
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies; gamma-Globulins; Rho(D) Immune Globulin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 groups of patients with Guillian Barrie syndrome were subjected to plasmapheresis or IVIG by percentage 2:1 respectively according to availability of IVIG
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: IVIG / plasmapheresis and Guillain-Barre Syndrome