title: Efficacy of Varunadi Ghritha (polyherbal compound) in treated head and neck cancer cases as a biological response modifier.
abstract: BACKGROUND
  Persistent immune suppression is reported in Head and Neck Cancers (HNC) even after treatment and a higher recurrence rate was observed in patients with poor CD3 count. Loco regional recurrences and second primary tumours are the common forms of failure in head and neck cancers. Several agents have been tried to overcome this problem without much benefit. In Ayurveda, several plant based products have been reported to have anti-tumour and immunomodulatory properties.
  
  
  OBJECTIVE
  To test the role of Varunadi Ghritha, as an immunomodulator in apparently healthy, treated and controlled HNC patients and to evaluate its effectiveness in preventing locoregional relapses and development of second primary tumours.
  
  
  METHODS
  Total 78 patients of treated head and neck cancers were randomly selected for intervention and control group. Patients in the intervention group (n = 38) received Varunadi Ghritha, 5gms twice daily for one year and followed up to two years. Patients in the control group (n = 40) were followed up at regular intervals. Immune parameters were assessed in the peripheral blood at base line and at the end of administration of the study compound.
  
  
  RESULTS
  In the intervention group, mean percentage increase in CD3, CD19 and CD16 positive cells were significantly higher after the administration of the study compound compared to the control group indicating an immunomodulatory effect of the study compound. A non-significant improvement in disease control was observed in patients with advanced stage of disease in the intervention group.
  
  
  CONCLUSIONS
  Administration of Varunadi Ghritha resulted in an increase in T cell counts in patients with treated HNC.
authors.affiliation: Department of Radiation Oncology, Regional Cancer Centre, Thiruvananthapuram, India.
authors.forename: Divya
authors.initials: D
authors.lastname: Ravindran
authors.affiliation: Integrated Cancer Research Program, Rajiv Gandhi Centre for Biotechnology, Thiruvananthapuram, Kerala, India.
authors.forename: Indhu
authors.initials: I
authors.lastname: Hariharan
authors.affiliation: Early Detection and Prevention Section, International Agency for Research on Cancer, Lyon, France.
authors.forename: Richard
authors.initials: R
authors.lastname: Muwonge
authors.affiliation: Department of Radiation Oncology, Regional Cancer Centre, Thiruvananthapuram, India.
authors.forename: Rejnish R
authors.initials: RR
authors.lastname: Kumar
authors.affiliation: Integrated Cancer Research Program, Rajiv Gandhi Centre for Biotechnology, Thiruvananthapuram, Kerala, India.
authors.forename: M Radhakrishna
authors.initials: MR
authors.lastname: Pillai
authors.affiliation: Department of Radiation Oncology, Regional Cancer Centre, Thiruvananthapuram, India.
authors.forename: Kunnambath
authors.initials: K
authors.lastname: Ramadas
keywords: Ayurveda; head and neck cancer; immunomodulation; loco-regional control; second primary tumour