Efficacy & safety of Carica papaya leaf extract (CPLE) in severe thrombocytopenia (≤30,000/μl) in adult dengue - Results of a pilot study

PLoS One. 2020 Feb 19;15(2):e0228699. doi: 10.1371/journal.pone.0228699. eCollection 2020.

Abstract

Severe thrombocytopenia in dengue often prompts platelet transfusion primarily to reduce bleeding risk. In India, about 11-43% of dengue patients report receiving platelet transfusions which is considered scarce and expensive especially in resource limited settings. Herein, we evaluated the efficacy and safety of Carica papaya leaf extract (CPLE) in the management of severe thrombocytopenia (≤30,000/μL) in dengue infection. 51 laboratory confirmed adult dengue patients with platelet counts ≤30,000/μL were randomly assigned to either treatment (n = 26) or placebo (n = 24) group. By day 3, CPLE treated patients reported significantly (p = 0.007) increased platelet counts (482%± 284) compared to placebo (331%±370) group. In the treatment group, fewer patients received platelet transfusions (1/26 v/s 2/24) and their median time for platelets to recover to ≥ 50,000/μL was 2 days (IQR 2-3) compared to 3 days (IQR 2-4) in placebo. Overall, CPLE was safe and well tolerated with no significant decrease in mean hospitalization days. Plasma cytokine profiling revealed that by day 3, mean percent increase in TNFα and IFNγ levels in treatment group was less compared to that observed in placebos; (TNFα: 58.6% v/s 127.5%; p = 0.25 and IFNγ: 1.93% v/s 62.6% for; p = 0.12). While a mean percent increase in IL-6 levels occurred in placebos (15.92%±29.93%) by day 3, a decrease was noted in CPLE group (12.95%±21.75%; p = 0.0232). Inversely, CPLE treated patients reported a mean percent increase compared to placebo by day 3 (143% ±115.7% v/s 12.03%± 48.4%; p = 0.006). Further, by day 3, a faster clearance kinetics of viral NS1 antigenemia occurred-mean NS1 titers in treatment group decreased to 97.3% compared to 88% in placebos (p = 0.023). This study demonstrates safety and efficacy of CPLE in increasing platelet counts in severe thrombocytopenia in dengue infections. A possible immunomodulatory and antiviral activity may be attributed to CPLE treatment. These findings merit validation in larger prospective studies. Trial registration Name of the registry: Clinical Trials Registry-India (CTRI) Registration No.: CTRI-REF/2017/02/013314.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Carica / chemistry*
  • Cohort Studies
  • Cytokines / metabolism
  • Dengue / complications*
  • Female
  • Hematocrit
  • Humans
  • Length of Stay
  • Male
  • Middle Aged
  • Pilot Projects
  • Plant Extracts / adverse effects
  • Plant Extracts / pharmacology*
  • Plant Extracts / therapeutic use
  • Plant Leaves / chemistry*
  • Platelet Count
  • Safety*
  • Thrombocytopenia / blood
  • Thrombocytopenia / complications*
  • Thrombocytopenia / drug therapy*
  • Thrombocytopenia / metabolism
  • Treatment Outcome
  • Viral Nonstructural Proteins / metabolism

Substances

  • Cytokines
  • Plant Extracts
  • Viral Nonstructural Proteins

Associated data

  • CTRI/CTRI-REF/2017/02/013314

Grants and funding

Funding by Micro Labs Ltd., Bangalore, India. Fund awarded to VM. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.