PMID- 33372366
OWN - NLM
STAT- MEDLINE
DCOM- 20211124
LR  - 20211124
IS  - 1099-1557 (Electronic)
IS  - 1053-8569 (Linking)
VI  - 30
IP  - 6
DP  - 2021 Jun
TI  - Safety of Andrographis paniculata: A systematic review and meta-analysis.
PG  - 727-739
LID - 10.1002/pds.5190 [doi]
AB  - PURPOSE: Andrographis paniculata is one of the commonly used herbal medicines 
      worldwide. Nevertheless, evidences on adverse events (AEs) associated with 
      Andrographis paniculata are very limited. This systematic review and 
      meta-analysis was conducted to estimate and to compare the AE incidence of oral 
      monotherapy Andrographis paniculata with others among patients with upper 
      respiratory tract infection, noninfective diarrhea, and autoimmune disease. 
      METHODS: Systematic search was performed through six databases from inception 
      until August 2018. Randomized controlled trial (RCT), cohort, or intensive 
      monitoring of AEs was eligible for review if AE incidence was examined. The 
      incidence of AEs was, then, pooled across studies using meta-analysis. RESULTS: 
      Ten RCTs and 3 intensive monitoring studies were included. Incidence of serious 
      AEs was very rare with the pooled incidence (95% CI) from RCTs of 0.02 per 1000 
      patients (0.0-0.5). However, the incidence of nonserious AEs was considered very 
      common with the pooled incidence (95% CI) from RCTs of 102.6 per 1000 patients 
      (10.7-256.1), and the pooled incidence (95% CI) from intensive monitoring of 34.2 
      per 1000 patients (0.0-229.6). The most common nonserious AEs were related to 
      gastrointestinal disorder, and skin and subcutaneous disorder system. 
      CONCLUSIONS: Like other medicine, Andrographis paniculata can cause some AEs. 
      However, it may be generally safe. Nevertheless, prospective patients who plan to 
      use Andrographis paniculata should be thoroughly advised and closely monitored 
      for common AEs. Due to the increasing use of Andrographis paniculata worldwide, 
      larger studies with adequate methodological quality are warranted to monitor the 
      safety of such product.
CI  - (c) 2020 John Wiley & Sons Ltd.
FAU - Worakunphanich, Wiwan
AU  - Worakunphanich W
AD  - Doctor of Philosophy Program in Social, Economic, and Administrative Pharmacy, 
      Department of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok, 
      Thailand.
AD  - Thai Traditional Medicine Research Institute, Department of Thai Traditional and 
      Alternative Medicine, Ministry of Public Health, Nonthaburi, Thailand.
FAU - Thavorncharoensap, Montarat
AU  - Thavorncharoensap M
AUID- ORCID: 0000-0002-8256-2167
AD  - Health Technology Assessment Graduate Program, Mahidol University, Bangkok, 
      Thailand.
AD  - Social and Administrative Pharmacy Excellence Research (SAPER) unit, Department 
      of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok, Thailand.
FAU - Youngkong, Sitaporn
AU  - Youngkong S
AD  - Health Technology Assessment Graduate Program, Mahidol University, Bangkok, 
      Thailand.
AD  - Social and Administrative Pharmacy Excellence Research (SAPER) unit, Department 
      of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok, Thailand.
FAU - Thadanipon, Kunlawat
AU  - Thadanipon K
AD  - Department of Clinical Epidemiology and Biostatistics, Faculty of Medicine 
      Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.
FAU - Thakkinstian, Ammarin
AU  - Thakkinstian A
AD  - Health Technology Assessment Graduate Program, Mahidol University, Bangkok, 
      Thailand.
AD  - Department of Clinical Epidemiology and Biostatistics, Faculty of Medicine 
      Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, Non-U.S. Gov't
PT  - Systematic Review
DEP - 20210109
PL  - England
TA  - Pharmacoepidemiol Drug Saf
JT  - Pharmacoepidemiology and drug safety
JID - 9208369
SB  - IM
MH  - *Andrographis
MH  - Cohort Studies
MH  - Humans
OTO - NOTNLM
OT  - Andrographis paniculata
OT  - adverse event
OT  - pharmacovigilance
OT  - safety
EDAT- 2020/12/30 06:00
MHDA- 2021/11/25 06:00
CRDT- 2020/12/29 06:06
PHST- 2020/04/10 00:00 [received]
PHST- 2020/12/17 00:00 [accepted]
PHST- 2020/12/30 06:00 [pubmed]
PHST- 2021/11/25 06:00 [medline]
PHST- 2020/12/29 06:06 [entrez]
AID - 10.1002/pds.5190 [doi]
PST - ppublish
SO  - Pharmacoepidemiol Drug Saf. 2021 Jun;30(6):727-739. doi: 10.1002/pds.5190. Epub 
      2021 Jan 9.