PMID- 26988798
OWN - NLM
STAT- MEDLINE
DCOM- 20170522
LR  - 20181202
IS  - 1618-095X (Electronic)
IS  - 0944-7113 (Linking)
VI  - 23
IP  - 11
DP  - 2016 Oct 15
TI  - Clinical efficacy of water extract of stem bark of Terminalia arjuna (Roxb. ex 
      DC.) Wight & Arn. in patients of chronic heart failure: a double-blind, 
      randomized controlled trial.
PG  - 1211-9
LID - S0944-7113(16)00048-9 [pii]
LID - 10.1016/j.phymed.2016.02.007 [doi]
AB  - BACKGROUND: The stem bark of Terminalia arjuna (Roxb. ex DC.) Wight and Arn. 
      (Arjuna) is used in Indian system of medicine (Ayurveda) for treatment of various 
      cardiac diseases, including heart failure. However, well designed clinical trials 
      exploring its efficacy and safety in chronic heart failure (CHF) are lacking. 
      PURPOSE: To ascertain the add-on efficacy and safety of a standardized water 
      extract of stem bark of Arjuna (Arjuna extract) in CHF patients on standard 
      pharmacotherapy. STUDY DESIGN: Double-blind, parallel, randomized, 
      placebo-controlled add-on clinical trial. METHODS: After approval of 
      institutional ethics committee, 100 patients of CHF of New York Heart Association 
      (NYHA) functional class II on standard pharmacotherapy having an 
      echocardiographic left ventricular ejection fraction (LVEF) </= 40% were 
      consecutively recruited with informed consent and randomized 1:1 to Arjuna 
      extract 750 mg or matching placebo twice daily. The primary outcome measure was 
      change in LVEF at 12 weeks. Secondary outcome measures included changes in (i) 
      NYHA functional class, (ii) distance covered in 6 min walk test (6MWT), (iii) 
      quality of life (QoL), as determined by the Kansas City Cardiomyopathy 
      Questionnaire (KCCQ), (iv) plasma brain natriuretic peptide, (v) plasma cytokines 
      (interleukin-6, high sensitivity C-reactive protein and tumour necrosis factor-alpha) 
      and (vi) oxidative stress markers [serum thiobarbituric acid reactive substances 
      (TBARS), red blood cell (RBC) superoxide dismutase (SOD), RBC catalase and RBC 
      glutathione (GSH)] at 6 and 12 weeks. Safety assessment was done by adverse event 
      monitoring and laboratory investigations. Results were expressed as mean +/- SD or 
      median (interquartile range) and analysed with intention-to- treat principle 
      using appropriate two-sided statistical tests. A p-value < 0.05 was considered 
      significant. RESULTS: Arjuna extract was well-tolerated, but did not change LVEF 
      (24.3 +/- 7.1 versus 25.5 +/- 7.7%; p = 0.4) or secondary outcome measures except 
      preservation of RBC catalase activity [1275(104, 10350) versus 1243.5(104, 10350) 
      U/g haemoglobin; p = 0.01] compared to placebo. Significantly greater percentage 
      increases occurred in distance covered in 6 MWT, RBC-SOD, RBC catalase, RBC GSH 
      and in symptom severity and stability domains of KCCQ in patients on Arjuna 
      extract versus those on placebo, on a post-hoc analysis, between subgroups of 
      patients who improved in these outcomes. CONCLUSION: Arjuna extract did not 
      improve LVEF in CHF patients over 12 weeks, although there was improvement in 
      functional capacity, antioxidant reserves and symptom-related QoL domains in some 
      patients.
CI  - Copyright (c) 2016 Elsevier GmbH. All rights reserved.
FAU - Maulik, Subir K
AU  - Maulik SK
AD  - Department of Pharmacology, All India Institute of Medical Sciences (A.I.I.M.S.), 
      Ansari Nagar, 110029 New Delhi, India.. Electronic address: skmaulik@aiims.ac.in.
FAU - Wilson, Vinu
AU  - Wilson V
AD  - Department of Pharmacology, All India Institute of Medical Sciences (A.I.I.M.S.), 
      Ansari Nagar, 110029 New Delhi, India.; Department of Pharmacology, Sree Gokulam 
      Medical College & Research Foundation, Venjaramoodu, Trivandrum, 695607 Kerala, 
      India.
FAU - Seth, Sandeep
AU  - Seth S
AD  - Department of Cardiology, All India Institute of Medical Sciences (A.I.I.M.S.), 
      Ansari Nagar, 110029 New Delhi, India.
FAU - Bhargava, Balram
AU  - Bhargava B
AD  - Department of Cardiology, All India Institute of Medical Sciences (A.I.I.M.S.), 
      Ansari Nagar, 110029 New Delhi, India.
FAU - Dua, Pamila
AU  - Dua P
AD  - Department of Pharmacology, All India Institute of Medical Sciences (A.I.I.M.S.), 
      Ansari Nagar, 110029 New Delhi, India.
FAU - Ramakrishnan, Sivasubramanian
AU  - Ramakrishnan S
AD  - Department of Cardiology, All India Institute of Medical Sciences (A.I.I.M.S.), 
      Ansari Nagar, 110029 New Delhi, India.
FAU - Katiyar, Chandra K
AU  - Katiyar CK
AD  - Dabur India Limited, Ghaziabad, 201010 Uttar Pradesh, India.; Emami Limited, 
      Kolkata, 700107 West Bengal, India.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20160223
PL  - Germany
TA  - Phytomedicine
JT  - Phytomedicine : international journal of phytotherapy and phytopharmacology
JID - 9438794
RN  - 0 (Plant Extracts)
RN  - 0 (Thiobarbituric Acid Reactive Substances)
RN  - 0 (Vasodilator Agents)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Chronic Disease/*drug therapy
MH  - Double-Blind Method
MH  - Female
MH  - Heart Failure/*drug therapy
MH  - Humans
MH  - India
MH  - Male
MH  - Medicine, Ayurvedic
MH  - Middle Aged
MH  - Plant Bark/chemistry
MH  - Plant Extracts/*pharmacology/*therapeutic use
MH  - Plant Stems/chemistry
MH  - Quality of Life
MH  - Terminalia/chemistry
MH  - Thiobarbituric Acid Reactive Substances/metabolism
MH  - Treatment Outcome
MH  - Vasodilator Agents/*therapeutic use
MH  - Ventricular Function, Left/*drug effects
OTO - NOTNLM
OT  - Arjuna
OT  - Ayurveda
OT  - Cardiac failure
OT  - Cardiovascular disease
OT  - Herbal drug
OT  - Terminalia arjuna
EDAT- 2016/03/19 06:00
MHDA- 2017/05/23 06:00
CRDT- 2016/03/19 06:00
PHST- 2015/08/18 00:00 [received]
PHST- 2016/02/04 00:00 [revised]
PHST- 2016/02/05 00:00 [accepted]
PHST- 2016/03/19 06:00 [entrez]
PHST- 2016/03/19 06:00 [pubmed]
PHST- 2017/05/23 06:00 [medline]
AID - S0944-7113(16)00048-9 [pii]
AID - 10.1016/j.phymed.2016.02.007 [doi]
PST - ppublish
SO  - Phytomedicine. 2016 Oct 15;23(11):1211-9. doi: 10.1016/j.phymed.2016.02.007. Epub 
      2016 Feb 23.