Plant-based formulation in the management of chronic obstructive pulmonary disease: a randomized double-blind study.
BACKGROUND
A randomized double-blind placebo controlled clinical study was undertaken to investigate the safety and efficacy of a plant-based formulation (DCBT1234-Lung KR), which earlier through 2 trials was found to improve FEV1 and the quality of life of COPD patients.


OBJECTIVE
The efficacy of DCBT1234-Lung KR was assessed using pulmonary function tests, arterial blood gas (ABG) analyses and the clinical symptoms of COPD in a 6-month study period against a matching placebo and a biomedical drug combination (salbutamol+theophylline+bromhexine).


METHODS
One hundred and five subjects aged between 35 and 85 years with a smoking history of more than 20 pack years, showing little or no improvement in FEV1 upon a bronchial challenge of 200 microg of inhaled salbutamol and exhibiting ABG percentage of less than 85% of oxygen saturation were taken up for the study. The study had 3 arms viz., the plant-based formulation (DCBT1234-Lung KR), placebo and salbutamol (12 mg/day) plus theophylline (300 mg/day) plus bromhexine (24 mg/day). The end point of the study was determined as an improvement of FEV1 by 200 mL and/or increased ABG values (>90% PaO2) and clinical symptoms like dyspnoea, wheezing, cough, expectoration, disability, and sleep disturbances.


RESULTS
DCBT1234-Lung KR patients showed statistically significant (95% level) improvement in FEV1 and PaO2 in comparison with salbutamol+theophylline+bromhexine and placebo patients. Twenty-three per cent of DCBT1234-Lung KR patients, 19% of salbutamol+theophylline+bromhexine group and 12% of placebo group patients showed the desired 200 mL improvement in FEV1 values in comparison with the other 2 arms. Improved PaO2 was observed in 15.4% of the DCBT1234-Lung KR patients while no improvement was seen with patients in any other arms. Symptoms like dyspnoea, wheezing, cough, expectoration, disability and sleep disturbances also significantly reduced in DCBT1234-Lung KR and the biomedical group patients, but not in the placebo arm.


CONCLUSIONS
DCBT1234-Lung KR was equivalent, if not better than the present day treatment with salbutamol, theophylline and bromhexine combination in COPD patients and this was ascertained using FEV1 and ABG values.
Murali
P M
PM
Dalmia Centre for Research and Development, B-133 & 134, Paripoorana Estates, Sundakkamuthur P.O., Coimbatore 641 010, India. dalmiabiotechnology@vsnl.com
Rajasekaran
S
S
Paramesh
P
P
Krishnarajasekar
O R
OR
Vasudevan
S
S
Nalini
K
K
Lakshmisubramanian
S
S
Deivanayagam
C N
CN
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000420:Albuterol / Q000627:therapeutic use; D001784:Blood Gas Analysis; D001964:Bromhexine / Q000627:therapeutic use; D001993:Bronchodilator Agents / Q000627:therapeutic use; D029772:Bryonia; D004311:Double-Blind Method; D029787:Drosera; D004359:Drug Therapy, Combination; D005100:Expectorants / Q000627:therapeutic use; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D007486:Ipecac / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy; D028321:Plant Preparations / Q000627:therapeutic use*; D029424:Pulmonary Disease, Chronic Obstructive / Q000097:blood / Q000188:drug therapy*; D011788:Quality of Life; D013806:Theophylline / Q000627:therapeutic use; D016896:Treatment Outcome
D001993:Bronchodilator Agents; D005100:Expectorants; D028321:Plant Preparations; D007486:Ipecac; D013806:Theophylline; D001964:Bromhexine; D000420:Albuterol