Plant-based formulation in the management of chronic obstructive pulmonary disease: a randomized double-blind study.

Abstract

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.

• Authors: P M Murali, S Rajasekaran, P Paramesh, O R Krishnarajasekar, S Vasudevan, K Nalini, S Lakshmisubramanian, C N Deivanayagam
• Journal: Respiratory medicine (Respir Med) Vol. 100 Issue 1 Pg. 39-45 (Jan 2006) ISSN: 0954-6111 [Print] England
• PMID: 15905081 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial)

Chemical References

• Bronchodilator Agents
• Expectorants
• Plant Preparations
• Ipecac
• Theophylline
• Bromhexine
• Albuterol

Topics

• Adult
• Aged
• Aged, 80 and over
• Albuterol (therapeutic use)
• Blood Gas Analysis
• Bromhexine (therapeutic use)
• Bronchodilator Agents (therapeutic use)
• Bryonia
• Double-Blind Method
• Drosera
• Drug Therapy, Combination
• Expectorants (therapeutic use)
• Female
• Forced Expiratory Volume (drug effects)
• Humans
• Ipecac (therapeutic use)
• Male
• Middle Aged
• Phytotherapy
• Plant Preparations (therapeutic use)
• Pulmonary Disease, Chronic Obstructive (blood, drug therapy)
• Quality of Life
• Theophylline (therapeutic use)
• Treatment Outcome