Plant-Based Formulation for Bronchial Asthma: A Controlled Clinical Trial to Compare Its Efficacy with Oral Salbutamol and Theophylline

Abstract

Background: Plant-based medicine is the 3rd most popular choice of both adults (11%) and children (6%) suffering from Asthma. While several plant-based formulations have been reported for the treatment of asthma in the past, many authors have published their reservations on clinical trials carried out using complementary and alternative medicines. Objectives: The authors desired to eliminate the shortcomings of the earlier clinical trials carried out by many investigators in a structured study. Therefore, a 12-week randomized double-blind placebo-controlled clinical study was conducted to investigate the efficacy of a plant-based formulation (DCBT4567-Astha-15) in comparison with oral salbutamol, salbutamol + theophylline and a matching placebo in patients with reversible asthma. Methods: Ninety-four patients between 15 and 50 years of age, showing 15% improvement in forced expiratory volume in 1 s (FEV₁) 15 min after a bronchial challenge of inhaled salbutamol (200 µg) were recruited, and the end point of the study was determined as a 15% improvement in FEV₁ and clinical symptoms like dyspnoea, wheezing, cough, expectoration, disability, sleep disturbances and respiration rate. Results: DCBT4567-Astha-15, salbutamol and salbutamol + theophylline patients showed statistically significant improvement in FEV₁, while placebo patients did not show any improvement. Fifty percent of DCBT4567-Astha-15, 48% of salbutamol, 58% of salbutamol + theophylline and 26% of placebo patients showed the desired 15% improvement in FEV₁. Improved mean FEV₁ values at the end of the trial indicated that the salbutamol - theophylline combination was superior followed by salbutamol and DCBT4567-Astha-15. Clinical symptoms like dyspnoea, wheezing, cough, expectoration, disability, and sleep disturbances were significantly reduced in DCBT4567-Astha-15 patients compared to patients of the other three arms. Conclusions: DCBT4567-Astha-15 was as efficacious as salbutamol (12 mg/day) or salbutamol (12 mg/day) in combination with theophylline (200 mg/day) in the treatment of reversible asthmatics. Quality of life of patients also improved with DCBT4567-Astha-15 drug treatment.

Herbal interventions for chronic asthma in adults and children: a systematic review and meta-analysis

“…The remainder were RCTs using either parallel groups 14,[18][19][20][21][22][23][24][25][26][27][28][29][30] or a crossover design. [31][32][33][34][35][36][37][38][39][40] All were double blinded except one single blinded study where the colours of study and placebo medicine sachets differed.…”

“…[31][32][33][34][35][36][37][38][39][40] All were double blinded except one single blinded study where the colours of study and placebo medicine sachets differed. 26 Sample sizes ranged from eight 32 to 334, 13 six studies recruited children 13,14,19,23,24,35 although one of these reported subjects up to age 55 24 (clarification was sought but not received) -and one a mixed age group of 14-20 yrs. 21 Age was not stated in five studies, 17,25,27,37,38 and the remainder recruited adults.…”

“…Mean duration of treatment was 8.4 weeks, ranging from three days 32 to 12 months. 29 Primary and secondary outcome measures were reported as follows: forced expiratory volume in one second (FEV 1)/forced vital capacity (FVC) in 14 studies [17][18][19]21,24,[27][28][29][30][32][33][34]39,40 or changes from baseline in four; 22,26,35,38 peak expiratory flow rate (PEFR) in eight 18,19,21,22,24,30,31,39 or changes in PEFR in five; 13,14,22,28,38 vital capacity (VC) in three; 28,35,38 FEF25-75 in one 34 and maximum breathing capacity (MBC) in one. 38 Three studies recorded exacerbation rates, 18,22,39 six changes in medication use, 14,19,28,30,31,37 and 14 recorded symptom scores.…”

“…38 Three studies recorded exacerbation rates, 18,22,39 six changes in medication use, 14,19,28,30,31,37 and 14 recorded symptom scores. 13,14,21,[24][25][26]28,30,33,[36][37][38][39][40] Five trials reported subjective assessments. 13,14,20,22,27 …”

“…For example, of the 20 studies recruiting adults, four explicitly excluded smokers, 18,26,28,40 one reported smoking rate, 17 but 15 did not describe smoking status at all. This uncertainty limits the applicability of findings to other populations.…”