Murali P M, Rajasekaran S, Krishnarajasekar O R, Perumal T, Nalini K, Lakshmisubramanian S, Deivanayagam C N
Dalmia Centre for Research and Development, Coimbatore, India.
Respiration. 2006;73(4):457-63. doi: 10.1159/000089922. Epub 2005 Nov 22.
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.
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.
Ninety-four patients between 15 and 50 years of age, showing 15% improvement in forced expiratory volume in 1 s (FEV(1)) 15 min after a bronchial challenge of inhaled salbutamol (200 microg) were recruited, and the end point of the study was determined as a 15% improvement in FEV(1) and clinical symptoms like dyspnoea, wheezing, cough, expectoration, disability, sleep disturbances and respiration rate.
DCBT4567-Astha-15, salbutamol and salbutamol + theophylline patients showed statistically significant improvement in FEV(1), 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 FEV(1). Improved mean FEV(1) 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.
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.
植物性药物是患有哮喘的成年人（11%）和儿童（6%）的第三大最受欢迎的选择。虽然过去已有多种植物性配方被报道用于治疗哮喘，但许多作者对使用补充和替代药物进行的临床试验表示保留意见。
作者希望在一项结构化研究中消除许多研究者早期进行的临床试验的缺点。因此，进行了一项为期12周的随机双盲安慰剂对照临床研究，以调查一种植物性配方（DCBT4567-Astha-15）与口服沙丁胺醇、沙丁胺醇+茶碱以及匹配的安慰剂相比，对可逆性哮喘患者的疗效。
招募了94名年龄在15至50岁之间的患者，这些患者在吸入沙丁胺醇（200微克）进行支气管激发试验15分钟后，1秒用力呼气量（FEV(1)）改善了15%，研究的终点确定为FEV(1)改善15%以及呼吸困难、喘息、咳嗽、咳痰、残疾、睡眠障碍和呼吸频率等临床症状。
DCBT4567-Astha-15组、沙丁胺醇组和沙丁胺醇+茶碱组患者的FEV(1)有统计学显著改善，而安慰剂组患者没有任何改善。50%的DCBT4567-Astha-15组患者、48%的沙丁胺醇组患者、58%的沙丁胺醇+茶碱组患者和26%的安慰剂组患者的FEV(1)有预期的15%的改善。试验结束时FEV(1)的平均改善值表明，沙丁胺醇-茶碱组合优于沙丁胺醇和DCBT4567-Astha-15。与其他三组患者相比，DCBT4567-Astha-15组患者的呼吸困难、喘息、咳嗽、咳痰、残疾和睡眠障碍等临床症状明显减轻。
DCBT4567-Astha-15在治疗可逆性哮喘方面与沙丁胺醇（12毫克/天）或沙丁胺醇（12毫克/天）联合茶碱（200毫克/天）一样有效。DCBT4567-Astha-15药物治疗也改善了患者的生活质量。
