Traditional Chinese medicine as an adjunctive therapy to oral montelukast for treating patients with chronic asthma

Abstract

Background:This study aimed to explore the efficacy and safety of Ping Chuan Ke Li (PCKL) as an adjunctive therapy to oral montelukast compared with placebo plus montelukast for treating patients with chronic asthma (CAS).Methods:This randomized controlled trial involved 72 patients with CAS. They were randomly allocated to an intervention group or a control group, 36 subjects per group. Participants in the intervention group received PCKL and oral montelukast, while those in the control group received placebo and oral montelukast. The primary outcome was lung function, measured by forced expiratory volume in 1 second (FEV1). The secondary outcomes included quality of life, measured by St. George's Respiratory Questionnaire (SGRQ), and adverse events (AEs).Results:Compared to placebo plus montelukast, PCKL and montelukast revealed greater efficacy in lung function, measured by FEV1 (P <.05), and quality of life, measured by the SGRQ scale (P <.05). Additionally, no significant differences were found in AEs between the 2 groups.Conclusion:Traditional Chinese medicine PCKL as an adjunctive therapy to oral montelukast alleviated the symptoms of CAS. Future studies with larger sample sizes are still needed to verify the efficacy and safety of PCKL plus montelukast in patients with CAS.

Traditional medicines for asthma in children and adults: A systematic review of placebo‐controlled studies

“…The results demonstrate that as baseline FEV 1 % increased, effect sizes within the TM groups tended to decrease. In the three studies unsuitable for meta‐analysis for which baseline data were available, the results demonstrated similar effects for baseline severity …”

“…Three studies provided data using different scales (Table ). The study of mild–moderate asthma reported a significant improvement in the TM group, while another study showed no difference between groups . In the third study there was a significant baseline difference favouring the control group, therefore the EoT result may not be accurate.…”

“…Blinding of personnel in six studies was judged unclear . Seven studies stated that the outcome assessments were blinded . Incomplete outcome data and selective outcome reporting were of low risk in 15 RCTs and unclear in one brief report .…”

“…In terms of clinical trial methodology, the former was of low risk while the latter showed some deficiencies. Overall, reporting quality tended to be higher in more recent studies (Table ) . Future studies should adhere to the CONSORT statement and the extensions for herbal medicines …”

“…One study investigated a TM for acute asthma in adults and children. 16 The remaining 17 studies investigated chronic asthma, with seven in children only, [17][18][19][20][21][22][23] seven in adults only [24][25][26][27][28][29][30] and one in adults and children. 31 One did not specify the age range but the mean age suggested adults.…”