Ivy Leaf Extract and Coptidis Rhizome Syrup is as Effective as Pelargonium sidoides in Treating Symptoms of Acute Bronchitis

by | Dec 11, 2024 | 2024, Botanicals, Lung Health, Recent Articles

Written by Chrystal Moulton, Science Writer. The combination of Coptidis rhizome syrup and Ivy leaf extract was as effective as one tablet of Pelargonium sidoides in treating symptoms of acute bronchitis.

lung x-rayAnti-tussives and expectorants from herbal medicines may also serve as viable alternatives for symptom support for individuals experiencing illness as a result of upper respiratory tract infection1,2. Current mixtures include Pelargonium sidoides from South African geranium, Hedera helix from ivy leaf extracts, thyme, and other herbs specific to Chinese medicine3. Coptidis rhizome syrup which is derived from Coptis chinensis Franch rhizomes is another viable alternative3. Research has demonstrated the effectiveness of ivy leaf extract and Coptidis rhizome in treating symptoms related to chronic bronchitis4,5. Pelargonium sidoides, in clinical trials, has also been effective in treating symptoms specific to acute bronchitis6-8. Unlike Pelargonium sidoides, no clinical trials have investigated the effectiveness of the combination of Ivy leaf extract and Coptidis rhizome syrup on acute bronchitis. In the current trial, researchers investigated the effectiveness of Ivy leaf extract and Coptidis rhizome syrup on acute bronchitis compared to Pelargonium sidoides3.

This study was designed as a double-blind, randomized, controlled phase III clinical trial. Patients between the age of 19 and 75 years old with symptoms of acute bronchitis were recruited for this clinical trial. Patients needed to score five points or more on the Bronchitis Severity Scale during the first visit and presented without fever and a chronic cough lasting less than two weeks to be enrolled in this trial. After meeting the above criteria, patients were requested to return for a second visit where they were randomized to either the treatment or control group. Demographic information, medical history, vitals, laboratory and electrocardiographic exams were conducted at baseline. Patients were told to discontinue any medication that could influence symptom outcome including antiviral agents, antihistamines, antitussives, mucolytics, expectorants, and the like. However, they were told to continue any medication that would not influence the results of the trial. The treatment period lasted between 7 and 10 days. Individuals in the treatment group received the mixture containing Coptidis rhizome syrup and Ivy leaf extract plus one placebo tablet of Pelargonium sidoides. Individuals in the control group received one tablet of Pelargonium sidoides and a placebo mixture of Ivy leaf extract and Coptidis rhizome syrup. Researchers utilized the Bronchitis Severity Score scale to evaluate any change in symptom severity from baseline to the end of the treatment period. Subjective measurement of treatment response was evaluated using the Integrative Medicine Outcome Scale. Patients were requested to report any adverse events. The primary end point of this trial was the change in the total Bronchitis Severity Score from baseline to the end of treatment period.

A total of 220 patients were randomized to the treatment or control. Four patients were excluded due to poor compliance or duplication of assignment. As a result, 219 patients were included in the full analysis and 216 in the per protocol analysis. The average age of participants was 39.05 ±11.58 years old. The average duration of acute bronchitis in the treatment group was 6.01±3.27 days and in the control group 5.89 ±3.10 days. No significant differences were observed at baseline between the treatment and the control. Researchers observed no statistically significant difference in total change of the Bronchitis Severity Scale between the control group and the treatment group in the per protocol analysis (P=0.5125) and full analysis (P=0.3793). Furthermore, there was no significant difference in the severity of each subcomponent in the Bronchitis Severity Scale (P>0.05) between the treatment and placebo group. Subjective analysis of symptom improvement showed that patients in both groups showed no statistical significance (P>0.05). Researchers reported that one participant in the placebo group experienced elevated aspartate aminotransferase levels and one patient in the treatment group had elevated alanine aminotransferase levels. However, this reaction was not generalizable. No other adverse outcomes were observed.

Results from this phase III clinical trial showed that the combination of Coptidis rhizome syrup and Ivy leaf extract was as effective as one tablet of Pelargonium sidoides in treating symptoms of acute bronchitis. Additional research will be needed to verify these results.

Source: Han, Kyung-Il, Tae-Hyung Kim, Seung Won Ra, Hyoung Kyu Yoon, Deog Kyeom Kim, Chin Kook Rhee, Jung Woong Park et al. “Efficacy and safety of mixture of ivy leaf extract and coptidis rhizome in the treatment of acute bronchitis: multicenter, randomized, double-blinded, active-controlled, parallel, therapeutic confirmatory clinical trial.” Current Medical Research and Opinion (2024): 1-9.

© 2024 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.

Click here to read the full text study.

Posted December 11, 2024.

Chrystal Moulton BA, PMP, is a 2008 graduate of the University of Illinois at Chicago. She graduated with a bachelor’s in psychology with a focus on premedical studies and is a licensed project manager. She currently resides in Indianapolis, IN.

References:

  1. Lee SW, Lyu YR, Kim SY, et al. Efficacy and Safety of GHX02 in the Treatment of Acute Bronchitis and Acute Exacerbation of Chronic Bronchitis: A Phase Ⅱ, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial. Front Pharmacol. 2021;12:761575. doi:10.3389/fphar.2021.761575
  2. Ra SW, Kim SY, Lim YY, et al. The safety and efficacy of CKD-497 in patients with acute upper respiratory tract infection and bronchitis symptoms: a multicenter, double-blind, double-dummy, randomized, controlled, phase II clinical trial. J Thorac Dis. Jan 2021;13(1):1-9. doi:10.21037/jtd-20-1567
  3. Han KI, Kim TH, Ra SW, et al. Efficacy and safety of mixture of ivy leaf extract and coptidis rhizome in the treatment of acute bronchitis: multicenter, randomized, double-blinded, active-controlled, parallel, therapeutic confirmatory clinical trial. Curr Med Res Opin. Jul 2024;40(7):1235-1243. doi:10.1080/03007995.2024.2362273
  4. Lee EG, Rhee CK. The clinical efficacy of AG NPP709 (Synatura(®)) in patients with chronic bronchitis type stable chronic obstructive pulmonary disease. J Thorac Dis. May 2020;12(5):2435-2442. doi:10.21037/jtd.2020.03.61
  5. Hong G, Kim Y-I, Park SJ, et al. Effects of a mixture of ivy leaf extract and coptidis rhizome on patients with chronic bronchitis and bronchiectasis. International Journal of Environmental Research and Public Health. 2021;18(8):4024.
  6. Chuchalin AG, Berman B, Lehmacher W. Treatment of acute bronchitis in adults with a pelargonium sidoides preparation (EPs 7630): a randomized, double-blind, placebo-controlled trial. Explore (NY). Nov 2005;1(6):437-45. doi:10.1016/j.explore.2005.08.009
  7. Agbabiaka TB, Guo R, Ernst E. Pelargonium sidoides for acute bronchitis: a systematic review and meta-analysis. Phytomedicine. May 2008;15(5):378-85. doi:10.1016/j.phymed.2007.11.023
  8. Matthys H, Eisebitt R, Seith B, Heger M. Efficacy and safety of an extract of Pelargonium sidoides (EPs 7630) in adults with acute bronchitis. A randomised, double-blind, placebo-controlled trial. Phytomedicine. 2003;10 Suppl 4:7-17. doi:10.1078/1433-187x-00308

 

×