Is the combination of oseltamivir and Chinese herbal formula maxingshigan-yinqiaosan effective in treating H1N1 Influenza?
Date of publication of randomized controlled trial: August 2011
Design
Randomized controlled trial (RCT).
Participants
410 adults aged 15 to 70 years presented within 72 hours of onset of H1N1 influenza A symptoms (mean age: 19.0 years; 57.1% male).
Intervention
The combination of oseltamivir and Chinese herbal formula maxingshigan-yinqiaosan. Oral oseltamivir, 75 mg twice daily; maxingshigan–yinqiaosan decoction which was composed of 12 Chinese herbal medicines, 200 mL orally 4 times daily. Duration of treatment lasted for 5 days.
Comparator
Comparison 1: Oseltamivir plus maxingshigan-yinqiaosan versus no intervention;
Comparison 2: Oseltamivir plus maxingshigan-yinqiaosan versus oseltamivir alone.
Major Outcomes
Outcome 1: Time from randomization to fever resolution (body temperature ≤37 °C
for 24 hours).
Settings
The trial was conducted in inpatient settings.
Comparison    Oseltamivir plus maxingshigan-yinqiaosan versus no intervention
Main Results
Compared to no intervention, oseltamivir plus maxingshigan-yinqiaosan significantly reduced the median time to fever resolution by 47% (95% CI: 35% to 56%).
Comparison 1: Oseltamivir plus maxingshigan-yinqiaosan versus no intervention among adults with H1N1 Influenza
Outcomes No. of studies (Total number of participants) Median time / No. of participants Heterogeneity test (I2) Difference in median time (95% CI) p value Overall quality of evidence*
Intervention Comparator
1 1(205) 15.0 hours /102 26.0 hours / 103 Not applicable as there is only 1 trial -47% (-56% to -35%) <0.001 High
Keys: CI: confidence interval.
Comparison    Oseltamivir plus maxingshigan-yinqiaosan versus oseltamivir alone among adults with H1N1 Influenza
Main Results
Compared to oseltamivir alone, the combination of oseltamivir and maxingshigan-yinqiaosan significantly reduced the median time to fever resolution by 19% (95% CI: 0.3% to 34%).
Comparison 2: Oseltamivir plus maxingshigan-yinqiaosan versus oseltamivir alone among adults with H1N1 Influenza
Outcomes No. of studies (Total number of participants) Median time / No. of participants Heterogeneity test (I2) Difference in median time (95% CI) p value Overall quality of evidence*
Intervention Comparator
1 1(204) 15.0 hours /102 20.0 hours / 102 Not applicable as there is only 1 trial -19% (-34% to -0.3%) 0.047 Moderate
Keys: CI: confidence interval.
Comparison    Oseltamivir plus maxingshigan-yinqiaosan versus no intervention
Main Results
Compared to no intervention, oseltamivir plus maxingshigan-yinqiaosan significantly reduced the median time to fever resolution by 47% (95% CI: 35% to 56%).
Comparison 1: Oseltamivir plus maxingshigan-yinqiaosan versus no intervention among adults with H1N1 Influenza
Outcomes 1
No. of studies (Total number of participants) 1(205)
Median time / No. of participants Intervention 15.0 hours /102
Comparator 26.0 hours / 103
Difference in median time (95% CI) -47% (-56% to -35%)
p value <0.001
Overall quality of evidence* High
Keys: CI: confidence interval.
Comparison    Oseltamivir plus maxingshigan-yinqiaosan versus oseltamivir alone among adults with H1N1 Influenza
Main Results
Compared to oseltamivir alone, the combination of oseltamivir and maxingshigan-yinqiaosan significantly reduced the median time to fever resolution by 19% (95% CI: 0.3% to 34%).
Comparison 2: Oseltamivir plus maxingshigan-yinqiaosan versus oseltamivir alone among adults with H1N1 Influenza
Outcomes 1
No. of studies (Total number of participants) 1(204)
Median time / No. of participants Intervention 15.0 hours /102
Comparator 20.0 hours / 102
Difference in median time (95% CI) -19% (-34% to -0.3%)
p value 0.047
Overall quality of evidence* Moderate
Keys: CI: confidence interval.
Conclusion
Benefits
This study showed that the combination of oseltamivir and maxingshigan-yinqiaosan significantly reduced the median time to fever resolution when compared to no intervention and Oseltamivir alone. For outcome 1 in Comparison 1, the overall quality of evidence is high. Further research is unlikely to have an important impact on our confidence in this estimate of effect. For outcomes 1 in Comparison 2, the overall quality of evidence is moderate. Further research is fairly likely to have an important impact on our confidence in this estimate of effect.
Harms
No adverse events were observed in no intervention group, oseltamivir alone group and the combination of oseltamivir and maxingshigan-yinqiaosan group.
Link to Original Article
https://www.ncbi.nlm.nih.gov/pubmed/21844547
The synopsis is based on the following article:
Wang C, Cao B, Liu QQ, Zou ZQ, Liang ZA, Gu L, Dong JP, Liang LR, Li XW, Hu K, He XS. Oseltamivir Compared With the Chinese Traditional Therapy Maxingshigan–Yinqiaosan in the Treatment of H1N1 InfluenzaA Randomized Trial. Annals of Internal Medicine. 2011 Aug 16;155(4):217-25.


* Interpretation of quality assessment results:
• Very low: Further research is most likely to have an important impact on our confidence in this estimate of effect.
• Low: Further research is likely to have an important impact on our confidence in this estimate of effect.
• Moderate: Further research is fairly likely to have an important impact on our confidence in this estimate of effect.
• High: Further research is unlikely to have an important impact on our confidence in this estimate of effect.
• Very high: Further research is most unlikely to have an important impact on our confidence in this estimate of effect.

Details of assessment method can be found at Chung VC, Wu XY, Ziea ET, Ng BF, Wong SY, Wu JC. Assessing internal validity of clinical evidence on effectiveness of CHinese and integrative medicine: Proposed framework for a CHinese and Integrative Medicine Evidence RAting System (CHIMERAS). European Journal of Integrative Medicine. 2015 Aug 31;7(4):332-41.