Limits...
Chinese patent medicines for the treatment of the common cold: a systematic review of randomized clinical trials.

Chen W, Liu B, Wang LQ, Ren J, Liu JP - BMC Complement Altern Med (2014)

Bottom Line: A total of five RCTs were identified.All of the RCTs were of high risk of bias with flawed study design and poor methodological quality.All RCTs included children aged between 6 months to 14 years.

View Article: PubMed Central - PubMed

Affiliation: Centre For Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China. jianping_l@hotmail.com.

ABSTRACT

Background: Many Chinese patent medicines (CPMs) have been authorized by the Chinese State of Food and Drug Administration for the treatment of the common cold. A number of clinical trials have been conducted and published. However, there is no systematic review or meta-analysis on their efficacy and safety for the common cold to justify their clinical use.

Methods: We searched CENTRAL, MEDLINE, EMBASE, SinoMed, CNKI, VIP, China Important Conference Papers Database, China Dissertation Database, and online clinical trial registry websites for published and unpublished randomized clinical trials (RCTs) of CPMs for the common cold till 31 March 2013. Revman 5.2 software was used for data analysis with effect estimate presented as relative risk (RR) and mean difference (MD) with a 95% confidence interval (CI).

Results: A total of five RCTs were identified. All of the RCTs were of high risk of bias with flawed study design and poor methodological quality. All RCTs included children aged between 6 months to 14 years. Results of individual trials showed that Shuanghuanglian oral liquid (RR 4.00; 95% CI: 2.26 to 7.08), and Xiaoer Resuqing oral liquid (RR 1.43; 95% CI: 1.15 to 1.77) had higher cure rates compared with antivirus drugs. Most of the trials did not report adverse events, and the safety of CPMs was still uncertain.

Conclusions: Some CPMs showed a potential positive effect for the common cold on cure rate. However, due to the poor methodology quality and the defects in the clinical design of the included RCTs, such as the lack of placebo controlled trials, the inappropriate comparison intervention and outcome measurement, the confirmative conclusions on the beneficial effect of CPMs for the common cold could not be drawn.

Show MeSH

Related in: MedlinePlus

Risk of bias summary about each risk of bias item for each included study.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
getmorefigures.php?uid=PMC4129119&req=5

Fig2: Risk of bias summary about each risk of bias item for each included study.

Mentions: All of the included trials were assessed to be of generally poor methodological quality. All the RCTs mentioned that ‘participants were randomized into groups’, but did not report the detailed methods for sequence generation. We contacted the authors of the included RCTs, one trial [11] claimed that they drew lots to assign the participants; the other trials did not respond to our inquiry. Allocation concealment and blinding was not mentioned in any RCT. And because of the different formulation of CPMs and control intervention, it was not likely to conduct blinding either to investigator or to patients. No trial reported drop-out or withdrawals, or mentioned intention-to-treat analysis. Selective reporting was unclear because we could not access to the protocols of included RCT. All the included RCTs did not register in relevant authoritative websites prior to the start of the study. The risk of bias summary about each risk of bias item for each included study is shown in Figure 2.Figure 2


Chinese patent medicines for the treatment of the common cold: a systematic review of randomized clinical trials.

Chen W, Liu B, Wang LQ, Ren J, Liu JP - BMC Complement Altern Med (2014)

Risk of bias summary about each risk of bias item for each included study.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4129119&req=5

Fig2: Risk of bias summary about each risk of bias item for each included study.
Mentions: All of the included trials were assessed to be of generally poor methodological quality. All the RCTs mentioned that ‘participants were randomized into groups’, but did not report the detailed methods for sequence generation. We contacted the authors of the included RCTs, one trial [11] claimed that they drew lots to assign the participants; the other trials did not respond to our inquiry. Allocation concealment and blinding was not mentioned in any RCT. And because of the different formulation of CPMs and control intervention, it was not likely to conduct blinding either to investigator or to patients. No trial reported drop-out or withdrawals, or mentioned intention-to-treat analysis. Selective reporting was unclear because we could not access to the protocols of included RCT. All the included RCTs did not register in relevant authoritative websites prior to the start of the study. The risk of bias summary about each risk of bias item for each included study is shown in Figure 2.Figure 2

Bottom Line: A total of five RCTs were identified.All of the RCTs were of high risk of bias with flawed study design and poor methodological quality.All RCTs included children aged between 6 months to 14 years.

View Article: PubMed Central - PubMed

Affiliation: Centre For Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China. jianping_l@hotmail.com.

ABSTRACT

Background: Many Chinese patent medicines (CPMs) have been authorized by the Chinese State of Food and Drug Administration for the treatment of the common cold. A number of clinical trials have been conducted and published. However, there is no systematic review or meta-analysis on their efficacy and safety for the common cold to justify their clinical use.

Methods: We searched CENTRAL, MEDLINE, EMBASE, SinoMed, CNKI, VIP, China Important Conference Papers Database, China Dissertation Database, and online clinical trial registry websites for published and unpublished randomized clinical trials (RCTs) of CPMs for the common cold till 31 March 2013. Revman 5.2 software was used for data analysis with effect estimate presented as relative risk (RR) and mean difference (MD) with a 95% confidence interval (CI).

Results: A total of five RCTs were identified. All of the RCTs were of high risk of bias with flawed study design and poor methodological quality. All RCTs included children aged between 6 months to 14 years. Results of individual trials showed that Shuanghuanglian oral liquid (RR 4.00; 95% CI: 2.26 to 7.08), and Xiaoer Resuqing oral liquid (RR 1.43; 95% CI: 1.15 to 1.77) had higher cure rates compared with antivirus drugs. Most of the trials did not report adverse events, and the safety of CPMs was still uncertain.

Conclusions: Some CPMs showed a potential positive effect for the common cold on cure rate. However, due to the poor methodology quality and the defects in the clinical design of the included RCTs, such as the lack of placebo controlled trials, the inappropriate comparison intervention and outcome measurement, the confirmative conclusions on the beneficial effect of CPMs for the common cold could not be drawn.

Show MeSH
Related in: MedlinePlus