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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Conference Papers Database, China Dissertation Database, and online clinical trial registry websites for published and unpublished randomized clinical trials (RCTs) of CPMs for the common cold till 31 March 2013.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.

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Flow chart of included studies in this systematic review.
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Fig1: Flow chart of included studies in this systematic review.

Mentions: A total of 33 CPMs were listed in ‘China national essential drug list 2012’ for the treatment of the common cold, and clinical studies of the 33 CPMs were searched from the above eight databases and two clinical trials registry websites. A flow chart depicts the search process and study selection (Figure 1). After primary searches, 83 citations were identified, and the majority was excluded due to obvious ineligibility from reading title/abstract. Full text papers of 31 studies were retrieved. At last, a total of 5 RCTs including 5 different CPMs [9–13] were included. These 5 CPMs were Chaihu injection [9], Ganmao Qingre granules [10], Shuanghuanglian oral liquid [11], Xiaoer Baotaikang granules [12], and Xiaoer Resuqing oral liquid [13]. One four-armed RCT [9] was included which compared Chaihu injection given by acupoint block, Chaihu injection given by intramuscular injection, saline given by acupoint block, and ribavirin given by intramuscular injection. The compositions and indications of the 5 CPMs included in the review were shown in Table 1. We collected the data of group that received Chaihu injection given by intramuscular injection and group that received ribavirin given by intramuscular injection. The search for ongoing registered trials identified no trial.Figure 1


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)

Flow chart of included studies in this systematic review.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Fig1: Flow chart of included studies in this systematic review.
Mentions: A total of 33 CPMs were listed in ‘China national essential drug list 2012’ for the treatment of the common cold, and clinical studies of the 33 CPMs were searched from the above eight databases and two clinical trials registry websites. A flow chart depicts the search process and study selection (Figure 1). After primary searches, 83 citations were identified, and the majority was excluded due to obvious ineligibility from reading title/abstract. Full text papers of 31 studies were retrieved. At last, a total of 5 RCTs including 5 different CPMs [9–13] were included. These 5 CPMs were Chaihu injection [9], Ganmao Qingre granules [10], Shuanghuanglian oral liquid [11], Xiaoer Baotaikang granules [12], and Xiaoer Resuqing oral liquid [13]. One four-armed RCT [9] was included which compared Chaihu injection given by acupoint block, Chaihu injection given by intramuscular injection, saline given by acupoint block, and ribavirin given by intramuscular injection. The compositions and indications of the 5 CPMs included in the review were shown in Table 1. We collected the data of group that received Chaihu injection given by intramuscular injection and group that received ribavirin given by intramuscular injection. The search for ongoing registered trials identified no trial.Figure 1

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