主题：贴，贴， -- 虽远必诛

High risk of selection bias: allocation concealment is reported

inadequately, or is not performed at all.

Level of blinding

Masking of both the participants and results assessor was considered

as a low risk of performance or/and detection bias.

Single blinding of the results assessor was considered as amoderate

risk of performance or/and detection bias. If single blinding was

performed on the participants but not the results assessor, it was

considered as a high risk of detection bias.

Non-blinding for detection of outcomes includes quality of life

(QoL); adverse events were considered as a high risk of detection

bias. Blinding was not considered necessary for reporting mortality.

Incomplete outcome data: assessment for potential bias of

exclusions and attrition

Low risk of bias: trials where few exclusions and attrition are noted

and an intention-to-treat (ITT) analysis is possible.

Moderate risk of bias: trials which report the rate of exclusions

or/and attrition to be about 10%, whatever ITT analysis is used.

High risk of bias: the rate of exclusion or/and attrition is higher

than 15%, or there are wide differences in exclusions between

groups, whatever ITT analysis is used.

Measures of treatment effect

We analysed the data using Review Manager 5 (RevMan 2008).

We compared outcome measures for binary data using risk ratios.

For continuous data, we used the mean difference.We conducted

a pooled analysis for two trials only (Chang 2002; Yu 2005).

Assessment of heterogeneity

We assessed heterogeneity by using the Chi2 test with a 10% level

of statistical significance and by using the I2 statistic to estimate

the total variation across studies that was due to heterogeneity

rather than chance. Less than 25% was considered as low level

heterogeneity; 25% to 50% was considered as a moderate level;

and higher than 50% as a high level of heterogeneity (Higgins

2002).

Assessment of reporting biases

No - low risk of reporting bias: all outcomes are reported in detail.

Probably yes - moderate risk of reporting bias: at least one of the

outcomes are mentioned, but not in detail.

Yes - high risk of reporting bias: at least one of the outcomes are

not reported.

Data synthesis

We used the random-effectsmodel for a pooled analysis of the two

studies (Chang 2002; Yu 2005) as most of the studies had a high

level of heterogeneity. We did not perform a pooled analysis for

the other trials due to unknown formulations used in these trials.

We listed non-randomised controlled studies and the reasons of

exclusion in the ’Characteristics of excluded studies’ table, but did

not discuss them further.

R E S U L T S

Description of studies

See:Characteristics of included studies;Characteristics of excluded

studies; Characteristics of studies awaiting classification.

Results of the search

A total of 430 trials that claimed to be randomised were retrieved.

We successfully contacted 365 trial authors by telephone.Of these

trials, 302 were excluded, either because the trial authors misunderstood

true random allocation or the trial reports were multiple

versions of same study (see the ’Characteristics of excluded studies’

table), of those, 67 were additional studies later excluded in this

updated version of review.

One hundred and nine are listed in the ’Studies awaiting classification’

section. One of these studies, for example, assessed an

intervention containing ’Yuxincao’, a drug which the State Food

and Drug Administration (SFDA) stopped production of, due to

unclear adverse events. Other trials are allocated to this section

as we could not locate the original trial authors to identify the

randomisation method.

Seventeen studies were identified as true RCTs and fulfilled our

inclusion criteria (Chang 2002; Chang 2005; Chang 2007; Chen

2004; Li 1998; Li 1999a; Liu 2002; Ma 2000; Pan 2000; Song

2004a; Wang 1998; Wang 2004; Wang 2008a; Yang 2000; Yu

1997; Yu 2005; Zhang 2008), of those, three (Chang 2007;Wang

2008a; Zhang 2008) were additional trials later included in this

updated version of review.

Included studies

All 17 included trials used a parallel group design. Four trials (

Chang 2007; Li 1999a; Wang 2008a; Zhang 2008) were multicentre

trials.

A total of 3212 participants were included in the 17 trials, with

numbers of participants in each trial varying from58 to 463. Only

three trials (Chang 2005; Chang 2007; Wang 2008a) mentioned

that the sample size was calculated according to the SFDA’s regulation

about sample size of non-inferiority test studies (that a total

number of 200 participants be included); extra participants were

also included in these trials to avoid possible attrition bias.

Nine trials included children aged from six months to 14 years (

Chen 2004; Li 1998; Liu 2002;Ma 2000; Pan 2000; Song 2004a;

Wang 1998; Yang 2000; Yu 1997). Eight trials included adults

Chinese medicinal herbs for the common cold (Review) 9

Copyright 2009 The Cochrane Collaboration. Published by JohnWiley & Sons, Ltd.

aged from 18 to 65 or 72 years old (Chang 2002; Chang 2005;

Chang 2007; Li 1999a;Wang 2004;Wang 2008a; Yu 2005;Zhang

2008).

Eleven trials included participants according to TCM signs. Nine

trials (Chang 2005; Chang 2007; Chen 2004; Li 1998; Li 1999a;

Ma 2000; Wang 2008a; Yang 2000; Zhang 2008) included patients

with “fever cold”. One trial (Yu 1997) included both “fever

cold” and “chills cold” patients. Three trials (Chang 2002; Wang

2004; Yu 2005) included “chills cold”.Two trials (Pan 2000;Wang

1998) did not sort the patients by TCM signs.

Two trials (Chang 2002; Yu 2005) compared the Chinese herbs

Sanhan Jiere Koufuye and (Fenghan) Biaoshi Ganmao Chongji.

Other trials used different interventions and comparators. These

are listed below:

Yu 1997 comparedCaichenQinreWeixinGuanchangji

with virazole and acetaminophen.

Li 1998 compared Qinwen Keli granule with Kangbingdu

Koufuye.

Wang 1998 compared JianerQinjie YewithQinre Jiedu

Koufuye.

Li 1999a compared Qinkailing injection with Lincomycine.

Ma 2000 compared Shuanghua Penhuji with

Shuanghuanglian Qiwuji.

Pan 2000 compared Xiaoer Reganning with Vitamin C

Yinqiao Chongji.

Yang 2000 compared Huanghu Jiere Daipaoji with

Shiqi Ganmao Daipaoji.

Liu 2002 compared Kangbingdupian with Banlangen

Chongji.

Chen 2004 comparedGegenCenlianweiWanwith Yinqiao

Jiedupian.

Song 2004a compared self-prepared TCM cream with

penicillin or lincomycin.

Wang 2004 compared Sufeng Ganmao Koufuye with

Ganmao Qinre Koufuye.

Chang 2005 compared Jinlian Qinre capsules with Jinlian

Qinre granules; that is the same ingredients in two

different forms. The principle of selecting the control

drug was that its “effect was commonly recognised”. A

double-dummy placebo was used in both arms.

Chang 2007 compared ChaigeQingre granule with Fufang

Shuanghua granule.

Wang 2008a used a double-dummy placebo in both

arms, and compared Yiqing Shuangjie granule and

Chaihuang tablet placebo with Chaihuang tablet, and

compared Yiqing Shuangjie tablet and Caihuang tablet

placebo with Chaihuang tablet.

Zhang 2008 comparedQingyin injectionwithQinkailing

injection

Recovery (expressed as a dichotomous event)was used as a primary

outcome in all trials, except for Pan 2000 and Zhang 2008. Inefficacy

was reported in 15 trials. Fever clearance time was reported in

six trials (Chang 2002; Chang 2005; Li 1998;Wang 1998;Wang

2008a; Yu 1997). The time point at which the temperature started

to abate was reported in four trials (Chang 2005; Li 1998; Wang

1998; Wang 2008a). Six trials (Chang 2002; Chang 2005; Chen

2004; Li 1999a;Wang 2008a; Yu 1997) compared the prevalence

of viral respiratory tract infection by a throat swab culture. Five

trials reported that liver and kidney function tests were carried

out to look for side effects or adverse events (Chang 2002; Chang

2005; Chang 2007; Wang 2008a; Zhang 2008).

Eight trials (Chang 2002; Chang 2005; Chang 2007; Chen

2004; Song 2004a;Wang 2004;Wang 2008a; Yu 2005) evaluated

changes of TCM signs, which included “e feng han” (fear of wind

and cold); “fa re” (fever); “bi sai liu ti” (snuffles and runny nose);

examination of the colour and surface of the tongue; and “mai