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
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