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

Table 2. Chinese herbs in different languages

Pingying name Latin name English name

Huangqin Radix Scutellariae Baical Skullcap root

Lianqiao Fructus Forsythiae Weeping Forsythia capsule

Huzhang Rhizoma Polygoni Cuspidati Giant Knotweed rhizome

Shanzhima Radix Helicteris Narrowleaf Screwtree root

Jinyinhua Flos Lonicerae Honeysuckle flower

Qinhao Herba Artemisiae SweetWormwood herb

Chaihu Radix Bupleuri Chinese Thorowax root /Red Thorowax root

Xixin Herba Asari Manchurian Wildginger

Gegen Radix Puerariae Kudzuvine root

Huanglian Rhizoma Coptidis Colden thread

Zhigancao Radix Glycyrrhizae Liquorice root

Hangjuhua Flos Chrysanthemi Chrysanthemun flower

Kuxinren Semen Armeniacae Amarum Apricot kernel

Shanzha Fructus Crataegi Hawthorn fruit

Chenpi Pericarpium Citri Reticulatae Dried Tangerine peel

Niuhuang Calculus Bovis Bezoar

Shuiniujiao Cornu Bubali Buffalo horn

Zhenzhumu Concha Margaritifera Usta Nacre

Zhizi Fructus Gardeniae Cape Jasmine fruit

Banlangen Radix Isatidis Isatis root

Shigao Gypsum Fibrosum Gypsum

Sangye Folium Mori Mulberry leaf

Yejuhua Flos Chrysanthemi Indici Wild Chrysanthemum

Yuxingcao Herba Houttuyniae Heartleaf Houttuynia Herb

Boheyou Herba Menthae oil Peppermint oil

Sisuye Folium Perillae Perilla leaf

Qianghuo Rhizoma Notopterygii Incised Notopterygium rhizome/Forbes Notopterygium rhizome

Jinjie Herba Schizonepetae Fineleaf Schizonepeta herb

Chinese medicinal herbs for the common cold (Review) 7

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

Table 2. Chinese herbs in different languages (Continued)

Guanghexiang Herba Pogostemonis Cablin Potchouli herb

Fangfeng Radix Saposhnikoviae Divaricate Saposhnikovia root

Qianhu Radix Peucedani Whiteflower Hogfennel root/Common Hongfennel root

Fuping Herba Spirodelae Common Ducksmeat herb

Fulinpi Poria skin Indian Buead skin

Jinlianhua Flos Trollii Chinese Globeflower flower

Daqingye Folium Isatidis Indigowoad leaf

Shenshigao Gypsum Fibrosum Gypsum

Zhimu Rhizoma Anemarrhenae Common Anemarrhena rhizome

Shendi Radix Rehmanniae Rehmannia root

Xuanshen Radix Scrophulariae Figwort root

Kuxingren Semen Armeniacae Amarum Bitter Apricot Seed

Yujin Radix Curcumae Turmeric root-tuber

Mahuang Herba Ephedrae Ephedra herb

Shandougen Radix Sophorae Tonkinensis Vietnamese Sophora root

Bohe Herba Menthae Peppermint

Bingpian Borneolum Borneol

Gancao Radix Glycyrrhizae Liquoric root

Shichangpu Rhizoma Acori Tatarinowii Grassleaf Sweelflag rhizome

Chuanxinlian Herba Andrographis Common Andrographis herb

We performed an intention-to-treat (ITT) analysis on three trials

(Chang 2005; Chang 2007; Wang 2008a). We performed perprotocol

analyses on the other studies. We reported the number

lost to follow up in the notes column of the ’Characteristics of

included studies’ table.

Assessment of risk of bias in included studies

We assessed the risk of bias of each trial in terms of generation

of allocation sequence, allocation concealment, blinding, uncompleted

data and selective reporting; and classified themas ’lowrisk’,

’moderate risk’, or ’high risk’ according to the guidelines of the

Cochrane Handbook for Systematic Reviews of Interventions 5.0.0 (

Higgins 2008) and as described in Wu 2007a. There was no disagreement

in this process.

Sequence generation

An adequate approach for generating allocation sequence with a

low risk of selection bias should be by using a random numbers table

or computer software, or other simple randomisationmethods,

for example, coin tossing or card shuffling. We considered a trial

which only mentions ’random’ but does not include a description

of the approach used as a moderate risk of selection bias.

Allocation sequence concealment

Low risk of selection bias: adequate measures to conceal allocation

sequence is defined as the person who generates an allocation

sequence not recruiting the participants, for example, by central

randomisation. Examples of concealing allocation sequences are

using sealed opaque envelopes or storing allocation sequences in

a locked computer.

Moderate risk of selection bias: where concealment of the allocation

sequence is mentioned but the approach used is not reported.

Chinese medicinal herbs for the common cold (Review) 8

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

3. Current Controlled Trials ( http:/ / www.controlledtrials.

com/);

4. Chinese Clinical Trial Register ( http:/ /

www.chictr.org);

5. Australian Clinical Trial Registry ( http:/ /

www.actr.org.au/); and

6. WHO ICTRP search portal ( http:/ / www.who.int/

trialsearch/).

Data collection and analysis

Selection of studies

Six review authors (WT, ZX, ZJ, XLX, QY, LG) performed the

searches and retrieved articles. The same review authors selected

the trials to be included in the study and no disagreements were

recorded.We retrieved the selected trials which claimed to be randomised.

We then confirmed that they were correctly randomised

by telephoning the original trial authors.

Data extraction and management

Two review authors (WT, LG) independently extracted data using

a piloted data extraction form.We extracted data on study characteristics

including methods, participants, interventions and outcomes.

There were no disagreements. The formulation contents of

included studies and herb names in three languages are described

in Table 1 and Table 2.

Table 1. Contents of the formulations used in the included studies

Study ID Contents Method of administration

Chang 2002 Did not provide any information about the contents of interventions

including Shanhanjiere Koufuye and Biaoshi

Ganmao Chongji

Each ml solution contained 2 g of raw drug material.

Each ampoule contained 4 ml. One ampoule for children

younger than 4 years of age was administered by the rectal

route; and 2 ampoules were administered for children

older than 4 years of age, 3 times a day.

Chang 2005 Jinlianhua, Daqinye, Shenshigao, Zhimu, Shendi, Xuanshen,

Kuxingren

Oral administration

Chang 2007 Gegen Qingre granule: Chaihu, Gegen, Huangqin,

Mahuang, Shigao, Xingren, Gancao

Oral water dilution

Chen 2004 Gegen, Huangqin, Huanglian, Zhigancao Oral administration

Chinese medicinal herbs for the common cold (Review) 5

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Table 1. Contents of the formulations used in the included studies (Continued)

Li 1998c Qinwinkeli: the author mentioned that Qinwinkeli consisted

of 5 herbs, but just listed 2 in the paper: Shigao,

Sangye

Oral water dilution

Li 1999b Qinkailing injection: Niuhuang, Shuiniujiao, Zhenzhumu,

Huangqin, Zhizi, Jinyinghua, Banlangen 10 ml

contains 50 mg baicalin

Intravenous injection

Liu 2002 Kangbingdupian: Banlangen, Lianqiao, Shigao, Shendi,

Guanghuoxiang, Yujin, Shichangpu

Oral administration

Ma 2000b Shuanhua aerosol: Yejuhua, Jinyinghua, Yuxingchao,

Chaihu, Boheyou

Mei 2003 Yujin injection: water extraction of Yuxingcao, Jinyinghua Intravenous injection

Pan 2000 Xiaoer RiganlingKoufuye:Gegen,Taurine (Taurine is not

a herb)

Oral administration

Song 2004a TCM cream Xiaoer Tuiresan: Mahuan 100 g, Jinyinhua

200 g, Shandougen 100 g, Xixin 10 g, Bohe 100 g, Bingpian

80 g, Gancao 60 g, grind themto be very fine powder

and mix them. Take 3 to 10 g preparation with the correct

amount of vinegar tomake a creamand smear on a plastic

membrane.

Apply to the skin

Wang 1998 Jianerqinjieye: Jinyinhua, Hangjuhua, Lianqiao, Kuxinren,

Shanzha, Chenpi

Oral administration

Wang 2004 Sufeng Ganmao Koufuye: Zisuye, Qianghuo, Jinjie,

Guanghexiang, Fangfeng, Qianhu, Fuping, Fulinpi

Oral administration

Wang 2008a Yiqing Shuangjie capsule and tablet: Huangqin, Chaihu,

Rengong Niuhuang

Oral administration

Yang 2000 Huanghu Bag Tea: Huangqin, Lianqiao, Huzhang,

Shanzhima, Jinyinhua, Qinhao, Chaihu

Oral administration

Yu 1997 Chaiqin Qingre enema lavage solution: Chaihu,

Huangqin, Xixin

Oral administration

Zhang 2001 Rebining: no other information was provided

Zhang 2008 Qingyin injection: Huangqin, Yinhua Intravenous injection

Chinese medicinal herbs for the common cold (Review) 6

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

sweat, generally have a high temperature, develop a thin, white fur

on the tongue, and experience a productive cough. ’Fever cold’,

on the other hand, is defined by the fact that patients do not feel

chilly, have an elevated temperature, develop a thin and slightly

yellow fur on the tongue, and experience a productive cough.

Herbs are indicated and dispensed in accordance with the symptoms

or causes of the cold. For example Shi Gao (Gypsum Fibrosum)

compounds can markedly abate fever (Deng 1998a),

and Chai Hu (Bupleurum chinesenes DC) and Jing Jie (Herba

Schizonepetae) act as analgesics (Wang 1998; Xu 1998). Ma

Huang (Herba Ephedrae) can be used to induce perspiration and

as an analgesic (Gong 1998); while Ban Xia (Rhizoma Pinelliae) is

dispensed to loosen sputumand suppress coughs (Xue 1998). Fang

Feng (Radix Saposhnikiviae) and Zhi Shu Ye (Folium Perillae) are

given for what is commonly termed ’chill cough’; Jin Ying Hua

(Flos Lonicerae) and Bo He (Herba Menthae) for ’fever cough’;

and Fructus Gardeniae for fever and convulsions.

Why it is important to do this review

Modern pharmacological experiments demonstrate that some

herbs, such as Jin Ying Hua (Flos Lonicerae) (Deng 1998b), Yu

Xin Chao (Herba Houttuyniae) (Deng 1998c), and Ban Lan Gen

(Radix Isatidis) (Deng 1998d) do have antiviral or antibacterial

functions. The principles of traditional Chinese medicine (TCM)

state that the ideal effect will result from using Chinese medicinal

herbs according to its guidelines. Using the herbs incorrectly may

cause harm rather than benefit; for example, the herbs for ’fever

cold’ should never be used for a ’chills cold’.

In China, more than 100 varieties of herbal preparation are used

in the prevention and treatment of the common cold. Hundreds

of millions of dollars are spent on treating colds each year (Zuo

2006). Hundreds of clinical studies have been carried out on Chinese

medicinal herbs for the common cold. These include five

randomised controlled trials (RCTs) involving 880 participants

conducted on “Huang Zhi Hua oral preparation” (Cheng 1999;

He 1999; Pan 1999; Wang 1999a; Yi 1999a). Almost all of these

studies have reported a positive effect.

In high-income countries there is increasing public interest in,

and use of, a wide range of therapies which lie outside the ’mainstream’

or traditionalWesternmedical practice. The recentHouse

of Lords Select Committee report on Complementary and Alternative

Medicine (CAM) heard that “we are now experiencing a

rapid increase in the use of CAM across the Western World” (

HLSC 2000). Whether we support or criticise their effectiveness,

herbal medicines are widely used.

There is evidence to indicate that not all herbs are risk-free. There

are concerns about adverse events, including allergic reactions and

Chinese herbal nephropathy (CHN) (Lampert 2002; Lord 2001;

Nortier 2000). Scientific evidence which indicates that Chinese

herbal medicines are more effective than antibiotics in the treatment

of acute respiratory infections is insufficient (Liu 1998).

O B J E C T I V E S

To assess the efficacy and safety of Chinese medicinal herbs for the

treatment of the common cold in children and adults.

Secondary objectives were to compare the efficacy of different

Chinese medicinal herbs and record any related adverse events.

When making comparisons between groups intended for treatment

with Chinese medicinal herbs and groups allocated to the

placebo or other current treatment regimes, or various Chinese

medicinal herbs, we tested the following hypotheses:

1. that there is no difference in the number of people cured

by the end of the third day; and

2. that there is no difference in the number of adverse

events.

M E T H O D S

Criteria for considering studies for this review

Types of studies

Randomised controlled trials (RCTs) studying the efficacy of Chinese

medicinal herbs for the common cold. If trials did not report

the outcome we were looking for, we contacted the trial authors

to ask for this additional information; the trials were excluded if

this information was not available.

Types of participants

Children (17 years or younger) and adults (18 years or older) with

the common cold.

The common cold is defined as acute inflammation of the nasal

cavity, pharynx or larynx, caused by viral infection(s). Typical

symptoms include runny nose, nasal congestion, sneezing, sore or

scratchy throat, cough, fatigue and fever. Ideally, the diagnostic

criteria for the common cold should be described in the trial. To

allow for changes in classification and diagnostic criteria of the disease,

the diagnosis should be established using the standard criteria

valid at the time of conducting the trial. Changes in diagnostic

criteriamay have produced variability in the clinical characteristics

of the patients included and the results obtained. We considered,

documented and explored these changes in a sensitivity analysis.

We excluded colds caused by influenza in this review - symptoms

always included headache, muscle ache and fatigue, high fever,

usually a cough, sometimes a runny nose, sneezing, sore throat,

and itching eyes, nose, or throat.We also excluded acute bronchitis

developing froma case of common cold.These illnesses are assessed

in other Cochrane Reviews (Chen 2005; Wei 2005).

Chinese medicinal herbs for the common cold (Review) 3

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

We excluded patients concurrently suffering fromother infectious

or febrile diseases, or both.

Types of interventions

Chinese herbal medicines compared with placebo or other treatments

for the common cold.We excluded prohibited or suspended

Chinese herbal preparations.

Types of outcome measures

Primary outcomes

Recovery refers to whether the symptoms of common cold were

cleared within three days after treatment. Trials use the following

outcome measures:

1. ’fast effect’ - which means that the fever abated within

two to four hours after treatment, with symptoms subsiding

after 24 hours. This was considered as a ’recovery’;

2. ’marked effect’ - which means that the fever abated

within 24 to 48 hours after treatment, with symptoms

of the common cold subsiding after 48 hours. This was

also considered as a ’recovery’.

Secondary outcomes

1. Fever clearance time: fever clearance time refers to the

time between commencing treatment and temperature

returning to normal.

2. Improvement: temperature returns to normal and most

of the symptoms disappear within three days of administration

of the Chinese herbal preparation.

3. Partial improvement: fever abatement and some symptoms

disappear within three days of administration of

the Chinese herbal preparation.

4. No improvement: no significant change in symptoms

was noted at the end of the third day following the administration

of theChinese herbal preparation. Patients

with a high fever treated with physiotherapy or antibiotics

(for clearance of fever during the treatment) were

considered in this category.

5. Adverse events: we defined serious adverse events according

to the ICHGuidelines (ICHEWG1997) as any

event that leads to death, is life-threatening, requires inpatient

hospitalisation or prolongation of existing hospitalisation,

results in persistent or significant disability,

and any important medical event whichmay have jeopardised

the patient or required intervention to prevent

it. We considered all other adverse events to be nonserious.

6. Additional outcomes: we attempted to analyse the effects

of the interventions on TCM signs, which follow

a particular theoretical and methodological pathway, as

additional outcomes in this review. See the final point in

the Discussion section with regards to validating methods

used to measure TCM signs.

Search methods for identification of studies

Electronic searches

We searched the Cochrane Central Register of Controlled Trials

(CENTRAL) (TheCochrane Library 2008, issue 2) which contains

the Cochrane Acute Respiratory Infections Group’s Specialised

Register; MEDLINE (1966 to May 2008); EMBASE (1980 to

May 2008); AMED(1985 toMay 2008); the Chinese Biomedical

Database (CBMdisc) (1978 to May 2008)

Chinese medicinal herbs for the common cold (Review)

Zhang X, Wu T, Zhang J, Yan Q, Xie L, Liu GJ

This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library

2009, Issue 4

http://www.thecochranelibrary.com

Chinese medicinal herbs for the common cold (Review)

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

T A B L E O F C O N T E N T S

HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

AUTHORS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99

Analysis 1.1. Comparison 1 Chinese herbs versus controls, Outcome 1 Change of symptoms. . . . . . . . . 101

Analysis 1.2. Comparison 1 Chinese herbs versus controls, Outcome 2 Change of symptoms (Sanhan Jiere Houfuye). 104

Analysis 1.3. Comparison 1 Chinese herbs versus controls, Outcome 3 Recovery. . . . . . . . . . . . . . 105

Analysis 1.4. Comparison 1 Chinese herbs versus controls, Outcome 4 Improvement. . . . . . . . . . . . 106

Analysis 1.5. Comparison 1 Chinese herbs versus controls, Outcome 5 Partial improvement. . . . . . . . . . 107

Analysis 1.6. Comparison 1 Chinese herbs versus controls, Outcome 6 No improvement. . . . . . . . . . . 108

Analysis 1.7. Comparison 1 Chinese herbs versus controls, Outcome 7 Number of participants whose temperature

normalised at 24, 48, 72 hours after drug administration. . . . . . . . . . . . . . . . . . . . 108

Analysis 1.8. Comparison 1 Chinese herbs versus controls, Outcome 8 Time temperature started to abate. . . . . 109

Analysis 1.9. Comparison 1 Chinese herbs versus controls, Outcome 9 Average duration of fever time. . . . . . 110

Analysis 1.10. Comparison 1 Chinese herbs versus controls, Outcome 10 TCM signs (ITT analysis). . . . . . . 111

APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111

WHAT’S NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112

HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112

CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112

DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112

SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112

DIFFERENCES BETWEEN PROTOCOL AND REVIEW . . . . . . . . . . . . . . . . . . . . . 113

NOTES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113

INDEX TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113

Chinese medicinal herbs for the common cold (Review) i

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

[Intervention Review]

Chinese medicinal herbs for the common cold

Xiaoge Zhang2, Taixiang Wu1, Jing Zhang3, Qiu Yan4, Lingxia Xie5, Guan Jian Liu1

1Chinese Cochrane Centre, Chinese EBM Centre,West China Hospital, Sichuan University, Chengdu, China. 2State Key Laboratory

ofOralDiseases,WestChina College of Stomatology, SichuanUniversity, Chengdu, China. 3Reproductive Endocrinology,Department

of Obstetrics and Gynecology, West China Second University Hospital, Sichuan University, Chengdu, China. 4West China Medical

School, Sichuan University, Chengdu, China. 5Clinical Medicine, West China Secondary Hospital, Sichuan University, Chengdu,

China

Contact address: Taixiang Wu, Chinese Cochrane Centre, Chinese EBM Centre, West China Hospital, Sichuan University, No. 37,

Guo Xue Xiang, Chengdu, Sichuan, 610041, China. [email protected]. [email protected]. (Editorial group: Cochrane Acute

Respiratory Infections Group.)

Cochrane Database of Systematic Reviews, Issue 4, 2009 (Status in this issue: Unchanged)

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

DOI: 10.1002/14651858.CD004782.pub2

This version first published online: 24 January 2007 in Issue 1, 2007.

Last assessed as up-to-date: 21 July 2008. (Help document - Dates and Statuses explained)

This record should be cited as: Zhang X, Wu T, Zhang J, Yan Q, Xie L, Liu GJ. Chinese medicinal herbs for the common cold.

Cochrane Database of Systematic Reviews 2007, Issue 1. Art. No.: CD004782. DOI: 10.1002/14651858.CD004782.pub2.

A B S T R A C T

Background

Chinese medicinal herbs are frequently used to treat the common cold in China. Until now, their efficacy has not been systematically

reviewed.

Objectives

To assess the effectiveness and safety of Chinese medicinal herbs for the common cold.

Search strategy

We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2008, issue 2), which contains the

Cochrane Acute Respiratory Infections Group’s Specialised Register;MEDLINE (1966 toMay 2008); EMBASE (1980 toMay 2008);

AMED (1985 to May 2008); the Chinese Biomedical Database (CBMdisc) (1978 to May 2008); and China National Knowledge

Infrastructure (CNKI) (1994 to May 2008).

Selection criteria

Randomised controlled trials (RCTs) studying the efficacy of Chinese medicinal herb(s) for the treatment of the common cold.

Data collection and analysis

Four review authors telephoned the original trial authors of the RCTs identified by our searches to verify the randomisation procedure.

Two review authors extracted and analysed data from trials which met the inclusion criteria.

Main results

We found17 studies involving 3212 patients. Themethods of 15 studies were at high risk of bias. In only two studies was the risk of bias

low. Trials used “positive drugs”, of which the efficacy was not known, as controls. Different Chinese herbal preparations were tested in

nearly all trials. In only one trial was a Chinese herbal preparation tested twice. In seven trials, six herbal preparations were found to be

Chinese medicinal herbs for the common cold (Review) 1

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

more effective at enhancing recovery than the control preparations. In the other 10 studies, seven herbal preparations were not shown

to be significantly different from the control. One study did not describe the difference between the intervention and control groups.

Authors’ conclusions

Chinese herbal medicines may shorten the symptomatic phase in patients with the common cold. However, the lack of trials of low

enough risk of bias, or using a placebo or a drug clearly identified as a control, means that we are uncertain enough to be unable to

recommend any kind of Chinese medicinal herbs for the common cold.

P L A I N L A N G U A G E S U M M A R Y

Chinese medicinal herbs to treat the common cold

The common cold is the most widespread acute respiratory tract illness affecting all age groups. Many Chinese herbal medicines are

used to treat this illness in China. Although we included 17 trials, involving 3212 patients, in this review, the risk of bias was so high that

the evidence did not support using any Chinese herbal preparation(s) for the common cold. Well-designed clinical trials are required.

B A C K G R O U N D

Description of the condition

The common cold is the most widespread acute respiratory tract

illness across all age groups