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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)