Traditional Chinese Medicine: An Update on Clinical Evidence

Abstract

Background:

As an alternative medical system, Traditional Chinese Medicine (TCM) has been increasingly used over the last several decades. Such a consumer-driven development has resulted in introduction of education programs for practitioner training, development of product and practitioner regulation systems, and generation of an increasing interest in research. Significant efforts have been made in validating the quality, effectiveness, and safety of TCM interventions evidenced by a growing number of published trials and systematic reviews. Commonly, the results of these studies were inconclusive due to the lack of quality and quantity of the trials to answer specific and answerable clinical questions.

Objectives:

The methodology of a randomized clinical trial (RCT) is not free from bias, and the unique features of TCM (such as individualization and holism) further complicate effective execution of RCTs in TCM therapies. Thus, data from limited RCTs and systematic reviews need to be interpreted with great caution. Nevertheless, until new and specific methodology is developed that can adequately address these methodology challenges for RCTs in TCM, evidence from quality RCTs and systematic reviews still holds the credibility of TCM in the scientific community.

Conclusions:

This article summarizes studies on TCM utilization, and regulatory and educational development with a focus on updating the TCM clinical evidence from RCTs and systematic reviews over the last decade. The key issues and challenges associated with evidence-based TCM developments are also explored.

Introduction

T raditional Chinese Medicine (TCM) has been a form of primary health care in China and its neighboring countries for several thousand years. In recent times, it has been gaining acceptance in the developed world as a form of complementary and alternative medicine (CAM).¹ TCM includes not only acupuncture, Chinese herbal medicine, and Chinese therapeutic massage (tuina), but also other modalities, such as moxibustion and t'ai chi.

While integration of TCM into conventional medical settings is not uncommon in some countries, such as China, Korea, and Vietnam, its increasing use in the Western world has been associated with concerns about safety and evidence of effectiveness, either used alone or concurrently with Western medical interventions. There are also concerns about the quality and authenticity of medicinal herbs. In the last decade, in addition to significant educational developments in TCM practitioner training,² there have been significant efforts to regulate TCM practitioners, practices, and herbal medicinal products to ensure public safety (e.g., the introduction of statutory registration of TCM practitioners in jurisdictions outside of China³).

Progressively, over the last 2 decades, governments in a number of Western countries have supported high-quality research into CAM including TCM. For example, from 2000 to 2006, the United States' National Center for CAM (NCCAM) funded over 1200 CAM research projects and since 2005, the annual research funding allocation for NCCAM has been in excess of over US$120 million.⁴ A similar initiative was launched by the Australian Government in 2007 with over AUD$7 million funding allocated to establish the National Institute of Complementary Medicine (NICM) and to support specific research projects in CAM. Within NICM, a National Collaborative Centre for TCM has been established, involving a consortium of eight universities.⁵ In Europe, as part of the “European Institute of Chinese Medicine” project, supported by the Ministry of Trade and Industry of Finland and the Ministry of Sciences and Technology of China, the European Consortium of Chinese Medicine was established in early 2007 to promote safe and rational use of TCM.⁶

This article updates TCM developments over the last decade, including global TCM utilization, the development of regulatory systems for acupuncture and Chinese herbal medicine in various countries, and the key research advances with respect to effectiveness, quality, and safety of TCM interventions. The key issues and challenges associated with TCM developments as a form of evidence-based healthcare are also explored.

Concerning clinical evidence, this review will not be able to deal with all types of evidence. Consequently, the effectiveness studies included are primarily based on completed Cochrane Database of Systematic Reviews (CDSR) and randomized controlled trials (RCTs) that have been published in leading general medical journals. TCM quality and safety data have been derived from published experimental studies and case reports. Only peer-reviewed journal articles, government reports, and guidelines published by the World Health Organisation (WHO) are included. Publications related to common TCM modalities such as Chinese herbal medicine, acupuncture, moxibustion, and t'ai chi were retrieved.

Prevalence of Use of Acupuncture and Chinese Herbal Medicine in Developed and Developing Countries

Over the last decade, the prevalence of use of CAM in Western countries, consisting of a broad range of therapies including TCM, has been extensively investigated. It was estimated that at least two fifths of Americans⁷ and two thirds of Australians⁸ had used some form of CAM. Although the rates of CAM use in such countries have been increasing over the last several decades, they are still much less than the use of various forms of traditional medicine in the countries of their origin. In developing countries, indigenous traditional medicine is commonly regarded as a form of primary health care, rather than a complementary or an alternative treatment to conventional medicine and thus, the use of certain CAM modalities such as TCM in China and its neighboring countries is more prevalent than in those countries where TCM is regarded as a form of CAM.¹

Apart from the WHO Global Atlas of Traditional, Complementary and Alternative Medicine, which provides prevalence data on the use of a range of traditional medicine including TCM,¹ little information is available on the prevalence of use of specific TCM interventions such as acupuncture and Chinese herbal medicine. Therefore, TCM prevalence data were extracted from published population studies on CAM (Table 1). For example, in Australia, a 2005 national study on CAM revealed that nearly 1 in 5 (19.3%) adult Australians used at least one form of TCM.⁸ This figure includes the use of the two most common forms of TCM, acupuncture (9.2%) and Chinese herbal medicine (7.0%) as well as other TCM therapies such as t'ai chi and TCM dietary therapy. Another study in 2007 on use of specific herbal medicines also found that aloe vera, garlic, and green tea were each used by about 10% of adult Australians.⁹ In contrast to the situation in Australia, in the United States, the 2002 National Health Interview estimated a lower prevalence of use of acupuncture (1.1%), t'ai chi (1.3%), and qigong (0.3%). The overall prevalence of other TCM modalities such as Chinese herbal medicine and Chinese therapeutic massage were not reported.⁷

Table 1.

Summary of Population Studies on the Use of Chinese Medicine Modalities in Selected Developed Countries

Author (year) & country	Prevalence of Chinese medicine modalities (% of users) ^a
Xue et al. (2007), Australia⁹	General use: At least one form of CM (19.3%). Specific use: acupuncture (9.2%), Chinese herbal medicine (7.0%), Chinese therapeutic massage (5.1%), Chinese medicine dietary therapy (2.3%), qigong, martial art, and t'ai chi (6.0%).
Ramsay et al. (1999), Canada⁴⁵	Use of massage (12%), herbal therapies (12%); lifetime use of acupuncture (12%), massage (23%), herbal therapies (17%).
Menniti-Ippolito et al. (2002), Italy⁴⁶	Used of herbal medicine (4.8%), acupuncture (2.9%) between 1997 and 1999.
Yamashita et al. (2002), Japan⁴⁷	Use of acupuncture and moxibustion (6.7%), massage, and acupressure (14.8%); herbs and over-the-counter Kampo (17.2%).
Thomas et al. (2004), United Kingdom⁴⁸	Visited practitioners for acupuncture (1.6%), herbal therapy (0.8%), massage (2.1%); Traditional Chinese Medicine (0.4%).
Barnes et al. (2004), United States⁸	Use of acupuncture (1.1%), t'ai chi (1.3%), qigong (0.3%).

Chinese medicine (CM) use and practitioner visits were in the 12-month period preceding the survey, unless specified.

In its region of origin, TCM is an essential part of the national health care system. Moreover, in some Asian countries such as China and Vietnam, TCM is utilized in parallel with the conventional medical system. However, TCM utilization has not been systematically investigated using validated approaches in epidemiological population research. Thus, estimates of use primarily depend on data from hospital authorities and/or health ministries.

In China, TCM practice has been fully integrated into the national health care system with traditional herbal therapies reported to represent 30%–50% of total national medication consumption.¹⁰ Statistics from the Ministry of Health of the People's Republic of China indicated that in 2006, there were 2665 TCM hospitals and over 216,452 registered Chinese medicine practitioners in China.¹¹ Overall, it has been suggested that about 40% of total health care in China is provided by TCM practitioners.¹²

In other Asian countries, traditional medicine is being practiced under different names such as traditional Korean medicine, Kampo (Japan), and traditional Vietnamese medicine within each country's health care system. It has been estimated that approximately 70%–80% of the population of Southeast Asia use traditional medicines. Besides TCM, the most commonly used forms of traditional medicines were Ayurvedic medicine (India), Jamu medicine (Indonesia), and Unani medicine (Bangladesh).¹

The use of TCM is increasing worldwide, but the rationales for its use are yet to be fully understood. At least three reasons have been proposed that might have contributed to the increasing popularity of TCM over the last decade: the holistic approach of TCM treatments for both health management and general health enhancement¹³; individuals proactively seeking alternative therapies where conventional medicine fails to adequately address their health problems⁹; and the increasing body of scientific evidence concerning the safety and effectiveness of TCM interventions.¹⁴

Research Progress on Effectiveness, Quality, and Safety of TCM

Effectiveness

The number of randomized clinical trials conducted on acupuncture and Chinese herbal medicine has increased significantly in recent years. In addition, systematic reviews on these trials have advanced our understanding of the therapeutic potential of these TCM modalities for the treatment of a broad range of conditions.

Up to issue 3 in 2009, a total of 68 Cochrane Library Systematic Reviews on TCM were identified through CDSR (Table 2). Of these, 20 are on acupuncture treatment for a range of chronic conditions such as low back pain, rheumatoid arthritis, depression, and insomnia. There were 39 reviews that investigated treatments using Chinese herbal medicines for both chronic (e.g., type 2 diabetes mellitus and hepatitis B), and acute conditions (e.g., severe acute respiratory syndrome, acute pancreatitis, and acute myocardial infarction). The remaining nine Cochrane reviews investigated the effect of using acupuncture-point stimulation for nausea or vomiting, the use of auricular acupuncture for cocaine dependence, moxibustion for breech birth presentation, and t'ai chi for rheumatoid arthritis. A few reviews provide preliminary evidence of the effect of TCM on specific conditions, while the majority of them were inconclusive due to the small numbers of trials available and the poor methodological quality, which present major threats to the internal and external validity of the findings.

Table 2.

Summary of Cochrane Reviews on Chinese Medicine Clinical Trials

		Cochrane reviewers' comments
Study ID	Condition (no. of trials; no. of participants)	Effectiveness	Adverse events	Overall trial quality
Acupuncture
Linde et al., 2009	Migraine prophylaxis (22; 4419)	There is consistent evidence that acupuncture provides additional benefit to treatment of acute migraine attacks only or to routine care. There is no evidence for an effect of “true” acupuncture over sham.	Between 8% and 11% of patients report minor adverse effects such as fatigue or temporary aggravations.	The quality of clinical trials of acupuncture for headache has clearly improved.
Linde et al., 2009	Tension-type headache (11; 2317)	Acupuncture could be a valuable nonpharmacological tool.	Not mentioned in the review.	Quality of trials varied significantly, newer trials tended to be of higher quality than older trials.
Cheong et al., 2008	Assisted conception (13; 2209)	Acupuncture around the time of embryo transfer achieves a higher live birth rate compared to without active acupuncture. There is no evidence of benefit for having acupuncture around the time of oocyte retrieval or for repeating acupuncture 2 to 3 days after embryo transfer.	Acupuncture may have potential harmful effects in early pregnancy.	All trials were rated A for allocation concealment; four trials used an intention-to-treat analysis.
Cheuk et al., 2008	Epilepsy (11; 914)	The current evidence does not support acupuncture as a treatment for epilepsy.	No adverse events were reported by any of the trials included.	Included studies were of poor methodological quality in general.
Cui et al., 2008	Restless legs syndrome (RLS) (2; 170)	There is insufficient evidence to determine whether acupuncture is an effective and safe treatment for RLS.	Neither trial reported the presence of harmful side-effects.	Included trials were either inadequately reported or had methodological flaws.
Xie et al., 2008	Dysphagia in acute stroke (1; 66)	There is not enough evidence to make any conclusion about the therapeutic effect of acupuncture.	Not mentioned in the review.	The trial was a low-quality study.
Cheuk et al., 2007	Insomnia (7; 590)	The current evidence is not sufficiently extensive or rigorous to support the use of any form of acupuncture.	Only one trial reported an adverse event, with 1 of 16 patients (6.3%) withdrawing from acupuncture because of pain.	Small number of trials, poor methodological quality and significant clinical heterogeneity.
He et al., 2007	Bell's palsy (6; 537)	No trials reported the outcomes specified for the review.	Harmful adverse events were not reported in any of the trials.	The quality of the included trials was inadequate.
Law et al., 2007	Glaucoma (0; 0)	No randomized clinical trials were found.	Not applicable (N/A)	N/A
Peng et al., 2007	Vascular dementia (0; 0)	No randomized clinical trials were found.	N/A	N/A
Lim et al., 2006	Irritable bowel syndrome (6; 489)	It is still inconclusive whether acupuncture is more effective than sham acupuncture or other interventions.	Only one trial collected information on adverse events, and no adverse events directly attributable to acupuncture were reported.	Most of the trials included in this review were of poor quality and were heterogeneous in terms of interventions, controls, and outcomes measured.
Trinh et al., 2006	Neck disorders (10; 661)	There is moderate evidence that acupuncture relieves pain better than some sham treatments. There is moderate evidence that those who received acupuncture reported less pain at short-term follow-up than those on a waiting list.	Adverse events were reported in four trials and included increased in pain, bruising, and dizziness. No life-threatening adverse events were noted.	The trials were of moderate methodological quality, but the number of participants in each trial was relatively low.
Wu et al., 2006	Stroke rehabilitation (5; 368)	No clear evidence on the effects of acupuncture.	No information on possible adverse events was reported.	Poor quality (all trials).
Green et al., 2005	Shoulder pain (9; 525)	There is little evidence to support or refute the use of acupuncture although there may be short-term benefit with respect to pain and function.	There was no difference in adverse events related to acupuncture when compared to placebo, based on only one trial.	Included trials were of varying methodological quality, most of which were small and incomplete descriptions of interventions.
Rathbone et al., 2005	Schizophrenia (5; 270)	Insufficient evidence to recommend the use of acupuncture.	Adverse event scores were significantly lower in the acupuncture/antipsychotic group.	Poor quality (all trials).
Zhang et al., 2005	Acute stroke (14; 1208)	No clear evidence on the effects of acupuncture.	Severe adverse events with acupuncture were rare (1.55%).	Number of patients is too small
Smith et al., 2004	Depression (7; 517)	There is insufficient evidence to determine the efficacy of acupuncture.	Limited data were reported on adverse events.	Scientific trial design was poor and the number of people studied was small.
Smith et al., 2004	Induction of labor (3; 212)	There is insufficient evidence describing the efficacy.	No information on adverse events from acupuncture was reported in the trials.	This review included one trial but failure to blind outcome assessments and 20% loss to follow-up.
McCarney et al., 2003	Chronic asthma (11; 324)	Current evidence has not shown an effect in favor of acupuncture	None of the included trials reported data on side-effects and tolerability.	Trial reporting was poor and trial quality was deemed inadequate to generalize findings.
Green et al., 2002	Lateral elbow pain (4; 239)	There is insufficient evidence to either support or refute the use of acupuncture.	No trial assessed or commented on adverse events.	Small number of trials and problems with methodology of the trials.
Acupuncture and dry-needling
Furlan et al., 2005	Low back pain (35; 2861)	Data do not allow firm conclusions about the effectiveness of acupuncture.	No serious adverse events were reported in the trials included in this review. The incidence of minor adverse events was 5% of patients in acupuncture group.	Most trials were of low methodological quality
Transcutaneous electrical nerve stimulation and acupuncture
Proctor et al., 2002	Primary dysmenorrhea (9; 220)	There is insufficient evidence to determine the effectiveness of acupuncture; however, a single small but methodologically sound trial of acupuncture suggests benefit.	None were reported for acupuncture trial.	Small sample size but methodologically sound.
Acupuncture and electroacupuncture
Casimiro et al., 2005	Rheumatoid arthritis (2; 84)	Acupuncture does not appear to improve the symptoms of rheumatoid arthritis.	Not measured in the review.	Low number of clinical trials and small sample size of the included trials.
Acupuncture and related interventions
White et al., 2006	Smoking cessation (24; 4939)	No consistent evidence that acupuncture and related interventions are effective.	Not mentioned in the review.	Methodological problems mean that no firm conclusions can be drawn.
Auricular acupuncture
Gates et al., 2006	Cocaine dependence (7; 1433)	No evidence that auricular acupuncture is effective.	Adverse events of treatment were not reported by any trial.	Methodology reporting of the included trials was poor.
Acupuncture-point stimulation
Lee A, 2009	Preventing postoperative nausea and vomiting (40; 4858)	P6 acupoint stimulation may be a suitable alternative or addition to antiemetic drugs for preventing postoperative nausea and vomiting.	The side-effects associated with P6 acupoint stimulation were minor and self-limiting.	The quality of the included trials was variable.
Ezzo et al., 2006	Chemotherapy-induced nausea or vomiting (11; 1247)	It reduced the incidence of acute vomiting but not acute or delayed nausea severity compared to control.	Acupuncture-point stimulation by any method was safe with only minimal and transient adverse events when they occurred at all.	Methodological quality was generally high.
Chinese herbal medicine (CHM)
Flower et al., 2009	Endometriosis (2; 158)	Useful in relieving endometriosis-related pain with fewer side-effects than experienced with conventional treatment.	In one trial, no significant adverse event observed in the CHM participants. In the second trial, 4/16 CHM patients had dry mouth and 1 patient had acne.	The trials included in this review are very small trials and of poor methodological quality.
Jing et al., 2009	Premenstrual syndrome (2; 549)	There is insufficient evidence to support the use of Chinese herbal medicine.	None of the trials reported any adverse events.	One trial is high quality and the other trial was of lower quality due to the risk of various biases.
Li et al., 2009	Epilepsy (5; 1125)	Insufficient to support the use of traditional Chinese medicinal herbs.	Two studies showed no obvious adverse effect. The other two studies reported only slight gastrointestinal discomfort.	All the studies were of poor methodological quality and had a high probability of bias.
Liu et al., 2009	Uterine fibroids (2; 150)	Evidence does not support or refute the use of herbal preparations.	The trials involved a small number of participants and the trial quality varied.	One trial reported one case of discomfort stomach. No serious adverse effects were reported.
Wei et al., 2008	Acute bronchitis (0; 0)	No trials met the inclusion criteria for this review.	N/A	N/A
Zhu et al., 2008	Primary dysmenorrhea (39; 3475)	Promising evidence supporting the use of CHM.	No significant adverse events were identified but the measurement and report of adverse events were poor.	The methodological quality of many trials included in this review was poor.
Chen et al., 2007	Influenza (2; 1012)	The present evidence is too weak to support or reject the use of CHM for preventing and treating influenza.	Adverse events were reported in one of the two included trials.	Both included trials were at high risk for bias and graded as category C (at high risk for bias).
Dengfeng et al., 2007	Ectopic pregnancy (2; 157)	The included trials did not provide clear evidence that CHM is beneficial.	One trial reported adverse events but no statistically significant difference between groups.	None of the trials reported adequate methodology in their original publications.
Shi et al., 2007	Sore throat (7; 1253)	The efficacy of CHM for treating sore throat is controversial and questionable.	None of the trials reported any adverse events.	All seven trials are “C” grade (at high risk for bias).
Wu et al., 2007	Common cold (14; 2440)	There is insufficient power to provide reliable estimates of the efficacy.	None of the trials reported any adverse events.	13 trials are at high risk for bias.
Zen et al., 2007	Hyperthyroidism (13; 1770)	CHM added to other routine treatment has therapeutic potential for hyperthyroidism.	Five trials reported adverse events.	All of the trials were of low quality.
Zhang et al., 2007	Side-effects of chemotherapy in breast cancer patients (7; 542)	Limited evidence of effectiveness	One trial reported adverse events.	Poor quality (all trials)
Gu et al., 2006	Measles (0; 0)	Did not identify any suitable trials for inclusion.	N/A	N/A
Liu et al., 2006	Irritable bowel syndrome (75; 7957)	Some herbal medicines may improve the symptoms of irritable bowel syndrome.	No serious adverse events from the herbal medicines were reported.	The quality of three trials was high but the remaining trials were generally low quality.
Zhang et al., 2006	Pre-eclampsia (0; 0)	No trials met the inclusion criteria for this review.	N/A	N/A
Liu et al., 2005	HIV infection and AIDS (9; 499)	There is no compelling evidence to support the use of the herbal medicines.	Majority of the trials reported outcome of adverse events. The occurrence of adverse events was higher in the herb group than in the placebo group. No serious adverse events were reported.	Methodological quality of trials was assessed as adequate in five full trials and unclear in other trials.
Rathbone et al., 2005	Schizophrenia (7; 1094)	There is no evidence to suggest that herbal medicine, when given alone, offers benefits equal to or beyond those obtained with antipsychotic drugs.	One trial reported on extrapyramidal symptoms, which were not significantly different between groups.	Overall, the quality of reporting on randomization and blinding was poor.
Wang et al., 2005	Acute pancreatitis (15; 845)	Some Chinese medicinal herbs may have positive effects on mortality in acute pancreatitis.	No trials reported adverse events	All trials had poor quality.
Wu et al., 2005	Chemotherapy side-effects in colorectal cancer patients (4; 342)	The herb may stimulate immunocompetent cells and decrease side-effects related to chemotherapy.	None of the trials reported any adverse events.	Poor quality (all trials)
Liu et al., 2004	Viral myocarditis (40; 3448)	Some herbal medicines may have antiarrhythmia effect in suspected viral myocarditis.	No serious adverse effect was reported. 7/40 trials reported outcome of adverse events.	The methodological quality was assessed as generally low.
Zhang et al., 2004	Atopic eczema (4; 159)	Some evidence shows that one type of CHM may be effective.	A few minor adverse events were reported.	Four small poorly reported trials were identified
Liu et al., 2002	Type 2 diabetes mellitus (66; 8302)	Some herbal medicines show hypoglycemic effects in type 2 diabetes.	17 included trials reported adverse events. No serious adverse events from the herbal medicines were reported.	Methodological quality was generally low.
Liu et al., 2001	Hepatitis C virus (HCV) infection (10; 517)	There is no firm evidence of efficacy of any medicinal herbs for HCV infection.	Adverse events were monitored and reported in six trials.	The quality was considered adequate in four trials and inadequate in six trials.
Liu et al., 2001	Asymptomatic carriers of hepatitis B virus (HBV) infection (3; 307)	One herbal compound may have antiviral activity in asymptomatic carriers of HBV.	No serious adverse events were reported. Minor adverse events were reported.	Poor quality (all trials)
Liu JP, 2000	Chronic hepatitis B (9; 936)	Some CHM may work in chronic hepatitis B. However, the evidence is too weak.	Adverse events were reported in eight trials. No serious adverse events were reported.	The majority of the trials included in this review had poor methodological quality.
Chinese herbal medicine Chuanxiong- type preparations
Yuan et al., 2008	Acute ischemic stroke (2; 161)	There is insufficient evidence to suggest any clinical recommendations.	One trial assessed the adverse effects of the treatment.	Both trials were of low quality.
Chinese herbal medicine Danshen or Danshen agents
Wu et al., 2008	Acute myocardial infarction (6; 2368)	The evidence to support use of Danshen preparations is too weak to make any judgment about its effects.	The safety of Danshen preparations is unproven, although some adverse events have been reported.	Evidence from RCTs is insufficient and of low quality.
Wu et al., 2007	Acute ischemic stroke (6; 464)	Does not provide any evidence to support the routine use of Danshen agents	Two trials reported adverse events.	Poor quality (all trials)
Chinese herbal medicine Dengzhanhua
Cao et al., 2008	Acute cerebral infarction (9; 723)	No trials reported data on the prespecified primary or secondary outcomes.	No trials provided any data on adverse events, and no case of serious adverse events was reported during the treatment period.	Generally low methodological quality and small sample size of the included trials.
Chinese herbal medicine Huangqi- type formulations
Yuan et al., 2008	Nephritic syndrome (3; 128)	Some positive effects.	Not clear from the review.	Quality of the included studies in this review was poor.
Chinese herbal medicine Mailuoning
Yang et al., 2009	Acute ischemic stroke (15; 1280)	No convincing evidence to support the routine use of Mailuoning to promote recovery after stroke.	Six trials reported adverse events; five events occurred in two trials.	With one exception, the trials included were assessed to be of poorer methodological quality.
Chinese herbal medicine Sanchi
Chen et al., 2008	Acute ischemic stroke (8; 660)	Sanchi appears to be beneficial and safe.	One study reported slight adverse events; two studies mentioned that there were no adverse events. The other studies did not mention adverse events.	Seven of the eight studies were of poor quality.
Chinese herbal medicine S uxiao jiuxin wan
Duan et al., 2008	Angina pectoris (15; 1776)	Suxiao jiuxin wan appears to be effective.	No serious side-effects were identified.	Poor quality (all trials)
Chinese herbal medicine Shengmai
Chen et al., 2007	Heart failure (19; 1663)	It is possible that Shengmai plus usual treatment may be beneficial.	No adverse events were reported in any of the included trials.	Poor quality (all trials)
Chinese herbal medicine Tongxinluo capsule
Zhuo et al., 2008	Acute stroke (2; 232)	Prespecified outcomes were not reported in the included studies.	Neither study found adverse effects in the use of Tongxinluo.	Poor quality
Wu et al., 2006	Unstable angina pectoris (18; 1413)	It is possible that Tongxinluo added to routine treatment has some benefit.	Eight trials reported adverse events.	Poor quality (all trials)
Chinese herbal medicine Yizhi capsule
Wu et al., 2007	Vascular dementia (0; 0)	No trials were found that met the inclusion criteria.	N/A	N/A
Chinese herbal medicine Zhiling decoction
Jirong et al., 2004	Vascular dementia (0; 0)	No trials were found that met the inclusion criteria.	N/A	N/A
Chinese herbs combined with Western medicine
Liu et al., 2006	Severe acute respiratory syndrome (SARS) (12; 654)	Chinese herbs combined with Western medicines decreased the morbidity of SARS patients compared to Western medicine alone.	Two trials reported adverse events.	All trials are graded C (high risk of selection bias, performance bias, attrition bias, and detection bias).
Moxibustion
Coyle et al., 2005	Breech presentation (3; 597)	Limited evidence suggests that moxibustion may be useful.	Two trials reported adverse events; however, actual data were not reported.	There are few well-designed trials; methodological quality of the trials varied.
T'ai chi
Han et al., 2004	Rheumatoid arthritis (4; 206)	T'ai chi does not exacerbate symptoms of rheumatoid arthritis. In addition, T'ai chi has statistically significant benefits on lower-extremity range of motion.	About one third of the patients complained of soreness in the knee, shoulder, or lower back.	Poor quality (all trials)

While acknowledging the methodological problems, for some common conditions, evidence of the effectiveness of TCM was supported by a number of reviews. For example, acupuncture was found to provide additional benefit to treatment of acute migraine attacks¹⁵ and could be a valuable nonpharmacological tool in treating patients with frequent episodic or chronic tension-type headaches.¹⁶ It was also recommended that self-administered acupuncture-point stimulation (acupressure) can be taught to patients for managing acute nausea or vomiting induced by chemotherapy.¹⁷ In addition, on the basis on 40 trials involving 4858 participants, it was determined that stimulation on a single acupoint (PC6) can be used as an alternative or an add-on treatment to antiemetic drugs for preventing postoperative nausea and vomiting.¹⁸ A small number of reviews with more than 30 trials concluded with some positive evidences in supporting the use of Chinese herbal medicine for primary dysmenorrhea,¹⁹ irritable bowel syndrome,²⁰ type 2 diabetes mellitus,²¹ and viral myocarditis.²²

Leading medical journals have also steadily increased the number of publications on RCTs that investigated the effectiveness of TCM therapies for a broad range of conditions. Literature search on MEDLINE^® showed that such studies include but are not limited to the use of acupuncture for migraine, headache, osteoarthritis of the knee, cocaine addition or dependence, pain due to human immunodeficiency virus (HIV)-related peripheral neuropathy, emesis, fibromyalgia, neck pain, pelvic girdle pain, low back pain, acute stroke, subacute stroke rehabilitation, nicotine withdrawal symptoms, and hypertension as well as studies that evaluated the effect of Chinese herbal medicine on hepatitis C, irritable bowel syndrome, and moderate–severe allergic asthma. Among these, positive results in using TCM were concluded in some large scale RCTs. For example, the German Acupuncture Trials (GERAC) for chronic low back pain involved 340 outpatient practices and including 1162 patients, and concluded that the effectiveness of acupuncture was almost twice that of conventional therapy.²³ Most recently, a pragmatic RCT involving 5327 patients suggested that adding acupuncture to routine care would lead to clinically persistent benefits for patients with allergic rhinitis.²⁴

There were also studies that used acupuncture and Chinese herbal medicine concurrently (e.g., for seasonal allergic rhinitis), and moxibustion for correction of breech presentation of the fetus. In addition, a number of systematic reviews and meta-analytic papers have also been published in the leading medical journals. For example, a recent review published in the British Medical Journal concluded that acupuncture increased the odds of clinically confirmed pregnancy by 65% compared with the control groups.²⁵

In addition to the increasing number of high quality randomized controlled trials, some high quality preclinical studies have also been conducted in the last decade to investigate the therapeutic potential of TCM for addressing major public health challenges. For example, researchers in Australia reported that berberine, a purified compound of Huanglian, a commonly used Chinese herbal medicine, reduced whole-body adiposity and improved insulin sensitivity in mice models of insulin resistance.²⁶

Quality

With regard to the quality of Chinese herbal medicines, the chemical composition of TCM herbs has been investigated using modern analytical technology such as gas chromatography, high-performance liquid chromatography, and liquid chromatography-mass spectrometry. DNA-based techniques have also been used in the identification of medicinal plants.²⁷ Authentication and quality control of the herbs are now one of the prerequisites for rigorous clinical studies that may be considered for publication in high-impact international journals.

Safety

Similar to all forms of medicine and therapeutic interventions, the safety of Chinese herbal products and acupuncture procedures is a major area of research and media interest.²⁸ Despite an increasing number of publications concerning potential interactions between herbs and drugs,²⁹ clinical reports on human herb–drug interaction have been infrequent. The literature on herb–drug interactions is largely based on findings from in vitro or animal experimental studies (for example, the interaction between Danshen [Radix Salviae miltiorrhizae] or Danggui [Radix Angelicae sinensis] with warfarin^30,31). On the other hand, adverse events have been increasingly documented in TCM clinical trials (Table 2). It appears that mild adverse events are relatively common, but serious adverse events are rare in clinical studies. However, it is critical to note that herbs classified as toxic in the traditional medicine literature or in government regulatory frameworks should be used cautiously or prohibited from use, such as the carcinogenic Aristolochia species.³²

In general, acupuncture is considered to be a relatively safe intervention when practiced by qualified professionals.^33
–35 For example, the 2000 York prospective survey of 34,000 treatments by traditional acupuncturists concluded that there were no reports of serious adverse events, and that there were only 1.3 minor adverse events per 1000 treatments.³³ This is supported by a review of six prospective surveys in Japan that concluded that between the 1980s and 2002, approximately 150 adverse events were reported in 120 published articles in acupuncture practice in Japan and that serious adverse events were rare in standard practice by adequately trained acupuncturists.³⁶

Global Development in Regulation on Acupuncture and Chinese Herbal Medicine Practice

In 1986, the State Administration of Traditional Chinese Medicine was established in the People's Republic of China to systematically regulate the practice and the products of TCM. Both acupuncture and Chinese herbal medicine are fully integrated into the national health care system in China, and practitioners are subject to regulation based on rigorous educational standards. A similar regulatory system has now been introduced for traditional medicines in a number of Asian countries including Singapore, the Philippines, and Thailand.³⁷ In addition, significant progress has been made toward statutory regulation in Malaysia.

In developed countries, the practice of acupuncture and that of Chinese herbal medicine are largely regulated separately. The regulation of Chinese herbal medicine practice is largely based on voluntary self-registration (e.g., the Register of Chinese Herbal Medicine in the UK), similar to other forms of herbal medicine, although the use of herbs as therapeutic products also needs to be compliant with relevant therapeutic acts or regulations. On the other hand, the practice of acupuncture has been regulated in an increasing number of countries and regions. In the United States, 42 of the 51 states have introduced a licensing system for the practice of acupuncture since 2002.³⁸ In Canada, acupuncture and TCM are regulated in a number of provinces such as British Columbia, Alberta, Quebec, and more recently, the province of Ontario. In the United Kingdom, the British Acupuncture Council expects that acupuncture practitioners will be regulated by statute by 2010³⁹ and in New Zealand, acupuncture has been proposed for regulation under the Health Practitioners Competence Assurance Act 2003.⁴⁰

In Australia, the State of Victoria was the first jurisdiction to adopt statutory regulation for TCM practice following passage of the Chinese Medicine Registration Act 2000. In 2007, the State took further steps to establish uniform regulatory standards for all health care professions through the implementation of the Health Professions Registration Act 2005. ⁴¹ This Act superseded the Chinese Medicine Registration Act 2000 by incorporating its provisions into the new omnibus legislation along with the respective acts for 10 registered health professions. The states of New South Wales and Western Australian have also been considering TCM registration in recent years. For those states for which statutory regulation for TCM practice does not exist, practitioners are represented by a number of associations that set standards through eligibility hurdles for membership.²⁸ In the context of national reform, it was agreed that the TCM profession will be included in the National Registration and Accreditation Scheme for the health professions from July 1, 2012.

By 2002, 25 of the 191 WHO member states indicated that they had national policies on CAM.⁴² In recent years, a number of WHO reports have been developed to assist the evaluation of traditional medicine education, such as WHO Guidelines for Quality Assurance of Traditional Medicine Education in the Western Pacific Region ⁴³; to assess the quality of herbal medicine products, such as WHO Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants ⁴⁴; and, to assist the conduct of acupuncture clinical trials, such as Acupuncture: Review and Analysis of Reports on Controlled Clinical Trial. ⁴⁵ In addition, to promote internationalization and integration of TCM with conventional Western medicine, a number of reports specifically devoted to Chinese medicine have been published (e.g., in the Western Pacific Region, the WHO Standard Acupuncture Point Locations,⁴⁶ and the WHO International Standard Terminologies on Traditional Medicine ⁴⁷).

Discussion

The current update provides an overview of the progress of Chinese medicine development in the last decade. There has been considerable progress toward a more stringent regulatory framework for both herbal medicines and TCM practitioners. Scientific research with a focus on evaluating effectiveness and safety has yielded critical data on the therapeutic potential of TCM interventions. However, there remain major challenges to the integration of TCM into national health care systems; these include both the overall lack of evidence of efficacy and research support.

Globally, there is a lack of public health research on TCM, particularly in those countries where TCM or equivalent form of traditional medicine is a form of primary health care, such as in China. There has been promising evidence of some traditional herbal medicines for the treatment of priority diseases such as malaria⁴⁸ and HIV/acquired immune deficiency syndrome (AIDS).⁴⁹ Thus, many CAM therapies including TCM may have the potential to address major public health problems such as HIV/AIDS and chronic noncommunicable diseases through effective international partnership.⁵⁰

While there has been an overall increasing number of clinical trials in TCM that have been published in both mainstream medical and CAM journals, the resources from government and industry support available for quality studies are limited. This might have contributed to the lack of studies on the effectiveness and safety of TCM interventions when they are used concurrently with Western medicine in the management of chronic noncommunicable diseases.

The conduct of RCTs on TCM can be more challenging due to a number of intrinsic and external factors noted-above. These must be taken into consideration when interpreting the results of RCTs and systematic reviews. Nevertheless, for leading medical journals, RCTs have been suggested to be reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) checklist, whether the intervention is conventional or CAM. Criticism of the methodological quality of TCM clinical trials remains a challenge, as it is difficult to align traditional medicine philosophies with modern scientific methods. On the other hand, existing RCTs on conventional medicine are not methodologically problem free (for example, the involvement of drug companies in design of studies and the outcome interpretation of the trials may present potential conflict of interest).

It is encouraging that a number of initiatives have been undertaken in recent years in some countries such as the international cooperation program in China, the Australian National Collaborative Centre for TCM, and the ongoing development of international standards for the quality, efficacy, safety, terminologies, and other aspects of TCM. These projects, through international collaboration, will contribute to the development of TCM as a form of evidence-based medicine and thus contribute further to global health.

International cooperation is also needed for the development of a mutual recognition system for practitioner regulation due to the mobility of the TCM workforce and increased use across countries. To promote rational use of traditional medicine including TCM globally, international collaboration and partnership are keys; these are reflected in the Beijing Declaration as a major outcome of the WHO Congress on Traditional Medicine held in Beijing, China in November 2008.⁵¹ Once adequate evidence of benefit versus risks of TCM interventions is made available, broader integration of TCM into national health systems will become a reality.

Footnotes

Acknowledgments

The authors thank the researchers at the RMIT University and partner institutions for their research projects cited in this article. We also thank Professor Jianping Liu for sharing his expert experiences in the interpretation of Cochrane Library Systematic Reviews.

Disclosure Statement

No competing financial interests exist.

References

Bodeker

, Ong

, Grundy

et al. WHO Global Atlas of Traditional, Complementary and Alternative Medicine. Kobe: World Health Organization, WHO Centre for Health Development, 2005.

Xue

, Wu

, Zhou

et al. Comparison of Chinese medicine education and training in China and Australia. Ann Acad Med Singapore, 2006; 35:775–779.

The Chinese Medicine Registration Board of Victoria. The Victorian Chinese Medicine Registration Act 2000Act No.18/2000Victoria: Australia, 2000.

National Centre for Complementary and Alternative Medicine (NCCAM). Director's Testimony, 2008. http://nccam.nih.gov/about/offices/od/directortestimony/index.htm. 2009 May 18.

National Institute of Complementary Medicine. NICM Background, 2007. www.nicm.edu.au/nicm-background.htm. 2009 May 18.

European Consortium of Chinese Medicine (ECCM). 2007. www.uku.fi/kansy/ECCM.shtml. 2009 May 18.

Barnes

, Powell-Griner

, McFann

, Nahin

. Complementary and alternative medicine use among adults: United States, 2002. Advance Data, 2004; 343:1–19.

Xue

, Zhang

, Lin

et al. Complementary and alternative medicine use in Australia: A national population-based survey. J Altern Complement Med, 2007; 13:643–650.

Zhang

, Story

, Lin

et al. A population survey on the use of 24 common medicinal herbs in Australia. Pharmacoepidemiol Drug Saf, 2008; 17:1006–1013.

10.

World Health Organization. Traditional Medicine Fact Sheet No. 134, 2003. www.who.int/mediacentre/factsheets/fs134/en/. 2009 May 5.

11.

Ministry of Health of the People's Republic of China. Chinese Health Statistical Digest, 2007. www.moh.gov.cn/newshtml/19165.htm. 2009 May 18.

12.

Chan

. Chinese medicinal materials and their interface with Western medical concepts. J Ethnopharmacol, 2005; 96:1–18.

13.

Cassidy

. Chinese medicine users in the United States. Part I: Utilization, satisfaction, medical plurality. J Altern Complement Med, 1998; 4:17–27.

14.

Xue

, Zhang

, Lin

et al. Acupuncture, chiropractic and osteopathy use in Australia: A national population survey. BMC Public Health, 2008; 8:105.

15.

Linde

, Allais

, Brinkhaus

et al. Acupuncture for migraine prophylaxis. Cochrane Database Syst Rev, 2009; 1:CD001218.

16.

Linde

, Allais

, Brinkhaus

et al. Acupuncture for tension-type headache. Cochrane Database Syst Rev, 2009; 1:CD007587.

17.

Ezzo

, Richardson

, Vickers

et al. Acupuncture-point stimulation for chemotherapy-induced nausea or vomiting. Cochrane Database Syst Rev, 2006; 2:CD002285.

18.

Lee

, Fan

. Stimulation of the wrist acupuncture point P6 for preventing postoperative nausea and vomiting. Cochrane Database Syst Rev, 2009; 2:CD003281.

19.

Zhu

, Proctor

, Bensoussan

et al. Chinese herbal medicine for primary dysmenorrhoea. Cochrane Database Syst Rev, 2008; 2:CD005288.

20.

Liu

, Yang

, Liu

et al. Herbal medicines for treatment of irritable bowel syndrome. Cochrane Database Syst Rev, 2006; 1:CD004116.

21.

Liu

, Zhang

, Wang

, Grimsgaard

. Chinese herbal medicines for type 2 diabetes mellitus. Cochrane Database Syst Rev, 2004; 3:CD003642.

22.

Liu

, Yang

, Du

. Herbal medicines for viral myocarditis. Cochrane Database Syst Rev, 2004; 3:CD003711.

23.

Haake

, Muller

, Schade-Brittinger

et al. German Acupuncture Trials (GERAC) for chronic low back pain: Randomized, multicenter, blinded, parallel-group trial with 3 groups. Arch Intern Med, 2007; 167:1892–1898.

24.

Brinkhaus

, Witt

, Jena

et al. Acupuncture in patients with allergic rhinitis: A pragmatic randomized trial. Ann Allergy Asthma Immunol, 2008; 101:535–543.

25.

Manheimer

, Zhang

, Udoff

et al. Effects of acupuncture on rates of pregnancy and live birth among women undergoing in vitro fertilisation: Systematic review and meta-analysis. BMJ, 2008; 336:545–549.

26.

Lee

, Kim

et al. Berberine, a natural plant product, activates AMP-activated protein kinase with beneficial metabolic effects in diabetic and insulin-resistant states. Diabetes, 2006; 55:2256–2264.

27.

Jayasinghe

, Kong

, Coram

et al. Construction and validation of a prototype microarray for efficient and high-throughput genotyping of angiosperms. Plant Biotechnol J, 2007; 5:282–289.

28.

Bensoussan

, Myers

. Towards a Safer Choice: The Practice of Traditional Chinese Medicine in Australia. Faculty of Health, University of Western Sydney, Macarthur. Australia, 1996.

29.

Zhou

S-F

, Zhou

Z-W

, Li

C-G

et al. Identification of drugs that interact with herbs in drug development. Drug Discovery Today, 2007; 12:664–673.

30.

Fugh-Berman

. Herb–drug interactions. Lancet, 2000; 355:134–138.

31.

, Yang

, Ho

et al. Herb–drug interactions: A literature review. Drugs, 2005; 65:1239–1282.

32.

Cheung

, Xue

CCL

, Leung

et al.

Aristolochic acids detected in some raw Chinese medicinal herbs and manufactured herbal products: A consequence of inappropriate nomenclature and imprecise labelling?

Clin Toxicol, 2006; 44:371–378.

33.

MacPherson

, Thomas

, Walters

, Fitter

. The York acupuncture safety study: Prospective survey of 34,000 treatments by traditional acupuncturists. BMJ, 2001; 323:486–487.

34.

White

, Hayhoe

, Hart

, Ernst

. Adverse events following acupuncture: Prospective survey of 32,000 consultations with doctors and physiotherapists. BMJ, 2001; 323:485–486.

35.

Melchart

, Weidenhammer

, Streng

et al. Prospective investigation of adverse effects of acupuncture in 97,733 patients. Arch Intern Med, 2004; 164:104–105.

36.

Yamashita

, Tsukayama

. Safety of acupuncture practice in Japan: Patient reactions, therapist negligence and error reduction strategies. eCAM, 2007nem086.

37.

World Health Organization. Legal Status of Traditional Medicine and Complementary/Alternative Medicine: A Worldwide Review. Geneva, 2001.

38.

Eisenberg

, Cohen

, Hrbek

et al. Credentialing complementary and alternative medical providers. Ann Intern Med, 2002; 137:965–973.

39.

British Acupuncture Council. British Acupuncture CouncilCited2008. www.acupuncture.org.uk/. 2009 May 18.

40.

New Zealand Ministry of Health. Regulation of the Profession of Acupuncture Under the Health Practitioners Competence Assurance Act 2003. Consultation Document. Wellington, 2006.

41.

Victorian Government. Health Professions Registration Act 2005Act No. 97/2005Melbourne, 2005.

42.

World Health Organization. World Health Organisation Traditional Medicine Strategy 2002–2005: Geneva, 2002.

43.

World Health Organization. WHO Guidelines for Quality Assurance of Traditional Medicine Education in the Western Pacific Region. Manila, 2005.

44.

World Health Organization. WHO Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants. Geneva, 2003.

45.

World Health Organization. Acupuncture: Review and Analysis of Reports on Controlled Clinical Trials WHO/2002/9241545437. Geneva, 2002.

46.

World Health Organization. WHO Standard Acupuncture Point Locations in the Western Pacific Region. Manila, 2008.

47.

World Health Organization. WHO International Standard Terminologies on Traditional Medicine in the Western Pacific Region. Manila, 2007.

48.

Willcox

, Bodeker

. Traditional herbal medicines for malaria. BMJ, 2004; 329:1156–1159.

49.

Liu

, Manheimer

, Yang

. Herbal medicines for treating HIV infection and AIDS. Cochrane Database Syst Rev, 2005; 3:CD003937.

50.

Bodeker

, Kronenberg

. A public health agenda for traditional, complementary, and alternative medicine. Am J Public Health, 2002; 92:1582–1591.

51.

World Health Organisation. WHO Congress on Traditional Medicine. www.who.int/dg/speeches/2008/20081107/en/index.html 2008 2009 May 18.