Traditional Chinese medicine for chronic fatigue syndrome: A systematic review of randomized clinical trials

doi:10.1016/j.ctim.2014.06.004

Complementary Therapies in Medicine

Volume 22, Issue 4, August 2014, Pages 826-833

https://doi.org/10.1016/j.ctim.2014.06.004 Get rights and content

Highlights

•
TCM therapies showed potential positive effect for alleviating fatigue symptoms.
•
Whether TCM could improve the QOL of patients is still inconclusive.
•
We could not draw a firm conclusion about the safety of TCM on CFS.

Summary

Background

There is no curative treatment for chronic fatigue syndrome (CFS). Traditional Chinese medicine (TCM) is widely used in the treatment of CFS in China.

Objective

To evaluate the effectiveness and safety of TCM for CFS.

Methods

The protocol of this review is registered at PROSPERO. We searched six main databases for randomized clinical trials (RCTs) on TCM for CFS from their inception to September 2013. The Cochrane risk of bias tool was used to assess the methodological quality. We used RevMan 5.1 to synthesize the results.

Results

23 RCTs involving 1776 participants were identified. The risk of bias of the included studies was high. The types of TCM interventions varied, including Chinese herbal medicine, acupuncture, qigong, moxibustion, and acupoint application. The results of meta-analyses and several individual studies showed that TCM alone or in combination with other interventions significantly alleviated fatigue symptoms as measured by Chalder's fatigue scale, fatigue severity scale, fatigue assessment instrument by Joseph E. Schwartz, Bell's fatigue scale, and guiding principle of clinical research on new drugs of TCM for fatigue symptom. There was no enough evidence that TCM could improve the quality of life for CFS patients. The included studies did not report serious adverse events.

Conclusions

TCM appears to be effective to alleviate the fatigue symptom for people with CFS. However, due to the high risk of bias of the included studies, larger, well-designed studies are needed to confirm the potential benefit in the future.

Introduction

Chronic fatigue syndrome (CFS) is a disorder characterized by unexplained and persistent fatigue, impaired memory or concentration, post exercise malaise/tiredness, sleep disturbances, musculoskeletal pain, and several other somatic complaints.¹ US Centers for Disease Control and Prevention (CDC) is offering a clinical definition (1994) of CFS, which was based on Holmes and Fukuda scoring and evaluating systems.¹ The pathogenesis of CFS is still not clear, but studies showed that multifactorial disease pathways might be contributing factors of its complex symptoms and mechanisms.² Studies reported that the prevalence rate of CFS in western countries ranged from 0.2% to 2.6%.3, 4 Similarly, the rates were 1.9% in Beijing and 3% in Hong Kong, China.⁵

Currently, no curative treatments are available for CFS. There are some encouraging evidences showing that CFS patients might benefit from graded exercise therapy,⁶ cognitive behavior therapy⁷ and rehabilitation programs.⁸ Patients with CFS in China can be referred to TCM therapies. A Cochrane systematic review in 2009⁹ evaluated the effectiveness of traditional Chinese herbal medicine (CHM) in treating idiopathic chronic fatigue and chronic fatigue syndrome. However, this systematic review set strict inclusion criteria which required control groups applying placebo or conventional standard of care, and finally no studies fulfilled the criteria. Besides herbal medicine, TCM covers a broad range of medical therapies which are customized and tailored according to TCM theories, and related to the symptoms and signs of individual patient.¹⁰ These therapies include CHM, acupuncture, moxibustion, massage (tuina), Qigong, cupping, Tai Chi.

The objective of this review is to evaluate the effectiveness and adverse events from available studies of TCM therapies on treating and managing patients with CFS.

Section snippets

Standard protocol registrations

This systematic review was registered in PROSPERO, and the registration identifier of the protocol is CRD42013005965.¹¹

Search strategy and study selection

The following six online databases were searched for relevant studies from their inception to September 2013: PubMed, the Cochrane Central Register of Controlled Trials (CENTRAL), China National Knowledge Infrastructure (CNKI), Chinese Scientific Journals Database (VIP), Chinese Biomedical Database (Sino-Med), and Wanfang Database. The following searching terms as abstract

Description of studies

The search process and study selection are presented by a flow chart (Fig. S1). Finally 23 RCTs13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35 involving 1776 participants with CFS were included.

The detailed characteristics of the included studies are listed in Table S1. All studies used CDC 1994 for CFS as their diagnostic criteria. Among the 23 RCTs, 18 studies13, 14, 15, 16, 17, 19, 20, 21, 22, 23, 25, 28, 24 performed in mainland China, four studies

Discussion

In this review, various types of TCM interventions were identified and evaluated for the effectiveness and safety for CFS. Several TCM interventions used alone or in combinations showed potential positive effect for alleviating fatigue symptoms. However, we should be cautious about these positive findings which were based on the low quality of included studies. In addition, whether TCM could improve the QOL of patients is still inconclusive. Because four studies18, 26, 28, 33 that evaluated QOL

Conclusions

In total, this review shows that TCM may have some beneficial effects on alleviating the fatigue symptom for people with CFS. However, the findings should be interpreted with cautions since most results were not concluded from the meta-analyses but individual studies, and the methodological quality of the included studies was poor. Therefore, large, well-designed studies are needed to confirm these findings in the future.

Ethical approval

Not applicable.

Source of funding

This research was supported by the Program for Innovative Research Team (2011-CXTD-09) of Beijing University of Chinese Medicine, the grant number 201207007 from the State Administration of Traditional Chinese Medicine in China, and the postgraduate program (532/0100604225) from Beijing University of Chinese Medicine. The study was also supported with a grant from the Norwegian Directorate of Health.

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Therefore, researchers have attempted to accumulate clinical evidence on the effectiveness of acupuncture, electroacupuncture, or qigong therapies,13 as well as moxibustion therapy.14 A systematic review revealed that the use of herbal medicines had better effects in terms of CFS management than did the control treatments; however, the included studies were highly heterogeneous.13 Sipjeondaebo-tang (SJDBT) is an herbal medicine widely used in Korea.
Sipjeondaebo-tang (SJDBT, Shi-quan-da-bu-tang in Chinese) is a widely prescribed herbal medicine in traditional Korean medicine. This study aimed to evaluate the effectiveness and safety of SJDBT for treating chronic fatigue syndrome (CFS).
Ninety-six eligible participants were randomly allocated to either the SJDBT or placebo groups in a 1:1 ratio. Nine grams of SJDBT or placebo granules were administered to the patients for 8 weeks. The primary outcome was the response rate, defined as the proportion of participants with a score of 76 or higher in the Checklist Individual Strength assessment. Other measurements for fatigue severity, quality of life, and qi/blood/yin/yang deficiency were included. Safety was assessed throughout the trial.
At week 8, the response rate did not significantly differ between the groups (SJDBT: 35.4%; placebo: 54.2%; P =  0.101, effect size [95% confidence interval] = 0.021 [-0.177, 0.218]). However, the scores of the visual analogue scale (P =  0.001, -0.327 [-0.506, -0.128]), Fatigue Severity Scale (P =  0.020, 0.480 [0.066, 0.889]), and Chalder fatigue scale (P =  0.004, -0.292 [-0.479, -0.101]) for the SJDBT group showed significant improvements in fatigue severity at the endpoint. Quality of life was not significantly different. Furthermore, SJDBT significantly ameliorated the severity of qi deficiency compared to that in the placebo group. No serious adverse events were observed.
This trial failed to show a significant improvement in fatigue severity, as assessed by the CIS-deprived response rate. It merely showed that SJDBT could alleviate the severity of fatigue and qi deficiency in patients with CFS. However, the further study is needed to confirm the details.
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Quercetin, epigallocatechin, and curcumin have all been demonstrated to ameliorate fatigue and other ME/CFS-related symptoms in rodent models. [135–139] Traditional herbal therapies for treating fatigue, many of which possess antioxidant properties, also have been explored for the treatment of ME/CFS, albeit with mixed results [140,141]. However, a recent RCT of the root extract Myelophil produced statistically significant improvement in fatigue in severely symptomatic ME/CFS patients and a phase 3 trial is planned [142].
Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a chronic debilitating disease characterized by severe and disabling fatigue that fails to improve with rest; it is commonly accompanied by multifocal pain, as well as sleep disruption, and cognitive dysfunction. Even mild exertion can exacerbate symptoms. The prevalence of ME/CFS in the U.S. is estimated to be 0.5–1.5 % and is higher among females. Viral infection is an established trigger for the onset of ME/CFS symptoms, raising the possibility of an increase in ME/CFS prevalence resulting from the ongoing COVID-19 pandemic. Current treatments are largely palliative and limited to alleviating symptoms and addressing the psychological sequelae associated with long-term disability. While ME/CFS is characterized by broad heterogeneity, common features include immune dysregulation and mitochondrial dysfunction. However, the underlying mechanistic basis of the disease remains poorly understood. Herein, we review the current understanding, diagnosis and treatment of ME/CFS and summarize past clinical studies aimed at identifying effective therapies. We describe the current status of mechanistic studies, including the identification of multiple targets for potential pharmacological intervention, and ongoing efforts towards the discovery of new medicines for ME/CFS treatment.
The effect of Delphinium denudatum (Jadwar) on fatigue: A randomized double blind placebo-controlled clinical trial
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This relatively common condition is an inevitable consequence of modern-day life, affecting all races and socioeconomic classes. CFS prevalence rate varies 1.5–3% in the general population.3,4 It is estimated that 836,000–2.5 million Americans have had CFS in 2015, most of which remained undiagnosed.5
Fatigue is a common problem in modern-day life. The aim of this study was to evaluate the effect of Delphinium denudatum (Jadwar) on fatigue.
This study was a randomized double-blind placebo-controlled clinical trial between healthy normal university students. In each group, participants were given one capsule of either WEACURE® (containing 500 mg of Jadwar root powder) or placebo for 15 consecutive days. Multidimensional Fatigue Inventory (MFI) questionnaire was used before and after the intervention to evaluate different aspects of fatigue.
A total number of 64 participants completed the study. Data analysis showed decrease in the scores of all five domains of fatigue in Jadwar group (13.31 ± 3.05–7.75 ± 2.66, 12.31 ± 3.55–7.63 ± 2.62, 12.22 ± 4.26–6.97 ± 2.06, 11.56 ± 4.21 to 7.28 ± 2.37, 12.91 ± 3.09–7.34 ± 2.13 in general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue domains, respectively) which was statistically significant (P value<0.0001). This situation was significantly superior to the placebo group. Prescribed dosage of WEACURE® capsule was well tolerated.
As a complementary tonic agent, Jadwar have a potential to reduce fatigue in normal population. However, objective evaluation of its anti-fatigue effect should be further evaluated.
Chronic Fatigue Syndrome
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Is there a role for traditional and complementary medicines in managing chronic fatigue? a systematic review of randomized controlled trials
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Challenges in phytotherapy research
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View full text

Traditional Chinese medicine for chronic fatigue syndrome: A systematic review of randomized clinical trials

Highlights

Summary

Background

Objective

Methods

Results

Conclusions

Introduction

Section snippets

Standard protocol registrations

Search strategy and study selection

Description of studies

Discussion

Conclusions

Ethical approval

Source of funding

Am J Med

The chronic fatigue syndrome: a comprehensive approach to its definition and study

Ann Intern Med

Chronic fatigue syndrome: identifying zebras amongst the horses

BMC Med

The prevalence and morbidity of chronic fatigue and chronic fatigue syndrome: a prospective primary care study

Am J Public Health

Psychiatric morbidity and illness experience of primary care patients with chronic fatigue in Hong Kong

Am J Psychiatry

Exercise therapy for chronic fatigue syndrome

Cochrane Database Syst Rev

Cognitive behaviour therapy for chronic fatigue syndrome in adults

Cochrane Database Syst Rev

Rehabilitation programs for individuals with chronic fatigue syndrome: a review

J Chronic Fatigue Syndr

Traditional Chinese medicinal herbs for the treatment of idiopathic chronic fatigue and chronic fatigue syndrome

Cochrane Database Syst Rev

Chinese herbal medicine for gout: a systematic review of randomized clinical trials

Clin Rheumatol

Traditional Chinese medicine for chronic fatigue syndrome: a systematic review. PROSPERO: CRD42013005965

Clinical observation of Xiaopiling particles in treatment of chronic fatigue syndrome

Mod J Integr Tradit Chin West Med

Clinical observation of Fufang Shenqi ointment in treatment of chronic fatigue syndrome

Northwest Pharm J

Clinical observation of Shenqi recovery tang in treatment of chronic fatigue syndrome

Chin J Inf Tradit Chin Med

Clinical study of Fuzheng Jieyu prescription in treatment of chronic fatigue syndrome

Chin J Inf Tradit Chin Med

Effect of Lixu Jieyu receipt in treating 75 patients with chronic fatigue syndrome

Chin J Integr Med