Tag: traditional Chinese medicine

Efficacy and safety of Sijunzi Decoction for chronic fatigue syndrome with spleen deficiency pattern: study protocol for a randomized, double-blind, placebo-controlled trial

Abstract:

BACKGROUND: Chronic fatigue syndrome (CFS), which is characterized by severe and disabling fatigue, has become an extensively concerned medical disorder in clinical practice. Due to the unclear etiology, current treatments are symptomatic or need assistance from psychology and kinesiology. Under the immature conditions in China, many patients would seek help from traditional Chinese medicine (TCM), in which Chinese herbal medicine (CHM) is one of the main interventions. Sijunzi Decoction (SJZD) is a classical formula and has been utilized in improving fatigue symptoms for a long time. However, lack of rigorously-designed randomized controlled trial limits its application and generalization in CFS management. Hence, we design this clinical trial to assess the effectiveness and safety of SJZD for CFS.

METHODS: This is a single-center, randomized, double-blind, placebo-controlled trial. Two hundred and twelve patients with CFS will be recruited from public and equally allocated to SJZD group and placebo group. Based on the general education, these two groups will receive corresponding drugs twice a day for consecutive 2 months. The follow-up period will be 1 month. The primary outcome will be the change of Chalder fatigue scoring after treatment. Secondary outcomes include the short form-36 physical function subscale (SF36-PF), spleen deficiency rating scale, quality of life and self-rated clinical global impression (CGI) scales.

DISCUSSION: The four ingredients of SJZD are Renshen (Radix Ginseng), Baizhu (Rhizoma Atractylodis Macrocephalae), Fulin (Poria) and Zhigancao (Radix Glycyrrhizae Preparata), which show potential to alleviate CFS on the foundation of available studies. The results of this trial will provide high-quality clinical evidence for the application of SJZD, and hope to further support a new TCM choice in CFS treatment.

TRIAL REGISTRATION: ISRCTN23930966 (ISRCTN registry, registered on 28th May, 2019).

Source: Dai L, Zhou WJ, Wang M, Zhou SG, Ji G. Efficacy and safety of Sijunzi Decoction for chronic fatigue syndrome with spleen deficiency pattern: study protocol for a randomized, double-blind, placebo-controlled trial. Ann Transl Med. 2019 Oct;7(20):587. doi: 10.21037/atm.2019.09.136. https://www.ncbi.nlm.nih.gov/pubmed/31807568

Qigong exercise for chronic fatigue syndrome

Abstract:

Chronic fatigue syndrome (CFS) is often overlooked, has unclear etiology and no effective cure except some symptomatic treatments. Additionally, most people with CFS do not seek medical attention. Qigong exercise, an ancient Eastern body-mind-spirit practice, has been long practiced in Chinese communities and may powerfully trigger the self-healing process.

Using full baseline data (n=1409), the average Hong Kong CFS respondent was found to be female, married, 42.5yo, highly educated and employed full-time, experiencing sleep disturbance (~95%), anxiety (>80%), and depressive symptoms (68%).

Here, we summarized our previous studies to evaluate the potential of Qigong as a complementary and alternative therapy for CFS. Two randomized controlled trials were conducted (RCT1 n1=137, RCT2 n2=150). In both trials, extensive online questionnaires allowed individuals with CFS-like illness (i.e., symptoms match CFS, yet without clinical confirmation) to be identified. RCT1 included a 5-week intervention. The intervention in RCT2 was 8weeks. In RCT1 Qigong group had reduced fatigue (P<0.001) and depressive symptoms (P=0.002), and improved telomerase activity (P=0.029). An effective practice regimen was identified (≥3 days/week, at ≥30min/session). Methods were slightly adjusted for RCT2, which replicated RCT1 findings, and further documented improved subjective sleep quality (P=0.008) and adiponectin levels (P<0.05). A significant dose-response relationship was founded.

Thus, Qigong exercise should be recognized as a possible standalone therapy and self-management skill in CFS. Strategies are needed to increase motivation for regular practice and to explore its possibility of self-management skill in brain health. Further clarity would come from studies comparing Qigong with other physical exercises.

Source: Chan JSM, Ng SM, Yuen LP, Chan CLW. Qigong exercise for chronic fatigue syndrome. Int Rev Neurobiol. 2019;147:121-153. doi: 10.1016/bs.irn.2019.08.002. https://www.ncbi.nlm.nih.gov/pubmed/31607352

Acupuncture for chronic fatigue syndrome: a systematic review and meta-analysis

Abstract:

OBJECTIVE: To evaluate evidence for the efficacy of acupuncture for chronic fatigue syndrome (CFS).

METHODS: Randomized controlled trials (RCTs) comparing acupuncture with sham acupuncture, other interventions that may have a therapeutic effect, or no intervention, for the treatment of CFS, were searched for in the following databases up to March 2018: Pubmed; Embase; the Cochrane Library; Web of Science; Wanfang database; China National Knowledge Infrastructure (CNKI); Chinese Biomedicine (CBM) database; and VIP database. Risk of bias was determined using the Cochrane tool. Meta-analyses were performed using RevMan V.5.3 software. The GRADE approach (Grading of Recommendations Assessment, Development and Evaluation) was adopted for levels of evidence.

RESULTS: Sixteen studies with 1346 subjects were included. Most studies had low methodological quality. Meta-analyses showed a favourable effect of acupuncture on overall response rate compared with sham acupuncture (four studies, 281 participants, RR=2.08, 95% CI 1.4 to 3.1, I2=64%, low certainty) and Chinese herbal medicine (three studies, 290 participants, RR=1.17, 95% CI 1.07 to 1.29, I2=0%, low certainty). Acupuncture also appeared to significantly reduce fatigue severity measured by Chalder’s Fatigue Scale and the Fatigue Severity Scale compared with other types of control.

CONCLUSION: Our review indicated that acupuncture was more effective than sham acupuncture and other interventions (Chinese herbal medicine, mainly), but no firm conclusion could be reached owing to limited data, poor quality and potentially exaggerated effect size evaluation. Further large, rigorously designed and reported RCTs are required.

Source: Zhang Q, Gong J, Dong H, Xu S, Wang W, Huang G. Acupuncture for chronic fatigue syndrome: a systematic review and meta-analysis. Acupunct Med. 2019 Jun 17:acupmed2017011582. doi: 10.1136/acupmed-2017-011582. [Epub ahead of print] https://www.ncbi.nlm.nih.gov/pubmed/31204859

Clinical research of auricular gold-needle therapy in treatment of chronic fatigue syndrome of qi deficiency constitution

Abstract:

OBJECTIVE: To observe the clinical therapeutic effects of auricular gold-needle therapy on chronic fatigue syndrome of qi deficiency constitution and explore its potential mechanism.

METHODS: A total of 120 patients were randomized into an auricular gold-needle therapy group, an auricular point pressure therapy group and a Chinese herb group, 40 cases in each one. Additionally, a health control group (40 cases) was set up, without any intervention. In the auricular gold-needle therapy group, the gold needle was used to stimulate the auricular points on one side and the cowherb seed pressure therapy on the other side. In the auricular point pressure therapy group, the cowherb seed pressure therapy was adopted only on one side. The auricular points were shen (CO10), xin (CO15), fei (CO14), pizhixia (AT4), etc. in the two groups. The auricular points on both sides were used alternatively. The treatment was given once a week, 4 treatments as one course and the consecutive 3 courses of treatment were required. In the Chinese herb group, buzhong yiqi wan was prescribed for oral administration, 6 g, twice a day, the medication for 1 month was as one session and the consecutive 3 sessions of medication were required. Before and after treatment, separately, the clinical symptom score, the levels of the serum immunoglobulins, i.e. IgA, IgG and IgM were observed in the patients of the three groups. The therapeutic effects were evaluated in the three groups.

RESULTS: The total effective rate was 90.0% (36/40) in the auricular gold-needle therapy group, better than 80.0% (32/40) in the auricular point pressure therapy group and 82.5% (33/40) in the Chinese herb group (both P<0.05). Before treatment, the clinical symptom scores of the patients in the three groups were obviously higher than the health control group (all P<0.001). After treatment, the symptom scores were all reduced as compared the scores before treatment in the three groups (all P<0.001) and the symptom scores in the auricular gold-needle therapy group were better than the auricular point pressure therapy group and the Chinese herb group (both P<0.01). Before treatment, the levels of serum IgA, IgG and IgM of the patients in the three groups were lower than the health control group (all P<0.001). The levels were all improved after treatment in the three groups (all P<0.01), and the levels in the auricular gold-needle therapy group was better than the auricular point pressure therapy group and the Chinese herb group (all P<0.05).

CONCLUSION: The auricular gold-needle therapy achieves the significant therapeutic effects on chronic fatigue syndrome of qi deficiency constitution and its mechanism is probably related to the regulation of immune function.

Source: Xu YY, Liu JH, Ding H, Tang H, Song SY, Zhong WQ, Pan ZB. Clinical research of auricular gold-needle therapy in treatment of chronic fatigue syndrome of qi deficiency constitution. Zhongguo Zhen Jiu. 2019 Feb 12;39(2):128-32. doi: 10.13703/j.0255-2930.2019.02.004.[Article in Chinese] https://www.ncbi.nlm.nih.gov/pubmed/30942029

Acupuncture in the treatment of chronic fatigue syndrome based on “interaction of brain and kidney” in TCM: a randomized controlled trial

Abstract:

OBJECTIVE: To observe the effects of acupuncture on the fatigue symptoms of chronic fatigue syndrome, the potential symptoms and cytokines on the base of the theory as “interaction of brain and kidney” and explore its clinical therapeutic effects and the potential mechanism.

METHODS: A total of 68 patients were randomized into an observation group and a control group, 34 cases in each one. In the control group, oryzanol and vitamin B1 were prescribed for oral administration and the patients were required to have a proper rest and physical exercise. In the observation group, on the base of the theory as “interaction of brain and kidney”, acupuncture was added to Baihui (BL 20), Fengchi (GB 20), Pishu (BL 20), Shenshu (BL 23), Sanyinjiao (SP 6) and Taixi (KI 3). The treatment was given once a day, 5 treatments a week, with 2 days break. The consecutive treatment for 4 weeks was required. Before and after treatment, the score of the fatigue scale-14 (FS-14), the score of the somatic and psychological health report (SPHERE) and the score of the Pittsburgh sleep quality index (PSQI) were observed in the patients of the two groups separately. The enzyme-linked immunosorbent assay (ELISA) was adopted to determine the levels of serum interleukin-6 (IL-6) and interferon-γ (INF-γ) before and after treatment.

RESULTS: After treatment, FS-14 scores, SPHERE scores and PSQI scores were all reduced as compared with the scores before treatment in the two groups (P<0.05, P<0.01). After treatment, the levels of IL-6 and INF-γ in the serum in the observation group were reduced as compared with the levels before treatment (both P<0.01). After treatment, the scores of FS-14, SPHERE and PSQI as well as the levels of serum IL-6 and INF-γ in the observation group were all lower than the results in the control group (P<0.05, P<0.01).

CONCLUSION: On the base of the theory as “interaction of brain and kidney”, acupuncture therapy relieves the fatigue symptoms and the potential symptoms and improves the sleep quality in the patients of chronic fatigue syndrome. The effect mechanism is probably related to the decrease of the levels of IL-6 and INF-γ in serum.

Source: Xu YX, Luo HS, Sun D, Wang R, Cai J. Acupuncture in the treatment of chronic fatigue syndrome based on “interaction of brain and kidney” in TCM: a randomized controlled trial. Zhongguo Zhen Jiu. 2019 Feb 12;39(2):123-7. doi: 10.13703/j.0255-2930.2019.02.003. [Article in Chinese] https://www.ncbi.nlm.nih.gov/pubmed/30942028

Artificial intelligence based discovery of the association between depression and chronic fatigue syndrome

Abstract:

BACKGROUND: Both of the modern medicine and the traditional Chinese medicine classify depressive disorder (DD) and chronic fatigue syndrome (CFS) to one type of disease. Unveiling the association between depressive and the fatigue diseases provides a great opportunity to bridge the modern medicine with the traditional Chinese medicine.

METHODS: In this work, 295 general participants were recruited to complete Zung Self-Rating Depression Scales and Chalder Fatigue Scales, and meanwhile, to donate plasma and urine samples for 1H NMR-metabolic profiling. Artificial intelligence methods was used to analysis the underlying association between DD and CFS. Principal components analysis (PCA) and partial least squares discriminant analysis (PLS-DA) were used to analyze the metabolic profiles with respect to gender and age. Variable importance in projection and t-test were employed in conjunction with the PLS-DA models to identify the metabolite biomarkers. Considering the asymmetry and complexity of the data, convolutional neural networks (CNN) model, an artificial intelligence method, was built to analyze the data characteristics between each groups.

RESULTS: The results showed the gender- and age-related differences for the candidate biomarkers of the DD and the CFS diseases, and indicated the same and different biomarkers of the two diseases. PCA analysis for the data characteristics reflected that DD and CFS was separated completely in plasma metabolite. However, DD and CFS was merged into one group.

LIMITATION: Lack of transcriptomic analysis limits the understanding of the association of the DD and the CFS diseases on gene level.

CONCLUSION: The unmasked candidate biomarkers provide reliable evidence to explore the commonality and differences of the depressive and the fatigue diseases, and thereby, bridge over the traditional Chinese medicine with the modern medicine.

Copyright © 2019 Elsevier B.V. All rights reserved.

Source: Zhang F, Wu C, Jia C, Gao K, Wang J, Zhao H, Wang W, Chen J. Artificial intelligence based discovery of the association between depression and chronic fatigue syndrome. J Affect Disord. 2019 Mar 8;250:380-390. doi: 10.1016/j.jad.2019.03.011. [Epub ahead of print]

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

Abstract:

BACKGROUND: Chronic fatigue is increasingly common. Conventional medical care is limited in treating chronic fatigue, leading some patients to use traditional Chinese medicine therapies, including herbal medicine.

OBJECTIVES: To assess the effectiveness of traditional Chinese medicine herbal products in treating idiopathic chronic fatigue and chronic fatigue syndrome.

SEARCH METHODS: The following databases were searched for terms related to traditional Chinese medicine, chronic fatigue, and clinical trials: CCDAN Controlled Trials Register (July 2009), MEDLINE (1966-2008), EMBASE (1980-2008), AMED (1985-2008), CINAHL (1982-2008), PSYCHINFO (1985-2008), CENTRAL (Issue 2 2008), the Chalmers Research Group PedCAM Database (2004), VIP Information (1989-2008), CNKI (1976-2008), OCLC Proceedings First (1992-2008), Conference Papers Index (1982-2008), and Dissertation Abstracts (1980-2008). Reference lists of included studies and review articles were examined and experts in the field were contacted for knowledge of additional studies.

SELECTION CRITERIA: Selection criteria included published or unpublished randomized controlled trials (RCTs) of participants diagnosed with idiopathic chronic fatigue or chronic fatigue syndrome comparing traditional Chinese medicinal herbs with placebo, conventional standard of care (SOC), or no treatment/wait lists. The outcome of interest was fatigue.

DATA COLLECTION AND ANALYSIS: 13 databases were searched for RCTs investigating TCM herbal products for the treatment of chronic fatigue. Over 2400 references were located. Studies were screened and assessed for inclusion criteria by two authors.

MAIN RESULTS: No studies that met all inclusion criteria were identified.

AUTHORS’ CONCLUSIONS: Although studies examining the use of TCM herbal products for chronic fatigue were located, methodologic limitations resulted in the exclusion of all studies. Of note, many of the studies labelled as RCTs and conducted in China did not utilize rigorous randomization procedures. Improvements in methodology in future studies is required for meaningful synthesis of data.

Source: Adams D, Wu T, Yang X, Tai S, Vohra S. WITHDRAWN: Traditional Chinese medicinal herbs for the treatment of idiopathic chronic fatigue and chronic fatigue syndrome. Cochrane Database Syst Rev. 2018 Oct 15;10:CD006348. doi: 10.1002/14651858.CD006348.pub3. [Epub ahead of print] https://www.ncbi.nlm.nih.gov/pubmed/30321452

Chaihu Longgu Muli decoction combined with acupuncture at back-shu points for chronic fatigue syndrome

Abstract:

OBJECTIVE: To observe the effect difference between Chaihu Longgu Muli decoction combined with acupuncture at back-shu points and simple Chaihu Longgu Muli decoction for chronic fatigue syndrome.

METHODS: Sixty patients were randomly assigned into an herbal group and a combination group, 30 cases in each one. Simple Chaihu Longgu Muli decoction was used in the herbal group for continuous one month, one decoction a day. Based on that in the herbal group, 30 min acupuncture was used in the combination group at bilateral Xinshu (BL 15), Feishu (BL 13), Pishu (BL 20), Ganshu (BL 18) and Shenshu (BL 23), with acupoints according to syndrome differentiation. Acupuncture was given for 3 courses, 10 times as a course with 3 days between two courses, once a day. Fatigue status was evaluated before and after treatment by fatigue scale 14 (FS-14) and self-rating anxiety scale (SAS).

RESULTS: The FS-14 scores, including body fatigue scores, mental fatigue scores and total scores, and SAS scores after treatment were lower than those before treatment in the two groups (all P<0.01), with better improvements in the combination group (all P<0.01).

CONCLUSION: Chaihu Longgu Muli decoction combined with acupuncture at back-shu points can improve chronic fatigue syndrome, which are better than simple Chaihu Longgu Muli decoction.

Source: Qi Y, Song S, Dou Z, Chen J, He G, Zhang L, Yao J. Chaihu Longgu Muli decoction combined with acupuncture at back-shu points for chronic fatigue syndrome. Zhongguo Zhen Jiu. 2017 Nov 12;37(11):1187-90. doi: 10.13703/j.0255-2930.2017.11.013. [Article in Chinese] https://www.ncbi.nlm.nih.gov/pubmed/29354956

Efficacy of acupoint catgut embedding combined with ginger-partitioned moxibustion on chronic fatigue syndrome of spleen-kidney yang deficiency syndrome and its effects on T lymphocyte subsets and activity of NK cell

Abstract:

OBJECTIVE: To observe the efficacy differences between acupoint catgut embedding combined with ginger-partitioned moxibustion and regular acupuncture on chronic fatigue syndrome (CFS) of spleen-kidney yang deficiency syndrome, and to explore its effects on T lymphocyte subsets and activity of NK cell.

METHODS: A total of 60 patients with CFS of spleen-kidney yang deficiency syndrome were randomly divided into a catgut embedding combined with ginger-partitioned moxibustion (CECGP) group and a regular acupuncture group, 30 cases in each one. The patients in the CECGP group were treated with acupoint catgut embedding combined with ginger-partitioned moxibustion; the acupoint catgut embedding was applied at Guanyuan (CV 4), Shenshu (BL 23), Pishu (BL 20), Zusanli (ST 36), Qihai (CV 6), once a week, while the ginger-partitioned moxibustion was applied at Guanyuan (CV 4), Qihai (CV 6) and Zusanli (ST 36), once every three days for consecutive one month. The patients in the regular acupuncture group were treated with regular acupuncture at Guanyuan (CV 4), Shenshu (BL 23), Pishu (BL 20), Zusanli (ST 36), Qihai (CV 6), once a day, 6 treatments per week (one day for rest) for consecutive one month. The clinical symptom scores, fatigue scale-14 (FS-14), fatigue assessment instrument (FAI), laboratory test results and total effective rate were compared between the two groups before and after treatment.

RESULTS: (1) After treatment, the clinical symptom scores, FS-14 and FAI were reduced in the two groups (all P<0.05); after treatment, the clinical symptom scores, FS-14 and FAI in the CECGP group were significantly lower than those in the regular acupuncture group (all P<0.05). (2) After treatment, the CD4+/CD8+, natural killer cell% (NK%), CD3+%, CD% were all increased in the two groups (all +4 P<0.05); the CD4+/CD8+, CD3+%, CD% in the CECGP group were significantly higher than those in the regular acupuncture group (all P<0.05). (3) After treatment, the total effective rate was 96.7% (29/30) in the CECGP group, which was similar to 93.3% (28/30) in the regular acupuncture group (P>0.05).

CONCLUSIONS: The acupoint catgut embedding combined with ginger-partitioned moxibustion, which could effectively relieve the symptoms, regulate T lymphocyte subsets and the activity of NK cell, is an effective method for CFS of spleen-kidney yang deficiency syndrome.

Source: Xia D, Chen P, Du P, Ding L, Liu A. [Efficacy of acupoint catgut embedding combined with ginger-partitioned moxibustion on chronic fatigue syndrome of spleen-kidney yang deficiency syndrome and its effects on T lymphocyte subsets and activity of NK cell]. Zhongguo Zhen Jiu. 2017 Aug 12;37(8):814-818. doi: 10.13703/j.0255-2930.2017.08.004. [Article in Chinese]

Effect of Acupuncture on the Expression of Transcription Factor T-bet/GATA-3 in Plasma of Rats with Chronic Fatigue Syndrome

Abstract:

OBJECTIVE: To observe the effect of acupuncture on the expression of T-box expressed in T cell (T-bet)/GATA binding factor-3 (GATA-3) in plasma of rats with chronic fatigue syndrome (CFS) and explore the mechanism of acupuncture treatment for CFS.

METHODS: Forty-eight healthy male SD rats were randomly divided into blank control group, CFS model group, acupuncture group, and ginsenoside group (12 rats in each group). CFS rat model was established by combining restriction and cold water swimming. Acupuncture was applied to “Baihui”(GV 20), “Guanyuan” (CV 4) and “Zusanli” (ST 36, bilate-ral) acupoints, once a day for two weeks. The ginsenoside group was gavage administrated with ginsenoside, once a day for two weeks. After 14 days, behavioural changes were observed, and the expression levels of T-bet/GATA-3 genes in plasma were detected by RT-PCR.

RESULTS: Compared with the blank control group, the time for immobility of forced suspensory test was signi-ficantly longer (P<0.05) and the time for exhaustive swimming was significantly shortened (P<0.05) in the CFS model group. Compared with the model group, the two indexes above-mentioned were reversed (P<0.05) both in the acupuncture group and the ginsenoside group, and the effects in the acupuncture group were more significant than those in the ginsenoside group (P<0.05). Compared with the blank control group, the expression level of T-cell transcription factor T-bet gene in plasma was higher in the CFS model group (P<0.05), companied with lower GATA-3 gene expression (P<0.05). The ratio of T-bet/GATA-3 was higher in the model group than in the blank control group(P<0.05). Compared with the CFS model group, all the indexes above-mentioned were reversed (P<0.05) in the two treatment groups. Acupuncture group showed a better effect on reducing T-bet gene expression than the ginsenoside group (P<0.05).

CONCLUSIONS: Acupuncture can decrease the expression level of T-bet gene while increase the expression of GATA-3 gene, which may be associated with its role in treating CFS.

Source: Wang XY, Liu CZ, Lei B. Effect of Acupuncture on the Expression of Transcription Factor T-bet/GATA-3 in Plasma of Rats with Chronic Fatigue Syndrome. Zhen Ci Yan Jiu. 2017 Jun 25;42(3):246-8. [Article in Chinese] https://www.ncbi.nlm.nih.gov/pubmed/29071982