Selective serotonin reuptake inhibitor combined with dengzhanshengmai capsule improves the fatigue symptoms: a 12-week open-label pilot study

Abstract:

OBJECTIVE: This study was to assess the efficacy and safety of selective serotonin reuptake inhibitor (SSRI) plus Dengzhanshengmai capsule in patients with chronic fatigue syndrome (CFS).

METHODS: SSRI at a moderate dose plus Dengzhanshengmai (n = 134) with SSRI alone (n = 134) were compared for the efficacy and safety in the treatment of CFS. The therapeutic efficacy and safety were evaluated.

RESULTS: As compared to monotherapy group, the efficacy in combined therapy group was better and characterized by the improvement of general fatigue (0.8±0.6 vs. 1.3±0.7), physical fatigue (0.6±0.3 vs. 1.0±0.4) and reduced activity (1.0±0.5 vs. 1.3±0.6) since the 2nd week (P<0.01) and in reduced motivation (2.1±0.8 vs. 2.4±1.0) since the 8th week (P<0.01) and the improvement continued thereafter. The mental fatigue score and HAD score were comparable between two groups (P>0.05). No significant difference was found in the drop-out rate between SSRI group (15.7%) and SSRI plus Dengzhanshengmai group (18.0%). The reasons for drop out were adverse events (7.5% vs. 9.7%), requests of the patients or career requirement (3.7% vs. 4.5%), loss to follow-up and others (2.2% vs. 3.0%) and lack of efficacy (2.2% vs. 0.7%). Although the patients in combined therapy group experienced a higher rate of hypertension than (5.8% vs. 1.5%), no significant difference was observed (P = 0.08).

CONCLUSION: SSRI combined with Dengzhanshengmai capsule may significantly improve the general fatigue, physical fatigue, reduced activity and reduced motivation of CFS patients as compared to monotherapy with SSRI. Furthermore, this combined therapy is safe and tolerable.

 

Source: Li DQ, Li ZC, Dai ZY. Selective serotonin reuptake inhibitor combined with dengzhanshengmai capsule improves the fatigue symptoms: a 12-week open-label pilot study. Int J Clin Exp Med. 2015 Jul 15;8(7):11811-7. eCollection 2015. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4565405/ (Full article)

 

Acupuncture for chronic fatigue syndrome and idiopathic chronic fatigue: a multicenter, nonblinded, randomized controlled trial

Abstract:

BACKGROUND: The causes of chronic fatigue syndrome (CFS) and idiopathic chronic fatigue (ICF) are not clearly known, and there are no definitive treatments for them. Therefore, patients with CFS and ICF are interested in Oriental medicine or complementary and alternative medicine. For this reason, the effectiveness of complementary and alternative treatments should be verified. We investigated the effectiveness of two forms of acupuncture added to usual care for CFS and ICF compared to usual care alone.

METHODS: A three-arm parallel, non-blinded, randomized controlled trial was performed in four hospitals. We divided 150 participants into treatment and control groups at the same ratio. The treatment groups (Group A, body acupuncture; Group B, Sa-am acupuncture) received 10 sessions for 4 weeks. The control group (Group C) continued usual care alone. The primary outcome was the Fatigue Severity Scale (FSS) at 5 weeks after randomization. Secondary outcomes were the FSS at 13 weeks and a short form of the Stress Response Inventory (SRI), the Beck Depression Inventory (BDI), the Numeric Rating Scale (NRS), and the EuroQol-5 Dimension (EQ-5D) at 5 and 13 weeks.

RESULTS: Group A showed significantly lower FSS scores than Group C at 5 weeks (P = 0.023). SRI scores were significantly lower in the treatment groups than in the control group at 5 (Group A, P = 0.032; B, P <0.001) and 13 weeks (Group A, P = 0.037; B, P <0.001). Group B showed significantly lower BDI scores than Group C at 13 weeks (P = 0.007). NRS scores from the treatment groups were significantly reduced compared to control at 5 (Group A and B, P <0.001) and 13 weeks (Group A, P = 0.011; B, P = 0.002).

CONCLUSIONS: Body acupuncture for 4 weeks in addition to usual care may help improve fatigue in CFS and ICF patients.

TRIAL REGISTRATION: Clinical Research Information Service (CRIS) KCT0000508; Registered on 12 August 2012.

 

Source: Kim JE, Seo BK, Choi JB, Kim HJ, Kim TH, Lee MH, Kang KW, Kim JH, Shin KM, Lee S, Jung SY, Kim AR, Shin MS, Jung HJ, Park HJ, Kim SP, Baek YH, Hong KE, Choi SM. Acupuncture for chronic fatigue syndrome and idiopathic chronic fatigue: a multicenter, nonblinded, randomized controlled trial. Trials. 2015 Jul 26;16:314. doi: 10.1186/s13063-015-0857-0. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4515016/ (Full article)

 

Effect of manual acupuncture stimulation of “Baihui” (GV 20), etc. on serum IFN-gamma and IL-4 contents in rats with chronic fatigue syndrome

Abstract:

OBJECTIVE: To observe the effect of manual acupuncture stimulation of “Baihui” (GV 20), etc. on serum IFN- gamma and IL-4 contents in rats with chronic fatigue syndrome (CFS).

METHODS: A total of 24 male SD rats were equally randomized into control group, model group and acupuncture group. CFS model was established by bounding and forced swimming in cold water once daily for 14 days. Rats in the acupuncture group were treated by manual acupuncture stimulation of bilateral “Zusanli” (ST 36), “Baihui” (GV 20), and “Guanyuan” (CV 4), once daily for 14 days. Serum IFN-gamma and IL-4 contents were detected by ELISA.

RESULTS: Compared with the control group, the contention of serum IFN-gamma and ratio of IFN-gamma/IL-4 were significant decreased in the model group (P<0.01). While in comparison with the model group, the contention of IFN-gamma and ratio of IFN-gamma/IL-4 were obviously increased in the acupuncture group (P<0.05). No significant differences were found among the three groups in serum IL-4 levels (P>0.05).

CONCLUSION: Manual acupuncture can inhibit CFS induced reduction of serum IFN-gamma level and the ratio of IFN-gamma/IL-4 in CFS rats, suggesting a favorable adjustment of acupuncture intervention for CFS by balancing the ratio of IFN-gamma/IL-4.

 

Source: Wang C, Xie WJ, Liu M, Yan J, Zhang JL, Liu Z, Guo LN. Effect of manual acupuncture stimulation of “Baihui” (GV 20), etc. on serum IFN-gamma and IL-4 contents in rats with chronic fatigue syndrome. Zhen Ci Yan Jiu. 2014 Oct;39(5):387-9. [Article in Chinese] https://www.ncbi.nlm.nih.gov/pubmed/25518113

 

Randomized controlled clinical trials of acupuncture and moxibustion treatment of chronic fatigue syndrome patients

Abstract:

OBJECTIVE: To observe the therapeutic effect of acupuncture and moxibustion interventions in the treatment of chronic fatigue syndrome (CFS).

METHODS: A total of 133 CFS patients were randomized into acupuncture group (47 cases), warm-needling group (44 cases) and non-acupoint group (42 cases). Manual acupuncture (MA) stimulation was applied to Baihui (GV 20), Danzhong (CV 17), Qihai (CV 6), Guanyuan (CV 4), bilateral Zusanli (ST 36), Hegu (LI 4), Taichong (LR 3) and Sanyinjiao (SP 6) for patients in the acupuncture group. For patients in the warm-needling group, moxa-heated needle was applied to Baihui (GV 20), Qihai (CV 6), Guanyuan (CV 4) and bilateral Zusanli (ST 36). Non-acupoints were located about 1-2 cm beside the Baihui (GV 20), Danzhong (CV 17), Qihai (CV 6), Guanyuan (CV 4), Zusanli (ST 36), Taichong (LR 3), Sanyinjiao (SP 6) and Hegu (LI 4). The treatment was given once daily for 20 days. The Chalder Fatigue Scale (14-item fatigue scale) was adopted to evaluate the changes of CFS before and after the treatment.

RESULTS: In comparison with pre-treatment, the scores of Chalder Fatigue Scale including physical and mental fatigue and total score were significantly decreased in both acupuncture and warm-needling groups (P < 0.05, P < 0.01), but not in the non-acupoint group (P > 0.05) except physical score (P < 0.05). The physical, mental and total scores of the acupuncture and warm-needling groups were significantly lower than those of the non-acupoint group (P < 0.05, P < 0.01), while the physical and total scores of the warm-needling group were markedly lower than those of the acupuncture group (P < 0.05). After the treatment, the CFS patients’ satisfactory rates of the acupuncture, warm-needling and non-acupoint groups were 36.2% (17/47), 72.7% (32/44) and 35.7% (15/42), respectively.

CONCLUSION: Both MA and warm-needling interventions have a good therapeutic effect in the treatment of CFS patients, while the latter is obviously better.

 

Source: Lu C, Yang XJ, Hu J. Randomized controlled clinical trials of acupuncture and moxibustion treatment of chronic fatigue syndrome patients. Zhen Ci Yan Jiu. 2014 Aug;39(4):313-7. [Article in Chinese] https://www.ncbi.nlm.nih.gov/pubmed/25219128

 

Impacts on chronic fatigue syndrome of qi deficiency syndrome and T cell subgroups in patients treated with acupuncture at selective time

Abstract:

OBJECTIVE: To verify the clinical efficacy on chronic fatigue syndrome of qi deficiency syndrome treated with acupuncture at selective time and explore the effect mechanism.

METHODS: Eighty patients were randomized into a selective-time-acupuncture group and an acupuncture group, 40 cases in each one. Qihai (CV 6), Guanyuan (CV 4), Hegu (LI 4), Taichong (LR 3), Sanyinjiao (SP 6) and Zusanli (ST 36) were selected in the two groups. In the selective-time-acupuncture group, acupuncture was used at 9:00am to 11:00am. In the acupuncture group, acupuncture was used at any time except in the range from 9:00am to 11:00am. No any manipulation was applied after the arrival of needling sensation. The treatment was given once every day, 10 day treatment made one session and two sessions of treatment were required. The fatigue scale was adopted to evaluate the efficacy before and after treatment in the patients of the two groups. The ratios among CD3+, CD4+ and CD8+ T cells in the peripheral blood were detected before ad b a after treatment.

RESULTS: In the acupuncture group, the total score of fatigue and the score of physical fatigue were reduced after treatment as compared with those before treatment (all P<0.05). In the selective-time -acupuncture group, the total score of fatigue, the s core of physical fatigue and the score of mental fatigue after treatment were reduced obviously as compared with those hefore treatment (all P<0. 01). The improvements in the scores of the selective-time-acupuncture group were superior to the acupuncture group (all P<0. 05). The ratio of CD3+ and CD8+ T cells was increased obviously after treatment in the two groups (all P<0. 05) and the ratio of CD4+ and CD8+ T cells was reduced obviously in the selective-time-acupuncture group (P<0. 05), which was better than that in the acupuncture group (all P<0.05). The total effective rate was 95.0% (38/40) in the selective-time-acupuncture group, which was better than 80.0% (32/40) in the acupuncture group (P<0.05).

CONCLUSION: The acupuncture therapy at selective time is effective in the treatment of chronic fatigue syndrome of qi deficiency syndrome, which is especially better at relieving mental fatigue. The effect of this therapy is achieved probably by improving the immune function via the regulation of the ratios among CD3+, CD4+ and CD8+ T cells.

 

Source: Ling JY, Shen L, Liu Q, Wang LY. Impacts on chronic fatigue syndrome of qi deficiency syndrome and T cell subgroups in patients treated with acupuncture at selective time. Zhongguo Zhen Jiu. 2013 Dec;33(12):1061-4. [Article in Chinese] https://www.ncbi.nlm.nih.gov/pubmed/24617226

 

Effect of acupuncture intervention on learning-memory ability and cerebral superoxide dismutase activity and malonaldehyde concentration in chronic fatigue syndrome rats

Abstract:

OBJECTIVE: To observe the effect of acupuncture intervention on learning-memory ability and cerebral superoxide dismutase (SOD) activity and malonaldehyde (MDA) content in chronic fatigure syndrome (CFS) rats so as to reveal its mechanism underlying improvement of clinical CFS.

METHODS: Thirty-six male SD rats were randomly divided into control group, model group and acupuncture group (n = 12 in each group). CFS model was established by double stress stimulation of suspending (1.0 – 2.5 h increasing gradually) and forced swimming [Morris water maze tasks, 7 min in (10 +/- 1) degrees C water], once daily for 12 days. Manual acupuncture stimulation was applied to “Baihui” (CV 20), bilateral “Zusanli” (ST 36) and “Sanyinjiao” (SP 6), once daily for 21 days (with 3 days’ interval between every two weeks). Learning-memory ability was determined by Morris water maze tests, and SOD activity and MDA concentration in the brain tissues were detected by xanthine oxidase method and thiobarbiturif acid method, respectively.

RESULTS: Compared with the control group, the escape latencies at time-points of day 1, 2, 3, 4 and 5 of Morris water maze tests were significantly longer, the target platform crossing times were markedly fewer and the target platform quadrant staying time obviously shorter, cerebral SOD activity was considerably decreased, and cerebral MDA content remarkably increased in the model group (P < 0.05, P < 0.01). Following acupuncture intervention, the escape latencies at time-points of day 1, 2, 3, 4 and 5 were significantly decreased, both target platform crossing times and staying time, and cerebral SOD activity were apparently increased, as well as cerebral MDA level was markedly lowered in comparison with the model group (P<0.05, P<0.01).

CONCLUSION: Acupuncture intervention can improve the learning-memory ability in CFS rats, which may be related to its effect in regulating metabolism of free radicals in the brain tissues.

 

Source: Liu CZ, Lei B. Effect of acupuncture intervention on learning-memory ability and cerebral superoxide dismutase activity and malonaldehyde concentration in chronic fatigue syndrome rats.Zhen Ci Yan Jiu. 2013 Dec;38(6):478-81. [Article in Chinese] https://www.ncbi.nlm.nih.gov/pubmed/24588031

 

Effects of qigong exercise on fatigue, anxiety, and depressive symptoms of patients with chronic fatigue syndrome-like illness: a randomized controlled trial

Abstract:

Background. Anxiety/depressive symptoms are common in patients with chronic fatigue syndrome- (CFS-) like illness. Qigong as a modality of complementary and alternative therapy has been increasingly applied by patients with chronic illnesses, but little is known about the effect of Qigong on anxiety/depressive symptoms of the patients with CFS-like illness.

Purpose. To investigate the effects of Qigong on fatigue, anxiety, and depressive symptoms in patients with CFS-illness.

Methods. One hundred and thirty-seven participants who met the diagnostic criteria for CFS-like illness were randomly assigned to either an intervention group or a waitlist control group. Participants in the intervention group received 10 sessions of Qigong training twice a week for 5 consecutive weeks, followed by home-based practice for 12 weeks. Fatigue, anxiety, and depressive symptoms were assessed at baseline and postintervention.

Results. Total fatigue score [F(1,135) = 13.888, P < 0.001], physical fatigue score [F(1,135) = 20.852, P < 0.001] and depression score [F(1,135) = 9.918, P = 0.002] were significantly improved and mental fatigue score [F(1,135) = 3.902, P = 0.050] was marginally significantly improved in the Qigong group compared to controls. The anxiety score was not significantly improved in the Qigong group.

Conclusion. Qigong may not only reduce the fatigue symptoms, but also has antidepressive effect for patients with CFS-like illness.

Trial registration HKCTR-1200.

 

Source: Chan JS, Ho RT, Wang CW, Yuen LP, Sham JS, Chan CL. Effects of qigong exercise on fatigue, anxiety, and depressive symptoms of patients with chronic fatigue syndrome-like illness: a randomized controlled trial. Evid Based Complement Alternat Med. 2013;2013:485341. doi: 10.1155/2013/485341. Epub 2013 Jul 31. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3747479/ (Full article)

 

Acupuncture for chronic fatigue syndrome: a randomized, sham-controlled trial with single-blinded design

Abstract:

CONTEXT: Given that the etiology of chronic fatigue syndrome (CFS) is believed to be multidimensional, interventions generally have been nonspecific and typically produce only mild to moderate effects. In medical practice, treatment for CFS remains largely symptomatic. Preliminary evidence of the efficacy of acupuncture for CFS is available, but the field has lacked high-quality trials.

OBJECTIVE: The research team conducted the study to determine the efficacy of acupuncture for CFS.

DESIGN: A two-arm, randomized, controlled, singleblinded design was adopted.

SETTING: The study took place in a teaching laboratory at the School of Chinese Medicine at the University of Hong Kong, Hong Kong, China.

PARTICIPANTS: Recruited through press publicity in Hong Kong, 127 individuals–40 men and 87 women–participated in the study. Intervention Through careful implementation of sham acupuncture in the control group (CG), the study blinded all participants with regard to their experimental or control status. The treatment regime was 2 sessions/wk for 4 consecutive wk.

OUTCOME MEASURES: Measures of fatigue (Chalder’s Fatigue Scale), health-related quality of life (SF-12), and general mental health (GH Q-12) were taken at baseline and upon completion of treatment.

RESULTS: Ninety-nine participants completed the interventions, with 50 and 49 participants in the experimental group (EG) and CG respectively. Repeated measures ANOVA revealed a significant decrease in physical (F(1,93) = 4.327; P = .040) and mental fatigue (F(1,96) = 10.451; P = .002) and improvement in the physical component score of SF-12 (F(1,93) = 4.774; P = .031). Considerable effects with Cohen’s d were observed in the sham-control group: 0.92, 0.78, and 0.38 for the three scores, respectively. These positive effects could have included some therapeutic effects due to pressure on the acupuncture points from the sham needles in addition to normal placebo effects. The EG showed moderate net effect sizes with Cohen’s d: 0.52, 0.63, and 0.54 for the three outcome measures, respectively.

CONCLUSION: Despite considerable positive effects for the CG, the EG demonstrated significant net-effect sizes at a moderate magnitude in physical and mental fatigue and in the physical component of health-related quality of life. The impacts on general mental health outcomes appeared to be smaller.

 

Source: Ng SM, Yiu YM. Acupuncture for chronic fatigue syndrome: a randomized, sham-controlled trial with single-blinded design. Altern Ther Health Med. 2013 Jul-Aug;19(4):21-6. https://www.ncbi.nlm.nih.gov/pubmed/23981369

 

An open-label study of effects of acupuncture on chronic fatigue syndrome and idiopathic chronic fatigue: study protocol for a randomized controlled trial

Abstract:

BACKGROUND: Even though chronic fatigue syndrome and idiopathic chronic fatigue are quite common, there are no clearly known causes. Most treatments are therefore symptomatic in nature, and chronic fatigue syndrome and idiopathic chronic fatigue patients are highly interested in using oriental medicine or complementary and alternative medicine treatment. Acupuncture, one of the major treatments used in oriental medicine, is effective in treating various diseases. This study will attempt to analyze the effectiveness and safety of acupuncture in the treatment of chronic fatigue by comparing the two treatment groups (body acupuncture, Sa-am acupuncture) and the control group (usual care).

METHODS/DESIGN: This study consists of a four-center, three-arm, randomized, controlled, and open-label trial. One hundred and fifty participants are randomly divided into treatment groups A and B and a control group. The treatment groups will receive acupuncture treatments either two or three times per week for a total of 10 sessions over a period of 4 weeks. The control group will not receive acupuncture treatments and will continue their usual care during this period. The primary outcome variable is the Fatigue Severity Scale, which will be utilized 5 weeks after randomization. Secondary outcome variables are the Fatigue Severity Scale at 13 weeks, a short form of the Stress Response Inventory, the Beck Depression Inventory, the Numeric Rating Scale, and the EuroQol-5 Dimension at 5 and 13 weeks after randomization.

DISCUSSION: This study will provide evidence with high external validity on the effectiveness and safety of acupuncture as a treatment for chronic fatigue syndrome and idiopathic chronic fatigue.

TRIAL REGISTRATION: Clinical Research Information Service KCT0000508.

 

Source: Kim JE, Hong KE, Kim HJ, Choi JB, Baek YH, Seo BK, Lee S, Kang KW, Lee MH, Kim JH, Lee S, Jung SY, Jung HJ, Shin MS, Choi SM. An open-label study of effects of acupuncture on chronic fatigue syndrome and idiopathic chronic fatigue: study protocol for a randomized controlled trial. Trials. 2013 May 21;14:147. doi: 10.1186/1745-6215-14-147. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3663812/ (Full article)

 

A randomized controlled trial of qigong exercise on fatigue symptoms, functioning, and telomerase activity in persons with chronic fatigue or chronic fatigue syndrome

Abstract:

BACKGROUND: Chronic fatigue is common in the general population. Complementary therapies are often used by patients with chronic fatigue or chronic fatigue syndrome to manage their symptoms.

PURPOSE: This study aimed to assess the effect of a 4-month qigong intervention program among patients with chronic fatigue or chronic fatigue syndrome.

METHODS: Sixty-four participants were randomly assigned to either an intervention group or a wait list control group. Outcome measures included fatigue symptoms, physical functioning, mental functioning, and telomerase activity.

RESULTS: Fatigue symptoms and mental functioning were significantly improved in the qigong group compared to controls. Telomerase activity increased in the qigong group from 0.102 to 0.178 arbitrary units (p < 0.05). The change was statistically significant when compared to the control group (p < 0.05).

CONCLUSION: Qigong exercise may be used as an alternative and complementary therapy or rehabilitative program for chronic fatigue and chronic fatigue syndrome.

Comment in: Contemplative practice, chronic fatigue, and telomerase activity: a comment on Ho et al. [Ann Behav Med. 2012]

 

Source: Ho RT, Chan JS, Wang CW, Lau BW, So KF, Yuen LP, Sham JS, Chan CL. A randomized controlled trial of qigong exercise on fatigue symptoms, functioning, and telomerase activity in persons with chronic fatigue or chronic fatigue syndrome. Ann Behav Med. 2012 Oct;44(2):160-70. doi: 10.1007/s12160-012-9381-6. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3442161/ (Full article)