Category: Clinical Trial

Effect of lixu jieyu recipe in treating 75 patients with chronic fatigue syndrome

Abstract:

OBJECTIVE: To investigate the effective Chinese medicine treatment of chronic fatigue syndrome (CFS).

METHODS: Seventy-five CFS patients meeting the inclusive criteria were enrolled from March 2007 to April 2008 and randomized into two groups. The 40 patients in the treated group were orally treated with Lixu Jieyu Recipe (LJR, consisted of milkvetch root 30 g, kudzuvine root 30 g, asiabell root 15 g, red sage root 10 g, aizoon stonecrop 15 g, epimeddium herb 10 g, curcuma root 10 g, and grassleaved sweetflag rhizome 10 g, made into 200 mL of decoction), for 100 mL twice a day. The 35 patients in the control group were treated with vitamin B tablets (10 mg twice a day), adenosine triphosphate (ATP, 20 mg, thrice a day) and Oryzanol tablets (20 mg thrice a day). The laboratory indicators including serum immunoglobulins (IgG, IgA, IgM, IgE), blood immune cells, as T-cells (Th and Ts), B-cells, natural killer cells, as well as CD4/CD8 ratio were measured before and after 3-month treatment.

RESULTS: After treatment the difference in scores of fatigue symptoms between the two groups was significant (P < 0.01), the scores of various SCL-90 factors and the total score significantly reduced in the treated group after treatment (P < 0.01). Levels of the immunoglobulins measured before treatment were in an equilibrium state, they all were unchanged after treatment in both groups (P > 0.05), and showed no significant difference between groups either before or after treatment. As for the immune cells, significant increase of the lowered Th, Ts cells, and decrease of CD4/CD8 ratio were found in both groups after treatment (P < 0.05), but the improvement was more significant in the treated group, so the difference between groups in these indices after treatment also showed statistical significance (P < 0.05).

CONCLUSION: LJR shows superiority in treating CFS.

 

Source: Zhang ZX, Wu LL, Chen M. Effect of lixu jieyu recipe in treating 75 patients with chronic fatigue syndrome. Zhongguo Zhong Xi Yi Jie He Za Zhi. 2009 Jun;29(6):501-5. [Article in Chinese] https://www.ncbi.nlm.nih.gov/pubmed/19702080

 

Randomized controlled clinical trials of acupuncture treatment of chronic fatigue syndrome

Abstract:

OBJECTIVE: To observe the effect of acupuncture on the fatigue degree in patients with chronic fatigue syndrome (CFS).

METHODS: Seventy CFS patients were equally randomized into control and treatment groups according to randomized block design. Acupuncture was applied to Baihui (GV 20), Danzhong (CV 17), Zhongwan (CV 12), etc., for patients in treatment group, and to non-acupoints (2 cm respectively to the abovementioned acupoints) for those in control group. The treatment was given once every other day, 14 times altogether. The fatigue degree and the therapeutic effect were assessed by Chalder’s fatigue scale (FS).

RESULTS: A total of 64 cases (32/group) were finished in this study. After the treatment, the physical FS (5.0 +/- 2.4 vs 6.8 +/- 1.5), mental FS (1.8 +/-1.8 vs 3.1 +/- 1.5) and the total FS (6.8 +/- 3.8 vs 9.9 +/- 2.5) in treatment group, physical FS (5.0 +/- 2.5 vs 6.4 +/- 1.5) and the total FS (7.5 +/- 3.4 vs 9.6 +/- 2.8) in control group decreased significantly compared with pre-treatment (P < 0.01, P < 0.05). There was no marked change in mental FS (2.5 +/- 11.6 vs 3.2 +/- 11.6) in control group after the treatment (P > 0.05). Comparison between two groups showed no significant differences in the 3 indexes (P > 0.05).

CONCLUSION: Acupuncture can relieve CFS patients’ physical and mental fatigue and the therapeutic effect of acupuncture of acupoints is relatively better than that of non-acupoints in reducing mental fatigue.

 

Source: Wang JJ, Song YJ, Wu ZC, Chu XO, Wang QM, Wang XJ, Wei LN, Meng H, Wang XH. Randomized controlled clinical trials of acupuncture treatment of chronic fatigue syndrome. Zhen Ci Yan Jiu. 2009 Apr;34(2):120-4. [Article in Chinese] https://www.ncbi.nlm.nih.gov/pubmed/19685727

 

A randomized, double-blind, placebo-controlled pilot study of a probiotic in emotional symptoms of chronic fatigue syndrome

Abstract:

Chronic fatigue syndrome (CFS) is complex illness of unknown etiology. Among the broad range of symptoms, many patients report disturbances in the emotional realm, the most frequent of which is anxiety. Research shows that patients with CFS and other so-called functional somatic disorders have alterations in the intestinal microbial flora. Emerging studies have suggested that pathogenic and non-pathogenic gut bacteria might influence mood-related symptoms and even behavior in animals and humans.

In this pilot study, 39 CFS patients were randomized to receive either 24 billion colony forming units of Lactobacillus casei strain Shirota (LcS) or a placebo daily for two months. Patients provided stool samples and completed the Beck Depression and Beck Anxiety Inventories before and after the intervention. We found a significant rise in both Lactobacillus and Bifidobacteria in those taking the LcS, and there was also a significant decrease in anxiety symptoms among those taking the probiotic vs controls (p = 0.01). These results lend further support to the presence of a gut-brain interface, one that may be mediated by microbes that reside or pass through the intestinal tract.

 

Source: Rao AV, Bested AC, Beaulne TM, Katzman MA, Iorio C, Berardi JM, Logan AC. A randomized, double-blind, placebo-controlled pilot study of a probiotic in emotional symptoms of chronic fatigue syndrome. Gut Pathog. 2009 Mar 19;1(1):6. doi: 10.1186/1757-4749-1-6. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2664325/ (Full article)

 

Cognitive-behavioural therapy v. mirtazapine for chronic fatigue and neurasthenia: randomised placebo-controlled trial

Abstract:

BACKGROUND: Single interventions in chronic fatigue syndrome have shown only limited effectiveness, with few studies of comprehensive treatment programmes.

AIMS: To examine the effect of a comprehensive cognitive-behavioural treatment (CCBT) programme compared with placebo-controlled mirtazapine medication in patients with chronic fatigue, and to study the effect of combined medication and CCBT.

METHOD: A three-armed randomised clinical trial of mirtazapine, placebo and a CCBT programme was conducted to investigate treatment effect in a patient group (n=72) with chronic fatigue referred to a specialist clinic. The CCBT programme was compared with mirtazapine or placebo therapy for 12 weeks, followed by 12 weeks treatment with a mixed crossover-combination design. Assessments were done at 12 weeks and 24 weeks.

RESULTS: By 12 weeks the treatment effect was significantly better in the group initially receiving CCBT, as assessed with the Fatigue Scale (P=0.014) and the Clinical Global Impression Scale (P=0.001). By 24 weeks the treatment group initially receiving CCBT for 12 weeks followed by mirtazapine for 12 weeks showed significant improvement compared with the other treatment groups on the Fatigue Scale (P<0.001) and the Clinical Global Impression Scale (P=0.002). Secondary outcome measures showed overall improvement with no significant difference between treatment groups.

CONCLUSIONS: Multimodal interventions may have positive treatment effects in chronic fatigue syndrome. Sequence of interventions seem to be of importance.

 

Source: Stubhaug B, Lie SA, Ursin H, Eriksen HR. Cognitive-behavioural therapy v. mirtazapine for chronic fatigue and neurasthenia: randomised placebo-controlled trial. Br J Psychiatry. 2008 Mar;192(3):217-23. doi: 10.1192/bjp.bp.106.031815. http://bjp.rcpsych.org/content/192/3/217.long (Full article)

 

Effectiveness of distant healing for patients with chronic fatigue syndrome: a randomised controlled partially blinded trial (EUHEALS)

Abstract:

BACKGROUND: Distant healing, a form of spiritual healing, is widely used for many conditions but little is known about its effectiveness.

METHODS: In order to evaluate distant healing in patients with a stable chronic condition, we randomised 409 patients with chronic fatigue syndrome (CFS) from 14 private practices for environmental medicine in Germany and Austria in a two by two factorial design to immediate versus deferred (waiting for 6 months) distant healing. Half the patients were blinded and half knew their treatment allocation. Patients were treated for 6 months and allocated to groups of 3 healers from a pool of 462 healers in 21 European countries with different healing traditions. Change in Mental Health Component Summary (MHCS) score (SF-36) was the primary outcome and Physical Health Component Summary score (PHCS) the secondary outcome.

RESULTS: This trial population had very low quality of life and symptom scores at entry. There were no differences over 6 months in post-treatment MHCS scores between the treated and untreated groups. There was a non-significant outcome (p = 0.11) for healing with PHCS (1.11; 95% CI -0.255 to 2.473 at 6 months) and a significant effect (p = 0.027) for blinding; patients who were unblinded became worse during the trial (-1.544; 95% CI -2.913 to -0.176). We found no relevant interaction for blinding among treated patients in MHCS and PHCS. Expectation of treatment and duration of CFS added significantly to the model.

CONCLUSIONS: In patients with CFS, distant healing appears to have no statistically significant effect on mental and physical health but the expectation of improvement did improve outcome.

Copyright (c) 2008 S. Karger AG, Basel.

 

Source: Walach H, Bosch H, Lewith G, Naumann J, Schwarzer B, Falk S, Kohls N, Haraldsson E, Wiesendanger H, Nordmann A, Tomasson H, Prescott P, Bucher HC. Effectiveness of distant healing for patients with chronic fatigue syndrome: a randomised controlled partially blinded trial (EUHEALS). Psychother Psychosom. 2008;77(3):158-66. doi: 10.1159/000116609. Epub 2008 Feb 14. https://www.ncbi.nlm.nih.gov/pubmed/18277062

 

Valacyclovir treatment in Epstein-Barr virus subset chronic fatigue syndrome: thirty-six months follow-up

Abstract:

BACKGROUND: We hypothesized that subset classification of Epstein-Barr virus (EBV) in chronic fatigue syndrome (CFS) is required. At first, a blinded-random placebo-controlled trial of valacyclovir in EBV CFS subset was performed (Group 1), and this EBV subset was followed for thirty-six months (Group 2). Patients were given valacyclovir at 14.3 mg/kg every 6 hours. The validated Energy Index (EI) point score assessing physical functional capacity, Holter monitor, multigated (radionuclide) MUGA rest/stress ventriculographic examination, EBV serum IgM viral capsid antibodies (VCA), and EBV early antigen diffuse (EA) were followed.

After six-months, Group 1 CFS patients receiving valacyclovir experienced an increased mean least square EI point score +1.12 units (122 kcal/day), while the placebo cohort increased +0.42 EI units (65 kcal/day). EI point scores at Group 2 increased progressively. Sinus tachycardias decreased and abnormal cardiac wall motion improved. Serum antibody titers to EBV VCA IgM decreased. Patients resumed normal activities.

 

Source: Lerner AM, Beqaj SH, Deeter RG, Fitzgerald JT. Valacyclovir treatment in Epstein-Barr virus subset chronic fatigue syndrome: thirty-six months follow-up. In Vivo. 2007 Sep-Oct;21(5):707-13. http://iv.iiarjournals.org/content/21/5/707.long (Full article)

 

A clinical trial of acupuncture for treating chronic fatigue syndrome in Hong Kong

Abstract:

OBJECTIVE: To evaluate the efficacy of acupuncture in treating chronic fatigue syndrome (CFS) in Hong Kong.

METHODS: A single-blinded, randomized controlled trial design was adopted. Participants meeting inclusion criteria were randomly assigned to a treatment and a control group according to 1:1 ratio, resulting in an effective sample size of 99, with 50 and 49 patients in treatment and control group respectively. The same set of acupuncture points, which were selected according to traditional Chinese medicine theories, was applied in both groups, while conventional needle acupuncture was applied in treatment group and sham acupuncture (without skin penetration) was applied in control group. Schedule of treatment was the same in both groups, i.e. twice a week for 4 weeks. Key outcome measures were Chalder’s Fatigue Scale, diagnostic criteria for CFS of the US’s Centre for Disease Control and SF-12 health-related quality of life (HQOL) questionnaire. Adverse events, if any, were recorded.

RESULTS: Improvements in physical and mental fatigue and HQOL in both groups were observed, but the improvements in treatment group were significantly bigger than in control group (P<0.01 or P<0.05). No adverse events occurred.

CONCLUSION: Acupuncture is a safe, effective treatment for CFS.

 

Source: Yiu YM, Ng SM, Tsui YL, Chan YL. A clinical trial of acupuncture for treating chronic fatigue syndrome in Hong Kong. Zhong Xi Yi Jie He Xue Bao. 2007 Nov;5(6):630-3. [Article in Chinese] http://www.jcimjournal.com/jim/showAbstrPage.aspx?articleid=167219772007060630 (Full article)

 

Open-label study of s-citalopram therapy of chronic fatigue syndrome and co-morbid major depressive disorder

Abstract:

OBJECTIVE: Chronic fatigue syndrome (CFS) is a debilitating disorder with prominent symptoms of malaise, fatigue, myalgia, arthralgia, and impaired concentration. The symptoms of CFS may often overlap those of Major Depressive Disorder (MDD). Treatment of CFS has generally been disappointing. We hypothesized that s-citalopram therapy may improve the symptoms of both disorders in CFS patients with co-morbid depression.

METHODS: 16 patients received s-citalopram 10 mg to 20 mg daily for up to 12 weeks. Outcome measures of CFS included the Chalder Fatigue Questionnaire (CFQ), the multi-dimensional Fatigue Impact Scale (FIS), the CFS symptom rating (CFS-SR) 100 mm visual analogue scale, and the clinical global impressions severity (CGI/S) and change (CGI/C) ratings. Secondary outcomes of MDD included the Hamilton Depression Rating (HAM-D), Beck Depression Inventory (BDI), and the CGI/S and CGI/C ratings of MDD.

RESULTS: We observed reductions in the mean CFQ score (p<0.0005), FIS score (p<0.0005), and CGI/S (p<0.0005) and CGI/C (p<0.0005) ratings over time. There was a significant improvement in 5 of the 8 CFS-SR symptoms: post-exertion malaise (p=0.001), headaches (p<0.0005), un-refreshing sleep (p<0.0005), and impaired memory and concentration (p<0.0005). There was also a reduction in mean HAM-D (p<0.0005), BDI (p<0.0005), CGI/S (p=0.001) and CGI/C (p<0.0005) ratings of MDD.

LIMITATIONS: The sample size was limited and the study design was not double-blind or placebo controlled.

CONCLUSION: We observed a significant reduction in both CFS and co-morbid MDD symptom severity ratings, and improvement in 5 of 8 core somatic symptoms of CFS during s-citalopram therapy.

 

Source: Amsterdam JD, Shults J, Rutherford N. Open-label study of s-citalopram therapy of chronic fatigue syndrome and co-morbid major depressive disorder. Prog Neuropsychopharmacol Biol Psychiatry. 2008 Jan 1;32(1):100-6. Epub 2007 Aug 3. https://www.ncbi.nlm.nih.gov/pubmed/17804135

 

The effect of acclydine in chronic fatigue syndrome: a randomized controlled trial

Abstract:

OBJECTIVES: It is unclear whether insulin-like growth factor (IGF) function is involved in the pathophysiology of chronic fatigue syndrome (CFS). Unpublished data and reports in patient organization newsletters suggest that Acclydine, a food supplement, could be effective in the treatment of CFS by increasing biologically active IGF1 levels. Here we aimed to measure the IGF1 and IGF binding protein (IGFBP) 3 status of CFS patients compared to age- and gender-matched neighborhood controls, and to assess the effect of Acclydine on fatigue severity, functional impairment, and biologically active IGF1 level (IGFBP3/IGF1 ratio).

DESIGN: A randomized, placebo-controlled, double-blind clinical trial.

SETTING: Radboud University Nijmegen Medical Centre, The Netherlands.

PARTICIPANTS: Fifty-seven adult patients who fulfilled the US Centers for Disease Control and Prevention criteria for CFS. IGF status of 22 CFS patients was compared to that of 22 healthy age- and gender-matched neighborhood control individuals.

INTERVENTION: Acclydine or placebo for 14 wk.

OUTCOME MEASURES: Outcomes were fatigue severity (Checklist Individual Strength, subscale fatigue severity [CIS-fatigue]), functional impairment (Sickness Impact Profile-8 [SIP-8]), and biologically active IGF1 serum concentrations. Analyses were on an intention-to-treat basis.

RESULTS: There was no difference in IGF status in 22 CFS patients compared to healthy age- and gender-matched control individuals. Treatment with Acclydine did not result in significant differences compared with the placebo group on any of the outcome measures: CIS-fatigue +1.1 (95% CI -4.4 to +6.5, p = 0.70), SIP-8 +59.1 (95% CI -201.7 to +319.8, p = 0.65), and IGFBP3/IGF1 ratio -0.5 (95% CI -2.8 to +1.7, p = 0.63).

CONCLUSION: We found no differences in IGF1 status in CFS patients compared to healthy matched neighborhood controls. In addition, the results of this clinical trial do not demonstrate any benefit of Acclydine over placebo in the treatment of CFS.

 

Source: The GK, Bleijenberg G, van der Meer JW. The effect of acclydine in chronic fatigue syndrome: a randomized controlled trial. PLoS Clin Trials. 2007 May 18;2(5):e19. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1876596/ (Full article)

 

Protocol for the PACE trial: a randomised controlled trial of adaptive pacing, cognitive behaviour therapy, and graded exercise, as supplements to standardised specialist medical care versus standardised specialist medical care alone for patients with the chronic fatigue syndrome/myalgic encephalomyelitis or encephalopathy

Abstract:

BACKGROUND: Chronic fatigue syndrome (CFS, also called myalgic encephalomyelitis /encephalopathy or ME) is a debilitating condition with no known cause or cure. Improvement may occur with medical care and additional therapies of pacing, cognitive behavioural therapy and graded exercise therapy. The latter two therapies have been found to be efficacious in small trials, but patient organisations surveys have reported adverse effects. Although pacing has been advocated by patient organisations, it lacks empirical support. Specialist medical care is commonly provided but its efficacy when given alone is not established. This trial compares the efficacy of the additional therapies when added to specialist medical care against specialist medical care alone.

METHODS: 600 patients, who meet operationalised diagnostic criteria for CFS, will be recruited from secondary care into a randomised trial of four treatments, stratified by current co morbid depressive episode and different CFS/ME criteria. The four treatments are standardised specialist medical care either given alone, or with adaptive pacing therapy or cognitive behaviour therapy or graded exercise therapy. Supplementary therapies will involve fourteen sessions over 23 weeks and a booster session at 36 weeks. Outcome will be assessed at 12, 24, and 52 weeks after randomisation. Two primary outcomes of self-rated fatigue and physical function will assess differential effects of each treatment on these measures. Secondary outcomes include adverse events and reactions, subjective measures of symptoms, mood, sleep and function and objective measures of physical activity, fitness, cost-effectiveness and cost-utility. The primary analysis will be based on intention to treat and will use logistic regression models to compare treatments. Secondary outcomes will be analysed by repeated measures analysis of variance with a linear mixed model. All analyses will allow for stratification factors. Mediators and moderators will be explored using multiple linear and logistic regression techniques with interactive terms, with the sample split into two to allow validation of the initial models. Economic analyses will incorporate sensitivity measures.

DISCUSSION: The results of the trial will provide information about the benefits and adverse effects of these treatments, their cost-effectiveness and cost-utility, the process of clinical improvement and the predictors of efficacy.

 

Source: White PD, Sharpe MC, Chalder T, DeCesare JC, Walwyn R; PACE trial group. Protocol for the PACE trial: a randomised controlled trial of adaptive pacing, cognitive behaviour therapy, and graded exercise, as supplements to standardised specialist medical care versus standardised specialist medical care alone for patients with the chronic fatigue syndrome/myalgic encephalomyelitis or encephalopathy. BMC Neurol. 2007 Mar 8;7:6. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2147058/