A placebo-controlled, double-blind, randomized controlled trial of a natural killer cell stimulant (BioBran MGN-3) in chronic fatigue syndrome

McDermott, Clare; Richards, Selwyn; Thomas, Peter; Montgomery, Jenny; Lewith, George

doi:10.1093/qjmed/hcl063

Cited by 32 publications

(31 citation statements)

References 18 publications

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“…Twenty of the included trials adopted a two-arm parallel group design [10-12,14,15,17-27,29,30,33,35], three adopted a three-arm parallel group design [16,28,34], and one used a four-arm parallel group design [13], while two trials employed a cross-over design [31,32]. Nine trials adopted the CDC criteria for the diagnosis of CFS [11,20,22,24,25,27,28,31,32], five studies diagnosed CFS according to the criteria published by Fukuda [10,15,16,19,21], five used the Oxford criteria [12,17,18,30,35], two combined with Fukuda and Oxford criteria [13,23], and one used a different classification system [33]. …”

Section: Resultsmentioning

confidence: 99%

“…Eleven RCTs had an adequate method for random sequence generation [10,11,13,15,17,19,24,25,28,29,33], whereas the remaining 15 RCTs did not [12,14,16,18,20-23,26,27,30-32,34,35]. Allocation concealments were adequately performed in 13 RCTs [10,11,13,17,19,24,25,29-33]. Patient and assessor blinding was reported in 16 of the RCTs [17-20,22-27,29-34], whereas two RCTs employed assessor blinding only [10,11].…”

Section: Resultsmentioning

confidence: 99%

“…Reasons for dropouts and withdrawals were fully described in 17 trials [10,11,13,17,19,22-26,28-30,32-35]. With respect to the intention-to-treat (ITT) analysis, 11 RCTs did not report the basis of the analysis [11,12,14-16,28,30-32,34,35], and 9 were analysed on a per-protocol basis [10,13,18,20,21,23,25-27]. The remaining 6 studies employed the ITT method [17,19,22,24,29,33].…”

Section: Resultsmentioning

confidence: 99%

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Complementary and alternative medicine for patients with chronic fatigue syndrome: A systematic review

Alræk

Lee

Choi

et al. 2011

BMC Complement Altern Med

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BackgroundThroughout the world, patients with chronic diseases/illnesses use complementary and alternative medicines (CAM). The use of CAM is also substantial among patients with diseases/illnesses of unknown aetiology. Chronic fatigue syndrome (CFS), also termed myalgic encephalomyelitis (ME), is no exception. Hence, a systematic review of randomised controlled trials of CAM treatments in patients with CFS/ME was undertaken to summarise the existing evidence from RCTs of CAM treatments in this patient population.MethodsSeventeen data sources were searched up to 13th August 2011. All randomised controlled trials (RCTs) of any type of CAM therapy used for treating CFS were included, with the exception of acupuncture and complex herbal medicines; studies were included regardless of blinding. Controlled clinical trials, uncontrolled observational studies, and case studies were excluded.ResultsA total of 26 RCTs, which included 3,273 participants, met our inclusion criteria. The CAM therapy from the RCTs included the following: mind-body medicine, distant healing, massage, tuina and tai chi, homeopathy, ginseng, and dietary supplementation. Studies of qigong, massage and tuina were demonstrated to have positive effects, whereas distant healing failed to do so. Compared with placebo, homeopathy also had insufficient evidence of symptom improvement in CFS. Seventeen studies tested supplements for CFS. Most of the supplements failed to show beneficial effects for CFS, with the exception of NADH and magnesium.ConclusionsThe results of our systematic review provide limited evidence for the effectiveness of CAM therapy in relieving symptoms of CFS. However, we are not able to draw firm conclusions concerning CAM therapy for CFS due to the limited number of RCTs for each therapy, the small sample size of each study and the high risk of bias in these trials. Further rigorous RCTs that focus on promising CAM therapies are warranted.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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Complementary and alternative medicine for patients with chronic fatigue syndrome: A systematic review

Alræk

Lee

Choi

et al. 2011

BMC Complement Altern Med

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“…The most likely reason for these discrepancies is that the present study examined healthy subjects, whereas the previous studies all examined the effects of RBEP in the context of cancer. McDermott et al [17] concluded that arabinoxylan supplementation was not effective for treating chronic fatigue syndrome, an assessment thought to indirectly measure NK cell activity. Cancer patients have been suggested to have reduced NK cell activity compared with healthy individuals [18,19]; thus, significant effects on NK cell activity in healthy individuals may be difficult to observe.…”

Section: Discussionmentioning

confidence: 99%

Dietary supplementation with rice bran fermented with Lentinus edodesincreases interferon-γ activity without causing adverse effects: a randomized, double-blind, placebo-controlled, parallel-group study

Choi

Paik

Kwon

et al. 2014

Nutr J

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BackgroundThe purpose of this study was to investigate the hypothesis that dietary supplementation with rice bran fermented with Lentinus edodes (rice bran exo-biopolymer, RBEP), a substance known to contain arabinoxylan, enhances natural killer (NK) cell activity and modulates cytokine production in healthy adults.MethodsThis study was designed in a randomized, double-blind, placebo-controlled, and parallel-group format. Eighty healthy participants with white blood cell counts of 4,000-8,000 cells/μL were randomly assigned to take six capsules per day of either 3 g RBEP or 3 g placebo for 8 weeks. Three participants in the placebo group were excluded after initiation of the protocol; no severe adverse effects from RBEP supplementation were reported. NK cell activity of peripheral blood mononuclear cells was measured using nonradioactive cytotoxicity assay kits and serum cytokine concentrations included interferon (IFN)-γ, tumor necrosis factor (TNF)-α, interleukin (IL)-2, IL-4, IL-10, and IL-12 were measured by Bio-Plex cytokine assay kit. This study was registered with the Clinical Research Information Service (KCT0000536).ResultsSupplementation of RBEP significantly increased IFN-γ production compared with the placebo group (P = 0.012). However, RBEP supplementation did not affect either NK cell activity or cytokine levels, including IL-2, IL-4, IL-10, IL-12, and TNF-α, compared with the placebo group.ConclusionsThe data obtained in this study indicate that RBEP supplementation increases IFN-γ secretion without causing significant adverse effects, and thus may be beneficial to healthy individuals. This new rice bran-derived product may therefore be potentially useful to include in the formulation of solid and liquid foods designed for treatment and prevention of pathological states associated with defective immune responses.

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“…Unfortunately, the best evidence based and standardized immunodulators without any side effects are plant extracts and they are all over the world registered only as food supplements. There are growing evidences that plant PAMP-like molecules (such as standardized rice bran arabinoxylan concentrate) exhibit a lot of immunological [15][16][17][18][19][20][21][22][23][24][25][26] and clinical benefit [27][28][29]. Therefore, further clinical trials are necessary to investigate this beneficial interaction.…”

Section: Discussionmentioning

confidence: 99%

Can a standardized plant immunomodulator (rice bran arabinoxylan concentrate/MGN-3) increase the effects of MEK and BRAF inhibitors with clinical benefit? Case report of a patient with carcinoma in biliary duct

Hajtò¹

2017

Res Rev Insights

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Background: Targeting hyperactive mitogen-activated protein kinase (MAPK) signaling cascade has proven to be an effective treatment for a variety of different cancers. Using an important member of this cascade, namely MEK (mitogen activated extracellular signal regulation kinase) inhibitors, the clinical responses are often transient and complete remission is rarely observed. Outgrowth of resistant clones within progressed tumors appears to be inevitable. Recent immunological and clinical observations suggest that in background of this resistance the tumor-.induced disturbance of immunoregulation at least in part may play a role. Namely, it was shown that growth factor receptor signaling pathway inhibitors can increase the immune sensitivity of tumor cells, but they can't activate the down regulated immune effectors. Consequently, the combination of MAPK cascade signaling pathway inhibitors and the immune effectors activating immunomodulators may be a promising new strategy.

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A placebo-controlled, double-blind, randomized controlled trial of a natural killer cell stimulant (BioBran MGN-3) in chronic fatigue syndrome

Abstract: The findings do not support a specific therapeutic effect for BioBran in CFS. The improvement showed by both groups over time highlights the importance of placebo controls when evaluating interventions in CFS.

Cited by 32 publications

References 18 publications

Complementary and alternative medicine for patients with chronic fatigue syndrome: A systematic review

Complementary and alternative medicine for patients with chronic fatigue syndrome: A systematic review

Dietary supplementation with rice bran fermented with Lentinus edodesincreases interferon-γ activity without causing adverse effects: a randomized, double-blind, placebo-controlled, parallel-group study

Can a standardized plant immunomodulator (rice bran arabinoxylan concentrate/MGN-3) increase the effects of MEK and BRAF inhibitors with clinical benefit? Case report of a patient with carcinoma in biliary duct

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