A placebo-controlled, double-blind, randomized controlled trial of a natural killer cell stimulant (Biobran MGN-3) in chronic fatigue syndrome
Previous research has suggested that natural killer (NK) cell activity may be reduced in patients with chronic fatigue syndrome (CFS). To evaluate the effectiveness of a putative NK cell stimulant, BioBran MGN-3, in reducing fatigue in CFS patients. Randomized, double-blind, placebo-controlled trial...
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| Veröffentlicht in: | QJM : An International Journal of Medicine 2006-07, Vol.99 (7), p.461-468 |
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| container_title | QJM : An International Journal of Medicine |
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| creator | MCDERMOTT, C RICHARDS, S. C. M THOMAS, P. W MONTGOMERY, J LEWITH, G |
| description | Previous research has suggested that natural killer (NK) cell activity may be reduced in patients with chronic fatigue syndrome (CFS).
To evaluate the effectiveness of a putative NK cell stimulant, BioBran MGN-3, in reducing fatigue in CFS patients.
Randomized, double-blind, placebo-controlled trial.
We recruited 71 patients with CFS (according to the Centers for Disease Control 1994 criteria) attending an out-patient specialist CFS service. Participants were given oral BioBran MGN-3 for 8 weeks (2 g three times per day) or placebo equivalent. The primary outcome measure was the Chalder physical fatigue score. Self-reported fatigue measures, self-assessment of improvement, change in key symptoms, quality of life, anxiety and depression measures were also included.
Data were complete in 64/71 patients. Both groups showed marked improvement over the study duration, but without significant differences. Mean improvement in the Chalder fatigue score (physical scale) was 0.3 (95%CI -2.6 to 3.2) lower in the BioBran group.
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. |
| doi_str_mv | 10.1093/qjmed/hcl063 |
| format | Article |
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To evaluate the effectiveness of a putative NK cell stimulant, BioBran MGN-3, in reducing fatigue in CFS patients.
Randomized, double-blind, placebo-controlled trial.
We recruited 71 patients with CFS (according to the Centers for Disease Control 1994 criteria) attending an out-patient specialist CFS service. Participants were given oral BioBran MGN-3 for 8 weeks (2 g three times per day) or placebo equivalent. The primary outcome measure was the Chalder physical fatigue score. Self-reported fatigue measures, self-assessment of improvement, change in key symptoms, quality of life, anxiety and depression measures were also included.
Data were complete in 64/71 patients. Both groups showed marked improvement over the study duration, but without significant differences. Mean improvement in the Chalder fatigue score (physical scale) was 0.3 (95%CI -2.6 to 3.2) lower in the BioBran group.
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.</description><identifier>ISSN: 1460-2725</identifier><identifier>EISSN: 1460-2393</identifier><identifier>DOI: 10.1093/qjmed/hcl063</identifier><identifier>PMID: 16809351</identifier><language>eng</language><publisher>Oxford: Oxford University Press</publisher><subject>Adult ; Biological and medical sciences ; Chronic fatigue syndrome ; Double-Blind Method ; England ; Fatigue Syndrome, Chronic - complications ; Fatigue Syndrome, Chronic - drug therapy ; Female ; General aspects ; Humans ; Killer Cells, Natural - drug effects ; Male ; Medical sciences ; Mental Disorders - complications ; Polysaccharides - therapeutic use ; Quality of Life ; Self Disclosure ; Treatment Outcome ; Xylans - therapeutic use</subject><ispartof>QJM : An International Journal of Medicine, 2006-07, Vol.99 (7), p.461-468</ispartof><rights>2006 INIST-CNRS</rights><rights>Copyright Oxford University Press(England) Jul 2006</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c443t-7c15f89fd430a670a1a1c08cac1663b793f423f24d770d6a5a33df051eb66b503</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=17984090$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/16809351$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>MCDERMOTT, C</creatorcontrib><creatorcontrib>RICHARDS, S. C. M</creatorcontrib><creatorcontrib>THOMAS, P. W</creatorcontrib><creatorcontrib>MONTGOMERY, J</creatorcontrib><creatorcontrib>LEWITH, G</creatorcontrib><title>A placebo-controlled, double-blind, randomized controlled trial of a natural killer cell stimulant (Biobran MGN-3) in chronic fatigue syndrome</title><title>QJM : An International Journal of Medicine</title><addtitle>QJM</addtitle><description>Previous research has suggested that natural killer (NK) cell activity may be reduced in patients with chronic fatigue syndrome (CFS).
To evaluate the effectiveness of a putative NK cell stimulant, BioBran MGN-3, in reducing fatigue in CFS patients.
Randomized, double-blind, placebo-controlled trial.
We recruited 71 patients with CFS (according to the Centers for Disease Control 1994 criteria) attending an out-patient specialist CFS service. Participants were given oral BioBran MGN-3 for 8 weeks (2 g three times per day) or placebo equivalent. The primary outcome measure was the Chalder physical fatigue score. Self-reported fatigue measures, self-assessment of improvement, change in key symptoms, quality of life, anxiety and depression measures were also included.
Data were complete in 64/71 patients. Both groups showed marked improvement over the study duration, but without significant differences. Mean improvement in the Chalder fatigue score (physical scale) was 0.3 (95%CI -2.6 to 3.2) lower in the BioBran group.
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.</description><subject>Adult</subject><subject>Biological and medical sciences</subject><subject>Chronic fatigue syndrome</subject><subject>Double-Blind Method</subject><subject>England</subject><subject>Fatigue Syndrome, Chronic - complications</subject><subject>Fatigue Syndrome, Chronic - drug therapy</subject><subject>Female</subject><subject>General aspects</subject><subject>Humans</subject><subject>Killer Cells, Natural - drug effects</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Mental Disorders - complications</subject><subject>Polysaccharides - therapeutic use</subject><subject>Quality of Life</subject><subject>Self Disclosure</subject><subject>Treatment Outcome</subject><subject>Xylans - therapeutic use</subject><issn>1460-2725</issn><issn>1460-2393</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2006</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqF0UtPFTEYBuDGSATRnWvTmGAwYaSd3maWSABNUDe6nnzTi_TYaQ_tzAJ_BL_ZHs9BEjeuenv69fIi9IqS95T07PR2NVlzeqMDkewJOqBckqZlPXv60Fet2EfPS1kRQrji3TO0T2VXtwp6gO7P8DqAtmNqdIpzTiFYc4JNWsZgmzH4WEcZokmT_2UNfkR4zh4CTg4DjjAvuQ5--rqSsbYh4DL7aQkQZ3z8waex1sCfr7407B32EeubnKLX2MHsfywWl7tocprsC7TnIBT7ctceou-XF9_OPzbXX68-nZ9dN5pzNjdKU-G63hnOCEhFgALVpNOgqZRsVD1zvGWu5UYpYiQIYMw4IqgdpRwFYYfo7bbuOqfbxZZ5mHzZXBuiTUsZZCcZE0L-F7ZE9fU4WuGbf-AqLTnWRwxt2wveSdFVdLJFOqdSsnXDOvsJ8t1AybBJc_iT5rBNs_LXu5rLuJn-i3fxVXC0A1A0BFc_Wfvy6FTfcdIT9htXhamk</recordid><startdate>20060701</startdate><enddate>20060701</enddate><creator>MCDERMOTT, C</creator><creator>RICHARDS, S. C. M</creator><creator>THOMAS, P. W</creator><creator>MONTGOMERY, J</creator><creator>LEWITH, G</creator><general>Oxford University Press</general><general>Oxford Publishing Limited (England)</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>K9.</scope><scope>7T5</scope><scope>H94</scope><scope>7X8</scope></search><sort><creationdate>20060701</creationdate><title>A placebo-controlled, double-blind, randomized controlled trial of a natural killer cell stimulant (Biobran MGN-3) in chronic fatigue syndrome</title><author>MCDERMOTT, C ; RICHARDS, S. C. M ; THOMAS, P. W ; MONTGOMERY, J ; LEWITH, G</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c443t-7c15f89fd430a670a1a1c08cac1663b793f423f24d770d6a5a33df051eb66b503</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2006</creationdate><topic>Adult</topic><topic>Biological and medical sciences</topic><topic>Chronic fatigue syndrome</topic><topic>Double-Blind Method</topic><topic>England</topic><topic>Fatigue Syndrome, Chronic - complications</topic><topic>Fatigue Syndrome, Chronic - drug therapy</topic><topic>Female</topic><topic>General aspects</topic><topic>Humans</topic><topic>Killer Cells, Natural - drug effects</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Mental Disorders - complications</topic><topic>Polysaccharides - therapeutic use</topic><topic>Quality of Life</topic><topic>Self Disclosure</topic><topic>Treatment Outcome</topic><topic>Xylans - therapeutic use</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>MCDERMOTT, C</creatorcontrib><creatorcontrib>RICHARDS, S. C. M</creatorcontrib><creatorcontrib>THOMAS, P. W</creatorcontrib><creatorcontrib>MONTGOMERY, J</creatorcontrib><creatorcontrib>LEWITH, G</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Immunology Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>QJM : An International Journal of Medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>MCDERMOTT, C</au><au>RICHARDS, S. C. M</au><au>THOMAS, P. W</au><au>MONTGOMERY, J</au><au>LEWITH, G</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A placebo-controlled, double-blind, randomized controlled trial of a natural killer cell stimulant (Biobran MGN-3) in chronic fatigue syndrome</atitle><jtitle>QJM : An International Journal of Medicine</jtitle><addtitle>QJM</addtitle><date>2006-07-01</date><risdate>2006</risdate><volume>99</volume><issue>7</issue><spage>461</spage><epage>468</epage><pages>461-468</pages><issn>1460-2725</issn><eissn>1460-2393</eissn><abstract>Previous research has suggested that natural killer (NK) cell activity may be reduced in patients with chronic fatigue syndrome (CFS).
To evaluate the effectiveness of a putative NK cell stimulant, BioBran MGN-3, in reducing fatigue in CFS patients.
Randomized, double-blind, placebo-controlled trial.
We recruited 71 patients with CFS (according to the Centers for Disease Control 1994 criteria) attending an out-patient specialist CFS service. Participants were given oral BioBran MGN-3 for 8 weeks (2 g three times per day) or placebo equivalent. The primary outcome measure was the Chalder physical fatigue score. Self-reported fatigue measures, self-assessment of improvement, change in key symptoms, quality of life, anxiety and depression measures were also included.
Data were complete in 64/71 patients. Both groups showed marked improvement over the study duration, but without significant differences. Mean improvement in the Chalder fatigue score (physical scale) was 0.3 (95%CI -2.6 to 3.2) lower in the BioBran group.
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.</abstract><cop>Oxford</cop><pub>Oxford University Press</pub><pmid>16809351</pmid><doi>10.1093/qjmed/hcl063</doi><tpages>8</tpages></addata></record> |
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| source | Oxford University Press Journals All Titles (1996-Current); MEDLINE; EZB-FREE-00999 freely available EZB journals |
| subjects | Adult Biological and medical sciences Chronic fatigue syndrome Double-Blind Method England Fatigue Syndrome, Chronic - complications Fatigue Syndrome, Chronic - drug therapy Female General aspects Humans Killer Cells, Natural - drug effects Male Medical sciences Mental Disorders - complications Polysaccharides - therapeutic use Quality of Life Self Disclosure Treatment Outcome Xylans - therapeutic use |
| title | A placebo-controlled, double-blind, randomized controlled trial of a natural killer cell stimulant (Biobran MGN-3) in chronic fatigue syndrome |
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