Fermented Wheat Germ Extract

Our assessments of evidence for each medical benefit fall into one of these categories:

• Strong evidence: consistent, significant effects in several large (or at least one very large) well designed clinical studies or at least two meta-analysesa statistical analysis that combines the results of two or more research studies; the results of smaller research studies addressing the same or similar questions can be analyzed as though they are one bigger, more powerful study of clinical studies of moderate or better quality (or one large meta-analysis) finding similar results
• Good evidence: significant effects in one large or several mid-sized and well-designed clinical studies ( randomized controlled trialsa study design in which people are randomly assigned to either an experimental group or a control group to compare the outcomes from different treatments; an RCT is considered a strong design for determining a therapy’s effects with an appropriate placebo or other strong comparison control or observational studies that control for confounds)
• Modest evidence: significant effects in at least three small but well-designed randomized controlled trials (RCTs), or one or more well-designed, mid-sized clinical studies of reasonably good quality (RCTs or observationala type of study in which individuals are observed or certain outcomes are measured, but no attempt is made to affect the outcome (for example, no treatment is given); an example is a study that records people’s diets, but doesn’t try to alter their diets, and looks for patterns of disease or other outcomes related to different foods studies), or several small studies aggregated into a meta-analysis
• Preliminary evidence: significant effects in small or poorly designed clinical studies OR conflicting results in adequate studies but a preponderance of evidence of an effect
• Weak evidence: one or more case studies, supported by animal evidence OR small treatment effects of limited clinical significance OR studies with no controls OR weak trends of effects
• Insufficient evidence: preclinical evidence only OR clinical studies with such poor or unclear methodology that no conclusion can be drawn OR conflicting findings across clinical studies with no preponderance of evidence in one direction; conflicting evidence occurs when studies find conflicting effects (positive effect vs no effect or negative effect) with the same treatment and the same general study population (same cancer type, for example)

• Fewer episodes of febrile neutropenia during chemotherapy among children with cancer treated with FWGE compared to controls in a small controlled triala study design in which people are assigned to either an experimental group or a control group to compare the outcomes from different treatment; assignment is not random, and so this is not as strong a study design as a randomized controlled trial, but still stronger than an uncontrolled trial⁶Garami M, Schuler D et al. Fermented wheat germ extract reduces chemotherapy-induced febrile neutropenia in pediatric cancer patients. Journal of Pediatric Hematology/Oncology. 2004 Oct;26(10):631-5.

• Fewer wasting (cachectic) symptoms during treatment for oral cancer among people treated with FWGE compared to baseline in a small uncontrolled triala study in which a therapy is used, but without a comparison group against which to judge outcomes; an uncontrolled trial is considered a weak study design⁷Boros LG, Nichelatti M, Shoenfeld Y. Fermented wheat germ extract (Avemar) in the treatment of cancer and autoimmune diseases. Annals of the New York Academy of Sciences. 2005 Jun;1051:529-42.

• Less fatigue during chemotherapy and/or radiotherapy among people with breast cancer or lung cancer treated with FWGE compared to baseline in small uncontrolled trialsa study in which a therapy is used, but without a comparison group against which to judge outcomes; an uncontrolled trial is considered a weak study design⁸Boros LG, Nichelatti M, Shoenfeld Y. Fermented wheat germ extract (Avemar) in the treatment of cancer and autoimmune diseases. Annals of the New York Academy of Sciences. 2005 Jun;1051:529-42.

• Less nausea, vomiting, and constipation among people with breast cancer treated with FWGE compared to baseline in a small uncontrolled triala study in which a therapy is used, but without a comparison group against which to judge outcomes; an uncontrolled trial is considered a weak study design⁹Boros LG, Nichelatti M, Shoenfeld Y. Fermented wheat germ extract (Avemar) in the treatment of cancer and autoimmune diseases. Annals of the New York Academy of Sciences. 2005 Jun;1051:529-42.

• Higher ratings of quality of life during conventional therapy among people with head and neck cancer treated with FWGE compared to conventional therapy alone  in a small controlled triala study design in which people are assigned to either an experimental group or a control group to compare the outcomes from different treatment; assignment is not random, and so this is not as strong a study design as a randomized controlled trial, but still stronger than an uncontrolled trial¹⁰Sukkar SG, Cella F et al. A multicentric prospective open trial on the quality of life and oxidative stress in patients affected by advanced head and neck cancer treated with a new benzoquinone-rich product derived from fermented wheat germ (Avemar). Mediterranean Journal of Nutrition and Metabolism. 2008;1:37–42.
• Higher ratings of quality of life after chemo/radiotherapy among people with lung cancer treated with FWGE compared to controls in a small uncontrolled triala study in which a therapy is used, but without a comparison group against which to judge outcomes; an uncontrolled trial is considered a weak study design¹¹Boros LG, Nichelatti M, Shoenfeld Y. Fermented wheat germ extract (Avemar) in the treatment of cancer and autoimmune diseases. Annals of the New York Academy of Sciences. 2005 Jun;1051:529-42.
• Better physical function, emotional function and global state of health among people with breast cancer treated with FWGE compared to controls in a small uncontrolled trial¹²Boros LG, Nichelatti M, Shoenfeld Y. Fermented wheat germ extract (Avemar) in the treatment of cancer and autoimmune diseases. Annals of the New York Academy of Sciences. 2005 Jun;1051:529-42.

• Less insomnia among people with breast cancer treated with FWGE compared to baseline in a small uncontrolled triala study in which a therapy is used, but without a comparison group to judge outcomes against; an uncontrolled trial is considered a weak study design¹³Boros LG, Nichelatti M, Shoenfeld Y. Fermented wheat germ extract (Avemar) in the treatment of cancer and autoimmune diseases. Annals of the New York Academy of Sciences. 2005 Jun;1051:529-42.

• Lower risk of colorectal cancer recurrence after radical surgery among people treated with standard anticancer therapies and FWGE compared to standard therapies alone in a mid-sized controlled triala study design in which people are assigned to either an experimental group or a control group to compare the outcomes from different treatment; assignment is not random, and so this is not as strong a study design as a randomized controlled trial, but still stronger than an uncontrolled trial¹⁴Jakab F, Shoenfeld Y et al. A medical nutriment has supportive value in the treatment of colorectal cancer. British Journal of Cancer. 2003 Aug 4;89(3):465-9.

• Substantially less recurrence among people with oral cancer treated with standard treatment and FWGE compared to standard treatment alone in a small controlled triala study design in which people are assigned to either an experimental group or a control group to compare the outcomes from different treatment; assignment is not random, and so this is not as strong a study design as a randomized controlled trial, but still stronger than an uncontrolled trial¹⁵Boros LG, Nichelatti M, Shoenfeld Y. Fermented wheat germ extract (Avemar) in the treatment of cancer and autoimmune diseases. Annals of the New York Academy of Sciences. 2005 Jun;1051:529-42.