Description
Colostrum is the milk secreted by mammals within the first few days after giving birth. Colostrum preparations used in CAM most often stem from cows and are marketed as powder or capsules for oral intake as dietary products. Colostrum contains high concentrations of immunoglobulins (particularly IgG), cytokines, growth factors, lactoferrin and other proteins, which play an important role for passive immunity of the offspring and act as immunomodulators.
Intake of bovine colostrum products are claimed to modulate the human immune system, alleviate inflammatory diseases and their symptoms and act against cancer cells in humans.
Efficacy
Supportive palliative care
Chemotherapy-induced-toxicity: No difference was observed in one RCT (n=62) between bovine colostrum and placebo for neutropenic fever, need for intravenous antibiotics, or incidence of bacteraemia in children with ALL. Peak severity of oral mucositis was significantly reduced by colostrum compared with placebo (moderate-certainty evidence).
Candida albicans infection after allogenic stem cell transplantation: Inconclusive evidence from one case series (n= 59) (very low-certainty evidence).
Antitumour treatment: Survival/remission: There is no evidence from one case series (n=17) that colostrum acts against cancer (very low-certainty evidence).
Safety
In general, bovine colostrum is considered safe and well tolerated. Reported adverse events are mainly gastrointestinal, e.g. bloating. The published studies with cancer patients report no or very minor adverse effects or interactions. People who are allergic to dairy products should not take colostrum preparations and only pasteurized products should be used.
Description and background
Colostrum is the milk secreted by mammals within the first few days after giving birth. It is naturally high in nutritious and physiologically active components such as immunoglobulins, growth factors, hormones, and lactoferrins. (Mehra 2022; Rathe 2014) In the context of CAM, bovine colostrum is usually used but colostrum from other sources including human colostrum have also been used.
The use of colostrum as part of nutrition and for health promotion has a long tradition in diverse cultures, including Western scientific medicine (Lewison 1960). No data could be identified how many cancer patients use colostrum but several companies market colostrum dietary products.
Ingredients and quality issues
Colostrum contains high concentrations of immunoglobulins (IgG, IgM, IgA), cytokines (interleukin 1beta, interleukin-6, tumour necrosis factor alpha, interferon gamma), growth factors (insuline-like growth factors I and II, transforming growth factor-beta, epidermal growth factor), lactoperoxidase, and lactoferrin (Inoue 1998; Arslan 2021). Bioactivity is influenced by breed, herd, milking times, and formulation. (Rathe 2014; Mehra 2022) Bovine colostrum is often standardized to immunoglobulin content. (NMD 2022)
Non-pasteurized animal colostrum as milk product may contain infectious germs and their trading and manufacturing is regulated by hygiene standards. Human colostrum may transmit HIV and cytomegalovirus (Playford 2000).
Alleged indications
The different constituents of colostrum have been ascribed immunomodulatory, antimicrobial and anti-inflammatory effects in humans (Guberti 2021; Mehra 2022). Colostrum has therefore been marketed for a wide range of indications, especially colitis, (Khan 2002) diarrhoea and other gastrointestinal disorders, (Playford 2000), infections, recovery after surgery, prevention of gastrointestinal side effects of drugs, treatment of different rheumatic pain syndromes and exercise performance. (Kelly 2003; Arslan 2021; Bagwe-Parab 2020).
In supportive cancer care, it has been used to alleviate therapy-associated adverse effects in particular those associated with an inflammation of the gastrointestinal tract or to support the immune system. Use for anticancer treatment has also been reported. (Guberti 2021; Rathe 2014)
Application and dosage
Preparations of colostrum, predominantly from bovine sources, are marketed as dietary supplements for oral intake in the form of powder or capsules. The optimal dosage and duration of bovine colostrum supplementation have not been established. (NMD 2022) Manufacturers of colostrum products recommend an average daily dosage of 1 to 2 g per day; however, studies with healthy volunteers/athletes doses have used doses as high as 10-60g. (Guberti 2021)
Mechanisms of action
An RCT healthy athletes reported that oral intake of colostrum modulated the human immune system and led to higher concentrations of cytotoxic/suppressor T cells and IgG after intensive training periods (Shing 2007). In vitro studies suggest bovine colostrum may exhibit anti-inflammatory properties (Shing 2011) by inhibiting the NFkappaB activation and cyclooxygenase-2 expression. (An 2009; Alsayed 2022). An anti-proliferative effect of oral bovine lactoferrin has been found in an animal study in rats (Masuda 2000) and in in-vitro studies in human cancer cells. (Tokuyama 1989; Alsayed 2022)
Legal issues
Bovine and goat colostrum are available as dietary supplements. In the US, hyperimmune bovine colostrum has received orphan status for the treatment of AIDS-related diarrhoea. (FDA 2022; Kelly 2008)
For fresh colostrum, regulations differ between European countries. Some countries prohibit trading of colostrum for human nutrition, while it is allowed in other countries if special hygiene regulations are followed.
Only one randomized controlled trial (RCT) is available which assessed the effects of colostrum on chemotherapy-induced toxicity in childhood acute lymphoblastic leukaemia. For survival and other outcomes only three case series are available.
Supportive palliative care
- Chemotherapy-induced-toxicity: One RCT in children with ALL (n=62) reports no difference between bovine colostrum and placebo for neutropenic fever, need for intravenous antibiotics, or incidence of bacteraemia. Peak severity of oral mucositis was significantly reduced by colostrum compared with placebo (moderate-certainty evidence).
- Infection with Candida albicans: Results from one case series (n= 59) of colostrum administration after allogenic stem cell transplantation do not allow any conclusions: (very low-certainty evidence).
Antitumour treatment
Survival/remission: There is no evidence from one case series (n=17) that colostrum has antineoplastic effects (very low-certainty evidence).
Description of included studies
Supportive care
Chemotherapy-induced toxicity
A double-blind, placebo-controlled RCT (n=62) investigated the effect of bovine colostrum supplementation on infectious complications (i.e. fever, infectious morbidity, need for antibiorics) and mucosal toxicity during induction treatment for childhood acute lymphoblastic leukaemia (ALL) (Rathe 2020). Children with newly diagnosed ALL were randomized to receive a daily colostrum or placebo supplement during 4 weeks of induction treatment. No differences were found for the primary outcome days with fever. No difference was observed for neutropenic fever, need for intravenous antibiotics, or incidence of bacteraemia. Although the differences in severity of mucositis between the 2 groups at each time point were not significant, patients in the placebo group had significantly higher peak NCI-oral mucositis scores than patients receiving the colostrum product (P = 0.02).
Infection reduction
A case series (n=59) investigated the use of a bovine immunoglobulin product (IgG) that was concentrated from the colostrum of cows immunized with killed Candida albicans germs (Tollemar 1999). Out of 59 bone marrow transplant recipients, 19 received orally 10 g of the colostrum concentrate as dissolved powder containing 4.2 g of IgG. The product was given from day 4 before bone marrow transplantation to day 28 after transplantation. Ten of the IgG-treated patients showed a high level of Candida colonization as evaluated in mouth wash prior to colostrum administration. In 7 of these 10 patients, a reduction in colonization burden was seen during colostrum treatment. This case series did not evaluate the intended clinical effect of this putative prophylactic measure against invasive candida infections, i.e. the reduction of these infections.
Graft-versus-host disease
Inoue and colleagues (1998) reported on a case series with 9 patients suffering from severe graft-versus-host-disease (GvHD) after bone marrow transplantation (Inoue 1998). Patients received 20 ml of human colostrum for 5 consecutive days. Clinical stage of GvHD improved in 6 patients, notably GvHD of the gut (from grade 4 to grade 0-4).
Antitumour treatment
Survival
The earliest identifiable study is a case series conducted in 1960 (Lewison 1960). Seventeen women with advanced breast cancer received 1.1 litre of bovine colostrum per day for periods between 5 and 595 days. All patients were in a palliative or preterminal treatment situation without further options of conventional cancer therapy. Eleven of them received colostrum from cows that were injected with a homogenate of human breast cancer tissue in the udder. At the end of the observation period, two patients were alive and 15 had died. In no patient a remission of the cancer disease was seen. Ten patients reported periods of subjective improvement. Study authors evaluated their attempt of “passive immunization therapy” with bovine colostrum as “unsuccessful”.
Adverse events
Colostrum is generally well tolerated and seems to be associated with few adverse events which are mild and transient.
In cancer patients no adverse effects were reported in the above-mentioned RCT (Rathe 2020) and case series (Lewison 1060; Tollemar 1999).
A SR published in 2014 included 51 studies of colostrum with a total of 2,326 participants (any population). Six studies reported mild and transient adverse such as unpleasant taste, nausea, flatulence, diarrhoea, skin rash, and unspecified abdominal discomfort. (Rathe 2014) Nine studies specifically reported an absence of adverse effects, the remaining studies did not report on safety. Similar results have been reported by a 2021 SR of bovine colostrum applications for any health condition or in healthy individuals, which included 24 RCTs and 4 observational studies (Guberti 2021). Only few included safety as an outcome measure but those that did reported either no (n=4) or mild (n=2) adverse events.
In a study with Alzheimer patients, in 30% of the 33 participants neuropsychological effects (anxiety, speech flow disturbances or insomnia) were observed during the first 3 to 4 days after commencement of colostrum intake (Leszek 2002).
Contraindications
Patients with allergies to dairy products should not use colostrum.
Interactions
No interactions with drugs have been reported.
Warnings
No data are available for the use of colostrum in pregnant or lactating women.
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Citation
Wider B, CAM Cancer Collaboration. Colostrum [online document], Feb 28, 2023.
Document history
Updated in February 2023 by Barbara Wider. Assessed as up to date in January 2019, February 2017, April 2016, January 2015 and September 2013 by Barbara Wider. Summary first published in September 2012, authored by Gabriele Dennert. Next update due in January 2026.
