Systematic review of breastfeeding and herbs.

OBJECTIVES: Despite popular and historical use, there has been little modern research conducted to determine the safety and efficacy of herb use during breastfeeding. The purpose of this study was to systematically review the clinical literature on herbal medicine and lactation. METHODS: The databases PubMed, CAB Abstracts, Cochrane Central Register of Controlled Trials, HealthSTAR, Cumulative Index to Nursing and Allied Health Literature, and Reprotox were systematically searched for human trials from 1970 until 2010. Reference lists from relevant articles were hand-searched. RESULTS: Thirty-two studies met the inclusion criteria. Clinical studies were divided into three categories: survey studies (n=11), safety studies (n=8), and efficacy studies (n=13). Six studies were randomized controlled trials. The most common herbs studied were St. John's wort (Hypericum perforatum L.) (n=3), garlic (Allium sativum L.) extract (n=2), and senna (Cassia senna L.) (n=2). Studies were very heterogeneous with regard to study design, herbal intervention, and outcome measures. Overall, poor methodological quality predominated among the studies. CONCLUSIONS: Our review concludes that further research is needed to assess the prevalence, efficacy, and safety of commonly used herbs during breastfeeding.

Nutritional supplements and their effect on glucose control.

As diabetes mellitus (DM) continues to be a growing health concern, many people have been turning to natural health products (NHPs) in order to manage this condition, adjunctive to, or even in place of conventional therapies. In order to keep up with this trend, research focussing on the efficacy and mechanisms behind the most common NHPs has been growing amongst the scientific community. The purpose of this chapter is to search and compile scientific literature focussing on the most commonly used NHPs in diabetes treatment, so to educate health professionals on the efficacy, safety and dosage of these products. From our findings, it is apparent that there are promising results from many studies on the potential benefit of NHPs in the treatment of diabetes. Nonetheless, many of the herbs and single nutraceuticals still require further studies in order to confirm safety, dosage and potential interactions with standard conventional therapies. Soluble fibre, alpha lipoic acid, milk thistle, prickly pear cactus and pycnogenol appear to be the most beneficial in the treatment of diabetes.

Nutritional supplements and their effect on glucose control.

Type 2 diabetes is a growing health concern. The use of nutritional supplements by patients with type 2 diabetes is estimated at somewhere between 8% to 49%. The objective of this review was to search the scientific literature for advances in the treatment and prevention of type 2 diabetes with nutritional supplements. Twelve databases were searched with a focus on extracting studies published in the past 3 years. The following nutritional supplements were identified as potentially beneficial for type 2 diabetes treatment or prevention: vitamins C and E, α-lipoic acid, melatonin, red mold, emodin from Aloe vera and Rheum officinale, astragalus, and cassia cinnamon. Beta-carotene was shown to be ineffective in the prevention of type 2 diabetes. Ranging from preclinical to clinical, there is evidence that nutritional supplements may be beneficial in the treatment or prevention of type 2 diabetes. Health providers should investigate drug-nutritional supplement interactions prior to treatment.

Herbal medicines and pregnancy.

The prevalence of herbal medicine use during pregnancy is between 7% and 55%, depending upon the geographic area surveyed and the surveyed group's socio-cultural aspects and ethnicity. Why are women taking natural health products (NHPs) in pregnancy? Women who learn they are pregnant are concerned about the safety of their fetus and may turn to NHPs rather than prescription medication. Use of NHPs in pregnancy is an area where more research is needed. The importance of knowing about these products is to understand their potential dangers in women of childbearing age, particularly when it is known that they are trying to conceive. Information on select NHPs is provided in this presentation.

Astragalus-containing Chinese herbal combinations for advanced non-small-cell lung cancer: a meta-analysis of 65 clinical trials enrolling 4751 patients.

BACKGROUND: Non-small-cell lung cancer (NSCLC) is a leading cause of death. Interventions to reduce mortality in patients with NSCLC represent a patient-important field of research. Little is known about interventions used outside the Western world for NSCLC. One intervention widely used in Asia is astragalus-based herbal preparations. METHODS: We conducted a comprehensive systematic review of all published randomized clinical trials (RCTs) evaluating astragalus-based herbal preparations in NSCLC patients. We searched independently, in duplicate, 6 English language electronic databases and 2 Chinese-language databases. We abstracted data independently, in duplicate on studies reporting of methods, survival outcomes, tumor responses, and performance score responses. We applied a random-effects meta-analysis and report outcomes as relative risks (RR) with 95% confidence intervals (CIs). RESULTS: We included 65 RCTs enrolling 4751 patients. All trials included the herbal preparations plus platinum-based chemotherapy versus chemotherapy alone. We pooled 7 studies (n = 529) reporting on survival at 6 months and found a pooled RR of 0.54 (95% CI, 0.45 to 0.65, P ≤ 0.0001). We included 20 trials (n = 1520) on survival at 12 months and found a pooled RR of 0.65 (95% CI, 0.54 to 0.79, P ≤ 0.0001). This effect was consistent at 24 and 36 months. When we applied a composite endpoint of any tumor treatment response, we pooled data from 57 trials and found a pooled RR of 1.35 in favor of herbal treatment (95% CI, 1.26 to 1.44, P ≤ 0.0001). Statistical heterogeneity was low across trials. LIMITATIONS: The quality of reporting the RCTs was generally poor. There is also reason to believe that studies reported as randomized may not be. CONCLUSIONS: We found a large treatment effect of adding astragalus-based herbal treatment to standard chemotherapy regimens. There is a pressing need for validation of these findings in well-conducted RCTs in a Western setting.

Traditional Chinese Medicines in the treatment of hepatocellular cancers: a systematic review and meta-analysis.

BACKGROUND: Liver cancer is a common malignancy with a high mortality rate. Given the poor prognosis associated with this cancer, many patients seek additional therapies that may improve quality of life or survival. Several Traditional Chinese Medicines (TCM) have been evaluated in clinical trials, but little is known about them outside of China. METHODS: We searched independently and in duplicate 8 electronic databases, including 2 Chinese language databases, until February 2009. We included any randomized clinical trials (RCT) evaluating a TCM oral preparation for the treatment of hepatocellular cancers. We abstracted data on survival, tumor response, and performance scores. We conducted a random-effects meta-analysis and applied a meta-regression analysis. RESULTS: We included 45 RCTs (n = 3,236). All studies employed an active control group. In general, the reporting of methodological issues was poor. We analyzed data from 37 trials reporting on complete response effects score (Relative Risk [RR] of 1.26 (95 CI, 1.04-1.52, P = 0.01, I2 = 0%, P = 0.99). Products containing ginseng, astragalus and mylabris had a larger treatment effect (OR 1.34, 95% CI, 1.04-1.71, P = 0.01) than the pooled broad estimate, also the case for astragalus-based treatments (OR 1.35, 95% CI, 1.001-1.80. P = 0.048). We examined survival rates and pooled 15 studies reporting on 6 month outcomes (RR 1.10, 95% CI, 1.04-1.15, P = < 0.0001, I2 = 0%, P = 0.60). This effect was consistent at other prospective dates, including 12 months (22 trials, RR 1.26, 95% CI, 1.17-1.36, P = < 0.0001, I2 = 7%, P = 0.36), 24 months (15 trials, 1.72, 95% CI, 1.40-2.03, P = < 0.0001, I2 = 0%, P = 0.75); and, at 36 months (8 trials, RR 2.40, 95% CI, 1.65-3.49, P = < 0.0001, I2 = 0%, P = 0.62). LIMITATIONS: All included trials were conducted in China where emerging evidence suggests many RCTs are not, in fact, randomized. Publication bias may exist, favouring positive reports. CONCLUSION: Our meta-analysis displays compelling evidence of effectiveness for hepatocellular cancers that should be evaluated in high-quality and transparent clinical trials.

Probiotic safety in pregnancy: a systematic review and meta-analysis of randomized controlled trials of Lactobacillus, Bifidobacterium, and Saccharomyces spp.

Our objective in this study was to review systematically the evidence for safety of Lactobacillus, Bifidobacterium and Saccharomyces spp. during pregnancy and to conduct a meta-analysis of randomized controlled trials (RCTs). Eleven databases were searched from inception to September 2007 for RCTs of probiotic use during pregnancy. Two independent reviewers searched databases. Random-effects models combined data. Eleven studies on Lactobacillus and/or Bifidobacterium examined 1505 patients for four outcomes with no data heterogeneity; no miscarriage data were reported. Five studies reported Caesarean section outcomes (OR 0.88; 95% CI 0.65 to 1.19). Six studies reported birth weight (weighted difference 45 g; 95% CI -181 to 271). Three studies reported gestational age (weighted difference 0.4 weeks; 95%CI -0.4 to 1.2). No malformations were reported in the probiotic group. No RCTs were available for Saccharomyces during pregnancy. Lactobacillus and Bifidobacterium had no effect on the incidence of Caesarean section, birth weight, or gestational age. The safety of Saccharomyces during pregnancy is unknown.

MotherNature: establishing a Canadian research network for natural health products (NHPs) during pregnancy and lactation.

BACKGROUND: It has been estimated that between 7% and 55% of expectant mothers use herbal medicines or other types of natural health products (NHPs). Unfortunately, the safety and efficacy of NHPs during pregnancy and lactation is largely unknown. The Motherisk Program, at the Hospital for Sick Children, Toronto, Ontario, Canada, the is the major Canadian group to counsel and monitor outcomes of women using medications or NHPs, or of women exposed to chemicals, radiation or infection during pregnancy and lactation. OBJECTIVE: To create a network for research on NHPs during pregnancy and lactation by forming longstanding collaborations among Canadian medical and complementary and alternative medicine (CAM) practitioners and scientists. METHODOLOGY: MotherNature Network members participated in three 2-day workshops and three conference calls throughout the length of this study. Each member was responsible to lead discussions surrounding one theme and address the following: initiation; development; presentation; and synthesis of comments of all members on the designated theme. RESULTS: We prioritized areas in high need for future research and collaborative means to conduct such research. NHPs were prioritized for their importance for future study. Areas for the prospective collection of data on NHP use in pregnancy and lactation were identified. A research and business plan was developed for the long-term sustainability of the Network. CONCLUSIONS: The MotherNature Network is well-situated to create a new climate in Canada, where data are collected and interpreted on the effects and safety of NHPs during pregnancy and lactation.

Safety and efficacy of blue cohosh (Caulophyllum thalictroides) during pregnancy and lactation.

BACKGROUND: There is a lack of basic knowledge on the part of both clinicians and patients as to the indications for use and safety of herbal medicines in pregnancy and lactation. This is one article in a series that systematically reviews the evidence for commonly used herbs during pregnancy and lactation. OBJECTIVES: To systematically review the literature for evidence on the use, safety and pharmacology of blue cohosh, focusing on issues pertaining to pregnancy and lactation. METHODS: We searched 7 electronic databases and compiled data according to the grade of evidence found. RESULTS: According to a survey of midwives in the United States, approximately 64% of midwives reported using blue cohosh as a labour-inducing aid. There are three case reports in the scientific literature that blue cohosh taken at the time of delivery may cause; 1) perinatal stroke, 2) acute myocardial infarction, profound congestive heart failure and shock and 3) severe multi-organ hypoxic injury. There is one case report that blue cohosh possesses abortifacient properties. There is in vitro evidence that blue cohosh may have teratogenic, embryotoxic and oxytoxic effects. In lactation, the safety of blue cohosh is unknown. CONCLUSIONS: Based on the available scientific information, blue cohosh should; 1) be used with extreme caution during pregnancy, 2) be used only under medical professional supervision and 3) not be available to the public as an over-the-counter product. There is an urgent need to conduct a retrospective or prospective cohort study of midwifes using blue cohosh in order to determine its safety. Key words: Blue cohosh, caulophyllum thalictroides, pregnancy, lactation, breastfeeding, systematic review.

Safety and efficacy of cranberry (vaccinium macrocarpon) during pregnancy and lactation.

BACKGROUND: There is a lack of basic knowledge on the part of both clinicians and patients as to the indications for use and safety of herbs used during pregnancy and lactation. This is one article in a series that systematically reviews the evidence for herbs commonly used during pregnancy and lactation. OBJECTIVES: To systematically review the literature for evidence on the use, safety and pharmacology of cranberry, focusing on issues pertaining to pregnancy and lactation. METHODS: We searched 7 electronic databases and compiled data according to the grade of evidence found. RESULTS: There is no direct evidence of safety or harm to the mother or fetus as a result of consuming cranberry during pregnancy. Indirectly, there is good scientific evidence that cranberry may be of minimal risk, where a survey of 400 pregnant women did not uncover any adverse events when cranberry was regularly consumed. In lactation, the safety or harm of cranberry is unknown. CONCLUSIONS: Women experience urinary tract infections with greater frequency during pregnancy. Given the evidence to support the use of cranberry for urinary tract infections (UTIs) and its safety profile, cranberry supplementation as fruit or fruit juice may be a valuable therapeutic choice in the treatment of UTIs during pregnancy.

Safety and efficacy of chastetree (Vitex agnus-castus) during pregnancy and lactation.

BACKGROUND: There is a lack of basic knowledge on the part of both clinicians and patients as to the indications for use and safety of herbs used during pregnancy and lactation. This is one article in a series that systematically reviews the evidence for herbs commonly used during pregnancy and lactation. OBJECTIVES: To systematically review the literature for evidence on the use, safety and pharmacology of chastetree, focusing on issues pertaining to pregnancy and lactation. METHODS: We searched 7 electronic databases and compiled data according to the grade of evidence found. RESULTS In pregnancy, there is poor evidence based on theoretical and expert opinion and in vitro studies that chastetree may have estrogenic and progesteronic activity, uterine stimulant activity, emmenagogue activity and prevent miscarriages. In lactation, theoretical and expert opinion conflict as to whether chastetree increases or decreases lactation. CONCLUSIONS: Given its relatively common use amongst women of childbearing age, it is likely that some women may consume chastetree while unknowingly pregnant. Complementary and alternative medicine, midwifery and medical practitioners should be aware of this fact when prescribing chastetree to women of childbearing age, particularly when the patient is planning a family. Key words: Chastetree, vitex agnus-castus, pregnancy, lactation, breastfeeding, systematic review.

Safety and efficacy of panax ginseng during pregnancy and lactation.

BACKGROUND: There is a lack of basic knowledge on the part of both clinicians and patients as to the indications for use and the safety of herbs used by women during pregnancy and lactation. This is one article in a series that systematically reviews the evidence for herbs commonly used during pregnancy and lactation. OBJECTIVES: To systematically review the literature for evidence on the use, safety and pharmacology of Panax ginseng, focusing on issues pertaining to pregnancy and lactation. METHODS: We searched 7 electronic databases and compiled data according to the grade of evidence that was found. RESULTS: Based on strong scientific evidence from a cohort study, Panax ginseng was not associated with adverse effects when used during pregnancy. Panax ginseng was misreported in the literature as causing androgenization, when, in fact, the case reported was due to an adulterant. There is in vitro evidence of teratogenicity with exposure to ginsenosides; however, this evidence is derived from animal embryos and is based on exposure to isolated ginsenosides at much higher levels than achievable through normal consumption in humans. There is also conflicting evidence as to whether or not Panax ginseng has estrogenic properties. In lactation, there are no human studies on the safety of Panax ginseng, only in vitro evidence based on three animal studies reporting minimal risk. CONCLUSIONS: Panax ginseng should be consumed with caution during pregnancy, especially during the first trimester, and during lactation. Key words: Panax ginseng, asian ginseng, ginseng, pregnancy, lactation, breastfeeding, systematic review.

From type 2 diabetes to antioxidant activity: a systematic review of the safety and efficacy of common and cassia cinnamon bark.

Common (Cinnamomum verum, C. zeylanicum) and cassia (C. aromaticum) cinnamon have a long history of use as spices and flavouring agents. A number of pharmacological and clinical effects have been observed with their use. The objective of this study was to systematically review the scientific literature for preclinical and clinical evidence of safety, efficacy, and pharmacological activity of common and cassia cinnamon. Using the principles of evidence-based practice, we searched 9 electronic databases and compiled data according to the grade of evidence found. One pharmacological study on antioxidant activity and 7 clinical studies on various medical conditions were reported in the scientific literature including type 2 diabetes (3), Helicobacter pylori infection (1), activation of olfactory cortex of the brain (1), oral candidiasis in HIV (1), and chronic salmonellosis (1). Two of 3 randomized clinical trials on type 2 diabetes provided strong scientific evidence that cassia cinnamon demonstrates a therapeutic effect in reducing fasting blood glucose by 10.3%-29%; the third clinical trial did not observe this effect. Cassia cinnamon, however, did not have an effect at lowering glycosylated hemoglobin (HbA1c). One randomized clinical trial reported that cassia cinnamon lowered total cholesterol, low-density lipoprotein cholesterol, and triglycerides; the other 2 trials, however, did not observe this effect. There was good scientific evidence that a species of cinnamon was not effective at eradicating H. pylori infection. Common cinnamon showed weak to very weak evidence of efficacy in treating oral candidiasis in HIV patients and chronic salmonellosis.

Safety and efficacy of black cohosh (Cimicifuga racemosa) during pregnancy and lactation.

BACKGROUND: There is a lack of basic knowledge on the part of both clinicians and patients as to the indications for use and safety of herbal medicines in pregnancy and lactation. This is one article in a series that systematically reviews the evidence for commonly used herbs during pregnancy and lactation. OBJECTIVES: To systematically review the literature for evidence on the use, safety, and pharmacology of black cohosh focusing on issues pertaining to pregnancy and lactation. METHODS: We searched 7 electronic databases and compiled data according to the grade of evidence found. RESULTS: Black cohosh, alone or in combination with other medicinal herbs as "mother's cordial", has a long traditional use and is frequently used by midwives as a uterine stimulant and labour-inducing aid. Low-level evidence based on theory and expert opinion shows the following concerns with respect to black cohosh use during pregnancy: 1) labour-inducing effects, 2) hormonal effects, 3) emmenagogue properties and, 4) anovulatory effects. During lactation, there is low-level evidence from theoretical and expert opinion of black cohosh having hormonal properties. CONCLUSIONS: Black cohosh should be used with caution during pregnancy, particularly during the first trimester where its purported labour-inducing effects could be of concern, and during lactation. Black cohosh should undergo rigorous high quality human studies to determine its safety in pregnancy and lactation.

Safety and efficacy of echinacea (Echinacea angustafolia, e. purpurea and e. pallida) during pregnancy and lactation.

BACKGROUND: There is a lack of basic knowledge on the part of both clinicians and patients as to the indications for use and safety of herbal medicines used in pregnancy and lactation. This is one article in a series that systematically reviews the evidence for commonly used herbs during pregnancy and lactation. OBJECTIVES: To systematically review the literature for evidence on the use, safety, and pharmacology of echinacea focusing on issues pertaining to pregnancy and lactation. METHODS: We searched 7 electronic databases and compiled data according to the grade of evidence found. RESULTS: There is good scientific evidence from a prospective cohort study that oral consumption of echinacea during the first trimester does not increase the risk for major malformations. Low-level evidence based on expert opinion shows that oral consumption of echinacea in recommended doses is safe for use during pregnancy and lactation. CONCLUSIONS: Echinacea is non-teratogenic when used during pregnancy. Caution with using Echinacea during lactation until further high quality human studies can determine its safety.

Safety and efficacy of St. John's wort (hypericum) during pregnancy and lactation.

BACKGROUND: There is a lack of basic knowledge on the part of both clinicians and patients as to the indications for use and safety of herbal medicines in pregnancy and lactation. This is one article in a series that systematically reviews the evidence for commonly used herbs during pregnancy and lactation. OBJECTIVES: To systematically review the literature for evidence on the use, safety, and pharmacology of St. John's wort focusing on issues pertaining to pregnancy and lactation. METHODS: We searched 7 electronic databases and compiled data according to the grade of evidence found. RESULTS: There is very weak scientific evidence based on a case report that St Johns wort is of minimal risk when taken during pregnancy. There is in vitro evidence from animal studies that St John's wort during pregnancy does not affect cognitive development nor cause long-term behavioral defects, but may lower offspring birth weight. There is weak scientific evidence that St. John's wort use during lactation does not affect maternal milk production nor affect infant weight, but, in a few cases, may cause colic, drowsiness or lethargy. There is weak scientific evidence that St John's wort induces CYP450 enzymes, which may lower serum medication levels below therapeutic range; this may be of concern when administering medications during pregnancy and lactation. CONCLUSIONS: Caution is warranted with the use of St John's wort during pregnancy until further high quality human research is conducted to determine its safety. St John's wort use during lactation appears to be of minimal risk, but may cause side effects. Caution is warranted when using medications along with St John's wort.

Safety and efficacy of ginkgo (Ginkgo biloba) during pregnancy and lactation.

BACKGROUND: There is a lack of basic knowledge on the part of both clinicians and patients as to the indications for use and safety of herbal medicines used in pregnancy and lactation. This is one article in a series that systematically reviews the evidence for commonly used herbs during pregnancy and lactation. OBJECTIVES: To systematically review the literature for evidence on the use, safety, and pharmacology of ginkgo focusing on issues pertaining to pregnancy and lactation. METHODS: We searched 7 electronic databases and compiled data according to the grade of evidence found. RESULTS: There is some very weak scientific evidence from animal and in vitro studies that ginkgo leaf has antiplatelet activity, which may be of concern during labour as ginkgo use could prolong bleeding time. Low-level evidence based on expert opinion shows that ginkgo leaf may be an emmenagogue and have hormonal properties. The safety of ginkgo leaf during lactation is unknown. Patients and clinicians should be aware of past reports of ginkgo products being adulterated with colchicine. CONCLUSIONS: Ginkgo should be used with caution during pregnancy, particularly around labour where its anti-platelet properties could prolong bleeding time. During lactation the safety of ginkgo leaf is unknown and should be avoided until high quality human studies are conducted to prove its safety.