Cathi Dennehy

Milk thistle for the treatment of liver disease: A systematic review and meta-analysis

PURPOSE Milk thistle, an herbal compound, is the dietary supplement taken most frequently by patients with chronic liver disease. We performed a systematic review of the literature to determine the efficacy and safety of this herb for the treatment of liver disease. METHODS We searched English and non-English reports through July 1999 using thirteen databases and reference lists, and contacting manufacturers and technical experts. Reviewers independently screened all reports to identify randomized placebo-controlled trials that evaluated milk thistle for the treatment of liver disease. Outcomes of primary interest included mortality, histological findings on liver biopsy specimens, serum aminotransferase and albumin levels, and prothrombin times. RESULTS Fourteen trials met inclusion criteria. Four trials reported outcomes for mortality among 433 participants. The overall summary odds ratio for mortality in the milk thistle group compared with placebo was 0.8 (95% confidence interval [CI]: 0.5 to 1.5; P = 0.6). Three trials assessed histology on liver biopsy; study quality was inversely associated with the likelihood of histological benefit for milk thistle compared with placebo. There were no differences in serum alanine aminotransferase, aspartate aminotransferase, or albumin levels, or prothrombin times, among participants assigned to milk thistle compared with those assigned to placebo. The only statistically significant difference was a greater reduction in alanine aminotransferase levels among patients with chronic liver disease assigned to milk thistle (-9 IU/L, 95% CI: -18 to -1 IU/L; P = 0.05), but this reduction was of negligible clinical importance and no longer statistically significant after limiting analyses to studies of longer duration or of higher quality. The frequency of adverse effects was low and, in clinical trials, indistinguishable from placebo. CONCLUSION Treatment with milk thistle appears to be safe and well tolerated. We found no reduction in mortality, in improvements in histology at liver biopsy, or in biochemical markers of liver function among patients with chronic liver disease. Data are too limited to exclude a substantial benefit or harm of milk thistle on mortality, and also to support recommending this herbal compound for the treatment of liver disease.

Clinical studyMilk thistle for the treatment of liver disease: A systematic review and meta-analysis☆

PURPOSE Milk thistle, an herbal compound, is the dietary supplement taken most frequently by patients with chronic liver disease. We performed a systematic review of the literature to determine the efficacy and safety of this herb for the treatment of liver disease. METHODS We searched English and non-English reports through July 1999 using thirteen databases and reference lists, and contacting manufacturers and technical experts. Reviewers independently screened all reports to identify randomized placebo-controlled trials that evaluated milk thistle for the treatment of liver disease. Outcomes of primary interest included mortality, histological findings on liver biopsy specimens, serum aminotransferase and albumin levels, and prothrombin times. RESULTS Fourteen trials met inclusion criteria. Four trials reported outcomes for mortality among 433 participants. The overall summary odds ratio for mortality in the milk thistle group compared with placebo was 0.8 (95% confidence interval [CI]: 0.5 to 1.5; P = 0.6). Three trials assessed histology on liver biopsy; study quality was inversely associated with the likelihood of histological benefit for milk thistle compared with placebo. There were no differences in serum alanine aminotransferase, aspartate aminotransferase, or albumin levels, or prothrombin times, among participants assigned to milk thistle compared with those assigned to placebo. The only statistically significant difference was a greater reduction in alanine aminotransferase levels among patients with chronic liver disease assigned to milk thistle (-9 IU/L, 95% CI: -18 to -1 IU/L; P = 0.05), but this reduction was of negligible clinical importance and no longer statistically significant after limiting analyses to studies of longer duration or of higher quality. The frequency of adverse effects was low and, in clinical trials, indistinguishable from placebo. CONCLUSION Treatment with milk thistle appears to be safe and well tolerated. We found no reduction in mortality, in improvements in histology at liver biopsy, or in biochemical markers of liver function among patients with chronic liver disease. Data are too limited to exclude a substantial benefit or harm of milk thistle on mortality, and also to support recommending this herbal compound for the treatment of liver disease.

A simple in vitro model to study the release kinetics of liposome encapsulated material

A simple in vitro model was developed to study the release kinetics of liposome encapsulated material in the presence of biologic components. Liposomes were embedded in an agarose gel (bottom layer) formed in a glass vial and separated from the receptor compartment buffer by a second layer of agarose gel (top layer). To follow the release of liposomal contents, aqueous space markers differing in molecular weight (from 205 Dalton to 17500 Dalton) were encapsulated. The isotonic buffer in the receptor was completely changed at various time points and the amount of marker released from the agarose matrix containing the liposomes into the receptor medium determined. The release of non-encapsulated markers from the gel followed a time0.5 relationship with about 75% of a 17500 Dalton protein being released from the matrix in 48 h. In the same period, about 7% of the intact liposomes added to the agarose gel appeared in the receptor phase. The release of calcein from various liposome compositions including: (A) egg phosphatidylcholine (EPC)/egg phosphatidylglycerol (EPG) 9:1, (B) dioleoylphosphatidylethanolamine (DOPE)/cholesterylhemisuccinate (CHEMS) 2:1, and (C) dioleoylphosphatidylglycerol (DOPC)/dioleoylphosphatidylglycerol (DOPG) 2:1 was measured. Components of the biological milieu such as serum proteins and calcium influenced release of encapsulated material. This in vitro model is a convenient and reproducible system that permits the study of the release of high molecular weight molecules such as proteins from liposomal formulations in the presence of serum. It may find applications with respect to release of proteins from a variety of colloidal drug delivery systems.

Dietary supplement use among menopausal women attending a San Francisco health conference.

ObjectiveThis study examined the usage patterns of dietary supplements during menopause, providing information about type, prevalence, and rationale for use. MethodsA survey instrument was distributed to self-identified peri- or postmenopausal women at a San Francisco womens health conference in March 2000. ResultsOf the 100 eligible women, 29% used hormone replacement therapy (HRT) alone, 16% used HRT with dietary supplements (Combo group), 32% used dietary supplements alone, and 13% used no product or used supplements excluded in this survey. The most common dietary supplements were soy (29%), ginkgo biloba (16%), and black cohosh (10%). Only 54% of women using dietary supplements reported such usage to their primary care providers. Women using HRT alone reported relief of hot flashes significantly more often than those using dietary supplements alone (63% vs. 30%;p = 0.016). Women using combination therapy reported enhanced improvement in vaginal dryness, libido, and mood compared with those using HRT alone. Perceived quality of life and overall control of menopausal symptoms were highest among women using dietary supplements alone and women using combination therapy, respectively. Satisfaction with menopausal counseling from a primary care provider was significantly greater in women receiving HRT alone (p = 0.02) and combination therapy (p = 0.006) compared with women receiving dietary supplements alone. ConclusionsDietary supplements were frequently used during menopause. Combined use of dietary supplements and HRT seemed to be associated with enhanced relief of certain menopausal symptoms. Women using dietary supplements alone seemed particularly dissatisfied with the menopausal counseling provided by a primary care provider.

A review of select vitamins and minerals used by postmenopausal women.

OBJECTIVES The purpose of this review is to summarize the effectiveness of select vitamins, minerals and trace elements in postmenopausal women for their effects on bone health, cardiovascular health, breast cancer, cognition and vasomotor symptoms. METHODS Review of the relevant literature and results from recent clinical studies, as well as critical analyses of published systematic reviews and meta-analyses were obtained from PubMed and Cochrane Library of Reviews. Vitamin A, the B vitamins, vitamin C, calcium, vitamin D, vitamin E, vitamin K, magnesium, selenium and zinc were selected for review. In circumstances where the vitamin, mineral or trace element has not been studied for a given condition, no information was provided. RESULTS AND DISCUSSION All vitamins, minerals and trace elements play an important role in maintaining health and wellbeing among menopausal women. Adequate dietary intake is essential and supplementation should be considered in women with documented malabsorption syndromes or deficiencies. Based on a review of the literature, supplementation with vitamin C, D, K and calcium can also be recommended for proper maintenance of bone health. The only supplement studied for vasomotor symptoms was vitamin E and this vitamin lacked clinical support. Supplementation in healthy postmenopausal women with vitamins and minerals in diet or pill forms cannot be recommended currently for any other indications.

Emergency Department Management of Pediatric Asthma at a University Teaching Hospital

Background: Asthma is a major health problem and the most frequent cause of chronic illness and emergency department (ED) visits in children. Limited data examining the ED management of pediatric asthma within university teaching hospitals across the US exist. Objective: To compare the ED management of children (aged 1–17 y) with asthma at a university teaching hospital using National Asthma Education and Prevention Program (NAEPP) guidelines. Methods: All cases of pediatric asthma that presented to the University ot California, San Francisco, Medical Center ED between October 1, 2003, and October 31, 2004, were included. Patients who required hospital admission were excluded. Data pertaining to patient demographics, primary diagnosis, pharmacologic management, diagnostic tests performed, and follow-up plans were abstracted and compared with NAEPP guidelines issued in 1997 and updated topics released in 2002. Results: A total of 141 cases were Identified. Mean patient age was 5.8 years. Most (61.7%) patients were male and of African American ethnicity (31.9%). Asthma severity was typically mild (66.7%) or moderate (29.1%). In persons at least 6 years of age (n = 58), peak expiratory flow rate (PEFR) was performed in 25.9% of cases. Pulse oximetry, however, was always performed. Based on NAEPP guidelines, β-agonists and corticosteroids should have been used, but were not, in 2.8% and 31.9% ot cases, respectively. At discharge, no corticosteroid prescription was given in 40.4% of the cases, no written action plan was prepared in 80.1% of the cases, no formal device training was administered in 67.3% of cases, and no peak flow meter was provided for persons at least 6 years of age in 50.0% of cases. Conclusions: NAEPP guidelines were met in all patients regarding pulse oximetry and in most patients with respect to the use of β-agonists. Improvements could be made, however, in the use of corticosteroids in the ED: in performing PEFR measurements for persons al least 6 years of age upon arrival; and in providing formal device training, a written action plan, prescriptions for steroids, and peak flow meters at discharge.

Horse chestnut:a multidisciplinary clinical review.

Horse chestnut seed extract (HCSE) is widely used in Europe for the management of chronic venous insufficiency (CVI). Although traditionally recommended for a variety of medical conditions, CVI is the only indication for which there is strong supportive scientific evidence. Review of the literature reveals 14 randomized controlled trials, of which seven are methodologically of high quality, albeit limited by small sample sizes and short durations. These studies support the superiority of HCSE over placebo, and suggest equivalence to compression stockings and to oral oxerutins. In the future, a longer and adequately powered randomized trial is warranted to compare HCSE to standard of care, and to further assess safety and long-term efficacy. There are no data to suggest that horse chestnut flower, raw seed, branch bark, or leaf are effective for any indication, and it is recommended that these products not be used, as they are known to be toxic when ingested.

The Use of Herbs by California Midwives

OBJECTIVE To characterize herbal product use (prevalence, types, indications) among Certified Nurse Midwives/Certified Midwives (CNMs/CMs) and Licensed Midwives (LMs) practicing in the state of California and to describe formal education related to herbal products received by midwives during midwifery education. DESIGN/SETTING/PARTICIPANTS Cross-sectional survey/California/Practicing midwives. METHODS A list of LMs and CNMs/CMs practicing in California was obtained through the California Medical Board (CMB) and the American College of Nurse Midwives (ACNM), respectively. The survey was mailed to 343 CNMs/CMs (one third of the ACNM mailing list) and 157 LMs (the complete CMB mailing list). RESULTS Of the 500 surveys mailed, 40 were undeliverable, 146 were returned, and 7 were excluded (30% response rate). Of the 139 completed surveys, 58/102 (57%) of CNMs/CMs and 35/37 (95%) of LMs used herbs, and LMs were more comfortable than CNMs/CMs in recommending herbs to their patients. A majority of LMs had >20 hours of midwifery education on herbs whereas a majority of CNMs/CMs received 0 to 5 hours. Some CNMs/CMs indicated that their practice site limited their ability to use herbs. Common conditions in which LMs and CNMs/CMs used herbs were nausea/vomiting (86% vs. 83%), labor induction (89% vs. 58%), and lactation (86% vs. 65%). Specific herbs for all indications are described. CONCLUSION Licensed midwives were more likely than CNMs/CMs to use herbs in clinical practice. This trend was likely a reflection of the amount of education devoted to herbs as well as herbal use limitations that may be encountered in institutional facilities.

Characterizing Adverse Events Reported to the California Poison Control System on Herbal Remedies and Dietary Supplements

Objective: The purpose of this study was to (1) characterize the pSopulation who uses and reports adverse events to the California Poison Control System (CPCS) related to herbal remedies (HR) and dietary supplements (DS), (2) to assess whether adverse drug reactions (ADRs) occur within the usual recommended dosing, and (3) to describe the nature of adverse events. Methods: A retrospective search of HR and DS related calls was conducted between 1997 and June 1998. Data collection included the demographics of callers, types of exposures, substances involved, amounts ingested and severity. Results: Of the 918 HR and DS calls received, 259 (28.2%) were drug information queries, 599 (65.3%) were exposures, and 60 (6.5%) were excluded. Exposures occurred most often in pediatric patients 324 (54.1%), but exposures resulting in ADRs occurred most often in adults at recommended doses. There were 233 ADRs, of which 67 (28.8%) occurred in children. The most common products involved in ADRs were zinc (38.2%), echinacea (7.7%), chromium picolinate (6.4%) and witch hazel (6%). Severity of ADRs required no treatment or was minor in a majority of cases, but may have contributed to hospitalization in three. Conclusion: Children were involved in a majority of exposure calls to the CPCS involving HR and DS. Adults, however, were more likely to develop an ADR from these products due to intentional exposure. Overall, the ADRs caused by HR and DS were mild, could be managed at home and rarely resulted in a severe outcome or other sequelae. Products involved in ADRs were consistent with the most common HR and DS products used by adult U.S. consumers.

Omega-3 Fatty Acids and Ginger in Maternal Health: Pharmacology, Efficacy, and Safety

Dietary supplements may be used by pregnant women if they perceive them to be natural and healthy products, if they are fearful of using prescription drugs, or if they are recommended by a health care provider. Usage surveys indicate that midwives feel comfortable in recommending some herbal products to their patients. There are sufficient data from randomized controlled trials on omega-3 fatty acids and ginger that their pharmacologic properties, efficacy, and safety data for specific indications in maternal health can be evaluated. Requests for information regarding these substances are likely to be encountered by health care providers who care for pregnant women. Omega-3 fatty acids benefit gestation, infant vision, and neurodevelopment, while effects on major depression in pregnancy and postpartum depression are less clear. Ginger is efficacious for nausea and vomiting in pregnancy but is limited in its safety data. Pharmacologic properties of each supplement and pathophysiology related to each indication are reviewed. It is recommended that pregnant and lactating women be advised to take an omega-3 fatty acid supplement daily, while the recommendation to use ginger is tentative and will likely be based on each practitioners comfort level with the safety data that are presented.