Herbal Science Research - clinical trial

[...] Ratanhia-based herbal oral care products for the prophylaxis of oral mucositis in cancer chemotherapy patients: a clinical

Site Editor — Fri, 02 Nov 2007 15:47:21 -0700

Administration of Ratanhia-based herbal oral care products for the prophylaxis of oral mucositis in cancer chemotherapy patients: a clinical trial.: Evid Based Complement Alternat Med. 2007 Sep; 4(3): 361-6 Tiemann P, Toelg M, Ramos F MH

Oral complications are a common side effect of cancer chemotherapy, as antineoplastic agents affect both the immune system and the oral mucosa. This study demonstrates preventive and therapeutic effects of dental treatment and regular use of Weleda Ratanhia-Mundwasser((R)) (herbal mouthwash) and Weleda Pflanzen-Zahngel((R)) (herbal toothgel) on oral mucositis during chemotherapy. Thirty-two female patients with breast cancer starting on chemotherapy were evaluated in this study. Plaque index, gingival index, degree of mucositis and 10 single symptoms were monitored once weekly for four consecutive weeks. After four weeks, plaque and gingival indexes were slightly decreased compared to baseline values. The degree of mucositis was increased by one grade in 15.6 % of the patients and over 70 % remained without symptoms. On the whole, single symptoms decreased from day 7 since beginning of chemotherapy to day 28. Mucositis symptoms were moderate in severity, and the results indicate a positive influence of using Weleda Ratanhia-Mundwasser and Weleda Pflanzen-Zahngel. Further studies might be promising.

Ginkgo biloba extract improves coronary blood flow in patients with coronary artery disease [...]

Site Editor — Fri, 02 Nov 2007 05:48:03 -0700

Ginkgo biloba extract improves coronary blood flow in patients with coronary artery disease: role of endothelium-dependent vasodilation.: Planta Med. 2007 Jun;73(7):624-8 Authors: Wu Y, Li S, Cui W, Zu X, Wang F, Du J

Ginkgo biloba extract (GBE) has well-documented cardioprotective effects on coronary flow and positive effects on vasodilation through endothelium-derived nitric oxide in experimental animals, but these impacts in patients with coronary artery disease (CAD) have not yet been investigated. We designed this study to test the effects of GBE on distal left anterior descending coronary artery (LAD) blood flow and endothelium-dependent brachial artery flow-mediated dilation (FMD) in patients with CAD. Eighty CAD patients were randomly assigned to either GBE or saline (control) groups. LAD blood flow and brachial artery FMD were measured non-invasively using high-resolution ultrasound before and after intravenous administration of GBE or saline. GBE significantly increased LAD blood flow in maximal diastolic peak velocity (MDPV), maximal systolic peak velocity (MSPV) and diastolic time velocity integral (DTVI) compared with the control group (16.14 +/- 10.93 % vs. 0.28 +/- 2.14 %, 9.14 +/- 8.23 % vs. 0.79 +/- 2.56 %, and 15.23 +/- 7.28 % vs. 0.42 +/- 2.43 %, respectively, p < 0.01). Brachial artery FMD was also increased by 69.75 % (from 3.95 +/- 1.49 % to 6.55 +/- 2.51 %, p < 0.01). A linear correlation was found between the percentage changes in MDPV, MSPV, or DTVI of LAD blood flow and the percentage change in brachial artery FMD following treatment with GBE (r = 0.612, 0.486, or 0.521, respectively, p < 0.01). In summary, our data demonstrate that GBE treatment in CAD patients leads to an increase of LAD blood flow in MDPV, MSPV and DTVI, and the increase response might relate to the improved endothelium-dependent vasodilatory capacity. CAD: coronary artery disease DTVI: diastolic time velocity integral FMD: flow-mediated dilation GBE: GINKGO BILOBA extract LAD: distal left anterior descending coronary artery MDPV: maximal diastolic peak velocity MSPV: maximal systolic peak velocity NO: nitric oxide TTDE: transthoracic Doppler echocardiography.

PMID: 17564952 [PubMed - indexed for MEDLINE]

Effects of warm water sitz bath on symptoms in post-anal sphincterotomy in chronic anal fissure [...]

Site Editor — Mon, 22 Oct 2007 18:21:51 -0700

Effects of warm water sitz bath on symptoms in post-anal sphincterotomy in chronic anal fissure--a randomized and controlled study.: World J Surg. 2007 Jul;31(7):1480-4 Authors: Gupta PJ

BACKGROUND: Sitz bath is frequently recommended by physicians for a variety of anal disorders including anal fissure. The aim of the present study was to determine whether sitz bath does have any therapeutic properties improving upon a patient's postoperative symptoms after a closed lateral sphincterotomy. MATERIALS AND METHODS: Forty-six patients were randomly assigned to receive analgesics and fiber supplement alone (control patients) or a twice-daily sitz bath along with identical fiber and analgesics (sitz bath group). A 24-h pain score--post-defecation anal burning and symptom improvement--was evaluated on a visual analog scale (VAS). RESULTS: The groups were equally matched for age, gender distribution, and duration of disease. No significant difference in mean pain score between groups (p = 0.284) was noticed after one week. However, the patients from the control group experienced significant anal burning compared with patients from sitz bath group (p < 0.0001). The improvement score was higher in the sitz bath group when compared with the control group; however, it did not reached a statistically significant level. CONCLUSIONS: Patients after sphincterotomy for anal fissure receiving sitz bath experienced similar levels of pain when compared with those not receiving sitz bath. However, they reported a significant relief in anal burning and a marginally better satisfaction score and no reported adverse side effects.

PMID: 17534541 [PubMed - indexed for MEDLINE]

[STW 5/Iberogast: multi-target-action for treatment of functional dyspepsia and irritable bowel syndrome]

Site Editor — Sun, 21 Oct 2007 05:52:12 -0700

[STW 5/Iberogast: multi-target-action for treatment of functional dyspepsia and irritable bowel syndrome]: Wien Med Wochenschr. 2007;157(13-14):301-7 Authors: Allescher HD, Wagner H

Functional gastro-intestinal diseases such as functional dyspepsia and irritable bowel syndrome are a therapeutic challenge, as they are not only characterized by a multitude of symptoms, some of them with severe consequences for affected patients, but are also caused by a multitude of factors. The clinical efficacy of the therapeutics STW 5/Iberogast in these diseases has been proven in a number of randomized prospective clinical studies. Several preclinical studies suggest that its efficacy could be due to its complex composition of nine standardized herbal extracts, which act differently on multiple sites. This principle, which is quite popular in clinical medicine, was introduced as a multi-target therapy for functional bowel disorders. Components of STW 5/Iberogast reduce gastro-intestinal hypersensitivity and act spasmolytic on spastic, tonicising on atonic gastro-intestinal muscle. In addition a stimulating effect on reduced mucus-secretion, an inhibitory effect on enhanced gastric acid secretion and an anti-inflammatory effect have been shown. These effects could explain the clinical efficacy of STW5/Iberogast in a large range of symptoms.

PMID: 17704976 [PubMed - indexed for MEDLINE]

Phytodolor--effects and efficacy of a herbal medicine.

Site Editor — Sun, 21 Oct 2007 05:50:54 -0700

Phytodolor--effects and efficacy of a herbal medicine.: Wien Med Wochenschr. 2007;157(13-14):343-7 Authors: Gundermann KJ, Müller J

Herbal antirheumatics are successfully used in painful inflammatory or degenerative rheumatic diseases. One of these herbal medicines is Phytodolor (STW 1), a fixed combination of extracts from aspen leaves and bark (Populus tremula), common ash bark (Fraxinus excelsior), and golden rod herb (Solidago virgaurea). Its effects as well as those of its components have been verified in experimental and human pharmacological investigations. The mode of action of STW 1 includes antiinflammatory, antioedematous, antioxidative and analgesic properties, and it is considered to be broader than that of synthetic antirheumatics. Open clinical studies and randomised, placebo- or verum-controlled double-blind trials, performed in different subtypes of rheumatic diseases, confirm the pharmacological evidence of efficacy, such as by reducing the intake of non-steroidal antiinflammatory drugs (NSAIDs). STW 1 has a high drug safety. CONCLUSION: Phytodolor (STW 1) is a reasonable alternative to NSAIDs and to cyclooxygenase(COX)-2-inhibitors such as rofecoxib.

PMID: 17704984 [PubMed - indexed for MEDLINE]

[...] the effects of naturopathic botanical and dietary interventions on sex steroid hormone metabolism in premenopausal women.

Site Editor — Sun, 14 Oct 2007 01:17:38 -0700

A pilot and feasibility study on the effects of naturopathic botanical and dietary interventions on sex steroid hormone metabolism in premenopausal women.: Cancer Epidemiol Biomarkers Prev. 2007 Aug;16(8):1601-9 Authors: Greenlee H, Atkinson C, Stanczyk FZ, Lampe JW

Naturopathic physicians commonly make dietary and/or dietary supplement recommendations for breast cancer prevention. This placebo-controlled, parallel-arm, pilot study tested the effects of two naturopathic interventions over five menstrual cycles on sex steroid hormones and metabolic markers in 40 healthy premenopausal women. The intervention arms were as follows: combination botanical supplement (Curcuma longa, Cynara scolymus, Rosmarinus officinalis, Schisandra chinensis, Silybum marinum, and Taraxacum officinalis; n = 15), dietary changes (3 servings/d crucifers or dark leafy greens, 30 g/d fiber, 1-2 liters/d water, and limiting caffeine and alcohol consumption to 1 serving each/wk; n = 10), and placebo (n = 15). Early-and late-follicular phase serum samples from cycles 1 and 5 were analyzed for estrogens (estrone, estrone-sulfate, total estradiol, and free estradiol), androgens (dehydroepiandrosterone, dehydroepiandrosterone-sulfate, androstenedione, total testosterone, and free testosterone), sex hormone-binding globulin, and metabolic markers (insulin, insulin-like growth factor-I, insulin-like growth factor binding protein-3, and leptin). Serum samples collected during the mid-luteal phase of cycles 1 and 5 were analyzed for total estradiol, free estradiol, and sex hormone-binding globulin. Urine samples collected during the late follicular phase of cycles 1 and 5 were analyzed for 2-hydroxyestrone and 16alpha-hydroxyestrone. During the early follicular phase, compared with placebo, the botanical supplement decreased dehydroepiandrosterone (-13.2%; P = 0.02), dehydroepiandrosterone-sulfate (-14.6%; P = 0.07), androstenedione (-8.6%; P = 0.05), and estrone-sulfate (-12.0%; P = 0.08). No other trends or statistically significant changes were observed. When comparing dietary changes with placebo, no statistically significant differences were observed. Overall, in this pilot study, the naturopathic interventions had no substantial effects on estrogen measures. Early-follicular phase androgens decreased with the botanical supplement.

PMID: 17684134 [PubMed - indexed for MEDLINE]

[...] complementary and alternative medicine utilization in hypertensive patients attending an urban tertiary care centre [...]

Site Editor — Thu, 04 Oct 2007 05:33:58 -0700

Frequency of complementary and alternative medicine utilization in hypertensive patients attending an urban tertiary care centre in Nigeria.: BMC Complement Altern Med. 2007 Sep 28;7(1):30 Authors: Amira OC, Okubadejo NU

ABSTRACT: BACKGROUND: To study the frequency and pattern of use of complementary and alternative medicine (CAM) in patients with essential hypertension attending a tertiary hypertension clinic. METHODS: Two hundred and twenty-five consecutive hypertensive patients attending the hypertension clinic of the Lagos University Teaching Hospital over a 3-month period were interviewed. Socio-demographic data, duration of hypertension, clinic attendance, current blood pressure, and compliance to conventional medications was documented. CAM utilization was explored using both structured and open-ended questions. RESULTS: There were 90 (40%) male and 135 (60%) female patients with mean age +/- SD overall was 55.1 +/- 12.4years. 88 (39.1%) of the respondents used CAM. Herbal products were the most commonly used CAM type. Amongst the CAM users, the most common herbal product used was garlic (69.3%). Others were native herbs (25%), ginger (23.9%), bitter leaf (Vernonia amygdalina) (9.1%), and aloe vera (4.5%). 2.5% used spiritual therapy. There was no difference in the clinical characteristics, socio-economic status, and blood pressure control of CAM users and non-users. Patients who utilized CAM had higher BMI compared with those who did not, but the difference was not statistically significant (mean BMI +/- SD of 29.1 +/- 5.6 vs 27.1 +/- 5.9 kg/m2; P = 0.05). CONCLUSION: A significant proportion of hypertensive patients attending our tertiary facility and receiving conventional treatment also use CAM therapies. Clinicians need to be aware of this practice, understand the rationale for this health-seeking behaviour, proactively enquire about their use, and counsel patients regarding the potential of some of the therapies for adverse reactions and drug interactions.

PMID: 17903257 [PubMed - as supplied by publisher]

Media portrayal of herbal remedies versus pharmaceutical clinical trials: impacts on decision.

Site Editor — Sun, 30 Sep 2007 02:39:54 -0700

Media portrayal of herbal remedies versus pharmaceutical clinical trials: impacts on decision.: Med Law. 2007 Jun; 26(2): 363-73
Bubela T, Koper M, Boon H, Caulfield T

The use of Complementary and Alternative Medicines (CAM) in Europe and North America is increasing significantly with a concomitant growth in business interest. Users are educated and self-empowered and rely on information sources beyond mainstream medical practitioners. Not surprisingly, media coverage, much of dubious quality, has increased to meet demand for information. Here we present data from a study that explores how knowledge is translated in the socioeconomic-political context of CAM as compared to conventional pharmaceuticals. Specifically, we are interested in the nature of the information provided by clinical trials and the media and how this might impact decision-making regarding the use of CAM versus conventional pharmaceuticals and the reporting of conflicts of interest and industry funding of research. Our results suggest that, in the media, there were significant errors of omission in describing clinical trial quality and a serious under-reporting of risks of herbal remedies. Consumers, who often self-administer CAM are not being provided with information sufficient to make informed choices about treatment alternatives. The next step in the research is to determine whether these reporting dynamics in describing CAM clinical trials differ from those of reporting on pharmaceutical clinical trials.

Cannabis, pain, and sleep: lessons from therapeutic clinical trials of Sativex, a cannabis-based medicine.

Site Editor — Sun, 30 Sep 2007 02:37:02 -0700

Cannabis, pain, and sleep: lessons from therapeutic clinical trials of Sativex, a cannabis-based medicine.: Chem Biodivers. 2007 Aug;4(8):1729-43 Authors: Russo EB, Guy GW, Robson PJ

Cannabis sativa L. has been utilized for treatment of pain and sleep disorders since ancient times. This review examines modern studies on effects of Delta9-tetrahydrocannabinol (THC) and cannabidiol (CBD) on sleep. It goes on to report new information on the effects on sleep in the context of medical treatment of neuropathic pain and symptoms of multiple sclerosis, employing standardized oromucosal cannabis-based medicines containing primarily THC, CBD, or a 1 : 1 combination of the two (Sativex). Sleep-laboratory results indicate a mild activating effect of CBD, and slight residual sedation with THC-predominant extracts. Experience to date with Sativex in numerous Phase I-III studies in 2000 subjects with 1000 patient years of exposure demonstrate marked improvement in subjective sleep parameters in patients with a wide variety of pain conditions including multiple sclerosis, peripheral neuropathic pain, intractable cancer pain, and rheumatoid arthritis, with an acceptable adverse event profile. No tolerance to the benefit of Sativex on pain or sleep, nor need for dosage increases have been noted in safety extension studies of up to four years, wherein 40-50% of subjects attained good or very good sleep quality, a key source of disability in chronic pain syndromes that may contribute to patients' quality of life.

PMID: 17712817 [PubMed - indexed for MEDLINE]

The effect of cinnamon cassia powder in type 2 diabetes mellitus.

Site Editor — Sun, 30 Sep 2007 02:36:09 -0700

The effect of cinnamon cassia powder in type 2 diabetes mellitus.: J Med Assoc Thai. 2006 Sep;89 Suppl 3:S200-5 Authors: Suppapitiporn S, Kanpaksi N, Suppapitiporn S

BACKGROUND: Type 2 diabetes is a chronic metabolic disorder and the incidence of cardiovascular is increased two- to fourfold in its complications. Cinnamon is expected to have some degree of anti-diabetic efficacy without troublesome side effects. The objective of the present study was to investigate the anti-diabetic effect of cinnamon cassia powder in type 2 diabetic patients MATERIAL AND METHOD: Sixty type 2 diabetic patients were randomized either 1.5 g/d of cinnamon cassia powder or placebo. Both groups were in combination with their current treatment (metformin or sulfonylurea) according to single blind randomized, placebo-control trial in a 12-week period. Efficacy was evaluated by HbA1c fasting plasma glucose, Lipid profile, BUN, creatinine, liver function test and adverse effects were recorded. RESULTS: After a 12-week period, HbA1c was decreased similarly in both groups from 8.14% to 7.76% in the cinnamon group and from 8.06% to 7.87% in the placebo group. This was not found statistically significantly different. However the proportion of patients achieving HbA1c < or = 7% was also greater in patients receiving cinnamon compared with patients receiving placebo, nevertheless, it was not found statistically significantly different (35% vs 15%, x2 = 3.14, p > 0.05). No significant intergroup differences were observed in lipid profile, fasting plasma glucose except in SGOT 27.1 (8.75) to 22.1 (5) in cinnamon group and 24.08 (8.5) to 23.63 (8.88) in the placebo group (p = 0.001). CONCLUSION: The cinnamon cassia powder 1.5 g/d did not have any significant difference in reducing fasting plasma glucose, HbA1c and serum lipid profile in type 2 diabetes patients who had mean fasting plasma glucose 154.40 +/- 24.72 mg/dl.

PMID: 17718288 [PubMed - indexed for MEDLINE]

Comparison of the effectiveness of commonly used clinic-based treatments for external genital warts.

Site Editor — Sun, 30 Sep 2007 02:34:33 -0700

Comparison of the effectiveness of commonly used clinic-based treatments for external genital warts.: Int J STD AIDS. 2007 Jun;18(6):365-8 Authors: Sherrard J, Riddell L

We describe a prospective study designed to assess the effectiveness of the commonly used clinic-based treatments for genital warts individually and in combination. Patients presenting with new or recurrent genital warts were randomly allocated to one of five treatments on a weekly basis. The clinical endpoint was wart clearance or eight treatments, whichever occurred sooner. If there was not a good response by the eighth treatment, an alternate modality was offered. Four hundred and nine individuals were enrolled in the study. Almost no patients withdrew in any group due to adverse effects. Three-quarters of patients treated with podophyllin 25% and cryotherapy concurrently required only two treatments to clear their warts. All had clearance in less than eight treatments. Single therapy with either trichloracetic acid or podophyllin 25% resulted in longer time to wart clearance, and more persistent warts.

PMID: 17609022 [PubMed - indexed for MEDLINE]

Gender- and age-related variations in blood viscosity in normal volunteers: [...] Allium sativum and Ginkgo biloba.

Site Editor — Wed, 26 Sep 2007 19:02:32 -0700

Gender- and age-related variations in blood viscosity in normal volunteers: a study of the effects of extract of Allium sativum and Ginkgo biloba.: Phytomedicine. 2007 Aug;14(7-8):447-51 Authors: Galduróz JC, Antunes HK, Santos RF

This study sought to compare the effects of age and gender on blood viscosity and to appraise the effectiveness of Ginkgo biloba and Allium sativum extracts in reducing blood viscosity. Stage 1: Our sample consisted of 80 male volunteers (40 aged 18-60 and 40 aged 61 and over) and 80 females with the same age profile. Stage 2: We studied 60 male volunteers allocated in groups: placebo, G. biloba, and A. sativum. Stage 3: We studied 25 male volunteers and in the initial, intermediate, and final evaluations, the measures of blood viscosity were repeated. Volunteers were given a clinical evaluation and submitted to laboratory tests. G. biloba led to the highest reduction in blood viscosity compared with placebo and A. sativum. In relation to the use of the two substances, G. biloba and A. sativum, dry extract of G. biloba proved to be more effective in reducing blood viscosity.

PMID: 17618098 [PubMed - indexed for MEDLINE]

Ayurvedic and collateral herbal treatments for hyperlipidemia: a systematic review of randomized controlled trials [...]

Site Editor — Sat, 22 Sep 2007 18:05:24 -0700

Ayurvedic and collateral herbal treatments for hyperlipidemia: a systematic review of randomized controlled trials and quasi-experimental designs.: Altern Ther Health Med. 2007 Jul-Aug; 13(4): 22-8 Singh BB, Vinjamury SP, Der-Martirosian C, Kubik E, Mishra LC, Shepard NP, Singh VJ, Meier M, Madhu SG

BACKGROUND: Ischemic heart disease (IHD) is a leading cause of morbidity and mortality in both developing and developed countries. An underlying cause of IHD involves retention and deposit of serum lipids in coronary arteries, decreasing blood flow. Drugs (conventional and herbal) are used to lower levels of serum cholesterol to help prevent IHD. The Ayurvedic medicine pharmacopoeia identified herbs that might contribute to a decrease in cholesterol and therefore reduce the risk of IHD. METHODS: Literature searches were conducted at 3 points: 2003, 2004, and 2007. Databases searched included PubMed, the National Library of Medicine, the National Center for Complementary and Alternative Medicine, Ovid, and EBSCO Information Services, and other search strategies also were used. Each article was assessed for quality by 3 people, and discrepancies were resolved by arbitration using a fourth person, who also read and scored each article. Additional assessments of safety using a scale and determination of reported efficacy/effectiveness of the randomized controlled trials (RCTs) and quasi-experimental designs (QEDs) were made. RESULTS: RCTs generally received high quality scores and improved by decade of publication. More than 50% of garlic, more than 80% of guggul, and 100% of Arjuna RCTs reported product effectiveness. Safety scores did not improve by decade. The QEDs received medium and high quality scores, and 93% of them reported effectiveness. The QEDs had a higher mean score for safety reporting than the RCTs. CONCLUSIONS: Many studies received high quality scores and noted safety information and reported effectiveness or efficacy in a clear manner. This finding was not consistent with other systematic reviews that have found the highest reported efficacy/ effectiveness in studies of poorer quality. Ayurvedic herbs reviewed here should be considered by physicians when trying to manage hyperlipidemia in their patients.

Challenges in the conduct of Thai herbal scientific study: efficacy and safety of phytoestrogen, pueraria mirifica [...]

Site Editor — Sat, 22 Sep 2007 18:02:00 -0700

Challenges in the conduct of Thai herbal scientific study: efficacy and safety of phytoestrogen, pueraria mirifica (Kwao Keur Kao), phase I, in the alleviation of climacteric symptoms in perimenopausal women.: J Med Assoc Thai. 2007 Jul; 90(7): 1274-80 Chandeying V, Lamlertkittikul S

OBJECTIVE: To evaluate the preliminary efficacy and safety of Pueraria mirifica (Kwao Keur Kao), phytoestrogen, for the alleviation of climacteric symptoms. MATERIAL AND METHOD: Perimenopausal women attending with climacteric symptoms, such as hot flushes and night sweats, were invited to join the present study, conducted at the Menopausal Clinic, Hat Yai Regional Hospital. The patients were voluntarily enrolled and randomly received the raw material of Pueraria mirifica, oral 50 and 100 mg capsule, once daily for six months, as an open-label study. RESULTS: Of the 10 enrolled patients, 8 cases were completely evaluated. The modified Greene climacteric scale (MGCS) was satisfactorily decreased in both groups. The average scale declined from 44.1 at baseline, to be 26, 17, and 11.1 at 1-, 3-, and 6- month follow-up respectively. No other laboratory abnormalities, except one case had transiently increased the creatinine level, and one case of increased blood urea nitrogen. The mean serum estradiol was slightly increased, while the mean serum follicle-stimulating hormone (FSH) and luteinizing hormone (LH) were nearly stable. CONCLUSION: Pueraria mirifica is relatively safe and preliminarily alleviates the climacteric symptoms in perimenopausal. women, but the data is insufficient to draw definite conclusions regarding the estrogenic effect.

Media portrayal of herbal remedies versus pharmaceutical clinical trials: impacts on decision.

Site Editor — Sat, 22 Sep 2007 17:59:35 -0700

Media portrayal of herbal remedies versus pharmaceutical clinical trials: impacts on decision.: Med Law. 2007 Jun; 26(2): 363-73 Bubela T, Koper M, Boon H, Caulfield T

The effect of Echinacea purpurea, Astragalus membranaceus and Glycyrrhiza glabra on CD25 expression in humans: a pilot study.

Site Editor — Sat, 22 Sep 2007 17:48:35 -0700

The effect of Echinacea purpurea, Astragalus membranaceus and Glycyrrhiza glabra on CD25 expression in humans: a pilot study.: Phytother Res. 2007 Jul 27;
Zwickey H, Brush J, Iacullo CM, Connelly E, Gregory WL, Soumyanath A, Buresh R

This phase 0, double-blind, repeated within subject, randomized pilot study examined CD25 expression on T cells after ingestion of three commonly used herbs: Echinacea purpurea, Astragalus membranaceus and Glycyrrhiza glabra, administered singly and in combination. CD25 expression on T cells was significantly increased for subjects ingesting Echinacea at 24 h with notable increases in activation from Astragalus and Glycyrrhiza. CD25 expression remains elevated with daily use of Echinacea for at least 7 days. Copyright (c) 2007 John Wiley & Sons, Ltd.

Oral Echinacea purpurea extract in low-grade, steroid-dependent, autoimmune idiopathic uveitis: a pilot study.

Site Editor — Sat, 22 Sep 2007 17:44:14 -0700

Oral Echinacea purpurea extract in low-grade, steroid-dependent, autoimmune idiopathic uveitis: a pilot study.: J Ocul Pharmacol Ther. 2006 Dec; 22(6): 431-6
Neri PG, Stagni E, Filippello M, Camillieri G, Giovannini A, Leggio GM, Drago F

AIM: The aim of to test efficacy and safety of Echinacea purpurea (echinacea) extract in the control of low-grade uveitis. METHODS: Fifty-one (51) patients with low-grade, steroid dependent, autoimmune uveitis were recruited; posterior uveitis was excluded. The start therapy was represented by topical desamethazone for anterior uveitis and oral prednisone, rapidly tapered, for anterior uveitis with inflammatory scores equal to +2 and in all cases of intermediate uveitis. Best-corrected visual acuity (BCVA) decrease or improvement was defined as a reduction or increase of 2 or more letters seen from the initial BCVA; ETDRS chart was used. Thirty-two (32) patients (21 with anterior uveitis and 11 with intermediate uveitis) received Echinacea (150 mg twice/day) as add-on therapy, whereas 20 patients (10 with anterior uveitis and 9 with intermediate uveitis) were treated with the conventional steroid therapy alone. RESULTS: Thirty-one (31) patients showed anterior uveitis and 20 intermediate uveitis. The follow-up duration was 9 months. At the last follow-up, 19/21 patients with anterior uveitis and 9/11 with intermediate uveitis treated with echinacea presented uveitis settled, with a steroid-off time of 209 and 146 days, respectively. BCVA was stable or improved in 19/21 of anterior uveitis and 9/11 of intermediate uveitis. No adverse reactions supposed to be resulting from commercial-grade echinacea were recorded. Patients who did not receive echinacea required a longer treatment period with steroids with a steroid-off time of 121 and 87 days. CONCLUSIONS: Systemic echinacea appears safe and effective in the control of low-grade autoimmune idiopathic uveitis.

Interleukin-1 genotype-selective inhibition of inflammatory mediators by a botanical: a nutrigenetics proof of concept.

Site Editor — Sat, 22 Sep 2007 17:12:00 -0700

Interleukin-1 genotype-selective inhibition of inflammatory mediators by a botanical: a nutrigenetics proof of concept.: Nutrition. 2007 Sep 18; Authors: Kornman K, Rogus J, Roh-Schmidt H, Krempin D, Davies AJ, Grann K, Randolph RK

OBJECTIVE: Although observational studies have shown that genotype may influence nutritional effects on target outcomes, there are few reported studies that stratified subjects by genotype before a nutritional intervention. This proof-of-concept trial determined whether specifically formulated botanical mixtures reduced inflammation in individuals with genetic variations that predispose to overexpression of interleukin-1beta (IL-1beta) and early heart disease. METHODS: Healthy adults with elevated C-reactive protein (CRP) were stratified into genetic groups based on being positive (IL1(Pos)) or negative (IL1(Neg)) for the at-risk IL-1 gene variations. IL1(Pos) (n = 39) and IL1(Neg) (n = 40) subjects were then randomized to the candidate botanical formulation or placebo. The botanical formulation included rose hips, a blueberry and blackberry mixture, and a grapevine extract. RESULTS: At 12 wk of dosing with the botanical formulation, IL-1beta gene expression by stimulated peripheral blood mononuclear cells was significantly lower than at baseline and significantly lower than placebo in IL1(Pos) and IL1(Neg) subjects. Mean IL-1beta gene expression treatment effect over the 12-wk period was greater in IL1(Pos) than in IL1(Neg) subjects. At 12 wk of dosing the botanical mixture produced no mean change in serum CRP levels. However, in IL1(Pos) subjects, significantly more subjects achieved a reduction in CRP with the botanical mixture than with placebo. No CRP effect was observed in the IL1(Neg) subjects. CONCLUSION: This study represents one of a few prospective clinical trials in which genetic variations were shown to differentially influence nutrient effects on outcomes.

PMID: 17884346 [PubMed - as supplied by publisher]

Matched-pair study showed higher quality of placebo-controlled trials in Western phytotherapy than conventional medicine.

Site Editor — Fri, 13 Jul 2007 18:17:56 -0700

Matched-pair study showed higher quality of placebo-controlled trials in Western phytotherapy than conventional medicine.: J Clin Epidemiol. 2007 Aug;60(8):787-94 Authors: Nartey L, Huwiler-Müntener K, Shang A, Liewald K, Jüni P, Egger M

OBJECTIVES: Herbal medicine (phytotherapy) is widely used, but the evidence for its effectiveness is a matter of ongoing debate. We compared the quality and results of trials of Western phytotherapy and conventional medicine. STUDY DESIGN AND SETTING: A random sample of placebo-controlled trials of Western phytotherapy was identified in a comprehensive literature search (19 electronic databases). Conventional medicine trials matched for condition and type of outcome were selected from the Cochrane Central Controlled Trials Register (issue 1, 2003). Data were extracted in duplicate. Trials described as double-blind, with adequate generation of allocation sequence and adequate concealment of allocation were assumed to be of higher methodological quality. RESULTS: Eighty-nine herbal medicine and 89 matched conventional medicine trials were analyzed. Studies of Western herbalism were smaller, less likely to be published in English, and less likely to be indexed in MEDLINE than their counterparts from conventional medicine. Nineteen (21%) herbal and four (5%) conventional medicine trials were of higher quality. In both groups, smaller trials showed more beneficial treatment effects than larger trials. CONCLUSIONS: Our findings challenge the widely held belief that the quality of the evidence on the effectiveness of herbal medicine is generally inferior to the evidence available for conventional medicine.

PMID: 17606174 [PubMed - in process]

Plasma LDL and HDL cholesterol [...] in normo- and hypercholesterolemic humans after intake of different levels of cocoa powder.

Site Editor — Fri, 13 Jul 2007 18:07:22 -0700

Plasma LDL and HDL cholesterol and oxidized LDL concentrations are altered in normo- and hypercholesterolemic humans after intake of different levels of cocoa powder.: J Nutr. 2007 Jun;137(6):1436-41 Authors: Baba S, Natsume M, Yasuda A, Nakamura Y, Tamura T, Osakabe N, Kanegae M, Kondo K

Cocoa powder is rich in polyphenols, such as catechins and procyanidins, and has been shown in a variety of subject models to inhibit oxidized LDL and atherogenesis. Our study evaluated plasma LDL cholesterol and oxidized LDL concentrations following the intake of different levels of cocoa powder (13, 19.5, and 26 g/d) in normocholesterolemic and mildly hypercholesterolemic humans. In this comparative, double-blind study, we examined 160 subjects who ingested either cocoa powder containing low-polyphenolic compounds (placebo-cocoa group) or 3 levels of cocoa powder containing high-polyphenolic compounds (13, 19.5, and 26 g/d for low-, middle-, and high-cocoa groups, respectively) for 4 wk. The test powders were consumed as a beverage after the addition of hot water, twice each day. Blood samples were collected at baseline and 4 wk after intake of the test beverages for the measurement of plasma lipids. Plasma oxidized LDL concentrations decreased in the low-, middle-, and high-cocoa groups compared with baseline. A stratified analysis was performed on 131 subjects who had a LDL cholesterol concentrations of > or =3.23 mmol/L at baseline. In these subjects, plasma LDL cholesterol, oxidized LDL, and apo B concentrations decreased, and the plasma HDL cholesterol concentration increased, relative to baseline in the low-, middle-, and high-cocoa groups. The results suggest that polyphenolic substances derived from cocoa powder may contribute to a reduction in LDL cholesterol, an elevation in HDL cholesterol, and the suppression of oxidized LDL.

PMID: 17513403 [PubMed - indexed for MEDLINE]

[Effect of glucocorticoid with traditional Chinese medicine in severe acute aespiratory syndrome (SARS)]

Site Editor — Fri, 13 Jul 2007 18:01:18 -0700

[Effect of glucocorticoid with traditional Chinese medicine in severe acute respiratory syndrome (SARS)]: Zhongguo Zhong Yao Za Zhi. 2005 Dec;30(23):1874-7 Authors: Liu BY, He LY, Liang ZW, Tong XY, Hu JQ, Jiao Q, Ni Q, Liu XM, Xie YM, Li P, Gao FZ, Wen TC, Liu WM

OBJECTIVE: To evaluate the effects of traditional Chinese medicine in 461 cases of severe acute respiratory syndrome(SARS) on glucocorticoid's dosage. METHOD: By using the polycentric nonrandomized concurrent controled trial and under the condition of glucocorticoid use, the patierts were divided into two groups: the integrated traditional Chinese and western mendicine(ITCWM) and simplicity western mendicine alone(WM). The observation indexes were time in hospital, pneumonia duration, mortality, glucocorticoid's gross dosage, glucocorticoid's average dosage of days and glucocorticoid use time. RESULT: In the ITCWM group, average time in hospital was shortened (P = 0.058), pneumonia duration was shortened (P = 0.057), mortality fell (P = -0.001). The median of glucocorticoid' s gross dosage was 1,277.0 mg x d(-1) in the ITCWM group, and that was 1,680.0 mg x d(-1) in the WM group (P = 0.083). The median of glucocorticoid's average dosage of days was 84.40 mg x d(-1) in the ITCWM group, and that was 115.33 mg x d(-1) in the WM group (P = 0.025). According to the analysis of 461 cases divided by stages and different ponderance, within 7 days after illness, in the ITCWM group, the glucocorticoid' s average dosage decreased. In the common type, the dosage in the ITCWM and in the WM was 146.43 mg x d(-1), and 183.64 mg x d(-1), respectively (P = 0.057), in the severe type, that was 137.71 and 177.86 mg x d(-1), respectively (P = 0.001). CONCLUSION: Compared with the group of simplicity western mendicine, in the group of integratived Chinese and western mendicine, time in hospital shorten, pneumonia duration shorten, mortality fall, simultaneity, glucocorticoid's average dosage is decreased. The use of TCM in the forepart of treatment can be capable of decreasing glucocorticoid's dosage.

PMID: 16499032 [PubMed - indexed for MEDLINE]

Review of Clinical Trials Evaluating Safety and Efficacy of Milk Thistle (Silybum marianum [L.] Gaertn.).

Site Editor — Mon, 11 Jun 2007 05:29:50 -0700

Review of Clinical Trials Evaluating Safety and Efficacy of Milk Thistle (Silybum marianum [L.] Gaertn.).: Integr Cancer Ther. 2007 Jun;6(2):146-57 Authors: Tamayo C, Diamond S

Milk thistle extracts have been used as traditional herbal remedies for almost 2000 years. The extracts are still widely used to protect the liver against toxins and to control chronic liver diseases. Recent experimental and clinical studies suggest that milk thistle extracts also have anticancer, antidiabetic, and cardioprotective effects. This article reviews clinical trials of milk thistle conducted in the past 5 years including pharmacokinetic and toxicity studies, herb-drug interactions, and other safety issues. Several trials have studied the effects of milk thistle for patients with liver diseases, cancer, hepatitis C, HIV, diabetes, and hypercholesterolemia. Promising results have been reported in the protective effect of milk thistle in certain types of cancer, and ongoing trials will provide more evidence about this effect. In addition, new established doses and improvement on the quality and standardization of this herb will provide the much-awaited evidence about the efficacy of milk thistle in the treatment of liver diseases. Milk thistle extracts are known to be safe and well tolerated, and toxic or adverse effects observed in the reviewed clinical trials seem to be minimal. The future of milk thistle research is promising, and high-quality randomized clinical trials on milk thistle versus placebo may be needed to further demonstrate the safety and efficacy of this herb.

[...] Tribulus terrestris [...] on Muscle Strength and Body Composition During Preseason Training in Elite Rugby League Players.

Site Editor — Wed, 30 May 2007 01:14:05 -0700

The Effect of Five Weeks of Tribulus terrestris Supplementation on Muscle Strength and Body Composition During Preseason Training in Elite Rugby League Players.: J Strength Cond Res. 2007 May 1;21(2):348-353 Authors: Rogerson S, Riches CJ, Jennings C, Weatherby RP, Meir RA, Marshall-Gradisnik SM

Rogerson, S., C.J. Riches, C. Jennings, R.P. Weatherby, R.A. Meir, and S.M. Marshall-Gradisnik. The effect of five weeks of Tribulus terrestris supplementation on muscle strength and body composition during preseason training in elite rugby league players. J. Strength Cond. Res. 21(2):348-353. 2007.- Tribulus terrestris is an herbal nutritional supplement that is promoted to produce large gains in strength and lean muscle mass in 5-28 days (15, 18). Although some manufacturers claim T. terrestris will not lead to a positive drug test, others have suggested that T. terrestris may increase the urinary testosterone/epitestosterone (T/E) ratio, which may place athletes at risk of a positive drug test. The purpose of the study was to determine the effect of T. terrestris on strength, fat free mass, and the urinary T/E ratio during 5 weeks of preseason training in elite rugby league players. Twenty-two Australian elite male rugby league players (mean +/- SD; age = 19.8 +/- 2.9 years; weight = 88.0 +/- 9.5 kg) were match-paired and randomly assigned in a double-blind manner to either a T. terrestris (n = 11) or placebo (n = 11) group. All subjects performed structured heavy resistance training as part of the club's preseason preparations. A T. terrestris extract (450 mg.d(-1)) or placebo capsules were consumed once daily for 5 weeks. Muscular strength, body composition, and the urinary T/E ratio were monitored prior to and after supplementation. After 5 weeks of training, strength and fat free mass increased significantly without any between-group differences. No between-group differences were noted in the urinary T/E ratio. It was concluded that T. terrestris did not produce the large gains in strength or lean muscle mass that many manufacturers claim can be experienced within 5-28 days. Furthermore, T. terrestris did not alter the urinary T/E ratio and would not place an athlete at risk of testing positive based on the World Anti-Doping Agency's urinary T/E ratio limit of 4:1.

Phytoestrogens in clinical practice: a review of the literature.

Site Editor — Fri, 25 May 2007 02:31:47 -0700

Phytoestrogens in clinical practice: a review of the literature.: Fertil Steril. 2007 May 8; Authors: Tempfer CB, Bentz EK, Leodolter S, Tscherne G, Reuss F, Cross HS, Huber JC

OBJECTIVE: To review clinical studies assessing the effect of phytoestrogen supplementation on the signs and symptoms of the climacteric syndrome and on the incidence of breast cancer, cardiovascular disease, and skeletal fractures. DESIGN: Literature research using PubMed and the Cochrane controlled trials register. SETTING: None. PATIENT(S): None. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): None. RESULT(S): Six systematic reviews and meta-analyses of 25 randomized, controlled trials (RCTs) assessing the use of phytoestrogens for the treatment of the climacteric syndrome were identified. Systematic reviews of RCTs show contradictory results, and meta-analyses demonstrate no statistically significant reduction of vasomotor symptoms for phytoestrogens. Individual RCTs report significant reductions in vasomotor symptoms for red clover and soy phytoestrogens. In selected patient populations, such as in women with early natural postmenopause and mild to moderate vasomotor symptoms, a systematic review of five RCTs found a significant reduction of hot flashes in five out of five RCTs. Twenty-two case-control and cohort studies examined the incidence of breast cancer among women with and without a diet high in phytoestrogens. A meta-analysis of 21 studies found a significantly reduced incidence of breast cancer among past phytoestrogen users. RCTs document beneficial effects of phytoestrogens on surrogate parameters such as bone mineral density, vasodilation, platelet aggregation, insulin resistance, and serum concentrations of triglycerides, high-density lipoprotein, and low-density lipoprotein. None of the available RCTs documents a protective effect of phytoestrogens for the clinical end points of breast cancer, bone fracture, or cardiovascular events. CONCLUSION(S): Based on the available evidence, phytoestrogens should only be used in selected women, i.e., those presenting with mild to moderate vasomotor symptoms in early natural postmenopause. None of the compounds investigated so far have been proven to protect against breast cancer, bone fracture, or cardiovascular disease.

Passiflora for anxiety disorder.

Site Editor — Fri, 25 May 2007 02:28:55 -0700

Passiflora for anxiety disorder.: Cochrane Database Syst Rev. 2007;(1):CD004518 Authors: Miyasaka LS, Atallah AN, Soares BG

BACKGROUND: Anxiety is a very common mental health problem in the general population and in the primary care setting. Herbal medicines are popularly used worldwide and could be an option for treating anxiety if shown to be effective and safe. Passiflora (passionflower extract) is one of these compounds. OBJECTIVES: To investigate the effectiveness and safety of passiflora for treating any anxiety disorder. SEARCH STRATEGY: The following sources were used: electronic databases: Cochrane Collaboration Depression, Anxiety and Neurosis Cochrane Controlled Trials Register (CCDANCTR-Studies), Medline and Lilacs; Cross-checking references; contact with authors of included studies and manufacturers of passiflora. SELECTION CRITERIA: Relevant randomised and quasi-randomised controlled trials of passiflora using any dose, regime, or method of administration for people with any primary diagnosis of general anxiety disorder, anxiety neurosis, chronic anxiety status or any other mental health disorder in which anxiety is a core symptom (panic disorder, obsessive compulsive disorder, social phobia, agoraphobia, other types of phobia, postraumatic stress disorder). Effectiveness was measured using clinical outcome measures such as Hamilton Anxiety Scale (HAM-A) and other scales for anxiety symptoms. DATA COLLECTION AND ANALYSIS: Two reviewers independently selected the trials found through the search strategy, extracted data, performed the trial quality analyses and entered data. Where any disagreements occured, the third reviewer was consulted. Methodological quality of the trials included in this review was assessed using the criteria described in the Cochrane Handbook. For dichotomous outcomes, relative risk with 95% confidence intervals (CI) were calculated, and for continuous outcomes, weighted mean difference with 95%CI was used. MAIN RESULTS: Two studies, with a total of 198 participants, were eligible for inclusion in this review. Based on one study, a lack of difference in the efficacy of benzodiazepines and passiflora was indicated. Dropout rates were similar between the two interventions. Although the findings from one study suggested an improvement in job performance in favour of passiflora (post-hoc outcome) and one study showed a lower rate of drowsiness as a side effect with passiflora as compared with mexazolam, neither of these findings reached statistical significance. AUTHORS' CONCLUSIONS: RCTs examining the effectiveness of passiflora for anxiety are too few in number to permit any conclusions to be drawn. RCTs with larger samples that compare the effectiveness of passiflora with placebo and other types of medication, including antidepressants, are needed.

A Randomized, Double-Blind, Placebo-Controlled Trial of Lessertia frutescens in Healthy Adults.

Site Editor — Fri, 25 May 2007 02:17:54 -0700

A Randomized, Double-Blind, Placebo-Controlled Trial of Lessertia frutescens in Healthy Adults.: PLoS Clin Trials. 2007;2(4):e16 Authors: Johnson Q, Syce J, Nell H, Rudeen K, Folk WR

OBJECTIVES: Indigenous medicines are widely used throughout Africa, despite a lack of scientific evidence for their safety or efficacy. The aims of this study were: (a) to conduct a pilot study of the safety of a common indigenous South African phytotherapy, Lessertia frutescens (Sutherlandia), in healthy adults; and (b) to contribute to establishing procedures for ethical and scientifically rigorous clinical trials of African indigenous medicines. DESIGN: A randomized, double-blind, placebo-controlled trial of Sutherlandia leaf powder in healthy adults. SETTING: Tiervlei Trial Centre, Karl Bremer Hospital, Bellville, South Africa. PARTICIPANTS: 25 adults who provided informed consent and had no known significant diseases or allergic conditions nor clinically abnormal laboratory blood profiles during screening. INTERVENTION: 12 participants randomized to a treatment arm consumed 400 mg capsules of Sutherlandia leaf powder twice daily (800 mg/d). 13 individuals randomized to the control arm consumed a placebo capsule. Each participant received 180 capsules for the trial duration of 3 mo. OUTCOME MEASURES: The primary endpoint was frequency of adverse events; secondary endpoints were changes in physical, vital, blood, and biomarker indices. RESULTS: There were no significant differences in general adverse events or physical, vital, blood, and biomarker indices between the treatment and placebo groups (p > 0.05). However, participants consuming Sutherlandia reported improved appetite compared to those in the placebo group (p = 0.01). Although the treatment group exhibited a lower respiration rate (p < 0.04) and higher platelet count (p = 0.03), MCH (p = 0.01), MCHC (p = 0.02), total protein (p = 0.03), and albumin (p = 0.03), than the placebo group, these differences remained within the normal physiological range, and were not clinically relevant. The Sutherlandia biomarker canavanine was undetectable in participant plasma. CONCLUSION: Consumption of 800 mg/d Sutherlandia leaf powder capsules for 3 mo was tolerated by healthy adults.

Sublingual immunotherapy with a latex extract in paediatric patients: a double-blind, placebo-controlled study.

Site Editor — Thu, 01 Feb 2007 16:30:25 -0800

Sublingual immunotherapy with a latex extract in paediatric patients: a double-blind, placebo-controlled study.: Curr Med Res Opin. 2006 Aug;22(8):1515-22 Authors: Bernardini R, Campodonico P, Burastero S, Azzari C, Novembre E, Pucci N, Massai C, De Martino M, Vierucci A

BACKGROUND: Natural rubber latex (NRL) allergy remains an important allergic disease triggering urticaria, asthma, angioedema and anaphylaxis. Specific immunotherapy can help to solve problems related to NRL allergy. So far, no controlled clinical trials have been performed in children suffering from NRL allergy. OBJECTIVES: To evaluate the safety and efficacy of sublingual immunotherapy (SLIT) with a commercial NRL extract in children with NRL allergy. RESEARCH DESIGN: Randomized, double-blind, placebo-controlled, 12-month trial. PATIENTS AND METHODS: Twenty-six children (aged 4-15 years) with NRL allergy, who had cutaneous and/or respiratory symptoms, including oral allergy syndrome to fruits containing cross-reactive allergens, were recruited. Twelve children were randomized to SLIT with a commercial NRL extract and eight to placebo (3:2). An additional six children with NRL allergy served as untreated controls. MAIN OUTCOMES MEASURES: A glove use test was utilized to monitor skin and systemic symptoms triggered by NRL exposure at baseline and 3, 6, 9 and 12 months later. Oral allergy symptoms were also monitored. RESULTS: No side effects related to treatments were observed in any patient. A significant improvement of symptom score in treated patients in comparison with baseline values was observed at 3 months (p = 0.01) and consolidated after 1 year of treatment (p = 0.0005). In comparison with placebo, significant improvements were observed starting at 9 months from study start (p = 0.015) and at 12 months (p = 0.005). The number of foods triggering oral allergy symptoms increased in placebo and control subjects, but not in active treated patients (p = 0.05). CONCLUSION: Latex SLIT was safe and efficacious in paediatric patients with NRL allergy.

Effects of choleretics on bile compositions drained from patients with pigment gallstone.

Site Editor — Thu, 01 Feb 2007 16:28:26 -0800

Effects of choleretics on bile compositions drained from patients with pigment gallstone.: Chin J Integr Med. 2006 Jun;12(2):101-6 Authors: Sun BJ, Cui NQ, Li DH, Wang Q

OBJECTIVE: To provide evidence for three-level prevention of cholelithiasis by means of observing the effects of some choleretics on bile compositions drained from patients with pigment gallstone. METHODS: Twenty-seven patients suffering from primary pigment gallstones and having received treatment of choledochostomies plus T-tube or endoscopic nasal bile drainage (ENBD) were divided equally into three groups, and administered respectively with Lidanling (the LDL group), ursodesoxycholic acid (the UDA group) and combination of LDL and UDA (the LDL + UDA group) through oral intake (7 patients in each group). Besides, 6 post-operational patients got no treatment with any drug were allocated in the control group. Bile of all the patients was collected before treatment and on the 1, 3, 5, 7 th day after the treatment started to detect levels of total bile acid (TBA), glycocholic acid (GCA), taurocholic acid (TCA), glycocholic cheno-desoxycholic acid (GCDCA), total bilirubin (TBIL), uncombined bilirubin (UCB), concentration of calcium ion (Ca(2+)) as well as the bacterio-genetic and endogenous beta-glucuronidase activity for comparing. RESULTS: Levels of TBA, GCA, TCA and GCDCA got gradually increased in the UDA group and the LDL + UDA group after treatment (P < 0.05), while those in the LDL group remained unchanged, showing an insignificant difference as compared with those in the control group. In the LDL group and the LDL + UDA group, TBIL gradually increased while UCB gradually decreased in the course of treatment (P < 0.05). Moreover, levels of Ca(2+) and endogenous beta-glucuronidase activity got significantly lowered (P < 0.05). CONCLUSION: Combined use of LDL and UDA could elevate levels of TBA, GCA, TCA, GCDCA, enhance the excretion of TBIL in patients with pigment gallstone after bile drainage, lower levels of UCB and Ca(2+) and the activity of endogenous beta-glucuronidase in the bile, so as to reduce the possibility of stone formation of bile, and therefore, it could be used to prevent the production of pigment gallstone, especially to prevent post-operative recurrence of stones.

Safety, tolerance, and metabolism of broccoli sprout glucosinolates and isothiocyanates: a clinical phase I study.

Site Editor — Sat, 20 Jan 2007 00:19:59 -0800

Safety, tolerance, and metabolism of broccoli sprout glucosinolates and isothiocyanates: a clinical phase I study.: Nutr Cancer. 2006;55(1):53-62 Authors: Shapiro TA, Fahey JW, Dinkova-Kostova AT, Holtzclaw WD, Stephenson KK, Wade KL, Ye L, Talalay P

Broccoli sprouts are widely consumed in many parts of the world. There have been no reported concerns with respect to their tolerance and safety in humans. A formal phase I study of safety, tolerance, and pharmacokinetics appeared justified because these sprouts are being used as vehicles for the delivery of the glucosinolate glucoraphanin and its cognate isothiocyanate sulforaphane [1-isothiocyanato-(4R)-(methylsulfinyl)butane] in clinical trials. Such trials have been designed to evaluate protective efficacy against development of neoplastic and other diseases. A placebo-controlled, double-blind, randomized clinical study of sprout extracts containing either glucosinolates (principally glucoraphanin, the precursor of sulforaphane) or isothiocyanates (principally sulforaphane) was conducted on healthy volunteers who were in-patients on our clinical research unit. The subjects were studied in three cohorts, each comprising three treated individuals and one placebo recipient. Following a 5-day acclimatization period on a crucifer-free diet, the broccoli sprout extracts were administered orally at 8-h intervals for 7 days (21 doses), and the subjects were monitored during this period and for 3 days after the last treatment. Doses were 25 micromol of glucosinolate (cohort A), 100 micromol of glucosinolate (cohort B), or 25 micromol of isothiocyanate (cohort C). The mean cumulative excretion of dithiocarbamates as a fraction of dose was very similar in cohorts A and B (17.8 +/- 8.6% and 19.6 +/- 11.7% of dose, respectively) and very much higher and more consistent in cohort C (70.6 +/- 2.0% of dose). Thirty-two types of hematology or chemistry tests were done before, during, and after the treatment period. Indicators of liver (transaminases) and thyroid [thyroid-stimulating hormone, total triiodothyronine (T3), and free thyroxine (T4)] function were examined in detail. No significant or consistent subjective or objective abnormal events (toxicities) associated with any of the sprout extract ingestions were observed.

Efficacy of an herbal dietary supplement (Smooth Move) in the management of constipation in nursing home residents...

Site Editor — Wed, 10 Jan 2007 21:44:48 -0800

Efficacy of an herbal dietary supplement (Smooth Move) in the management of constipation in nursing home residents: A randomized, double-blind, placebo-controlled study.: J Am Med Dir Assoc. 2006 Nov;7(9):556-61 Authors: Bub S, Brinckmann J, Cicconetti G, Valentine B

OBJECTIVE: To investigate the efficacy and cost effectiveness of an herbal tea, Smooth Move, in nursing home residents with chronic constipation. DESIGN: Double-blind, placebo-controlled, 2-armed, parallel-group clinical trial. SETTING: A 483-bed nursing home in Allentown, Pennsylvania, operated by Lehigh County Government. PARTICIPANTS: A total of 86 nursing home residents with chronic constipation. INTERVENTIONS: Participants (n = 86) were randomly assigned to receive Smooth Move (n = 42) or a placebo (n = 44), once daily, in addition to standard treatment for chronic constipation. The study period was 28 days. MEASUREMENTS: The primary efficacy parameter was the difference in total number of bowel movements. Secondary parameters included the difference in average number of standard treatment doses dispensed, and the difference in total medication costs. RESULTS: Compared to placebo, in the intention to treat (ITT analysis) there was a statistically significant increase in the number of bowel movements in the Smooth Move group. The Smooth Move group (n = 42) compared with the placebo group (n = 44) experienced an average of 4.14 more bowel movements during the 28-day study period versus the 28-day pre-study period (P = .017). CONCLUSION: Smooth Move herbal tea, when added to the standard treatment regimen for nursing home residents with chronic constipation, increased the average number of bowel movements compared to the addition of a placebo tea.