Herbal Science Research - randomized controlled trial

Comparison of glucosamine sulfate and a polyherbal supplement for the relief of osteoarthritis of the knee [...]

Site Editor — Fri, 02 Nov 2007 15:31:58 -0700

Comparison of glucosamine sulfate and a polyherbal supplement for the relief of osteoarthritis of the knee: a randomized controlled trial [ISRCTN25438351].:
BMC Complement Altern Med. 2007 Oct 31;7(1):34 Authors: Mehta K, Gala J, Bhasale S, Naik S, Modak M, Thakur H, Deo N, Miller MJ

ABSTRACT: BACKGROUND: The efficacy and safety of a dietary supplement derived from South American botanicals was compared to glucosamine sulfate in osteoarthritis subjects in a Mumbai-based multi-center, randomized, double-blind study. METHODS: Subjects (n=95) were screened and randomized to receive glucosamine sulfate (n= 47, 1500 mg/day) or reparagen (n=48, 1800 mg/day), a polyherbal consisting of 300 mg of vincaria (Uncaria guianensis) and 1500 mg of RNI 249 (Lepidium meyenii) administered orally, twice daily. Primary efficacy variable was response rate based on a 20% improvement in WOMAC pain scores. Additional outcomes were WOMAC scores for pain, stiffness and function, visual analog score (VAS) for pain, with assessments at 1, 2, 4, 6 and 8 weeks. Tolerability, investigator and subject global assessments and rescue medication consumption (paracetamol) were measured together with safety assessments including vital signs and laboratory based assays. RESULTS: Subject randomization was effective: age, gender and disease status distribution was similar in both groups. The response rates (20% reduction in WOMAC pain) were substantial for both glucosamine (89%) and reparagen (94%) and supported by investigator and subject assessments. Using related criteria response rates to reparagen were favorable when compared to glucosamine. Compared to baseline both treatments showed significant benefits in WOMAC and VAS outcomes within one week (P<0.05), with a similar, progressive improvement over the course of the 8 week treatment protocol (45-62% reduction in WOMAC or VAS scores). Tolerability was excellent, no serious adverse events were noted and safety parameters were unchanged. Rescue medication use was significantly lower in the reparagen group (p <0.01) at each assessment period. Serum IGF-1 levels were unaltered by treatments. CONCLUSION: Both reparagen and glucosamine sulfate produced substantial improvements in pain, stiffness and function in subjects with osteoarthritis. Response rates were high and the safety profile was excellent, with significantly less rescue medication use with reparagen. Reparagen represents a new natural productive alternative in the management of joint health. Trial registration: Current Controlled Trials ISRCTN25438351.

PMID: 17974032 [PubMed - as supplied by publisher]

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]

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]

Kava in generalized anxiety disorder: three placebo-controlled trials.

Site Editor — Thu, 04 Oct 2007 06:16:11 -0700

Kava in generalized anxiety disorder: three placebo-controlled trials.: Int Clin Psychopharmacol. 2006 Sep;21(5):249-53 Authors: Connor KM, Payne V, Davidson JR

In this study, we evaluated the efficacy and safety of kava kava (Piper methysticum) in generalized anxiety disorder. Data were analyzed from three randomized, double-blind, placebo-controlled trials of kava, including one study with an active comparator (venlafaxine), in adult outpatients with DSM-IV generalized anxiety disorder. The pooled sample (n=64) included the following number of participants: kava, n=28; placebo, n=30; and venlafaxine, n=6. Given the comparability of the study designs, the data comparing kava and placebo were then pooled for further efficacy and safety analyses. No significant differences were observed between the treatment groups in any of the trials. In the pooled analyses, no effects were found for kava, while a significant effect in favor of placebo was observed in participants with higher anxiety at baseline. No evidence of hepatotoxicity was found with kava, and all of the treatments were well tolerated. Findings from these three controlled trials do not support the use of kava in DSM-IV generalized anxiety disorder.

PMID: 16877894 [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]

A randomized, placebo-controlled, double-blind clinical trial of curcuminoids in oral lichen planus.

Site Editor — Wed, 26 Sep 2007 19:01:00 -0700

A randomized, placebo-controlled, double-blind clinical trial of curcuminoids in oral lichen planus.: Phytomedicine. 2007 Aug;14(7-8):437-46 Authors: Chainani-Wu N, Silverman S, Reingold A, Bostrom A, Mc Culloch C, Lozada-Nur F, Weintraub J

We studied the efficacy of curcuminoids in the treatment of oral lichen planus (OLP), a chronic, mucocutaneous, immunological disease. Curcuminoids are components of turmeric (Curcuma longa) that have anti-inflammatory activity. Turmeric has been used in Ayurveda (Indian traditional medicine) for centuries. A randomized, double-blind, placebo-controlled trial was conducted. In all, 100 consecutive, eligible patients with OLP presenting to the oral medicine clinic at the University of California, San Francisco, were to be selected. Two interim analyses were to be conducted during the trial. The trial was conducted between February 2003 and September 2004. The first interim analysis was conducted in October 2004 using data from the first 33 subjects. Study subjects were randomized to receive either placebo or curcuminoids at 2000 mg/day for 7 weeks. In addition, all subjects received prednisone at 60 mg/day for the first 1 week. The primary outcome was a change in symptoms from baseline. Secondary outcomes were changes in clinical signs and occurrence of side effects. The first interim analysis did not show a significant difference between the placebo and curcuminoids groups. Conditional power calculations suggested a less than 2% chance that the curcuminoids group would have a significantly better outcome as compared with the placebo group if the trial were continued to completion. Therefore, the study was ended early for futility. Reaching a conclusion regarding the efficacy of curcuminoids based on the results of this study is not possible as it was ended early for futility. Curcuminoids at this dose were well tolerated and the results suggest that for future studies a larger sample size, a higher dose and/or longer duration of curcuminoids administration should be considered; however, for the next step, an RCT of a shorter duration, using a higher dose of curcuminoids, and without an initial course of prednisone, should be considered.

PMID: 17604143 [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.

[...] Rheum rhaponticum decreases anxiety and improves health state and general well-being in perimenopausal women.

Site Editor — Sat, 23 Jun 2007 05:37:43 -0700

The special extract ERr 731 of the roots of Rheum rhaponticum decreases anxiety and improves health state and general well-being in perimenopausal women.:

The special extract ERr 731 of the roots of Rheum rhaponticum decreases anxiety and improves health state and general well-being in perimenopausal women.

Menopause. 2007 Mar-Apr;14(2):270-83

Authors: Kaszkin-Bettag M, Ventskovskiy BM, Kravchenko A, Rettenberger R, Richardson A, Heger PW, Heger M

OBJECTIVE: To investigate the efficacy of the special extract ERr 731 from the roots of Rheum rhaponticum compared with placebo on anxiety, health state, and general well-being in perimenopausal women. DESIGN: This study is a multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial, in which 109 perimenopausal women with climacteric complaints and anxiety received either 1 enteric coated tablet of ERr 731 (n=54) or placebo (n=55) daily for 12 weeks. The Hamilton Anxiety Scale, the Menopause Rating Scale II, the Women's Health Questionnaire, and the Psychological General Well-Being Index were used to measure anxiety, health state, and subjective psychological well-being. RESULTS: The results demonstrate that ERr 731 is highly effective in reducing anxiety in perimenopausal women compared with placebo. After 12 weeks, the Hamilton Anxiety Scale total score decreased significantly with ERr 731 (from 27.5+/-6.8 to 9.4+/-4.2 points) compared with placebo (from 25.1+/-6.0 to 21.6+/-8.6 points). ERr 731 also reduced the Hamilton Anxiety Scale factor scores for somatic and psychic anxiety. After 12 weeks, a reduction in the severity of anxiety from "moderate" or "severe" to "slight" was observed in 33 of 39 ERr 731 women completing the double-blind phase, which correlated well with the reduction in number and severity of hot flushes. This was reflected by a high rate of ERr 731 women reporting a marked improvement in health state and general well-being. CONCLUSIONS: ERr 731 is an effective medication for women with menopause-related anxiety and improves their health state and general well-being.

PMID: 17213754 [PubMed - indexed for MEDLINE]

Randomised clinical trial of a laxative alone versus a laxative and a bulking agent [...]

Site Editor — Mon, 11 Jun 2007 05:37:58 -0700

Randomised clinical trial of a laxative alone versus a laxative and a bulking agent after primary repair of obstetric anal sphincter injury.: BJOG. 2007 Jun;114(6):736-40 Authors: Eogan M, Daly L, Behan M, O'Connell PR, O'Herlihy C

OBJECTIVE: To compare two postpartum laxative regimens in women who have undergone primary repair of obstetric anal sphincter injury. DESIGN: Randomised controlled trial. SETTING: National Maternity Hospital, Dublin. POPULATION: A total of 147 postpartum women who had sustained anal sphincter injury at vaginal birth. METHODS: Women were randomised to receive either lactulose alone thrice daily for the first three postpartum days followed by sufficient lactulose to maintain a soft stool over the following 10 days (lactulose group, n = 77) or the lactulose regimen combined with a sachet of ispaghula husk daily for the first 10 postpartum days (Fybogel group, n = 70). All patients kept a diary of bowel habit for the first 10 postpartum days and were invited to return for review at 3 months postpartum. MAIN OUTCOME MEASURES: Patient discomfort with first postpartum bowel motion, incidence of postnatal constipation and incontinence and incontinence score in postnatal period. RESULTS: Pain scores were similar in the two treatment groups; but incontinence in the immediate postnatal period was more frequent with the two preparations compared with lactulose alone (32.86% versus 18.18%, P = 0.03). CONCLUSIONS: This study does not support routine prescribing of a stool-bulking agent in addition to a laxative in the immediate postnatal period for women who have sustained anal sphincter injury at vaginal delivery.

AKL1, a botanical mixture for the treatment of asthma: a randomised, double-blind, placebo-controlled, cross-over study.

Site Editor — Fri, 25 May 2007 02:20:11 -0700

AKL1, a botanical mixture for the treatment of asthma: a randomised, double-blind, placebo-controlled, cross-over study.: BMC Pulm Med. 2007;7:4 Authors: Thomas M, Sheran J, Smith N, Fonseca S, Lee AJ

BACKGROUND: Despite effective treatments, asthma outcomes remain suboptimal. Interest exists in complementary therapies, particularly in herbal remedies for asthma treatment, currently with inconclusive evidence of efficacy. The encapsulated botanical mixture AKL1 has anecdotal evidence of effectiveness in asthma. METHODS: We performed a randomised controlled cross over study comparing the effectiveness of AKL1 with indistinguishable placebo as add-on therapy in patients uncontrolled on standard asthma treatment. Thirty two adult asthmatics completed a 36 week trial consisting of a 4 week single blind run in period, during which placebo was added to usual treatment, a 12 week double blind active phase in which subjects received AKL1 or placebo, a single blind 8 week washout period receiving placebo and a final 12 week double blind cross-over active treatment phase. Daily diaries were kept of peak expiratory flow and symptoms, and spirometry, validated symptom and health status questionnaire scores and adverse events were monitored at study visits. Paired T tests were used to compare the effects of placebo and AKL1 on outcomes. Changes in outcome measures over treatment phases are presented as means and 95% confidence intervals (CI) of means. RESULTS: No significant differences in lung function (active-placebo) were found (Forced Expiratory Volume in 1 second: mean difference [95% CI] = 0.01 [-0.12 to 0.14] L, p = 0.9. Peak Expiratory Flow: -4.08 [-35.03 to 26.89]. L/min, p = 0.8).Trends to clinical improvements favouring active treatment were however consistently seen in the patient-centered outcomes: Asthma Control Questionnaire mean difference (active - placebo) [95% CI] = -0.35 [-0.78 to 0.07], p = 0.10, Asthma Quality of Life Questionnaire mean difference 0.42 [-0.08 to 0.93], p = 0.09, Leicester Cough Questionnaire mean difference 0.49, [-0.18 to 1.16], p = 0.15.Nine exacerbations occurred during placebo treatment and five whilst on AKL1. No significant adverse events were noted. CONCLUSION: AKL1 treatment was well tolerated. No significant improvements in lung function, symptoms, or quality of life were seen, although consistent trends were seen to improvements in patient-centered outcomes. Further studies 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.

Randomized controlled trial of cannabis-based medicine in spasticity caused by multiple sclerosis.

Site Editor — Fri, 11 May 2007 15:54:21 -0700

Randomized controlled trial of cannabis-based medicine in spasticity caused by multiple sclerosis.: Eur J Neurol. 2007 Mar;14(3):290-6 Authors: Collin C, Davies P, Mutiboko IK, Ratcliffe S,

Symptoms relating to spasticity are common in multiple sclerosis (MS) and can be difficult to treat. We have investigated the efficacy, safety and tolerability of a standardized oromucosal whole plant cannabis-based medicine (CBM) containing delta-9 tetrahydrocannabinol (THC) and cannabidiol (CBD), upon spasticity in MS. A total of 189 subjects with definite MS and spasticity were randomized to receive daily doses of active preparation (n = 124) or placebo (n = 65) in a double blind study over 6 weeks. The primary endpoint was the change in a daily subject-recorded Numerical Rating Scale of spasticity. Secondary endpoints included a measure of spasticity (Ashworth Score) and a subjective measure of spasm. The primary efficacy analysis on the intention to treat (ITT) population (n = 184) showed the active preparation to be significantly superior (P = 0.048). Secondary efficacy measures were all in favour of active preparation but did not achieve statistical significance. The responder analysis favoured active preparation, 40% of subjects achieved >30% benefit (P = 0.014). Eight withdrawals were attributed to adverse events (AEs); six were on active preparation and two on placebo. We conclude that this CBM may represent a useful new agent for treatment of the symptomatic relief of spasticity in MS.

Pharmacokinetics and systemic endocrine effects of [...] 8-prenylnaringenin after single oral doses postmenopausal women

Site Editor — Fri, 11 May 2007 15:41:22 -0700

Pharmacokinetics and systemic endocrine effects of the phyto-oestrogen 8-prenylnaringenin after single oral doses to postmenopausal women.: Br J Clin Pharmacol. 2006 Sep;62(3):288-96 Authors: Rad M, Hümpel M, Schaefer O, Schoemaker RC, Schleuning WD, Cohen AF, Burggraaf J

AIMS: Pre-clinical data suggest that the racemic phyto-oestrogen 8-prenylnaringenin (8-PN) may have beneficial effects in postmenopausal women and may become an alternative to classical hormone replacement therapy (HRT) treatment regimes. The aim of this study was to investigate the pharmacokinetics, endocrine effects and tolerability of chemically synthesized 8-PN in postmenopausal women. METHODS: The study was performed using a randomized, double-blind, placebo-controlled, dose-escalation design with three groups of eight healthy postmenopausal women. In each group six subjects received 8-PN and two subjects placebo. 8-PN was given orally in doses of 50, 250 or 750 mg. Drug concentrations in serum, urine and faeces were measured up to 48 h and follicle-stimulating hormone/luteinizing hormone (LH) concentrations up to 24 h. RESULTS: All treatments were well tolerated and associated with a low incidence of (drug unrelated) adverse events. Serum concentrations of free 8-PN showed rapid drug absorption and secondary peaks suggestive of marked enterohepatic recirculation. Independent of the treatment group, approximately 30% of the dose was recovered in excreta as free compound or conjugates over the 48-h observation period. The first C(max) and AUC(0-48 h) showed dose linearity with ratios of 1 : 4.5 : 13.6 (C(max)) and 1 : 5.2 : 17.1 (AUC). The750- mg dose decreased LH concentrations by 16.7% (95% confidence interval 0.5, 30.2). CONCLUSION: Single oral doses of up to 750 mg 8-PN were well tolerated by postmenopausal women. The pharmacokinetic profile of 8-PN was characterized by rapid and probably complete enteral absorption, high metabolic stability, pronounced enterohepatic recirculation and tight dose linearity. The decrease in LH serum concentrations found after the highest dose demonstrates the ability of 8-PN to exert systemic endocrine effects in postmenopausal women.

[...] studies in matched-pair design for the long-term therapy of breast cancer patients with a mistletoe preparation (Iscador).

Site Editor — Wed, 21 Feb 2007 18:21:15 -0800

Randomised and non-randomised prospective controlled cohort studies in matched-pair design for the long-term therapy of breast cancer patients with a mistletoe preparation (Iscador): a re-analysis.: Eur J Med Res. 2006 Nov 30;11(11):485-95 Authors: Grossarth-Maticek R, Ziegler R

OBJECTIVE: Expanded presentation and re-analysis of previously published data of randomized and non-randomized studies on mistletoe therapy with breast cancer patients [3, 4]. The main question is: Does a re-analysis confirm the previously reported effects of prolonging the survival of patients with breast cancer under long-term application of a complementary/anthroposophic therapy with the European mistletoe preparation Iscador? DATA SOURCES: (1) Randomised matched-pairs study: Breast cancer patients with only lymphatic metastases (17 pairs) that had never used mistletoe therapy were matched for several prognostic factors. By paired random allocation, one patient of a pair received a suggestion of mistletoe therapy to be applied by the attending physician. (2) Non-randomised matched-pairs studies: Patients that had already received mistletoe (Iscador) therapy were matched to control patients from the same pool using the same prognostic criteria. Three groups were recruited by this procedure: breast cancer with local recurrences and no metastases (42 pairs), breast cancer with only lymphatic metastases (55 pairs), and breast cancer with distant metastases (83 pairs). ANALYSIS: Cox proportional hazard models and sensitivity analyses based on subsets of the original data sets according to strict or lose application of the matching criteria. RESULTS: The results of this re-analysis are consistent with the earlier results, even when comparing different methods and subsets. In the randomised study, the effect of long-term Iscador therapy on overall survival is significantly in favour of the Iscador therapy: Estimate of the median difference and 95 % confidence interval in years 2.5 (0.83, 4.50). The results for the non-randomised studies were also in favour of the Iscador therapy: Breast cancer with local recurrences and no metastases: estimate of hazard ratio and 95 % confidence interval 0.52 (0.23, 1.17); breast cancer with lymphatic metastases: 0.27 (0.15, 0.50); breast cancer with distant metastases: 0.53 (0.32, 0.88). As a short-term effect of this therapy, psychosomatic self-regulation noticeably increases within 3 months in the Iscador group in comparison to the control group in the randomised study: estimate of the median difference 0.90 (0, 1.75). CONCLUSION: The re-analysis demonstrates that the effects shown in the previously published data are consistent despite using different analytic methods and different subsets. Overall, the survival of patients receiving mistletoe treatment with Iscador is longer in these studies. In the short term, psychosomatic self-regulation, as a measure of autonomous coping with the disease, rises more under Iscador therapy than under conventional therapy alone.

Clinical studies of immunomodulatory activities of Yunzhi-Danshen in patients with nasopharyngeal carcinoma.

Site Editor — Thu, 01 Feb 2007 16:56:02 -0800

Clinical studies of immunomodulatory activities of Yunzhi-Danshen in patients with nasopharyngeal carcinoma.: J Altern Complement Med. 2006 Oct;12(8):771-6 Authors: Bao YX, Wong CK, Leung SF, Chan AT, Li PW, Wong EL, Leung PC, Fung KP, Yin YB, Lam CW

OBJECTIVES: Nasopharyngeal carcinoma (NPC) is a prevalent tumor in Hong Kong. The immune system of such patients could be adversely affected during the course of conventional chemotherapy or radiotherapy. We investigated the immunomodulatory effects of Traditional Chinese Medicine (TCM) Yunzhi-Danshen capsules in NPC patients treated with radiotherapy. DESIGN: Randomized, double-blind, placebo-controlled 16-week study. SETTING/LOCATION: The Prince of Wales Hospital, the Chinese University of Hong Kong, Hong Kong. SUBJECTS: Twenty-seven (27) patients with histologically proven NPC, at least 18 years of age. METHODS: Twenty-seven patients with histologically proven NPC were recruited to take Yunzhi (3.6 g daily) and Dangshem (1.4 g daily) in the form of 12 combination capsules (TCM group) or placebo (12 capsules) daily for 16 weeks, respectively. Flow cytometry was used to assess the percentages and absolute counts of human lymphocyte subsets in whole blood. Plasma concentration of soluble interleukin-2 receptor and soluble tumor necrosis factor receptor 2 was measured by enzyme-linked immunosorbent assay (ELISA). Ex vivo production of tumor necrosis factor-alpha, interleukin (IL)-6, and IL-10 in the whole blood assay culture supernatant was measured by ELISA. RESULTS: The decreases in percentage and absolute count of T lymphocytes in the TCM group were less than those in the placebo group after they took the capsules for 16 weeks (both p < 0.05). Furthermore, the decreases in absolute count of T suppressor cells plus cytotoxic T lymphocytes, and T helper cells in the TCM group were significantly lower than those in the placebo group after they took the capsules for 16 weeks (both p < 0.05). CONCLUSION: These results suggest that Yunzhi-Danshen can exert an immunomodulating effect in alleviating lymphopenia during radiotherapy in NPC patients.

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.

The extent of induction of CYP3A by St. John's wort varies among products and is linked to hyperforin dose.

Site Editor — Sat, 20 Jan 2007 00:23:18 -0800

The extent of induction of CYP3A by St. John's wort varies among products and is linked to hyperforin dose.: Eur J Clin Pharmacol. 2006 Jan;62(1):29-36 Authors: Mueller SC, Majcher-Peszynska J, Uehleke B, Klammt S, Mundkowski RG, Miekisch W, Sievers H, Bauer S, Frank B, Kundt G, Drewelow B

OBJECTIVE: Induction of CYP3A by St. John's wort (SJW) extracts with high hyperforin (HYF) content is well described. Since SJW products vary in the amount of HYF and other main constituents, the aim of the study was to evaluate the effect on CYP3A function of SJW preparations with a range from very low to high HYF content. METHODS: Forty-two male, healthy volunteers were randomized into six parallel SJW medication groups with varying composition especially with regard to HYF content. Midazolam plasma concentration profiles were characterized after a single oral dose of 7.5 mg midazolam on the day before and on the 14th day of SJW medication. RESULTS: All SJW preparations tested resulted in a decrease in midazolam AUC, although the extent of the effect differed. The extract LI 160 (HYF 41 mg/day) decreased midazolam AUC0-12h by 79.4% (95% CI -88.6; -70.1), which was significantly greater than the effect by any other medication (p<0.05). SJW powder tablets 2.7 g/day (HYF 12 mg/day) resulted in a midazolam AUC0-12h decrease of 47.9% (95% CI -59.7;-36.2), while 2.7 g/day SJW powder tablets that were almost devoid of HYF (0.13 mg/day) reduced midazolam AUC0-12h by only 21.1% (95% CI -33.9; -8.3). Considering all six SJW medications tested, the extent of midazolam AUC decrease correlated significantly with increasing HYF dose (r=-0.765, p<0.001), but not with hypericin dose (r=-0.067; p=0.673). CONCLUSION: The extent of induction of CYP3A varies among St. John's wort products and depends on hyperforin dose.

Sunflower therapy for children with specific learning difficulties (dyslexia): A randomised, controlled trial.

Site Editor — Sat, 13 Jan 2007 21:32:13 -0800

Sunflower therapy for children with specific learning difficulties (dyslexia): A randomised, controlled trial.: Complement Ther Clin Pract. 2007 Feb; 13(1): 15-24 Bull L

The aim of the study was to determine the clinical and perceived effectiveness of the Sunflower therapy in the treatment of childhood dyslexia. The Sunflower therapy includes applied kinesiology, physical manipulation, massage, homeopathy, herbal remedies and neuro-linguistic programming. A multi-centred, randomised controlled trial was undertaken with 70 dyslexic children aged 6-13 years. The research study aimed to test the research hypothesis that dyslexic children 'feel better' and 'perform better' as a result of treatment by the Sunflower therapy. Children in the treatment group and the control group were assessed using a battery of standardised cognitive, Literacy and self-esteem tests before and after the intervention. Parents of children in the treatment group gave feedback on their experience of the Sunflower therapy. Test scores were compared using the Mann Whitney, and Wilcoxon statistical tests. While both groups of children improved in some of their test scores over time, there were no statistically significant improvements in cognitive or Literacy test performance associated with the treatment. However, there were statistically significant improvements in academic self-esteem, and reading self-esteem, for the treatment group. The majority of parents (57.13%) felt that the Sunflower therapy was effective in the treatment of learning difficulties. Further research is required to verify these findings, and should include a control group receiving a dummy treatment to exclude placebo effects.

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.

Treatment of ADHD with French maritime pine bark extract, Pycnogenol.

Site Editor — Thu, 04 Jan 2007 17:42:46 -0800

Treatment of ADHD with French maritime pine bark extract, Pycnogenol.: Eur Child Adolesc Psychiatry. 2006 Sep;15(6):329-35 Authors: Trebatická J, Kopasová S, Hradecná Z, Cinovský K, Skodácek I, Suba J, Muchová J, Zitnanová I, Waczulíková I, Rohdewald P, Duracková Z

Attention Deficit/Hyperactivity Disorder (ADHD) is the most common psychiatric disorder in children. Pycnogenol, an extract from the bark of the French maritime pine, consisting of phenolic acids, catechin, taxifolin and procyanidins, has shown improvement of ADHD in case reports and in an open study. Aim of the present study was to evaluate the effect of Pycnogenol on ADHD symptoms. Sixty-one children were supplemented with 1 mg/kg/day Pycnogenol or placebo over a period of 4 weeks in a randomised, placebo-controlled, doubleblind study. Patients were examined at start of trial, 1 month after treatment and 1 month after end of treatment period by standard questionnaires: CAP (Child Attention Problems) teacher rating scale, Conner's Teacher Rating Scale (CTRS), the Conner's Parent Rating Scale (CPRS) and a modified Wechsler Intelligence Scale for children. Results show that 1-month Pycnogenol administration caused a significant reduction of hyperactivity, improves attention and visual-motoric coordination and concentration of children with ADHD. In the placebo group no positive effects were found. One month after termination of Pycnogenol administration a relapse of symptoms was noted. Our results point to an option to use Pycnogenol as a natural supplement to relieve ADHD symptoms of children.

Treatment of vasomotor symptoms of menopause with black cohosh, multibotanicals, soy, hormone therapy, or placebo...

Site Editor — Wed, 03 Jan 2007 19:07:14 -0800

Treatment of vasomotor symptoms of menopause with black cohosh, multibotanicals, soy, hormone therapy, or placebo: a randomized trial.: Ann Intern Med. 2006 Dec 19;145(12):869-79 Authors: Newton KM, Reed SD, LaCroix AZ, Grothaus LC, Ehrlich K, Guiltinan J

BACKGROUND: Herbal supplements are widely used for vasomotor symptoms. OBJECTIVE: To test the efficacy of 3 herbal regimens and hormone therapy for relief of vasomotor symptoms compared with placebo. DESIGN: 1-year randomized, double-blind, placebo-controlled trial conducted from May 2001 to September 2004. SETTING: Group Health, Washington State. PARTICIPANTS: 351 women age 45 to 55 years with 2 or more vasomotor symptoms per day; 52% of the women were in menopausal transition and 48% were postmenopausal. MEASUREMENTS: Rate and intensity of vasomotor symptoms (1 = mild to 3 = severe), and Wiklund Vasomotor Symptom Subscale. INTERVENTIONS: 1) Black cohosh, 160 mg daily; 2) multibotanical with black cohosh, 200 mg daily, and 9 other ingredients; 3) multibotanical plus dietary soy counseling; 4) conjugated equine estrogen, 0.625 mg daily, with or without medroxyprogesterone acetate, 2.5 mg daily; or 5) placebo. RESULTS: Vasomotor symptoms per day, symptom intensity, Wiklund Vasomotor Symptom Subscale score did not differ between the herbal interventions and placebo at 3, 6, or 12 months or for the average over all the follow-up time points (P > 0.05 for all comparisons) with 1 exception: At 12 months, symptom intensity was significantly worse with the multibotanical plus soy intervention than with placebo (P = 0.016). The difference in vasomotor symptoms per day between placebo and any of the herbal treatments at any time point was less than 1 symptom per day; for the average over all the follow-up time points, the difference was less than 0.55 symptom per day. The difference for hormone therapy versus placebo was -4.06 vasomotor symptoms per day for the average over all the follow-up time points (95% CI, -5.93 to -2.19 symptoms per day; P < 0.001). LIMITATIONS: The trial did not simulate the whole-person approach used by naturopathic physicians. Differences between treatment groups smaller than 1.5 Vasomotor symptoms per day cannot be ruled out. CONCLUSION: Black cohosh used in isolation, or as part of a multibotanical regimen, shows little potential as an important therapy for relief of vasomotor symptoms. Clinical Trials Registration number: NCT00169299.

Hypotensive effects of hawthorn for patients with diabetes taking prescription drugs: a randomised controlled trial.

Site Editor — Wed, 04 Oct 2006 18:59:39 -0700

Hypotensive effects of hawthorn for patients with diabetes taking prescription drugs: a randomised controlled trial.: Br J Gen Pract. 2006 Jun; 56(527): 437-43 Walker AF, Marakis G, Simpson E, Hope JL, Robinson PA, Hassanein M, Simpson HC

BACKGROUND: Hawthorn (Crataegus laevigata) leaves, flowers and berries are used by herbal practitioners in the UK to treat hypertension in conjunction with prescribed drugs. Small-scale human studies support this approach. AIM: To investigate the effects of hawthorn for hypertension in patients with type 2 diabetes taking prescribed drugs. DESIGN OF STUDY: Randomised controlled trial. SETTING: General practices in Reading, UK. METHOD: Patients with type 2 diabetes (n = 79) were randomised to daily 1200 mg hawthorn extract (n = 39) or placebo (n = 40) for 16 weeks. At baseline and outcome a wellbeing questionnaire was completed and blood pressure and fasting blood samples taken. A food frequency questionnaire estimated nutrient intake. RESULTS: Hypotensive drugs were used by 71% of the study population with a mean intake of 4.4 hypoglycaemic and/or hypotensive drugs. Fat intake was lower and sugar intake higher than recommendations, and low micronutrient intake was prevalent. There was a significant group difference in mean diastolic blood pressure reductions (P = 0.035): the hawthorn group showed greater reductions (baseline: 85.6 mmHg, 95% confidence interval [CI] = 83.3 to 87.8; outcome: 83.0 mmHg, 95% CI = 80.5 to 85.7) than the placebo group (baseline: 84.5 mmHg, 95% CI = 82 to 87; outcome: 85.0 mmHg, 95% CI = 82.2 to 87.8). There was no group difference in systolic blood pressure reduction from baseline (3.6 and 0.8 mmHg for hawthorn and placebo groups, respectively; P = 0.329). Although mean fat intake met current recommendations, mean sugar intake was higher and there were indications of potential multiple micronutrient deficiencies. No herb-drug interaction was found and minor health complaints were reduced from baseline in both groups. CONCLUSIONS: This is the first randomised controlled trial to demonstrate a hypotensive effect of hawthorn in patients with diabetes taking medication.

Reporting random controlled trials of herbal medicines.

Site Editor — Wed, 04 Oct 2006 18:54:24 -0700

Reporting random controlled trials of herbal medicines.: Explore (NY). 2006 Mar; 2(2): 143-9 Gagnier J, Boon H, Rochon P, Barnes J, Moher D, Bombardier C

BACKGROUND: Given that herbal medicinal products are widely used, vary greatly in content and quality, and are actively tested in randomized controlled trials (RCTs), such RCTs must clearly report the specifics of the intervention. OBJECTIVE: Our objective was to develop recommendations for reporting RCTs of herbal medicine interventions. METHODS: We identified and invited potential participants with expertise in clinical trial methodology, clinical trial reporting, pharmacognosy, herbal medicinal products, medical statistics, and/or herbal product manufacturing to participate in phone calls and a consensus meeting. Three phases were conducted: (1) Premeeting item generation via telephone calls, (2) Consensus meeting, and (3) Postmeeting feedback. Sixteen experts participated in premeeting phone calls for item generation, and 14 participants attended a consensus meeting in Toronto, Ontario, Canada, in June of 2004. During the consensus meeting, a modified Delphi technique was used to aid discussion and debate of information required for reporting RCTs of herbal medicines. RESULTS: After extensive discussion, the group decided that context-specific elaborations of nine Consolidated Standards of Reporting Trials (CONSORT) items to RCTs of herbal medicines were necessary: Item 1 (Title and Abstract), 2 (Background), 3 (Participants), 4 (Interventions), 6 (Outcomes), 15 (Baseline data), 20 (Interpretation), 21 (Generalizability), and 22 (Overall evidence). DISCUSSION: The elaboration of item 4 of the CONSORT statement outlines specific information required for complete reporting of the herbal medicine intervention. The reporting suggestions presented will support clinical trialists, editors, and reviewers in reporting and reviewing RCTs of herbal medicines and readers in interpreting the results.

Saw palmetto for benign prostatic hyperplasia.

Site Editor — Fri, 09 Jun 2006 07:23:58 -0700

Saw palmetto for benign prostatic hyperplasia.: N Engl J Med. 2006 Feb 9;354(6):557-66 Authors: Bent S, Kane C, Shinohara K, Neuhaus J, Hudes ES, Goldberg H, Avins AL

BACKGROUND: Saw palmetto is used by over 2 million men in the United States for the treatment of benign prostatic hyperplasia and is commonly recommended as an alternative to drugs approved by the Food and Drug Administration. METHODS: In this double-blind trial, we randomly assigned 225 men over the age of 49 years who had moderate-to-severe symptoms of benign prostatic hyperplasia to one year of treatment with saw palmetto extract (160 mg twice a day) or placebo. The primary outcome measures were changes in the scores on the American Urological Association Symptom Index (AUASI) and the maximal urinary flow rate. Secondary outcome measures included changes in prostate size, residual urinary volume after voiding, quality of life, laboratory values, and the rate of reported adverse effects. RESULTS: There was no significant difference between the saw palmetto and placebo groups in the change in AUASI scores (mean difference, 0.04 point; 95 percent confidence interval, -0.93 to 1.01), maximal urinary flow rate (mean difference, 0.43 ml per minute; 95 percent confidence interval, -0.52 to 1.38), prostate size, residual volume after voiding, quality of life, or serum prostate-specific antigen levels during the one-year study. The incidence of side effects was similar in the two groups. CONCLUSIONS: In this study, saw palmetto did not improve symptoms or objective measures of benign prostatic hyperplasia. (ClinicalTrials.gov number, NCT00037154.).

Femal, a herbal remedy made from pollen extracts, reduces hot flushes and improves quality of life in menopausal women...

Site Editor — Fri, 09 Jun 2006 07:21:12 -0700

Femal, a herbal remedy made from pollen extracts, reduces hot flushes and improves quality of life in menopausal women: a randomized, placebo-controlled, parallel study.: Climacteric. 2005 Jun;8(2):162-70 Authors: Winther K, Rein E, Hedman C

BACKGROUND: The fact that hormone replacement therapy has been claimed to increase the risk of breast cancer has made it relevant to search for new non-hormonal treatments of menopausal symptoms. OBJECTIVES: This study aimed to evaluate whether Femal, a herbal remedy made from pollen extracts, alleviates the symptoms of the menopause, especially hot flushes. DESIGN: A randomized, double-blind, placebo-controlled, parallel trial of 64 menopausal women, of whom 54 completed the trial. After an initial run-in phase of 1 month, the women were randomly given either two Femal tablets each morning, or two identical placebo tablets, for 3 months of treatment. On inclusion, and then at 4-week intervals, the patients were asked to evaluate 16 symptoms of the menopause using Menopause Rating Scales (MRS). In addition, every day throughout the study, certain menopausal symptoms were recorded in a diary. RESULTS: The two treatment groups were identical regarding demographic data and the initial symptom scores. In the active-treatment group, 65% responded with a reduction in hot flushes compared with 38% in the placebo group (p<0.006) and, in this group, the number of hot flushes registered in diaries declined after 3 months by 27% as compared to the placebo group (p<0.026). MRS evaluation of hot flushes yielded similar results (p<0.031). There were 23% and 22% decreases in hot flushes after 2 and 3 months of treatment, respectively, and after both intervals of time the inter-group comparisons were significantly affected. An overall evaluation of the trend in 15 other 'quality-of-life' parameters showed likewise in favor of the pollen extract (p<0.031). CONCLUSION: The pollen extract Femal significantly reduces hot flushes and certain other menopausal symptoms when compared to placebo.

Astragalus-based Chinese herbs and platinum-based chemotherapy for advanced non-small-cell lung cancer...

Site Editor — Fri, 09 Jun 2006 07:21:01 -0700

Astragalus-based Chinese herbs and platinum-based chemotherapy for advanced non-small-cell lung cancer: meta-analysis of randomized trials.: J Clin Oncol. 2006 Jan 20;24(3):419-30 Authors: McCulloch M, See C, Shu XJ, Broffman M, Kramer A, Fan WY, Gao J, Lieb W, Shieh K, Colford JM

PURPOSE: Systemic treatments for advanced non-small-cell lung cancer have low efficacy and high toxicity. Some Chinese herbal medicines have been reported to increase chemotherapy efficacy and reduce toxicity. In particular, Astragalus has been shown to have immunologic benefits by stimulating macrophage and natural killer cell activity and inhibiting T-helper cell type 2 cytokines. Many published studies have assessed the use of Astragalus and other Chinese herbal medicines in combination with chemotherapy. We sought to evaluate evidence from randomized trials that Astragalus-based Chinese herbal medicine combined with platinum-based chemotherapy (versus platinum-based chemotherapy alone) improves survival, increases tumor response, improves performance status, or reduces chemotherapy toxicity. METHODS: We searched CBM, MEDLINE, TCMLARS, EMBASE, Cochrane Library, and CCRCT databases for studies in any language. We grouped studies using the same herbal combinations for random-effects meta-analysis. RESULTS: Of 1,305 potentially relevant publications, 34 randomized studies representing 2,815 patients met inclusion criteria. Twelve studies (n = 940 patients) reported reduced risk of death at 12 months (risk ratio [RR] = 0.67; 95% CI, 0.52 to 0.87). Thirty studies (n = 2,472) reported improved tumor response data (RR = 1.34; 95% CI, 1.24 to 1.46). In subgroup analyses, Jin Fu Kang in two studies (n = 221 patients) reduced risk of death at 24 months (RR = 0.58; 95% CI, 0.49 to 0.68) and in three studies (n = 411) increased tumor response (RR = 1.76; 95% CI, 1.23 to 2.53). Ai Di injection (four studies; n = 257) stabilized or improved Karnofsky performance status (RR = 1.28; 95% CI, 1.12 to 1.46). CONCLUSION: Astragalus-based Chinese herbal medicine may increase effectiveness of platinum-based chemotherapy when combined with chemotherapy. These results require confirmation with rigorously controlled trials.

Preliminary assessment of the efficacy, tolerability and safety of a cannabis-based medicine (Sativex) in the treatment of pain.

Site Editor — Fri, 09 Jun 2006 07:20:11 -0700

Preliminary assessment of the efficacy, tolerability and safety of a cannabis-based medicine (Sativex) in the treatment of pain caused by rheumatoid arthritis.: Rheumatology (Oxford). 2006 Jan;45(1):50-2 Authors: Blake DR, Robson P, Ho M, Jubb RW, McCabe CS

OBJECTIVES: To assess the efficacy of a cannabis-based medicine (CBM) in the treatment of pain due to rheumatoid arthritis (RA). METHODS: We compared a CBM (Sativex) with placebo in a randomized, double-blind, parallel group study in 58 patients over 5 weeks of treatment. The CBM was administered by oromucosal spray in the evening and assessments were made the following morning. Efficacy outcomes assessed were pain on movement, pain at rest, morning stiffness and sleep quality measured by a numerical rating scale, the Short-Form McGill Pain Questionnaire (SF-MPQ) and the DAS28 measure of disease activity. RESULTS: Seventy-five patients were screened and 58 met the eligibility criteria. Thirty-one were randomized to the CBM and 27 to placebo. Mean (S.D.) daily dose achieved in the final treatment week was 5.4 (0.84) actuations for the CBM and 5.3 (1.18) for placebo. In comparison with placebo, the CBM produced statistically significant improvements in pain on movement, pain at rest, quality of sleep, DAS28 and the SF-MPQ pain at present component. There was no effect on morning stiffness but baseline scores were low. The large majority of adverse effects were mild or moderate, and there were no adverse effect-related withdrawals or serious adverse effects in the active treatment group. CONCLUSIONS: In the first ever controlled trial of a CBM in RA, a significant analgesic effect was observed and disease activity was significantly suppressed following Sativex treatment. Whilst the differences are small and variable across the population, they represent benefits of clinical relevance and show the need for more detailed investigation in this indication.

Antihypertensive effect of green coffee bean extract on mildly hypertensive subjects.

Site Editor — Fri, 09 Jun 2006 07:19:30 -0700

Antihypertensive effect of green coffee bean extract on mildly hypertensive subjects.: Hypertens Res. 2005 Sep;28(9):711-8 >Authors: Kozuma K, Tsuchiya S, Kohori J, Hase T, Tokimitsu I

A water-soluble green coffee bean extract (GCE) has been shown to be effective against hypertension in both spontaneously hypertensive rats and humans. This multicenter, randomized, double-blind, placebo-controlled, parallel group study evaluated the dose-response relationship of GCE in 117 male volunteers with mild hypertension. Subjects were randomized into four groups: a placebo and three drug groups that received 46 mg, 93 mg, or 185 mg of GCE once a day. After 28 days, systolic blood pressure (SBP) in the placebo, 46 mg, 93 mg, and 185 mg groups was reduced by -1.3+/-3.0 mmHg, -3.2+/-4.6 mmHg, -4.7+/-4.5 mmHg, and -5.6+/-4.2 mmHg from the baseline, respectively. The decreases in SBP in the 93 mg group (p<0.05) and the 185 mg group (p<0.01) were statistically significant compared with the placebo group. Diastolic blood pressure (DBP) in the placebo, 46 mg, 93 mg, and 185 mg groups was reduced by -0.8+/-3.1 mmHg, -2.9+/-2.9 mmHg, -3.2+/-3.2 mmHg, and -3.9+/-2.8 mmHg from the baseline, respectively, and significant effects were observed in the 93 mg group (p<0.05) and the 185 mg group (p<0.01) compared with the placebo group. Both blood pressures were significantly reduced in a dose-related manner by GCE (p<0.001). Adverse effects caused by GCE were not observed. The results suggested that daily use of GCE has a blood pressure-lowering effect in patients with mild hypertension.

The Comparative Effects of 0.12% Chlorhexidine and Herbal Oral Rinse on Dental Plaque-Induced Gingivitis.

Site Editor — Fri, 09 Jun 2006 07:14:03 -0700

The Comparative Effects of 0.12% Chlorhexidine and Herbal Oral Rinse on Dental Plaque-Induced Gingivitis.: J Dent Hyg. 2006;80(1):12 Authors: Southern EN, McCombs GB, Tolle SL, Marinak K

PURPOSE: The purpose of this study was to determine the effects of two oral rinses-one 0.12% chlorhexidine rinse (CHX) and one herbal rinse (HBR)-on gingival health status over time. METHODS: Sixty-three participants were randomly assigned to one of three treatment groups: CHX, HBR, or placebo. For three months, participants rinsed twice daily (morning and evening) with (1/2) ounce of allocated rinse after brushing and flossing. Individuals were given the same type of soft bristle toothbrush and whitening toothpaste. No attempt was made to modify participants' routine oral care, except they were advised to refrain from use of any other oral rinse for the duration of the study. Data were collected at baseline (B), month one (1), two (2), and three (3) utilizing the Gingival Index (GI), Plaque Index (PI), and bleeding on probing (BOP). A full mouth periodontal probing was performed at baseline and at the completion of the study. A soft tissue oral assessment was completed at each visit. CHX, HBR, and placebo data were compared between three time intervals, B-1, B-2, and B-3. Statistical analysis was conducted by means of multiple regression using generalized linear models. Paired comparison tests - ANOVA followed by a post hoc Tukey test - were used to confirm results. RESULTS: CHX was the only oral rinse to demonstrate a statistically significant effect on the reduction of mean GI, BOP, and PI scores when compared to placebo. CHX demonstrated a 31% reduction in the proportion of GI scores between B-2 and a 29% reduction between B-3 (p=.003 and p=.012, respectively). CHX demonstrated a 19% reduction of BOP sites between B-1, 32% reduction between B-2, and 29% reduction between B-3 (p=.028, p=.000, and p=.005, respectively). CHX demonstrated a 20% reduction in PI scores between B-1, and a 28% reduction between B-2 (p=.005 and p=.032, respectively). The effects of HBR on reducing mean GI, BOP, and PI scores were not statistically greater than placebo at any time during the study.

Beneficial effects of the bioflavonoids curcumin and quercetin on early function in cadaveric renal transplantation...

Site Editor — Fri, 09 Jun 2006 07:12:22 -0700

Beneficial effects of the bioflavonoids curcumin and quercetin on early function in cadaveric renal transplantation: a randomized placebo controlled trial.: Transplantation. 2005 Dec 15;80(11):1556-9 Authors: Shoskes D, Lapierre C, Cruz-Corerra M, Muruve N, Rosario R, Fromkin B, Braun M, Copley J

BACKGROUND: The bioflavonoids quercetin and curcumin are renoprotective natural antioxidants. We wished to examine their effects on early graft function (EF). METHODS: Between September 2002 and August 2004, 43 dialysis dependent cadaveric kidney recipients were enrolled into a study using Oxy-Q which contains 480 mg of curcumin and 20 mg of quercetin, started after surgery and taken for 1 month. They were randomized into three groups: control (placebo), low dose (one capsule, one placebo) and high dose (two capsules). Delayed graft function (DGF) was defined as first week dialysis need and slow function (SGF) as Cr >2.5 mg/dl by day 10. Category variables were compared by chi squared and continuous variables by Kruskal-Wallis. RESULTS: There were four withdrawals: one by patient choice and three for urine leak. The control group had 2/14 patients with DGF vs. none in either treatment group. Incidence of EF was control 43%, low dose 71% and high dose 93% (P=0.013). Serum creatinine was significantly lower at 2 days (control 7.6+/-2.1, low 5.4+/-0.6, high 3.96+/-.35 P=0.0001) and 30 days (control 1.82+/-.16, low 1.65+/-.09, high 1.33 +/-.1, P=0.03). Acute rejection incidence within 6 months was control 14.3%, low dose 14.3% and high dose 0%. Tremor was detected in 13% of high dose patients vs. 46% of others. Urinary HO-1 was higher in bioflavonoid groups. CONCLUSION: Bioflavonoid therapy improved early graft function. Acute rejection and neurotoxicity were lowest in the high dose group. These bioflavonoids improve early outcomes in cadaveric renal transplantation, possibly through HO-1 induction.