Impact of risk factors on cardiovascular risk: a perspective on risk estimation in a Swiss population.

INTRODUCTION: In models and scores for estimating cardiovascular risk (CVR), the relative weightings given to blood pressure measurements (BPMs), and biometric and laboratory variables are such that even large differences in blood pressure lead to rather low differences in the resulting total risk when compared with other concurrent risk factors. We evaluated this phenomenon based on the PROCAM score, using BPMs made by volunteer subjects at home (HBPMs) and automated ambulatory BPMs (ABPMs) carried out in the same subjects. METHODS: A total of 153 volunteers provided the data needed to estimate their CVR by means of the PROCAM formula. Differences (deltaCVR) between the risk estimated by entering the ABPM and that estimated with the HBPM were compared with the differences (deltaBPM) between the ABPM and the corresponding HBPM. In addition to the median values (= second quartile), the first and third quartiles of blood pressure profiles were also considered. PROCAM risk values were converted to European Society of Cardiology (ESC) risk values and all participants were assigned to the risk groups low, medium and high. RESULTS: Based on the PROCAM score, 132 participants had a low risk for suffering myocardial infarction, 16 a medium risk and 5 a high risk. The calculated ESC scores classified 125 participants into the low-risk group, 26 into the medium- and 2 into the high-risk group for death from a cardiovascular event. Mean ABPM tended to be higher than mean HBPM. Use of mean systolic ABPM or HBPM in the PROCAM formula had no major impact on the risk level. CONCLUSIONS: Our observations are in agreement with the rather low weighting of blood pressure as risk determinant in the PROCAM score. BPMs assessed with different methods had relatively little impact on estimation of cardiovascular risk in the given context of other important determinants. The risk calculations in our unselected population reflect the given classification of Switzerland as a so-called cardiovascular "low risk country".

Oral herbal therapies for treating osteoarthritis.

BACKGROUND: Medicinal plant products are used orally for treating osteoarthritis. Although their mechanisms of action have not yet been elucidated in full detail, interactions with common inflammatory mediators provide a rationale for using them to treat osteoarthritic complaints. OBJECTIVES: To update a previous Cochrane review to assess the benefits and harms of oral medicinal plant products in treating osteoarthritis. SEARCH METHODS: We searched electronic databases (CENTRAL, MEDLINE, EMBASE, AMED, CINAHL, ISI Web of Science, World Health Organization Clinical Trials Registry Platform) to 29 August 2013, unrestricted by language, and the reference lists from retrieved trials. SELECTION CRITERIA: Randomised controlled trials of orally consumed herbal interventions compared with placebo or active controls in people with osteoarthritis were included. Herbal interventions included any plant preparation but excluded homeopathy or aromatherapy products, or any preparation of synthetic origin. DATA COLLECTION AND ANALYSIS: Two authors used standard methods for trial selection and data extraction, and assessed the quality of the body of evidence using the GRADE approach for major outcomes (pain, function, radiographic joint changes, quality of life, withdrawals due to adverse events, total adverse events, and serious adverse events). MAIN RESULTS: Forty-nine randomised controlled studies (33 interventions, 5980 participants) were included. Seventeen studies of confirmatory design (sample and effect sizes pre-specified) were mostly at moderate risk of bias. The remaining 32 studies of exploratory design were at higher risk of bias. Due to differing interventions, meta-analyses were restricted to Boswellia serrata (monoherbal) and avocado-soyabean unsaponifiables (ASU) (two herb combination) products.Five studies of three different extracts from Boswellia serrata were included. High-quality evidence from two studies (85 participants) indicated that 90 days treatment with 100 mg of enriched Boswellia serrata extract improved symptoms compared to placebo. Mean pain was 40 points on a 0 to 100 point VAS scale (0 is no pain) with placebo, enriched Boswellia serrata reduced pain by a mean of 17 points (95% confidence interval (CI) 8 to 26); number needed to treat for an additional beneficial outcome (NNTB) 2; the 95% CIs did not exclude a clinically significant reduction of 15 points in pain. Physical function was 33 points on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) 0 to 100 point subscale (0 is no loss of function) with placebo, enriched Boswellia serrata improved function by 8 points (95% CI 2 to 14); NNTB 4. Assuming a minimal clinically important difference of 10 points, we cannot exclude a clinically important benefit in some people. Moderate-quality evidence (one study, 96 participants) indicated that adverse events were probably reduced with enriched Boswellia serrata (18/48 events versus 30/48 events with placebo; relative risk (RR) 0.60, 95% CI 0.39 to 0.92). Possible benefits of other Boswellia serrata extracts over placebo were confirmed in moderate-quality evidence from two studies (97 participants) of Boswellia serrata (enriched) 100 mg plus non-volatile oil, and low-quality evidence from small single studies of a 999 mg daily dose of Boswellia serrata extract and 250 mg daily dose of enrichedBoswellia serrata. It was uncertain if a 99 mg daily dose of Boswellia serrata offered benefits over valdecoxib due to the very low-quality evidence from a small single study. It was uncertain if there was an increased risk of adverse events or withdrawals with Boswellia serrata extract due to variable reporting of results across studies. The studies reported no serious adverse events. Quality of life and radiographic joint changes were not measured.Six studies examined the ASU product Piasclidine®. Moderate-quality evidence from four studies (651 participants) indicated that ASU 300 mg produced a small and clinically questionable improvement in symptoms, and probably no increased adverse events compared to placebo after three to 12 months treatment. Mean pain with placebo was 40.5 points on a VAS 0 to 100 scale (0 is no pain), ASU 300 mg reduced pain by a mean of 8.5 points (95% CI 1 to 16 points); NNTB 8. ASU 300 mg improved function (standardised mean difference (SMD) -0.42, 95% CI -0.73 to -0.11). Function was estimated as 47 mm (0 to 100 mm scale, where 0 is no loss of function) with placebo, ASU 300 mg improved function by a mean of 7 mm (95% CI 2 to 12 mm); NNTB 5 (3 to 19). There were no differences in adverse events (5 studies, 1050 participants) between ASU (53%) and placebo (51%) (RR 1.04, 95% CI 0.97 to 1.12); withdrawals due to adverse events (1 study, 398 participants) between ASU (17%) and placebo (15%) (RR 1.14, 95% CI 0.73 to 1.80); or serious adverse events (1 study, 398 participants) between ASU (40%) and placebo (33%) (RR 1.22, 95% CI 0.94 to 1.59). Radiographic joint changes, measured as change in joint space width (JSW) in two studies (453 participants) did not differ between ASU 300 mg treatment (-0.53 mm) and placebo (-0.65 mm); mean difference of -0.12 (95% CI -0.43 to 0.19). Moderate-quality evidence from a single study (156 participants) confirmed possible benefits of ASU 600 mg over placebo, with no increased adverse events. Low-quality evidence (1 study, 357 participants) indicated there may be no differences in symptoms or adverse events between ASU 300 mg and chondroitin sulphate. Quality of life was not measured.All other herbal interventions were investigated in single studies, limiting conclusions. No serious side effects related to any plant product were reported. AUTHORS' CONCLUSIONS: Evidence for the proprietary ASU product Piasclidine® in the treatment of osteoarthritis symptoms seems moderate to high for short term use, but studies over a longer term and against an apparently active control are less convincing. Several other medicinal plant products, including extracts of Boswellia serrata, show trends of benefits that warrant further investigation in light of the fact that the risk of adverse events appear low.There is no evidence that Piasclidine® significantly improves joint structure, and limited evidence that it prevents joint space narrowing. Structural changes were not tested for with any other herbal intervention.Further investigations are required to determine optimum daily doses producing clinical benefits without adverse events.

Best available evidence in cochrane reviews on herbal medicine?

Cochrane reviews are considered by many to be the "gold standard" or the final word in medical conversation on a topic. We explored the eleven most relevant Cochrane reviews on herbal medicine and identified that frequently herbal medicines in the included studies had not been sufficiently well characterised. If data on the effects of the plant parts are unavailable, effects of co-active ingredients need to be considered and the plausibility of the study medications for the specific indications discussed. Effect sizes calculated from exploratory studies would be best used to determine the sample sizes required for future confirmatory studies, rather than as definitive reports of intervention effects. Reviews should be comprehensive, including discussion of putative adverse events and possible drug interactions. We suggest that the guidelines for preparing Cochrane reviews be revised and offer assistance in this task.

Topical herbal therapies for treating osteoarthritis.

BACKGROUND: Before extraction and synthetic chemistry were invented, musculoskeletal complaints were treated with preparations from medicinal plants. They were either administered orally or topically. In contrast to the oral medicinal plant products, topicals act in part as counterirritants or are toxic when given orally. OBJECTIVES: To update the previous Cochrane review of herbal therapy for osteoarthritis from 2000 by evaluating the evidence on effectiveness for topical medicinal plant products. SEARCH METHODS: Databases for mainstream and complementary medicine were searched using terms to include all forms of arthritis combined with medicinal plant products. We searched electronic databases (Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, AMED, CINAHL, ISI Web of Science, World Health Organization Clinical Trials Registry Platform) to February 2013, unrestricted by language. We also searched the reference lists from retrieved trials. SELECTION CRITERIA: Randomised controlled trials of herbal interventions used topically, compared with inert (placebo) or active controls, in people with osteoarthritis were included. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials for inclusion, assessed the risk of bias of included studies and extracted data. MAIN RESULTS: Seven studies (six different medicinal plant interventions; 785 participants) were included. Single studies (five studies) and non-comparable studies (two studies) precluded pooling of results.Moderate evidence from a single study of 174 people with hand osteoarthritis indicated that treatment with Arnica extract gel probably results in similar benefits as treatment with ibuprofen (non-steroidal anti-inflammatory drug) with a similar number of adverse events. Mean pain in the ibuprofen group was 44.2 points on a 100 point scale; treatment with Arnica gel reduced the pain by 4 points after three weeks: mean difference (MD) -3.8 points (95% confidence intervals (CI) -10.1 to 2.5), absolute reduction 4% (10% reduction to 3% increase). Hand function was 7.5 points on a 30 point scale in the ibuprofen-treated group; treatment with Arnica gel reduced function by 0.4 points (MD -0.4, 95% CI -1.75 to 0.95), absolute improvement 1% (6% improvement to 3% decline)). Total adverse events were higher in the Arnica gel group (13% compared to 8% in the ibuprofen group): relative risk (RR) 1.65 (95% CI 0.72 to 3.76).Moderate quality evidence from a single trial of 99 people with knee osteoarthritis indicated that compared with placebo, Capsicum extract gel probably does not improve pain or knee function, and is commonly associated with treatment-related adverse events including skin irritation and a burning sensation. At four weeks follow-up, mean pain in the placebo group was 46 points on a 100 point scale; treatment with Capsicum extract reduced pain by 1 point (MD -1, 95% CI -6.8 to 4.8), absolute reduction of 1% (7% reduction to 5% increase). Mean knee function in the placebo group was 34.8 points on a 96 point scale at four weeks; treatment with Capsicum extract improved function by a mean of 2.6 points (MD -2.6, 95% CI -9.5 to 4.2), an absolute improvement of 3% (10% improvement to 4% decline). Adverse event rates were greater in the Capsicum extract group (80% compared with 20% in the placebo group, rate ratio 4.12, 95% CI 3.30 to 5.17). The number needed to treat to result in adverse events was 2 (95% CI 1 to 2).Moderate evidence from a single trial of 220 people with knee osteoarthritis suggested that comfrey extract gel probably improves pain without increasing adverse events. At three weeks, the mean pain in the placebo group was 83.5 points on a 100 point scale. Treatment with comfrey reduced pain by a mean of 41.5 points (MD -41.5, 95% CI -48 to -34), an absolute reduction of 42% (34% to 48% reduction). Function was not reported. Adverse events were similar: 6% (7/110) reported adverse events in the comfrey group compared with 14% (15/110) in the placebo group (RR 0.47, 95% CI 0.20 to 1.10).Although evidence from a single trial indicated that adhesive patches containing Chinese herbal mixtures FNZG and SJG may improve pain and function, the clinical applicability of these findings are uncertain because participants were only treated and followed up for seven days. We are also uncertain if other topical herbal products (Marhame-Mafasel compress, stinging nettle leaf) improve osteoarthritis symptoms due to the very low quality evidence from single trials.No serious side effects were reported. AUTHORS' CONCLUSIONS: Although the mechanism of action of the topical medicinal plant products provides a rationale basis for their use in the treatment of osteoarthritis, the quality and quantity of current research studies of effectiveness are insufficient. Arnica gel probably improves symptoms as effectively as a gel containing non-steroidal anti-inflammatory drug, but with no better (and possibly worse) adverse event profile. Comfrey extract gel probably improves pain, and Capsicum extract gel probably will not improve pain or function at the doses examined in this review. Further high quality, fully powered studies are required to confirm the trends of effectiveness identifed in studies so far.

Comparison of the effects of pelargonic acid vanillylamide and capsaicin on human vanilloid receptors.

Pelargonic acid vanillylamide is like capsaicin a natural capsaicinoid from chili peppers and commonly used in food additives to create a hot sensation, even in self-defense pepper sprays and as an alternative to capsaicin in medical products for topical treatment of pain. Although the chemical structures of both compounds are similar, preclinical data suggest that capsaicin is the more potent compound. We therefore performed voltage-clamp recordings using cells transfected with the human vanilloid receptor TRPV1 in order to assess the responses of pelargonic acid vanillylamide and capsaicin at the receptor level. We provide evidence that at the molecular target TRPV1, the concentration-response curves, kinetics of current activation, as well as inhibition by the competitive antagonist capsazepine were not significantly different between the two capsaicinoids. We suggest that the different effects of the two capsaicinoids observed in previous studies may rather be due to different physicochemical or pharmacokinetic properties than to different pharmacological profiles at the receptor level.

Effectiveness and safety of a mouthwash containing essential oil ingredients.

The mouthwash, Listerine®, was compounded in 1879 from four essential oils. Later, the oils were replaced by one ingredient per oil with approximately 25% ethanol as a vehicle to keep them in solution. From then on, Listerine® was no longer a medicinal plant product. In 2003, a review by the FDA Subcommittee on Oral Health Care Drug Products for Over-the-Counter Human Use concluded that the product is effective and safe, and a review of studies published in the meantime showed that Listerine® fulfils the consensus criteria for an effective antigingivitis/antiplaque product. However, concerns have been raised about the long-term safety of some of the ingredients, particularly the ethanol content, and in the light of these concerns, the evidence has been re-examined for both the efficacy and safety of Listerine®. In summary, the studies support the claim that Listerine® shows benefit for oral health, but the concerns over its safety remain to be clarified. Until these have been addressed, high risk populations (children, alcohol addicts, patients with genetic deficiencies in ethanol metabolism) should use alcohol-free mouthwashes for the maintenance of oral health.

Rise and fall of oral health products with Canadian bloodroot extract.

The rhizome of Sanguinaria canadensis (SC, bloodroot) contains an active principle with antimicrobial, antiinflammatory, antioxidative and immunomodulatory effects. For this reason SC extract has been added to toothpastes and mouthwashes in various concentrations. When tested separately, neither the toothpastes nor the mouthwashes with SC extract had any demonstrable clinical effectiveness against dental plaque and gingivitis. Although using them together twice a day seemed more effective than using placebo, more recent studies have shown conflicting results. Preclinical safety studies up to 2000, which did not include studies longer than 6 months, were thought not to indicate any appreciable potential for harm - to the oral mucosa in particular. In 2003, the FDA Subcommittee on Oral Health Care Drug Products for Over-the-Counter Human Use concluded from a review that using SC-containing products is safe. However, for reasons unknown, the review failed to consider publications between 1999 and 2001 that suggested a possible link between the use of SC-containing products and the pre-neoplastic lesion, leukoplakia. As it happened, bloodroot had already been removed (in 2001) from the formula of one of the most widely used products in question and the brand has since then disappeared altogether from the worldwide market.

Efficacy of a benzocaine lozenge in the treatment of uncomplicated sore throat.

Benzocaine lozenges are popular in symptomatic treatment of acute sore throat. The aim of this study was to evaluate if sucking a benzocaine lozenge was superior to a placebo lozenge in patients with pain while swallowing. Volunteers with acute, uncomplicated sore throat received randomly and double-blind either a benzocaine 8 mg or a placebo lozenge. Pain was assessed on a numerical visual rating scale. The primary outcome measure was the sum of the pain intensity differences (SPID) over 2 h. Secondary outcome measures included the number of patients who reported 50% or more of their baseline pain score (responders) and those with worthwhile and complete pain relief, the times to worthwhile/complete pain relief and to pain recurrence and the occurrence of any adverse effects. A predefined interim analysis after including 50 patients revealed the superiority of benzocaine versus placebo in the SPID (p = 0.0086). At this time, a total of 165 patients had been recruited (full analysis set, FAS) and underwent statistical analysis. In the FAS, median SPID had significantly more decreased in patients receiving benzocaine compared to placebo (-12 vs. - 5, p = 0.001). There were significantly more responders and patients with worthwhile pain relief in group benzocaine. The number of patients with complete pain relief was very small. Median time to worthwhile pain relief was 20 min (benzocaine) and >45 min (placebo). Adverse events were not observed. Benzocaine lozenges are superior to placebo lozenges and a useful, well-tolerated treatment option to reduce painful pharyngeal discomfort.

A double-blind placebo-controlled trial to study therapeutic effects of probiotic Escherichia coli Nissle 1917 in subgroups of patients with irritable bowel syndrome.

PURPOSE: To study the therapeutic effects of probiotic Escherichia coli Nissle 1917 (EcN) in irritable bowel syndrome (IBS) and identify subgroups benefiting most. BACKGROUND: Some trials investigating therapeutic effects in irritable bowel syndrome have shown benefits in IBS subgroups only. Probiotic treatment seems to be promising. METHODS: Patients with irritable bowel syndrome (120; Rome II) were recruited to a prospective double-blind study and randomized to either EcN (n = 60) or placebo (n = 60) given for 12 weeks. Objectives were to describe efficacy and safety of EcN in different groups of irritable bowel syndrome. Outcome was assessed by 'Integrative Medicine Patient Satisfaction Scale'. RESULTS: Altogether, the responder rate was higher in the EcN than in the placebo group. However, only after 10 and 11 weeks, the differences were significant (Δ 20.0% points [95% CI 2.6; 37.4], p = 0.01 and Δ 18.3% points [95% CI 1.0; 35.7], p = 0.02, respectively). The best response was observed in the subgroup of patients with gastroenteritis or antibiotics prior to irritable bowel syndrome onset (Δ 45.7% points, p = 0.029). No significant differences were observed in any other subgroup. Both treatment groups showed similar adverse events and tolerance. CONCLUSIONS: Probiotic EcN shows effects in irritable bowel syndrome, especially in patients with altered enteric microflora, e.g. after gastroenterocolitis or administration of antibiotics.

Herbal therapy for treating rheumatoid arthritis.

BACKGROUND: Herbal medicine interventions have been identified as having potential benefit in the treatment of rheumatoid arthritis (RA). OBJECTIVES: To update an existing systematic (Cochrane) review of herbal therapies in RA. SEARCH STRATEGY: We searched electronic databases Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library), MEDLINE, EMBASE, AMED, CINAHL, Web of Science, Dissertation Abstracts (1996 to 2009), unrestricted by language, and the WHO International Clinical Trials Registry Platform in October 2010. SELECTION CRITERIA: Randomised controlled trials of herbal interventions compared with placebo or active controls in RA. DATA COLLECTION AND ANALYSIS: Two authors selected trials for inclusion, assessed risk of bias and extracted data.  MAIN RESULTS: Twelve new studies were added to the update, a total of 22 studies were included.Evidence from seven studies indicate potential benefits of gamma linolenic acid (GLA) from evening primrose oil, borage seed oil, or blackcurrent seed oil, in terms of reduced pain intensity (mean difference (MD) -32.83 points, 95% confidence interval (CI) -56.25 to -9.42,100 point pain scale); improved disability (MD -15.75% 95% CI -27.06 to -4.44%); and an increase in adverse events (GLA 20% versus placebo 3%), that was not statistically different (relative risk 4.24, 95% CI 0.78 to 22.99).Three studies compared Tripterygium wilfordii (thunder god vine) to placebo and one to sulfasalazine and indicated improvements in some outcomes, but data could not be pooled due to differing interventions, comparisons and outcomes. One study reported serious side effects with oral Tripterygium wilfordii Hook F. In the follow-up studies, all side effects were mild to moderate and resolved after the intervention ceased. Two studies compared Phytodolor(®) N to placebo but poor reporting limited data extraction. The remaining studies each considered differing herbal interventions. AUTHORS' CONCLUSIONS: Several herbal interventions are inadequately justified by single studies or non-comparable studies in the treatment of rheumatoid arthritis. There is moderate evidence that oils containing GLA (evening primrose, borage, or blackcurrant seed oil) afford some benefit in relieving symptoms for RA, while evidence for Phytodolor® N is less convincing.Tripterygium wilfordii products may reduce some RA symptoms, however, oral use may be associated with several side effects. Many trials of herbal therapies are hampered by research design flaws and inadequate reporting. Further investigation of each herbal therapy is warranted, particularly via well designed, fully powered, confirmatory clinical trials that use American College of Rheumatology improvement criteria to measure outcomes and report results according to CONSORT guidelines.

Variability of office, 24-hour ambulatory, and self-monitored blood pressure measurements.

BACKGROUND: The diagnosis of hypertension is difficult when faced with several different blood pressure measurements in an individual. Using the average of several office measurements is recommended, although considerable uncertainty remains. Twenty-four-hour ambulatory monitoring is often considered the gold standard, but self-monitoring of blood pressure has been proposed as a superior method. AIM: Determination of within-individual variability of blood pressure measured in the office, by ambulatory monitoring, and by a week of self-monitoring. DESIGN OF STUDY: Retrospective analysis of a clinical trial of 163 subjects. METHOD: Within-patient variability of office and ambulatory blood pressure was determined from measurements at 0 and 6 weeks. Subjects had performed self-monitoring of blood pressure twice each morning and evening, for at least 6 weeks; variability was determined from the means of week 1 and week 6. RESULTS: The within-individual coefficients of variation (CVs) for systolic blood pressure were: office, 8.6%; ambulatory, 5.5%; self, 4.2%. Equivalent values for diastolic blood pressure were 8.6%, 4.9%, and 3.9%. CVs tended to be lower with longer self-monitoring duration, and higher with longer intervals between self-monitoring. CONCLUSION: Office blood pressure is impractical for precise assessment, as 10-13 measurements are required to give the accuracy required for rational titration of antihypertensive drugs. Twenty-four-hour ambulatory monitoring is better than a single office measurement, but considerable uncertainty remains around the estimate. A week of self-monitoring appears to be the most accurate method of measuring blood pressure, but remains imperfect. Further research may identify superior self-monitoring schedules. Given the inherent accuracy in blood pressure measurement, the importance of considering overall cardiovascular risk is emphasised.

Evidence of effectiveness of herbal medicinal products in the treatment of arthritis. Part 2: Rheumatoid arthritis.

Herbal medicinal products (HMPs) that interact with the mediators of inflammation are used in the treatment of rheumatoid arthritis (RA). The aim of this study was to update a previous systematic review published in 2000. We searched electronic databases (MEDLINE, EMBASE, CISCOM, AMED, CINAHL, Cochrane registers) to June 2007, unrestricted by date or language, and included randomized controlled trials that compared HMPs with inert (placebo) or active controls in patients with rheumatoid arthritis. Five reviewers contributed to data extraction. Disagreements were discussed and resolved by consensus with reference to Cochrane guidelines and advice from the Cochrane Collaboration. Twenty studies (10 identified for this review update, and 10 of the 11 studies of the original review) investigating 14 HMPs were included. Meta-analysis was restricted to data from previous seven studies with oils from borage, blackcurrant and evening primrose containing gamma linolenic acid (GLA). GLA doses equal or higher than 1400 mg/day showed benefit in the alleviation of rheumatic complaints whereas lower doses ( approximately 500 mg) were ineffective. Three studies compared products from Tripterygium wilfordii (thunder god vine) to placebos and returned favorable results but data could not be pooled because the interventions and measures differed. Serious adverse effects occurred in one study. In a follow-up study all side effects were mild to moderate and resolved after the intervention ceased, but time to resolution was variable. Two studies comparing Phytodolor NR to placebo were of limited use because some measures were poorly defined. The remaining studies, each considering differing HMPs, were assessed individually. For most HMPs used in the treatment of RA, the evidence of effectiveness was insufficient to either recommend or discourage their use. Interventions with HMPs containing GLA or Tripterygium wilfordii extract appear to produce therapeutic effects but further investigations are warranted to prove their effectiveness and safety.

Evidence of effectiveness of herbal medicinal products in the treatment of arthritis. Part I: Osteoarthritis.

Herbal medicinal products (HMPs) are used in a variety of oral and topical forms for the treatment of osteoarthritis. The aim of this study was to update a previous systematic review published in 2000. We searched electronic databases (MEDLINE, EMBASE, CISCOM, AMED, CINAHL, Cochrane registers) to June 2007, unrestricted by date or language, and included randomized controlled trials that compared HMPs with inert (placebo) or active controls in patients with osteoarthritis. Five reviewers contributed to data extraction. Disagreements were discussed and resolved by consensus with reference to Cochrane guidelines and advice from the Cochrane Collaboration.Thirty-five studies (30 studies identified for this review update, and 5 studies included in the original review) evaluating the effectiveness of 22 HMPs were included. However, due to differing HMPs, interventions, comparators, and outcome measures, meta-analysis was restricted to data from studies of three HMPs: topical capsaicin, avocado-soybean unsaponifiables, and the Chinese herbal mixture SKI306X showed benefit in the alleviation of osteoarthritic pain.Several studies investigating products from devil's claw, and a powder from rose hip and seed, reported favorable effects on osteoarthritic pain, whereas two studies of a willow bark extract returned disparate results. Three studies of Phytodolor N(R) were of limited use because doses and measures were inconsistent among trials. The remaining single studies for each HMP provided moderate evidence of effectiveness. No serious side effects were reported with any herbal intervention.Despite some evidence, the effectiveness of none of the HMPs is proven beyond doubt. The obvious potential benefits of HMPs in the treatment of osteoarthritis are reduced reliance on synthetic medications with the associated risks of harmful adverse events, but further clinical trials are necessary before HMPs can be adopted in osteoarthritis treatment guidelines.

Asparagus P(R) cannot compete with first-line diuretics in lowering the blood pressure in treatment-requiring antihypertensives.

A six week clinical surveillance of 163 patients receiving maximally tolerable doses of Asparagus P((R)), a proprietary mixture pulversied dried asparagus root and parsley leaf, has not indicated any clinically useful antihypertensive effect. The profile of adverse events (with 7 patients leaving the surveillance early because of renally related complaints) contraindicates its use in hypertension or to promote flushing of the efferent tract in rental inflammatory conditions or urolithiasis.

A systematic review on the Rosa canina effect and efficacy profiles.

Rose hip, rose hip and seed and rose hip seed, all were negatively monographed by the German Commission E due to insufficient evidence of effects and effectiveness. Therefore a comprehensive review of the literature was conducted to summarize the pharmacological and clinical effects of Rosa canina L. to reevaluate its usefulness in traditional medicine. For various preparations of rose hip and rose hip and seed, antioxidative and antiinflammatory effects have been demonstrated. Lipophilic constituents are involved in those mechanisms of action. The proprietary rose hip and seed powder Litozin has been employed successfully in a number of exploratory studies in patients suffering from osteoarthritis, rheumatoid arthritis and low back pain. However, the sizes of the clinical effects for the different indications need to be determined to assure clinical significance. There is also a rationale behind the use of Litozin as part of a hypocaloric diet based on the rose hip probiotic, stool regulating and smooth muscle-relaxing actions, as well as the rose hip seed lipid-lowering, antiobese and antiulcerogenic effects. Further research is needed to clarify the importance of the reported promising experimental effects in clinical use and to characterize the optimum rose hip seed oil preparation for topical use in the treatment of skin diseases.

An observational study and quantification of the actives in a supplement with Sambucus nigra and Asparagus officinalis used for weight reduction.

The aim of the study was to obtain information on the content of co-active compounds of a food supplement recommended as a weight reduction diet and on its short-term effectiveness and safety as a starter for lifestyle change. Eighty participants completed the protocol. The Sambucus nigra L. berry juice enriched with flower extract and tablets containing berry powder and flower extract provided a total of 1 mg anthocyanins, 370 mg flavonol glycosides and 150 mg hydroxycinnamates per day; the Asparagus officinalis L. powder tablets provided 19 mg saponins per day. After the diet, the mean weight, blood pressure, physical and emotional well-being and the quality of life had significantly improved (ITT analysis). The effectiveness and tolerability of the regimen were rated as very good or good by most of the completers. It remains to be established if any particular compounds contribute to the efficacy of the diet.

Impact of a proprietary concentrate of Sambucus nigra L. on urinary pH.

A proprietary concentrate from Sambucus nigra L.--in its diluted preparation as part of a hypocaloric diet available in Switzerland--had no impact on urinary pH, urinary hydrogen ion concentrations or 24 h excretion and thus did not influence the solubility of stone-inducing ions.