ACIDFORM: a review of the evidence

Objective

ACIDFORM is a candidate microbicide with spermicidal properties. A large Phase 3 trial is underway, and it is anticipated that this product will be approved for contraceptive use and marketed soon in the United States. The goal of this article is to critically review the evidence supporting the properties, safety profile and different uses of ACIDFORM gel.

Study design

We searched PubMed and Medline for any published literature on ACIDFORM.

Results

ACIDFORM is an acidifying agent that works by lowering the vaginal pH to enhance the normal vaginal defenses. In addition to strong acid-buffering properties, ACIDFORM has high bioadhesive and viscosity-retaining properties. Several Phase 1 clinical trials have demonstrated the vaginal safety of ACIDFORM used alone or in combination with a diaphragm, although dose-dependent side effects appear to be present. Studies investigating the efficacy of ACIDFORM against sexually transmitted infections (STIs) are promising, but further trials are needed.

Conclusions

The properties of ACIDFORM offer many advantages for use, either alone or in combination with another active ingredient, such as Tenofovir. Potential applications for ACIDFORM include use as a personal lubricant, a vaginal contraceptive (alone or with a barrier method) and a microbicidal product or as a formulation vehicle for an active ingredient.

Implications

ACIDFORM is a candidate female-controlled vaginal preparation with microbicidal and spermicidal properties. A dual protection method could prevent unwanted pregnancies and reduce the risk of STI acquisition.     

Economic evidence in addiction: a review

The European Journal of Health Economics -     

Economic evidence in epilepsy: a review

The European Journal of Health Economics -     

Economic evidence in dementia: a review

The European Journal of Health Economics -     

Economic evidence in stroke: a review

The European Journal of Health Economics -     

Economic evidence in trauma: a review

The European Journal of Health Economics -     

Probiotics and health: a review of the evidence

Probiotics are live microorganisms – mainly bacteria – which when administered in adequate amounts confer a health benefit on the host. There is rising interest in this area, but reports in the media are often conflicting. The aim of this review is to consider the current evidence on the effects of probiotics on health, focusing on gut‐related health issues and the immune system, with the objective to provide a clearer picture of whether and how probiotics can be beneficial for health. The outcomes of this review are based on more than 100 original studies, meta‐analyses and systematic reviews. A variety of different strains have been used in studies on probiotics, and it is important to remember that the effectiveness of probiotics is strain‐specific, which means that each single probiotic strain has to be tested to assess its potential health benefits. Overall, despite the diversity of strains used in the studies included in this review, there is evidence that probiotics have the potential to be beneficial for our health. Studies in patients with inflammatory bowel disease show probiotic strains to be able to decrease the recurrence of ulcerative colitis and occurrence and recurrence of pouchitis, however, current evidence suggests that probiotics are ineffective in treating patients with Crohn's disease. Patients with irritable bowel syndrome show a reduction in symptoms when treated with selected probiotic strains, but high placebo effects have been reported as well. The evidence of the efficacy of probiotics in patients suffering from constipation is limited, but the evidence seems promising for some strains to bring relief to patients suffering from constipation. There is good evidence that a number of probiotic strains are effective in preventing antibiotic‐associated diarrhoea. The most commonly studied strains are Lactobacillus rhamnosus GG (LGG) and Saccharomyces boulardii, but other strains and mixtures of strains seem to be effective as well. There is also promising evidence of a preventive effect of probiotics in Clostridium difficile‐associated diarrhoea, although some studies have been too small to obtain statistically significant findings. The effect of probiotics in acute diarrhoea, particularly in children, is well studied. Selected probiotic strains seem to be effective in reducing the duration of acute diarrhoea. LGG and S. boulardii are again the most commonly used strains and a number of studies have shown them to be effective, although one meta‐analysis showed that the effect of LGG was only significant in children in Western countries, not in children in developing countries, which may be due to different causes of diarrhoea in these regions. Studies investigating the preventive effect of probiotics in the context of common cold and flu infections show that the studied strains failed to lower the incidence of episodes but that they have the potential to decrease the duration of episodes, which suggests that the immune system may be more efficient in fighting off common cold and flu infections after consuming these strains. The evidence so far does not suggest that probiotics are effective in preventing or treating allergies or in treating eczema. However, some probiotic strains seem to lower the risk of developing eczema if taken by pregnant women and their infants in early life.     

Economic evidence in anxiety disorders: a review

The European Journal of Health Economics -     

Economic evidence in brain tumour: a review

The European Journal of Health Economics -     

Economic evidence in psychotic disorders: a review

The European Journal of Health Economics -     

Economic evidence in affective disorders: a review

The European Journal of Health Economics -     

Economic evidence in multiple sclerosis: a review

The European Journal of Health Economics -     

Probiotics in clinical practice: a critical review of the evidence

The interaction of the gastrointestinal microflora with the human host has been the subject of considerable debate in the last decade. Manipulation of the enteric microflora with probiotic organisms has been attempted in a wide range of clinical settings, in the hope of achieving health benefits in the host. This review presents the evidence from human clinical trials of probiotics in the areas of diarrhoeal illness, inflammatory bowel disease, surgical prophylaxis, critical care and serum lipid modulation. With the exception of childhood viral diarrhoea, there is little evidence to support the use of probiotics in clinical practice at present. There are, however, sound theoretical reasons to support the role of probiotics in many other disease states.     

Parenting interventions: a systematic review of the economic evidence

Conduct disorder (CD) places huge costs on the individual, family and society. Parenting programmes can reduce CD symptomatology, but economic evaluations of their cost-effectiveness are rarely undertaken. The objective of this paper was to conduct the first specific systematic review of the published economic evidence of parenting programmes as a means to support families with children with or at risk of developing CD. A systematic search of 12 electronic databases was conducted. We identified 93 papers, of which six fulfilled the inclusion criteria. The search found one review article, mainly focusing upon clinical evidence with secondary focus on cost-effectiveness, one cost-effectiveness study, two partial economic evaluations and two cost studies. The costs of group parenting programme delivery ranged from ￡629.00 to ￡3839.00. Cost-effectiveness was influenced by intervention type and delivery method, i.e. individual versus group programme. The review highlights a need for a more standardized approach towards the comparison of the cost-effectiveness of parent programmes. In future studies it may be helpful to adopt a 'complex intervention approach', exploring in detail the attribution of cause and effect, the role of socio-economic setting and ripple effects, e.g. benefits to other family members.     

Breast cancer screening methods: a review of the evidence

Breast cancer remains a major health problem among Canadian women. Efforts directed at primary prevention of the disease are limited. Secondary prevention through screening appears to be the most promising intervention available in controlling the disease. In recent years, there have been ongoing debates over the effectiveness of available breast screening modalities (breast self-examination [BSE], clinical breast examination [CBE], and screening mammography). In this article I provide an overview of evidence related to each of the three breast screening modalities. The evidence shows that screening mammography and proper examination of breasts can be useful in reducing breast cancer mortality.     

Preoperative carbohydrate loading: a review of the current evidence

Background: Surgery induces a stress response associated with injury resulting in insulin resistance (Thorell et al., 1999). Fasting is a common procedure presurgery and leads to reduced insulin sensitivity as a result of disturbances in glucose, protein and fat metabolism. Reduced insulin sensitivity has been associated with increased surgical outcome and enhanced patient recovery (van den Berghe et al., 2001). The purpose of this study was to review the current evidence relating to preoperative carbohydrate loading, particularly focusing on outcomes including post‐operative complications, patient well‐being and length of hospital stay. Methods: A structured review was carried out in a systematic manner of randomised clinical trials published between 1998 and 2008 using four medical databases (Medline, CSA Illumni, Pubmed and ISI Web of Knowledge). The available literature published within the last 10 years that measured an objective clinical load was considered for inclusion. Initially, literature searches were commenced using the broad terms ‘preoperative’ and ‘carbohydrate’ (both terms present). This approach was then refined to improve specificity using the following terms in a variety of different combinations: preoperative carbohydrate load; oral carbohydrate; post‐operative period; hospital stay; preoperative nutrition; and treatment outcomes. Exclusion criteria included duplicate records, those not written in English language, animal studies, observational studies with and without controls, protocols, proposals, discussion papers and conference abstracts. The bibliographies of relevant literature were searched for further studies not found by the database searches. Results: A total of 16 randomised control trials were identified from initial searches. Of the 16 that were assessed in full form, three were excluded. The remaining thirteen randomised trials all measured clinical outcomes after a preoperative carbohydrate load 2–3 h prior to elective surgery. The study intervention was similar in each study. The number of patients included in each study varied greatly, from 12 to 252, with seven studies having unequal sample sizes between comparison groups. Nine of the 13 studies had a placebo group, and six studies had a control group. The post‐operative regimen was similar in all thirteen studies and was standardised in studied groups. The clinical, metabolic and nutritional outcomes were reported in all of the studies. Results showed that a preoperative carbohydrate load could reduce post‐operative insulin resistance. Statistical significance was not reached for length of hospital stay, improved well‐being and reduced loss of lean tissue, although trends were seen. None of the trials noted any adverse affects as a result of preoperative carbohydrate load. Discussion: The body of evidence surrounding reduced insulin resistance was of good quality and was consistent with a study by Nygren et al. (1995) where insulin resistance was shown to be reduced by 50% in the same population group. Statistically, individual studies did not provide significant evidence with regard to reduced length of stay, reduced loss of lean muscle mass and patient well‐being. Further research is warranted in all of the reported outcomes because a small sample size has resulted in trends, rather than conclusive evidence. A meta‐analysis may produce more conclusive results. Conclusions: A preoperative oral carbohydrate was associated with several positive outcomes; however, statistical significance was not reached as a result of the small nature of the studies. No adverse affects were associated with a preoperative oral carbohydrate 2–3 h prior to surgery; therefore, overnight fasting guidelines in elective surgery should be questioned. References Nygren, J., Thorell, A., Jacobsson, H., Larsson, S., Schnell, P., Hylen, L. & Ljundqvist, O. (1995) Preoperative gastric emptying: effects of anxiety and oral carbohydrate administration. Ann. Surg. 222 , 728–734. Thorell, A. Nygren, J. & Ljundqvist, O. (1995) Insulin resistance – a marker of surgical stress. Curr. Opin. Clin. Nutr. Metab Care 2 , 69–79. Van den Berghe, G., Wouters, P. & Weekers, F. (2001) Intensive insulin therapy in critically ill patients. N. Engl. J. Med. 345 , 1359–1367.