Double-blind Placebo-controlled Pilot Study Research Articles

Acute intake of mulberry leaf aqueous extract affects postprandial glucose response after maltose loading: Randomized double-blind placebo-controlled pilot study

Mulberry leaf extract was investigated as a potent alpha-glucosidase inhibitor, especially for individuals with prediabetes. We evaluated the effect of the ingestion of mulberry leaf aqueous extract (MLAE) on postprandial glucose responses in healthy subjects. We carried out a randomized, double-blind, placebo-controlled trial to determine the intake amount of MLAE (1.25, 2.5, or 5g) and time necessary to impact postprandial blood glucose levels after 75g of maltose loading in 50 healthy subjects. Ingestion of MLAE led to a decrease in postchallenge acute glucose levels following intake of 2.5 or 5g of MLAE at 30 and 60min (P=0.0137 and 0.0423, respectively). There was no significant difference between pre- and simultaneous administration of MLAE. The ingestion of MLAE resulted in improved postprandial glycemic control in healthy subjects.

Consumption of gluten with gluten-degrading enzyme by celiac patients: A pilot-study

To assesses the safety and efficacy of Aspergillus niger prolyl endoprotease (AN-PEP) to mitigate the immunogenic effects of gluten in celiac patients. Patients with initial diagnosis of celiac disease as confirmed by positive serology with subtotal or total villous atrophy on duodenal biopsies who adhere to a strict gluten-free diet (GFD) resulting in normalised antibodies and mucosal healing classified as Marsh 0 or I were included. In a randomised double-blind placebo-controlled pilot study, patients consumed toast (approximately 7 g/d gluten) with AN-PEP for 2 wk (safety phase). After a 2-wk washout period with adherence of the usual GFD, 14 patients were randomised to gluten intake with either AN-PEP or placebo for 2 wk (efficacy phase). Measurements at baseline included complaints, quality-of-life, serum antibodies, immunophenotyping of T-cells and duodenal mucosa immunohistology. Furthermore, serum and quality of life questionnaires were collected during and after the safety, washout and efficacy phase. Duodenal biopsies were collected after the safety phase and after the efficacy phase. A change in histological evaluation according to the modified Marsh classification was the primary endpoint. In total, 16 adults were enrolled in the study. No serious adverse events occurred during the trial and no patients withdrew during the trial. The mean score for the gastrointestinal subcategory of the celiac disease quality (CDQ) was relatively high throughout the study, indicating that AN-PEP was well tolerated. In the efficacy phase, the CDQ scores of patients consuming gluten with placebo or gluten with AN-PEP did not significantly deteriorate and moreover no differences between the groups were observed. During the efficacy phase, neither the placebo nor the AN-PEP group developed significant antibody titers. The IgA-EM concentrations remained negative in both groups. Two patients were excluded from entering the efficacy phase as their mucosa showed an increase of two Marsh steps after the safety phase, yet with undetectable serum antibodies, while 14 patients were considered histologically stable on gluten with AN-PEP. Also after the efficacy phase, no significant deterioration was observed regarding immunohistological and flow cytometric evaluation in the group consuming placebo compared to the group receiving AN-PEP. Furthermore, IgA-tTG deposit staining increased after 2 wk of gluten compared to baseline in four out of seven patients on placebo. In the seven patients receiving AN-PEP, one patient showed increased and one showed decreased IgA-tTG deposits. AN-PEP appears to be well tolerated. However, the primary endpoint was not met due to lack of clinical deterioration upon placebo, impeding an effect of AN-PEP.

233 Forearm Ultrasound-Guided Nerve Blocks versus Anatomic Wrist Blocks for Hand Anesthesia in Healthy Volunteers: A Randomized Double-Blinded Placebo-Controlled Pilot Study

Emergency department (ED) patients commonly present with painful hand injuries requiring anesthesia for exploration, manipulation, drainage, and/or repair. Forearm ultrasound-guided nerve (FUN) blocks by emergency physicians have been described, yet no study has directly compared this technique to anatomic wrist (AW) blocks. This study aims to compare the degree of anesthesia produced by FUN blocks versus AW blocks. Secondary outcomes include subjective perception of anesthesia, and the pain associated with each procedure. This is a prospective randomized double-blinded placebo-controlled study of healthy volunteers. Subjects chose between 1 and 3 nerves (median, ulnar or radial) for nerve block. When a nerve was selected, subjects underwent injections targeting this nerve at bilateral wrists (AW blocks) and bilateral forearms (FUN blocks). One arm was randomly assigned to receive an anesthetic block at the forearm and a placebo block at the wrist, while the other arm received a placebo block at the forearm and an anesthetic block at the wrist. All anesthetic blocks were performed with 3ml of 1% lidocaine buffered (1:10) with sodium bicarbonate. All placebo injections consisted of 3ml of normal saline. A single operator trained in both AW and FUN blocks performed all injections. The operator and subjects were blinded to the contents of the syringes. Objective evaluation of blocks was performed by a blinded observer, performing pinprick tests at pre-selected standard locations on the hand corresponding to the appropriate sensory nerve distribution. Evaluation began 15 minutes after injections, and was repeated at 15-minute intervals for a total of 60 minutes. A block was considered successful if complete anesthesia was obtained at 15 minutes after the injection was finished. Sample size was estimated at 18 pairs of nerves to detect a difference of 45% in block success. 12 subjects underwent blocks of 18 pairs of nerves (3 median, 7 ulnar, 8 radial). Mean time for AW block injection was 35 seconds, and for FUN block injection was 67 seconds. At 15 minutes post injection, 14/18 (78%; 95% confidence interval (CI) 59% to 97%) of nerves blocked using the FUN block were successfully blocked, as opposed to 10/18 (56%; 95% CI 33% to 79%) of nerves blocked using the AW block. Subjects felt that the pain of the procedure was greater in 5/18 (28%; 95% CI 7% to 48%) FUN blocks, and 10/18 (56%; 95% CI 33% to 79%) AW blocks. Subjectively, subjects felt that more complete anesthesia was achieved in 12/18 (67%; 95% CI 45% to 89%) FUN blocks, as opposed to 1/18 (6%; 95% CI -5% to 16%) AW blocks. This preliminary study did not detect a statistically significant difference in hand anesthesia at 15 minutes when comparing forearm ultrasound-guided (FUN) blocks to traditional anatomic wrist (AW) blocks. While there was a trend toward higher block success with FUN blocks, this study was underpowered to detect a difference less than 45% between the 2 techniques. Of note, FUN blocks did result in statistically higher overall subjective anesthesia, and this may be of significant value when applied to patients who require painful procedures to address their injuries. A randomized trial comparing FUN blocks to AW blocks for ED patients with hand injuries is warranted.

A randomized double-blind placebo-controlled pilot study to assess the efficacy of a 24-week topical treatment by latanoprost 0.1% on hair growth and pigmentation in healthy volunteers with androgenetic alopecia

Latanoprost is a prostaglandin analogue used to treat glaucoma. It can cause adverse effects, such as iridial and periocular hyperpigmentation, and eyelash changes including pigmentation and increased thickness, length, and number. Latanoprost has been used to treat eyelash alopecia, but knowledge on its effects on human scalp hair growth is not available. The primary objectives were to assess the efficacy of latanoprost on hair growth and pigmentation. The secondary objectives were to assess the effect on scalp pigmentation; investigate the treatment duration needed to affect hair growth, hair pigmentation, and scalp pigmentation; and assess safety of latanoprost. Sixteen men with mild androgenetic alopecia (Hamilton II-III) were included. Latanoprost 0.1% and placebo were applied daily for 24 weeks on two minizones on the scalp. Measurements on hair growth, density, diameter, pigmentation, and anagen/telogen ratio were performed throughout the study. At 24 weeks, an increased hair density on the latanoprost-treated site was observed compared with baseline (n = 16, P < .001) and placebo-treated site (P = .0004). Only young men with mild androgenetic alopecia were included. The results may not be applicable to other patient groups. Choice of investigational site may have affected the results. Latanoprost significantly increased hair density (terminal and vellus hairs) at 24 weeks compared with baseline and the placebo-treated area. Latanoprost could be useful in stimulating hair follicle activity and treating hair loss.

American ginseng does not improve fatigue in multiple sclerosis: a single center randomized double-blind placebo-controlled crossover pilot study

This study examined the safety and efficacy of an escalating dose (100 mg, 200 mg, 400 mg/day) of American ginseng over 6 weeks in a single-center, randomized, double-blind, placebo-controlled, crossover trial with 56 subjects with multiple sclerosis and fatigue. There were no serious adverse events but fatigue on ginseng, as assessed by the Fatigue Severity Scale, was not significantly different from fatigue on placebo.

Effects of the α7 Nicotinic Acetylcholine Receptor Agonist Gts-21 on the Innate Immune Response in Humans

The vagus nerve can reflexively attenuate the innate immune response via binding of the vagal neurotransmitter acetylcholine (ACh) to the α7 nicotinic ACh receptor (α7nAChR). We recently reported potent anti-inflammatory effects of the α7nAChR agonist GTS-21 in human leukocytes. In the present work, we investigated the anti-inflammatory effects of GTS-21 on the innate immune response during experimental human endotoxemia. We performed a double-blind placebo-controlled pilot study in 14 healthy nonsmoking male volunteers. Subjects received 150 mg GTS-21 (n = 7) or placebo (n = 7) orally three times per day during 3 days before endotoxin administration and on the day of the human endotoxemia experiment. This GTS-21 dosage scheme is the highest reported to be safe in humans. Subsequently, subjects were i.v. administered 2 ng/kg endotoxin (LPS derived from Escherichia coli O:113). Serial blood withdrawals were performed to determine GTS-21 plasma concentrations and inflammatory mediators. Plasma concentrations of GTS-21 and its active metabolite 4-OH-GTS-21 were highly variable between subjects. LPS administration resulted in a transient inflammatory response. There were no differences in the LPS-induced cytokine response between the GTS-21- and placebo-treated groups. However, within the GTS-21-treated group, higher GTS-21 plasma concentrations correlated with lower levels of TNF-α (r = -0.78, P = 0.03), IL-6 (r = -0.76, P = 0.04), and IL-1RA (r = -0.86, P = 0.01), but not IL-10 (r = -0.35, P = 0.25). In conclusion, although higher GTS-21 plasma concentrations significantly correlated with lower cytokine levels, the highest dose tested to be safe in humans did not result in significant differences in inflammatory mediators between the GTS-21- and placebo-treated groups.

Efficacy of N-Acetylcysteine in the Treatment of Nicotine Dependence: A Double-Blind Placebo-Controlled Pilot Study

Relapse is the rule rather than the exception in smokers aiming to quit smoking. Recently, evidence has emerged that glutamate transmission plays an important role in relapse. N-acetylcysteine (NAC), a cysteine prodrug, restores glutamate homeostasis and appears to be a potential new treatment for substance dependence. In the current pilot study, the effects of NAC on short-term abstinence of smoking were investigated. Subjects were heavy smokers randomized to receive placebo (n = 12) or NAC 3,600 mg/day (n = 10) in a double-blind fashion during 3.5 days. Subjects were asked to stop smoking and report on nicotine craving, nicotine withdrawal symptoms, and cigarette smoking during treatment. At the end of the treatment, subjects were invited to smoke a cigarette and to rate the rewarding effect of this cigarette. There was no significant effect of NAC on craving (p = 0.23, d = 0.52) and only a statistical trend towards fewer withdrawal symptoms in the NAC condition (p = 0.07, d = 0.80). Interestingly, subjects receiving NAC rated the first cigarette after the abstinence period of 3.5 days as significantly less rewarding than subjects on placebo (p = 0.04, d = 0.85). It is concluded that the results of this pilot study are encouraging and suggest that NAC might be a promising new treatment option for relapse prevention in nicotine dependence.

A pilot study of the effectiveness of d-cycloserine during cue-exposure therapy in abstinent alcohol-dependent subjects

Cue-exposure therapy (CET) has been advocated as a potentially effective treatment of addictive behaviours. Strategies that enhance learning may improve the outcome of CET. D-cycloserine (DCS), a partial N-methyl-D-aspartate receptor agonist, has been shown to facilitate extinction of learned fear in rats and augment exposure-based treatment in some anxiety disorders in man. This double-blind placebo-controlled pilot study used a cue-exposure paradigm, salient for an individual's alcohol drinking, to see if DCS would reduce cue-reactivity compared with placebo. Sixteen abstinent, alcohol-dependent individuals were randomised to receive either a single-dose (250 mg) DCS or placebo before CET sessions, separated by at least 1 week. Subjective responses were assessed using the Alcohol Urge Questionnaire (AUQ) and visual analogue scales. Cardiovascular responses were assessed using Finapres©. The cue-exposure paradigm significantly increased craving assessed with the AUQ during the first session. In subsequent sessions, the degree of craving was reduced. However, no significant difference was seen between the DCS and placebo groups in any outcome measure. The variability of responses between individuals was great with more than half the groups reporting no or very small changes in AUQ scores. This is the first human study to our knowledge to assess the efficacy of DCS in facilitating CET in alcohol dependence. The high proportion of subjects with little or no response to cue-exposure would make any effect of DCS very difficult to detect. It is important that future studies carefully consider the criteria for inclusion.

Lactobacillus GG as an immune adjuvant for live-attenuated influenza vaccine in healthy adults: a randomized double-blind placebo-controlled trial

Background/ObjectivesLive attenuated influenza vaccine (LAIV) protects against influenza by mucosal activation of the immune system. Studies in animals and adults have demonstrated that probiotics improve the immune response to mucosally delivered vaccines. We hypothesized that Lactobacillus GG (LGG) would act as an immune adjuvant to increase rates of seroconversion after LAIV administration.Subjects/MethodsWe conducted a randomized double-blind placebo-controlled pilot study to determine if LGG improved rates of seroconversion after administration of LAIV. We studied 42 healthy adults during the 2007–8 influenza season. All subjects received LAIV and then were randomized to LGG or placebo twice daily for 28 days. HAI titers were assessed at baseline, day 28, and day 56 to determine rates of seroconversion. Subjects were assessed for adverse events throughout the study period.Results39 subjects completed the per protocol analysis. Both LGG and LAIV were well tolerated. Protection rates against the vaccine H1N1 and B strains was similar suboptimal in subjects receiving LGG and placebo. For the H3N2 strain, 84% receiving LGG vs. 55% receiving placebo had a protective titer 28 days after vaccination (odds of having a protective titer was 1.84 95% CI 1.04–3.22, P=0.048).ConclusionLactobacillus GG is potential as an important adjuvant to improve influenza vaccine immunogenicity. Future studies of probiotics as immune adjuvants may need to consider specifically examining vaccine naïve or seronegative subjects, target mucosal immune responses, or focus on groups known to have poor response to influenza vaccines.

Effect of N-acetyl-cysteine after ovarian drilling in clomiphene citrate-resistant PCOS women: a pilot study

The aim of this randomized double-blind placebo-controlled pilot study was to evaluate N-acetyl-cysteine (NAC) as an adjunctive therapy following unilateral laparoscopic ovarian drilling (LOD) for clomiphene citrate-resistant women with polycystic ovary syndrome (PCOS). A total of 60 patients with clomiphene citrate-resistant PCOS who underwent unilateral LOD were assigned randomly to receive either NAC 1.2 g/d (group A=30) or placebo (group B=30) for 5 days starting at day 3 of the cycle for 12 consecutive cycles. The primary outcome was pregnancy rate; secondary outcomes were ovulation rates, endometrial thickness and pregnancy outcome. Baseline clinical, endocrine, and sonographic characteristics were similar in the two groups. A significant increase in both ovulation and pregnancy rates was observed in the NAC group, compared with placebo [87% versus 67% (RR 1.3; 95% CI 1.2-2.7) and 77% versus 57% (RR 1.4; 95% CI 1.1-2.7), respectively, P<0.01]. Moreover, miscarriage rates were significantly lower and live birth rates were significantly higher in the NAC group [8.7% versus 23.5% (RR 0.4; 95% CI 0.1-3.7) and 67% versus 40% (RR 1.7; 95% CI 0.3-3.5), respectively, P<0.01]. In conclusion, NAC is a novel adjuvant therapy after unilateral LOD which might help improve overall reproductive outcome.

Supplementation of Vitamin E, Vitamin C, and Zinc Attenuates Oxidative Stress in Burned Children: A Randomized, Double-Blind, Placebo-Controlled Pilot Study

The aim of this study was to investigate the effect of supplementation of vitamin E, vitamin C, and zinc on the oxidative stress in burned children. In a prospective double-blind placebo controlled pilot study, 32 patients were randomized as no supplementation (n = 15) or antioxidant supplementation (n = 17) groups. Supplementation consisted of the antioxidant mixture of vitamin C (1.5 times upper intake level), vitamin E (1.35 times upper intake level), and zinc (2.0 times recommended dietary allowance) administered during 7 days starting on the second day of admittance into the hospital. Energy requirement was calculated by the Curreri equation, and protein input was 3.0 g/kg of ideal body mass index (percentile 50). Total antioxidant capacity of plasma and malondialdehyde were used to monitor oxidative stress. The time of wound healing was evaluated as the main clinical feature. Patients (age 54.2 +/- 48.9 months, 65.6% males), who exhibited 15.5 +/- 6.7% of total burn area, showed no differences in age and sex, when compared with controls. Intake of the administered antioxidants was obviously higher in treated subjects (P = .005), and serum differences were confirmed for vitamin E and C, but not for zinc (P = .180). There was a decrease in lipid peroxidation (malondialdehyde level) (P = .006) and an increase in vitamin E concentrations in the antioxidant supplementation group (P = .016). The time of wound healing was lower in the supplemented group (P < .001). The antioxidant supplementation through vitamin E and C and the mineral zinc apparently enhanced antioxidant protection against oxidative stress and allowed less time for wound healing.

A carbohydrate-rich drink shortly before surgery affected IGF-I bioavailability after a total hip replacement. A double-blind placebo controlled study on 29 patients

In response to surgical stress, the body reacts with a change in metabolism to a catabolic state. This is further aggravated by the fasting state preoperatively. We aimed to determine the effects on catabolism i.e., body composition and IGF-I bioavailability as measured by the serum IGF-I/IGFBP-1 ratio, of a carbohydrate rich drink given shortly before surgery. Twenty-nine patients scheduled for a total hip replacement (THR) were randomized in a double-blind placebo-controlled pilot study to a carbohydrate-rich drink or to placebo pre-operatively. The nutritional supplementation consisted of an iso-osmolar carbohydrate-rich drink (12.5 g carbohydrates/100 ml, pH 5.0). Fasting blood samples were collected before surgery and repeated after 5 days and after 2 months. IGF-I and IGFBP-1 were determined in serum by RIA. Body composition was determined by dual energy X-ray absorptiometry (DXA). Compared with placebo we found a relative increase in IGF-I bioavailability post-operatively after a carbohydrate-rich drink given shortly before surgery. There were no significant longterm differences in the changes in fat or lean body mass between groups, but, in a subgroup with late scheduled surgery, there was a tendency to a difference (p=0.08) of fat loss after 2 months, with less fat loss in those who received another carbohydrate drink close to surgery. The pre-operative intake of a 200-200 x 2 ml carbohydrate drink was well tolerated and safe. There were no adverse events such as pulmonary aspiration before, during or after operation. A carbohydrate- rich drink given shortly before surgery increases IGF-I bioavailability post-operatively in patients undergoing a THR, but has no significant effects on body composition after 2 months in physically active people. We suggest that, if the operation is postponed for more than four hours on the same day, an additional carbohydrate drink should be given.

A double-blind placebo-controlled pilot study of controlled-release paroxetine on depression and quality of life in chronic heart failure

Depression is frequently observed in patients with heart failure and is associated with poor quality of life and adverse prognosis. However, the prevalence of depression in heart failure could be overestimated because symptoms of depression overlap with those of heart failure. Similarly, the importance of depression may be overestimated if depression merely reflects worse heart failure. Because the response to depression treatment has not been evaluated in this patient population, we evaluated the efficacy of controlled-release paroxetine (paroxetine CR), a selective serotonin reuptake inhibitor, on depression and quality of life in chronic heart failure. A double-blind, randomized, placebo-controlled design was used to evaluate reductions in depression following 12 weeks of treatment with paroxetine CR (n = 14, age 62.1 +/- 12.3 years) or placebo (n = 14, age = 61.9 +/- 9.0 years). Patients with symptomatic congestive heart failure and a score of at least 10 on the Beck Depression Inventory (BDI) were eligible. Beck Depression Inventory was obtained at baseline and 4, 8, and 12 weeks of follow-up. Quality of life was assessed using the Medical Outcomes Study Short Form and the Minnesota Living with Heart Failure Questionnaire. Controlled-release paroxetine resulted in significantly more recovery from depression (BDI <10) than placebo (69% vs 23%, P = .018) and resulted in lower continuous BDI scores throughout the intervention (P = .024). Controlled-release paroxetine was associated with higher general health levels compared with placebo on the Medical Outcomes Study 36-Item Short Form survey (38 +/- 10 vs 30 +/- 6, P = .016) at 12 weeks of follow-up. Reductions in depression were correlated with improvements in psychological aspects of quality of life (P < .05) but not with physical quality of life measures (P > .10). Antidepressant therapy with paroxetine CR results in significant reductions in depression among patients with heart failure. The reductions in depression with paroxetine CR are accompanied by improvements in psychological aspects of quality of life. Larger controlled trials are needed to further document the effectiveness of paroxetine CR and other selective serotonin reuptake inhibitors in patients with heart failure and to determine patient subgroups that are most likely to benefit from antidepressive interventions.

A Novel Treatment of Contact Dermatitis by Topical Application of Phospholipase A2 Inhibitor: A Double-Blind Placebo-Controlled Pilot Study

Phospholipase A2 hydrolyzes membrane phospholipids releasing arachidonic acid and lysophospholipids. These are key precursors of inflammatory mediators, such as prostaglandins, leukotrienes, thromboxanes and PAF, in numerous inflammatory/allergic diseases, including skin inflammation. Accordingly, inhibition of PLA2 has long been postulated as a potentially potent anti-inflammatory therapy. In the present study we tested the effect of a novel PLA2 inhibitor on contact dermatitis in human subjects. A double-blind, placebo-controlled pilot study was conducted on contact dermatitis patients (n = 11) treated with the inhibitor-containing topical preparation (1% cream). Disease severity was assessed by physicians assessment before treatment (day 0) as well as after 14-days and 30-days. Patients treated with 1% PLA2 inhibitor-containing cream showed a 69.9% reduction in disease score while placebo-treated patients showed a reduction of 36.5% with p = 0.0024. The clear improvement in the disease score of inhibitor-treated patients supports the involvement of PLA2 activity in skin inflammation and the therapeutic prospective of its inhibition.

Analysis of a Pilot Study for Amelioration of Itching in Liver Disease

This article presents an analysis of a small “failed clinical trial” that shows how the combination of solid statistical theory and methods and expert collaboration from other disciplines can lead to new areas of research. A double-blind placebo-controlled pilot study of 15 subjects was conducted in order to examine the efficacy of gabapentin in reducing itching and scratching secondary to liver disease. The data from the study contained missing values due to a number of mechanisms. In addition, the measurement instrument produced highly variable data, including large outliers. This article describes how these issues were resolved for this trial in an expedient manner, and particular attention is paid to a modification of nearest-neighbor hot-deck imputation. Although the study results were inconclusive with respect to the efficacy of gabapentin on itching, when they are considered in the light of other known properties of the drug, the outcome points to an exciting new line of inquiry on the role of gabapentin in regulating the placebo effect itself.

Effects of Lithium on Saccadic Eye Movements in Healthy Subjects in a Ten-Day Double-Blind Placebo-Controlled Cross-Over Pilot Study

Although previous studies have shown that lithium modifies eye movements or psychomotor speed, no studies have ever explored the predictive saccades or memory guided saccades during lithium administration. We took the objective to determine the influence of lithium in pseudo-random, predictive or memory-guided saccades in healthy subjects with a view to detect reduced psychomotor speed, inability to anticipate incoming events, or working memory deficits. A ten day lithium-placebo randomized double-blind cross-over pilot study was carried out with 12 healthy male volunteers. The cognitive assessment included pseudo-random, predictive and memory guided saccades before and after lithium and placebo periods. A biological assay substantiated the lithium effect on TSH and thyroid hormones. There was no change in pseudo-random or memory guided saccades when comparing lithium or placebo administration. However the ratio of anticipated saccades decreased under the lithium sequence while it remained stable under placebo. Also, subjects having lithium serum levels of > 0.5 meq/l had longer latencies in anticipated saccades. The findings do not support a major effect of lithium on alertness or on working memory, although the dosage and duration of lithium was sufficient to modify TSH blood level. Nevertheless, lithium treatment was associated with decreased anticipation in predictive saccades, suggesting this could reflect a reduced ability to anticipate quick motor movements and could be related to the well-known effect of lithium as an anti-impulsive medication.

Activated recombinant factor VII after cardiopulmonary bypass reduces allogeneic transfusion in complex non-coronary cardiac surgery: randomized double-blind placebo-controlled pilot study

Receiving an allogeneic transfusion may be an independent predictor of mortality for patients undergoing cardiac surgery. Furthermore, these patients utilize 15% of all donated blood in the UK. In our unit, 80% of patients undergoing complex non-coronary cardiac surgery requiring cardiopulmonary bypass (CPB) receive an allogeneic transfusion. Activated recombinant FVII (rFVIIa) may be effective in reducing this need for transfusion. Twenty patients undergoing complex cardiac surgery were randomized to receive rFVIIa or placebo after CPB and reversal of heparin. Two patients in the rFVIIa group received 13 units of allogeneic red cells and coagulation products compared with eight patients receiving 105 units of allogeneic red cells and coagulation products in the placebo group (relative risk of any transfusion 0.26; confidence interval 0.07-0.9; P=0.037). The groups did not differ for adverse events. Despite major limitations (underpowered study and prone to type I error), we have shown that rFVIIa significantly reduces the need for allogeneic transfusion in complex non-coronary cardiac surgery without causing adverse events.

Qualitative and quantitative evaluation of a new regimen for malignant wounds in women with advanced breast cancer

To investigate the experience of women with advanced breast cancer who have a malignant fungating wound and to test the benefits of a structured, evidence-based, management regimen, combined with psychosocial support. Twelve women with advanced breast cancer were consecutively selected for inclusion in a four-week intervention. The patients were interviewed and the condition of the wounds was recorded before and after the intervention. Prior to the intervention, participants were anxious about seepage, bleeding and odour emanating from the wounds and were concerned these might be obvious to others. After the intervention, nine wounds (75%) showed an improvement, with increased granulation and epithelialisation and complete wound healing in one participant. Seepage was considerably reduced in 83% of cases and there was an average 75% reduction in dressing changes. The women's sense of well-being improved, as did their independence and self-confidence. A wound-care intervention built on evidence-based practice and psychosocial support resulted in an improvement in 75% of the wounds, and increased the women's sense of well-being, independence and security.

A pilot study to determine whether a static magnetic device can promote chronic leg ulcer healing

To determine if UlcerCare, a specialised self-securing static magnetic device, can promote the healing of chronic leg ulcers. This double-blind placebo-controlled pilot study involved 26 patients with chronic leg ulcers, receiving care consistent with RCN guidelines, who were randomly allocated to receive either UlcerCare leg wrap (treatment) or an identical sham non-magnetic device (control). Wounds were assessed for 12 weeks at four weekly intervals using digital photography, Verge Videometer analysis and patient questionnaires to determine changes in ulcer size, level of pain and function. Statistically significant reductions in ulcer measurement were noted in the treatment group when compared with the placebo group. The results demonstrate a significant healing effect in the treatment group. A larger randomised controlled study is recommended to investigate the effects on ulcer-associated pain and quality of life.

The effect of famotidine addition on olanzapine-induced weight gain in first-episode schizophrenia patients: a double-blind placebo-controlled pilot study

Olanzapine treatment is associated with substantial weight gain. In this double-blind placebo-controlled study we evaluated whether the H2 antagonist famotidine may prevent/attenuate olanzapine-induced weight gain. Fourteen first-episode DSM-IV schizophrenia patients were randomly allocated to receive either famotidine (40 mg/day, n =7) or placebo ( n =7) in addition to olanzapine (10 mg/day) for 6 weeks. All patients completed the trial. Patients in both groups showed a similar increase in body weight (olanzapine/famotidine: 4.8 (3.2) kg and olanzapine/placebo: 4.9 (1.6) kg, respectively; a between-group difference of 0.14 (1.3) kg). Four of seven (57.1%) patients in the olanzapine/famotidine group and three of seven (42.9%) in the olanzapine/placebo group gained at least 7% of their initial body weight, a cut-off for clinically significant weight gain. Famotidine addition was safe and well tolerated and did not interfere with olanzapine's therapeutic effect. In conclusion, famotidine (40 mg/day for 6 weeks) is not effective in preventing/attenuating weight gain in olanzapine-treated first-episode schizophrenia patients.