General practitioners' stay-at-work practices in patients with musculoskeletal disorders: using Intervention Mapping to develop a training program.

OBJECTIVES: To describe current stay-at-work practices among Danish general practitioners (GPs) in relation to patients with musculoskeletal disorders, to identify potential avenues for improvement, and to suggest a training program for the GPs. DESIGN AND SETTING: We followed the principles of Intervention Mapping. Data were collected by means of literature searches, focus group interviews with GPs, and interaction with stakeholder representatives from the Danish labour market. RESULTS: GPs' current stay-at-work practices were influenced by systemic, organisational, and legislative factors, and by personal determinants, including knowledge and skills relating to stay-at-work principles and musculoskeletal disorders, recognition of the patient's risk of long-term work disability, their role as a GP, and expectations of interactions with other stay-at-work stakeholders. GPs described themselves as important partners and responsible for the diagnostic and holistic assessments of the patient but placed themselves on the side line relying on the patient or workplace stakeholders to act. Their practices are influenced both by patients, employers, and by other stakeholders. We propose a training course for GPs that incorporate both concrete tools and behaviour change techniques. CONCLUSIONS: We have identified varied perspectives on the roles and responsibilities of GPs, as well as legislative and organisational barriers, and proposed a training program. Not all barriers identified can be addressed by a training course, and some questions are left unanswered, among others - who are best suited to help patients staying at work?

Musculoskeletal disorders are highly prevalent and one of the most common causes for visiting a GP.In many countries, GPs are important in facilitating that patients stay at work, when they are experiencing musculoskeletal pain and disability.In our research, GPs place themselves on the side line as coaches relying on the patient or workplace to act.Barriers such as role identity, systemic and organisational issues prevent GPs from being more involved in stay-at-work practices.GPs' with knowledge about stay-at-work practices may empower patients to better self-management.

Analgesic efficacy of local infiltration analgesia in hip and knee arthroplasty: a systematic review.

In recent years, there has been an increasing interest in local infiltration analgesia (LIA) as a technique to control postoperative pain. We conducted a systematic review of randomized clinical trials investigating LIA for total knee arthroplasty (TKA) and total hip arthroplasty (THA) to evaluate the analgesic efficacy of LIA for early postoperative pain treatment. In addition, the analgesic efficacy of wound catheters and implications for length of hospital stay (LOS) were evaluated. Twenty-seven randomized controlled trials in 756 patients operated on with THA and 888 patients operated on with TKA were selected for inclusion in the review. In THA, no additional analgesic effect of LIA compared with placebo was reported in trials with low risk of bias when a multimodal analgesic regimen was administered perioperatively. Compared with intrathecal morphine and epidural analgesia, LIA was reported to have similar or improved analgesic efficacy. In TKA, most trials reported reduced pain and reduced opioid requirements with LIA compared with a control group treated with placebo/no injection. Compared with femoral nerve block, epidural or intrathecal morphine LIA provided similar or improved analgesia in the early postoperative period but most trials had a high risk of bias due to different systemic analgesia between groups. Overall, the use of wound catheters for postoperative administration of local anaesthetic was not supported in the included trials, and LOS was not related to analgesic efficacy. Despite the many studies of LIA, final interpretation is hindered by methodological insufficiencies in most studies, especially because of differences in use of systemic analgesia between groups. However, LIA provides effective analgesia in the initial postoperative period after TKA in most randomized clinical trials even when combined with multimodal systemic analgesia. In contrast, LIA may have limited additional analgesic efficacy in THA when combined with a multimodal analgesic regimen. Postoperative administration of local anaesthetic in wound catheters did not provide additional analgesia when systemic analgesia was similar and LOS was not related to use of LIA with a fast-track set-up.

Spreading of chronic pain between body regions: prospective cohort study among health care workers.

OBJECTIVE: To estimate the prognostic value of pain in one body region on the risk for developing chronic pain in other body regions. METHODS: Prospective cohort study among 5052 Danish female health care workers responding to a baseline and follow-up questionnaire in 2005 and 2006, respectively. Using adjusted logistic regression analysis, the risk for developing chronic pain (>30 days last year) at follow-up in the low back (among those without low back pain during the last year at baseline) when experiencing sub-chronic (1-30 days last year) or chronic pain in other body regions (i.e., the neck/shoulders and/or the knees at baseline) was modelled. Similar risks were modelled for developing chronic pain in the neck/shoulders and knees. RESULTS: Chronic pain in the neck/shoulders (OR 3.14; 95% CI 1.74-5.70) or knees (OR 2.57; 95% CI 1.28-5.16) at baseline increased the risk for developing chronic pain in the low back at follow-up. Likewise, chronic pain in the neck/shoulders (OR 2.39; 95% CI 1.36-4.17) or low back (OR 1.82 95%; CI 1.07-3.09) at baseline increased the risk for developing chronic pain in the knees at follow-up. The risk for developing chronic neck/shoulder pain was not significantly increased when having pain in the low back or knees at baseline. CONCLUSION: Among health care workers, chronic musculoskeletal pain in one body region increases the risk for developing chronic pain in other pain-free body regions. Prevention of musculoskeletal disorders among health care workers should focus holistically on the musculoskeletal system.

Impact of gender on vitamin D deficiency in morbidly obese patients: a cross-sectional study.

BACKGROUND/OBJECTIVE: Obesity is associated with vitamin D deficiency (25-hydroxyvitamin D (25(OH)D) <50 nmol/l). We aimed to examine the effect of gender on vitamin D status in severe obesity. SUBJECTS/METHODS: Cross-sectional study of 2026 morbidly obese patients examined consecutively at a tertiary care centre between November 2005 and June 2010. Serum 25(OH)D concentration and use of vitamin D supplements were registered in all patients. Total vitamin D intake (µg/day) was assessed in a subgroup of 154 patients using a validated food frequency questionnaire. RESULTS: The male (n=690) and female (n=1336) patients had a mean (s.d.) age of 45.0 (12.1) years and 42.2 (12.2) years (P<0.001), body mass index (BMI) of 44.6 (6.0) kg/m(2) and 44.3 (5.9) kg/m(2) (P=0.30) and waist circumference (WC) of 140 (13) cm and 127 (13) cm (P<0.001), respectively. Male patients had significantly lower mean 25(OH)D concentrations than female patients 50.0 (22.0) nmol/l versus 53.6 (22.4) nmol/l (P=0.001) and a higher rate of vitamin D deficiency (56% versus 47%; P<0.001). Obese men had significantly higher odds of vitamin D deficiency than women (odds ratio=1.41; 95% confidence interval: 1.17-1.70, P<0.001), also after adjustment for season, age, current smoking, intake of vitamin D supplements, BMI and WC (odds ratio=1.39; 95% confidence interval: 1.10-1.76). CONCLUSIONS: Morbidly obese Norwegian men seeking weight loss treatment have significantly higher odds of vitamin D deficiency than women. Monitoring of 25(OH)D concentrations in obese patients should therefore take gender into account.

Local infiltration analgesia in joint replacement: the evidence and recommendations for clinical practice.

Relief of acute pain after hip and knee replacement represents a major therapeutic challenge as post-operative pain hinders early mobilisation and rehabilitation with subsequent consequences on mobility, duration of hospitalisation and overall recovery. In recent years, there has been increased interest in high-volume local wound infiltration/infusion techniques in these operations with a combined administration of local anaesthetics, NSAIDs and epinephrine. This review provides an update of the current knowledge of the efficacy of the high-volume wound infiltration technique based on randomised trials. It is concluded that a predominant part of the data have had an insufficient design by not being placebo-controlled or with comparable systemic analgesia provided in the investigated groups. It is concluded that there is little evidence to support the use of the technique in hip replacement either intraoperatively or with a post-operative wound infusion catheter technique, provided that multimodal, oral non-opioid analgesia is given. In knee replacement, the data support the intraoperative use of the local infiltration technique but not the post-operative use of wound catheter administration. In knee replacement, a compression bandage prolongs the analgesic effect. There are limited data to support the use of NSAIDs or epinephrine in the solution and the data on post-operative hospitalisation and recovery are conflicting. Thus, shorter lengths of stay have been achieved by oral multimodal, non-opioid analgesia together with organisational optimisation of care according to the fast-track methodology.

The use of EMG biofeedback for learning of selective activation of intra-muscular parts within the serratus anterior muscle: a novel approach for rehabilitation of scapular muscle imbalance.

Motor control and learning possibilities of scapular muscles are of clinical interest for restoring scapular muscle balance in patients with neck and shoulder disorders. The aim of the study was to investigate whether selective voluntary activation of intra-muscular parts within the serratus anterior can be learned with electromyographical (EMG) biofeedback, and whether the lower serratus anterior and the lower trapezius muscle comprise the lower scapula rotation force couple by synergistic activation. Nine healthy males practiced selective activation of intra-muscular parts within the serratus anterior with visual EMG biofeedback, while the activity of four parts of the serratus anterior and four parts of the trapezius muscle was recorded. One subject was able to selectively activate both the upper and the lower serratus anterior respectively. Moreover, three subjects managed to selectively activate the lower serratus anterior, and two subjects learned to selectively activate the upper serratus anterior. During selective activation of the lower serratus anterior, the activity of this muscle part was 14.4+/-10.3 times higher than the upper serratus anterior activity (P<0.05). The corresponding ratio for selective upper serratus vs. lower serratus anterior activity was 6.4+/-1.7 (P<0.05). Moreover, selective activation of the lower parts of the serratus anterior evoked 7.7+/-8.5 times higher synergistic activity of the lower trapezius compared with the upper trapezius (P<0.05). The learning of complete selective activation of both the lower and the upper serratus anterior of one subject, and selective activation of either the upper or lower serratus anterior by five subjects designates the promising clinical application of EMG biofeedback for restoring scapular muscle balance. The synergistic activation between the lower serratus anterior and the lower trapezius muscle was observed in only a few subjects, and future studies including more subjects are required before conclusions of a lower scapula rotation couple can be drawn.

High-volume infiltration analgesia in total knee arthroplasty: a randomized, double-blind, placebo-controlled trial.

BACKGROUND: High-volume infiltration analgesia may be effective with a low risk of side effects in hip and knee arthroplasty. The present placebo-controlled study was carried out to evaluate the analgesic effect of high-volume infiltration analgesia in bilateral total knee arthroplasty, along with a detailed description of the infiltration technique. METHODS: In a randomized, double-blind, placebo-controlled trial in 12 patients undergoing bilateral knee arthroplasty, saline or high-volume (170 ml) ropivacaine (0.2%) with epinephrine was infiltrated around each knee, with repeated doses administered through an intra-articular catheter for 24 h and pain and opioid requirements assessed for 48 h in a fast-track setting. RESULTS: Pain at rest and during movement was significantly reduced for up to 32 h with the high-volume local anesthetic infiltration technique. No major side effects were observed. The median hospital stay was 4 days. CONCLUSION: High-volume infiltration analgesia is effective in knee arthroplasty and, due to its simplicity, may be preferable compared with other analgesic techniques in knee arthroplasty.

Effect of parenteral zinc sulfate on colon anastomosis repair in the rat.

BACKGROUND AND AIMS: To prevent colonic anastomotic dehiscence, pharmaceutical interventions should inhibit degradation of existing submucosal collagen fibers and accelerate the synthesis of new collagen molecules. Zinc has multiple functions in collagen metabolism and was recently found beneficial in colonic anastomosis repair. We have investigated the effect of daily intraperitoneal zinc (2 mg/kg) injections on the development of the biomechanical integrity of left colon anastomoses. MATERIALS AND METHODS: Sixty Sprague-Dawley male rats (median 245 g) were allocated to treatment with zinc sulfate in saline (n = 30) or with saline alone (n = 30) starting 1 h before the anastomoses were made. Serum zinc levels and anastomotic breaking strength were determined on postoperative days 3 (n = 30) and 7 (n = 30). The initial breaking strength or suture-binding capacity was determined in additional ten non-treated animals (277 g). RESULTS: The breaking strength of the anastomoses decreased in the two groups combined (n = 30) by 50% (p < 0.001) on day 3 but was regained by postoperative day 7 compared with the initial anastomotic biomechanical strength. Serum zinc levels also increased from day 3 to day 7 in both intervention groups and correlated significantly with breaking strength (r = 0.57, p < 0.001). Although the median serum zinc level was 14% higher (p < 0.01) on day 7 in zinc-treated than in saline-treated animals, the breaking strength did not differ significantly between zinc-treated and saline-treated rats on either day 3 (p = 0.95) or day 7 (p = 0.70). CONCLUSION: In contrast to previous report in rabbits, we failed to demonstrate the beneficial effects of parenteral zinc supplementation on colon anastomosis repair in a rat model.

An assessment of an oil spill in Gladstone, Australia - impacts on intertidal areas at one month post-spill.

In January 2006, 25 tonnes of heavy fuel oil spilled into the Port of Gladstone in Queensland, Australia, from the breached hull of a bulk carrier ship. Over the following days, approximately 18 tonnes of the oil was recovered, however a certain amount of oil was deposited in the intertidal areas of Port Curtis leaving a highly visible, viscous residue. The objectives of this research were to assess the immediate impacts on the intertidal habitat and to gain baseline information for future comparative assessments. Sediment PAH and metal concentrations, mangrove communities and intertidal macroinvertebrates were assessed within one month post-spill at oil-impacted sites; adjacent sites which were not visibly impacted; and reference sites which were located outside the recorded distribution of the oil spill. Highest PAH concentrations were found at the impacted sites, with concentrations of some PAHs exceeding Australian and New Zealand Sediment Quality Guidelines (ANZECC/ARMCANZ, 2000). These sites contained very few or no crab holes in the high intertidal area, indicating a low crab density in comparison to reference sites. Little immediate impact was evident on the mangrove and macrobenthic communities, however future surveys may show evidence of longer-term impacts on these communities.

Mass screening for antimicrobial resistant Escherichia coli in dairy cows in northern New South Wales.

OBJECTIVE: To describe aspects of the epidemiology of antimicrobial resistance in Escherichia coli shed in the faeces of milking cows in a dairying region of New South Wales. DESIGN: A survey based on multi-stage sampling with repeated measures made within herds for estimating within-herd correlation of resistance status, and with repeated measures made on identical specimens for estimating test-retest reliability. PROCEDURE: From a population of 110 dairy herds, 30 were selected at random and from each herd between 5 and 10 faecal specimens were obtained from fresh manure pats. E coli from faecal specimens were grown on hydrophobic grid membrane filters (HGMF) and replicated onto chromogenic agar and agar containing antimicrobials (gentamicin, ampicillin, tetracycline and sulfamethoxazole). Image analysis was used to assess colony growth. Data were analysed descriptively, by generalised linear mixed models and by Taylor series linearisation to account for attributes of the survey design. RESULTS: Of the 10,279 E coli isolates assessed, 91% expressed no resistance, 7.3% were resistant to sulfamethoxazole, 3.6% to tetracycline, 2.2% to ampicillin and 0.09% to gentamicin. The most common multiple resistance phenotype was ampicillin-tetracycline-sulfamethoxazole (1.8% of isolates). Most multiple resistant isolates appeared clustered within particular herds but were too rare to obtain valid estimates of variance, confidence intervals or intra-herd correlation. The estimated proportion of isolates in the population that were susceptible to all four antimicrobials was 97% (95% CI: 91% to 100%) and 55% of cows had no resistance detected in faecal E coli (95% CI: 27% to 83%). Within-herd correlation of shedding status (any resistance pattern) was absent and test-retest reliability of the measurement system was estimated to be at the lower end of good (0.40) but increased to excellent (0.89) after excluding sulfamethoxazole resistance, which had a greater measurement error. CONCLUSION: Antimicrobial resistance was uncommon in E coli in the population of dairy cows studied. HGMF and image analysis is an effective tool for detecting rare forms of resistant E coli that are not uniformly distributed in livestock populations.

Routine database registration of biological therapy increases the reporting of adverse events twentyfold in clinical practice. First results from the Danish Database (DANBIO).

OBJECTIVE: To present from the Danish Database for Biological Therapies in Rheumatology (DANBIO) the frequencies and types of adverse events as well as risk factors during treatment with biological agents in clinical practice. METHODS: Adverse events during the first 2 years of clinical use of biological agents in Denmark were reported to the nationwide DANBIO and compared to the mandatory reports to the Danish Medicines Agency. RESULTS: Almost 90% of the patients treated with biological agents were registered in the DANBIO, and the database picked up 20 times as many adverse events as the Danish Medicines Agency. Infections and hypersensitivity reactions were the most prevalent adverse events. Age, disease duration, and previous number of disease-modifying anti-rheumatic drugs (DMARDS) were found to be risk factors for bacterial infections. CONCLUSION: A routine-based Danish database for biological therapies covers approximately 90% of patients and improves the reporting of adverse events.

Validation of a semi-quantitative food-frequency questionnaire used among 12-month-old Norwegian infants.

OBJECTIVE: To assess the validity of a semi-quantitative food-frequency questionnaire (SFFQ) used in a large nation-wide dietary survey among 12-month-old Norwegian infants. METHODS: The SFFQ was administered to the parents about 1 week before the infants turned 12-month-old. The participants filled in the SFFQ and 1-2 weeks later they kept weighed food records for a total of 7 days. Both methods were completed for 64 infants. RESULTS: The SFFQ overestimated energy intake with 25% and gave significantly higher estimates of all nutrients compared with the records, except for calcium. Much of the difference between the methods disappeared when nutrient density was compared. Spearman correlation coefficients between pairwise measurements of nutrient intakes from the food records and the SFFQ ranged from 0.18 for vitamin D to 0.72 for polyunsaturated fatty acid intake (median r=0.50). On average 38% of the infants were classified in the same quartile with the two methods, and 3% in the opposite quartile. The correlations for food items varied from 0.28 for sweetened drinks to 0.83 for commercial porridge (median r=0.62). CONCLUSION: This study indicated that the SFFQ overestimates average absolute nutrient intakes. However, the questionnaire gave better estimates for average nutrient densities than for absolute nutrient intakes. The capability of the questionnaire to rank infants according to intake of nutrients and food items was moderate, but at the same level as others have observed with food-frequency questionnaires.

Infant feeding practices and associated factors in the first six months of life: the Norwegian infant nutrition survey.

AIM: To describe and evaluate infant feeding practices during the first 6 mo of life in relation to recommendations, and to study infant feeding practices in relation to maternal and infant characteristics. METHODS: Data from 2383 Norwegian infants aged 6 mo were collected by a self-administered semi-quantitative food-frequency questionnaire measuring feeding practices at 6 mo and feeding practices retrospectively at < or = 5.5 mo of age. RESULTS: Only 1% of the infants had never been breastfed. The proportion of breastfed infants was 96% at 1 mo, 85% at 4 mo and 80% at 6 mo. The proportion of exclusively breastfed infants was 90% at 1 mo, 44% at 4 mo and 7% at 6 mo. Twenty-one percent of the infants were introduced to solid foods before the age of 4 mo. For exclusive breastfeeding at 4 mo, breastfeeding at 6 mo and timely introduction of solid foods (not before 4 mo) significant positive trends were found for maternal age, education and degree of urbanization. Negative associations were found for maternal smoking. Furthermore, exclusive breastfeeding at 4 mo was associated with infant gender and marital status, and the odds of breastfeeding at 6 mo significantly decreased with decreasing infant birthweight. Finally, both the odds of exclusive breastfeeding at 4 mo and of breastfeeding at 6 mo increased with increasing numbers of children. CONCLUSION: These results indicate that a majority of Norwegian infants are fed in accordance with infant feeding recommendations during their first 6mo of life. However, the duration of exclusive breastfeeding is shorter than recommended. Infant feeding practices are significantly associated with maternal and infant characteristics.

Risk factors for peptic ulcer disease: a population based prospective cohort study comprising 2416 Danish adults.

BACKGROUND: No population based prospective cohort study has previously assessed the impact of multiple risk factors, including Helicobacter pylori infection, on the incidence of peptic ulcer disease (PUD). AIMS: To identify risk factors for PUD and estimate their relative impact on ulcer incidence. SUBJECTS: Random sample of 2416 Danish adults with no history of PU. METHODS: Sample members were interviewed in 1982 and 1994. PUs diagnosed within the observation period were verified through medical records. Information on psychosocial factors, lifestyle practices, and medication was obtained from a questionnaire completed at study entry. H pylori infection status was determined by ELISA. RESULTS: The main risk factors for PUD were H pylori infection (odds ratio 4.3 (95% confidence interval 2.2; 8.3)), tobacco smoking (3.8 (1.7; 9.8)), and use of minor tranquillisers (3.0 (1.4; 6.6)). Intake of non-steroid anti-inflammatory drugs did not affect the incidence of PUD (0.4 (0.1; 2.3)). In those with increased antibodies to H pylori, tobacco smoking (12.7 (2.8; 56.8)) and intake of spirits (2.4 (1.1; 5.4)) increased the risk of PUD whereas moderate leisure time physical activity (0.3 (0.2; 0.7)) protected against PUD. CONCLUSIONS: Tobacco smoking and H pylori infection are the main risk factors for PUD in Danish adults. Physical activity may protect against PUD in those infected with H pylori.

Resonance in periodic chemotherapy: a case study of acute myelogenous leukemia.

The effects of periodic chemotherapy administration are evaluated within the context of a G(0)model of the cell cycle. Parameters are estimated for normal bone marrow cells and malignant cells in acute myelogenous leukemia (AML). This model explicitly includes the resting G(0)phase and the feedback mechanism that recruits the cells back into the cell cycle. Periodic chemotherapy administration can induce resonance within our model under high cell kill rate where the average cell cycle times may change during the course of treatment, and therapeutic benefits from these resonances cannot be solely based on cell cycle times in untreated tissue. The depletion rate under chemotherapy and the regrowth rate may differ between the cell populations, and our analysis suggests that this favors the tumour cells. We were able to distinguish between the effects of cycle-non-specific, S -phase-specific and M -phase-specific drugs, and found that these can show differences in sharpness and location of the resonance phenomenon. We conclude that resonance chemotherapy (chronotherapy) is unlikely to be efficacious in the treatment of AML.

Sulfur amino acid deficiency depresses brain glutathione concentration.

Dietary sulfur amino acid content is a major determinant of glutathione concentration in some tissues. We examined whether brain glutathione (GSH), a key component of antioxidant defense important for minimizing ischemic injury, was also responsive to short-term sulfur amino acid deficiency. Female Long-Evans adult rats were fed a sulfur-deficient L-amino acid defined diet for five days; the control diet was supplemented with L-cystine and L-methionine (n = 6). Sulfur amino acid deficiency was confirmed by a reduction in liver cysteine and GSH concentrations, marked decreases in food intake, and weight loss. GSH concentration analyzed by reverse-phase high performance liquid chromatography was significantly depressed in the neocortex and thalamus of deficient rats. Brain cysteine was not decreased in a parallel manner. Classical glutathione peroxidase activity was increased in the liver and brain of sulfur amino acid deficient rats. This suggests an upregulation of antioxidant defense but these findings may be complicated by alterations in tissue composition. The depletion of brain GSH by a reduced supply of dietary precursors may be important during brain ischemia when the rate of GSH utilization and the need for synthesis are increased.

Effects of body-mind training and relaxation stretching on persons with chronic toxic encephalopathy.

The purpose of this project was to investigate the psychological and physical effects of training of body awareness and slow stretching on persons with chronic toxic encephalopathy (CTE). In the present study, a method of self-regulation, a body-mind training, is presented. The body-mind training used was a guided relaxation technique combined with meditative stretching. The techniques are introduced and the psychological and physiological effects of the training is presented. Eight subjects with CTE, 48.5 years, were trained for 8 weeks. Outcome measures were percentage alpha brain waves (alpha%), electromyography (EMG) on the frontalis muscle, state-trait anxiety (STAI), creativity (RAT), and mood measured as anxiousness, humour and mental fatigue. The mean alpha% increased 52% during the training period (P < 0.01), and the EMG decreased 31% (P < 0.001. State anxiety decreased 22% during the training period (P < 0.01), but no changes were observed in trait anxiety and in the creativity score. The level of anxiousness and fatigue before a training session decreased during the training period. In conclusion, the body-mind training resulted in an improved ability for physical and mental relaxation as indicated from the lower EMG, the higher alpha% and the decrease in state anxiety.

Treatment of breast-cancer-related lymphedema with or without manual lymphatic drainage--a randomized study.

A prospective randomized study was carried out to investigate whether the addition of manual lymphatic drainage (MLD) to the standard therapy could improve treatment outcome in women with lymphedema of the ipsilateral arm after breast cancer treatment. Forty-two patients were randomly assigned to receive standard therapy or standard therapy plus MLD 8 times in 2 weeks and training in self-massage. The standard therapy consisted of use of a compression garment, exercises and information about lymphedema and skin care. The efficacy of treatment was evaluated by reduction in lymphedema volume during treatment and by improvement in symptoms potentially related to lymphedema. The patients were followed-up for a total of 12 months. The study showed that both groups obtained a significant reduction in edema and that MLD did not contribute significantly to reduce edema volume.

A randomized, placebo-controlled, cross-over study of ginger extracts and ibuprofen in osteoarthritis.

OBJECTIVE: Alternative medicine is used extensively by patients with chronic pain due to e.g., osteoarthritis. Only few of these drugs have be tested in a controlled setting and the present study was undertaken to examine the effect of ginger extract, one of the most popular herbal medications. DESIGN: Ginger extract was compared to placebo and Ibuprofen in patients with osteoarthritis of the hip or knee in a controlled, double blind, double dummy, cross-over study with a wash-out period of one week followed by three treatment periods in a randomized sequence, each of three weeks duration. Acetaminophen was used as rescue medication throughout the study. The study was conducted in accordance with Good Clinical Practice (European Guideline for GCP). RESULTS: A ranking of efficacy of the three treatment periods: Ibuprofen>ginger extract>placebo was found for visual analogue scale of pain (Friedman test: 24.65, P< 0.00001) and the Lequesne-index (Friedman test: 20.76, P< 0.00005). In the cross-over study, no significant difference between placebo and ginger extract could be demonstrated (Siegel-Castellan test), while explorative tests of differences in the first treatment period showed a better effect of both Ibuprofen and ginger extract than placebo (Chi-square, P< 0.05). There were no serious adverse events reported during the periods with active medications. CONCLUSION: In the present study a statistically significant effect of ginger extract could only be demonstrated by explorative statistical methods in the first period of treatment before cross-over, while a significant difference was not observed in the study as a whole.

Thermal balloon endometrial ablation: safety aspects evaluated by serosal temperature, light microscopy and electron microscopy.

OBJECTIVES: Thermal balloon endometrial ablation is a new method for treating menorrhagia. The technique appears to be less difficult compared to standard hysteroscopic ablation techniques and to be significantly safer. The influence into the uterine wall of the thermal balloon ablation procedure was investigated with special reference to the ability of total destruction of the endometrium and the thermal action on the myometrium and the serosa. STUDY DESIGN: Temperatures were measured at the uterine serosal surface during thermal balloon endometrial ablation for 8-16 min in eight patients. After subsequent hysterectomy the extent of thermal damage into the myometrium was assessed by light and electron microscopy. RESULTS: The highest temperature measured on the uterine serosa was 39.1 degrees C. Coagulation of the myometrium adjacent to the endometrium could be demonstrated by light microscopy in all patients, with a maximum depth of 11.5 mm. By electron microscopy no influence of heat could be demonstrated beyond 15 mm from the endometrial surface. CONCLUSION: Up to 16 min of thermal balloon endometrial ablation therapy can destroy the endometrium and the submucosal layers. The myometrium is only coagulated to a depth where full thickness necrosis or injury is unlikely.