Topical Fat Reduction

The fat on women's thighs is more difficult to mobilize due to increased α-2 adrenergic receptor activity induced by estrogen. Lipolysis can be initiated through adipocyte receptor stimulation (β adrenergic) or inhibition (adenosine or α-2 adrenergic) or by inhibition of phosphodiesterase. Since many women desire regional thigh fat loss, a series of clinical trials were initiated using one thigh as a double-blinded control. Trial #1: Five overweight women had injections of isoproterenol at intervals around the thigh three times a week for 4 weeks with diet and walking. Trial #2: Five overweight woman had ointment containing forskolin, yohimbine and aminophylline applied to the thigh five times a week for 4 weeks after hypertonic warm soaks with a diet and walking. Trial #3: Eighteen overweight women were divided into three groups of six and trial #2 was repeated with each agent alone vs. placebo using forskolin, yohimbine or aminophylline in separate ointments. Trial #4: Thirty overweight women had 10% aminophylline ointment applied to the thigh five times a week for 6 weeks with diet and walking. Chemistry panel, theophylline level and patch testing wereperformed. Trial#5: Twelve women had trial #4 repeated with 2% aminophylline cream without a diet or walking. Trial #6: Trial #5 was repeated with 0.5% aminophylline cream. All trials except yohimbine ointment gave significantly more girth loss from the treated thigh (p < 0.05 to p < 0.001). Chemistry panel showed no toxicity. Theophylline was undetectable and patch testing was negative. We conclude that topical fat reduction for women's thighs can be achieved without diet or exercise.     

Reproductive performance of dairy cows following treatment with fenprostalene, dinoprost, or cloprostenol between 24 and 31 Days post partum: a field trial

Three hundred and one Holstein cows (n=301), calving at a commercial free-stall dairy farm, were randomly assigned to 1 of 3 prostaglandin treatment groups or a placebo group. The placebos were packaged 3 ways to mimic the 3 commercial prostaglandin preparations. Group 1 received 1 mg fenprostalene and 1.6 mg oxytetracycline; Group 2 received the fenprostalene placebo (2 ml polyethylene glycol and 1.6 mg oxytetracycline); while Group 3 was given 25 mg dinoprost. Group 4, the dinoprost placebo received 5 ml saline; Group 5 received 500 ug cloprostenol; and Group 6 the cloprostenol placebo received 2 ml saline. The treatments were administered between Days 24 and 31 post partum. Double blind techniques were used in administering treatments and in assessing the response to treatment. There were no significant differences among treatment groups with respect to incidence of retained fetal membranes, endometritis, pyometra, anestrus, number of services per pregnancy, calving-to-first estrus interval, services per conception, number of prostaglandin treatments other than those administered between Days 24 and 31 post partum, the percentage culled for reproductive reasons and all factors combined. Cows receiving fenprostalene, dinoprost or cloprostenol had a decreased calving-to-conception interval compared with that of the controls (P = 0.05). It is concluded that, in the herd studied, treatment with any of the 3 commercially available prostaglandin products between Days 24 and 31 post partum was beneficial for reproductive performance.     

Treatment of the restless legs syndrome with carbamazepine: a double blind study.

One hundred and seventy four patients suffering from the restless legs syndrome were examined in a double blind, between patient, placebo controlled study in general practice for five weeks to investigate the effects of carbamazepine and placebo on the syndrome. The syndrome was more common among middle aged women with relatively low systolic blood pressure. The median haemoglobin concentration was about average for the population, but the severity of the symptoms seemed to increase with decreasing concentrations of haemoglobin. Both placebo and carbamazepine showed a significant therapeutic effect (p less than 0.01). Carbamazepine was significantly more effective than placebo (p less than or equal to 0.03). The significant therapeutic effect of placebo in restless legs showed that only double blind controlled trials can confirm the efficacy of suggested treatments.     

Topical treatment of erectile dysfunction: randomised double blind placebo controlled trial of cream containing aminophylline,isosorbide dinitrate,and co-dergocrine mesylate.

OBJECTIVE--To examine the effectiveness in treating impotence to topically applied cream containing three vasodilators--aminophylline, isosorbide dinitrate, and co-dergocrine mesylate--which act by different mechanisms. DESIGN--Randomised double blinded placebo controlled crossover trial over two weeks. SUBJECTS--36 men with erectile dysfunction randomly allocated to two equal groups. INTERVENTIONS--Active cream containing aminophylline 3%, isosorbide dinitrate 0.25%, and co-dergocrine mesylate 0.05% for one week and placebo for another. MAIN OUTCOME MEASURES--Patients'' reported experience of penile responses and side effects of treatment in questionnaires. Penile tumescence and arterial flow in the laboratory. RESULTS--21 patients reported full erection and satisfactory intercourse with the active cream. Three men reported full erection and satisfactory intercourse with either cream. The active cream was more effective in psychogenic than organic impotence (eight out of nine men with psychogenic impotence achieved a full erection upsilon four out of eight with neurogenic impotence and two out of seven with arterial insufficiency). No major side effects were reported. In the laboratory the active cream increased penile arterial flow (0.19 (SD 0.08) m/s upsilon 0.02 (0.15) m/s with placebo) and induced tumescence in 24 patients. CONCLUSIONS--Topical treatment with a cream containing three different vasodilators might be considered before intracavernous injection of vasoactive agents, particularly in psychogenic impotence.     

Glycyrrhetinic acid, the active principle of licorice, can reduce the thickness of subcutaneous thigh fat through topical application

Cortisol is involved in the distribution and deposition of fat, and its action is regulated by the activity of 11beta-hydroxysteroid dehydrogenase. Glycyrrhetinic acid, the active principle of licorice root, blocks 11beta-hydroxysteroid dehydrogenase type 1, thus reducing the availability of cortisol at the level of adipocytes. We evaluated the effect of topical application of a cream containing glycyrrhetinic acid in the thickness of fat at the level of the thigh. Eighteen healthy women (age range 20-33 years) with normal BMI were randomly allocated to treatment, at the level of the dominant thigh, with a cream containing 2.5% glycyrrhetinic acid (n=9) or with a placebo cream containing the excipients alone (n=9). Before and after 1 month of treatment both the circumference and the thickness of the superficial fat layer of the thighs (by ultrasound analysis) were measured. The circumference and the thickness of the superficial fat layer were significantly reduced in comparison to the controlateral untreated thigh and to control subjects treated with the placebo cream. No changes were observed in blood pressure, plasma renin activity, plasma aldosterone or cortisol. The effect of glycyrrhetinic acid on the thickness of subcutaneous fat was likely related to a block of 11beta-hydroxysteroid dehydrogenase type 1 at the level of fat cells; therefore, glycyrrhetinic acid could be effectively used in the reduction of unwanted local fat accumulation.     

Topical treatment with eberconazole of the experimental guinea pig cutaneous candidosis.

Eberconazole is a new azole antifungal drug for topical treatment of superficial mycoses. The usefulness of this drug was evaluated in an experimental model of cutaneous candidosis in guinea pigs comparing with the classical clotrimazole in a single blind trial. Twenty-five animals were inoculated in two symmetrical areas of the back with Candida albicans developing skin infection. One group of 10 animals were treated once per day with clotrimazole 1% cream in one side and with excipient in the other. Other group of 10 guinea pigs received eberconazole 1% cream and excipient. Five animals did not receive any treatment and were used as controls. After five days of treatment most lesions cured or improved and cultures were negative when clotrimazole or eberconazole were applied. Seventy per cent of lesions treated with excipient were clinically improved and 10% cured, but 85% of cultures remained positive for C. albicans. The therapeutic efficacy of eberconazole 1% cream was similar to clotrimazole 1% cream in the guinea ping model of cutaneous candidosis. Tolerance of both drugs was excellent. These results suggest the usefulness of eberconazole in human cutaneous infections due to C. albicans.     

Relationships between legs bone mineral density, anthropometry and jumping height in prepubertal children

The aim of this study was to determine how the legs bone mineral density (BMD) is influenced by anthropometry and vertical jumping height in prepubertal children. In total, 64 8-11-year-old schoolchildren (27 boys and 37 girls) were studied. All children were at Tanner stage 1. The subjects' height and body mass were measured and BMI calculated. The following anthropometric parameters directly connected with leg were measured: skinfolds--front thigh and medial calf girths--gluteal, thigh, mid-thigh, calf and ankle; lengths--iliospinale height, trochanterion height, trochanteriontibiale laterale, tibiale-laterale height and tibiale mediale-spyrion tibiale; and breadths--biiliocristal, foot length and biepicondylar femur. Total body and legs fat mass and fat %, lean body mass (LBM) and both legs BMD were measured by DXA. Maximal jumping height was measured on the contact mat. Stepwise multiple regression analysis indicated that body height in boys (54.6%; R2 x 100) and body mass in girls (57.3%) were the most important basic anthropometric parameters that influenced BMD in legs. From the measured skinfolds, that of the front thigh characterized legs BMD by 24.9-35.6%. From the girths, the most important parameter to characterize legs BMD was that of calf (50.0-59.1%). Tibiale laterale height was the only length parameter which was highly related with legs BMD (51.1-54.5%). Biepicondylar femur was the most important breadth parameter which characterized legs BMD (51.0-54.8%). Femur breadth and tibiale-laterale height were selected (68.7%) in boys, and tibiale-laterale height and front thigh skinfold thickness (66.0%) in girls when all measured leg anthropometric parameters were analyzed together. From the body composition parameters, the most important parameter to characterize legs BMD was legs LBM (48.9-59.5%). Jumping height did not correlate with legs BMD in any studied groups. In summary, the present study demonstrated that legs LBM together with tibiale-laterale height are the main predictors of legs BMD in prepubertal children.     

Controlled trial of slow-release aminophylline in childhood asthma: are short-term trials valid?

Slow-release aminophylline, although widely used for the prophylaxis of childhood asthma, has had only limited formal assessment. A four-month double-blind cross-over trial of slow-release aminophylline (14 mg/kg twice daily) was carried out in 24 children with perennial asthma. Satisfactory serum theophylline concentrations were obtained in 17 children, with few side effects. There was a significant improvement in mild daytime and night-time symptoms. The incidence of more severe symptoms was unaffected. Treatment did not improve the mean peak expiratory flow or reduce the incidence of use of bronchodilators. It is concluded that slow-release aminophylline has a place in the prophylaxis of perennial childhood asthma but is unsuitable for children who suffer from severe attacks. The cross-over trial design has severe limitations.     

Tolerability of omega-3 fatty acid supplements in perinatal women

BACKGROUND: Benefits of omega-3 fatty acids in perinatal women are well documented, although fish intake has declined among perinatal women. OBJECTIVE: To determine the tolerability of omega-3 fatty acid supplementation in perinatal women. DESIGN: Pregnant and postpartum women with major depressive disorder (MDD) entered an 8-week double-blind, placebo-controlled trial of omega-3 fatty acids. Four capsules provided 1.84 g/day of eicosapentanoic acid (EPA) and docosahexaenoic acid (DHA), or matching placebo (corn oil with 1% fish oil to maintain blind). Tolerability was assessed by clinician interview biweekly. RESULTS: Fifty-nine women enrolled. Thirteen (22%) reported mainly transient side effects including dizziness, diarrhea, nausea, burping, heartburn/reflux, difficulty swallowing capsules, unpleasant breath/bad taste or feeling tired. The most common were unpleasant breath/bad taste and heartburn/reflux. Six reporting side effects received omega-3 fatty acids; seven received placebo. Neither pregnant nor postpartum women discontinued due to intolerability. CONCLUSIONS: Omega-3 fatty acid supplements were well tolerated by perinatal women.     

Failure of acyclovir cream in treatment of recurrent herpes labialis.

A double blind, randomised, crossover placebo controlled trial of 5% acyclovir cream, applied topically five times a day for five days, was carried out in 45 patients with recurrent herpes labialis. These patients had a total of 72 episodes, 34 of which were treated with the 5% acyclovir cream and 38 with placebo cream. Treatment was begun by the patients as soon as possible after the onset of prodromal symptoms. There was no significant clinical benefit from treatment with acyclovir cream compared with placebo cream. The median healing times were nine days with acyclovir cream, 10 days with placebo cream, and 13 days when no treatment was given. The possibility that the 40% propylene glycol cream base alone has a therapeutic effect must therefore be considered.     

Construct validation of lower limb segmental excursion as a measure of potential risk for lower limb injury in Division I women’s basketball players

The region of limb stability (ROLS) is an inertial sensor-based measure of static knee joint stability, defined by thigh and shank movements of the supporting limb during single limb stance. Changes in thigh and shank movements and/or symmetry differences between limbs may predict risk of injury to the less stable limb or the need for rehabilitation. In this study, construct validity of the ROLS metrics was examined in twelve Division I women’s basketball players during pre-season in preparation for their exercise training program. The subjects were categorized based on their injury history during the season: (Group 1) No reported injuries throughout the season, (Group 2) lower limb injury that did not result in missing any games, and (Group 3) lower limb injury that resulted in missing both practice and the remainder of their season. Significant differences were found in ROLS metrics at pre-season between Group 3 and other groups in a prospective cohort study (p < 0.05). Study findings provided pilot data for supporting ROLS as a measure of postural stability impairment and potential risk for lower limb injury in athletes.     

Electroconvulsive therapy: results in depressive illness from the Leicestershire trial.

Electroconvulsive therapy was investigated in a double blind trial. Altogether 186 clinically selected patients were referred to the trial, but 48 of these did not participate. According to the present state examination, 95 of the remaining 138 patients fell into one of the classes of major depression. Patients were randomly allocated to a course of real or simulated electroconvulsive therapy. Treatment was given twice a week with a maximum of eight treatments. On the Hamilton depressive rating scale the improvement in the group given real treatment was significantly greater than that in the group given simulated treatment both at two weeks (p = 0.014) and at four weeks (p = 0.0001). At follow up at 12 and 28 weeks there was no difference between the treatment groups. At the end of the four week trial consultants, who were blind to the allocation of treatment, rated the patients who had received real treatment as having made a significantly greater improvement than the patients who had received simulated treatment (p less than 0.00005). Further analysis showed that electroconvulsive therapy was effective in depression associated with delusions and in depression associated with retardation.     

Effects of the anabolic steroid, boldenone undecylenate, on certain reproductive parameters in bulls

A total of 17 bulls was used to study the effects of boldenone undecylenate on growth and semen characteristics in beef bulls. In trial 1 nine mature mixed-breed beef bulls with satisfactory semen quality were divided into two groups. Group I (n = 5) received boldenone undecylenate (1.1 mg/kg) at 21 d intervals for a total of seven treatments (147 d). Group II (n = 4) served as untreated controls. Semen was collected from each group by electroejaculation on each treatment day and evaluated according to the standards of the Society for Theriogenology. Although neither the percentage of spermatozoa with primary or secondary morphological abnormalities was different, the ejaculates of Group I bulls contained a higher percentage of abnormal spermatozoa than those in Group II. In trial 2, eight mixed-breed bull calves, average weight 140.4 kg, were maintained under drylot conditions in a single paddock. The bulls were divided into two equal groups. Group I (n = 4) received boldenone undecylenate as in Trial 1. Group II (n = 4) served as untreated controls. The bulls were weighed and the scrotal circumference (SC) was measured every 21 d until it reached 30 cm, at which time semen was collected and evaluated as in Trial 1. Group I bulls had a higher percentage of spermatozoa with primary morphological abnormalities than bulls in Group II. Group I bulls had a higher average daily gain (ADG) than Group II bulls and required 21 d longer for the SC to reach 30 cm. Semen quality for all bulls was satisfactory at each sampling day.     

Informed consent: study of quality of information given to participants in a clinical trial.

OBJECTIVE--To determine whether the participants in a clinical trial had perceived adequate information about the trial according to the guidelines of the Declaration of Helsinki. DESIGN--About 18 months after the end of a gynaecological clinical trial the participants received a questionnaire by post, which focused on the quality of the information given to them before entering the trial. Neither researchers nor participants were aware in advance that the trial would become the subject of this follow up investigation. SETTING--Eight different centres in Sweden. SUBJECTS--43 women out of the 53 who completed the trial (mean (range) age 23 (16 to 35) years) returned the questionnaire. MAIN OUTCOME MEASURES--Adequacy of the information (based on requirements of the Declaration of Helsinki) to enable the following: understanding of the aims of the study; awareness of what participation meant; and awareness of the possibility of withdrawing from participation at any time. Motives for agreeing to participate, and a subjective evaluation of the given information were also recorded. RESULTS--All but one of the participants had been aware that they were taking part in a research project. Five women stated that they had not been aware that a second laparoscopy was performed only for research reasons. Seven women reported that they had not been aware of the meaning of participating in the project and 17 that they had had no information about the possibility of withdrawing from the study whenever they wanted. In the subjective rating 22 women considered the information given as good or very good. There was a systematic variation in the quality of the given information among the eight centres. CONCLUSION--Although all but one of the participants had been aware that they were taking part in a clinical trial, the quality of the information understood and recalled by participants varied, and in many cases clearly did not meet the guidelines of the Declaration of Helsinki. Variations among centres in participants'' perception of information suggest that deficiencies in perception may be caused by informers rather than the participants.     

Treatment of superficial thrombophlebitis: a randomized,bouble-blind trial of heparinoid cream.

In a prospective, double-blind, randomized trial the efficacy of a heparinoid in ointment form was assessed in treating superficial thrombophlebitis developing after continuous intravenous infusion. One hundred surgical patients were studied, and clinical examination and the iodine-125-labelled fibrinogen test used to assess the results. The mean time required for the relief of local symptoms and signs and the rate of local decline in radioactivity differed significantly between patients receiving the heparinoid cream and those recieving the placebo.     

Zinc supplementation during pregnancy: a double blind randomised controlled trial.

OBJECTIVE--To see whether zinc supplementation during pregnancy improves maternal and fetal outcome. DESIGN--Prospective study started at booking and continued till discharge of mother and baby from the maternity hospital. Mothers were randomly assigned to receive zinc supplementation or placebo in a double blind trial. SETTING--Mothers booking at one hospital. PATIENTS--Women booking before 20 weeks of gestation who agreed to take part in the study. 494 Mothers were followed up till the end of pregnancy. There was no difference between the groups given zinc and placebo in their social or medical backgrounds. INTERVENTIONS--Mothers in the active treatment group received one capsule of 20 mg elemental zinc daily and those in the placebo treated group a capsule identical in appearance and taste with the active capsule but which contained inert substances. MAIN OUTCOME MEASURE--Various adverse outcomes were tested, including maternal bleeding, hypertension, complications of labour and delivery, gestational age, Apgar scores, and neonatal abnormalities. The main outcome measure was birth weight. RESULTS--There were no differences whatsoever between mothers given a zinc supplement and those given a placebo. CONCLUSION--Zinc supplementation in pregnancy in the United Kingdom does not seem to offer any benefits to the mother or her fetus.     

Urinary incontinence: prevalence,need for treatment,and effectiveness of intervention by nurse.

OBJECTIVE--To measure the unmet need of patients with regular urinary incontinence (incontinence twice or more a month) treatable by a nurse. DESIGN--Self completed postal questionnaire and randomised controlled trial of assessment and intervention by a nurse. SETTING--One urban and one rural general practice in Somerset. SUBJECTS--7300 adults randomly selected from 10,300 aged 35 and over on the combined practice lists. 515 women and 185 men with regular incontinence were offered assessment and treatment, of whom 134 women and 49 men had no intervention for three months (historical controls). They then joined the assessment and treatment programme. INTERVENTION--Four sessions of pelvic floor exercises and bladder retraining supervised by non-specialist nurse who had taken a three week course on assessing and treating uncomplicated incontinence. MAIN OUTCOME MEASURES--Number of patients desiring treatment; self reported cure, improvement, or deterioration in continence after three months. RESULTS--The questionnaire achieved a 79% response. Validated responses showed a prevalence of 4.4% in men and 16.4% in women aged 35-64. 315 (45%) of the 700 patients offered assessment refused it and seven had moved away or died, 64 men and 41 women were referred to their general practitioner. 197 of 292 treated women (68%) reported cure or improvement compared with seven (5%) of controls. 22 of the 86 men desiring treatment were suitable for intervention by the nurse. Seventeen were cured or improved compared with none of the men in the control group. CONCLUSIONS--About half the people with regular urinary incontinence took up the offer of treatment (9.2% of women and 3.4% of men in the study population). This condition can be effectively managed by a nurse with limited training.     

Control of FSH, follicular development and estrus synchronization in the mare with steroid-free follicular fluid

Twenty-two pony mares were used in a project designed to determine the effectiveness of different treatments in controlling FSH, follicular development and synchronization of estrus and ovulation. Mares in Group 1 (n=8) received daily oral altrenogest (0.044 mg/kg); those in Group 2 (n=7) received daily altrenogest (0.044 g/kg) and, during the last 4 days of treatment they received steroid-free follicular fluid, (15 cc) intravenously (I.V.) two times a day; Mares in Group 3 (n=7) received daily intramuscular (I.M.) injections of progesterone (80 mg) and estradiol valerate (7 mg). All treatments lasted for 10 days, at the end of which prostaglandin (PgF(2)alpha, 10 mg) was administered. Sexual behavior, follicular development and FSH concentrations were monitor daily. Concentrations of FSH in Group 2 mares, were not significantly different (P>0.05) from those of Group 1 until the mares in Group 2 were treated with follicular fluid (P<0.05). Concentrations of FSH in Group 3 mares, were significantly lower than those of Groups 1 and 2 (P<0.05) until the mares in Group 2 were treated with steroid-free follicular fluid. At this point there was no significant difference between groups 2 and 3 (P>0.05). Steroid-free follicular fluid appears to induce atresia in larger follicles (>11 mm), and the initiation of new follicular wave. The combination of progesterone and estradiol valerate appears to delay follicular growth and not to induce atresia, since larger follicles (>11 mm) continued to grow after treatment. Both treatments (groups 2 and 3) resulted in ovulations within 5 days period. The treatment in Group 1 did not have any effect on FSH or follicular development and ovulations were dispersed through a 9-day period. We concluded that steroid-free follicular fluid offers a new possibility to synchronize ovulation in the mare by controlling FSH and follicular development.     

Evaluation of a package of continuum of care interventions for improved maternal,newborn, and child health outcomes and service coverage in Ghana: A cluster-randomized trial

BackgroundIn low- and middle-income countries (LMICs), the continuum of care (CoC) for maternal, newborn, and child health (MNCH) is not always complete. This study aimed to evaluate the effectiveness of an integrated package of CoC interventions on the CoC completion, morbidity, and mortality outcomes of woman–child pairs in Ghana.Methods and findingsThis cluster-randomized controlled trial (ISRCTN: 90618993) was conducted at 3 Health and Demographic Surveillance System (HDSS) sites in Ghana. The primary outcome was CoC completion by a woman–child pair, defined as receiving antenatal care (ANC) 4 times or more, delivery assistance from a skilled birth attendant (SBA), and postnatal care (PNC) 3 times or more. Other outcomes were the morbidity and mortality of women and children. Women received a package of interventions and routine services at health facilities (October 2014 to December 2015). The package comprised providing a CoC card for women, CoC orientation for health workers, and offering women with 24-hour stay at a health facility or a home visit within 48 hours after delivery. In the control arm, women received routine services only. Eligibility criteria were as follows: women who gave birth or had a stillbirth from September 1, 2012 to September 30, 2014 (before the trial period), from October 1, 2014 to December 31, 2015 (during the trial period), or from January 1, 2016 to December 31, 2016 (after the trial period). Health service and morbidity outcomes were assessed before and during the trial periods through face-to-face interviews. Mortality was assessed using demographic surveillance data for the 3 periods above. Mixed-effects logistic regression models were used to evaluate the effectiveness as difference in differences (DiD). For health service and morbidity outcomes, 2,970 woman–child pairs were assessed: 1,480 from the baseline survey and 1,490 from the follow-up survey. Additionally, 33,819 cases were assessed for perinatal mortality, 33,322 for neonatal mortality, and 39,205 for maternal mortality. The intervention arm had higher proportions of completed CoC (410/870 [47.1%]) than the control arm (246/620 [39.7%]; adjusted odds ratio [AOR] for DiD = 1.77; 95% confidence interval [CI]: 1.08 to 2.92; p = 0.024). Maternal complications that required hospitalization during pregnancy were lower in the intervention (95/870 [10.9%]) than in the control arm (83/620 [13.4%]) (AOR for DiD = 0.49; 95% CI: 0.29 to 0.83; p = 0.008). Maternal mortality was 8/6,163 live births (intervention arm) and 4/4,068 live births during the trial period (AOR for DiD = 1.60; 95% CI: 0.40 to 6.34; p = 0.507) and 1/4,626 (intervention arm) and 9/3,937 (control arm) after the trial period (AOR for DiD = 0.11; 95% CI: 0.11 to 1.00; p = 0.050). Perinatal and neonatal mortality was not significantly reduced. As this study was conducted in a real-world setting, possible limitations included differences in the type and scale of health facilities and the size of subdistricts, contamination for intervention effectiveness due to the geographic proximity of the arms, and insufficient number of cases for the mortality assessment.ConclusionsThis study found that an integrated package of CoC interventions increased CoC completion and decreased maternal complications requiring hospitalization during pregnancy and maternal mortality after the trial period. It did not find evidence of reduced perinatal and neonatal mortality.Trial registrationThe study protocol was registered in the International Standard Randomised Controlled Trial Number Registry (90618993).

Akira Shibanuma and co-workers study a package of maternal and child health interventions in a cluster-randomized trial done in Ghana.     

Evaluation of EMLA Cream for Preventing Pain during Tattooing of Rabbits: Changes in Physiological, Behavioural and Facial Expression Responses

Background

Ear tattooing is a routine procedure performed on laboratory, commercial and companion rabbits for the purpose of identification. Although this procedure is potentially painful, it is usually performed without the provision of analgesia, so compromising animal welfare. Furthermore, current means to assess pain in rabbits are poor and more reliable methods are required. The objectives of this study were to assess the physiological and behavioural effects of ear tattooing on rabbits, evaluate the analgesic efficacy of topical local anaesthetic cream application prior to this procedure, and to develop a scale to assess pain in rabbits based on changes in facial expression.

Methodology/Principal Findings

In a crossover study, eight New Zealand White rabbits each underwent four different treatments of actual or sham ear tattooing, with and without prior application of a topical local anaesthetic (lidocaine/prilocaine). Changes in immediate behaviour, heart rate, arterial blood pressure, serum corticosterone concentrations, facial expression and home pen behaviours were assessed. Changes in facial expression were examined to develop the Rabbit Grimace Scale in order to assess acute pain. Tattooing without EMLA cream resulted in significantly greater struggling behaviour and vocalisation, greater facial expression scores of pain, higher peak heart rate, as well as higher systolic and mean arterial blood pressure compared to all other treatments. Physiological and behavioural changes following tattooing with EMLA cream were similar to those in animals receiving sham tattoos with or without EMLA cream. Behavioural changes 1 hour post-treatment were minimal with no pain behaviours identifiable in any group. Serum corticosterone responses did not differ between sham and tattoo treatments.

Conclusions

Ear tattooing causes transient and potentially severe pain in rabbits, which is almost completely prevented by prior application of local anaesthetic cream. The Rabbit Grimace Scale developed appears to be a reliable and accurate way to assess acute pain in rabbits.