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PubMed2003

The effects of 3 gonadorelin products on luteinizing hormone release, ovulation, and follicular wave emergence in cattle.

The objective was to determine luteinizing hormone (LH) secretion and follicular dynamics in cattle following administration of 3 gonadorelin formulations that are commercially available in Canada. In experiment 1, nonlactating Holstein cows (n = 4 per group) were randomly assigned to receive 100 micrograms gonadorelin diacetate tetrahydrate, intramuscularly (C; Cystorelin, or FE; Fertagyl). Blood samples (for LH analysis) were collected 0, 1, 2, and 4 hours after treatment. In experiment 2, nonlactating Holstein cows (n = 10 per group) were randomly allocated to receive 100 micrograms gonadorelin, intramuscularly as follows: 2 mL of C; 1 mL of FE; or 2 mL of Factrel (FA, gonadorelin hydrochloride). Gonadorelin treatment was done on days 6 or 7 after ovulation and blood samples for LH analysis were collected at 0, 1, 2, 4, and 6 hours after treatment. Ovaries were examined by ultrasonography, twice daily, to detect ovulation. A replicate was conducted using only C (n = 10) or FE (n = 10); blood samples were collected at 0, 1, 2, 3, and 4 hours. In experiment 3, beef heifers (n = 10 per group) were randomly assigned to receive 1 of 3 GnRH gonadorelin treatments (as in the first phase of experiment 2) on days 6 or 7 after ovulation and blood samples were collected at 0, 0.5, 1, 1.5, 2, and 4 hours. In experiments 2 and 3, both mean and mean peak plasma LH concentrations were higher (P < 0.05) in cattle treated with C. The proportion of dominant follicles that ovulated was higher (P < 0.02) in Holstein cows treated with C than in those treated with FE or FA (18/19, 11/19, and 4/7, respectively), but there was no significant difference among the products in beef heifers (6/10, 6/10, and 4/10, respectively). No significant differences were found in the interval from treatment to the emergence of the next follicular wave. In summary, C induced a greater LH release and this resulted in a higher ovulatory rate in Holstein cows but not in beef heifers.

Animals↗

PubMed2004

The aging/precancerous gastric mucosa: a pilot nutraceutical trial.

The aim of this study was to test the effect of antioxidant supplementation on enzymatic abnormalities and free radical-modified DNA adducts associated with premalignant changes in the gastric mucosa of elderly patients with HP-negative atrophic gastritis (CAG). Sixty patients with atrophic gastritis and intestinal metaplasia underwent a nutritional interview and a gastroscopy with multiple biopsy samples in the antrum that were processed for histology and for assaying: alpha-tocopherol, MDA, xanthine oxidase (XO), ornithine decarboxylase (ODC), and 8-OHdG. Patients were randomly allocated into three matched groups and supplemented for 6 months with (1) vitamin E, 300 mg/day; (2) multivitamin, two tablets t.i.d.; and (3) Immun-Age 6 g/day nocte (ORI, Gifu, Japan), a certified fermented papaya preparation with basic science-validated antioxidant/immunomodulant properties. Ten dyspeptic patients served as controls. Histology and biochemistry were blindly repeated at 3 and 6 months. CAG patients showed a significantly (P <.05) increased level of mucosal MDA and XO concentration that were reverted to normal by each supplementation (P <.05). All supplements caused a significant decrease of ODC (P <.01), but Immun-Age yielded the most effective (P < 0.05) and was the only one significantly decreasing 8-OhdG (P < 0.05). These data suggest that antioxidant supplementation, and, namely, Immun-Age, might be potential chemopreventive agents in HP-eradicated CAG patients and especially in the elderly population.

8-Hydroxy-2'-Deoxyguanosine↗

PubMed2003

Computerized, interactive, multimedia cognitive-behavioural program for anxiety and depression in general practice.

BACKGROUND: Cognitive-behavioural therapy (CBT) brings about significant clinical improvement in anxiety and depression, but therapists are in short supply. We report the first phase of a randomized controlled trial of an interactive multimedia program of cognitive-behavioural techniques, Beating the Blues (BtB), in the treatment of patients in general practice with anxiety, depression or mixed anxiety/depression. METHOD: One hundred and sixty-seven adults suffering from anxiety and/or depression and not receiving any form of psychological treatment or counselling were randomly allocated to receive, with or without medication, BtB or treatment as usual (TAU). Measures were taken on five occasions: prior to treatment, 2 months later, and at 1, 3 and 6 months follow-up using the Beck Depression Inventory, Beck Anxiety Inventory and Work and Social Adjustment Scale. RESULTS: Patients who received BtB showed significantly greater improvement in depression and anxiety compared to TAU by the end of treatment (2 months) and to 6 months follow-up. Symptom reduction was paralleled by improvement in work and social adjustment. There were no interactions of BtB with concomitant pharmacotherapy or duration of illness, but evidence, on the Beck Anxiety Inventory only, of interaction with primary care practice. Importantly, there was no interaction between the effects of BtB and baseline severity of depression, from which we conclude that the effects of the computer program are independent of starting level of depression. CONCLUSIONS: These results demonstrate that computerized interactive multimedia cognitive-behavioural techniques under minimal clinical supervision can bring about improvements in depression and anxiety, as well as in work and social adjustment, with and without pharmacotherapy and in patients with pre-treatment illness of durations greater or less than 6 months. Thus, our results indicate that wider dissemination of cognitive-behavioural techniques is possible for patients suffering from anxiety and/or depression.

Adult↗

PubMedDate not supplied

Planning with elderly outpatients for contingencies of severe illness: a survey and clinical trial.

The authors examined whether elderly patients would report positive or adverse emotional effects after their doctor, during a routine clinic visit, asked them to begin planning for future serious illness. Seventy-four patients, 65 years old or older, who were followed at a university hospital medical clinic were randomly allocated to an intervention or a control group. The intervention was a detailed discussion with the patient's physician of the patient's wishes about decision making and life support therapy in the event of extreme or incapacitating illness. A blinded interviewer then asked all consenting patients how they felt about the physician, the clinic visit, and their medical care. Intervention-group patients were questioned about their reactions to the physician and the discussion. Four important findings emerged: 1) Some emotional uncertainty was created when doctors raised these questions unexpectedly: one patient became visibly upset during the discussion, and three who gave consent to be interviewed afterward said that the discussion had made them wonder about their health. Nonetheless, all patients who received the intervention and completed the study were pleased that their doctor had asked. 2) Only 44% of all consenting patients reported having discussed these issues previously; only one had done so with a doctor. 3) 97% of patients who responded wanted to be kept informed by the doctor about their medical situations in times of serious illness. 4) Patients' replies to specific questions about life-sustaining therapy in the event of their own severe illnesses were quite variable. During routine clinic visits doctors can encourage most elderly patients to begin specific planning for potential severe illnesses.

Aged↗

PubMed1987

The Newbury Maternity Care Study: a randomized controlled trial to assess a policy of women holding their own obstetric records.

To assess a policy of women holding and thus having constant access to their own obstetric records, 290 women attending a peripheral consultant clinic in Newbury, West Berkshire, were randomly allocated to hold either their full case notes, or the more usual co-operation card. Women holding their full records were significantly more likely to feel in control of their antenatal care (rate ratio 1.45; 95% confidence interval 1.08-1.95) and to feel it was easier to talk to doctors and midwives (rate ratio 1.73; 95% confidence interval 1.16-2.59). No other beneficial effects were detected. Asked about their preferences for any subsequent pregnancies, women holding their own records in the index pregnancy were more likely to say they would prefer to hold the same kind of record again in a subsequent pregnancy than were women holding a co-operation card (rate ratio 1.56; 95% confidence interval 1.34-1.81). There was no evidence of negative effects. In particular, women holding their case notes did not feel more anxious than co-operation card holders. The policy of women holding their notes resulted in savings in clerical time, without evidence of an increase in the rate of lost notes.

Clinical Trials as Topic↗

PubMed1990

Discomfort after outpatient abortion using paracervical block: a comparison between two opioids and one non-opioid drug for premedication.

One hundred and one patients undergoing outpatient abortion using local anesthesia were randomly allocated to one of three different premedications: morphine-scopolamine, pethidine or midazolam. The incidence of pain, anxiety, emetic (nausea-vomiting) and patient cooperation was analyzed. Discomfort was frequently noticed, 79 patients reported pain, 57 nausea and 26 vomited at least once during the postoperative period which lasted 2.6 h (mean value). There were no major differences in complaints among the different premedication groups. Nausea, though, was correlated to pain. Symptoms of pain, nausea and vomiting were frequent after abortion under paracervical block. These complaints were not found to be related to the type of premedication or other circumstances in the perioperative period.

Abortion, Induced↗

PubMed1992

A cost-effectiveness study of the management of intractable urinary incontinence by urinary catheterisation or incontinence pads.

STUDY OBJECTIVE: The aim was to compare the costs and effects of management of intractable urinary incontinence by urinary catheterisation or incontinence pads. DESIGN: This was a prospective, randomised study comparing catheterisation with pads, supplemented by additional data collected from patients with chronic indwelling catheters. Main outcome measures were costs of equipment, nursing time, patient preference, nursing preference, and clinical and bacteriological assessment of urinary infection. SUBJECTS: 78 intractably incontinent elderly female patients were randomly allocated to management by urinary catheter or pads and toileting. Supplementary data on equipment costs and nursing time were collected from 27 patients, of whom 22 were already catheterised at the time of the randomisation and five were catheterised by the nursing staff after the last date for entry into the randomisation. MAIN RESULTS: Of the 38 patients randomised to catheterisation, 14 refused consent so only 24 were catheterised on day 1 of the study. There was a rapid removal of catheters, especially in the first six weeks of the study and only four of the randomised catheter patients completed the full 26 weeks of the study. However, eight of the pads patients were catheterised between the 7th and 22nd week because of deteriorating general condition and all retained their catheters for the remainder of the study period. Of 35 patients who had experienced catheters and pads, 12 expressed a clear preference for catheters, 12 for pads, and 11 were undecided. Nurses were in favour of the use of pads, mainly because of concerns about urinary infection with catheters. Comparing costs for patients managed with catheters (532 patient weeks) or pads (903 patient weeks), catheter patients required less nursing time (15.4 v 29.0 h per patient per week) but equipment costs were higher (19.20-24.65 pounds v 8.79-11.35 pounds per patient per week), mainly because of the cost of catheter care (12.75 pounds per patient per week). Asymptomatic bacteriuria was prevalent in both groups but 73% of catheterised patients received treatment for clinical signs of infection compared with 40% of pads patients. Only 30% of patients who were treated had any generalised symptoms of infection. CONCLUSIONS: Use of catheters reduces nursing time but may increase weekly equipment costs depending on the cost of laundry. Despite the high dropout rate among patients randomised to catheters a minority of patients (12/35) expressed a clear preference for catheters and we believe that more patients with intractable incontinence should be given a trial of catheterisation to assess acceptability. Bacteriuria was prevalent in pads or catheter patients but no major episodes of invasive infection were noted in either group.

Aged↗

PubMed2003

The context of a study influences the reporting of symptoms.

OBJECTIVES: To study whether different information on a study may influence the reporting of symptoms suspected to be related to poor indoor climate at the workplace or at home. METHODS: A questionnaire was mailed to a random sample (n=4,000) of the general population in Denmark. The participants were randomly allocated to two study groups, each group receiving a slightly different information letter. There were 2,710 subjects (67.8%) who completed the questionnaire, and 2,164 subjects, who were in employment, were included in the study. All subjects were informed that the purpose of the study was to assess the prevalence of non-specific symptoms related to the indoor climate at work and in dwellings. However, in the letter to one study group it was stated that knowledge was especially lacking about health effects related to the indoor climate at work (n=1,468). To the other study group the words at work were replaced with at home (n=696). The questionnaires were similar for each study group. RESULTS: The prevalence rates of symptoms were similar, but reporting of work-relatedness and home-relatedness differed considerably between the two study groups. If the information letter focused slightly more on the workplace than the home, the subjects were more likely to report that their symptoms were work-related (significant unadjusted odds ratios (ORs) between 1.8 and 5.5). We found that adjusting the results for several confounders mainly led to higher estimates of ORs. Likewise, the subjects reported more home-related symptoms if focus was on the environment at home (significant unadjusted ORs between 5.7 and 20.6). CONCLUSIONS: The information about a study may play an important role in the reporting of symptoms.

Adolescent↗

PubMed1984

Effects of cimetidine, ranitidine, and antacid on renal function.

Serum creatinine and beta 2-microglobulin levels, endogenous creatinine clearance, the urinary beta 2-microglobulin excretion rate, and urinary protein levels were monitored serially in 29 patients with duodenal ulcers randomly allocated to receive eight weeks of treatment with cimetidine, ranitidine, or an antacid. A clinically insignificant increase in endogenous creatinine clearance was noted in patients given ranitidine. No adverse change in any of the variables measured was detected in any group of patients during the 12-week period of study.

Adolescent↗

PubMed2002

Sedatives for opiate withdrawal in newborn infants.

BACKGROUND: Neonatal abstinence syndrome (NAS) due to opiate withdrawal may result in disruption of the mother-infant relationship, sleep-wake abnormalities, feeding difficulties, weight loss and seizures. Treatments used to ameliorate symptoms and reduce morbidity include opiates, sedatives and non-pharmacological treatments. OBJECTIVES: To assess the effectiveness and safety of using a sedative compared to a non-opiate control for NAS due to withdrawal from opiates, and to determine which type of sedative is most effective and safe. SEARCH STRATEGY: The standard search strategy of the Neonatal Review Group was used. This included searches of the Cochrane Controlled Trials Register (The Cochrane Library, Issue 1, 2002) and MEDLINE 1966-2002. SELECTION CRITERIA: Trials enrolling infants with NAS born to mothers with an opiate dependence, with > 80% follow up and using random or quasi-random allocation to sedative or control. Control could include another sedative or non-pharmacological treatment. DATA COLLECTION AND ANALYSIS: Each author assessed study quality and extracted data independently. Primary outcomes included treatment failure (failure to achieve symptom control or use of additional drug treatment), seizure occurrence, mortality and neurodevelopment. Treatment effect was expressed using (RR), risk difference (RD), mean difference (MD) and weighted mean difference (WMD). Meta-analysis was performed using a fixed effect model. MAIN RESULTS: Five studies enrolling a total of 285 patients met inclusion criteria (Finnegan 1984, Kahn 1969, Kaltenbach 1986, Khoo 1995, Madden 1977); however, two (Finnegan 1984, Kaltenbach 1986) may be sequential reports that include some identical patients. Methodological concerns included the use of quasi-random rather than random patient allocation methods in three studies, and sizeable, largely unexplained differences in reported numbers allocated to each group in three studies. Phenobarbital compared to supportive care alone has not been shown to reduce treatment failure or time to regain birthweight (one study). However, the duration of supportive care required to be given to infants each day was significantly reduced (MD -162.1 minutes/day, 95% CI -249.2, -75.1). Comparing phenobarbital to diazepam, meta-analysis of two studies found that phenobarbital produced a significant reduction in treatment failure (typical RR 0.39, 95% CI 0.24, 0.62). There was no significant difference in duration of treatment or duration of hospital stay. Comparing phenobarbital with chlorpromazine, one study found no significant difference in treatment failure rate. No data for neurodevelopment were available, reported by treatment group as allocated. No trials were eligible that assessed clonidine for NAS. REVIEWER'S CONCLUSIONS: In newborn infants with NAS, there is no evidence that phenobarbital, compared with supportive care alone, reduces treatment failure; however, phenobarbital may reduce the daily duration of supportive care needed. Phenobarbital, compared to diazepam, reduces treatment failure. There is insufficient evidence to support the use of chlorpromazine or clonidine in newborn infants with NAS. Clonidine and chlorpromazine should only be used in the context of a randomised clinical trial. The results of this review, taken in conjunction with the related review, Opiate treatment for opiate withdrawal in newborn infants (Osborn 2002), indicate that treatment with opiates is the preferred initial therapy for NAS. It is hypothesised that this is particularly true for infants whose mothers have used only opiates during pregnancy. If a sedative is used, phenobarbital is preferred to diazepam. The results of an ongoing trial of the addition of phenobarbital to an opiate are awaited.

Chlorpromazine↗

PubMed2006

Effect of eprinomectin pour-on treatment around calving on reproduction parameters in adult dairy cows with limited outdoor exposure.

The objective of this study was to investigate if treatment of cows with eprinomectin around calving had any beneficial effects on the calving to first artificial insemination interval, calving to conception interval, and number of services per conception in totally- and semi-confined dairy herds. In totally-confined herds lactating- and dry-cows were housed throughout the summer and had no access to pasture. In semi-confined herds lactating- and dry-cows had limited outdoor exposure to a small pasture or paddock but were still fed a ration that met all their nutritional requirements. The study was carried out between February 2002 and February 2003 in 35 herds (2381 cows) located in Quebec, Ontario and Minnesota (USA) participating in a larger clinical trial. The herds kept electronic reproduction records. Cows were randomly allocated to receive eprinomectin or a placebo, with treatment being administered on or close to the day of calving. Monthly bulk tank milk samples from each farm were tested with an indirect ELISA using a crude Ostertagia ostertagi antigen and these data were averaged over the study year. The optical density ratio (ODR) values were then dichotomized into high and low using a cut-point of 0.50. Treatment effects were analyzed using Cox proportional hazards survival models with herd frailty effects for calving to conception and calving to first service intervals. Aalen's linear hazards model was used to investigate time-varying effects in the Cox models. A random effects poisson regression model was used to model the number of services per conception. Other predictor variables tested in the models were lactation number, calving season, study site, peak milk production, ODR and the lactating- and dry-cow housing variables. Overall, there was no significant effect of treatment on the three indices of reproductive performance. The effect of season of calving depended on how much time had passed since calving. Presumably this effect reflected a seasonal effect at the time of breeding. Hazard of conception in younger cows was higher than in older cows. Early bred cows tended to have a higher number of inseminations per conception than those bred late. The results of the study suggested that eprinomectin treatment at calving was not beneficial to reproduction.

Animal Husbandry↗

PubMed1981

A study to determine the effect of Betadine Vaginal Cleansing Kit on cervical flora after insertion of an intra-uterine contraceptive device.

Twenty-four women with negative high vaginal swabs, who attended for insertion of an intra-uterine contraceptive device, were randomly allocated to two groups. One group used the Betadine Vaginal Cleansing Kit before and after insertion of the intra-uterine device; the other group did not use any cleansing agent. After 4 to 6 weeks, the patients were re-examined and a cervical swab was taken. The bacteriological findings were of interest and significance. In the study group there was bacterial in only one patient out of the twelve, whereas in the control group there was bacterial growth in ten out of the twelve. The bacteria grown were of doubtful clinical significance, but in certain circumstances they could take a pathogenic role. The marked absence of bacterial growth in the study group is significant because, during a 4 to 6 week period, the cervical mucus remained sterile thus minimizing the risk of pelvic infection during and immediately after insertion. Whether is has any significant effect in the long-term reduction of the incidence of pelvic infection remains to be seen, and further studies are needed.

Adolescent↗

PubMed2002

Opiate treatment for opiate withdrawal in newborn infants.

BACKGROUND: Neonatal abstinence syndrome (NAS) due to opiate withdrawal may result in disruption of the mother-infant relationship, sleep-wake abnormalities, feeding difficulties, weight loss and seizures. Treatments used to ameliorate symptoms and reduce morbidity include opiates, sedatives and non-pharmacological treatments. OBJECTIVES: To assess the effectiveness and safety of using an opiate, compared to a sedative or non-pharmacological treatment, for treatment of NAS due to withdrawal from opiates. The evidence for use of different opiates was assessed in subgroup analyses. SEARCH STRATEGY: The standard search strategy of the Cochrane Neonatal Review Group including searches (up to March 2002) of the Oxford Database of Perinatal Trials, Cochrane Controlled Trials Register (The Cochrane Library, Issue 1, 2002), MEDLINE (1966-March 2002), previous reviews including cross references, abstracts, conferences and symposia proceedings, expert informants, journal handsearching mainly in the English language. SELECTION CRITERIA: Trials enrolling infants with NAS born to mothers with an opiate dependence, with > 80% follow up and using random or quasi-random allocation to opiate or control. Control could include an opiate, sedative or non-pharmacological treatment. DATA COLLECTION AND ANALYSIS: Each author assessed study quality and extracted data independently. Primary outcomes included control of symptoms, seizure occurrence, mortality and neurodevelopment. Treatment effect was expressed using relative risk (RR), risk difference (RD), mean difference (MD) and weighted mean difference (WMD). Meta-analysis was performed using a fixed effect model. MAIN RESULTS: Six studies enrolling a total of 511 infants met inclusion criteria (Carin 1983, Finnegan 1984, Kaltenbach 1986, Kandall 1983, Khoo 1995, Madden 1977); however, two (Finnegan 1984, Kaltenbach 1986) may be sequential reports that include some identical patients. The studies enrolled infants of mothers who had used opiates with or without other drugs during pregnancy. Methodological concerns included the use of quasi-random rather than random patient allocation methods in three studies, and sizeable, largely unexplained differences in reported numbers allocated to each group in four studies. Opiate (morphine) vs supportive care only: One study (Khoo 1995) found no significant effect on treatment failure (RR 1.29, 95% CI 0.41, 4.07), a significant increase in hospital stay (MD 15.0 days, 95% CI 8.9, 21.1) and significant reductions in time to regain birthweight (MD -2.8 days, 95% -5.3, -0.3) and duration of supportive care (MD -197.2 minutes/day, 95% CI -274.2, -120.3). Opiate vs phenobarbital: Meta-analysis of three studies found no significant difference in treatment failure (typical RR 0.78, 95% CI 0.46, 1.32). One of these studies (Finnegan 1984) reported that opiate treatment resulted in a significant reduction in treatment failure among infants of mothers who had used only opiates; however, as this was a post-hoc analysis, this result should be interpreted with caution. One study (Kandall 1983) reported a reduction in seizures, of borderline statistical significance, with the use of opiate. Opiate vs diazepam: Meta-analysis of two studies found a significant reduction in treatment failure (RR 0.43, 95% CI 0.23, 0.80) with the use of opiate. No study reported neurodevelopment by allocated treatment group. REVIEWER'S CONCLUSIONS: Opiates, as compared to supportive care only, appear to reduce the time to regain birth weight and reduce the duration of supportive care, but increase the duration of hospital stay; there is no evidence of effect on treatment failure. When compared to phenobarbital, opiates may reduce the incidence of seizures but, overall, there is no evidence of effect on treatment failure. When compared to diazepam, opiates reduce the incidence of treatment failure. A post-hoc analysis generates the hypothesis that treatment effects may vary according to whether the population includes infants born to all opiate users (i.e. with or without other drug exposure) or is restricted to infants of mothers who used opiates only. In view of the methodologic limitations of the included studies the conclusions of this review should be treated with caution. Further research is needed.

Humans↗

PubMed2005

Opiate treatment for opiate withdrawal in newborn infants.

BACKGROUND: Neonatal abstinence syndrome (NAS) due to opiate withdrawal may result in disruption of the mother-infant relationship, sleep-wake abnormalities, feeding difficulties, weight loss and seizures. Treatments used to ameliorate symptoms and reduce morbidity include opiates, sedatives and non-pharmacological treatments. OBJECTIVES: To assess the effectiveness and safety of using an opiate, compared to a sedative or non-pharmacological treatment, for treatment of NAS due to withdrawal from opiates. SEARCH STRATEGY: The previous review was updated with additional searches of the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 1, 2005), MEDLINE (1966-December 2004) and EMBASE (1980-December 2004) supplemented by searches of conference abstracts and citation lists of published articles. SELECTION CRITERIA: Trials enrolling infants with NAS born to mothers with an opiate dependence, with > 80% follow up and using random or quasi-random allocation to opiate or control. Control could include an opiate, sedative or non-pharmacological treatment. DATA COLLECTION AND ANALYSIS: Each author assessed study quality and extracted data independently. Primary outcomes included control of symptoms, seizure occurrence, mortality and neurodevelopment. Treatment effect was expressed using relative risk (RR), risk difference (RD), mean difference (MD) and weighted mean difference (WMD). Meta-analysis was performed using a fixed effect model. MAIN RESULTS: Seven studies enrolling a total of 585 infants met inclusion criteria (Carin 1983; Finnegan 1984; Jackson 2004; Kaltenbach 1986; Kandall 1983; Khoo 1995; Madden 1977); however, two (Finnegan 1984; Kaltenbach 1986) may be sequential reports that include some identical patients. The studies enrolled infants of mothers who had used opiates with or without other drugs during pregnancy. Methodological concerns included the use of quasi-random rather than random patient allocation methods in three studies; sizeable, largely unexplained differences in reported numbers allocated to each group in four studies; and imbalances in group characteristics after randomisation in one study. Opiate (morphine) vs supportive care only: One study (Khoo 1995) found no significant effect on treatment failure (RR 1.29, 95% CI 0.41, 4.07), a significant increase in hospital stay (MD 15.0 days, 95% CI 8.9, 21.1) and significant reductions in time to regain birthweight (MD -2.8 days, 95% -5.3, -0.3) and duration of supportive care (MD -197.2 minutes/day, 95% CI -274.2, -120.3). Opiate vs phenobarbitone: Meta-analysis of four studies found no significant difference in treatment failure (typical RR 0.76, 95% CI 0.51, 1.11). One of these studies (Finnegan 1984) reported that opiate treatment resulted in a significant reduction in treatment failure among infants of mothers who had used only opiates; however, as this was a post-hoc analysis, this result should be interpreted with caution. One study (Jackson 2004) reported a significant reduction in duration of treatment and admission to the nursery for infants receiving morphine compared to phenobarbitone. One study (Kandall 1983) reported a reduction in seizures, of borderline statistical significance, with the use of opiate. Opiate vs diazepam: Meta-analysis of two studies found a significant reduction in treatment failure (RR 0.43, 95% CI 0.23, 0.80) with the use of opiate. No study reported neurodevelopment by allocated treatment group. AUTHORS' CONCLUSIONS: Opiates, as compared to supportive care only, appear to reduce the time to regain birth weight and reduce the duration of supportive care, but increase the duration of hospital stay; there is no evidence of effect on treatment failure. When compared to phenobarbitone, opiates may reduce the incidence of seizures but, overall, there is no evidence of effect on treatment failure. One study reported a reduction in duration of treatment and nursery admission for infants on morphine. When compared to diazepam, opiates reduce the incidence of treatment failure. A post-hoc analysis generates the hypothesis that treatment effects may vary according to whether the population includes infants born to all opiate users (i.e. with or without other drug exposure) or is restricted to infants of mothers who used opiates only. In view of the methodologic limitations of the included studies the conclusions of this review should be treated with caution.

Diazepam↗

PubMed1984

A randomized controlled trial of cervical cerclage in women at high risk of spontaneous preterm delivery.

The effect of cervical suture on pregnancy outcome was studied in 194 women with a high risk (approximately 30%) of having a late abortion or a preterm delivery. The women were randomly allocated either to have a cervical suture inserted (n = 96) or to be managed without a suture (n = 98). There was no evidence that cervical cerclage either prolonged gestation or improved survival. Patients allocated to receive cerclage spent significantly longer in hospital, even when the period of admission for insertion was excluded. The patients in the cerclage group were more likely to receive tocolytic drugs, and more of them experienced puerperal pyrexia, although these differences between the groups were not statistically significant.

Adolescent↗

PubMed1996

Extramyocardial acidosis impairs cardiac resuscitability in isolated, perfused, rat hearts.

OBJECTIVES: Patients suffering out-of-hospital cardiac arrest have various degrees of acidemia when cardiopulmonary resuscitation is initiated. Myocardial hypercarbia, rather than decreases in myocardial pH, may determine cardiac resuscitability. Accordingly, we questioned whether different degrees of acidemia accompanying cardiac arrest affect cardiac resuscitability. We evaluated the effect of different degrees of extramyocardial acidosis on cardiac performance and resuscitability after ventricular fibrillation using isolated, perfused, rat hearts. DESIGN: Prospective, randomized, controlled study. SETTING: Experimental animal laboratory in a university hospital. SUBJECTS: Thirty-one male, Sprague-Dawley rats. INTERVENTIONS: Rat hearts were perfused with N-[2-hydroxyethyl]piperazine-N-[2-ethanesulfonic acid] (HEPES) buffered solution (sodium chloride 145 mM, potassium chloride 4 mM, sodium dihydrogen phosphate dihydrate 1.25 mM, magnesium chloride 1.5 mM, calcium chloride 2 mM, HEPES 6 mM, glucose 10 mM), which was bubbled with 100% oxygen and adjusted to a pH of 7.4. The perfusion pressure was held constant at 60 mm Hg. After 60 mins of stabilization, the control perfusion solution was switched to one of the solutions titrated to pH 6.2, 6.5, 6.8, 7.1, or 7.4, using 1 N of sodium hydroxide. Hearts were allocated randomly to each group. After 15 mins of perfusion, the perfusion was discontinued, and artificial ventricular fibrillation was induced by electrical stimulation for 5 mins. The hearts were then perfused again in one of the same acidotic solutions for 30 mins. MEASUREMENTS AND MAIN RESULTS: Left ventricular developed pressure (left ventricular pressure minus end-diastolic left ventricular pressure), positive change in left ventricular pressure over time, heart rate (HR), and coronary flow were continuously measured. After 60 mins of stabilization, the values of left ventricular developed pressure, positive change in left ventricular pressure over time, HR, and coronary flow were not significantly different between groups. After 5 mins of ventricular fibrillation, all hearts were asystolic and left ventricular developed pressure, positive change in left ventricular pressure over time, HR, and coronary flow were all zero. After 30 mins of reperfusion, all values in the acidotic groups were significantly lower than the values in the pH 7.4 group. When we judged the recovery of left ventricular developed pressure at > 35 mm Hg as "resuscitated," resuscitability was impaired at a pH of < 7.1. No hearts recovered after perfusion below a pH of 6.5. CONCLUSIONS: Extramyocardial acidosis below pH 7.1 decreased cardiac performance and resuscitability after ventricular fibrillation. This result indicates that progressive acidemia during cardiac arrest is one of the important determinants of cardiac resuscitability.

Acidosis↗

PubMed1978

[Planning and data analysis in prospective controlled clinical trials (author's transl)].

Planning of prospective controlled clinical trials in surgery requires the use of test and control groups, sufficiently frequent repetition of experiments, random allocation of patients to the groups (example), and balancing. The descriptive data analysis should be performed in a stepwise manner (list of new data, rank list, range, median, quartiles, histogram, mean value standard deviation). The advantages of the median-quartile-system and the prerequisites for application of various significance tests are pointed out. In the conduct of controlled clinical trials, the consultative role of experimental surgeons is proposed.

Clinical Trials as Topic↗

PubMed2002

Effects of dose and route of administration of cloprostenol on luteolysis, estrus and ovulation in beef heifers.

Four experiments were conducted (with crossbred beef heifers) to determine the effects of dose and route of administration of cloprostenol on luteolysis, estrus and ovulation. In Experiment 1, 19 heifers with a CL > or = 17 mm in diameter were randomly allocated to receive cloprostenol as follows: 100 microg s.c., 250 microg s.c., or 500 microg i.m. Heifers given 100 microg s.c. had a longer (P<0.03) interval (120.0 h+/-10.7 h; mean+/-S.E.M.) from treatment to ovulation than those given either 250 microg s.c. or 500 microg i.m. (92.0 h+/-7.4 h and 84.0 h+/-8.2 h, respectively). In Experiment 2, 28 heifers were given porcine LH (pLH), followed in 7 days by cloprostenol (same doses and routes as in Experiment 1), and a second dose of pLH 48 h after cloprostenol. Luteolysis occurred in all heifers, and no difference was detected among treatment groups in the interval from cloprostenol treatment to ovulation (mean, 101 h; P<0.9). In Experiment 3, 38 heifers at random stages of the estrous cycle (but with plasma progesterone concentrations > or =1.0 ng/ml) received 500 or 125 microg cloprostenol by either i.m. or s.c. injection (2/2 factorial design). There was no difference (P<0.4) among groups in the proportions of heifers that were detected in estrus or that ovulated. However, the interval from cloprostenol treatment to estrus was shorter (P<0.02) in the group that received 500 microg i.m. (58.5h) than in the other three groups (500 microg s.c., 75.0 h; 125 microg i.m., 78.0 h; and 125 microg s.c., 82.3h). In Experiment 4, 36 heifers were treated (as in Experiment 3) on Day 7 after ovulation. The proportions of heifers detected in estrus and ovulating after 125 microg s.c. (33 and 44%, respectively) or 125 microg i.m. (55 and 55%) were lower (P<0.05) than in those that received 500 microg s.c. (100 and 100%), but not different from those receiving 500 microg i.m. (78 and 89%, respectively). Overall, ovulation was detected in 9/18 heifers given 125 microg and 17/18 heifers given 500 microg of cloprostenol, on Day 7 (P<0.01) and was detected in 17/20 heifers given 125 microg and 18/18 heifers given 500 microg of cloprostenol, at random stages of the estrous cycle (P>0.05). Although there was no significant difference in luteolytic efficacy between i.m. and s.c. injections of the recommended dose (500 microg) of cloprostenol, variability in responsiveness to a reduced dose depended upon CL sensitivity, therefore, reduced doses cannot be recommended for routine use.

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