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PubMed2001

Amniotomy plus intravenous oxytocin for induction of labour.

BACKGROUND: Induction of labour is a common obstetric intervention. Amniotomy alone for induction of labour is reviewed separately and oxytocin alone for induction of labour is being prepared for inclusion in The Cochrane Library. This review will address the use of the combination of these two methods for induction of labour in the third trimester. This is one of a series of reviews of methods of cervical ripening and labour induction using standardised methodology. OBJECTIVES: To determine, from the best available evidence, the efficacy and safety of amniotomy and intravenous oxytocin for third trimester induction of labour. SEARCH STRATEGY: The Cochrane Pregnancy and Childbirth Group Trials Register, the Cochrane Controlled Trials Register and reference lists of articles were searched. Date of last search: May 2001. SELECTION CRITERIA: The criteria for inclusion included the following: (1) clinical trials comparing amniotomy plus intravenous oxytocin used for third trimester cervical ripening or labour induction with placebo/no treatment or other methods listed above it on a predefined list of labour induction methods; (2) random allocation to the treatment or control group; (3) adequate allocation concealment; (4) violations of allocated management not sufficient to materially affect conclusions; (5) clinically meaningful outcome measures reported; (6) data available for analysis according to the random allocation; (7) missing data insufficient to materially affect the conclusions. DATA COLLECTION AND ANALYSIS: Trial quality assessment and data extraction were done by both reviewers. A strategy was developed to deal with the large volume and complexity of trial data relating to labour induction. This involved a two-stage method of data extraction. The initial data extraction was done centrally, and incorporated into a series of primary reviews arranged by methods of induction of labour, following a standardised methodology. The data is to be extracted from the primary reviews into a series of secondary reviews, arranged by category of woman. MAIN RESULTS: Seventeen trials involving 2566 women were included. Amniotomy and intravenous oxytocin were found to result in fewer women being undelivered vaginally at 24 hours than amniotomy alone (relative risk (RR) 0.03, 95% confidence intervals (CI) 0.001-0.49). This finding was based on the results of a single study of 100 women. As regards secondary results amniotomy and intravenous oxytocin resulted in significantly fewer instrumental vaginal deliveries than placebo (RR 0.18, CI 0.05-0.58). Amniotomy and intravenous oxytocin resulted in more postpartum haemorrhage than vaginal prostaglandins (RR 5.5, CI 1.26-24.07). Significantly more women were also dissatisfied with amniotomy and intravenous oxytocin when compared with vaginal prostaglandins, RR 53, CI 3.32-846.51. REVIEWER'S CONCLUSIONS: Data on the effectiveness and safety of amniotomy and intravenous oxytocin are lacking. No recommendations for clinical practice can be made on the basis of this review. Amniotomy and intravenous oxytocin is a combination of two methods of induction of labour and both methods are utilised in clinical practice. If their use is to be continued it is important to compare the effectiveness and safety of these methods, and to define under which clinical circumstances one may be preferable to another.

Amnion↗

PubMed2001

Breast stimulation for cervical ripening and induction of labour.

BACKGROUND: Breast stimulation has been suggested as an effective means of inducing labour. It is both an inexpensive and non-medical intervention which allows women greater control over the induction process. It is not clear how breast stimulation increases uterine contractions, however it has been shown to be effective for contraction stress tests and for the augmentation of labour. This is one of a series of reviews of methods of cervical ripening and labour induction using a standardised methodology. OBJECTIVES: To determine the effectiveness of breast stimulation for third trimester cervical ripening or induction of labour in comparison with placebo/no intervention or other methods of induction of labour. SEARCH STRATEGY: The Cochrane Pregnancy and Childbirth Group trials register, the Cochrane Controlled Trials Register and bibliographies of relevant papers. Last searched: April 2001. SELECTION CRITERIA: (1) randomised controlled trials comparing breast stimulation used for third trimester cervical ripening or labour induction with no intervention or other methods listed above it on a predefined list of labour induction methods; (2) random allocation to the treatment or the control group; (3) adequate allocation concealment; (4) violations of allocated management not sufficient to materially affect conclusions; (5) clinically meaning outcome measures reported; (6) data available for analysis according to the random allocation; (7) missing data insufficient to materially affect the conclusions. DATA COLLECTION AND ANALYSIS: A generic strategy has been developed to deal with the large volume and complexity of trial data relating to labour induction. This involved a two-stage method of data extraction. The initial data extraction was done centrally. MAIN RESULTS: Six randomised controlled trials were included in the analysis involving 719 women. When trials comparing breast stimulation with no intervention were analysed there was a significant reduction in the number of women not in labour at 72 hours (62.7% versus 93.6%, relative risk (RR) 0.67, 95% confidence interval (CI) 0.60 - 0.74). However, this result did not remain significant in women with an unfavourable cervix. There were no instances of uterine hyperstimulation. A reduction in the rate of postpartum haemorrhage was reported (0.7% versus 6%, RR 0.16, 95% CI 0.03 - 0.87). No significant difference was detected in the caesarean section rate (9% versus 10%, relative risk RR 0.90, 95% CI 0.38 - 2.12) or rates of meconium staining. Three perinatal deaths were reported (1.8% versus 0%, RR 8.17, 95% CI 0.45 - 147.77). This finding should be interpreted with caution. The three deaths occurred in the breast stimulation arm of a three-armed trial (breast stimulation versus no intervention versus oxytocin) of questionable quality. The study was very small (n = 57), involved only high risk women, and the method of randomisation was not reported. When comparing breast stimulation with oxytocin alone the analysis found no difference in caesarean section rates (28% versus 47%, RR 0.60, 95% CI 0.31 - 1.18). No difference was detected in the number of women not in labour after 72 hours (58.8% versus 25%, RR 2.35, 95% CI 1.00 - 5.54). There was no significant difference in the rates of meconium staining. There were four perinatal deaths. Three in the breast stimulation arm, and one in the oxytocin arm of the three-armed trial noted above (17.6% versus 5%, RR 3.53, 95% CI 0.40-30.88). REVIEWER'S CONCLUSIONS: Breast stimulation cannot be fully evaluated on efficacy and safety grounds from the included studies. Whilst it would appear beneficial in terms of a reduction in the number of women not in labour after 72 hours, and a reduction in postpartum haemorrhage, until safety issues have been fully evaluated it should not be considered for use in a high risk population.

Breast↗

PubMed1977

Blood glucose control and glomerular capillary basement membrane thickening in experimental diabetes.

Glomerular capillary basement membrane thickness (BMT) was measured in 23 rats which had had streptozocin-induced diabetes for 14 months and in 12 age-matched controls. Diabetic rats were randomly allocated to different groups, either receiving no treatment or treated with a low carbohydrate diet or insulin, or both. Control rats were randomly allocated to a normal or low carbohydrate diet. Among the diabetic rats mean plasma glucose concentrations for the groups ranged from 27-4 mmol/l (494 mg/100 ml) in the untreated rats to 9-8 mmol/l (177 mg/100 ml) in those receiving both a low carbohydrate diet and insulin. A highly significant positive relation was found between BMT and plasma glucose concentration for individual rats. When BMT was corrected for body weight a similar relation was observed.

Animals↗

PubMed2002

Persistent activity of moxidectin pour-on and injectable against sucking and biting louse infestations of cattle.

To evaluate the persistent activity of pour-on and injectable moxidectin against natural challenge by sucking (predominantly Linognathus vituli) and chewing (Bovicola bovis) cattle lice, 96 mixed-breed calves that had been treated to remove all lice were blocked by body weight and randomly allocated to three treatments: untreated control, moxidectin at 500 microg/kg by topical application and moxidectin at 200 microg/kg by subcutaneous injection. Twelve pens were blocked into groups of four and randomly allocated to four challenge times: 14, 21, 28 and 35 days post-treatment. Treatment groups were assigned to challenge pens randomly. Two donor calves, with demonstrated infestations of both sucking and chewing lice, were introduced into each pen containing eight principal calves at the start of each challenge time. Donors remained in the challenge pen for 7 days. Principal calves were examined for lice, 7, 14, 21 and 28 days after donor removal using a standardized hair-parting technique. Moxidectin injectable prevented re-infestation with L. vituli for up to 42 days, but did not provide persistent activity against B. bovis longer than 35 days post-treatment. Moxidectin pour-on demonstrated persistent activity against both B. bovis and L. vituli for 42 days.

Administration, Topical↗

PubMed2001

A cluster randomized controlled trial of a dental health education program for 10-year-old children.

OBJECTIVE: Using a cluster randomized trial, this study tested the effectiveness of a dental health education program designed to improve the oral hygiene and dental knowledge of 10-year-old children. METHODS: Thirty-two primary schools in the northwest of England participated. After a baseline assessment of plaque and the completion of a dental knowledge questionnaire by the children, the schools were allocated randomly to active or control groups. Children in schools allocated to the active group received the dental health program, which consisted of four one-hour lessons. After four months the children were examined clinically and scored for plaque, and a second questionnaire was administered. The schools in the control group were then allocated randomly to receive the program or not over the following three months, the program being withdrawn from the schools who initially received it. A further assessment of plaque was made and a questionnaire administered seven months after the baseline of the study. RESULTS: The active groups had 20 percent and 17 percent lower mean plaque scores than the control group at four and seven months (P < .001). The children's knowledge of which type of toothbrush should be used and the role of disclosing tablets improved in the initial test group when compared with the control group and this was retained over the second part of the study. CONCLUSION: The children receiving the program had significantly lower mean plaque scores and greater knowledge about toothbrushes and disclosing tablets than the control children who had not received the program.

Attitude to Health↗

PubMed2026

Moderate alcohol intake and heart rate variability adaptations to high-intensity interval training in healthy young adults: the BEER-HIIT study.

BACKGROUND: It is unknown whether daily alcohol consumption influences training effects on heart rate variability (HRV). This study investigated: (i) the effects of a 10-week high-intensity interval training (HIIT) on HRV in healthy young adults; and (ii) the effects of daily alcohol consumption on HRV responses to exercise. METHODS: 71 healthy young adults (18-40 years old; 52.1% women) participated in the BEER-HIIT study. We conducted a 10-week (2 days/week) controlled trial (ClinicalTrials.gov ID: NCT03660579). Participants were allocated to 5 groups: a non-training group (N-T) and four HIIT groups. Participants in the training groups chose whether to consume alcohol. Those choosing alcohol were randomly allocated to receive beer (5.4%; T-Beer) or an equivalent amount of alcohol (vodka; T-Ethanol) in sparkling water. Those choosing no alcohol were randomly allocated to receive alcohol-free beer (0.0%; T-Zero) or sparkling water (T-Water). Training comprised eight weight-bearing exercises performed in circuit form. HRV was measured before and after the intervention. RESULTS: No statistically significant between-group differences in HRV outcomes were detected after the intervention (all p > 0.05). CONCLUSIONS: Our findings indicate that: (i) no statistically significant differences in HRV responses were detected following a 10-week HIIT program using weight-bearing exercises performed twice per week; and (ii) no statistically significant differences in HRV responses were observed among the assigned beverage intervention groups. These findings should be interpreted cautiously because HRV was a secondary outcome and the study was not specifically powered to detect differences in these parameters.

alcohol↗

PubMed1988

The community management of schizophrenia. A controlled trial of a behavioural intervention with families to reduce relapse.

Schizophrenic patients were recruited into a trial of a prophylactic behavioural intervention with families. Families with at least one high Expressed Emotion (EE) relative were randomly allocated to one of four intervention groups: Behavioural Intervention Enactive; Behavioural Intervention Symbolic; Education Only; Routine Treatment. Patients from low-EE families were randomly allocated to two groups: Education Only or Routine Treatment. Relapse rates over nine months after discharge were significantly lower for patients in the two Behavioural Intervention, compared with Education Only and Routine Treatment groups. There was little difference between the two low-EE groups. Patients returning to high-EE relatives showed significantly higher relapse rates than those returning to low-EE relatives, in groups not receiving active intervention. Changes from high to low EE occurred in the Behavioural Intervention groups, and similar although less extensive changes occurred in the Education Only and Routine Treatment groups. Changes in criticism and marked emotional over-involvement (EOI) occurred generally in high-EE groups but were larger in magnitude in the Enactive and Symbolic groups. Reduction of hostility only occurred in the Behavioural Intervention groups. These results give partial support for the causal role of EE in relapse. There were no significant differences between the groups with respect to contact with the psychiatric services or medication.

Adult↗

PubMed1985

Prophylactic amantadine dose and plasma concentration-effect relationships in healthy adults.

Amantadine dose, plasma concentration, prophylactic and adverse effect relationships for prevention of influenza A virus infection in healthy young adult subjects were investigated in a double-blind, placebo-controlled study. Seventy-four subjects with hemagglutination inhibition antibody titers less than or equal to 16 against an attenuated influenza A virus AF9/Montreal/3/72 (H3N2) were randomly allocated to groups taking 0 (placebo), 25, 100, or 150 mg amantadine syrup prophylactically twice a day for 31 doses. Eighteen other subjects were randomly allocated to control groups for investigation of drug toxicity (150 mg) or concurrent other virus infection (placebo). Steady-state trough plasma concentrations were 110 +/- 39, 302 +/- 80, and 572 +/- 207 ng/ml (X +/- SD) for the three amantadine doses and increased out of proportion to dose. Prophylaxis groups were challenged intranasally with virus after the fifth dose at steady state; control subjects received saline solution. No subject became ill. Input virus was recovered 48 or 72 hr after challenge from nose or throat swabs of nine of 21 subjects taking placebo, one of 18 subjects taking 100 mg amantadine, three of 18 subjects taking 25 mg amantadine, and six of 17 subjects taking 150 mg amantadine. There were no differences in seroconversion rates or adverse symptoms. Our data do not support a change in the recommended amantadine prophylactic dose for influenza A virus infection in healthy young adults. We defined trough steady-state plasma concentrations associated with the recommended amantadine dose of 100 mg twice a day that should be mimicked in devising dose schedules for populations with differing amantadine kinetics.

Adolescent↗

PubMed1999

Postoperative pain facilitates nonthermoregulatory tremor.

BACKGROUND: Spontaneous tremor is relatively common in normothermic patients after operation and has been attributed to many causes. The hypothesis that nonthermoregulatory shivering-like tremor is facilitated by postoperative pain was tested. In addition, the effects of intravenous lidocaine on nonthermoregulatory tremor were evaluated. METHODS: Patients undergoing knee surgery were anesthetized with 2 microg/kg intravenous fentanyl and 0.2 mg/kg etomidate. Anesthesia was maintained with 1.7 +/- 0.8% (mean +/- SD) isoflurane. Intraoperative forced-air heating maintained normothermia The initial 44 patients were randomly allocated to receive an intra-articular injection of 20 ml saline (n = 23) or lidocaine, 1.5% (n = 21). The subsequent 30 patients were randomly allocated to receive an intravenous bolus of 250 microg/kg lidocaine followed by an infusion of 13 microg x kg(-1) x h(-1) lidocaine or an equivalent volume of saline when shivering was observed. Patient-controlled analgesia was provided for all patients: 3.5 mg piritramide, with a lockout interval of 5 min, for an unlimited total dose. Shivering was graded by a blinded investigator using a four-point scale. Pain was assessed by a 100-mm visual analog scale (0 = no pain and 100 = worst pain). The arteriovenous shunt status was evaluated with forearm-minus-fingertip skin-temperature gradients. RESULTS: Morphometric characteristics and hemodynamic responses were similar in the four groups. Core and mean skin temperature remained constant or increased slightly compared with preoperative values, and postoperative skin-temperature gradients were negative (indicating vasodilation) in nearly all patients. After intra-articular injection of saline, pain scores for the first postoperative hour averaged 46 +/- 32 mm (mean +/- SD), and 10 of the 23 (43%) patients shivered. In contrast, the pain scores of patients who received intra-articular lidocaine were significantly reduced to 5 +/- 9 mm and shivering was absent in this group (P < 0.05). In the second portion of the study, neither intravenous lidocaine nor saline reduced the magnitude or duration of nonthermoregulatory tremor or the patients' pain scores. CONCLUSIONS: Intra-articular, but not intravenous, lidocaine reduced surgical pain and prevented nonthermoregulatory shivering. Therefore, these data indicate that postoperative pain facilitates nonthermoregulatory shivering.

Adult↗

PubMed2001

The contextual interference effect in acquisition of dart-throwing skill tested on a transfer test with extended trials.

Previous studies of contextual interference have shown that practicing several motor skills randomly (high contextual interference) facilitates retention and transfer in comparison to practicing the same tasks in a blocked order (low contextual interference). However, many studies have not supported this phenomenon in motor learning, and some researchers have questioned whether the effect can be tested by using only a few trials on the transfer test. The present study used a different methodological approach in which the number of test trials was increased to assess whether the contextual interference effect is sustained over an extended number of trials in the transfer phase. Undergraduate students (N=32) were randomly allocated to either a blocked or random group. The participants practiced 80 acquisition trials in the dart-throwing task from distances of 300 cm and 420 cm, using two different grips. The transfer test after a 10-min. interval consisted of 40 trials with a new grip at a distance of 360 cm. The results did not support the contextual interference effect since there were no significant differences between groups on transfer. These findings suggest that the contextual interference effect may not be a global learning phenomenon which can be generalized to all learning situations.

Adult↗

PubMed1992

Effects of skirting on processing characteristics of Targhee wool.

Ninety mature Targhee ewes were randomly allocated to nine lots. Lots were randomly assigned to three fleece preparation treatments: 1) nonskirted (control); 2) bellies removed, in which bellies and topknots were removed on the shearing floor; and 3) skirted, in which bellies and topknots were removed and remaining fleece was thrown on a table and lightly skirted. Bellies and topknots composed about 6 to 7% of the fleece weight. An additional 6.6% was removed when fleeces were skirted. Top fiber diameters were not affected (P greater than .10) by skirting. Although not significant (P greater than .10), percentage yield, vegetable content, percentage of noilage, top fiber length, and yellowness indexes tended to be most desirable for skirted lots and least desirable for unskirted lots. Lots with bellies removed were intermediate. Removal of bellies reduced vegetable contamination by 8.4%, with an additional reduction of about .5% by further skirting. Skirting reduced the number of fibers less than 25.4 mm (P less than .10) by 42%. Minimal colored fiber contamination of top was observed. One colored fiber per 15 g of top was detected in two lots of the treatment with bellies removed. All other lots contained no colored fibers. All wools evaluated were well below industry limits set for use in high-quality white or pastel fabrics. All skirted lots of wool evaluated in this study had improved processing characteristics for all processing traits evaluated.

Animal Husbandry↗

PubMed1995

Effectiveness of health checks conducted by nurses in primary care: final results of the OXCHECK study. Imperial Cancer Research Fund OXCHECK Study Group.

OBJECTIVE: To determine the effectiveness of health checks, performed by nurses in primary care, in reducing risk factors for cardiovascular disease and cancer. DESIGN: Randomised controlled trial. SETTING: Five urban general practices in Bedfordshire. SUBJECTS: 2205 men and women who were randomly allocated a first health check in 1989-90 and a re-examination in 1992-3 (the intervention group); 1916 men and women who were randomly allocated an initial health check in 1992-3 (the control group). All subjects were aged 35-64 at recruitment in 1989. MAIN OUTCOME MEASURES: Serum total cholesterol concentration, blood pressure, body mass index, and smoking prevalence (with biochemical validation of cessation); self reported dietary, exercise, and alcohol habits. RESULTS: Mean serum total cholesterol was 3.1% lower in the intervention group than controls (difference 0.19 mmol/l (95% confidence interval 0.12 to 0.26)); in women it was 4.5% lower (P < 0.0001) and in men 1.6% (P < 0.05), a significant difference between the sexes (P < 0.01). Self reported saturated fat intake was also significantly lower in the intervention group. Systolic and diastolic blood pressures and body mass index were respectively 1.9%, 1.9%, and 1.4% lower in the intervention group (P < 0.005 in all cases). There was a 3.9% (2.4 to 5.3) difference in the percentage of subjects with a cholesterol concentration > or = 8 mmol/l, but no significant differences in the number with diastolic blood pressure > or = 100 mm Hg or body mass index > or = 30 kg/m2. There was no significant difference between the two groups in prevalence of smoking or excessive alcohol use. Annual rechecks were no more effective than a single recheck at three years, but health checks led to a significant increase in visits to the nurse according to patients' degree of cardiovascular risk. CONCLUSIONS: The benefits of health checks were sustained over three years. The main effects were to promote dietary change and reduce cholesterol concentrations; small differences in blood pressure may have been attributable to accommodation to measurement. The benefits of systematic health promotion in primary care are real, but must be weighed against the costs in relation to other priorities.

Adult↗

PubMed1990

Combined luteinizing hormone releasing hormone analogue and exogenous gonadotrophins for the treatment of infertility associated with polycystic ovaries.

This study was designed to compare the results of treatment with, firstly, exogenous gonadotrophins, with (57 cycles) and without (65 cycles) pretreatment with a superactive analogue of luteinizing hormone releasing hormone (LHRH) and, secondly, pure follicle stimulating hormone (FSH) (50 cycles) with those of human menopausal gonadotrophin (HMG) (72 cycles) in 46 women with clomiphene-citrate-resistant anovulation associated with polycystic ovaries. Patients randomly allocated to the analogue group received buserelin (Suprefact, Hoechst, UK, Ltd, Hounslow, Middlesex), 800 micrograms/day by nasal insufflation and when hypogonadism was achieved, patients were again randomly allocated for ovarian stimulation with either FSH or HMG. Controls received FSH or HMG alone. Patients pretreated with the analogue had similar pregnancy and ovulation rates, needed larger doses and more days of gonadotrophin therapy and had more ovarian overstimulation than those receiving no pretreatment. The role of superactive LHRH analogues for induction of a single ovulation for in-vivo fertilization is thus uncertain. Pure FSH had no advantages over HMG, the LH content of HMG having no deleterious effect on the ovary.

Adult↗

PubMed2001

Endoscopic versus open subfascial division of incompetent perforating veins in the treatment of venous leg ulceration: long-term follow-up.

PURPOSE: Subfascial division of incompetent perforating veins seems to be a successful treatment for patients with venous leg ulceration (CEAP 6). For postoperative wound complications, endoscopic techniques are more common than open subfascial division of incompetent perforating veins (Linton procedure). We investigated the long-term results of ulcer healing and recurrence rates and compared them with preoperative and postoperative duplex findings. METHODS: Patients with venous ulceration on the medial side of the lower leg were randomly allocated to endoscopic exploration or open exploration by means of the modified Linton approach. Ulcer healing and recurrence rates were documented. RESULTS: Thirty-nine patients were randomly allocated to exploration, 19 patients to open subfascial division of incompetent perforating veins (Linton group), and 20 patients to subfascial endoscopic division of incompetent perforating veins (SEPS group). During the follow-up period, four patients in the SEPS group died, all of causes other than the venous leg ulcer. Because of a squamous cell carcinoma that had developed in the venous ulcer, one patient in the SEPS group underwent a below-knee amputation. In a mean follow-up period of 50.6 months, the venous ulceration of all 18 patients in the Linton group who were available for follow-up initially healed. The recurrence rate in this group was 22% (4 patients). In the SEPS group, the mean follow-up period for 19 patients was 46.1 months, with the ulceration healing in 17 patients and a recurrence rate of 12% (2 patients). The presence of deep venous incompetence (DVI) did not influence the recurrence rates (P =.044, Fisher exact test), but it significantly influenced the development of new incompetent perforating veins (3 of 10 without DVI; 7 of 10 with DVI; P =.011, binomial test). CONCLUSION: The long-term follow-up results of the endoscopic division of perforating veins are comparable with those of the open division of perforating veins (modified Linton procedure).

Adult↗

PubMed2001

Lithium for maintenance treatment of mood disorders.

BACKGROUND: Mood disorders are common, disabling and tend to be recurrent. They carry a high risk of suicide. Maintenance treatment, aimed at the prevention of relapse, is therefore of vital importance. Lithium has been used for some years as the mainstay of maintenance treatment in bipolar affective disorder, and to a lesser extent in unipolar disorder. However, the efficacy and effectiveness of prophylactic lithium therapy has been disputed. Low suicide rates in lithium-treated patients have led to claims that lithium has a specific anti-suicidal effect. If so, this is of considerable importance as treatments for mental disorders in general have not been shown convincingly to be effective in suicide prevention. OBJECTIVES: 1. To investigate the efficacy of lithium treatment in the prevention of relapse in recurrent mood disorders. 2. To examine the effect of lithium treatment on consumers' general health and social functioning, its acceptability to consumers, and the side-effects of treatment. 3. To investigate the hypothesis that lithium has a specific effect in reducing the incidence of suicide and deliberate self-harm in persons with mood disorders. SEARCH STRATEGY: The Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register (CCDANCTR) and The Cochrane Controlled Clinical Trials Register (CCTR) were searched. Reference lists of relevant papers and major text books of mood disorder were examined. Authors, other experts in the field and pharmaceutical companies were contacted for knowledge of suitable trials, published or unpublished. Specialist journals concerning lithium were hand searched. SELECTION CRITERIA: Randomised controlled trials comparing lithium with placebo, where the stated intent of treatment was maintenance or prophylaxis. Participants were males and females of all ages with diagnoses of mood disorder. Discontinuation studies (in which all participants had been stable on lithium for some time before being randomised to either continued lithium treatment or placebo substitution) were excluded. DATA COLLECTION AND ANALYSIS: Data were extracted from the original reports independently by two reviewers. The main outcomes studied were related to the objectives stated above. Data were analysed for all diagnoses of mood disorder and for bipolar and unipolar disorder separately. Data were analysed using Review Manager version 4.0. MAIN RESULTS: Nine studies were included in the review, reporting on 825 participants randomly allocated to lithium or placebo. Lithium was found to be more effective than placebo in preventing relapse in mood disorder overall, and in bipolar disorder. The most consistent effect was found in bipolar disorder (random effects OR 0.29; 95% CI 0.09 to 0.93 ). In unipolar disorder, the direction of effect was in favour of lithium, but the result (when heterogeneity between studies was allowed for) did not reach statistical significance. Considerable heterogeneity was found between studies in all groups of patients. The direction of effect was the same in all studies; no study found a negative effect for lithium. Heterogeneity may have been due to differences in selection of participants, and to differing exposures to lithium in the pre-study phase resulting in variable influence of a discontinuation effect. There was little reported data on overall health and social functioning of participants under the different treatment conditions, or on the participants' own views of their treatment. Descriptive analysis showed that assessments of general health and social functioning generally favoured lithium. Small absolute numbers of deaths and suicides, and the absence of data on non-fatal suicidal behaviours, made it impossible to draw meaningful conclusions about the place of lithium therapy in suicide prevention. REVIEWER'S CONCLUSIONS: This systematic review indicates that lithium is an efficacious maintenance treatment for bipolar disorder. In unipolar disorder the evidence of efficacy is less robust. This review does not cover the relative efficacy of lithium compared with other maintenance treatments, which is at present unclear. There is no definitive evidence from this review as to whether or not lithium has an anti-suicidal effect. Systematic reviews and large scale randomised studies comparing lithium with other maintenance treatments (e.g. anti-convulsants, antidepressants) are necessary. Outcomes relating to death and suicidal behaviour should be included in all future maintenance studies of mood disorder.

Antimanic Agents↗

PubMed1999

Pain after primary inguinal herniorrhaphy: influence of surgical technique.

BACKGROUND: Pain is an important problem after ambulatory hernia repair. To assess the influence of the surgical technique on postoperative pain, two separate randomized, patient-blinded, controlled trials were performed in men with an indirect inguinal hernia. STUDY DESIGN: In study A, 48 patients with an internal inguinal ring smaller than 1.5 cm were randomly allocated to either simple extirpation of the hernial sac or extirpation plus annulorrhaphy. In study B, 84 patients with an internal inguinal ring wider than 1.5 cm were randomly allocated to extirpation plus annulorrhaphy or extirpation plus Lichtenstein mesh repair (modified). All operations were performed under unmonitored local anesthesia with standardized perioperative analgesia using methadone and tenoxicam. Pain was scored daily for the first postoperative week and after 4 weeks on a four-point verbal-rank scale (no, light, moderate, or severe pain) during rest, while coughing, and during mobilization (rising to the sitting position). Use of supplementary analgesics (paracetamol) was recorded. Cumulative daily pain scores for the first postoperative week and the number of patients who used supplementary analgesics were the main outcome measures. RESULTS: There were no significant differences in cumulative pain scores or use of supplementary analgesics between the treatment groups in either study. Cumulative pain scores were significantly higher during coughing and mobilization than during rest in both studies. CONCLUSIONS: Choice of surgical technique for open repair of a primary indirect inguinal hernia has no influence on postoperative pain.

Adolescent↗

PubMed1976

A headache protocol for nurses: effectiveness and efficiency.

To test the effectiveness and efficiency of a nurse-administered protocol for headache in the primary care setting, we conducted a prospective controlled trial. Two hundred three randomly allocated patients were evaluated by nurses using the protocol who managed independently 55.2% of the patients and received physician consultation on the others. A total of 193 patients were randomly allocated to the physician-control group. Nurse-protocol group patients experienced equivalent symptomatic relief and expressed significantly greater satisfaction with the care they had received than did patients in the physician-control group. A retrospective study of the presenting findings in patients with serious diseases of the CNS provided evidence supporting the safety of the protocol logic. We conclude that nurse-protocol management of headache in this primary care practice was effective and efficient.

Ambulatory Care↗

PubMed1998

Tamoxifen in treatment of hepatocellular carcinoma: a randomised controlled trial. CLIP Group (Cancer of the Liver Italian Programme)

BACKGROUND: Results from small randomised trials on tamoxifen in the treatment of hepatocellular carcinoma (HCC) are conflicting. We studied whether the addition of tamoxifen to best supportive care prolongs survival of patients with HCC. METHODS: Patients with any stage of HCC were eligible, irrespective of locoregional treatment. Randomisation was centralised, with a minimisation procedure accounting for centre, evidence of disease, and time from diagnosis. Patients were randomly allocated best supportive care alone or in addition to tamoxifen. Tamoxifen was given orally, 40 mg per day, from randomisation until death. RESULTS: 496 patients from 30 institutions were randomly allocated treatment from January, 1995, to January, 1997. Information was available for 477 patients. By Sept 15, 1997, 119 (50%) of 240 and 130 (55%) of 237 patients had died in the control and tamoxifen arms, respectively. Median survival was 16 months and 15 months (p=0.54), respectively. No differences were found within subgroups defined by prognostic variables. Relative hazard of death for patients receiving tamoxifen was 1.07 (95% CI 0.83-1.39). INTERPRETATION: Our findings show that tamoxifen is not effective in prolonging survival of patients with HCC.

Adult↗