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PubMed2007

2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: a randomised controlled trial.

BACKGROUND: Trastuzumab--a humanised monoclonal antibody against HER2--has been shown to improve disease-free survival after chemotherapy in women with HER2-positive early breast cancer. We investigated the drug's effect on overall survival after a median follow-up of 2 years in the Herceptin Adjuvant (HERA) study. METHODS: HERA is an international multicentre randomised trial that compared 1 or 2 years of trastuzumab treatment with observation alone after standard neoadjuvant or adjuvant chemotherapy in women with HER2-positive node positive or high-risk node negative breast cancer. 5102 women participated in the trial; we analysed data from 1703 women who had been randomised for treatment with trastuzumab for 1 year and 1698 women from the control group, with median follow-up of 23.5 months (range 0-48 months). The primary endpoint of the trial was disease-free survival. Here, we assess overall survival, a secondary endpoint. Analyses were done on an intent-to-treat basis. This trial is registered with the European Clinical Trials Database, number 2005-002385-11. FINDINGS: 97 (5.7%) patients randomised to observation alone and 58 (3.4%) patients randomised to 1 year of treatment with trastuzumab were lost to follow-up. 172 women stopped trastuzumab prematurely. 59 deaths were reported for trastuzumab and 90 in the control group. The unadjusted hazard ratio (HR) for the risk of death with trastuzumab compared with observation alone was 0.66 (95% CI 0.47-0.91; p=0.0115). 218 disease-free survival events were reported with trastuzumab compared with 321 in the control group. The unadjusted HR for the risk of an event with trastuzumab compared with observation alone was 0.64 (0.54-0.76; p<0.0001). INTERPRETATION: Our results show that 1 year of treatment with trastuzumab after adjuvant chemotherapy has a significant overall survival benefit after a median follow-up of 2 years. The emergence of this benefit after only 2 years reinforces the importance of trastuzumab in the treatment of women with HER2-positive early breast cancer.

Adult↗

PubMed2026

Effect of brewers' yeast or beta-glucan derived from Saccharomyces cerevisiae on breast milk supply following preterm birth: the BLOOM randomised controlled trial.

OBJECTIVE: Breast milk is the optimal source of nutrition for preterm infants; however, low breast milk production is common following a preterm birth. This study aimed to determine if taking brewers' yeast or beta-glucan improves daily expressed breast milk volume. DESIGN: Randomised, blinded, parallel, placebo-controlled trial. SETTING: Three Australian tertiary-level neonatal units. PATIENTS: Mothers with a singleton or twin pregnancy who gave birth at <34 weeks' gestation. INTERVENTIONS: Mothers were randomised within 72 hours of birth into three parallel groups in a 1:1:1 ratio to receive either brewers' yeast, beta-glucan or placebo capsules for 7 days. MAIN OUTCOME MEASURE: Total expressed breast milk volume over a 24-hour period on day 7 of intervention. RESULTS: A total of 105 mothers underwent randomisation between August 2022 and April 2024 (36 brewers' yeast, 35 beta-glucan and 34 placebo). The adjusted mean difference in daily expressed breast milk volume was 94 mL/day (95% CI -51 mL/day to 239 mL/day) between the brewers' yeast and placebo groups and -25 mL/day (95% CI -173 mL/day to 123 mL/day) between the beta-glucan and placebo groups. Maternal side effects were similar across groups. CONCLUSION: We found no clear effect of short-term administration of brewers' yeast or beta-glucan on breast-milk production following preterm birth; both interventions were well tolerated. Given the small sample size, these findings do not rule out the possibility of a clinically meaningful benefit of brewers' yeast and suggest further research with a larger sample size may be warranted to clarify the potential clinical impact. TRIAL REGISTRATION NUMBER: ACTRN12622000968774.

Intensive Care Units, Neonatal↗

PubMed2002

Evaluation of immediate versus delayed shoulder exercises after breast cancer surgery including lymph node dissection--a randomised controlled trial.

Two hundred and thirty women who had undergone surgery for breast cancer were randomised to a prospective study, comparing early (group A) and delayed (group B) shoulder exercise. Preoperatively, group A received instructions and an exercise programme supervised by a physiotherapist, whereas group B received written instructions to use the arm normally but to avoid heavy work. Two weeks after surgery both groups were given identical exercise programmes. Shoulder mobility, hand strength and arm volume were measured preoperatively, 1 month, 6 months and 2 years postoperatively. After 2 years 13.8% of the women had lymphoedema, but there were no significant differences between the groups. Grip strength was slightly decreased during the postoperative period in both groups (n.s.). Postoperatively, all movements in both groups were decreased after 2 weeks and 1 month and shoulder elevation and abduction remained decreased at 2 years. Mobility in group A recovered significantly earlier than in group B.

Clinical Trial↗

PubMed2005

Duration of protection with RTS,S/AS02A malaria vaccine in prevention of Plasmodium falciparum disease in Mozambican children: single-blind extended follow-up of a randomised controlled trial.

BACKGROUND: RTS,S/AS02A is a pre-erythrocytic stage malaria vaccine that provides partial protection against infection in malaria-naive adult volunteers and hyperimmune adults. A previous report showed that this vaccine reduced risk of clinical malaria, delayed time to new infection, and reduced episodes of severe malaria over 6 months in African children. An important remaining issue is the durability of protection against clinical disease in these children. METHODS: We did a randomised, controlled, phase IIb trial of RTS,S/AS02A given at 0, 1, and 2 months in 2022 Mozambican children aged 1-4 years. We previously determined vaccine efficacy (VE) against clinical malaria in a double-blind phase that included study months 2.5-8.5 (VE(2.5-8.5)). We now report VE in a single-blind phase up to month 21 (VE(8.5-21)). The primary endpoint was time to first or only clinical episode of Plasmodium falciparum malaria (axillary temperature 37.5 degrees C and P falciparum asexual parasitaemia >2500 per microL) detected through a passive case detection system. We also determined VE for other case definitions and for episodes of severe malaria. This study is registered with the ClinicalTrials.gov identifier NCT00197041. FINDINGS: During the single-blind phase, VE(8.5-21) was 28.9% (95% CI 8.4-44.8; p=0.008). At month 21, prevalence of P falciparum infection was 29% lower in the RTS,S/AS02A group than in the control (p=0.017). Considering the entire study period, VE(2.5-21) was 35.3% (95% CI 21.6-46.6; p<0.0001) and VE(2.5-21) for severe malaria was 48.6% (95% CI 12.3-71.0; p=0.02). INTERPRETATION: These results show that RTS,S/AS02A confers partial protection in African children aged 1-4 years living in rural endemic areas against a range of clinical disease caused by P falciparum for at least 18 months, and confirm the potential of malaria vaccines to become credible control tools for public-health use.

Animals↗

PubMed2002

Patients' and carers' preferences in two models of care for acute exacerbations of COPD: results of a randomised controlled trial.

BACKGROUND: Patients with an acute exacerbation of chronic obstructive pulmonary disease (COPD) were randomised to either hospital at home (HaH) or inpatient management, and patient and carer preferred site of management and satisfaction with care received in the two arms was determined. METHODS: Emergency admissions with an acute exacerbation of COPD were randomised to inpatient care or HaH care. After discharge an independent observer administered a questionnaire to both patients and carers on the preferred site of care and scored satisfaction with the care received. RESULTS: Of 60 patients recruited, 30 were randomised to receive HaH care. Retrospective patient preference for HaH care was 96.3% in the domiciliary arm and 59.3% in the conventional arm; carer preference figures were 85.7% and 42.9%, respectively. There was a higher preference for domiciliary care by both patients and carers in the HaH arm than in the inpatient arm (p=0.001 and p=0.01, respectively). Patients recorded equal satisfaction with care in the two arms (88.1% in the conventional arm, 91.7% in the domiciliary arm); carer scores were 91.3% and 91.9%, respectively. CONCLUSIONS: The results of this study show that both patients and carers were significantly more likely to prefer domiciliary care if they were in the HaH arm. Since patients had to be willing to be looked after at home, both patients' and carers' perceptions of the benefits of HaH care were reinforced by their experience. HaH care of acute exacerbations of COPD is the preferred option in suitable patients.

Acute Disease↗

PubMed2004

Educational psychology in medical learning: a randomised controlled trial of two aide memoires for the recall of causes of electromechanical dissociation.

OBJECTIVES: Although mnemonics are commonly used in medical education there are few data on their effectiveness. A RCT was undertaken to test the hypothesis that a new aide memoire, "EMD-aide", would be superior to the conventional "4Hs+4Ts" mnemonic in facilitating recall of causes of electromechanical dissociation (EMD) among house officers. METHOD: "EMD-aide", organises causes of EMD by frequency of occurrence and ease of reversibility: four groups organised by shape, colour, position, numbering, clockwise sequence, and use of arrows. Eight hospitals were randomised in a controlled trial and 149 house officers were then recruited by telephone. Baseline ability to recall causes of EMD was recorded at one minute and overall. House officers were then sent a copy of either "4Hs+4Ts" or "EMD-aide" according to randomisation group. Recall ability was retested at one month. RESULTS: 68 of 80 and 51 of 69 house officers completed the study in the "4Hs+4Ts" and "EMD-aide" groups respectively (NS) with similar baseline recall. After intervention median number of recalled causes was greater in the "EMD-aide" group, eight compared with seven at one minute (p = 0.034) and eight compared with seven overall, p = 0.067. Recall of all eight causes was more common in "EMD-aide" group, 54% compared with 35%, p = 0.054, and these house officers spent longer examining their aide memoire, p<0.001. CONCLUSIONS: "EMD-aide" may be superior to "4Hs+4Ts" in facilitating the recall of the causes of electromechanical dissociation. Educational psychology of medical learning and the use of aide memoires in general are worthy of further study.

Abbreviations as Topic↗

PubMed2005

Is hydrotherapy cost-effective? A randomised controlled trial of combined hydrotherapy programmes compared with physiotherapy land techniques in children with juvenile idiopathic arthritis.

OBJECTIVES: To compare the effects of combined hydrotherapy and land-based physiotherapy (combined) with land-based physiotherapy only (land) on cost, health-related quality of life (HRQoL) and outcome of disease in children with juvenile idiopathic arthritis (JIA). Also to determine the cost-effectiveness of combined hydrotherapy and land-based physiotherapy in JIA. DESIGN: A multicentre randomised controlled, partially blinded trial was designed with 100 patients in a control arm receiving land-based physiotherapy only (land group) and 100 patients in an intervention arm receiving a combination of hydrotherapy and land-based physiotherapy (combined group). SETTING: Three tertiary centres in the UK. PARTICIPANTS: Patients aged 4-19 years diagnosed more than 3 months with idiopathic arthritides, onset before their 16th birthday, stable on medication with at least one active joint. INTERVENTIONS: Patients in the combined and land groups received 16 1-hour treatment sessions over 2 weeks followed by local physiotherapy attendances for 2 months. MAIN OUTCOME MEASURES: Disease improvement defined as a decrease of > or =30% in any three of six core set variables without there being a 30% increase in more than one of the remaining three variables was used as the primary outcome measure and assessed at 2 months following completion of intervention. Health services resource use (in- and outpatient care, GP visits, drugs, interventions, and investigations) and productivity costs (parents' time away from paid work) were collected at 6 months follow-up. HRQoL was measured at baseline and 2 and 6 months following intervention using the EQ-5D, and quality-adjusted life-years (QALYs) were calculated. Secondary outcome measures at 2 and 6 months included cardiovascular fitness, pain, isometric muscle strength and patient satisfaction. RESULTS: Seventy-eight patients were recruited into the trial and received treatment. Two months after intervention 47% patients in the combined group and 61% patients in the land group had improved disease with 11 and 5% with worsened disease, respectively. The analysis showed no significant differences in mean costs and QALYs between the two groups. The combined group had slightly lower mean costs (-6.91 pounds Sterling) and lower mean QALYs (-0.0478, 95% confidence interval -0.11294 to 0.0163 based on 1000 bootstrap replications). All secondary measures demonstrated a mean improvement in both groups, with the combined group showing greater improvements in physical aspects of HRQoL and cardiovascular fitness. CONCLUSIONS: JIA is a disease in which a cure is not available. This research demonstrates a beneficial effect from both combined hydrotherapy and land-based physiotherapy treatment and land-based physiotherapy treatment alone in JIA without any exacerbation of disease, indicating that treatments are safe. The caveat to the results of the cost-effectiveness and clinical efficacy analysis is that the restricted sample size could have prevented a true difference being detected between the groups. Nevertheless, there appears to be no evidence to justify the costs of building pools or initiating new services specifically for use in this disease. However, this conclusion may not apply to patients with unremitting active disease who could not be entered into the trial because of specified exclusion criteria. For this group, hydrotherapy or combined treatment may still be the only physiotherapy option. Further research is suggested into: the investigation and development of appropriate and sensitive outcome measures for use in future hydrotherapy and physiotherapy trials of JIA; preliminary studies of methodologies in complex interventions such as physiotherapy and hydrotherapy to improve recruitment and ensure protocol is acceptable to patients and carers; hydrotherapy in the most common paediatric user group, children with neurological dysfunction, ensuring appropriate outcome measures are available and methodologies previously tried; patient satisfaction and compliance in land-based physiotherapy and hydrotherapy and European studies of hydrotherapy in rare disorders such as JIA.

Adolescent↗

PubMed2003

Effectiveness of multidisciplinary lifestyle intervention for hypertension: a randomised controlled trial.

Lifestyle factors like weight, alcohol consumption, salt intake and physical activity have shown to be important in treating hypertension. There have been made some randomised trials about the effects of lifestyle interventions, but the numbers of patients have been relatively small and the durations of follow-ups have been short. No controlled trials assessing the effects of lifestyle intervention in a rehabilitation setting have been reported. In this study, the effects of multidisciplinary lifestyle intervention in rehabilitation centres among middle-aged hypertensive employees were described. A total of 731 hypertensives from 45 worksites were randomised to lifestyle intervention in a rehabilitation centre or to usual care in an occupational or primary health-care centre for 12 months. Standard measurements were conducted before the intervention and 1-year later. Blood pressure (BP) levels were clearly reduced in the intervention group, while only minor changes were observed in the control group. The net changes between the two groups both for systolic and diastolic BPs were -2.1 mmHg (95% confidence intervals (CI) -4.0 to -0.1) and -1.5 mmHg (95% CI -2.6 to -0.4), respectively. The net changes were greater among men than women. The multidisciplinary lifestyle intervention in a rehabilitation centre setting produced significant reductions in BP among middle-aged employees with hypertension.

Cardiovascular Diseases↗

PubMed2002

Sildenafil for treatment of lung fibrosis and pulmonary hypertension: a randomised controlled trial.

BACKGROUND: Lung fibrosis can be complicated by pulmonary hypertension, limiting exercise tolerance and life expectancy. Furthermore, vasodilators might cause deterioration in gas exchange. Our aim was to compare acute effects of sildenafil, nitric oxide, and epoprostenol in individuals with pulmonary hypertension secondary to lung fibrosis. METHODS: We did a randomised controlled, open-label trial, in 16 individuals admitted to our hospital with pulmonary hypertension secondary to lung fibrosis. After inhalation of nitric oxide (10-20 ppm), we assigned patients to either maximum tolerated dose of intravenous epoprostenol (mean 8.0 ng/kg per min; n=8) or oral sildenafil (50 mg; n=8). Our primary objective was to assess pulmonary vasodilative potency (decrease in pulmonary vascular resistance index) of sildenafil by comparison with inhaled nitric oxide and infused epoprostenol. Analyses were by intention to treat. FINDINGS: Pulmonary vascular resistance index was reduced by nitric oxide (-21.9%, 95% CI -14.1 to -36.2), epoprostenol (-36.9%, -24.4 to -59.6), and sildenafil (-32.5%, -10.2 to -54.1). However, ratio of pulmonary to systemic vascular resistance decreased only in individuals who received nitric oxide and sildenafil. Baseline measurement of multiple-inert-gas elimination showed right-to-left shunt flow (4.8%, 0.0-28.2) and little perfusion of low ventilation(V)/perfusion(Q) areas (0.1%, 0.0-13.0). Prostacyclin increased V/Q mismatch (shunt 16.8%, 10.8-35.9; low V/Q 3.8%, 0.0-13.0) and decreased arterial oxygenation. By contrast, nitric oxide (4.5%, 0.0-18.0; 0.0%, 0.0-17.3) and sildenafil (3.3%, 0.0-11.3; 0.0%, 0.0-12.4) maintained V/Q matching, with raised arterial partial pressure of oxygen (14.3 mm Hg, -1.7 to 31.3) noted for sildenafil. We recorded no adverse events. INTERPRETATION: Sildenafil causes preferential pulmonary vasodilation and improves gas exchange in patients with severe lung fibrosis and secondary pulmonary hypertension.

Adult↗

PubMed1999

Effects of systematic education on heart failure patients' knowledge after 6 months. A randomised, controlled trial.

BACKGROUND: Many procedures for patient education are introduced in clinical practice without proper evaluation in randomised trials. AIMS: To compare systematic nurse and pharmacist led education including an interactive Kodak Photo-CD Portfolio technique with conventional information regarding heart failure patients' knowledge. METHODS: One hundred and thirty heart failure patients discharged from hospital were randomised to receive either conventional information or additional structured education with a follow-up of 6 months. Difference in knowledge was tested by questionnaire after 6 months. RESULTS: At the end of the study there was a significant difference in the intervention group (n = 50) compared to the control group (n = 58) regarding knowledge as tested by a questionnaire. Of maximal 28 points the intervention group attained 17.2 points (mean) and the control group 14.3 points (mean), 95% confidence interval for difference 1.0-4.7 points (P = 0.0051). CONCLUSIONS: Two to 3 hours of systematic education improved heart failure patients' knowledge on essential issues. High age does not preclude the introduction of a new technique for patient education.

Aged↗

PubMed2006

External cephalic version for breech presentation before term.

BACKGROUND: External cephalic version (ECV) of the breech fetus at term (after 37 weeks) has been shown to be effective in reducing the number of breech presentations and caesarean sections, but the rates of success are relatively low. This review examines studies initiating ECV prior to term (before 37 weeks' gestation). OBJECTIVES: To assess the effectiveness of a policy of beginning ECV before term (before 37 weeks' gestation) for breech presentation on fetal presentation at birth, method of delivery, and the rate of preterm birth, perinatal morbidity, stillbirth or neonatal mortality. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group Trials Register (April 2005), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 1, 2005), MEDLINE (1965 to April 2005), EMBASE (1988 to April 2005), and Controlled Clinical Trials randomised controlled trials registry (April 2005). SELECTION CRITERIA: Randomised trials of ECV beginning before term (before 37 weeks' gestation) compared with a control group in women with breech presentation before term. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed eligibility and trial quality and extracted data. MAIN RESULTS: Three studies are included. One study reported on ECV that was undertaken and completed before 37 weeks' gestation compared to no ECV. No difference was found in the rate of non-cephalic presentation at birth. One study reported on a policy of ECV that was initiated before term (33 weeks) and up until 40 weeks' gestation and which could be repeated up until delivery compared to no ECV. This study showed a decrease in the rate of non-cephalic presentation at birth (relative risk 0.59, 95% confidence interval 0.45 to 0.77). One study reported on ECV started at between 34 to 35 weeks' gestation compared to beginning at 37 to 38 weeks' gestation. Although findings were not statistically significant, a 9.5% decrease in the rate of non-cephalic presentation at birth and a 7% decrease in the caesarean section rate were reported when ECV was started early. AUTHORS' CONCLUSIONS: Compared with no ECV attempt, ECV commenced before term reduces non-cephalic births. Compared with ECV at term, beginning ECV at between 34 to 35 weeks may have some benefit in terms of decreasing the rate of non-cephalic presentation, and caesarean section. Further trials are needed to confirm this finding and to rule out increased rates of preterm birth, or other adverse perinatal outcomes. A large pragmatic trial is ongoing (www.utoronto.ca/miru/eecv2).

Breech Presentation↗

PubMed1998

Potentiation of the response to chemotherapy in patients with breast cancer by dietary supplementation with L-arginine: results of a randomised controlled trial.

Patients with large primary breast cancers are being treated with neo-adjuvant chemotherapy. Studies in animals have shown that responses to chemotherapy can be increased by dietary manipulation of tumour cell metabolism. Also dietary supplementation with the amino acid L-arginine, resulted in an increase in tumour metabolic activity expression of the nuclear activation antigen, Ki67, in patients with breast cancer. Therefore, we have carried out a randomised, double blind, placebo controlled trial to determine if L-arginine supplementation is beneficial in patients with breast cancer, undergoing neo-adjuvant chemotherapy. 96 patients were randomised to receive L-arginine (30 g/day) for three days (n = 48) or placebo (n = 48) prior to undergoing chemotherapy (doxorubicin, cyclophosphamide, vincristine, prednisolone), 6 pulses at 21-day intervals. Clinical and pathological responses were assessed in both groups of patients following completion of chemotherapy. The clinical response rate was 77% (23% complete and 54% partial responses) in the L-arginine treated group, compared with 71% (15% complete and 56% partial) in the placebo group of patients (p = ns). However, in patients with tumours less than 6 cm in initial diameter, there was a significant increase in the better histopathological responses in the L-arginine group, when compared with the placebo group of patients (88% vs 52%, p = 0.04). This may have important implications for clinical practice.

Adenocarcinoma↗

PubMed2006

Sustained efficacy up to 4.5 years of a bivalent L1 virus-like particle vaccine against human papillomavirus types 16 and 18: follow-up from a randomised control trial.

BACKGROUND: Effective vaccination against HPV 16 and HPV 18 to prevent cervical cancer will require a high level of sustained protection against infection and precancerous lesions. Our aim was to assess the long-term efficacy, immunogenicity, and safety of a bivalent HPV-16/18 L1 virus-like particle AS04 vaccine against incident and persistent infection with HPV 16 and HPV 18 and their associated cytological and histological outcomes. METHODS: We did a follow-up study of our multicentre, double-blind, randomised, placebo-controlled trial reported in 2004. We included women who originally received all three doses of bivalent HPV-16/18 virus-like particle AS04 vaccine (0.5 mL; n=393) or placebo (n=383). We assessed HPV DNA, using cervical samples, and did yearly cervical cytology assessments. We also studied the long-term immunogenicity and safety of the vaccine. FINDINGS: More than 98% seropositivity was maintained for HPV-16/18 antibodies during the extended follow-up phase. We noted significant vaccine efficacy against HPV-16 and HPV-18 endpoints: incident infection, 96.9% (95% CI 81.3-99.9); persistent infection: 6 month definition, 94.3 (63.2-99.9); 12 month definition, 100% (33.6-100). In a combined analysis of the initial efficacy and extended follow-up studies, vaccine efficacy of 100% (42.4-100) against cervical intraepithelial neoplasia (CIN) lesions associated with vaccine types. We noted broad protection against cytohistological outcomes beyond that anticipated for HPV 16/18 and protection against incident infection with HPV 45 and HPV 31. The vaccine has a good long-term safety profile. INTERPRETATION: Up to 4.5 years, the HPV-16/18 L1 virus-like particle AS04 vaccine is highly immunogenic and safe, and induces a high degree of protection against HPV-16/18 infection and associated cervical lesions. There is also evidence of cross protection.

Adult↗

PubMed2005

Intracervical application of the nitric oxide donor isosorbide dinitrate for induction of cervical ripening: a randomised controlled trial to determine clinical efficacy and safety prior to first trimester surgical evacuation of retained products of conception.

OBJECTIVE: To determine the therapeutic efficacy and safety of a nitric oxide (NO) isosorbide dinitrate donor to induce cervical ripening of women with missed abortions before surgical evacuation of the uterus. DESIGN: A prospective, randomised, double-blind controlled trial. SETTING: Tertiary referral maternity teaching hospital. Population Sixty women with missed abortions and no cervical dilation. METHODS: Women requesting surgical evacuation of the uterus were randomly selected to receive endocervical 80 mg/1.5 mL isosorbide dinitrate gel solution (n= 30) or 400 mug/1.5 mL misoprostol gel solution (n= 30) every 3 hours to a maximum of four doses or until reaching cervical ripening. Vital signs and symptoms were recorded at baseline and then every 3 hours until finishing therapy. Adverse events, such as headache, abdominal pain, pelvic pain, backache, nausea and vomiting, were evaluated. MAIN OUTCOME MEASURES: Probability of reaching cervical ripening >8 mm Hegar dilator; evaluated at 3, 6, 9 and 12 hours after application of isosorbide dinitrate or misoprostol. RESULTS: The probabilities of induction of cervical ripening by isosorbide dinitrate and misoprostol after four repeated doses at 3-hour intervals were significantly different (P<0.001). Efficacy of therapy after 12 hours was 97% for the isosorbide dinitrate group and 70% for the misoprostol group. Systolic and diastolic blood pressures were lower after administration of isosorbide dinitrate than prostaglandin analogues. The difference in the mean systolic and diastolic blood pressure between treatment groups was greatest at 3 hours, with a difference of 7.7 mmHg (P<0.001) and 5.9 mmHg (P<0.003), respectively. The most frequent side effect associated with isosorbide dinitrate administration was headache, which occurred in 18 out of 30 patients, compared with only 5 out of 30 women in the misoprostol group [relative risk (RR) 2.41, 95% confidence interval (CI) 1.45-4.03, P<0.001). Women treated with misoprostol reported mainly pelvic pain (RR 3.24, 95% CI 1.99-5.27, P<0.001). CONCLUSIONS: Intracervical administration of 80 mg isosorbide dinitrate in women with missed abortions appears to be effective for cervical ripening prior to surgical evacuation of the uterus. Differences in the incidence of non-serious adverse events are not likely to be clinically significant.

Abortion, Induced↗

PubMed2002

A randomised controlled trial of the closure or non-closure of peritoneum at caesarean section: effect on post-operative pain.

OBJECTIVE: To compare the analgesic requirement in the post-operative period after closure or non-closure of the peritoneum at the caesarean delivery with a standardised anaesthetic and surgical technique. DESIGN: A randomised double-blind controlled trial was performed on 100 women who underwent elective caesarean delivery. MAIN OUTCOME MEASURES: Analgesic requirement assessed by morphine usage via patient controlled analgesia pump over the first 24-hour period after surgery, oral analgesia used during the first four days, postoperative pain assessed by a visual analogue scale and a verbal rating scale, and patient satisfaction assessed by verbal rating scale were the main outcome measures. RESULTS: Pain scores at 24 hours were similar in both groups (43.5 in closure and 40.5 in non-closure) but during the first 24 hours the non-closure group had used significantly less morphine than the closure group (0.64 mg/kg of body weight vs 0.82 mg/kg, P = 0.04). The patients in non-closure group had significantly higher satisfaction scores after 24 hours than the closure group. CONCLUSION: Non-closure of both visceral and parietal peritoneum at the caesarean section produces a significant reduction in the post-operative use of patient controlled analgesia pump morphine and significantly higher patient satisfaction at 24 hours post-operatively.

Adult↗

PubMed1993

Arrhythmia prophylaxis after coronary artery surgery. A randomised controlled trial of intravenous magnesium chloride.

One hundred and thirty patients undergoing elective myocardial revascularisation were randomised to receive an intravenous infusion containing either 50 mmol magnesium chloride or placebo during the first 48 h following surgery. Magnesium was given to 66 patients and a placebo infusion to 64 patients. Postoperative serum magnesium concentrations fell in the placebo group (from 0.83 +/- 0.06 to 0.79 +/- 0.11 mmol/l) but were elevated in the magnesium group (from 0.82 +/- 0.05 to 1.2 +/- 0.25 mmol/l). In total, 35 patients (26.9%) had a supraventricular arrhythmia, of which 11 were in the magnesium group (16.7%) and 24 (37.5%) in the placebo group (P = 0.013). Three patients in the magnesium group had an episode of ventricular fibrillation and three patients in the placebo group had frequent ventricular ectopics. There was one death in the magnesium group associated with a perioperative myocardial infarction. This study shows that intravenous magnesium supplements reduce the incidence of supraventricular arrhythmias following coronary artery surgery.

Aged↗

PubMed2006

A randomised-controlled trial in Sweden of acupuncture and care interventions for the relief of inflammatory symptoms of the breast during lactation.

OBJECTIVES: to further compare acupuncture treatment and care interventions for the relief of inflammatory symptoms of the breast during lactation and to investigate the relationship between bacteria in the breast milk and clinical signs and symptoms. DESIGN: randomised, non-blinded, controlled trial of acupuncture and care interventions. SETTING: a midwife-led breast feeding clinic in Sweden. PARTICIPANTS: 205 mothers with 210 cases of inflammatory symptoms of the breast during lactation agreed to participate. The mothers were randomly assigned to one of three treatment groups, two of which included acupuncture among the care interventions and one without acupuncture. All groups were given essential care. Protocols, which included scales for erythema, breast tension and pain, were maintained for each day of contact with the breast feeding clinic. A Severity Index (SI) for each mother and each day was created by adding together the scores on the erythema, breast tension and pain scales. The range of the SI was 0 (least severe) to 19 (most severe). FINDINGS: no significant difference was found in numbers of mothers in the treatment groups, with the lowest possible score for severity of symptoms on contact days 3, 4 or 5. No statistically significant differences were found between the treatment groups for number of contact days needed until the mother felt well enough to discontinue contact with the breast feeding clinic or for number of mothers prescribed antibiotics. Significant differences were found in the mean SI scores on contact days 3 and 4 between the non-acupuncture group and the two acupuncture groups. Mothers with less favourable outcomes (6 contact days, n=61) were, at first contact with the midwife, more often given advice on correction of the baby's attachment to the breast. An obstetrician was called to examine 20% of the mothers, and antibiotic treatment was prescribed for 15% of the study population. The presence of Group B streptococci in the breast milk was related to less favourable outcomes. KEY CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: if acupuncture treatment is acceptable to the mother, this, together with care interventions such as correction of breast feeding position and babies' attachment to the breast, might be a more expedient and less invasive choice of treatment than the use of oxytocin nasal spray. Midwives, nurses or medical practitioners with specialist competence in breast feeding should be the primary care providers for mothers with inflammatory symptoms of the breast during lactation. The use of antibiotics for inflammatory symptoms of the breast should be closely monitored in order to help the global community reduce resistance development among bacterial pathogens.

Acupuncture Therapy↗

PubMed2026

Whole cell inactivated poly-bacterial preparation MV130 effect on nasal mucosal immunity and experimental human pneumococcal carriage: double-blind randomised controlled trial with controlled human infection model.

BACKGROUND: Bacterial mucosal immunotherapy has shown protection of children and adults from both viral and bacterial respiratory infections, offering the potential to reduce antimicrobial use, and hence also control antimicrobial resistance (AMR). Pneumococcal carriage of vaccine type Streptococcus pneumoniae remains high in Malawi despite infant conjugate vaccination and AMR is increasing. We compared nasal inflammation following sublingual bacterial immunotherapy including S. pneumoniae (MV130, Inmunotek, Spain) or placebo and determined the effect in an experimental human pneumococcal carriage model. METHODS: A double-blind, randomised, placebo-controlled trial in healthy adult volunteers was conducted at Queen Elizabeth Central Hospital in Blantyre, Malawi. Participants were randomly allocated to receive MV130 or placebo sublingually once daily for 42 days. Mucosal inflammation (neutrophil to T cell ratio, NTR) was measured in nasal micro-biopsies. Post-treatment, participants were challenged with 160,000 CFU/naris S. pneumoniae 6B (Spn6b). Experimental pneumococcal carriage rates post inoculation were compared between the two arms. All participants completing the study were included in the analysis. Prospective trial registration: PACTR202403820001276. FINDINGS: 107 participants were enrolled and randomised to MV130/placebo between May and December 2024. There were no serious adverse events, complete compliance was good (72%) and all adverse events were mild. 96 participants (53 male, 43 female) completed the study with 52 participants randomised to MV130 and 44 to placebo. There was no difference in mucosal inflammation (neutrophil to T cell ratio) at day 14 of the intervention MV130 NTR median = 0.737 (IQR 0.294, 2.059) and placebo NTR = 0.831 (IQR 0.450, 2.073), p = 0.64. Secondary analyses showed a rise in mucosal neutrophils after MV130 treatment and after experimental pneumococcal inoculation. There was no difference in nasal or serum anti-pneumococcal immunoglobulin or in experimental pneumococcal carriage proportion between MV130 (12/52, 23%) and placebo (10/44, 23%) groups (unadjusted risk ratio 1.02 (CI 0.49-2.12) p = 1.0). INTERPRETATION: MV130 induced non-specific mild neutrophil inflammation of the nasal mucosa but had no protective effect against experimental human pneumococcal carriage. FUNDING: Wellcome Trust.

Humans↗