Additive effect of interferential therapyover pelvic floor exercise alone in the treatment of female urinary stress and urge incontinence: A randomized controlled trial

This pilot study attempted to examine the additional efficacy of interferential therapy in reducing the symptoms of urinary stress and urge incontinence. Twenty-four subjects were randomly allocated to the experimental group, which received interferential therapy plus pelvic floor exercises, or the control group, which received pelvic floor exercises only. Treatment was given three times a week for 4 weeks. Subjects were given urinary diaries to record urinary symptoms (including frequency of passing urine and number of times woken by desire to pass urine) for 5 days prior to and after treatment. Perineometer readings, pad weighing test and start/stop test were also performed in a physiotherapy clinic before and at completion of treatment regimes. Significant improvements were observed in all the outcome variables in the experimental group, but in only the perineometer readings in controls. When the changes from pre- to post-treatment were compared between the two groups, four of the dependent variables did not reach statistical significance. Power analysis indicated that the sample size for each group needed to be 70 for all results to be statistically significant. This study shows that interferential therapy plus pelvic floor exercise appears to be a more effective treatment modality than pelvic floor muscle strengthening exercise alone for incontinence, but a larger trial with longer followup is needed before definitive conclusions can be reached.

Randomized controlled trial comparing traditional with two "mobile" epdural techniques

Background: The authors recently showed that “mobile” epidural analgesia, using low-dose local anesthetic–opioid mixtures, reduces the impact of epidural analgesia on instrumental vaginal delivery, relative to a traditional technique. The main prespecified assessment of pain relief efficacy, women’s postpartum estimates of labor pain after epidural insertion, did not differ. The detailed analgesic efficacy and the anesthetic characteristics of the techniques are reported here.
Methods: A total of 1,054 nulliparous women were randomized, in labor, to receive boluses of 10 ml 0.25% bupivacaine (traditional), combined spinal–epidural (CSE) analgesia, or lowdose infusion (LDI), the latter groups utilizing 0.1% bupivacaine with 2 g/ml fentanyl. Visual analog scale pain assessments were collected throughout labor and delivery and 24 h later. Details of the conduct of epidural analgesia, drug utilization, and requirement
for anesthesiologist reattendance were recorded.
Results: A total of 353 women were randomized to receive traditional epidural analgesia, 351 received CSE, and 350 received LDI. CSE was associated with a more rapid onset of analgesia, lower median visual analog scale pain scores than traditional in the first hour after epidural insertion, and a significant reduction in bupivacaine dose given during labor. Pain scores reported by women receiving LDI were similar to those in the traditional group throughout labor and delivery. Anesthesiologist reattendance was low but greater with each mobile technique.
Conclusions: Relative to traditional epidural analgesia, LDI is at least as effective and CSE provided better pain relief in the early stages after insertion. The proven efficacy of mobile epidurals and their beneficial impact on delivery mode make them the preferred techniques for epidural pain relief in labor.

Regional specificity of exercise and calcium during skeletal growth in girls: a randomized controlled trial

Combining exercise with calcium supplementation may produce additive or multiplicative effects at loaded sites; thus, we conducted a single blind, prospective, randomized controlled study in pre- and early-pubertal girls to test the following hypotheses. (1) At the loaded sites, exercise and calcium will produce greater benefits than exercise or calcium alone. (2) At non-loaded sites, exercise will have no benefit, whereas calcium with or without exercise will increase bone mass over that in exercise alone or no intervention. Sixty-six girls aged 8.8 ± 0.1 years were randomly assigned to one of four study groups: moderate-impact exercise with or without calcium or low-impact exercise with or without calcium. All participants exercised for 20 minutes, three times a week and received Ca-fortified (434 ± 19 mg/day) or non-fortified foods for 8.5 months. Analysis of covariance (ANCOVA) was used to determine interaction and main effects for exercise and calcium on bone mass after adjusting for baseline bone mineral content and growth in limb lengths. An exercise-calcium interaction was detected at the femur (7.1%, p < 0.05). In contrast, there was no exercise-calcium interaction detected at the tibia-fibula; however, there was a main effect of exercise: bone mineral content increased 3% more in the exercise than non-exercise groups (p < 0.05). Bone mineral content increased 2-4% more in the calcium-supplemented groups than the non-supplemented groups at the humerus (12.0% vs. 9.8%, respectively, p < 0.09) and radius-ulna (12.6% vs. 8.6%, respectively, p < 0.01). In conclusion, greater gains in bone mass at loaded sites may be achieved when short bouts of moderate exercise are combined with increased dietary calcium, the former conferring region-specific effects and the latter producing generalized effects.

Reaching out to promote physical activity in Australia: a statewide randomized controlled trial of a stage-targeted intervention

Purpose. This study examined the broader use of a print-media intervention, which was previously shown to be effective at promoting physical activity to participants recruited from a regional Australian community, as a strategy suitable for a more diverse statewide population sample.
Methods. Participants were randomly selected adults who responded to a telephone interview conducted by the New South Wales Health Department and consented to Participate in a randomized controlled trial. Consenters were allocated to either intervention (n = 361) or control (n = 358) conditions. The intervention, a personalized letter plus stage-targeted booklets, was sent 1 week postbaseline. Data were collected via telephone interview at baseline and 2 and 8 months and were analyzed using repeated measures analysis of variance (ANOVA) and mean squared statistics.
Results. The groups were similar at baseline (mean age 43 +/- 3 years; 64 % women). Process evaluation showed high intervention recall (76 % at 2 months) and high follow-up response rates (> 85 % at 8 months) were achieved. Nonsignificant increases in physical activity were observed (Fl,719 = 2.18, p = .14).
Discussion. A single mailing of stage-targeted print materials was not effective in promoting increases in physical activity among participants selected from the statewide population. Future research could examine how the effectiveness of print media might be enhanced, possibly by using supplementary media, community-based prompts, or other incentives.

A randomized controlled trial of buprenorphine in the management of short-term ambulatory heroin withdrawal

Aim: To determine whether buprenorphine is more effective than clondine and other symptomatic medications in managing ambulatory heroin withdrawal.
Design: Open label. prospective randomized controlled trial examining
withdrawal and 4-week postwithdrawal outcomes on intention-to-treat.
Setting: Two specialist, out-patient drug treatment centres in inner city
Melbourne and Sydney, Australia.
Participants: One hundred and fourteen dependent heroin users were recruited. Participants were 18 yea rs or over. and with no significant other drug dependence, medical or psychiatric conditions or recent methadone treatment. One hundred and one (89%) participants completed a day 8 research interview examining withdrawal outcomes, and 92 (81%) completed day 35 research interview examining postwithdrawal outcomes.
Interventions: Participants randomized to control (n = 56) (up to 8 days or
clonidine and other symptomatic medications) or experimental (n = 58) (up to 5 days of buprenorphine) withdrawal groups. Following the 8-day withdrawal episode, participants could self-select from range of postwithdrawal options (naltrexone, substitution maintenance or counselling).
Measurements: Retention in withdrawal: heroin use during withdrawl: and
retention in drug treatment 4 weeks after withdrawal.
Secondary outcomes: Withdrawal severity: adverse events, and heroin use in the postwithdrawal period.
Findings: The experimental group had better treatment retention at day 8 (86% versus 57%, P = 0.001, 95% CI for numbers needed to treat (NNT) = 3-8) and day 35 (62% versus 39%, P = 0.02, 95% CI for NNT = 4-18): used heroin on fewer days during the withdralwal programlme (2.6 ± 2.5 versus 4.5 ± 2. 3.
P < 0.001. 95% CI = 1- 2.5 days) and in the postwithdrawal period (9.0±8.2
versus 14.6± 10. P<O.Ol. 95% CI = I .8- 9.4): and reported less withdrawal
severity. No severe adverse events reported.
Conclusions: Buprenorphine is effective for short-term ambulatory heroin
withdrawaI, with greater retention, less heroin use and less withdrawal discomfort during withdrawal: and increased postwithdrawal treatment retention than symptomatic medications.

Population-Based Randomized Controlled Trial of a Stage-Targeted Physical Activity Intervention

BACKGROUND: Intervention trials with self-selected participants have shown that mailed stage-targeted print materials can increase participation in physical activity in the short term. We examined the effects of a mailed stage-targeted print intervention designed to promote physical activity, in a random sample of adults living in a regional city.

METHOD: Participants (n = 462, 40-60 years of age) were randomly allocated to an intervention (n = 227) or control group (n = 235). Measures included validated 2-week physical activity recall and stage of motivational readiness for physical activity. The intervention consisted of a single mailing of a letter and full-color stage-targeted booklets (specific to precontemplation, contemplation, preparation, and action/maintenance) 1 week postbaseline. Follow-up interviews were conducted at 2 and 6 months postbaseline.

RESULTS: After 2 months, participants in the intervention group were significantly more likely to meet the current American College of Sports Medicine/Centers for Disease Control and Prevention recommendation for sufficient physical activity than those in the control group (adjusted odds ratio [OR] = 2.40; 95% confidence interval [CI] = 1.44-3.99). After 6 months, intervention participants who reported receiving and reading the intervention materials were significantly more likely to be meeting the sufficient physical activity criterion compared with the control group (adjusted OR = 2.03; 95% CI = 1.16-3.56).

CONCLUSIONS: The stage-targeted print intervention was effective in promoting short-term increases in physical activity and was most effective for participants who recognized and used the materials. This low-cost, generalizable intervention has demonstrated potential as a practical population-based physical activity promotion strategy. Further research is required before widespread dissemination would be justified, as additional strategies may be required to ensure sustained change.

Blood-nourishing and hard-softening capsule costs less in the management of osteoarthriticknee pain : A randomized controlled trial

The blood-nourishing and hard-softening (BNHS) capsule is a traditional Chinese formula used in the symptomatic treatment of inflammation and pain. We conducted this randomized controlled trial to compare the efficacy of BNHS with other commonly prescribed drugs. We recruited 120 patients from two teaching hospitals; 30 patients in each hospital were randomly assigned to receive BNHS. In one hospital, the 30 controls were given another traditional Chinese drug; whereas a Western medicine (chondroprotection drug/Viartril-s) was used as the control in the other hospital. Intervention was carried out over a period of 4 weeks. Primary outcome measures included self-reported pain level, and changes in stiffness and functional ability as measured by the Western Ontario McMaster Universities Osteoarthritis (WOMAC) index. Mixed models were used for statistical analysis. Substantial improvements in disease-specific symptoms were observed, after 4 weeks of treatment, in patients taking BNHS capsules. As assessed by the WOMAC index, pain level of the BNHS group decreased by 57% [95% confidence interval (CI) = 50, 63], stiffness by 63% (95% CI = 55, 71) and functional ability increased by 56% (95% CI = 50, 63). No significant differences were found in any of the outcome measures between the BNHS group and either of the comparison groups. No severe adverse effects were reported. However, this study lacked a placebo group; therefore, we conclude that BNHS appears to be as effective as commonly prescribed medicines for the relief of pain and dysfunction in knee osteoarthritis patients, but costs a lot less than other Western and herbal drugs in the study.

Can Australain general practitioners tackle chidhood overweight/obesity? Methods and processes from the LEAP (live, eat, and play) randomized controlled trial

Background: General practitioners (GPs) could make an important contribution to management of childhood overweight. However, there are no efficacy data to support this, and the feasibility of this approach is unknown.

Objectives: To determine if GPs and families can be recruited to a randomized controlled trial (RCT), and if GPs can successfully deliver an intervention to families with overweight/obese 5- to 9-year-old children.

Methods: A convenience sample of 34 GPs from 29 family medical practices attended training sessions on management of childhood overweight. Practice staff trained in child anthropometry conducted a cross-sectional body mass index (BMI) survey of 5- to 9-year-old children attending these practices. The intervention focused on achievable goals in nutrition, physical activity and sedentary behaviour, and was delivered in four solution-focused behaviour change consultations over 12 weeks.

Results: General practitioners were recruited from across the sociodemographic spectrum. All attended at least two of the three education sessions and were retained throughout the trial. Practice staff weighed and measured 2112 children in the BMI survey, of whom 28% were overweight/obese (17.5% overweight, 10.5% obese), with children drawn from all sociodemographic quintiles. Of the eligible overweight/obese children, 163 (40%) were recruited and retained in the LEAP RCT; 96% of intervention families attended at least their first consultation.

Conclusions: Many families are willing to tackle childhood overweight with their GP. In addition, GPs and families can participate successfully in the careful trials that are needed to determine whether an individualized, family-based primary care approach is beneficial, harmful or ineffective.

Outcome data from the LEAP (Live, Eat and Play) trial: a randomized controlled trial of a primary care intervention for childhood overweight/mild obesity

OBJECTIVES: To reduce gain in body mass index (BMI) in overweight/mildly obese children in the primary care setting.
DESIGN: Randomized controlled trial (RCT) nested within a baseline cross-sectional BMI survey.
SETTING: Twenty nine general practices, Melbourne, Australia.
PARTICIPANTS: (1) BMI survey: 2112 children visiting their general practitioner (GP) April-December 2002; (2) RCT: individually randomized overweight/mildly obese (BMI z-score <3.0) children aged 5 years 0 months-9 years 11 months (82 intervention, 81 control).
INTERVENTION: Four standard GP consultations over 12 weeks, targeting change in nutrition, physical activity and sedentary behaviour, supported by purpose-designed family materials.
MAIN OUTCOME MEASURES: Primary: BMI at 9 and 15 months post-randomization. Secondary: Parent-reported child nutrition, physical activity and health status; child-reported health status, body satisfaction and appearance/self-worth.
RESULTS: Attrition was 10%. The adjusted mean difference (intervention-control) in BMI was -0.2 kg/m(2) (95% CI: -0.6 to 0.1; P=0.25) at 9 months and -0.0 kg/m(2) (95% CI: -0.5 to 0.5; P=1.00) at 15 months. There was a relative improvement in nutrition scores in the intervention arm at both 9 and 15 months. There was weak evidence of an increase in daily physical activity in the intervention arm. Health status and body image were similar in the trial arms.
CONCLUSIONS: This intervention did not result in a sustained BMI reduction, despite the improvement in parent-reported nutrition. Brief individualized solution-focused approaches may not be an effective approach to childhood overweight. Alternatively, this intervention may not have been intensive enough or the GP training may have been insufficient; however, increasing either would have significant cost and resource implications at a population level.

Targeted clinical education for staff attitudes towards deliberate self-harm in borderline personality disorder : randomized controlled trial

Objective: The aim of the present study was to assess the impact of attending targeted clinical education on borderline personality disorder on the attitudes of health clinicians towards working with deliberate self-harm behaviours commonly exhibited by patients diagnosed with this complex disorder. Comparisons of clinicians across service settings, occupational fields, and other demographic areas were also made.

Method: A purpose-designed demographic questionnaire and the Attitudes Towards Deliberate Self-Harm Questionnaire were used to collect the demographic information and assess the attitudes of 99 mental health and emergency medicine practitioners across two Australian health services and a New Zealand health service, both before and after education attendance.

Results: Statistically significant improvements in attitude ratings were found for both emergency medicine clinicians and mental health clinicians in working with deliberate self-harm behaviours in borderline personality disorder, following attendance at the education program with a medium affect size (t(32)=−3.45, p=0.002, d=0.43 and t(65)=−5.12, p=0.000, d=0.42, respectively). Clinicians across occupational areas of nursing, allied health, and medical fields demonstrated equivocal levels of improvement in their attitude ratings.

Conclusions: Results are discussed in terms of the necessity of providing regular access to targeted clinical education for health professionals working with patients diagnosed with borderline personality disorder.

Cost-efficacy of surgically induced weight loss for the management of type 2 diabetes : a randomized controlled trial

OBJECTIVE -- To determine the within-trial cost-efficacy of surgical therapy relative to conventional therapy for achieving remission of recently diagnosed type 2 diabetes in class I and II obese patients.

RESEARCH DESIGN AND METHODS -- Efficacy results were derived from a 2-year randomized controlled trial. A health sector perspective was adopted, and within-trial intervention costs included gastric banding surgery, mitigation of complications, outpatient medical consultations, medical investigations, pathology, weight loss therapies, and medication. Resource use was measured based on data drawn from a trial database and patient medical records and valued based on private hospital costs and government schedules in 2006 Australian dollars (AUD). An incremental cost-effectiveness analysis was undertaken.

RESULTS -- Mean 2-year intervention costs per patient were 13,400 AUD for surgical therapy and 3,400 AUD for conventional therapy, with laparoscopic adjustable gastric band (LAGB) surgery accounting for 85% of the difference. Outpatient medical consultation costs were three times higher for surgical patients, whereas medication costs were 1.5 times higher for conventional patients. The cost differences were primarily in the first 6 months of the trial. Relative to conventional therapy, the incremental cost-effectiveness ratio for surgical therapy was 16,600 AUD per case of diabetes remitted (currency exchange: 1 AUD = 0.74 USD).

CONCLUSIONS -- Surgical therapy appears to be a cost-effective option for managing type 2 diabetes in class I and II obese patients.

Weight, physical activity and dietary behavior change in young mothers : short term results of the HeLP-her cluster randomized controlled trial

Background
Preventing weight gain rather than treating established obesity is an important economic and public health response to the rapidly increasing rates of obesity worldwide. Treatment of established obesity is complex and costly requiring multiple resources. Preventing weight gain potentially requires fewer resources to reach broad population groups, yet there is little evidence for successful interventions to prevent weight gain in the community. Women with children are an important target group because of high rates of weight gain and the potential to influence the health behaviors in family members.

Methods
The aim of this cluster randomized controlled trial was to evaluate the short term effect of a community-based self-management intervention to prevent weight gain. Two hundred and fifty mothers of young children (mean age 40 years ± 4.5, BMI 27.9 kg/m2 ± 5.6) were recruited from the community in Melbourne, Australia. The intervention group (n = 127) attended four interactive group sessions over 4 months, held in 12 local primary schools in 2006, and was compared to a group (n = 123) receiving a single, non-interactive, health education session. Data collection included self-reported weight (both groups), measured weight (intervention only), self-efficacy, dietary intake and physical activity.

Results
Mean measured weight decreased significantly in the intervention group (-0.78 kg 95% CI; -1.22 to -0.34, p < 0.001). Comparing groups using self-reported weight, both the intervention and comparison groups decreased weight, -0.75 kg (95% CI; -1.57 to 0.07, p = 0.07) and -0.72 kg (95% CI; -1.59 to 0.14 p = 0.10) respectively with no significant difference between groups (-0.03 kg, 95% CI; -1.32 to 1.26, p = 0.95). More women lost or maintained weight in the intervention group. The intervention group tended to have the greatest effect in those who were overweight at baseline and in those who weighed themselves regularly. Intervention women who rarely self-weighed gained weight (+0.07 kg) and regular self-weighers lost weight (-1.66 kg) a difference of -1.73 kg (95% CI; -3.35 to -0.11 p = 0.04). The intervention reported increased physical activity although the difference between groups did not reach significance. Both groups reported replacing high fat foods with low fat alternatives and self-efficacy deteriorated in the comparison group only.

Conclusion
Both a single health education session and interactive behavioral intervention will result in a similar weight loss in the short term, although more participants in the interactive intervention lost or maintained weight. There were small non-significant changes to physical activity and changes to fat intake specifically replacing high fat foods with low fat alternatives such as fruit and vegetables. Self-monitoring appears to enhance weight loss when part of an intervention.

Getting your life back on track after stroke : a phase II multi-centered, single-blind, randomized, controlled trial of the Stroke Self-Management Program vs. the Stanford Chronic Condition Self-Management Program or standard care in stroke survivors

Background Self-management is seen as a primary mechanism to support the optimization of care for people with chronic diseases such as symptomatic vascular disease. There are no established and evidence-based stroke-specific chronic disease self-management programs. Our aim is to evaluate whether a stroke-specific program is safe and feasible as part of a Phase II randomized-controlled clinical trial.
Methods Stroke survivors are recruited from a variety of sources including: hospital stroke services, local paper advertisements, Stroke South Australia newsletter (volunteer peer support organization), Divisions of General Practice, and community service providers across Adelaide, South Australia. Subjects are invited to participate in a multi-center, single-blind, randomized, controlled trial. Eligible participants are randomized to either;
• standard care,
• standard care plus a six week generic chronic condition self-management group education program, or,
• standard care plus an eight week stroke specific self-management education group program.
Interventions are conducted after discharge from hospital. Participants are assessed at baseline, immediate post intervention and six months.
Study Outcomes The primary outcome measures determine study feasibility and safety, measuring, recruitment, participation, compliance and adverse events.
Secondary outcomes include:
• positive and active engagement in life measured by the Health Education Impact Questionnaire,
• improvements in quality of life measured by the Assessment of Quality of Life instrument,
• improvements in mood measured by the Irritability, Depression and Anxiety Scale,
• health resource utilization measured by a participant held diary and safety.

Conclusion The results of this study will determine whether a definitive Phase III efficacy trial is justified.