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PubMed2006

Once versus twice daily formoterol via Novolizer for patients with moderate to severe COPD--a double-blind, randomised, controlled trial.

STUDY OBJECTIVES: To evaluate in patients with moderate to severe COPD whether a single morning dose of 24 microg formoterol from the Novolizer is not inferior to two divided doses of 12 microg formoterol inhaled in the morning and in the evening. DESIGN: Randomised, double blind, active-controlled, parallel-group, multi-centre study with a 2-week run-in period and a 12-week treatment phase. SETTING: Forty-seven outpatient centres in Germany, including private practices. PARTICIPANTS: N=321 symptomatic patients with moderate to severe COPD aged 40-70 years with an FEV1 of 30-80% predicted and the requirement of 3-12 actuations of salbutamol per day on 5 days during the run-in period. TREATMENT: Eligible patients were randomised to inhale formoterol either (a) as a single 24 microg dose in the morning (OD) or (b) in two divided 12 microg doses in the morning and in the evening (b.i.d.). MEASUREMENTS AND RESULTS: The mean age was 60.3 (SD 7.3) years, and mean baseline pre-dose FEV1 was 1.5l (0.5l) or 50% (12%) of predicted, respectively. After 12 weeks of treatment, pre-dose FEV(1) improved in both groups (mean: OD, +104 ml, b.i.d., +135 ml, mean difference between groups: 31 ml). The 95% CI exceeded the pre-determined margin of 100ml by 2 ml, so that the statistical hypothesis of non-inferiority of once daily dosing was not confirmed. No statistically significant differences were seen for improvements in PEF, MEF75, MEF50, and MEF25. COPD symptoms, percentage of symptom-free days and quality of life (SGRQ) improved in both groups to a similar degree. There were no relevant differences in the incidence of adverse events. CONCLUSIONS: Based on a comparable efficacy and tolerability, the dosing schedule with formoterol via Novolizer as once daily in the morning seems to be an alternative compared to twice daily treatment. The primary endpoint suggests the equivalence of both treatment schedules from a clinical perspective. This regimen can be considered as an alternative therapeutic approach for a subgroup of COPD patients and may help to improve patient compliance.

Adult↗

PubMed2001

Variations in treatment benefits influence smoking cessation: results of a randomised controlled trial.

OBJECTIVE: To assess the impact and costs of coverage for tobacco dependence treatment benefits with no patient cost sharing for smokers with employer sponsored coverage in two large independent practice association (IPA) model health maintenance organisations (HMOs) in California, USA. METHODS: A randomised experimental design was used. 1204 eligible smokers were randomly assigned either to the control group, which received a self-help kit (video and pamphlet), or to the treatment group, which received the self-help kit and fully covered benefits for over the counter (OTC) nicotine replacement therapy (NRT) gum and patch, and participation in a group behavioural cessation programme with no patient cost sharing. RESULTS: The quit rates after one year of follow up were 18% in the treatment group and 13% in the control group (adjusted odd ratio (OR) 1.6, 95% confidence interval (CI) 1.1 to 2.4), controlling for health plan, sociodemographics, baseline smoking characteristics, and use of bupropion. Rates of quit attempts (adjusted OR 1.4, 95% CI 1.1 to 1.8) and use of nicotine gum or patch (adjusted OR 2.3, 95% CI 1.6 to 3.2) were also higher in the treatment group. The annual cost of the benefit per user who quit ranged from $1495 to $965 or from $0.73 to $0.47 per HMO member per month. CONCLUSIONS: Full coverage of a tobacco dependence treatment benefit implemented in two IPA model HMOs in California has been shown to be an effective and relatively low cost strategy for significantly increasing quit rates, quit attempts, and use of nicotine gum and patch in adult smokers.

Adult↗

PubMed2006

Provision of taped conversations with neonatologists to mothers of babies in intensive care: randomised controlled trial.

OBJECTIVE: To determine whether providing mothers of babies in neonatal intensive care units with audiotapes of their conversations with a neonatologist improves recall of information and psychological wellbeing. DESIGN: Randomised, single blinded trial. SETTING: Neonatal intensive care unit, North Queensland, Australia. PARTICIPANTS: 200 mothers of babies in a neonatal intensive care unit. INTERVENTIONS: Mothers given (n=102) or not given (n=98) audiotapes of their conversations with a neonatologist. MAIN OUTCOME MEASURES: Recall of information, attitudes to and use of the tape, satisfaction with conversations, postnatal depression, anxiety, general health, and stress about parenting, at 10 days and four and 12 months. RESULTS: 91% (n=93) of mothers in the tape group listened to the tape (once by day 10, twice by four months, and three times by 12 months; range 1-10). At 10 days and four months, mothers in the tape group recalled significantly more information about diagnosis, treatment, and outcome than mothers in the control group. At four months mothers in the tape group were 75% more likely to recall all of the information about treatment than mothers in the control group (59% v 34%; risk ratio 1.75, 95% confidence interval 1.27 to 2.4). Six mothers, all in the control group, could not recall their conversations. No statistically significant differences were found between the groups in satisfaction with conversations (10 days), postnatal depression and anxiety scores (10 days, four and 12 months), and stress about parenting (12 months). CONCLUSION: Providing the mothers of babies in neonatal intensive care units with audiotapes of conversations with a neonatologist enhanced their recall of information (up to four months). The taped conversations did not affect the mothers' wellbeing or satisfaction with the neonatologist. TRIAL REGISTRATION: Australian Clinical Trials Registry 12606000478516.

Anxiety↗

PubMed2005

Treatment with supplementary arginine, vitamin C and zinc in patients with pressure ulcers: a randomised controlled trial.

BACKGROUND & AIMS: Nutrients putatively implicated in pressure ulcer healing were evaluated in a clinical setting. METHODS: Sixteen inpatients with a stage 2, 3 or 4 pressure ulcer randomised to receive daily a standard hospital diet; a standard diet plus two high-protein/energy supplements; or a standard diet plus two high-protein/energy supplements containing additional arginine (9 g), vitamin C (500 mg) and zinc (30 mg). Nutritional status measurements (dietary, anthropometric and biochemical) and pressure ulcer size and severity (by PUSH tool; Pressure Ulcer Scale for Healing; 0=completely healed, 17=greatest severity) were measured weekly for 3 weeks. RESULTS: Patients' age and BMI ranges were 37-92 years and 16.4-28.1 k g/m2) respectively. Baseline PUSH scores were similar between groups (8.7+/-0.5). Only patients receiving additional arginine, vitamin C and zinc demonstrated a clinically significant improvement in pressure ulcer healing (9.4+/-1.2 vs. 2.6+/-0.6; baseline and week 3, respectively; P<0.01). All patient groups presented with low serum albumin and zinc and elevated C-reactive protein. There were no significant changes in biochemical markers, oral dietary intake or weight in any group. CONCLUSIONS: In this small set of patients, supplementary arginine, vitamin C and zinc significantly improved the rate of pressure ulcer healing. The results need to be confirmed in a larger study.

Adult↗

PubMed2001

Cognitive behaviour therapy for chronic fatigue syndrome: a multicentre randomised controlled trial.

BACKGROUND: Cognitive behaviour therapy (CBT) seems a promising treatment for chronic fatigue syndrome (CFS), but the applicability of this treatment outside specialised settings has been questioned. We compared CBT with guided support groups and the natural course in a randomised trial at three centres. METHODS: Of 476 patients diagnosed with CFS, 278 were eligible and willing to take part. 93 were randomly assigned CBT (administered by 13 therapists recently trained in this technique for CFS), 94 were assigned the support-group approach, and 91 the control natural course. Multidimensional assessments were done at baseline, 8 months, and 14 months. The primary outcome variables were fatigue severity (on the checklist individual strength) and functional impairment (on the sickness impact profile) at 8 and 14 months. Data were analysed by intention to treat. FINDINGS: 241 patients had complete data (83 CBT, 80 support groups, 78 natural course) at 8 months. At 14 months CBT was significantly more effective than both control conditions for fatigue severity (CBT vs support groups 5.8 [2.2-9.4]; CBT vs natural course 5.6 [2.1-9.0]) and for functional impairment (CBT vs support groups 263 [38-488]; CBT vs natural course 222 [3-441]). Support groups were not more effective for CFS patients than the natural course. Among the CBT group, clinically significant improvement was seen in fatigue severity for 20 of 58 (35%), in Karnofsky performance status for 28 of 57 (49%), and self-rated improvement for 29 of 58 (50%). Prognostic factors for outcome after CBT were a higher sense of control predicting more improvement, and a passive activity pattern and focusing on bodily symptoms predicting less improvement. INTERPRETATION: CBT was more effective than guided support groups and the natural course in a multicentre trial with many therapists. Our study showed a lower proportion of patients with improvement than CBT trials with a few highly skilled therapists.

Adult↗

PubMed2000

A randomised controlled trial of short term growth and collagen turnover in asthmatics treated with inhaled formoterol and budesonide.

AIMS: To determine effects on short term growth and collagen turnover of adding formoterol (Eformoterol) to half the glucocorticoid dose in children with asthma, treated with inhaled budesonide (Pulmicort Turbuhaler). DESIGN: A randomised double blind, placebo controlled crossover study with two six-week periods. SETTING: Outpatient clinic in secondary referral centre. SUBJECTS: A total of 27 prepubertal children aged 6-13 years. INTERVENTIONS: Formoterol 12 microg and dry powder budesonide 100 microg twice daily in one period; placebo and dry powder budesonide 200 microg twice daily in the other. OUTCOME MEASURES: Primary outcome measures were lower leg growth rate, and serum and urine markers of type I and type III collagen turnover. Secondary outcome measures were inflammation markers in serum, and parameters of asthma control. RESULTS: During budesonide 200 microg twice daily treatment, mean lower leg growth rate was 0.14 mm/week (p = 0.02) lower than during the formoterol and budesonide period. Similar statistically significant effects on markers of collagen turnover were found, whereas inflammation markers and asthma control did not vary statistically significantly between the two periods. CONCLUSIONS: In children treated with inhaled glucocorticoids, halving the dose and adding formoterol is associated with faster short term growth and an increase in markers of collagen turnover, with no loss of asthma control.

Adolescent↗

PubMed2001

Prevention of mucositis in bone marrow transplantation: a double blind randomised controlled trial of sucralfate.

Mucositis is still a leading side effect of high dose chemotherapy and irradiation delivered in autologous and allogeneic bone marrow transplantation. In this double blind randomised study, we tested the efficacy of sucralfate for the prevention of mucositis induced by such conditioning treatments. Treatment was started one day before conditioning regimen and patients were prospectively evaluated. The main endpoint was severe mucositis that was more frequent in the placebo group than in the sucralfate group (47% vs. 29%, P = 0.07). This trend was confirmed after adjustment on total body irradiation (TBI) (P = 0.06), the sole stratification parameter. Interestingly, patients receiving sucralfate showed a significant reduction of diarrhoea (25%) vs. 53%, P = 0.005). Overall, the preventive administration of sucralfate appears to be an effective procedure to diminish the occurrence of severe oral and intestinal mucositis in patients treated by high dose chemotherapy alone or combined with TBI before bone marrow transplantation.

Adolescent↗

PubMed2003

Advice to eat fish and mood: a randomised controlled trial in men with angina.

People with high intake of fish have lower reported rates of depression and a small trial in psychiatric patients suggested that fish oil supplements reduced episodes of depression and mania. As part of a factorial trial of interventions to reduce mortality in angina 452 men were randomised to advice to eat more fatty fish or no fish advice. Maxepa fish oil capsules were supplied to men who found the fish unpalatable. Fish intake and mood were assessed at baseline and six months. Most men (83%) had mood assessed using the Derogatis Stress Profile at baseline and follow-up. Self reported intake of fish was higher in the fish advice group at six months. There was, however, no difference in depression or anxiety in those allocated to receive fish advice. After controlling for baseline mood, the difference in depression score between those randomised to fish advice and those not was 1.29 (95% CI -0.29 to 2.88) and the difference in anxiety was 0.82 (95% CI -0.57 to 2.22) with positive differences indicating more depression or anxiety in those allocated to the fish arm. This trial provides no evidence that increased fatty fish intake in people without depressive symptoms has any substantial effect on mood.

Adult↗

PubMed2001

Improved recovery after music and therapeutic suggestions during general anaesthesia: a double-blind randomised controlled trial.

PURPOSE: This study was designed to determine whether music or music in combination with therapeutic suggestions in the intra-operative period under general anaesthesia could improve the recovery of hysterectomy patients. METHODS: In a double-blind randomised clinical investigation, 90 patients who underwent hysterectomy under general anaesthesia were intra-operatively exposed to music, music in combination with therapeutic suggestion or operation room sounds. The anaesthesia was standardised. Postoperative analgesia was provided by a patient-controlled analgesia (PCA). The pain scores were recorded by means of a visual analogue scale. Nausea, emesis, bowel function, fatigue, well-being and duration of hospital stay were studied as outcome variables. RESULTS: On the day of surgery, patients exposed to music in combination with therapeutic suggestions required less rescue analgesic compared with the controls. Patients in the music group experienced more effective analgesia the first day after surgery and could be mobilised earlier after the operation. At discharge from the hospital patients in the music and music combined with therapeutic suggestion group were less fatigued compared to the controls. No differences were noted in nausea, emesis, bowel function, well-being or length of hospital stay between the groups. CONCLUSION: This double-blind study has demonstrated that intra-operative music and music in combination with therapeutic suggestions may have some beneficial effects on postoperative recovery after hysterectomy. Further controlled studies are necessary to confirm our results.

Analgesics, Opioid↗

PubMed2004

Additional task-related practice improves mobility and upper limb function early after stroke: a randomised controlled trial.

The purpose of this study was to investigate whether additional practice of either upper limb or mobility tasks improved functional outcome during inpatient stroke rehabilitation. This prospective, randomised, single blind clinical trial recruited 30 stroke subjects into either an Upper Limb or a Mobility Group. All subjects received their usual rehabilitation and an additional session of task-related practice using a circuit class format. Independent assessors, blinded to group allocation, tested all subjects. Outcome measures used were three items of the Jebsen Taylor Hand Function Test (JTHFT), two arm items of the Motor Assessment Scale (MAS), and three mobility measures, the Timed Up and Go Test (TUGT), Step Test, and Six Minute Walk Test (6MWT). Both groups improved significantly between pre- and post-tests on all of the mobility measures, however only the Upper Limb Group made a significant improvement on the JTHFT and MAS upper arm items. Following four weeks training, the Mobility Group had better locomotor ability than the Upper Limb Group (between-group differences in the 6MWT of 116.4 m, 95% CI 31.4 to 201.3 m, Step Test 2.6 repetitions, 95% CI -1.0 to 6.2 repetitions, and TUGT -7.6 sec, 95% CI -15.5 to 0.2 sec). The JTHFT dexterity scores in the Upper Limb Group were 6.5 sec (95% CI -7.4 to 20.4 sec) faster than the Mobility Group. Our findings support the use of additional task-related practice during inpatient stroke rehabilitation. The circuit class format was a practical and effective means to provide supervised additional practice that led to significant and meaningful functional gains.

Arm↗

PubMedDate not supplied

Health-related quality of life during four-layer compression bandaging for venous ulcer disease: a randomised controlled trial.

BACKGROUND: Venous leg ulceration is a chronic debilitating condition which negatively impacts on patients' quality of life. Despite the application of gold standard treatment a number of patients suffer from 'slow to heal' ulcers, which can require treatment for years. AIMS: The aim of this study was to compare the effects of four-layer compression bandaging (4LB) for treating venous leg ulcers with other available treatments on health-related quality of life duringtreatment. METHODS: In this pragmatic trial, 200 patients with venous leg ulceration were randomised either to 4LB (intervention group; n = 100) or to continue their usual system of care (control group; n = 100). Analysis was by intention to treat; quality of life measurements were taken at randomisation and after six weeks of treatment. RESULTS: 4LB provided greater quality of life benefits than the control group particularly in the area of physical activity and social functioning. CONCLUSION: Due to the long-term nature of treatment for many of these patients, the effects on quality of life should be considered when prescribing treatment. This study has shown that 4LB significantly improves the quality of life of patients during treatment for venous leg ulceration.

Bandages↗

PubMed2001

Helicobacter pylori and symptomatic relapse of gastro-oesophageal reflux disease: a randomised controlled trial.

BACKGROUND: There is little information on the effects of Helicobacter pylori eradication in patients with a primary diagnosis of gastro-oesophageal reflux disease (GORD). Our aim was to investigate the effect of H pylori eradication in this group of patients. METHODS: We did a double-blind, randomised, placebo-controlled study in 70 patients with GORD. We assigned individuals to three groups. All patients received lansoprazole 30 mg twice daily for 10 days, followed by 30 mg once daily for 8 weeks. Patients infected with H pylori received either antibiotics (clarithromycin 500 mg and amoxicillin 1000 mg twice daily) or placebo for the first 10 days. Controls were patients not infected with H pylori. Patients were followed up for 6 months at 2-week intervals for GORD symptoms. At the end of the study we repeated endoscopy and oesophageal and gastric 24 h-pH monitoring. FINDINGS: 58 of 70 patients completed our study. At the end of the study 16 of these patients were H pylori-positive (14 placebo and two eradication failures), 13 were negative because of successful H pylori eradication, and 29 were controls. H pylori-positive patients relapsed earlier (54 days) than did those in whom H pylori was eradicated (100 days) (p=0.046). The H pylori-negative control group relapsed after the longest period (110 days). However, time to relapse was also affected by oesophagitis grade (no oesophagitis 127 days, grade III or IV oesophagitis 18 days). When results were corrected for the affect of oesophagitis grade, H pylori-positive patients relapsed earlier (p=0.086) than H pylori-eradiated patients and controls (p=0.001). INTERPRETATION: H pylori infection positively affects the relapse rate of GORD. Eradication of H pylori could, therefore, help to prolong disease-free interval in patients with GORD.

2-Pyridinylmethylsulfinylbenzimidazoles↗

PubMed1996

Dexamethasone in bronchiolitis: a randomised controlled trial.

BACKGROUND: Although corticosteroids are commonly prescribed in the treatment of bronchiolitis, there is no evidence on the efficacy of these drugs in this disorder. We designed a randomised, double-blind, prospective study to assess the efficacy of dexamethasone in infants with bronchiolitis who require hospital management. METHODS: Infants younger than 12 months who had been admitted to hospital for an initial episode of wheezing, were randomly allocated intramuscular dexamethasone (1 mg/kg daily) or placebo, every 24 h for three doses. We excluded infants who were younger than 4 weeks, who required admission to the intensive care unit, or who had a history of congenital heart disease, mechanical ventilation, or supplemental oxygen use. We assessed infants on admission and every 12 h thereafter--vital signs were taken, severity of accessory muscle use and wheezing were measured by a clinical severity score, and pulse oximetry in room air was done. Our primary endpoints were the time to resolution of symptoms--defined as the number of assessments needed to reach oxygen saturation of more than 95% while receiving no supplemental oxygen, an accessory muscle score of 0, a wheeze score of 0 or 1, and resumption of normal feeding--and duration of oxygen therapy. Follow-up assessments were made 10-14 days after discharge by telephone. We used a proportional-hazards model for our survival analysis. FINDINGS: 197 infants presented with bronchiolitis that required inpatient management. 75 were not enrolled (31 no consent, 28 no approach made, 16 transferred elsewhere). Of the 122 enrolled, four were excluded (clinical deterioration, diagnosis of cystic fibrosis, previous intubation, did not receive all study treatment). There were no differences between the dexamethasone (n = 65) and placebo-treated infants in demographic factors, exposure to tobacco smoke, duration of illness, presence of respiratory syncytial virus (RSV) antigen, respiratory rate, or severity score. More dexamethasone-treated patients had an initial oxygen saturation of 95% or less (51 [79%] dexamethasone vs 31 [59%] placebo, p = 0.02). There were no differences in duration of oxygen therapy (p = 0.74) or time to resolution of symptoms (p = 0.22). Stratification for presence of RSV antigen or family history of atopy did not affect the results. INTERPRETATION: Our findings do not support the use of dexamethasone in the treatment of bronchiolitis in infants.

Anti-Inflammatory Agents, Non-Steroidal↗

PubMed2001

A specific aromatase inhibitor and potential increase in adult height in boys with delayed puberty: a randomised controlled trial.

BACKGROUND: The role of oestrogens in the closure of growth plates in both sexes is unequivocal. We postulated that inhibition of oestrogen synthesis in boys with delayed puberty would delay maturation of the growth plates and ultimately result in increased adult height. METHODS: We did a randomised, double-blind, placebo-controlled study in which we treated boys with constitutional delay of puberty with testosterone and placebo, or testosterone and letrozole. Boys who decided to wait for the spontaneous progression of puberty without medical intervention composed the untreated group. FINDINGS: Letrozole effectively inhibited oestrogen synthesis and delayed bone maturation. Progression of bone maturation was slower in the letrozole group than in the placebo group. In 18 months, bone age had advanced 1.1 (SD 0.8) years in the untreated group and 1.7 (0.9) years in the group treated with testosterone and placebo, but only 0.9 (0.6) years in the letrozole group (p=0.03 between the treatment groups). Predicted adult height did not change significantly in the untreated group and in the placebo group, whereas in the group treated with letrozole the increase was 5.1 (3.7) cm (p=0.004). INTERPRETATIONS: Our findings suggest that if oestrogen action is inhibited in growing adolescents, adult height will increase. This finding provides a rationale for studies that aim to delay bone maturation in several growth disorders.

Adolescent↗

PubMed2004

A randomised, controlled trial of low dose naltrexone for the treatment of opioid dependence.

AIM: To investigate the efficacy of low doses of naltrexone in relapse prevention for heroin dependence. DESIGN: Double blind, randomised comparison of three groups-Group 1 taking 50mg per day, Group 2: 0.5mg per day, and Group 3: 0.05 mg per day. PARTICIPANTS: Sixty-six dependent heroin users. INTERVENTIONS: After detoxification followed by 1 week on 50mg per day naltrexone, participants were randomised to trial medication. All were offered counselling and monitored with weekly clinical reviews. Research interviews were conducted at three and 6 months. OUTCOME MEASURES: Retention in treatment and heroin use at 3 and 6 months. Secondary outcome measures were side effects and craving. FINDINGS: Mean days retained in randomised treatment were-Group 1: 58.9 days; Group 2: 46.6 days; and Group 3: 47.8 days. Differences in retention were not significant using survival analysis. However, nine of the first 60 participants, transferred to the 50 mg dose, and one transferred to a lower dose (chi-square = 0.142; P = 0.018). At follow-up, there was no relationship between abstinence from heroin and naltrexone dose, nor between level of heroin use and dose. There were no differences between groups in craving or depression. CONCLUSION: Low doses of naltrexone had no discernible advantage, and participants preferred 50mg per day. Despite preference for blocking doses of naltrexone, outcomes appeared to be independent of naltrexone dose.

Adolescent↗

PubMed2004

Effects of transfusion with red cells filtered to remove leucocytes: randomised controlled trial in patients undergoing major surgery.

OBJECTIVE: To compare postoperative complications in patients undergoing major surgery who received non-filtered or filtered red blood cell transfusions. DESIGN: Prospective, randomised, double blinded trial. SETTING: 19 hospitals throughout the Netherlands (three university; 10 clinical; six general). PARTICIPANTS: 1051 evaluable patients: 79 patients with ruptured aneurysm, 412 patients undergoing elective surgery for aneurysm, and 560 undergoing gastrointestinal surgery. INTERVENTIONS: The non-filtered products had the buffy coat removed and were plasma reduced. The filtered products had the buffy coat removed, were plasma reduced, and filtered before storage to remove leucocytes. MAIN OUTCOME MEASURES: Mortality and duration of stay in intensive care. Secondary end points were occurrence of multi-organ failure, infections, and length of hospital stay. RESULTS: No significant differences were found in mortality (odds ratio for filtered v non-filtered 0.80, 95% confidence interval 0.53 to 1.21) and in mean stay in intensive care (- 0.4 day, - 1.6 to 0.6 day). In the filtered group the mean length of hospital stay was 2.4 days shorter (- 4.8 to 0.0 day; P = 0.050) and the incidence of multi-organ failure was 30% lower (odds ratio 0.70, 0.49 to 1.00; P = 0.050). There were no differences in rates of infection (0.98, 0.73 to 1.32). CONCLUSION: The use of filtered transfusions in some types of major surgery may reduce the length of hospital stay and the incidence of postoperative multi-organ failure.

Adolescent↗

PubMed1999

Effectiveness of home exercise on pain and disability from osteoarthritis of the knee: a randomised controlled trial.

OBJECTIVE: To assess the effect of a home based exercise programme, designed to improve quadriceps strength, on knee pain and disability. METHODS: 191 men and women with knee pain aged 40-80 were recruited from the community and randomised to exercise (n = 113) or no intervention (n = 78). The exercise group performed strengthening exercises daily for six months. The primary outcome measure was change in knee pain (Western Ontario McMaster Osteoarthritis index (WOMAC)). Secondary measures included visual analogue scales (VAS) for pain on stairs and walking and WOMAC physical function scores. RESULTS: WOMAC pain score reduced by 22.5% in the exercise group and by 6.2% in the control group (between group difference p < 0.05, unpaired t test). VAS scores for pain also reduced in the exercise group compared with the control group (p < 0.05). Physical function scores reduced by 17.4% in the exercise group and were unchanged in controls (p < 0.05). CONCLUSION: A simple programme of home quadriceps exercises can significantly improve self reported knee pain and function.

Adult↗

PubMed1998

A practice-based randomised controlled trial of the efficacy of an electric and a manual toothbrush on gingival health in patients with fixed orthodontic appliances.

OBJECTIVES: The aim of the present study was to evaluate the efficacy of an electric toothbrush with a specially designed orthodontic brush head compared with a manual toothbrush in controlling plaque and gingivitis in patients with fixed orthodontic appliances over an 8-week period in a dental practice setting. METHODS: This was a randomised controlled, single blind, stratified, parallel group trial conducted in two specialist orthodontic dental practices by a specialist orthodontist. Group 1 comprised 41 subjects who used the electric toothbrush and Group 2 consisted of 43 subjects who brushed with a manual toothbrush around the orthodontic appliance for a timed 2 minutes twice daily for 8 weeks. Plaque around the fixed appliance attachments was measured using an orthodontic modification to the Silness and Loe plaque index, while gingival condition was scored using the gingival index and Eastman interdental bleeding index. RESULTS: There was baseline balance for all clinical variables (p > 0.05). Both groups had significantly less plaque after 8 weeks than at baseline (p < 0.001) but the group using the electric brush also had significantly less interdental gingival bleeding, as determined by the Eastman interdental bleeding index both at week 4 (p < 0.001) and week 8 (p = 0.004). The majority of subjects (n = 54, 64.3%) preferred the electric toothbrush. CONCLUSIONS: In conclusion, the results from this study would suggest that use of an electric toothbrush with an orthodontic brush head may be of benefit in promoting gingival health in fixed orthodontic appliance patients; however, the long-term effects (over at least 6 months) need to be evaluated.

Adolescent↗