PubMed Health⌕ Search

SEARCH · PubMed Health

Results for “Randomised controlled trials as topic”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 73 records · Page 4Linked to original sources
PubMed2001

A pilot study to assess the viability of a randomised controlled trial of methods of supplementary feeding of breast-fed pre-term babies.

OBJECTIVES: to compare the impact of two methods of supplementary feeding of pre-term babies (bottle vs cup) on subsequent breast feeding and to assess the feasibility of using a randomised controlled trial (RCT) to investigate the topic. DESIGN AND METHOD: small scale prospective RCT. Data on breast feeding, as defined as the exclusive method of feeding, were collected. A range of relevant bio-data was also collected and their impact on breast feeding assessed. SETTING: a special care baby unit in a District General Hospital in the UK. PARTICIPANTS: over a three-month period, all pre-term babies (32-37 weeks' gestation) who fulfilled the inclusion criteria and has been born to mothers who had expressed a pre-partum desire to breast feed, who had consented to take part, were included (n=14). PROCEDURE: the eligible babies were randomly allocated to supplementary feeding of breast milk, via either a cup or a bottle. Whether or not the baby was being breast fed at discharge was noted. FINDINGS: the study suggested that this RCT framework is a viable method of investigating baby feeding. Because of the small-scale nature of the project, the actual database must be treated with extreme caution. No significant differences were found between the two groups in terms of breast feeding. However, the mothers reported high levels of support and also the breast-feeding rates were above the national averages. These two findings could have contributed to the non-significant results observed in this analysis. CONCLUSIONS: if the present findings could be supported by further research, then the non-significant results relating method of supplementary feeds to subsequent breast feeding could be explained by reference to three factors. Firstly, there is, in fact, no real effect of method of supplementary feeding and subsequent breast feeding; secondly, the method adopted differed from existing research and thus may be expected to produce non-corroborative results; and finally, the overall levels of breast feeding within the Unit generally were higher than the national average. The relevance of the RCT for investigating this subject is also discussed with reference to the present data set. Further experimental work to develop these ideas and to identify causal links is required.

Bottle Feeding↗
PubMedDate not supplied

Effect of topical treatment with skin barrier-enhancing emollients on nosocomial infections in preterm infants in Bangladesh: a randomised controlled trial.

BACKGROUND: Infections and complications of prematurity are main causes of neonatal mortality. Very low birthweight premature infants have compromised skin barrier function, and are at especially high risk for serious infections and mortality. Our aim was to ascertain whether topical application of emollients to enhance skin barrier function would prevent nosocomial infections in this population. METHODS: We randomly assigned infants born before week 33 of gestation after admission to Dhaka Shishu Hospital, Bangladesh, to daily massage with sunflower seed oil (n=159) or Aquaphor (petrolatum, mineral oil, mineral wax, lanolin alcohol; n=157). We then compared incidence of nosocomial infections among infants in these two groups with an untreated control group (n=181) by an intention-to-treat analysis. FINDINGS: 20 patients in the control group, and 22 in each of the treatment groups left the hospital early, but were included in the final analysis. Overall, infants treated with sunflower seed oil were 41% less likely to develop nosocomial infections than controls (adjusted incidence rate ratio [IRR] 0.59, 95% CI 0.37-0.96, p=0.032). Aquaphor did not significantly reduce the risk of infection (0.60, 0.35-1.03, p=0.065). No adverse events were seen. INTERPRETATION: Our findings confirm that skin application of sunflower seed oil provides protection against nosocomial infections in preterm very low birthweight infants. The low cost, availability, simplicity, and effect of treatment make it an important intervention for very low birthweight infants admitted to hospital in developing countries.

Adult↗
PubMed1999

A placebo-controlled clinical trial to compare a gel containing a combination of isotretinoin (0.05%) and erythromycin (2%) with gels containing isotretinoin (0.05%) or erythromycin (2%) alone in the topical treatment of acne vulgaris.

PURPOSE: To compare the clinical benefit of isotretinoin (0.05%) and erythromycin (2%) gels alone and in combination (Isotrexintrade mark) in acne patients. PROCEDURE: The study was a randomised placebo-controlled trial in acne patients who should benefit from topical therapy. RESULTS: All treatment groups except placebo produced a time-related reduction in lesion counts, with the combined therapy producing the largest mean decrease. Between-group comparisons showed several significant differences. CONCLUSION: Isotrexin was significantly better than placebo at all time points for inflamed and total lesions, and was better than isotretinoin at week 4. Side-effects were minimal.

Acne Vulgaris↗
PubMed2006

Effect of a topical antimicrobial paste on healing after extraction of molars in HIV positive patients: randomised controlled clinical trial.

AIM: To assess the efficacy of a medicated dressing in the socket on the healing after dental extractions in HIV positive patients. PATIENTS AND METHODS: Forty HIV positive patients with CD4 counts below 200 cells/mm(3) who were to have molar teeth extracted were randomly allocated to have the socket dressed with a medicated paste (Rifocort) with camphorated parachlorophenol and iodoform) and sutured (treated group), or merely sutured (control group). RESULTS: The sockets in the treated group healed more quickly than in the control group.

Administration, Topical↗
PubMed1995

Fibrin sealant reduces suture line bleeding during carotid endarterectomy: a randomised trial.

OBJECTIVES: To determine whether topical fibrin sealant reduced suture line bleeding during carotid endarterectomy with polytetrafluoroethylene (PTFE) patch closure. DESIGN: Prospective randomised non-blinded control trial. SETTING: Regional vascular surgery unit. MATERIALS: Seventeen patients undergoing carotid endarterectomy were randomised either to receive fibrin sealant as a topical haemostatic agent at the arteriotomy suture line or to act as control. OUTCOME MEASURES: Time taken to achieve haemostasis at the suture line. Intraoperative blood loss. Total operative time. RESULTS: The median time to achieve haemostasis was 5.5 min (range 4-31 min) in the treatment group and 19 min (range 10-47 min) in the control group. This difference was statistically significant p < 0.005 by Mann-Whitney test. There was no statistical difference in total operative time. Operative blood loss was lower in the treatment group (median 420ml, range 300-500ml) than in the control group (median 550ml, range 350-1200ml) but this difference was not statistically significant. One patient in the control group suffered a perioperative thrombo-embolic event. CONCLUSION: Fibrin sealant is an effective topical haemostatic agent for arteriotomy suture lines involving PTFE material.

Aged↗
PubMed1999

Topical antiseptic agent after large loop excision of the transformation zone: results of a randomised controlled trial.

One hundred patients undergoing large loop excision of the transformation zone (LLETZ) were randomised to receive postoperative local treatment with sultrin (sulphathiazole 3.42%, sulphacetamide 2.86%, sulphabenzamide 3.7%) pessaries: one pessary twice daily for 5 days, or no treatment. Outcome measures included duration and severity of vaginal bleeding, discharge, pelvic pain, need for oral antibiotic therapy and unplanned hospital admission. There was no significant difference in the severity of symptoms in the treatment and control groups for bleeding, discharge or pain, averaged over the study period. Postoperative morbidity following LLETZ was frequent but mild. Use of prophylactic antiseptic agents is not recommended.

Clinical Trial↗
PubMed2006

Comparison of the efficacy and safety of 0.1% tacrolimus ointment with topical corticosteroids in adult patients with atopic dermatitis: review of randomised, double-blind clinical studies conducted in Japan.

Tacrolimus (FK506) ointment is widely used in the treatment of patients with atopic dermatitis. The drug exerts its action by down-regulating antigen-specific T-cell activities and associated proinflammatory cytokine production. A number of clinical studies have evaluated the efficacy and safety of 0.1% tacrolimus ointment compared with vehicle or topical corticosteroids in adult patients with atopic dermatitis. These studies have suggested that topical tacrolimus has a rapid onset of action and exerts sustained therapeutic effects, with an efficacy similar to that of moderate to potent topical corticosteroids, but without causing skin atrophy. Two phase III randomised, controlled clinical trials have been conducted in Japanese adult patients with atopic dermatitis to compare the efficacy and safety of topical 0.1% tacrolimus with topical corticosteroid ointments. In the first study, patients with moderate or severe atopic dermatitis on the trunk and extremities were randomised to 3 weeks of treatment with topical 0.1% tacrolimus or the mid-potency topical corticosteroid 0.12% betamethasone valerate. Over 90% of the patients in each study group experienced at least a moderate improvement at the end of the study. In the second study, patients with moderate or severe atopic dermatitis on the head or neck were randomised to 1 week of treatment with 0.1% tacrolimus or the mild-potency corticosteroid 0.1% alclometasone dipropionate. Significantly greater improvements in individual symptom scores were observed with topical tacrolimus compared with alclometasone dipropionate, with overall global improvement at 1 week being statistically superior with tacrolimus. Furthermore, in a long-term open-label study involving 568 patients, at least a moderate global improvement in symptoms was observed in 85% of patients at 6 weeks, increasing to 91% at both 26 weeks and 52 weeks; this rate was maintained throughout the 2-year duration of the study. 0.1% tacrolimus ointment was considered to be safe in the majority of patients. The most prevalent adverse reactions were local application site irritations, which generally resolved with continued therapy. In summary, these findings suggest that 0.1% tacrolimus ointment is an effective and safe nonsteroidal alternative therapy for adult patients with atopic dermatitis.

Adult↗
PubMed2006

[From the Cochrane Library: topical antibiotic treatment is more effective than systemic antibiotic treatment for chronic otitis media with eardrum perforation and purulent discharge].

Chronic suppurative otitis media with underlying persistent eardrum perforation is a common cause of preventable hearing impairment. A Cochrane systematic review compared topical treatment (antibiotics or antiseptics) with systemic antibiotics to identify which is best. Nine randomised controlled trials were included (833 randomised patients; 842 analysed patients or ears). Topical treatment with quinolones was more effective in stopping (purulent) discharge than systemic treatment with quinolones or non-quinolones. No benefit from adding systemic treatment to topical antibiotics was detected. The effects of topical non-quinolone antibiotics or antiseptics were not clear. Little is known about secondary outcomes (prevention of complications, healing the eardrum, and improving hearing) or about the efficacy and safety of topical antibiotics in the long term.

Administration, Topical↗
PubMed2004

Topical tea tree oil effective in canine localised pruritic dermatitis--a multi-centre randomised double-blind controlled clinical trial in the veterinary practice.

Tea tree oil, a volatile oil, is well known for its broad antibacterial and antifungal activity. A standardised and stabilised 10% tea tree oil cream was tested against a commercial skin care cream (control cream) in the management of canine localised acute and chronic dermatitis. Fifty-seven dogs with clinical manifestations of mostly pruritic skin lesions or alterations, skin fold pyodermas and other forms of dermatitis, corroborated by predominantly positive fungal and bacterial skin isolates, were enrolled by seven practising veterinarians and randomly allocated to two study groups (28:29) and were treated twice daily with a blinded topical preparation. After 10 days of treatment, success rates of 71% for the tea tree oil cream and 41% for the control cream (over-all efficacy documented by the veterinary investigator) differed significantly (p = 0.04), favouring tea tree oil cream treatment. Accordingly on day 10, the tea tree oil cream caused significantly faster relief than the control cream (p = 0.04) for two common clinical dermatitis signs, pruritus (occurring in 84 % of dogs) and alopecia. Only one adverse event was reported in the tea tree oil group (suspected not to be causally related to the study drug) and none in the control cream group. The tested herbal cream appears to be a fast-acting safe alternative to conventional therapy for symptomatic treatment of canine localised dermatitis with pruritus.

Administration, Topical↗
PubMed2004

Dressings and topical agents for surgical wounds healing by secondary intention.

BACKGROUND: Many different wound dressings and topical applications are used to cover surgical wounds healing by secondary intention. It is not known whether these dressings heal wounds at different rates. OBJECTIVES: To assess the effectiveness of dressings and topical agents on surgical wounds healing by secondary intention SEARCH STRATEGY: We sought relevant trials from the Cochrane Central Register of Controlled Trials, Cochrane Wounds Group Specialised Trials Register, MEDLINE, EMBASE, and CINAHL databases in March 2002. SELECTION CRITERIA: All randomised controlled trials (RCTs) evaluating the effectiveness of dressings and topical agents for surgical wounds healing by secondary intention. DATA COLLECTION AND ANALYSIS: Eligibility for inclusion was confirmed by two reviewers who independently judged the methodological quality of the trials according to the Dutch Cochrane Centre list of factors relating to internal and external validity. Two reviewers summarised data from eligible studies using a data extraction sheet, any disagreements were referred to a third reviewer. MAIN RESULTS: Fourteen reports of 13 RCTs on dressings or topical agents for postoperative wounds healing by secondary intention were identified. WOUND HEALING: Whilst a single small trial of aloe vera supplementation vs gauze suggests delayed healing with aloe vera, the results of this trial are un interpretable since there was a large differential loss to follow up. A plaster cast applied to an amputation stump accelerated wound healing compared with elastic compression, WMD -25.60 days, 95% CI -49.08 to -2.12 days (1 trial). There were no statistically significant differences in healing for other dressing comparisons (e.g. gauze, foam, alginate; 11 trials). PAIN: Gauze was associated with significantly more pain for patients than other dressings (4 trials). PATIENT SATISFACTION: Patients treated with gauze were less satisfied compared with those receiving alternative dressings (3 trials). COSTS: Gauze is inexpensive but its use is associated with the use of significantly more nursing time than foam (2 trials). LENGTH OF HOSPITAL STAY: Four trials showed no difference in length of hospital stay. One trial found shorter hospital stay in people after amputation when plaster casts were applied compared with elastic compression (WMD -30.10 days; 95% CI -49.82 to -10.38). REVIEWERS' CONCLUSIONS: We found only small, poor quality trials; the evidence is therefore insufficient to determine whether the choice of dressing or topical agent affects the healing of surgical wounds healing by secondary intention. Foam is best studied as an alternative for gauze and appears to be preferable as to pain reduction, patient satisfaction and nursing time.

Bandages↗
PubMed2004

Topical treatments for seasonal allergic conjunctivitis: systematic review and meta-analysis of efficacy and effectiveness.

BACKGROUND: Evidence for the effectiveness of topical treatments, in providing symptomatic relief from ocular allergy, remains uncertain. AIMS: To assess the effectiveness and relative efficacy of topical treatments for the management of seasonal allergic conjunctivitis. DESIGN OF STUDY: A systematic review and meta-analysis. SETTING: A literature search of the Cochrane Library, Medline, and EMBASE bibliographic databases. METHOD: Double-masked randomised controlled trials were identified, that compared the use of topical mast cell stabilisers (sodium cromoglycate, nedocromil, lodoxamide) with placebo, topical antihistamines with placebo, and topical mast cell stabilisers with topical antihistamines. RESULTS: A meta-analysis of six trials showed that patients using sodium cromoglycate were 17 times (95% confidence interval [CI] = 4 to 78) more likely to perceive benefit compared with those using a placebo, although this estimate may be partially influenced by publication bias. Five trials indicated that those patients using nedocromil were 1.8 times (95% CI = 1.3 to 2.6) more likely to perceive their allergy to be moderately or totally controlled than those using a placebo. Four trials showed that those using antihistamines were 1.3 times (95% CI = 0.8 to 2.2) more likely to perceive a 'good' treatment effect than those using mast cell stabilisers, although this beneficial effect was not statistically significant. Limited evidence suggests that antihistamines might have a faster therapeutic effect compared to mast cell stabilisers. CONCLUSION: Overall, these findings confirm the benefit of topical mast cell stabilisers and antihistamines over placebo for the treatment of allergic conjunctivitis. There is, however, insufficient evidence to recommend the use of one type of medication over another. Treatment preferences should therefore be based on convenience of use (with reduced frequency of instillation for some preparations), patient preference, and costs, especially as important side effects were not reported with any medication.

Administration, Topical↗
PubMed2005

The treatment of acute infectious conjunctivitis with fusidic acid: a randomised controlled trial.

BACKGROUND: Acute infectious conjunctivitis is a common disorder in primary care. Despite a lack of evidence regarding the effectiveness of topical antibiotics for the treatment of acute infectious conjunctivitis, most patients presenting in primary care with the condition receive topical antibiotics. In The Netherlands, fusidic acid is most frequently prescribed. AIM: To assess the effectiveness of fusidic acid gel compared to placebo for acute infectious conjunctivitis. DESIGN: Double-blind randomised placebo-controlled trial. SETTING: Twenty-five Dutch primary care centres. METHOD: Adults presenting with a red eye and either (muco)purulent discharge or glued eyelid(s) were allocated to either one drop of fusidic acid gel 1% or placebo, four times daily during one week. The main outcome measure was the difference in recovery rates at 7 days. Secondary outcome measures were difference in bacterial eradication rates, a survival time analysis of the duration of symptoms, and the difference in recovery rates in culture-positive and culture-negative patients. RESULTS: One hundred and eighty-one patients were randomised and 163 patients were analysed. Forty-five of the 73 patients in the treatment and 53 of the 90 patients in the placebo group recovered (adjusted risk difference = 5.3% [95% confidence interval {CI} = -11 to 18]). There was no difference between the median duration of symptoms in the two groups. At baseline, the prevalence of a positive bacterial culture was 32% (58/181). The bacterial eradication rate was 76% in the treatment and 41% in the placebo group (risk difference = 35% [95% CI = 9.3 to 60.4]). In culture positive patients, the treatment effect tended to be strong (adjusted risk difference = 23% [95% CI = -6 to 42]). CONCLUSION: At 7 days, cure rates in the fusidic acid gel and placebo group were similar, but the confidence interval was too wide to clearly demonstrate their equivalence. These findings do not support the current prescription practices of fusidic acid by GPs.

Anti-Bacterial Agents↗
PubMed2003

Efficacy and safety of stabilised hydrogen peroxide cream (Crystacide) in mild-to-moderate acne vulgaris: a randomised, controlled trial versus benzoyl peroxide gel.

BACKGROUND: Benzoyl peroxide (BP) is a first-line topical treatment in acne vulgaris (AV). However, its use can cause mild skin irritation and dryness. A new formulation of hydrogen peroxide stabilised (HPS) in monoglycerides cream (Crystacide 1%), indicated in the topical treatment of superficial skin infections, is now available as an alternative treatment. STUDY AIM: To evaluate efficacy and local tolerability of HPS in mild-to-moderate AV in comparison with BP gel. METHODS AND PATIENTS: In a randomised, prospective, investigator-masked parallel-group, 8-week trial, 60 patients (24 men, 36 women, mean age 25 +/- 6 years) with mild-to-moderate AV, affecting mainly the face, were enrolled in the study, after their informed consent. HPS or BP (PanOxyl gel 4%) was applied topically twice daily for 8 weeks. STUDY OUTCOMES: The study endpoints were: (1) Reduction in mean inflammatory (IL), noninflammatory (NIL) and total (TL) acneic lesions in comparison with baseline; (2) Local tolerability assessed evaluating erythema, dryness and burning sensation, using a 0-3 qualitative score (score 0 = poor tolerability; score 3 = very good tolerability). RESULTS: TL, NIL, and IL were assessed by an investigator unaware of treatment allocation at baseline, and week 8. The tolerability score (TS) was assessed at week 4 and 8. At baseline, the two groups were well matched for the main clinical and demographic characteristics. All patients concluded the trial. At week 0, in the HPS group TL, NIL and IL (mean +/- SD) were: 35 +/- 8, 20 +/- 6 and 16 +/- 7. At week 8, HPS reduced TL to 16 +/- 7; NIL to 9 +/- 3 and IL to 7 +/- 3 (p < 0.001). At baseline, TL, NIL and IL, in the BP group, were 32 +/- 9, 24 +/- 8 and 18 +/- 7, respectively. At week 8, BP reduced TL, NIL and IL to 14 +/- 9; 7 +/- 5 and 7 +/- 3 (p < 0.001). In comparison with baseline values, the percentage reductions of IL were 58% and 61% for HPS and BP,respectively (p = n.s.). At the end of the study the TS was 2.9 +/- 0.2 in HPS group and 2.4 +/- 0.8 in BP group (p < 0.025). Two patients in HPS group (6%) and seven patients (23%) in BP group suffered from mild-to-moderate local erythema. CONCLUSIONS: HPS has shown to be as effective as BP in reducing both inflammatory and noninflammatory AV lesions in patients with mild-to-moderate disease. In comparison with BP 4% gel, HPS cream shows a better local tolerability profile.

Acne Vulgaris↗
PubMed2001

Topical antibiotics for acute bacterial conjunctivitis: a systematic review.

There has been uncertainty about whether antibiotic therapy confers significant benefit in the treatment of acute bacterial conjunctivitis. This study aimed to assess the efficacy of antibiotic therapy in the management of acute bacterial conjunctivitis. Using standard Cochrane search methods, we identified double-blind randomised controlled trials in which any form of antibiotic treatment (topical, systemic or combination) had been compared with placebo in the management of acute bacterial conjunctivitis. Data extraction and analysis followed a pre-defined protocol. Meta-analysis was performed to obtain summary measures of relative risk. Six published trials were identified, of which three fulfilled the eligibility criteria for inclusion in this review. The trials were heterogeneous in terms of their inclusion and exclusion criteria, the nature of the intervention, and the outcome measures assessed. Meta-analysis indicates that acute bacterial conjunctivitis is frequently a self-limiting condition, as clinical remission occurred by days 2 to 5 in 64% (95% confidence interval (CI) = 57-71) of those treated with placebo. Treatment with antibiotics was, however, associated with significantly better rates of clinical remission (days 2 to 5: relative risk (RR) = 1.31, 95% CI = 1.11-1.55), with a suggestion that this benefit was maintained for late clinical remission (days 6 to 10: RR = 1.27, 95% CI = 1.00-1.61). Acute bacterial conjunctivitis is frequently a self-limiting condition but the use of antibiotics is associated with significantly improved rates of early clinical remission, and early and late microbiological remission. Since trials to date have been conducted in selected specialist care patient populations, generalisation of these results to a primary care-based population should be undertaken with a degree of caution.

Acute Disease↗