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Results for “Randomised controlled trials as topic”

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At least 163 records · Page 9Linked to original sources
PubMed1998

Randomised, controlled trial of spirometric changes in elderly people receiving timolol or betaxolol as initial treatment for glaucoma.

AIM: To investigate respiratory and cardiovascular side effects in elderly people in the first 12 months after commencing topical beta antagonists. METHODS: 40 patients (mean age 74 years) were recruited to a randomised, masked study. Spirometry, pulse, and blood pressure were recorded before, 1 month, and 12 months after starting topical therapy with either timolol 0.5% twice daily or betaxolol 0.5% twice daily. RESULTS: After 1 month five of 20 patients allocated timolol and three of 20 given betaxolol had discontinued it for respiratory reasons, not always accompanied by symptoms. There were no significant differences in changes in mean values of spirometry, pulse, or blood pressure between groups. No further changes were made in therapy for respiratory reasons in the following year. One patient suffered a hypotensive stroke within 2 days of starting timolol. CONCLUSIONS: By performing spirometry before starting topical beta antagonist therapy and repeating it after 1 month most patients at risk of respiratory impairment can be identified.

Aged↗
PubMed2004

A randomised controlled trial of a psychoeducational intervention for women at increased risk of breast cancer.

This study aimed to compare the impact of two versions of a psychoeducational written intervention on cancer worry and objective knowledge of breast cancer risk-related topics in women who had been living with an increased risk of familial breast cancer for several years. Participants were randomised to three conditions: scientific and psychosocial information pack (Group 1), scientific information pack only (Group 2) or standard care control (Group 3). They completed postal questionnaires at baseline (n=163) and 4 weeks (n=151). As predicted, there was a significant decrease in cancer worry for Group 1, but not Group 2. Objective knowledge significantly improved for both Group 1 and Group 2 as expected, but not Group 3. However, there was an unpredicted decline in cancer worry for Group 3. This study supports the value of a scientific and psychosocial information pack in providing up-to-date information related to familial risk of breast cancer for long-term attendees of a familial breast cancer clinic. Further research is warranted to determine how the information pack could be incorporated into the existing clinical service, thus providing these women with the type of ongoing psychosocial support that many familial breast cancer clinics are currently lacking.

Adult↗
PubMed2003

Efficacy of lignocaine 2% gel in chalazion surgery.

BACKGROUND/AIMS: To determine whether topical 2% lignocaine (lidocaine) gel is an effective anaesthetic agent for chalazion surgery. METHODS: In a randomised controlled clinical trial, 57 subjects aged 12 years or over requiring incision and curettage for chalazion were recruited over an 8 month period. Patients were randomised into two groups. One group received 1.5 ml of lignocaine 2% injection and the other 1.5 ml of lignocaine 2% gel topically. Standard incision and curettage was then performed. The primary outcome of interest was the total pain experienced during the entire procedure including anaesthetic administration as well as incision and curettage. The pain from the local anaesthetic administration and during incision and curettage was assessed independently using a visual analogue scale (0-100). The sum of these two scores would be the total pain score out of 200. "Fear of injection" score (0-100) was also assessed. RESULTS: There was a statistically significant difference in the mean total pain scores between the injection and the gel groups (95.6 v 57.0) (p <0.001) (alpha = 0.05) (1 - beta = 0.9394). There was a statistically significant difference in the mean scores on "pain of anaesthetic administration" (47.0 v 5.5) (p <0.000). There was no statistically significant differences in the mean scores on "fear of injection" (43.9 v 47.7) (p = 0.668) and "pain during incision and curettage" (48.28 v 51.4) (p=0.679). CONCLUSIONS: Lignocaine 2% gel is effective in chalazion surgery especially in lowering the pain caused by anaesthetic administration.

Adult↗
PubMed2006

Anticholinergic drugs in patients with bladder outlet obstruction and lower urinary tract symptoms: A systematic review.

OBJECTIVES: To review the available evidence concerning the use of anticholinergic drugs, alone or in combination with alpha-blockers, in patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) and concomitant overactive bladder syndrome, to assess whether the currently available evidence suggests a role for antimuscarinic drugs in patients with BPH. METHODS: A systematic review of the literature was performed using Embase, MEDLINE, and Web of Science through a complex search strategy including "free text" and "MeSH" protocols. Moreover, the Cochrane database of systematic review was browsed for records regarding BPH and the abstract books of the American Urological Association, European Association of Urology, and International Continence Society annual meetings from 2000 to 2005 were hand-searched for studies concerning the topic of the review. RESULTS: From the literature search, we identified four randomised controlled trials (RCTs), two prospective case series, and a few congress abstracts. For methodologic issues, the best RCT was based on urodynamic data, but did not provide any clinical insight on the patients' symptoms. The other papers were affected by significant methodologic or clinical drawbacks. CONCLUSION: The available data may be considered promising in terms of safety and efficacy. The evidence of the limited number of RCTs available, considering their methodologic or clinical shortcomings, is not sufficient to support the clinical use of combination therapy with alpha-blockers and anticholinergic drugs in patients with associated storage and voiding symptoms. Well-designed, large, double-blind, placebo-controlled, long-term RCTs are needed to assess the long-term safety and efficacy of antimuscarinic drugs, alone or in combination with alpha-blockers, in this category of patients.

Cholinergic Antagonists↗
PubMed2001

Systematic review of the use of honey as a wound dressing.

OBJECTIVE: To investigate topical honey in superficial burns and wounds though a systematic review of randomised controlled trials. DATA SOURCES: Cochrane Library, MEDLINE, EMBASE, PubMed, reference lists and databases were used to seek randomised controlled trials. Seven randomised trials involved superficial burns, partial thickness burns, moderate to severe burns that included full thickness injury, and infected postoperative wounds. REVIEW METHODS: Studies were randomised trials using honey, published papers, with a comparator. Main outcomes were relative benefit and number-needed-to-treat to prevent an outcome relating to wound healing time or infection rate. RESULTS: One study in infected postoperative wounds compared honey with antiseptics plus systemic antibiotics. The number needed to treat with honey for good wound healing compared with antiseptic was 2.9 (95% confidence interval 1.7 to 9.7). Five studies in patients with partial thickness or superficial burns involved less than 40% of the body surface. Comparators were polyurethane film, amniotic membrane, potato peel and silver sulphadiazine. The number needed to treat for seven days with honey to produce one patient with a healed burn was 2.6 (2.1 to 3.4) compared with any other treatment and 2.7 (2.0 to 4.1) compared with potato and amniotic membrane. For some or all outcomes honey was superior to all these treatments. Time for healing was significantly shorter for honey than all these treatments. The quality of studies was low. CONCLUSION: Confidence in a conclusion that honey is a useful treatment for superficial wounds or burns is low. There is biological plausibility.

Anti-Bacterial Agents↗
PubMed2000

Topical treatments for fungal infections of the skin and nails of the foot.

OBJECTIVES: The objective of this review is to identify and evaluate the evidence of efficacy for topical treatments for fungal infections of the skin and nails of the human foot. To establish the effectiveness of topical treatments in achieving a cured condition and in preventing recurrence SEARCH STRATEGY: Randomised controlled trials were identified from the MEDLINE, EMBASE and CINHAL databases, from the beginning of these databases to December 1997. Also we screened the Cochrane Controlled Trials Register, the Science Citation Index BIOSIS, CAB - Health, Healthstar and Economic databases. References and unpublished studies were searched, podiatry journals handsearched and the pharmaceutical industry contacted. SELECTION CRITERIA: Only randomised controlled trials (RCTs) using participants who have mycologically diagnosed fungal infections of the skin and nails of the human foot are included in the analysis. DATA COLLECTION AND ANALYSIS: Two reviewers independently summarised the included trials and appraised their quality of reporting using a structured data extraction tool which assessed 12 quality criteria. MAIN RESULTS: Of 126 trials identified in 121 papers, 72 met the inclusion criteria. Placebo-controlled trials yielded the following pooled relative risks of failure to cure (RRFC) for skin infections: allylamines 0.30 (95% confidence interval 0.23 to 0.37); azoles 0.53 (0.42 to 0.68); undecenoic acid 0.28 (0.11 to 0.74); tolnaftate 0.46 (0.17 to 1.22). Though meta-analysis of 11 trials comparing allylamines and azoles showed an RRFC of 0.88 (0.78 to 0.99) in favour of allylamines, there was evidence of language bias. Seven English language reports favoured allylamines (RRFC = 0.79; 0.68 to 0.93) but four foreign language reports showed no difference between the two drugs (RRFC = 1.00; 0.90 to 1.12). The two trials of nail infections did not provide any evidence of benefit for topical treatments compared with placebo. REVIEWER'S CONCLUSIONS CONCLUSIONS: In placebo-controlled trials allylamines, azoles and undecenoic acid were efficacious. There are sufficient comparative trials to judge relative efficacy only between allylamines and azoles. Allylamines cure slightly more infections than azoles but are much more expensive. The most cost-effective strategy is first to treat with azoles or undecenoic acid and to use allylamines only if that fails.

Administration, Topical↗
PubMed1993

Topical tromantadine in the treatment of genital herpes. A double-blind placebo controlled study.

A randomised double-blind placebo controlled trial was performed to assess the efficacy and safety of tromantadine ointment 1% in male patients with genital herpes. 45 patients with penile genital herpes of less than three days duration were randomised to local treatment with tromantadine ointment 1% or placebo (ointment base alone) five times daily up to 12 days. No difference in time of healing could be detected between the two groups (p = 1.0). Both the objective signs (vesicles, pustules, ulceration, and glandular swelling) and the subjective symptoms (itching, burning, pain and dysuria) all diminished simultaneously in the two groups.

Administration, Topical↗
PubMed1999

Randomised controlled trial shows that glyceryl trinitrate heals anal fissures, higher doses are not more effective, and there is a high recurrence rate.

BACKGROUND: Topical application of glyceryl trinitrate (GTN) ointment heals chronic anal fissures, providing an alternative to the traditional first line treatment of surgical sphincterotomy. AIMS: To determine the most effective dose of topical GTN for treatment of chronic anal fissures and to assess long term results. METHODS: Seventy consecutive patients with chronic anal fissure, were randomly allocated to eight weeks treatment with placebo, 0.2% GTN three times daily, or GTN starting at 0.2% with weekly 0.1% increments to a maximum of 0.6%, in a double blind study. RESULTS: After eight weeks fissure had healed in 67% of patients treated with GTN compared with 32% with placebo (p=0.008). No significant difference was seen between the two active treatments. Headaches were reported by 72% of patients on GTN compared with 27% on placebo (p<0.001). Maximum anal sphincter pressure reduced significantly from baseline by GTN treatment (p=0.02), but not placebo (p=0.8). Mean pain scores were lower after treatment with GTN compared with placebo (NS). Of fissures healed with placebo 43% recurred, compared with 33% of those healed with 0.2% GTN and 25% healed with escalating dose GTN (p=0.7). CONCLUSIONS: GTN is a good first line treatment for two thirds of patients with anal fissure. An escalating dose of GTN does not result in earlier healing. Significant recurrence of symptomatic fissures and a high incidence of headaches are limitations of the treatment.

Adult↗