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PubMed1998

Randomised placebo-controlled trial of use of topical recombinant bovine basic fibroblast growth factor for second-degree burns.

BACKGROUND: Wound healing is a dynamic process that could be accelerated by growth factors. We investigated the effect of recombinant bovine basic fibroblast growth factor (rbFGF) on burn healing in a randomised placebo-controlled trial. METHODS: We recruited 600 patients with superficial or deep second-degree burns. Patients received 150 AU/cm2 daily topical rbFGF (n=300) or placebo (n=300) plus vehicle. We assessed healing by photography, punch-biopsy, and clinical examination. FINDINGS: All patients treated with rbFGF had faster granulation tissue formation and epidermal regeneration than those in the placebo group. Superficial and deep second-degree burns treated with rbFGF healed in a mean of 9.9 (SD 2.5) days and 17.0 (4.6) days, respectively, compared with 12.4 (2.7) and 21.2 (4.9) days (p=0.0008 and p=0.0003, respectively). No adverse effects were seen locally or systemically with rbFGF. INTERPRETATION: rbFGF effectively decreased healing time and improved healing quality. Clinical benefits would be shorter hospital stays and the patient's skin quickly becoming available for harvesting and grafting.

Administration, Cutaneous↗
PubMed2005

Topically applied anaesthetics for treating perineal pain after childbirth.

BACKGROUND: Perineal trauma is a major problem affecting millions of women around the world each year. The degree of perineal pain and discomfort associated with perineal trauma is often underestimated. Pain often interferes with basic daily activities for the woman such as walking, sitting and passing urine and also negatively impacts on motherhood experiences. OBJECTIVES: To assess the effects of topically applied anaesthetics for relief of perineal pain following childbirth whilst in hospital and following discharge. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group Trials Register (February 2004), CINAHL (1982 to December 2002) and MIDIRS (last searched February 2003). We checked reference lists of trials and review articles. SELECTION CRITERIA: Randomised controlled trials comparing topically applied anaesthetic with no treatment, placebo or alternative treatment. DATA COLLECTION AND ANALYSIS: Two authors independently assessed trial eligibility and quality and double-entered the data. We contacted study authors for additional information. MAIN RESULTS: Eight trials made up of 976 women were included in the review. Five of these trials measured pain experienced up to 24 hours after birth but different methods to assess pain were used in each of the studies. All five trials showed no difference in pain relief when the topical anaesthetic was compared with placebo. One of these studies looked at topical anaesthetics compared with indomethacin vaginal suppositories but there was no significant difference in mean pain scores. All trials reported only short-term follow up (up to four days). Two trials looked at additional analgesia taken for perineal pain, with one trial finding that less additional analgesia was required with epifoam use in comparison with placebo (relative risk (RR) 0.58, 95% confidence interval (CI) 0.40 to 0.84, one trial, 97 women). However, lignocaine/lidocaine showed no difference with regard to additional analgesia use. Adverse effects were not formally measured in the studies; however, some studies commented that there were no side-effects severe enough to discontinue treatment. One study found that the women in the treatment group were more satisfied than the placebo group (RR 0.09, 95% CI 0.01 to 0.65, one trial, 103 women). AUTHORS' CONCLUSIONS: Evidence for the effectiveness of topically applied local anaesthetics for treating perineal pain is not compelling. There has been no evaluation for the long-term effects of topically applied local anaesthetics.

Anesthetics, Local↗
PubMed2005

Topical antibiotics without steroids for chronically discharging ears with underlying eardrum perforations.

BACKGROUND: Chronic suppurative otitis media (CSOM) causes ear discharge and impairs hearing. OBJECTIVES: Assess topical antibiotics (excluding steroids) for treating chronically discharging ears with underlying eardrum perforations (CSOM). SEARCH STRATEGY: The Cochrane Ear, Nose and Throat Disorders Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library Issue 1, 2005), MEDLINE (January 1951 to March 2005), EMBASE (January 1974 to March 2005), LILACS (January 1982 to March 2005), AMED (1985 to March 2005), CINAHL (January 1982 to March 2005), OLDMEDLINE (January 1958 to December 1965), PREMEDLINE, metaRegister of Controlled Trials (mRCT), and article references. SELECTION CRITERIA: Randomised controlled trials; any topical antibiotic without steroids, versus no drug treatment, aural toilet, topical antiseptics, or other topical antibiotics excluding steroids; participants with CSOM. DATA COLLECTION AND ANALYSIS: One author assessed eligibility and quality, extracted data, entered data onto RevMan; two authors inputted where there was ambiguity. We contacted investigators for clarifications. MAIN RESULTS: Fourteen trials (1,724 analysed participants or ears). CSOM definitions and severity varied; some included otitis externa, mastoid cavity infections and other diagnoses. Methodological quality varied; generally poorly reported, follow-up usually short, handling of bilateral disease inconsistent. Topical quinolone antibiotics were better than no drug treatment at clearing discharge at one week: relative risk (RR) was 0.45 (95% confidence interval (CI) 0.34 to 0.59) (two trials, N = 197). No statistically significant difference was found between quinolone and non-quinolone antibiotics (without steroids) at weeks one or three: pooled RR were 0.89 (95% CI 0.59 to 1.32) (three trials, N = 402), and 0.97 (0.54 to 1.72) (two trials, N = 77), respectively. A positive trend in favour of quinolones seen at two weeks was largely due to one trial and not significant after accounting for heterogeneity: pooled RR 0.65 (0.46 to 0.92) (four trials, N = 276) using the fixed-effect model, and 0.64 (95% CI 0.35 to 1.17) accounting for heterogeneity with the random-effects model. Topical quinolones were significantly better at curing CSOM than antiseptics: RR 0.52 (95% CI 0.41 to 0.67) at one week (three trials, N = 263), and 0.58 (0.47 to 0.72) at two to four weeks (four trials, N = 519). Meanwhile, non-quinolone antibiotics (without steroids) compared to antiseptics were more mixed, changing over time (four trials, N = 254). Evidence regarding safety was generally weak. AUTHORS' CONCLUSIONS: Topical quinolone antibiotics can clear aural discharge better than no drug treatment or topical antiseptics; non-quinolone antibiotic effects (without steroids) versus no drug or antiseptics are less clear. Studies were also inconclusive regarding any differences between quinolone and non-quinolone antibiotics, although indirect comparisons suggest a benefit of topical quinolones cannot be ruled out. Further trials should clarify non-quinolone antibiotic effects, assess longer-term outcomes (for resolution, healing, hearing, or complications) and include further safety assessments, particularly to clarify the risks of ototoxicity and whether quinolones may result in fewer adverse events than other topical treatments.

Anti-Bacterial Agents↗
PubMed1998

Effect of topical oral G-CSF on oral mucositis: a randomised placebo-controlled trial.

Oral mucositis is a dose-limiting toxicity of intensive chemotherapy. It is caused directly by the cytotoxic effect of chemotherapeutic agents and indirectly by sustained neutropenia. Severe oral mucositis is an important predisposing factor for life-threatening septic complications during aplasia. It also reduces quality of life. At present, no effective causal prophylaxis or treatment against oral mucositis is established. We performed a prospective randomised placebo-controlled trial using topical oral r-metHuG-CSF (filgrastim) in high-grade lymphoma patients treated according to the B-NHL protocol, which contains high-dose methotrexate and causes severe oral mucositis (WHO grades I-IV) in >50% of patients. Between August 1996 and July 1997, a total of 32 chemotherapy cycles were documented in eight patients (four male, four female). Mucosal erythema and ulceration were recorded. All patients assessed their oral pain and impact on swallowing daily, using a subjective scale from no to maximal discomfort (1-10). In addition, oral mucositis was assessed according to the WHO score. Filgrastim was administered in 16 cycles as a viscous mouthrinse (carboxymethylcellulose 2%, oleum citrii) 4 x 120 microg/day from days 10 to 16. Sixteen cycles were given to control patients, of these 14 with placebo, and another two cycles with no treatment. Severe mucositis (WHO grade III/IV) was documented in 21 of 32 cycles (65.5%). A difference of borderline significance was observed for the reduction of maximum severity of oral mucositis between G-CSF vs placebo (P = 0.058), with a reduction of WHO grade IV of 50% (four G-CSF vs eight control). The number of days in hospital was reduced significantly in the G-CSF group (P = 0.02). In conclusion, topical oral G-CSF mouthrinses may be beneficial to reduce oral mucositis.

Administration, Topical↗
PubMed1996

Topical treatment of erectile dysfunction: randomised double blind placebo controlled trial of cream containing aminophylline, isosorbide dinitrate, and co-dergocrine mesylate.

OBJECTIVE: To examine the effectiveness in treating impotence to topically applied cream containing three vasodilators--aminophylline, isosorbide dinitrate, and co-dergocrine mesylate--which act by different mechanisms. DESIGN: Randomised double blinded placebo controlled crossover trial over two weeks. SUBJECTS: 36 men with erectile dysfunction randomly allocated to two equal groups. INTERVENTIONS: Active cream containing aminophylline 3%, isosorbide dinitrate 0.25%, and co-dergocrine mesylate 0.05% for one week and placebo for another. MAIN OUTCOME MEASURES: Patients' reported experience of penile responses and side effects of treatment in questionnaires. Penile tumescence and arterial flow in the laboratory. RESULTS: 21 patients reported full erection and satisfactory intercourse with the active cream. Three men reported full erection and satisfactory intercourse with either cream. The active cream was more effective in psychogenic than organic impotence (eight out of nine men with psychogenic impotence achieved a full erection upsilon four out of eight with neurogenic impotence and two out of seven with arterial insufficiency). No major side effects were reported. In the laboratory the active cream increased penile arterial flow (0.19 (SD 0.08) m/s upsilon 0.02 (0.15) m/s with placebo) and induced tumescence in 24 patients. CONCLUSIONS: Topical treatment with a cream containing three different vasodilators might be considered before intracavernous injection of vasoactive agents, particularly in psychogenic impotence.

Administration, Topical↗
PubMed2005

A prospective, randomised, single-blinded, controlled trial comparing two topical anaesthetic modalities for the application of a tenaculum to the cervix.

The aim of this study was to compare the efficacy of equivalent doses of lignocaine spray vs lignocaine jelly in reducing pain during the application of a tenaculum to the cervix. A total of 58 women undergoing hysterosalpingography were prospectively randomised to receive either two doses of 10% lignocaine spray or 1 ml of 2% lignocaine jelly (both doses equivalent to 20 mg of lignocaine base) topically onto the cervix before tenaculum attachment. There was no difference in pain scores (measured by visual analogue scale and 4-point verbal descriptor scale) between lignocaine spray and lignocaine jelly during the attachment of the tenaculum to the cervix. In conclusion, there was no difference in pain during tenaculum attachment to the cervix following topical application of equivalent doses of either lignocaine jelly or spray.

Administration, Intravaginal↗
PubMed2006

Conjoint analysis: a novel, rigorous tool for determining patient preferences for topical antibiotic treatment for acne. A randomised controlled trial.

BACKGROUND: Acne vulgaris is an extremely common skin disorder that can be treated effectively with drugs that are currently available. Poor compliance, however, is a major factor in the high failure rates seen in acne treatment. Compliance might be enhanced by considering patient preferences for acne medications. Conjoint analysis is well suited for the study of patient preferences in healthcare, but is novel to the field of dermatology. OBJECTIVES: The study aimed to determine and compare patient preferences for four topical antibiotics used for 1 week, once or twice daily, to treat acne vulgaris. METHODS: A randomised, phase IV, single-centre, cross-over study was performed using conjoint analysis and a traditional patient questionnaire. Over 4 weeks, the patients used each of four topical antibiotics for 1 week: erythromycin/zinc solution, clindamycin phosphate lotion, benzoyl peroxide (BP)/erythromycin gel (each applied twice daily) and clindamycin phosphate gel (applied once daily). The conjoint analysis examined five different attributes of acne medications: form, storage, product life once opened, method of application and regimen (each with two or three possible options). From 108 possible permutations of the five attributes, 16 hypothetical medications were selected at random and described on printed cards. Pre- and post-treatment, the patients ranked the cards in order of preference and rated each hypothetical product based on their likelihood to use it. For each patient, product 'utilities' were then calculated by multiple regression. The patients also completed a patient acceptability questionnaire, by which they rated the product acceptability after 1 week of treatment with each of the four topical antibiotics. The patients later ranked the medications in order of preference after using all four treatments. Adverse events were recorded in diary cards to assess tolerability. RESULTS: Of 67 patients recruited, 64 used all four medications and completed the study. The conjoint analysis found that a gel formulation, room temperature storage, product life of up to 18 months once opened, application with fingers and once-daily regimen were the options ranked first for the five product attributes. According to the ranking order (out of 108) for the combination of attributes representing the four study medications, clindamycin phosphate gel had the highest rankings (6 and 1 pre- and post-treatment, respectively) and BP/erythromycin gel had the lowest rankings (93 and 70 pre- and post-treatment). The rankings of clindamycin phosphate lotion and erythromycin/zinc solution worsened from pre- to post-treatment, indicating a shift in patient preference after they experienced products 'in-use' during the study. Based on the questionnaire, clindamycin phosphate gel was liked best by the highest proportion of patients (33%). In terms of overall satisfaction, the order of preference was: (i) clindamycin phosphate gel, (ii) clindamycin phosphate lotion, (iii) BP/erythromycin gel and (iv) erythromycin/zinc solution. Adverse events related to medication occurred most frequently with erythromycin/zinc solution and BP/erythromycin gel. Clindamycin phosphate gel was the only product not associated with any episodes resulting in a change of medication or dose. CONCLUSIONS: Conjoint analysis provided a convenient, reliable tool for assessing patient preferences for topical antibiotics used to treat acne. The patients clearly preferred a gel formulation that could be applied with the fingers once daily and stored at room temperature for as long as 18 months. One product (clindamycin phosphate gel) combined all five of the preferred attributes, a preference confirmed by the simulated product rankings. These findings of the conjoint analysis are consistent with the safety profiles and the results of the traditional questionnaire.

Acne Vulgaris↗
PubMed2002

Randomised controlled trial of short bursts of a potent topical corticosteroid versus prolonged use of a mild preparation for children with mild or moderate atopic eczema.

OBJECTIVE: To determine whether a three day burst of a potent corticosteroid is more effective than a mild preparation used for seven days in children with mild or moderate atopic eczema. DESIGN: Randomised, double blind, parallel group study of 18 weeks' duration. SETTING: 13 general practices and a teaching hospital in the Nottingham area. PARTICIPANTS: 174 children with mild or moderate atopic eczema recruited from general practices and 33 from a hospital outpatient clinic. INTERVENTIONS: 0.1% betamethasone valerate applied for three days followed by the base ointment for four days versus 1% hydrocortisone applied for seven days. MAIN OUTCOME MEASURES: Primary outcomes were total number of scratch-free days and number of relapses. Secondary outcomes were median duration of relapses, number of undisturbed nights, disease severity (six area, six sign atopic dermatitis severity scale), scores on two quality of life measures (children's life quality index and dermatitis family impact questionnaire), and number of patients in whom treatment failed in each arm. RESULTS: No differences were found between the two groups. This was consistent for all outcomes. The median number of scratch-free days was 118.0 for the mild group and 117.5 for the potent group (difference 0.5, 95% confidence interval -2.0 to 4.0, P=0.53). The median number of relapses for both groups was 1.0. Both groups showed clinically important improvements in disease severity and quality of life compared with baseline. CONCLUSION: A short burst of a potent topical corticosteroid is just as effective as prolonged use of a milder preparation for controlling mild or moderate atopic eczema in children.

Administration, Topical↗
PubMed1979

Effectiveness of topical steroids in the control of radiation dermatitis: a randomised trial using 1% hydrocortisone cream and 0.05% clobetasone butyrate (Eumovate).

Radiation dermatitis often presents as a problem for patients and radiotherapists during treatment. Topical corticosteroids have been shown to have an anti-inflammatory effect in the treatment of many skin diseases and are commonly prescribed during a course of radiation treatment. A comparison of two different steroid creams, 1% hydrocortisone cream and 0.05% clobetasone butyrate (Eumovate), in a double blind trial was carried out in 54 patients undergoing radiation therapy for breast cancer. 'The cream' was administered when patients reached a given dose of 2000 rad (or earlier if required) whether a skin reaction was present or not. The aim of the trial was to evaluate the general effectiveness of steroids in controlling radiation dermatitis and whether one type of cream was superior to the other. The majority of patients using either cream derived benefit in its soothing effect. There was, however, a significant difference in the intensity of reactions seen, patients using clobetasone butyrate developed more severe radiation reactions despite both groups having similar radiation doses. The possibility of two differing populations having different responses to radiation is discussed as is the 'breakthrough phenomenon' described in the literature. It is concluded that neither cream should be used as first choice in the control of radiation dermatitis.

Administration, Topical↗
PubMed2005

Topical vitamin A, or its derivatives, for treating and preventing napkin dermatitis in infants.

BACKGROUND: Napkin dermatitis (nappy or diaper rash) is a non-specific term used to describe inflammatory eruptions (rashes) in the napkin area. Most infants develop napkin dermatitis at least once during their infancy. Topical vitamin A has been suggested as a treatment for napkin dermatitis. OBJECTIVES: To determine if treatment with topical vitamin A is successful in either preventing napkin dermatitis, or producing resolution or decreasing the severity of napkin dermatitis. SEARCH STRATEGY: We searched the Cochrane Skin Group Specialised Register (May 2005); Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 3, 2005); Ovid MEDLINE from 1966 to August 2005; EMBASE (2003 to May 2005); Ovid OLDMEDLINE (1950 to 1965); and CINAHL (1982 to August 2005). We also searched reference lists of articles. SELECTION CRITERIA: Randomised controlled trials, where the topical application of medication containing vitamin A (or its derivatives) was compared with either placebo, no treatment or other topical medication, for the prevention or treatment of napkin dermatitis in infants aged from zero to two years. DATA COLLECTION AND ANALYSIS: Two authors (AJD and MWD) identified and checked titles and abstracts obtained from the searches, and reviewed the full text where necessary. They decided which trials met the inclusion criteria, and recorded their methodological quality. They assessed studies as either adequate, unclear or inadequate using the following key criteria: (a) randomisation (method of generation and concealment of allocation); (b) blinding; (c) loss to follow-up. MAIN RESULTS: We did not find any studies for the treatment of napkin dermatitis. We found only one study comparing the use of topical application of medication containing vitamin A, with another topical medication or placebo, to prevent napkin dermatitis. This included study, of 114 newborn infants, reported no significant differences between groups with regard to the severity or duration of napkin dermatitis. AUTHORS' CONCLUSIONS: For the treatment of napkin dermatitis there is no evidence to support or refute the use of topical vitamin A preparations. For the prevention of napkin dermatitis there is no evidence to suggest that topical vitamin A alters the development of napkin dermatitis. Further RCTs are required to determine whether topical vitamin A is efficacious in treating or preventing napkin dermatitis.

Administration, Topical↗
PubMed2005

Randomised controlled trial of sub-Tenon's block versus topical anaesthesia for cataract surgery: a comparison of patient satisfaction.

BACKGROUND/AIM: Sub-Tenon's block (STB) or topical anaesthesia alone (TOP) are popular techniques employed during cataract surgery. TOP is often preferred by healthcare providers because of financial or staffing reasons, despite existing evidence that pain during surgery is better controlled with STB. Pain is not the only consideration that determines patient preference for the anaesthesia technique. The authors decided to investigate the issue of patient satisfaction using the recently developed Iowa Satisfaction with Anesthesia Scale (ISAS). METHOD: In a randomised controlled pilot trial, 28 patients were enrolled to receive either STB with 3 ml of 2% lidocaine and hyaluronidase, or TOP with proxymetacaine 0.5% and amethocaine 1% (Tetracaine) eye drops. Postoperatively patients rated their satisfaction with anaesthesia care by filling in the self administered written questionnaire, the ISAS. RESULTS: One patient in the TOP group dropped out of the study because of intolerable pain. Analysis of the questionnaire results with a two sample Wilcoxon rank sum test showed a significant difference in patient satisfaction (p<0.0085). The median satisfaction score was higher in the STB group 2.77 (interquartile range IQR 2.45 to 3), than in the TOP group 2.04 (IQR 1.54 to 2.5). CONCLUSION: In the setting of day case cataract surgery, patients report significantly higher satisfaction scores with STB than with TOP alone.

Administration, Topical↗
PubMed2026

Eligibility of real-world patients for aspirin primary prevention trials in cardiovascular disease.

BACKGROUND: Evidence for the net benefit of aspirin for primary prevention of cardiovascular disease (CVD) is finely balanced, leading to variation in guideline recommendations internationally. External validity of randomised clinical trial (RCT) evidence may therefore be of particular importance. The aim of this study is to characterise real-world patients according to their eligibility for guideline-cited aspirin RCTs for primary CVD prevention. METHODS: Eligibility criteria from 14 RCTs were applied to a linked primary care/hospital discharge dataset of people&#x2009;&#x2265;&#x2009;40 years without CVD. Proportions eligible for each trial were calculated, and characteristics of eligible and ineligible patients compared for each trial, including Cox regression analysis of event rates for major adverse cardiovascular events (MACE), major bleeding events, and non-cardiovascular mortality. RESULTS: Of 570,211 included patients (300,500 [52.7%] women, 336,877 [59%]&#x2009;<&#x2009;60 years), the median proportion ineligible for 14 RCTs was 90.7% (range 42.5-99.4%) and 24.0% of patients were ineligible for all RCTs. On average, trial-ineligible populations were younger (median age trial-ineligible 57.8 vs trial-eligible 62.6 years, p&#x2009;=&#x2009;0.008) and a lower proportion had hypertension (23.9% vs 50.9%, p&#x2009;=&#x2009;0.004), diabetes (6.4% vs 11.5%, p&#x2009;=&#x2009;0.015), or a regular statin prescription (11.8% vs 26.7%, p&#x2009;=&#x2009;0.001). Trial-ineligible populations had a higher hazard of MACE compared to trial-eligible in four RCTs and lower in ten (hazard ratio [HR] range across all RCTs 0.45 [95%CI 0.40-0.51] to 2.78 [95%CI 2.61-2.96]). Hazards of bleeding events in the trial-ineligible were lower than the trial-eligible in eight RCTs and higher in four (HR range across all RCTs 0.63 [95%CI, 0.59-0.66] to 1.69 [95%CI, 1.53-1.86]), and time-varying hazards of non-CVD death were consistently lower in four RCTs and higher in five (HR range across all RCTs and time points 0.29 [95%CI 0.24-0.36] to 11.42 [95%CI 9.91-13.17]). CONCLUSIONS: Compared with trial-ineligible populations within the same age and sex strata, RCTs recruited people of varying CVD risk but often excluded people at high risk of bleeding or non-CVD death, highlighting that many trials may overestimate the net benefit of aspirin for primary prevention.

Humans↗
PubMed2002

Multidisciplinary bio-psycho-social rehabilitation for chronic low back pain.

BACKGROUND: Chronic low back pain is, in many countries, the main cause of long term disability in middle age. Patients with chronic low back pain are often referred for multidisciplinary treatment. Previous published systematic reviews on this topic included no randomised controlled trials and pooled together controlled and non-controlled studies. OBJECTIVES: To assess the effect of multidisciplinary bio-psycho-social rehabilitation on pain, function, employment, quality of life and global assessment outcomes in subjects with chronic disabling low back pain. SEARCH STRATEGY: We searched MEDLINE, EMBASE, PsychLIT, CINAHL, Health STAR, and The Cochrane Library from the beginning of the database to June 1998 using the comprehensive search strategy recommended by the Back Review Group of the Cochrane Collaboration. INTERVENTION specific key words for this review were: patient care team, patient care management, multidisciplinary, interdisciplinary, multiprofessional, multimodal, pain clinic and functional restoration. We also reviewed reference lists and consulted the editors of the Back Review Group of the Cochrane Collaboration. SELECTION CRITERIA DESIGN: randomised controlled trials comparing multidisciplinary bio-psycho-social rehabilitation with a non-multidisciplinary control intervention. POPULATION: Adults with disabling low back pain of more than three months in duration. INTERVENTION: Patients had to be assessed and treated by qualified professionals according to a plan that addresses physical and at least one of psychological, or social/occupational dimensions. OUTCOMES: Only trials which reported treatment effect in at least one of pain, function, employment status, quality of life or global improvement. Exclusion: Pure educational interventions (back schools) and pure physical interventions were excluded. DATA COLLECTION AND ANALYSIS: Selection, data extraction and quality grading of studies was done by two independent reviewers using pre-tested data forms. Study quality was assessed according to the scheme recommended by the Back Review Group of the Cochrane Collaboration. Trials with internal validity scores of five or more in a ten point scale were considered high quality. Discrepancies between reviewers were resolved by consensus or by a third reviewer. Given the marked heterogeneity in study settings, interventions and control groups we decided not to pool trial results in a meta-analysis. Instead, we summarized findings by strength of evidence and nature of intervention and control treatments. The evidence was judged to be strong when multiple high quality trials produced generally consistent findings. It was judged to be moderate when multiple low quality or one high quality and one or more low quality trials produced generally consistent findings. Evidence was considered to be limited when only one randomised trial existed or if findings of existing trials were inconsistent. MAIN RESULTS: Ten trials (12 randomised comparisons) were included. They randomised a total of 1964 patients with chronic low back pain. There was strong evidence that intensive multidisciplinary bio-psycho-social rehabilitation with a functional restoration approach improved function when compared with inpatient or outpatient non-multidisciplinary treatments. There was moderate evidence that intensive multidisciplinary bio-psycho-social rehabilitation with a functional restoration approach improved pain when compared with outpatient non-multidisciplinary rehabilitation or usual care. There was contradictory evidence regarding vocational outcomes of intensive multidisciplinary bio-psycho-social intervention. Some trials reported improvements in work readiness, but others showed no significant reduction in sickness leaves. Less intensive outpatient psycho-physical treatments did not improve pain, function or vocational outcomes when compared with non-multidisciplinary outpatient therapy or usual care. Few trials reported effects on quality of life or global assessments. REVIEWER'S CONCLUSIONS: The reviewed trials provide evidence that intensive multidisciplinary bio-psycho-social rehabilitation with a functional restoration approach improves pain and function. Less intensive interventions did not show improvements in clinically relevant outcomes.

Back Pain↗
PubMed2006

Radiation effects on the cosmetic outcomes of immediate and delayed autologous breast reconstruction: an argument about timing.

OBJECTIVE: To conduct a systematic review to gather the available evidence on the optimum timing of the radiotherapy in relation to autologous breast reconstruction. MATERIAL AND METHODS: The data was extracted from scientific databases, and a manual follow-up of references. The studies were selected which included at least 20 patients with any method of autologous breast reconstruction who were treated with adjuvant radiotherapy either before or after their reconstruction, and had addressed the effects of radiotherapy on the cosmetic outcome in their results. The principal outcome was cosmetic appearance. Secondary outcomes were immediate and delayed complications. RESULTS: We could not find any randomised controlled trial on this topic. Ten studies were included, most were retrospective, heterogeneous in terms of control groups, radiation doses, follow-up duration, and outcome measurements. Two studies included no control groups, and four studies compared the outcomes of patients with radiotherapy either before (n=3) or after (n=1) autologous breast reconstruction. The overall incidence of complications was increased in patients with radiotherapy in three out of these four studies. Only four studies directly compared the outcomes of patients who received radiotherapy before with patients who received radiotherapy after autologous breast reconstruction and two out of these reported worse outcomes associated with post-reconstruction radiotherapy. CONCLUSIONS: Despite the paucity of the published data, the current evidence suggests that the radiation has a deleterious effect on autologous flap reconstruction. Until better methods of radiation delivery can be devised to minimise the long term radiation sequelae in the irradiated tissue, delayed reconstruction seems to be a safe option in most of the cases. However, the findings from these studies should be interpreted with great caution before generalising from their results.

Adult↗
PubMed2000

Treatment of postherpetic neuralgia: an update.

Postherpetic neuralgia (PHN) is a chronic pain syndrome that is often refractory to treatment and can last for years, causing physical and social disability, psychological distress, and increased use of the healthcare system. In this paper we provide an update on recent developments in the treatment of PHN. We emphasise the results of recent studies that provide an evidence-based approach for treating PHN that was not available until very recently. In randomised, controlled clinical trials, the topical lidocaine patch, gabapentin, and controlled release oxycodone have been shown to provide superior pain relief in patients with PHN when compared with placebo. It has also recently been demonstrated that the tricyclic antidepressant nortriptyline provides equivalent analgesic benefit when compared with amitriptyline, but is better tolerated. Based on these results, nortriptyline can now be considered the preferred antidepressant for the treatment of PHN, although desipramine may be used if the patient experiences unacceptable sedation from nortriptyline. The topical lidocaine patch, gabapentin and controlled release oxycodone all appear to be as effective as tricyclic antidepressants in the treatment of patients with PHN, and the results of these recent studies suggest that each of these treatments should be considered early in the course of treatment. Additional controlled trials are needed to compare the efficacy and tolerability of these 4 treatments- tricyclic antidepressants, gabapentin, the topical lidocaine patch and controlled release opioid analgesics--used singly and in various combinations in the treatment of patients with PHN.

Herpes Zoster↗
PubMed1983

Topical acyclovir in the treatment of initial genital herpes.

In a double-blind randomised placebo-controlled trial of topical acyclovir in initial (first episode) genital herpes 18 patients received acyclovir ointment and 22 matching placebo ointment. Acyclovir significantly reduced the duration of viral shedding from external and all genital lesions, the duration of vesicles, the time to crusting, the time to complete healing of external and all genital lesions, new lesion formation, and the duration of pain, itching, and all symptoms combined for all patients. In female patients alone the time to crusting was not significantly different and the duration of pain only approached significance but the effects were otherwise the same as for all patients. No patients reported any adverse effects of treatment. Topical acyclovir is well tolerated and effective in treating initial genital herpes.

Acyclovir↗
PubMed2006

Oral or topical nasal steroids for hearing loss associated with otitis media with effusion in children.

BACKGROUND: Otitis media with effusion (OME) is common and may cause hearing loss with associated developmental delay. Treatment remains controversial. OBJECTIVES: To examine evidence for or against treating children with hearing loss associated with OME with systemic or topical intranasal steroids. SEARCH STRATEGY: We searched the Cochrane Ear, Nose and Throat Disorders Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library Issue 4 2005, MEDLINE (1966 to 2006), EMBASE (1974 to 2006), and the CINAHL, LILACS, Zetoc, IndMED, SAMED, KoreaMed, MEDCARIB and Cambridge Scientific Abstracts databases in January 2006. SELECTION CRITERIA: Randomised controlled trials of oral and topical intranasal steroids, either alone or in combination with another agent such as an antibiotic, were included. EXCLUSIONS: publications in abstract form only; uncontrolled, non-randomised or retrospective studies; studies reporting outcomes with ears (rather than children). DATA COLLECTION AND ANALYSIS: Data were extracted from the published reports by the authors independently using standardised data extraction forms and methods. The methodological quality of the included studies was independently assessed by the authors as described in the Cochrane Handbook. Dichotomous results were expressed as an odds ratio using a fixed-effect model together with the 95% confidence intervals. Continuous data were analysed using the weighted mean difference in a fixed-effect model. Tests for heterogeneity between studies were performed using a Mantel-Haenszel approach. In trials with a cross-over design, post cross-over treatment data were not used. MAIN RESULTS: No study prospectively documented hearing loss associated with OME prior to randomisation. Follow up was mainly short term. The odds ratio for OME persisting after short-term follow up in children treated with oral steroids compared to control was 0.22 (95% CI 0.08 to 0.63). The odds ratio for OME persisting after short-term follow up for children treated with oral steroids plus antibiotic compared to control plus antibiotic was 0.37 (95% CI 0.25 to 0.56). However, there was significant heterogeneity between studies included in the latter comparison (P < 0.01). Trends favoured steroids for most other comparisons, but confidence intervals included unity. There was no evidence of benefit for steroid treatment for OME or hearing loss associated with OME in the longer term. AUTHORS' CONCLUSIONS: Both oral and topical intranasal steroids alone or in combination with an antibiotic lead to a quicker resolution of OME in the short term, however, there is no evidence of longer term benefit.

Administration, Intranasal↗