[Cost-effectiveness analysis of Biyuan Tongqiao Granules combined with Triamcinolone Acetonide Nasal Spray in treatment of chronic rhinosinusitis].

This study aims to evaluate the effectiveness and economic efficiency of Biyuan Tongqiao Granules combined with Triamcinolone Acetonide Nasal Spray in the treatment of chronic rhinosinusitis(CRS). The randomized controlled trial(RCT) of Biyuan Tongqiao Granules combined with Triamcinolone Acetonide Nasal Spray in the treatment of CRS was searched against EMbase, PubMed, Cochrane Library, CNKI, VIP, SinoMed, and Wanfang. The efficacy, nasal mucociliary transport time, and safety of the therapy above in the treatment of CRS were analyzed with single-group rate and Meta-analysis, and the economy and sensitivity were evaluated from the perspective of payer. A total of 9 RCTs were included, including 1 145 patients. Meta-analysis showed that compared with Triamcinolone Acetonide Nasal Spray alone, Biyuan Tongqiao Granules combined with Triamcinolone Acetonide Nasal Spray in the treatment of CRS patients increased the effective rate(RR=1.17, 95%CI[1.11, 1.24], P<0.000 01) and shortened the nasal mucociliary transport time(MD=-3.32, 95%CI[-5.86,-0.78], P=0.01), there was no significant difference in the incidence of adverse reactions between the two groups. The incremental cost-effectiveness analysis showed that the treatment costs of the control group and the observation group were 44.15 yuan and 1 044.96 yuan, respectively. In the Biyuan Tongqiao Granules combined with Triamcinolone Acetonide Nasal Spray treatment group, 75.48 yuan was spent to improve the effective rate of CRS by 1%. The one-way sensitivity analysis indicated the days of treatment, the RR of Biyuan Tongqiao Granules combined with Triamcinolone Acetonide Nasal Spray, the price of unit preparation of Biyuan Tongqiao Granules, and the effective rate of Triamcinolone Acetonide Nasal Spray alone had great influence on the incremental cost-effectiveness ratio. In conclusion, Biyuan Tongqiao Granules combined with Triamcinolone Acetonide Nasal Spray improves the therapeutic effect on CRS. The probabilistic sensitivity analysis showed that when the willingness to pay was greater than 7 920 yuan(less than 0.1 of GDP per capita 8 098 yuan), the combined therapy was economically superior to the control. Due to the limited number of articles published, it is necessary to carry out a real-world clinical trial of Biyuan Tongqiao Gra-nules and Triamcinolone Acetonide Nasal Spray in the treatment of CRS, so as to compare the cost-effectiveness of Biyuan Tongqiao Granules and Triamcinolone Acetonide Nasal Spray.

A randomised controlled trial of adjunctive triamcinolone acetonide in eyes undergoing vitreoretinal surgery for open globe trauma - the ASCOT study.

Background: Eyes sustaining open globe trauma are at high risk of severe visual impairment. Proliferative vitreoretinopathy is the most common cause of retinal detachment and visual loss in eyes with open globe trauma. There is evidence from experimental studies and pilot clinical trials that the use of adjunctive steroid medication triamcinolone acetonide can reduce the incidence of proliferative vitreoretinopathy and improve outcomes of surgery for open globe trauma. Objective: The Adjunctive Steroid Combination in Ocular Trauma or ASCOT study aimed to investigate the clinical effectiveness of adjunctive triamcinolone acetonide given at the time of vitreoretinal surgery for open globe trauma. Design: A phase 3 multicentre double-masked randomised controlled trial randomising patients undergoing vitrectomy following open globe trauma to either adjunctive triamcinolone acetonide or standard care. Setting: Hospital vitreoretinal surgical services dealing with open globe trauma. Participants: Patients undergoing vitrectomy surgery who had sustained open globe trauma. Interventions: Triamcinolone acetonide 4 mg/0.1 ml into the vitreous cavity and 40 mg/1 ml sub-Tenon's or standard vitreoretinal surgery and postoperative care. Main outcome measures: The primary outcome was the proportion of patients with at least 10 letters of improvement in corrected visual acuity at six months. Secondary outcomes included retinal detachment secondary to proliferative vitreoretinopathy, retinal reattachment, macula reattachment, tractional retinal detachment, number of operations, hypotony, elevated intraocular pressure and quality of life. Health-related quality of life was assessed using the EuroQol Five Domain and Visual Function Questionnaire 25 questionnaires. Results: A total of 280 patients were randomised; 129 were analysed from the control group and 130 from the treatment group. The treatment group appeared, by chance, to have more severe pathology on presentation. The primary outcome (improvement in visual acuity) and principal secondary outcome (change in visual acuity) did not demonstrate any treatment benefit for triamcinolone acetonide. The proportion of patients with improvement in visual acuity was 47% for triamcinolone acetonide and 43% for standard care (odds ratio 1.03, 95% confidence interval 0.61 to 1.75, p = 0.908); the baseline adjusted mean difference in the six-month change in visual acuity was -2.65 (95% confidence interval -9.22 to 3.92, p = 0.430) for triamcinolone acetonide relative to control. Similarly, the secondary outcome measures failed to show any treatment benefit. For two of the secondary outcome measures, stable complete retinal reattachment and stable macular retinal reattachment, outcomes for the treatment group were significantly worse for triamcinolone acetonide at the 5% level (respectively, odds ratio 0.59, 95% confidence interval 0.36 to 0.99, p = 0.044 and odds ratio 0.59, 95% confidence interval 0.35 to 0.98, p = 0.041) compared with control in favour of control. The cost of the intervention was £132 per patient. Health economics outcome measures (Early Treatment Diabetic Retinopathy Study, Visual Function Questionnaire 25 and EuroQol Five Dimensions) did not demonstrate any significant difference in quality-adjusted life-years. Conclusions: The use of combined intraocular and sub-Tenon's capsule triamcinolone acetonide is not recommended as an adjunct to vitrectomy surgery for intraocular trauma. Secondary outcome measures are suggestive of a negative effect of the adjunct, although the treatment group appeared to have more severe pathology on presentation. Future work: The use of alternative adjunctive medications in cases undergoing surgery for open globe trauma should be investigated. Refinement of clinical grading and case selection will enable better trail design for future studies. Trial registration: This trial is registered as ISRCTN 30012492, EudraCT number 2014-002193-37, REC 14/LNO/1428, IRAS 156358, Local R&D registration CHAD 1031. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (12/35/64) and will be published in full in Health Technology Assessment; Vol. 27, No. 12. See the NIHR Journals Library website for further project information.

Despite advances in surgical techniques, eye trauma remains a leading cause of blindness and visual impairment. The main cause of trauma is a scarring process within the eye ­ proliferative vitreoretinopathy. There is good evidence from laboratory work and small-scale clinical studies that the addition of a steroid medication, triamcinolone acetonide, given in and around the eye at the time of surgery for eye trauma, can reduce the incidence of proliferative vitreoretinopathy scarring and improve the outcomes of surgery. The Adjunctive Steroid Combination in Ocular Trauma or ASCOT study was a multicentre clinical trial designed to test the use of triamcinolone acetonide as an addition to surgery to improve outcomes in eyes with 'open globe' penetrating injuries. A total of 280 patients were recruited and randomised to receive standard surgery or surgery with the additional steroid (triamcinolone acetonide). No benefit was found from the addition of the steroid medication. The addition of steroid medication was not good value for money. Secondary outcome measures suggested that triamcinolone acetonide may have had a negative effect on outcomes, although this may have been due to the presence of more severe cases amongst the patients allocated to receive the additional steroid (triamcinolone acetonide). The use of adjunctive triamcinolone acetonide in eye trauma cases undergoing surgery is therefore not recommended. Future studies with different additional medications and/or more targeted case selection are indicated to improve outcomes for eyes experiencing penetrating trauma.

Clinical and biochemical assessment of the effect of topical use of coenzyme Q10 versus topical corticosteroid in management of symptomatic oral lichen planus: randomized controlled clinical trial.

BACKGROUND: Oral lichen planus (OLP) is a chronic mucocutaneous immunologically mediated condition that has a great adverse effect on oral functions. Corticosteroids are still the first drugs of choice used in the treatment of OLP; however, they have extensive medical side effects. The present study was carried out to assess the clinical therapeutic effect of the topical use of coenzyme Q10 (coQ10 or ubiquinol) versus topical corticosteroids in the management of symptomatic OLP and to determine whether the effect, if any, was due to the powerful antioxidant activity of coQ10. SUBJECTS AND METHODS: We performed a randomized, double blinded controlled trial at the Faculty of Dentistry, Cairo University, Egypt. The study was conducted on 34 patients suffering from symptomatic OLP. Patients were randomly divided into two groups: intervention group (I),who received topical CoQ10 in the form of mucoadhesive tablets (40% CoQ10) 3 times daily for one month and control group (II),who received topical corticosteroid (kenacort in Orabase: triamcinolone acetonide 0.1% 5-g adhesive paste - dermapharm), 4 times daily for one month. Patients were evaluated at one-week intervals using the clinical parameters (score) of pain (VAS) and lesion size. Additionally, salivary levels of malondialdehyde (MDA) were detected in both groups before and after treatment using ELISA. All recorded data were analysed using independent t test, ANOVA followed by Bonferroni post hoc test for lesion size and salivary level of MDA data and Mann-Whitney U test and Friedman test for VAS data. RESULTS: Both groups showed a significant reduction in pain and the size of the lesions (p ≤ 0.05) with no statistically significant difference between them (p > 0.05), and this clinical improvement was associated with a reduction in the salivary levels of MDA in both groups. CONCLUSIONS: The topical use of CoQ10 mucoadhesive tablets was as effective as the topical use of triamcinolone acetonide, and its clinical effect was associated with a reduction in the salivary level of MDA. TRIAL REGISTRATION: The study protocol was registered at www. CLINICALTRIAL: gov (NCT04091698) and registration date: 17/9/2019.

Suprachoroidal Injection of Triamcinolone Acetonide Injectable Suspension for the Treatment of Macular Edema Associated With Uveitis in the United States: A Cost-Effectiveness Analysis.

OBJECTIVES: Suprachoroidal injection of triamcinolone acetonide is the first Food and Drug Administration-approved treatment for macular edema associated with uveitis. A cost-effectiveness analysis was performed comparing this treatment with best supportive care (BSC) for the management of this indication from US Medicare and commercial payer perspectives. METHODS: A patient-level simulation was developed per the patient characteristics and changes in best-corrected visual acuity letter scores observed in a phase III study of triamcinolone acetonide (PEACHTREE). The wholesale acquisition cost of triamcinolone acetonide was $1650/injection; suprachoroidal injection cost was assumed at $200/injection. Healthcare costs were informed by a US claims-based analysis. Mortality risk associated with severe vision loss and blindness was modeled by applying a hazard ratio to all-cause mortality rates of the US general population. Health-related quality of life weights, obtained from a regression model fitted to the Visual Function Questionnaire-25 data from PEACHTREE, were applied based on the best-corrected visual acuity scores of both eyes. Costs (2020 US dollar) and benefits were discounted at 3% annually. Incremental cost-effectiveness ratios were estimated over a 10-year horizon. RESULTS: In the base-case, the incremental cost-effectiveness ratio comparing triamcinolone acetonide with BSC was $28 479 per quality-adjusted life-year gained. The wholesale acquisition cost for triamcinolone acetonide for suprachoroidal use was ∼68%, ∼56%, and ∼27% below the willingness-to-pay thresholds of $150 000, $100 000, and $50 000 per quality-adjusted life-year gained, respectively. Results were robust in sensitivity and scenario analyses. CONCLUSIONS: Triamcinolone acetonide for suprachoroidal use is cost-effective compared with BSC for patients with macular edema associated with uveitis.

Economic evaluation of prevention of cystoid macular edema after cataract surgery in diabetic patients: ESCRS PREMED study report 6.

PURPOSE: To investigate the cost-effectiveness of prophylactic treatments against cystoid macular edema after cataract surgery in diabetic patients. SETTING: 7 ophthalmology clinics in the Netherlands and Belgium. DESIGN: Prospective trial-based cost-effectiveness analysis using data from a European multicenter randomized clinical trial. METHODS: Diabetic patients (n = 163) undergoing uneventful cataract surgery were randomized to perioperative subconjunctival triamcinolone acetonide (n = 36), perioperative intravitreal bevacizumab (n = 36), combination treatment (n = 45), or no additional treatment (control group, n = 46). The cost analysis was performed from a healthcare perspective within a 12-week postoperative time horizon. The main effectiveness outcome was quality-adjusted life years (QALYs). The main cost-effectiveness outcome was the incremental cost-effectiveness ratio (ICER; cost per QALY). RESULTS: The mean total healthcare costs and QALYs were as follows: triamcinolone group €1827 (U.S. dollars [$] 2295)/0.166; bevacizumab group €2050 ($2575)/0.144; combination group €2027 ($2546)/0.166; and control group €2041 ($2564)/0.156. Bevacizumab and control treatment were most costly and least effective. The ICER was €321 984 ($404 503) per QALY for the combination group compared with that of the triamcinolone group. Assuming the willingness-to-pay as €20 000 ($25 126) per QALY, the cost-effectiveness probability was 70% and 23% in the triamcinolone and combination groups, respectively. No patient who received triamcinolone developed clinically significant macular edema (CSME). A secondary cost-effectiveness analysis based on this outcome showed a clear preference for triamcinolone. CONCLUSIONS: In diabetic patients, subconjunctival triamcinolone was effective in preventing CSME after cataract surgery. The cost-effectiveness analysis showed that triamcinolone is also cost-effective.

Assessment of various intralesional injections in keloid: comparative analysis.

 : In reaction to skin injury in genetically predisposed persons, the keloid is formed and marked by benignant overgrowth of dermic collagen. Intralesional triamcinolone was used in the treatment of keloids with varying results. AIM: Intralesional triamcinolone is a gold standard in treating the keloids in comparison with its effectiveness versus intralesional 5-fluorouracil intralesional verapamil and intralesional platelet-rich plasma. PATIENTS AND METHODS: Several 160 cases were categorized into four groups of each group-containing 40 cases. Group-A (control) treated with intralesional triamcinolone and Group-B intralesional verapamil, Group-C intralesional 5-fluorouracil, and Group-D intralesional platelet-rich plasma. Patients were assessed for clinical response based on a decrease in the patient and observer scar assessment scale (POSAS) at baseline and the end of treatment. RESULTS: The mean base-line POSAS score was 91 ± 10.98 SD check-in Group-A, 90 ± 10.85 in Group-B, 89 ± 10.06 in Group-C, and 92 ± 10.84 in Group-D. POSAS score after 24 weeks 36 ± 12.74 in Group-A, 29 ± 10.91 in Group-B, 39 ± 13.74 in Group-C, 36 ± 12.74 in Group-D. Statistically, a significant difference was observed between groups. CONCLUSION: Intralesional verapamil reported to be the most effective therapy and platelet-rich plasma was effective as intralesional triamcinolone acetonide with no serious side effects and 5-fluorouracil was less effective in treating the keloids.

Does Injection Site Matter? A Randomized Controlled Trial to Evaluate Different Entry Site Efficacy of Knee Intra-articular Injections.

BACKGROUND: Complaints of knee pain secondary to early osteoarthritis may account for up to 30% of visits to primary care physicians. Due to the proposed inflammatory changes in early osteoarthritis, intra-articular injections of corticosteroids (IACS) have been considered as an option for disease progression modification, pain control, and improvement of function. However, some studies have suggested poor accuracy rates of IA injections depending on the entry site chosen. It is therefore the aim of this study to evaluate the efficacy of IA knee corticosteroid injection in reducing pain and improving function in patients with early osteoarthritis and whether the low accuracy rates reported with the Anterolateral joint line injection site translate to worse functional and pain outcome measures as compared to Suprapatellar lateral injections. MATERIALS AND METHODS: The study was carried out as an open-label, randomized controlled trial with 60 sequential patients recruited. Simple randomization separated groups into anterolateral joint line or suprapatellar lateral injection sites. Improvements were measured with WOMAC and VAS scores after injection of Lidocaine and steroid solution. RESULTS: Patients receiving IACS injections had a measurable improvement in self-reported outcomes as evidenced by standard deviation change in WOMAC and VAS scores. The majority of patients had a clinically significant improvement in VAS scores as compared to their initial measures with a notable amount of patients improving significantly as well on their WOMAC scores, irrespective of the injection site chosen. CONCLUSIONS: We have therefore continued the use of palpation-guided intra-articular knee injections in an effort to reduce costs as compared to other injection modalities with positive results in our osteoarthritis patients.

[A cost-effectiveness study of dexamethasone implants in macular edema]. / Resultados coste-efectividad del implante de dexametasona en edema macular.

OBJECTIVE: To analyze the cost-effectiveness and benefits of a dexamethasone intravitreal implant (Ozurdex®, Allergan, Irvine, CA, USA.) in its clinically relevant applications. MATERIAL AND METHODS: A total of 88 eyes of 86 patients with macular edema of > 300 µm measured by optical coherence tomography (Cirrus Zeiss, Dublin, CA, USA) were included in this two-year retrospective study, with a minimum of 6 months follow-up. The patients were divide into 3 groups: group 1 with macular edema in retinal vein occlusion, group 2 with non-infectious posterior uveitis, and group 3 with diabetic macular edema. The treatment was off-label but supported by the literature. Before implantation, and on days 1, 30, 60, 90 and 180, corrected visual acuity (Snellen), central retinal thickness, intraocular pressure and biomicroscopy were evaluated. The cost-benefit analysis was tabulated by line of visual acuity gained, comparing the main therapeutic alternatives and assessment of the safety profile of the dexamethasone intravitreal implant (Ozurdex®, Allergan, Irvine, CA, USA). RESULTS: The results of this study did not differ from the published studies, in terms of visual acuity improvement in 63.3% of cases, and with central macular thickness improvement in 97% of cases. There were relapses, which occurred after 120 days on average, and the need for retreatment was 40.9%. Increased intraocular pressure >23 mm Hg was among the side effects in 29.54%, and was controlled with topical treatment, except in 1.13% requiring surgical treatment. The development of cataract was 44.7%, and 10.6% required surgery. Treatment results showed less frequent use of Ozurdex® than other treatments for disease control, being a cost saving option. DISCUSSION: Cost-effectiveness analyses are clinically relevant when applying treatment strategies in patients with macular edema. Dexamethasone intravitreal implant appears to be a safe and efficient therapy.

Psoriasis treatments by payment type in the US outpatient office setting.

BACKGROUND: Many factors, including patients' methods of payment, may influence psoriasis treatment decisions. OBJECTIVE: To characterize psoriasis treatments by patients' types of payment in the US outpatient office setting. METHODS: Using the National Ambulatory Medical Care Survey (NAMCS), a large survey that samples outpatient office visits to US non-federally funded physicians, visits linked with sole diagnoses for psoriasis (ICD-9-CM: 696.1) were identified. There were 545 unweighted records. The types and number of treatments prescribed at these visits were categorized by expected major payment type to be used for the visit. RESULTS: Mainstay psoriasis therapies such as vitamin D analogs and clobetasol were prescribed regardless of payment type. Retinoids were also within the most frequently prescribed psoriasis medications for all payment types, however they were less frequently prescribed than vitamin D analogs. Payment type did not have a significant effect on the number of medications prescribed at psoriasis visits. LIMITATIONS: Data on treatment adherence and filling of prescriptions are not included in the NAMCS database. CONCLUSION: Prescribing patterns for psoriasis medications are similar across payment type. Additional factors appear to modulate therapy choice for patients with psoriasis.

Green or yellow laser treatment for diabetic macular edema: exploratory assessment within the Diabetic Retinopathy Clinical Research Network.

PURPOSE: Explore differences in green compared with yellow focal/grid laser treatment on functional and anatomical endpoints in eyes with diabetic macular edema. METHODS: Data from two randomized clinical trials were evaluated for differences in visual acuity and optical coherence tomography parameters for eyes assigned to sham injection + prompt laser, ranibizumab + prompt laser, or prompt laser only: among subgroups of eyes treated exclusively and electively with either green or yellow laser. RESULTS: In the sham injection + prompt laser group, the mean visual acuity letter score change for eyes receiving green and yellow laser treatment, respectively, was +2.4 ± 14 and +5.1 ± 13 at the 52-week visit (P = 0.06) and +2.4 ± 15 and +6.0 ± 13 at the 104-week visit (P = 0.13), with no corresponding evidence of differences in optical coherence tomography thickness. When comparing wavelength groups in the ranibizumab + prompt laser and prompt laser-only groups, meaningful differences in visual acuity and optical coherence tomography thickness were not detected at 1 year or 2 years. CONCLUSION: A trend toward improved vision outcome with yellow laser observed in one trial was not corroborated by anatomical outcomes or by the other trial. In this study, without random assignment to different wavelengths controlling for bias and confounding, it is not possible to determine whether one wavelength is better than the other.

Treating retinal vein occlusions in France, Germany, and Italy: an analysis of treatment patterns, resource consumption, and costs.

PURPOSE: To describe treatment patterns among patients with central or branch retinal vein occlusion (CRVO or BRVO) in France, Germany, and Italy, and to estimate retinal vein occlusion (RVO)-related direct medical costs. METHODS: We used a retrospective chart review to determine 18-month RVO-related resource utilization and calculate 12-month health care costs. Country-specific unit costs (€) were assigned to each resource from the perspective of the health care payer. Costs for France and Germany were based on 2005, and for Italy on 2007 values. RESULTS: Data from a total of 109 BRVO and 119 patients with CRVO were used in the analysis. Laser therapy was the most commonly used intervention in Germany, for both CRVO and patients with BRVO (95%-98% of treatments), while patients in France with either condition had triamcinolone injections most often (63%-67% of treatments). Injections were also administered frequently in Italy and were the most common treatment for CRVO (50%), whereas patients with BRVO used laser therapy most often (41%). Inpatient treatment was most common in Germany (42% of CRVO and 34% of patients with BRVO), and did not occur at all in Italy except for day admissions. Total costs were higher for patients with CRVO in all countries. Most costs in Italy and France were attributable to outpatient treatment. In Germany, hospitalization made up the largest proportion of costs (80%), although more patients used outpatient services. CONCLUSIONS: Approaches to treating BRVO and CRVO vary across European countries. Development of agreed-upon guidelines would support consistency in patient care and reimbursement policy.

Cost-effectiveness analysis of ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema.

OBJECTIVE: Perform a cost-effectiveness analysis of the treatment of diabetic macular edema (DME) with ranibizumab plus prompt or deferred laser versus triamcinolone plus prompt laser. Data for the analysis were drawn from reports of the Diabetic Retinopathy Clinical Research Network (DRCRnet) Protocol I. DESIGN: Computer simulation based on Protocol I data. Analyses were conducted from the payor perspective. PARTICIPANTS: Simulated participants assigned characteristics reflecting those seen in Protocol I. METHODS: Markov models were constructed to replicate Protocol I's 104-week outcomes using a microsimulation approach to estimation. Baseline characteristics, visual acuity (VA), treatments, and complications were based on Protocol I data. Costs were identified by literature search. One-way sensitivity analysis was performed, and the results were validated against Protocol I data. MAIN OUTCOME MEASURES: Direct cost of care for 2 years, change in VA from baseline, and incremental cost-effectiveness ratio (ICER) measured as cost per additional letter gained from baseline (Early Treatment of Diabetic Retinopathy Study). RESULTS: For sham plus laser (S+L), ranibizumab plus prompt laser (R+pL), ranibizumab plus deferred laser (R+dL), and triamcinolone plus laser (T+L), effectiveness through 104 weeks was predicted to be 3.46, 7.07, 8.63, and 2.40 letters correct, respectively. The ICER values in terms of dollars per VA letter were $393 (S+L vs. T+L), $5943 (R+pL vs. S+L), and $20 (R+dL vs. R+pL). For pseudophakics, the ICER value for comparison triamcinolone with laser versus ranibizumab with deferred laser was $14 690 per letter gained. No clinically relevant changes in model variables altered outcomes. Internal validation demonstrated good similarity to Protocol I treatment patterns. CONCLUSIONS: In treatment of phakic patients with DME, ranibizumab with deferred laser provided an additional 6 letters correct compared with triamcinolone with laser at an additional cost of $19 216 over 2 years. That would indicate that if the gain in VA seen at 2 years is maintained in subsequent years, then the treatment of phakic patients with DME using ranibizumab may meet accepted standards of cost-effectiveness. For pseudophakic patients, first-line treatment with triamcinolone seems to be the most cost-effective option.

Flares in lupus: Outcome Assessment Trial (FLOAT), a comparison between oral methylprednisolone and intramuscular triamcinolone.

OBJECTIVE: Systemic lupus erythematosus (SLE) is a chronic systemic autoimmune disease characterized by a relapsing-remitting course. When a mild/moderate flare occurs, treatment with corticosteroids is often instituted. There are 2 methods of acutely giving a boost of steroids: triamcinolone injection or a short-term boost of oral prednisone or methylprednisolone. We investigated whether triamcinolone is superior to oral corticosteroids for mild/moderate flare in patients with lupus. METHODS: In a clinical trial, 50 patients with SLE presenting with a mild or moderate flare [defined using the Safety of Estrogens in Lupus Erythematosus: National Assessment-SLE Disease Activity Index (SELENA-SLEDAI) flare instrument] were randomized to receive oral methylprednisolone with rapid tapering (medrol dose-pack) or triamcinolone 100 mg, given intramuscularly. The patients completed a Likert scale of activity and the Medical Outcomes Study Short Form-36 health status questionnaire on the randomization day, and repeated them the next day, 2 days, one week, 2 weeks, 3 weeks, and one month later. RESULTS: Complete improvement occurred in 0% at one day, 0% at 2 days, 8.3% at one week, 20.8% at 2 weeks, 20.8% at 3 weeks, and 25% at 4 weeks in the methylprednisolone group versus 4.3% at one day, 4.3% at 2 days, 8.6% at one week, 12.5% at 2 weeks, 30.4% at 3 weeks, and 34.7% at 4 weeks in the triamcinolone group. Improvement in health status by Week 4 occurred in 66.6% of the patients in the methylprednisolone group versus 73.9% in the triamcinolone group. CONCLUSION: The triamcinolone and oral methylprednisolone groups did equally well. Triamcinolone may lead to a more rapid response than the oral methylprednisolone (69.5% vs 41.6% with some improvement at day one).

Cost-effectiveness and safety of epidural steroids in the management of sciatica.

OBJECTIVES: To investigate the clinical effectiveness of epidural steroid injections (ESIs) in the treatment of sciatica with an adequately powered study and to identify potential predictors of response to ESIs. Also, to investigate the safety and cost-effectiveness of lumbar ESIs in patients with sciatica. DESIGN: A pragmatic, prospective, multicentre, double-blind, randomised, placebo-controlled trial with 12-month follow-up was performed. Patients were stratified according to acute (<4 months since onset) versus chronic (4-18 months) presentation. All analyses were performed on an intention-to-treat basis with last observation carried forward used to impute missing data. SETTING: Rheumatology, orthopaedic and pain clinics in four participating centres: three district hospitals and one teaching hospital in the south of England. PARTICIPANTS: Total of 228 patients listed for ESI with clinically diagnosed unilateral sciatica, aged between 18 and 70 years, who had a duration of symptoms between 4 weeks and 18 months. INTERVENTIONS: Patients received up to three injections of epidural steroid and local anaesthetic (active), or an injection of normal saline into the interspinous ligament (placebo). MAIN OUTCOME MEASURES: The primary outcome measure was the Oswestry Disability Questionnaire (ODQ); measures of pain relief and psychological and physical function were collected. Health economic data on return to work, analgesia use and other interventions were also measured. Quality-adjusted life-years (QALYs) were calculated using the SF-6D, calculated from the Short Form (SF-36). Costs per patient were derived from figures supplied by the centres' finance departments and a costings exercise performed as part of the study. A cost-utility analysis was performed using the SF-36 to calculate costs per QALY. RESULTS: ESI led to a transient benefit in ODQ and pain relief, compared with placebo at 3 weeks (p = 0.017, number needed to treat = 11.4). There was no benefit over placebo between weeks 6 and 52. Using incremental QALYs, this equates to and additional 2.2 days of full health. Acute sciatica seemed to respond no differently to chronic sciatica. There were no significant differences in any other indices, including objective tests of function, return to work or need for surgery at any time-points. There were no clinical predictors of response, although the trial lacked sufficient power to be confident of this. Adverse events were uncommon, with no difference between groups. Costs per QALY to providers under the trial protocol were 44,701 pounds sterling. Costs to the purchaser per QALY were 354,171 pounds sterling. If only one ESI was provided then costs per QALY fell to 25,745 pounds sterling to the provider and 167,145 pounds sterling to the purchaser. ESIs thus failed the QALY threshold recommended by the National Institute for Health and Clinical Excellence (NICE). CONCLUSIONS: Although ESIs appear relatively safe, it was found that they confer only transient benefit in symptoms and self-reported function in a small group of patients with sciatica at substantial costs. ESIs do not provide good value for money if NICE recommendations are followed. Additional research is suggested into the epidemiology of radicular pain, producing a register of all ESIs, possible subgroups who may benefit from ESIs, the use of radiological imaging, optimal early interventions, analgesic agents and nerve root injections, the use of cognitive behavioural therapy in rehabilitation, improved methods of assessment, a comparative cost-utility analysis between various treatment strategies, and methods to reduce the effect of scarring and inflammation.

Contrast-enhanced power Doppler sonography of knee synovitis in rheumatoid arthritis: assessment of therapeutic response.

The aim of this study was to evaluate the ability of power Doppler sonography (PDS) with ultrasound contrast agent to assess the synovial perfusion changes induced by intra-articular steroid injection therapy in the knee joints of patients with rheumatoid arthritis (RA). Eighteen RA patients (16 women, 2 men) with a history and signs of active knee synovitis were studied. Tenderness was evaluated using Thompson's modified index of synovitis activity. All patients underwent joint aspiration followed by intra-articular injection of 40 mg of triamcinolone hexacetonide. Gray-scale ultrasonography and PDS with an intravenous ultrasound contrast agent (Levovist) examinations were carried out before and 3 weeks after the intra-articular steroid injection. The calculation of the time--intensity curves provided a quantitative estimation of the synovial perfusion. The median values of the index of synovitis activity decreased significantly from 7.0 (95% confidence interval (CI) 6.0-8.0) to 3.0 (95% CI 2.0-4.0) ( p<0.01) 3 weeks after the intra-articular steroid injection. All patients showed a reduction of PDS signal after intra-articular steroid therapy and the baseline and follow up median values of the area underlying time-intensity curves were 7.48 (95% CI 5.79-8.73) and 2.45 (95% CI 1.92-3.61), respectively. The comparison between baseline and follow-up median values of the area under the curves showed a statistically significant reduction of PDS findings ( p<0.01). At follow-up examinations the changes in the index score of the synovitis activity were significantly correlated to the changes in the values of the area underlying time-intensity curves ( r=0.785; p<0.01). A significant correlation was also observed between baseline values of the area underlying time-intensity curves and C-reactive protein (CRP) ( r=0.548; p=0.023). In conclusion, PDS with an intravenous ultrasound contrast agent has been shown to be able to detect changes in synovial perfusion after intra-articular steroid injection and may be an additional useful method in the evaluation of synovial inflammation and in the assessment of the therapeutic response.

Effect of intranasal triamcinolone acetonide on bronchial hyper-responsiveness in children with seasonal allergic rhinitis and comparison of perceptional nasal obstruction with acoustic rhinometric assessment.

OBJECTIVE: Many patients with allergic rhinitis (AR) have bronchial hyper-responsiveness (BHR), and seasonal variation of BHR has been demonstrated in these patients. We aimed to investigate how BHR in children with seasonal AR is modified by triamcinolone acetonide aqueous nasal spray (TANS) therapy during the pollen season. A secondary aim was to assess the efficacy of TANS on nasal congestion by acoustic rhinometry and symptom scores. METHODS: A total of 34 children aged 7-18 years with grass pollen-induced AR and 18 age and sex-matched healthy controls were included in study. The patients were divided into the following two subgroups: 22 patients who had AR only; and 12 patients who had AR and asthma. All of them had a baseline BHR (PC20FEV1 methacholine < 8mg/ml). All patients received 220 microg TANS once daily for 4 weeks following a 1-week run-in period. Nasal patency was measured by acoustic rhinometry and patients recorded their nasal obstruction scores in a diary. RESULTS: There was no significant difference at baseline pulmonary function test parameters between the patients and the healthy control children. None of the control subjects had BHR. Asthmatic children with AR had significantly reduced baseline PC20FEV1 when compared with the AR only group [mean +/- S.E.M., (1.60 +/- 0.57 mg/ml versus 2.93 +/- 0.42 mg/ml, P = 0.021)]. The mean PC20FEV1 values increased slightly at the end of treatment in both group (from 1.60 +/- 0.57 mg/ml to 3.25 +/- 1.11 and from 2.93 +/- 0.42 mg/ml to 3.93 +/- 1.41 mg/ml), but the change was not statistically significant. TANS produced substantial symptomatic recovery in nasal obstruction according to patients' daily diary assessments, and significantly improved all objective acoustic rhinometry parameters. CONCLUSIONS: Once-daily intranasal TANS 220 microg effectively controlled nasal obstruction in children with seasonal AR according to subjective and objective assessments, and blocked the increase in BHR to methacholine after high-load natural pollen exposure. There was no correlation between patients' own subjective assessment of nasal obstruction and objective acoustic rhinometric assessment.

Combination therapy with inhaled long-acting beta2-agonists and inhaled corticosteroids: a paradigm shift in asthma management.

Long-acting inhaled beta2-agonists and inhaled corticosteroids are classes of drugs with different mechanisms of action that are commonly used to provide effective long-term control of persistent asthma. Scientific and clinical data support the complementary mechanisms of action of the inhaled corticosteroids and the long-acting beta2-agonists in achieving a superior level of asthma control. In addition, evidence supports significant reductions in exacerbations and effective control of airway inflammation with an inhaled corticosteroid and a long-acting beta2-agonist versus higher dosages of inhaled corticosteroids or combinations of other therapeutic agents with an inhaled corticosteroid. Finally, there are distinct economic advantages to combining an inhaled corticosteroid and a long-acting beta2-agonist in the treatment of asthma relative to other treatment regimens.

A risk-benefit assessment of intranasal triamcinolone acetonide in allergic rhinitis.

The efficacy of intranasal triamcinolone acetonide in seasonal and allergic rhinitis has been evaluated in clinical trials and has been compared with antihistamines and other intranasal corticosteroids. Intranasal corticosteroids are either as equally effective as or more effective than comparative drugs. Intranasal corticosteroids are particularly useful as they decrease membrane permeability and inhibit both early and late phase reactions to allergens. They minimise the nasal secretory response and reduce the sensitivity of local nasal irritant receptors. A potential benefit of topical application is the flushing action of the nasal mucosa, which may reduce allergens and secretions. In addition to seasonal and perennial rhinitis, intranasal corticosteroids have additional benefits when used to reduce inflammation in the treatment of sinusitis and may help in decreasing secondary rhinovirus infections. Furthermore, suboptimal control of asthma can be avoided by treatment of allergic rhinitis with intranasal corticosteroids. In clinical trials, common adverse effects for triamcinolone acetonide include sneezing, dry, mucosa, nasal irritation, sinus discomfort, throat discomfort, epistaxis and headache. Posterior subcapsular cataract formation has not been seen with triamcinolone acetonide. Recent literature evaluating systemic absorption of intranasal corticosteroids have shown surprising results where significant absorption has occurred with intranasal budesonide and fluticasone propionate. Growth and hypothalamic pituitary axis (HPA) function studies have been reviewed, with some intranasal corticosteroids showing changes with continual use. A retrospective study in children receiving daily triamcinolone acetonide for 12 months showed no effect on height and bodyweight. Triamcinolone acetonide at standard dosages (110 or 220microg once or twice a day) does not appear to suppress adrenal gland function and is effective in relieving most symptoms of allergic rhinitis. The International Consensus Conference Proceedings on Rhinitis now currently recommends the use of intranasal corticosteroids as first line therapy, since they have been found to be well tolerated and effective with minimal adverse effects and, specifically, no cognitive impairment. The recommended maximum dose of aqueous triamcinolone acetonide in adults and children is 220microg once a day. The aerosol form may be recommended in children between 7 and 12 years old, up to 440microg once a day or in divided doses. Duration of allergy treatment is generally for the length of each allergy season. If symptoms are perennial, then a reduction of dosage is made to the lowest effective dose with monitoring every 3 months for risk and benefit assessment. Complications to watch for include bleeding, and possible septal perforation and nasal candidiasis, although these are rare.