Topical Placebo Research Articles

Combined micro-needling with topical metformin versus micro-needling with topical placebo in the treatment of melasma: a concurrent split-face study.

Melasma is an acquired dysfunction of melanogenesis, that poses a major therapeutic challenge and tends to recur after therapy. Several combination therapies are being tested nowadays for the treatment of melasma, with promising results. Metformin, an anti-diabetic medication, seems to inhibit melanogenesis by different mechanisms. In addition, there has been a long-term improvement in melasma after microneedle therapy. To evaluate the potential therapeutic role of topical metformin combined with micro-needling for the treatment of melasma. Eighteen patients with melasma received treatment in split-face manner, right side with micro-needling and topical metformin, while the left side was treated with micro-needling and topical placebo for four sessions at 2-week intervals. Hemi-mMASI score was used for the final evaluation of results. ThevariabilitypatterninHemi-mMASI score between both sides revealed significant reduction in the right side (micro-needling + metformin), as compared to the left side (micro-needling + placebo) (2.39 ± 1.42 vs 4.72 ± 1.27, p = 0.001). The effectiveness of topical metformin in the management of melasma could be significantly improved by pretreatment with micro-needling as a combined therapy, without any apparent side effects.

The Effect of Ginkgo Biloba Extract on Oxidative Stress, Anti-Inflammatory and Antiapoptotic in Vitiligo Treated with Topical Desoxymethasone

Vitiligo is a progressive and multifactorial condition of skin, mucosa, and hair depigmentation. Loss of functional melanocytes leads to the appearance of white macules on the skin, often affecting the lips and genitalia. The impact extends to psychological stress, decreased quality of life, and risk of psychiatric morbidity. Various therapeutic strategies have been designed to inhibit the immune response in vitiligo to reduce melanocyte damage while increasing melanocyte repopulation. There is no standardized method of evaluating treatment outcomes in vitiligo patients. Herbal medicines several studies have shown that GB also has many benefits for health and healing skin diseases, one of which is used in treating vitiligo. Therefore, this study aimed to evaluate the potential of Ginkgo biloba extract as a therapeutic supplement in enhancing the positive effects of desoxymethasone on vitiligo. Using a double-blind randomized control trial clinical trial research design, 26 subjects were divided into treatment and control groups. The control group received standard vitiligo therapy with topical desoxymethasone and placebo, while the treatment group received topical desoxymethasone plus Ginkgo biloba extract. Melanin index, VASI score, MDA, TNF-α, CD8 expression, and caspase 3 were measured before and after treatment. The results showed that the administration of Ginkgo biloba extract had a significant effect in reducing MDA, TNF-α, CD8 expression, and caspase 3 levels, and improving melanin index and erythema in vitiligo patients who received topical desoxymethasone therapy. These findings demonstrate the positive potential of Ginkgo biloba extract as an adjunct to vitiligo therapy, resulting in favorable clinical and molecular impacts in patients undergoing combination treatments.

Descemet Endothelial Thickness Comparison Trial II (DETECT II): multicentre, outcome assessor-masked, placebo-controlled trial comparing Descemet membrane endothelial keratoplasty (DMEK) to Descemet stripping only (DSO) with adjunctive ripasudil for Fuchs dystrophy

IntroductionIt remains uncertain whether Descemet membrane endothelial keratoplasty (DMEK) or Descemet stripping only (DSO) yields better outcomes in patients with symptomatic Fuchs endothelial corneal dystrophy (FECD). This paper presents the...

Correlation Between Reduced IL-1β Levels in Acne Lesions and the Decrease in Acne Inflammatory Lesions Following Topical Vitamin D Administration: A Double-Blind Randomized Controlled Trial.

The inflammatory process in acne vulgaris (AV) is characterized by the upregulation of specific pro-inflammatory cytokines, including interleukin (IL)-1β, IL-6, and IL-8, within sebocytes and keratinocytes. Sebocytes have been identified as target cells for bioactive vitamin D. Experimental studies on animal models have demonstrated the potent comedolytic effects of topical vitamin D. However, further research is required to specifically evaluate the impact of vitamin D on inflammatory lesions in acne vulgaris (AV). To evaluate the effectiveness of topical vitamin D in treating acne vulgaris (AV) lesions by investigating its anti-inflammatory effects on pro-inflammatory cytokine modulation, specifically assessing the correlation between IL-1β levels in acne lesions and the reduction in AV severity. This study is a double-blind, randomized, placebo-controlled clinical trial with a 2-arm design over an 8-week intervention period. Participants were randomly assigned to either the topical vitamin D group (cholecalciferol 50 mcg) or the topical placebo group, with each group comprising 32 subjects. All participants received concomitant treatment with topical adapalene 0.1%. Cytokine levels within acne lesions were assessed using Luminex Polystyrene Screening Assays to detect and quantify IL-1β levels. The effectiveness of the treatment was evaluated by monitoring the reduction in the number of inflammatory lesions, while the safety of topical vitamin D was assessed by documenting and analyzing any reported side effects. The study found a significant correlation between the reduction in IL-1β levels within acne lesions and the decrease in moderate and severe inflammatory lesions in acne vulgaris (p = 0.028). The topical application of vitamin D led to a significant reduction in inflammatory AV lesions (p = 0.045). No significant topical side effects were observed in either the vitamin D or placebo groups. This study demonstrates that the topical administration of vitamin D in acne vulgaris (AV) lesions is effective in reducing pro-inflammatory cytokine levels within acne lesions and in decreasing the severity of AV. NCT05758259. September 5, 2022.

Transdermal Carboxytherapy for Treating Vulvovaginal Atrophy: A Pilot Study

Objective: Genitourinary syndrome of menopause (GSM) is a prevalent disorder that can negatively impact the overall health, sexual function, and quality of life of affected women; however, available data do not support specific treatment protocols. A novel product enables the noninvasive transdermal administration of carboxytherapy with a topical gel (CO2Lift®, Lumisque, Inc.; Weston, FL). The following randomized, placebo-controlled pilot study assessed the safety and efficacy of the transdermal carboxytherapy gel for treating GSM-related vulvovaginal changes. Methods: Menopausal or postmenopausal women 40 to 70 years old with signs or symptoms of vulvovaginal atrophy and Female Sexual Dysfunction were randomized to receive topical carboxytherapy gel (n=40) or placebo gel (n=10) in a randomized, double-blind fashion. The assigned treatments were placed into the vagina and on the vulva for 45 minutes before removal. Treatment was applied daily for 5 days, stopped for 2 days, then continued for 5 additional days. Subjects completed four validated pre- and posttreatment questionnaires to assess female sexual function, sexual health, and genital self-image. Additionally, control (n=10) and treatment subjects (n=10) were randomized to undergo 3 mm pre- and posttreatment punch biopsies of vulva and vaginal tissue. Results: Overall, carboxytherapy-treated subjects achieved significant improvements in Female Sexual Function Index scores with strong positive correlations between sexual desire and arousal, arousal and sexual satisfaction, and sexual satisfaction and desire. The Day-to-Day Impact of Vaginal Aging Questionnaire results demonstrated a significant difference in mean pre- and posttreatment values for each assessment among subjects receiving topical carboxytherapy. Biopsy improvements included hyperplasia of the keratinized squamous epithelium, discrete hyperplasia of the basal layer and neovascularization, and increased thickness of mucous squamous epithelium. There were no adverse events. Conclusion: Transdermal carboxytherapy represents a safe, noninvasive means of treating the genitourinary syndrome of menopause symptoms and is suitable for home use. Additional research on this treatment is warranted.

Topical dorzolamide for macular holes: A randomised, double-blind, placebo-controlled trial.

To assess topical dorzolamide as medical therapy for idiopathic full-thickness macular holes (FTMHs). Randomised, double-blinded, placebo-controlled, single-centre clinical trial involving 32 patients with idiopathic small FTMHs (<400 ). Participants in both arms used topical dorzolamide 2% or saline thrice daily for 8 weeks with monthly OCT. Those with persisting FTMH underwent vitrectomy with ILM peel and gas tamponade. The primary outcome was the rate of FTMH closure at the end of treatment. Between 6 March 2020 and 16 June 2023, 32 eligible patients were enrolled: 16 participants in each arm. All participants in both groups were included in the final analysis. At the final visit, 3 of 16 (18.8%) patients in both the topical dorzolamide and placebo group demonstrated closure. There was no statistically significant difference in the proportion of FTMH closure between the control and treatment group (p = 1.00), nor statistically significant difference in the mean change in best corrected visual acuity (BCVA; p = 0.909). There was no difference in the change in FTMH diameter between groups (p = 0.225). No serious adverse events were reported in either group. Topical dorzolamide was safe but not superior to placebo in the functional and anatomical outcomes of FTMH.

Effect of topical brinzolamide on visual function and waveform in patients of infantile nystagmus syndrome: A randomized control trial.

To evaluate the effect of topical carbonic anhydrase inhibitor (brinzolamide) versus placebo on visual function and waveforms in infantile nystagmus syndrome (INS). Prospective, placebo-controlled, double-blind, cross-over study. Setting- A tertiary eye care center. Patients- Cases of idiopathic INS with and without abnormal head posture aged ≥10 years who had not received previous treatment for nystagmus. Intervention- Patients were randomized into two groups. Group 1 was given placebo for 3 months, and after a washout period of 7 days started on topical brinzolamide for the next 3 months. In group 2, the order was reversed. The drops were administered topically three times (every 8 hours) in both eyes. Outcome measure- Binocular best corrected visual acuity (BCVA) using the ETDRS chart, eXpanded nystagmus acuity function (NAFX) score and INS waveforms obtained from eye movement recordings, intraocular pressure (IOP) by Goldmann applanation tonometer, near stereopsis by TNO stereo test, and change in abnormal head posture before and after intervention in the null position. A total of 29 cases completed the study (23 with abnormal head posture; 6 without abnormal head posture). While brinzolamide shows improvement in visual acuity and NAFX score in idiopathic INS, its clinical significance needs further evidence.

Oral and topical analgesia in pediatric electrodiagnostic studies.

Electrodiagnostic examinations, such as nerve conduction studies (NCS) and needle electromyography (EMG), are perceived as painful by children and their parents/guardians. Methods to reduce peri-procedural pain improve compliance and have neurocognitive and neuropsychiatric benefits. This study aimed to assess the efficacy of combined oral and topical analgesics (COTA), oral analgesics (OA), and placebo in reducing pain during NCS/EMG in children. We performed a double-blind, randomized, placebo-controlled trial on children presenting to our neurophysiology lab. Patients were stratified into two age groups (6M-6Y and 7Y-18Y) and randomized into three arms: COTA, OA, and placebo. Pain scores post-NCS/EMG were assessed using the Modified Behavioral Pain Scale (MBPS) and Faces Pain Scale-Revised (FPS-R). One hundred thirteen participants were enrolled. A comparison of participants from both age groups combined revealed no significant differences in guardian FPS-R scores across all arms for NCS and EMG. A significant difference in the distribution of post-NCS FPS-R score severities in children aged 7Y-18Y was noted between OA and placebo (p = .007). EMG was more painful than NCS across all arms (p < .05). In children aged 6M-6Y undergoing at least 10 muscle samplings during EMG, those receiving COTA had significantly lower pain scores (p = .014). This study reveals the complexity of pediatric pain perception during NCS/EMG and highlights that other methods to reduce experienced pain are required. Our findings suggest that procedural characteristics, such as number of muscles sampled, may influence the effectiveness of analgesia and serve as a foundation for future research aimed at optimizing pain management strategies.

Oral Minoxidil vs Topical Minoxidil for Male Androgenetic Alopecia

There has been increased interest in low-dose oral minoxidil for androgenetic alopecia (AGA) treatment. However, the efficacy of oral minoxidil for male AGA is yet to be evaluated in comparative therapeutic trials. To compare the efficacy, safety, and tolerability of daily oral minoxidil, 5 mg, vs twice-daily topical minoxidil, 5%, for 24 weeks in the treatment of male AGA. This double-blind, placebo-controlled randomized clinical trial was conducted at a single specialized clinic in Brazil. Eligible men with AGA aged 18 to 55 years classified using the Norwood-Hamilton scale as 3V, 4V, or 5V were included and randomized. Data were collected from January to December 2021, and data were analyzed from September 2022 to February 2023. Participants were randomized 1:1 into 2 groups: oral minoxidil, 5 mg, daily and topical placebo solution; or 1 mL of topical minoxidil, 5%, twice daily and oral placebo for 24 weeks. The primary outcome was change in terminal hair density on the frontal and vertex regions of the scalp. The secondary outcomes were change in total hair density and photographic evaluation. Among 90 enrolled participants, 68 completed the study; of these, the mean (SD) age was 36.6 (7.8) years. A total of 33 participants were enrolled in the oral minoxidil group and 35 in the topical treatment group. Both groups were homogenous in terms of demographic data and AGA severity. For the frontal area, the mean change from baseline to week 24 between groups was 3.1 hairs per cm2 (95% CI, -18.2 to 21.5; P = .27) for terminal hair density and 2.6 hairs per cm2 (95% CI, -10.3 to 15.8; P = .32) for total hair density. For the vertex area, the mean change from baseline to week 24 was 23.4 hairs per cm2 (95% CI, -0.3 to 43.0; P = .09) for terminal density and 5.5 hairs per cm2 (95% CI, -12.5 to 23.5; P = .32) for total hair density. According to the photographic analysis, oral minoxidil was superior to topical minoxidil on the vertex (24%; 95% CI, 0 to 48; P = .04) but not on the frontal scalp (12%; 95% CI, -12 to 36; P = .24). The most common adverse effects in the oral minoxidil group were hypertrichosis (22 of 45 [49%]) and headache (6 of 45 [14%]). In this study, oral minoxidil, 5 mg, once per day for 24 weeks did not demonstrate superiority over topical minoxidil, 5%, twice per day in men with AGA. Brazilian Registry of Clinical Trials Identifier: RBR-252w9r.

Effectiveness of nanosilver fluoride in arresting dental caries in children with one- year follow-up-a systematic review.

This systematic review assesses the effectiveness of nanosilver fluoride in arresting dental caries in children, with one-year follow-up. Multiple databases were searched for RCTs (randomized controlled trials) according to specified inclusion-exclusion criteria. PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analysis) reporting guidelines were followed to conduct the systematic review. Nanosilver fluoride was compared against silver diamine fluoride varnish or topical fluoride varnish or placebo. The primary outcome was effectiveness in arresting dental caries. The Cochrane risk of bias tool was used to assess the risk of bias. Articles were searched in the following databases: PubMed, Ovid, Web of Science, Wiley Online, Proquest and Cinahl. The initial search yielded a total of 3660 hits. After deduplication, a total of 2507 articles were obtained. After screening the title and abstract, 11 studies were included. After the full-text screening, a total of three articles that fulfilled the eligibility criteria were included in the analyses. All the three studies were RCTs carried out in school children, andinvolved application of the material in primary teeth with a follow-up of one year. In two studies, nanosilver fluoride varnish group showed significantly higher arrest of dental caries compared to placebo group. In the study comparing nanosilver fluoride and silver diamine, both the groups showed arrest of dental caries and there was no significant difference between the groups. One study showed high risk of bias for allocation concealment. The included studies in the final review effectively demonstrated the benefit of using nanosilver fluoride in the arrest of dental caries.

A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Effect of Topical Urea for Secondary Prophylaxis of Hand Foot Skin Reaction in Renal Cell Cancer Patients on Sunitinib Therapy

IntroductionHand foot skin reaction (HFSR) is a common dose-limiting adverse effect of multi kinase inhibitors (MKI) whose mechanism is not fully understood, and the prophylaxis is inadequate. ObjectiveIn this pilot study, a double-blind, randomized placebo-controlled trial was conducted to evaluate the effect of topical urea in secondary prevention of sunitinib-induced HFSR in renal cell cancer patients. MethodsOut of 55 screened patients, 14 were randomized to receive topical urea or placebo for four weeks. The association of HFSR with drug levels of sunitinib and its metabolite (n-desethyl sunitinib), genetic polymorphism of VEGFR2 gene, quality of life (QOL) and biochemical markers was also assessed. ResultsThe results showed that urea-based cream was not superior to placebo (P = .075). There was no change in the QOL in both the groups. Single nucleotide polymorphism was checked for two nucleotides rs1870377 and rs2305948 located in VEGFR2 gene on chromosome 4. SNP (variant T > A) at rs1870377 was associated with appearance of new HFSR as compared to the wild type, although the association was not statistically significant (OR 0.714). There was no statistically significant difference between mean plasma levels of sunitinib and N-desethyl sunitinib in urea arm as compared to placebo arm as compared to placebo. The best fit population pharmacokinetic model for sunitinib was one compartment model with first order absorption and linear elimination. The median (IQR) of population parameters calculated from the population pharmacokinetics model for Ka, V and Cl was 0.22 (0.21-0.24) h-1, 4.4 (4.09-4.47) L, 0.049 (0.042-0.12) L/hr, respectively. ConclusionThe study suggested that the urea-based cream was not superior to placebo in decreasing the appearance of new HFSR in renal cancer patients receiving 4:2 regimen of sunitinib.

Clinical Efficacy and Tolerability of a New Experimental Mucoadhesive Patch for Topical Anesthesia of Oral Mucosa in Pediatric Dentistry.

Background: The injection of local anesthetics is the procedure that still causes the most fear and anxiety in a dental session; to minimize this problem, we can use topical anesthesia. The aim of this study is to analyze the tolerability and the clinical efficacy in the control of pain, during the subsequent injection of the local anesthetic, of an experimental anesthetic patch with a new formulation, which was previously tested in gel formula. Methods: A total of 150 children, aged 4 to 9 years, were included in the study. Each patient was treated using three different pre-anesthesia methods (placebo gel, experimental gel, and experimental patch), according to a split-mouth procedure, within a week of each other. The injection pain was analyzed using the WBFPRS and FLACC scales. Patients' caregivers' satisfaction was recorded at the end of the procedures. The data were analyzed using one-way ANOVA-RM, Wilcoxon-Mann-Whitney, Mann-Whitney U, and χ2 tests. Results: In this study, significantly higher pain ratings were observed with the topical placebo gel and lower pain ratings were observed with the experimental patch. Conclusion: The use of the patch proved to be very effective in reducing pain both subjectively and objectively, in the absence of both local and systemic side effects, validating its use in the oral mucosa.

Topical Diclofenac for Prevention of Capecitabine-Associated Hand-Foot Syndrome: A Double-Blind Randomized Controlled Trial.

Hand-foot syndrome (HFS) is a dose-limiting side effect of capecitabine. Celecoxib prevents HFS by inhibiting cyclooxygenase-2 (COX-2) that is upregulated because of the underlying associated inflammation. However, systemic side effects of celecoxib have limited routine prescription. Topical diclofenac inhibits COX-2 locally with minimal risk of systemic adverse events. Therefore, we conducted this study to assess the efficacy of topical diclofenac in the prevention of capecitabine-induced HFS. In this single-site phase III randomized double-blind trial, we enrolled patients with breast or GI cancer who were planned to receive capecitabine-based treatment. Participants were randomly assigned in a 1:1 ratio to receive topical diclofenac or placebo gel for 12 weeks or until the development of HFS, whichever occurred earlier. The primary end point was the incidence of grade 2 or 3 HFS (Common Terminology Criteria for Adverse Events version 5), which was compared between the two groups using simple logistic regression. In total, 264 patients were randomly assigned to receive topical diclofenac gel (n = 131) or placebo (n = 133). Grade 2 or 3 HFS was observed in 3.8% of participants in the diclofenac group compared with 15.0% in the placebo group (absolute difference, 11.2%; 95% CI, 4.3 to 18.1; P = .003). Grade 1-3 HFS was lower in the diclofenac group than in the placebo group (6.1% v 18.1%; absolute risk difference, 11.9%; 95% CI, 4.1 to 19.6). Capecitabine dose reductions because of HFS were less frequent in the diclofenac group (3.8%) than in the placebo group (13.5%; absolute risk difference, 9.7%; 95% CI, 3.0 to 16.4). Topical diclofenac prevented HFS in patients receiving capecitabine. This trial supports the use of topical diclofenac to prevent capecitabine-associated HFS.

497 - Lebrikizumab in combination with topical corticosteroids maintains improvements in itch and sleep at 68 weeks in patients with moderate-to-severe atopic dermatitis

Abstract Introduction/Background Atopic dermatitis (AD) is a chronic disease affecting children and adults and requires long-term treatment. Moderate-to-severe AD causes itching, which considerably impacts sleep. Interleukin (IL)-13 is the key cytokine in the skin of patients with AD. Lebrikizumab (LEB) is a novel monoclonal antibody that binds with high affinity and slow off-rate to IL-13, thereby blocking the downstream effects of IL-13 with high potency. LEB has demonstrated efficacy and maintained improvement in measures of itch and sleep over 52 weeks in previous phase 3 trials. ADhere (NCT04250337) was a 16-week, randomized, double-blinded, placebo-controlled, phase 3 clinical trial, where patients were treated with LEB and topical corticosteroids (TCS) vs placebo and TCS. LEB responders from ADhere at week 16 were defined as having Investigator’s Global Assessment response of 0 or 1 or reporting 75% improvement from ADhere baseline in Eczema Area and Severity Index who did not use rescue medications. ADhere LEB responders were rerandomized 2:1 into ADjoin (NCT04392154) for blinded treatment with LEB 250 mg every 2 weeks (Q2W) or every 4 weeks (Q4W), respectively, with TCS use as needed, for an additional 100 weeks with itch and sleep data being collected for the first 52 weeks. Objectives The objectives of the study are to report the impact of LEB on itch and sleep improvements over a longer period (68 weeks) in ADhere week 16 LEB responders with moderate-to-severe AD who entered a long-term extension study, ADjoin. Methods Itch was reported using the Pruritus Numeric Rating Scale (NRS), a patient-reported, single-item, daily, 11-point scale, where the minimal clinically important difference (MCID) is 3 points. Sleep loss due to itch was reported using the Sleep-Loss Scale, a patient-reported, single-item, 5-point scale, where the MCID is 1 point. We report ≥3-point improvement in Pruritus NRS among patients with baseline score at least 3, percent change from ADhere baseline (PCFB) in Pruritus NRS, Pruritus NRS (0,1), ≥1-point improvement in Sleep-Loss Scale score among patients with baseline score at least 1, ≥2-point improvement in Sleep-Loss Scale score among patients with baseline score at least 2 and PCFB in Sleep-Loss Scale score. All outcomes were reported at week 52 of ADjoin study, after a total of 68 weeks of LEB treatment. As observed analyses used all data collected. Results At week 68, most patients reported maintaining ≥3-point improvement in Pruritus NRS treated with LEB Q2W (80.6%, 29/36) and LEB Q4W (88.9%, 16/18). Patients treated with LEB Q2W and LEB Q4W reported maintaining 65.3% and 59.4% improvement in Pruritus NRS at week 68 compared to ADhere baseline, respectively. At week 68, 45.9% (17/37) patients in LEB Q2W group and 31.6% (6/19) in LEB Q4W group reached Pruritus NRS of 0 or 1. At week 68, most patients reported maintaining ≥1-point improvement in Sleep-Loss Scale score treated with LEB Q2W (96.9%, 31/32) and LEB Q4W (85.7%, 12/14). Similarly, most patients reported maintaining ≥2-point improvement in Sleep-Loss Scale score treated with LEB Q2W (60.9%, 14/23) and LEB Q4W (75.0%, 6/8). Patients treated with LEB Q2W and Q4W reported maintaining 84.1% and 58.8% improvement in Sleep-Loss Scale score at week 68, respectively, compared to ADhere baseline. Conclusions LEB + TCS maintained itch and sleep improvement at 68 weeks in patients with moderate-to-severe atopic dermatitis.

Efficacy and safety of topical analgesic agents for the treatment of chronic musculoskeletal pain

According to a prior systematic study, systemic NSAIDs effectively ease pain associated with chronic conditions such as osteoarthritis and tendinitis. A new evaluation is required in light of more trials, improved knowledge reclassification of some drugs, and trial quality and bias evaluation. Electronic database searches and letters to manufacturers assisted in finding studies for adults with persistent pain and discovered randomized, double-anonymized studies contrasting topical NSAID with a successful placebo treatment. At two weeks, 50% less pain was an important result; secondary results included local and systemic problems and withdrawals given negative incidents. Utilizing sensitivity and number-needed-to-harm (NNH) analyses as well as estimations of relative benefit, the impacts of reported outcome, trial size, reported trial quality, and condition treated are still assessed. There are 14 studies total, including 12 new trials and 13 trials of an earlier evaluation. Nearly 1,500 patients were involved in 14 double-blind, placebo-controlled studies. With a relative benefit of 1.9 and an NNT of 4.6, topical NSAID considerably outperformed a placebo. The trial's validity, quality, and size, a given outcome, treated affect findings. There was no difference in effectiveness between oral and topical NSAIDs in three studies, including 764 participants. Topical NSAIDs and placebos caused 6% of local adverse events, 3% of systemic adverse events, and patient withdrawals because of adverse events. Topically applied NSAIDs for two weeks offered a secure and effective treatment for long-term musculoskeletal conditions. Larger and longer studies are required to explain a part of topical NSAIDs in healthcare properly.

Descemet Endothelial Thickness Comparison Trial 1 (DETECT 1): outcome masked, placebo-controlled trial comparing two types of corneal transplant surgeries and effect of rho kinase inhibitors on endothelial cell loss protocol

BackgroundIt remains uncertain which endothelial keratoplasty (EK) technique yields the best outcomes while maintaining safety, particularly in eyes with coexisting ocular conditions. Moreover, the impact of endothelial cell loss (ECL)...

The Analgesic Efficacy of Lidocaine/Prilocaine Cream during Fine-needle Aspiration Biopsy of Thyroid Nodules: A Randomized Double-blind Clinical Trial

Introduction: Fine-needle aspiration biopsy (FNAB) method is an effective method in diagnosis and approach to patients with thyroid nodules that create pain. This study investigates the analgesic effect of lidocaine/prilocaine cream during fine-needle aspiration (FNA) of thyroid nodules to reduce discomfort in patients during the procedure. Materials and Methods: In a double-blind clinical trial, two groups including patients with thyroid nodules who were rubbed with lidocaine + prilocaine 5% on their skin before FNA and patients with thyroid nodules, who have had topical placebo cream applied to their skin before FNA, were recruited. The Numerical Rating Scale was used to check the pain level. The Chi-square test, Fisher’s exact test, independent t-test, and Mann–Whitney’s nonparametric test were used for data analysis in SPSS software. Results: The average pain sensation in the intervention group is lower than the scores obtained in the control group, but despite the existing difference, this difference was not statistically significant (P = 0.7). The investigations showed that with the increase in the size and diameter of the thyroid nodules, the amount of pain that the patient feels during the procedure is reduced. Moreover, increasing the size of the nodule significantly reduces the amount of pain felt by the patient in the intervention group (P = 0.04). Conclusion: The results of this study indicated that the use of lidocaine/prilocaine cream in patients who are candidates for thyroid nodule biopsy did not have a significant effect on reducing their pain in contrast with literature. Therefore, based on the findings of the study, the use of lidocaine/prilocaine cream in these patients does not offer any significant decrease in pain sensation compared to using just a placebo.

Treatments for alopecia areata: a network meta-analysis.

Treatments for alopecia areata: a network meta-analysis.

The efficacy of Nigella sativa L. oil on serum biomarkers of inflammation and oxidative stress and quality of life in patients with knee osteoarthritis: A parallel triple-arm double-blind randomized controlled trial.

The aim of this double-blind clinical trial was to investigate the effects of Nigella sativa oil on serum inflammatory and oxidative stress biomarkers and quality of life in patients with knee osteoarthritis (OA). Forty-five patients who met the eligibility criteria were randomly divided into three groups with a ratio of 1:1:1. The first group received 2.5 mL oral N. sativa oil twice/day plus placebo topical oil, the second group received 2.5 mL topical N. sativa oil three times/day plus placebo oral oil, and the third group received oral and topical oil placebos. There were no intergroup differences in baseline characteristics. After 6 weeks of supplementation, oral N. sativa caused a significant improvement in the serum levels of hs-CRP (p = .003), MDA (p = .003), and TAC (p = .001). Oral N. sativa oil compared to placebo (aMD (95% CI): -0.81 (-1.45 to -0.19); p = .012) and topical N. sativa oil [aMD (95% CI): -0.76 (-1.38 to -0.15); p = .016] significantly reduced hs-CRP serum levels. Significant improvements were observed in the general, physical, and mental health subscales in the oral and topical N. sativa oil compared to the placebo group (p < .05). The six-week oral N. sativa oil supplementation was effective in improving inflammatory biomarkers in knee OA. Both oral and topical N. sativa oil increased the quality of life.

Effect of Topical Nonsteroidal Anti-inflammatory Drugs Around the Incision on Postoperative Pain in Transforaminal Lumbar Interbody Fusion Surgery: A Double-blind Randomized Controlled Trial

BACKGROUND: How to minimize postoperative pain following spinal surgery has been a great challenge. We hypothesized that topical nonsteroidal anti-inflammatory drugs (NSAIDs) around the incision could relieve postoperative pain following transforaminal lumbar interbody fusion (TLIF) surgery. OBJECTIVE: This study tested the effect of topical NSAIDs around the incision for pain management after TLIF surgery. STUDY DESIGN: A double-blind randomized controlled trial. SETTING: Qilu Hospital of Shandong University. METHODS: Eighty patients who underwent single-level TLIF surgery were randomized into 2 groups. The treatment group received postoperative topical NSAIDs around the incision. The control group received a postoperative topical placebo around the incision. All patients in both groups received postoperative patient-controlled analgesia (PCA) via an analgesia pump. The primary outcome measures were the amount of opioid consumption and pain measurement via the visual analog scale (VAS). The secondary outcome measures were the time of first analgesic demand, operation time, postoperative drain output, side effects of opioids, postoperative stay, and Oswestry Disability Index (ODI) score. RESULTS: The consumption of opioids in the treatment group was significantly less than in the control group at postoperative 12 hours, 12 to 24 hours, and 24 to 48 hours (P &lt; 0.005). The VAS in the treatment group was significantly lower than those in the control group at all assessment times within 72 hours postoperative (P &lt; 0.005). The time of first analgesic demand of PCA in the treatment group was significantly longer than that in the control group (P &lt; 0.005). The side effects of opioids were significantly less in the treatment group than in the control group (P &lt; 0.05). There was no significant difference in operation time, postoperative drain output, postoperative stay, and ODI between the 2 groups (P &gt; 0.05). LIMITATIONS: This was a single-center study for single-level TLIF surgery. CONCLUSION: Postoperative topical NSAID around the incision is a highly effective and safe method for postoperative pain management following single-level TLIF surgery. In our study it reduced postoperative opioid requirements and prolonged the time of first analgesic demand with no increased side effects. KEY WORDS: Transforaminal lumbar interbody fusion, postoperative pain, NSAID, topical NSAID, nonsteroidal anti-inflammatory drug, loxoprofen