Efficacy of hypertonic dextrose injection (prolotherapy) in temporomandibular joint dysfunction: a systematic review and meta-analysis.

Hypertonic dextrose prolotherapy (DPT) has been reported to be effective for temporomandibular disorders (TMDs) in clinical trials but its overall efficacy is uncertain. To conduct a systematic review with meta-analysis of randomized controlled trials (RCTs) to synthesize evidence on the effectiveness of DPT for TMDs. Eleven electronic databases were searched from their inception to October, 2020. The primary outcome of interest was pain intensity. Secondary outcomes included maximum inter-incisal mouth opening (MIO) and disability score. Studies were graded by "Cochrane risk of bias 2" tool; if data could be pooled, a meta-analysis was performed. Ten RCTs (n = 336) with some to high risk of bias were included. In a meta-analysis of 5 RCTs, DPT was significantly superior to placebo injections in reducing TMJ pain at 12 weeks, with moderate effect size and low heterogeneity (Standardized Mean Difference: - 0.76; 95% CI - 1.19 to - 0.32, I2 = 0%). No statistically significant differences were detected for changes in MIO and functional scores. In this systematic review and meta-analysis, evidence from low to moderate quality studies show that DPT conferred a large positive effect which met criteria for clinical relevance in the treatment of TMJ pain, compared with placebo injections.Protocol registration at PROSPERO: CRD42020214305.

Treatment of Chylothorax complicating pulmonary resection with hypertonic glucose Pleurodesis.

BACKGROUND: To retrospectively assess the efficacy of hypertonic glucose pleurodesis for treatment of chylothorax after pulmonary resection. METHODS: Out of a total of 8252 patients who underwent pulmonary resection (at least lobectomy) at department of thoracic surgery, between June 2008 and December 2015, 58 patients (0.7%) developed postoperative chylothorax. All patients received conservative treatment, including thoracic closed drainage, oral fasting, and total parenteral nutrition. RESULTS: Conservative treatment was successful in 50 (86.2%) patients, while eight patients [mean age: 58.0 years (range, 45-75)] were treated with hypertonic glucose pleurodesis. All eight patients had undergone operation for lung cancer (four squamous cell carcinomas and four adenocarcinomas). The bronchial stump was covered by pleural flap in three patients. After pleurodesis, three patients developed fever but without empyema; thoracentesis was performed in two patients. The mean time interval between pleurodesis and operation was 4.3 days (range,3-5) days. The average length of stay was 23.1 days (range, 18-31). No recurrent pleural effusion was observed over a mean follow-up duration of 28 months. CONCLUSION: Hypertonic glucose pleurodesis performed via the chest drainage tube is a viable treatment option for chylothorax after lung resection, prior to resorting to a thoracoscopic or thoracotomic ductus thoracicus ligation of the thoracic duct leak. It is a simple, safe and efficient modality associated with rapid recovery and less pain.

Efficacy of Intra-Articular Hypertonic Dextrose (Prolotherapy) for Knee Osteoarthritis: A Randomized Controlled Trial.

PURPOSE: To test the efficacy of intra-articular hypertonic dextrose prolotherapy (DPT) vs normal saline (NS) injection for knee osteoarthritis (KOA). METHODS: A single-center, parallel-group, blinded, randomized controlled trial was conducted at a university primary care clinic in Hong Kong. Patients with KOA (n = 76) were randomly allocated (1:1) to DPT or NS groups for injections at weeks 0, 4, 8, and 16. The primary outcome was the Western Ontario McMaster University Osteoarthritis Index (WOMAC; 0-100 points) pain score. The secondary outcomes were the WOMAC composite, function and stiffness scores; objectively assessed physical function test results; visual analogue scale (VAS) for knee pain; and EuroQol-5D score. All outcomes were evaluated at baseline and at 16, 26, and 52 weeks using linear mixed model. RESULTS: Randomization produced similar groups. The WOMAC pain score at 52 weeks showed a difference-in-difference estimate of -10.34 (95% CI, -19.20 to -1.49, P = 0.022) points. A similar favorable effect was shown on the difference-in-difference estimate on WOMAC function score of -9.55 (95% CI, -17.72 to -1.39, P = 0.022), WOMAC composite score of -9.65 (95% CI, -17.77 to -1.53, P = 0.020), VAS pain intensity score of -10.98 (95% CI, -21.36 to -0.61, P = 0.038), and EuroQol-5D VAS score of 8.64 (95% CI, 1.36 to 5.92, P = 0.020). No adverse events were reported. CONCLUSION: Intra-articular dextrose prolotherapy injections reduced pain, improved function and quality of life in patients with KOA compared with blinded saline injections. The procedure is straightforward and safe; the adherence and satisfaction were high.

Hematological complications under hyper conditions of glucose and distilled water.

This work presents a pilot method of hematological diagnosis about changes in: shape, size and rouleaux formation, cell count of leucocytes and platelet cells in the presence of different glucose [C6H12O6] and water [H2O] concentrations. The 2D microscopic images after addition of ten different glucose concentrations to normal blood (0 mM- 450 mM) revealed the lyses (disintegration) of white blood cells (WBCs). This work provides a baseline to diagnose blood disorders and complications at labs and clinical environment.

Prospective Evaluation of Atrophic Acne Scars on the Face With Needle-Free High-Pressure Pneumatic Injection: Quantitative Volumetric Scar Improvement.

BACKGROUND: Atrophic acne facial scars still pose a treatment challenge. Needle-free high-pressure pneumatic injection has recently been introduced; however, few studies exist regarding its effectiveness. OBJECTIVE: To evaluate the efficacy and safety of pneumatic injection for treating atrophic acne scars using a 3-dimensional optical profiling system. METHODS AND MATERIALS: A pneumatic injection device with a 0.2-mm nozzle diameter, 50% pressure power, and 85-µL injection volume was used. The degree of depression was examined and analyzed using a 3-dimensional optical profiling system and clinical photographs. The patients also evaluated any side effects. Each subject underwent a single treatment session and was followed up after 1 and 2 months. RESULTS: A total of 13 atrophic acne scars from 10 Korean men and women aged 20 to 29 (mean age 25.8 ± 2.4) years were studied. The mean scar volume values were 0.964, 0.741, and 0.566 mm, respectively, at baseline, 1 month, and 2 months after the injection. Scar volumes after 2 months were significantly different compared with baseline volumes. However, there was no significant difference between the baseline and 1-month volumes. CONCLUSION: Treatment with pneumatic injection is safe and effective in reducing atrophic acne facial scars; it results in quantitative improvement in scar volumes.

Split-face comparison study of transcutaneous pneumatic injection therapy with isotonic and hypertonic glucose solutions.

BACKGROUND: Transcutaneous pneumatic injection (TPI) is a minimally invasive, needle-free modality that can be used to forcefully deliver solution into soft tissues of the face and scalp. OBJECTIVE: To evaluate the effects of TPI of 5% isotonic and 20% hypertonic glucose solutions in in vivo human skin for face lifting. METHODS AND MATERIALS: A prospective, split-face, evaluator-blinded comparison study was performed on 10 Korean participants who were treated with three sessions of TPI using 5% isotonic and 20% hypertonic glucose solutions. RESULTS: The following assessment parameters were improved after TPI therapy using 5% isotonic glucose solution in descending order of mean global aesthetic improvement scale (GAIS) score: perioral expression wrinkles, zygomatic wrinkles or mid-cheek furrows, eyebrow ptosis, jowl sagging, marionette line, horizontal forehead lines, nasolabial folds, and blepharochalasis. Meanwhile, TPI therapy using 20% hypertonic glucose solution improved the following assessment parameters: zygomatic wrinkles or mid-cheek furrows, perioral expression wrinkles, eyebrow ptosis, blepharochalasis, marionette line, jowl sagging, nasolabial folds, and horizontal forehead lines. Linear mixed models revealed a significant interaction between treatment groups and time. CONCLUSION: Our data demonstrated that TPI treatment with 20% hypertonic glucose solution elicited earlier and more pronounced therapeutic responses, compared to 5% isotonic glucose solution.

The efficacy of dextrose prolotherapy over placebo for temporomandibular joint hypermobility: A systematic review and meta-analysis.

OBJECTIVE: The aim of the systematic review was to analyse the available evidence in order to assess the efficacy of dextrose prolotherapy in improving outcomes in temporomandibular joint (TMJ) hypermobility patients as compared to placebo. METHODS: An electronic search of PubMed, Scopus, CENTRAL and Google scholar databases was performed for English language papers published up to February 2018. Randomised clinical trials (RCTs) and controlled clinical trials (CCTs) comparing dextrose prolotherapy with placebo for TMJ hypermobility were included. RESULTS: Three RCTs were included in the review. Frequency of subluxation/dislocation was reported by two trials which found no difference between dextrose and placebo. A statistical significant difference in reduction of MMO with the use of dextrose prolotherapy was seen on pooling of data (random: MD = -3.32, 95% CI -5.26 to -1.28; P = 0.0008; I2  = 0%). A statistical significant difference in pain reduction was also seen with dextrose as compared to placebo (random: MD = -1, 95% CI -1.58 to -0.42; P = 0.0007; I2  = 0%). CONCLUSION: Within the limitations of the study, dextrose prolotherapy may cause significant reduction in mouth opening and pain associated with TMJ hypermobility. Conclusions with regard to reduction of episodes of subluxation/dislocation cannot be drawn. There is a need of more high-quality RCTs with larger sample size and homogenous prolotherapy protocol to draw stronger conclusions on the effect of dextrose prolotherapy in patients with TMJ hypermobility.

A novel combination regimen with intense focused ultrasound and pressure- and dose-controlled transcutaneous pneumatic injection of hypertonic glucose solution for lifting and tightening of the aging face.

BACKGROUND: Intense focused ultrasound (IFUS) has demonstrated moderate efficacy for facial laxity of the aging face. Pressure- and dose-controlled transcutaneous pneumatic injections of hypertonic glucose solution (TPIG) are a minimally invasive way to deliver solution into the skin for therapeutic purposes. Recently, its application around temporal areas is known to exert early-onset lifting effects with facial contour rejuvenation. AIMS: We sought to evaluate the safety and efficacy of this novel combination regimen with IFUS and TPIG for lifting and tightening of aging face. PATIENTS AND METHODS: Twenty-two Korean subjects with mild-to-moderate facial skin laxity were evaluated after receiving a sequential single session of IFUS and TPIG treatments. Dermatologists' objective assessments for general appearance, and mid- and low faces based on photographic images were performed at 1- and 12-week post-treatment follow-ups. Patients' subjective assessments were also conducted. Skin biopsies were taken at baseline and the last visit. RESULTS: Among 22 subjects, twenty (91%) demonstrated improvement after 12-week follow-up. We also observed similarly improved state just after 1 week of treatments (82%: 18/22). Specifically, improvement of the mid-face was evident from the first week, while the progress of the low face improvement was observed at the twelve week. Subjective assessments paralleled these findings. No seriously adverse effect was observed during procedures. Histologic evaluation showed greater dermal collagen fibers throughout the dermis after treatments. CONCLUSION: Combination treatment with IFUS and TPIG has beneficial effects for skin lifting and tightening with early-onset time.

Sclerotherapy for Reticular Veins in the Lower Limbs: A Triple-Blind Randomized Clinical Trial.

Importance: Reticular veins are subdermal veins located in the lower limbs and are mainly associated with aesthetic complaints. Although sclerotherapy is the treatment of choice for reticular veins in the lower limbs, no consensus has been reached regarding to the optimal sclerosant. Objective: To compare the efficacy and safety of 2 sclerosants used to treat reticular veins: 0.2% polidocanol diluted in 70% hypertonic glucose (HG) (group 1) vs 75% HG alone (group 2). Design, Setting, and Participants: Prospective, randomized, triple-blind, controlled, parallel-group clinical trial with patients randomly assigned in a 1:1 ratio between the 2 treatment groups from March through December 2014, with 2 months' follow-up. The study was conducted in a single academic medical center. Eligible participants were all women, aged 18 to 69 years, who had at least 1 reticular vein with a minimum length of 10 cm in 1 of their lower limbs. Interventions: The patients underwent sclerotherapy in a single intervention with either 0.2% polidocanol plus 70% HG or 75% HG alone to eliminate reticular veins. Main Outcomes and Measures: The primary efficacy end point was the disappearance of the reticular veins within 60 days after treatment with sclerotherapy. The reticular veins were measured on images obtained before treatment and after treatment using ImageJ software. Safety outcomes were analyzed immediately after treatment and 7 days and 60 days after treatment and included serious adverse events (eg, deep vein thrombosis and systemic complications) and minor adverse events (eg, pigmentation, edema, telangiectatic matting, and hematomas). Results: Ninety-three women completed the study, median (interquartile range) age 43.0 (24.0-61.0) years for group 1 and 41.0 (27.0-62.0) years for group 2. Sclerotherapy with 0.2% polidocanol plus 70% HG was significantly more effective than with 75% HG alone in eliminating reticular veins from the treated area (95.17% vs 85.40%; P < .001). No serious adverse events occurred in either group. Pigmentation was the most common minor adverse event, with a 3.53% treated-vein pigmentation length for group 1 and 7.09% for group 2, with no significant difference between the groups (P = .09). Conclusions and Relevance: Sclerotherapy with 0.2% polidocanol diluted in 70% HG was superior to 75% HG alone in sclerosing reticular veins, with no statistical difference for complications. Pigmentation occurred in both groups, with no statistical difference between them. No serious adverse events occurred in either group. Trial Registration: clinicaltrials.gov Identifier: NCT02054325.

No increase in small-solute transport in peritoneal dialysis patients treated without hypertonic glucose for fifty-four months.

BACKGROUND: Glucose is widely used as an osmotic agent in peritoneal dialysis (PD), but exerts untoward effects on the peritoneum. The potential protective effect of a reduced exposure to hypertonic glucose has never been investigated. METHODS: The cohort of PD patients attending our center which tackled the challenge of a restricted use of hypertonic glucose solutions has been prospectively followed since 1992. Small-solute transport was assessed using an equivalent of the glucose peritoneal equilibration test after 6 months, and then every year. Study was stopped on July 1st, 2008, before use of biocompatible solutions. Repeated measures in patients treated with PD for 54 months were analyzed by using (1) the slopes of the linear regression for D4/D0 ratios over time computed for each individual, and (2) a linear mixed model. RESULTS: In the study period, 44 patients were treated for a total of 2376 months, 2058 without hypertonic glucose. There was one episode of peritoneal infection every 18 patient-months. The mean of slopes of the linear regression for D4/D0 ratios was found to be significantly positive (Student's test, p < .001) and the results of the mixed model reflected a similar significant increase for D4/D0 ratios over time. These results reflected a significant decrease of small-solute transport. CONCLUSION: In this large series, minimizing the use of hypertonic glucose solutions was associated in patients on long term PD with an overall decrease of small-solute transport within 54 months, despite a high rate of peritoneal infection.

Pressure- and dose-controlled transcutaneous pneumatic injection of hypertonic glucose solution for the treatment of atrophic skin disorders.

BACKGROUND: Needleless transcutaneous pneumatic injections (TPIs) are a minimally invasive way to deliver the solution into the skin for therapeutic purposes. The suggested action mechanisms of TPI therapy include mechanical stimulation, immediate tissue shrinkage and late wound healing. METHODS: Thirteen Korean patients were treated with TPI for atrophic skin disorders, including acne scars, striae albae, post-furuncle, or carbuncle scars, and horizontal wrinkles with lipoatrophy. At each TPI treatment session, a single pass was made along with the atrophic skin lesions without overlapping. Thereafter, two dermatologists objectively evaluated the clinical improvement in the lesions in the photographs via the global aesthetic improvement scale (GAIS). RESULTS: One month after the final treatment, the overall mean GAIS score was 2.3 ± 0.8. Six of the 13 (46.2%) patients exhibited clinical improvement of grade 3, five (38.5%) patients grade 2 and two (15.4%) patients grade 1. The overall mean subjective satisfaction score with the TPI treatment was 2.3 ± 0.9. Six of the 13 (46.2%) patients achieved subjective satisfaction of grade 3, six (46.2%) patients grade 2 and one (7.7%) patient grade 0. CONCLUSIONS: The present study demonstrated that the TPI treatment is effective and safe for treating atrophic skin disorders of varying causes in Korean patients.

D10 in the Treatment of Prehospital Hypoglycemia: A 24 Month Observational Cohort Study.

INTRODUCTION: Prehospital first responders historically have used an IV bolus of 50 mL of 50% dextrose solution (D50) for the treatment of hypoglycemia in the field. A local Emergency Medical Services (EMS) system recently approved a hypoglycemia treatment protocol of IV 10% dextrose solution (D10) due to occasional shortages and higher cost of D50. We use the experience of this EMS system to report the feasibility, safety, and efficacy of this approach. METHODS: Over the course of 104 weeks, paramedics treated 1,323 hypoglycemic patients with D10 and recorded patient demographics and clinical outcomes. Of these, 1,157 (87.5%) patients were treated with 100 mL of D10 initially upon EMS arrival, and full data on response to treatment was available on 871 (75%) of these 1,157. We captured the 871 patients' capillary glucose response to initial infusion of 100 mL of D10 and fit a linear regression line between elapsed time and difference between initial and repeat glucose values. We also explored the need for repeat glucose infusions as well as feasibility, and safety. RESULTS: The study cohort included 469 men and 402 women with a median age of 66. The median initial field blood glucose was 37 mg/dL, while the subsequent blood glucose had a median of 91 mg/dL. The median time to second glucose testing was eight minutes after beginning the 100mL D10 infusion. Of 871 patients, 200 (23.0%) required an additional dose of IV D10 solution due to persistent or recurrent hypoglycemia and seven (0.8%) patients required a third dose. There were no reported deaths or other adverse events related to D10 administration for hypoglycemia. Linear regression analysis of elapsed time and difference between initial and repeat glucose values showed near-zero correlation. CONCLUSIONS: The results of one local EMS system over a 104-week period demonstrate the feasibility, safety, and efficacy of using 100 mL of D10 as an alternative to D50. D50 may also have theoretical risks including extravasation injury, direct toxic effects of hypertonic dextrose, and potential neurotoxic effects of hyperglycemia. Additionally, our data suggest that there may be little or no short-term decrease in blood glucose results after D10 administration.

Hyperglycemia and subsequent torsades de pointes with marked QT prolongation during refeeding.

OBJECTIVE: A fatal cardiac complication can occasionally present in malnourished patients during refeeding; this is known as refeeding syndrome. However, to our knowledge, hyperglycemia preceding torsades de pointes with QT prolongation during refeeding has not been reported. In the present study, we present a case in which hyperglycemia preceded torsades de pointes with QT prolongation during refeeding. The aim of this study was to determine the possible mechanism underlying QT prolongation during refeeding and indicate how to prevent it. METHODS: A 32-y-old severely malnourished woman (body mass index 14.57 kg/m2) was admitted to the intensive care unit of our institution after resuscitation from cardiopulmonary arrest due to ventricular fibrillation. She was diagnosed with anorexia nervosa. Although no obvious electrolyte abnormalities were observed, her blood glucose level was 11 mg/dL. A 12-lead electrocardiogram at admission showed sinus rhythm with normal QT interval (QTc 0.448). RESULTS: Forty mL of 50% glucose (containing 20 g of glucose) was intravenously injected, followed by a drip infusion of glucose to maintain blood glucose level within normal range. After 9 h, the patient's blood glucose level increased to 569 mg/dL. However, after 38 h, an episode of marked QT prolongation (QTc 0.931) followed by torsades de pointes developed. CONCLUSIONS: Hyperglycemia during refeeding can present with QT prolongation; consequently, monitoring blood glucose levels may be useful in avoiding hyperglycemia, which can result in QT prolongation. Furthermore, additional monitoring of QT intervals using a 12-lead electrocardiogram should allow the early detection of QT prolongation when glucose solution is administered to a malnourished patient with (severe) hypoglycemia.

Hypertonic dextrose injections (prolotherapy) in the treatment of symptomatic knee osteoarthritis: A systematic review and meta-analysis.

Hypertonic dextrose injections (prolotherapy) is an emerging treatment for symptomatic knee osteoarthritis (OA) but its efficacy is uncertain. We conducted a systematic review with meta-analysis to synthesize clinical evidence on the effect of prolotherapy for knee OA. Fifteen electronic databases were searched from their inception to September 2015. The primary outcome of interest was score change on the Western Ontario and McMaster Universities Arthritis Index (WOMAC). Three randomized controlled trials (RCTs) of moderate risk of bias and one quasi-randomized trial were included, with data from a total of 258 patients. In the meta-analysis of two eligible studies, prolotherapy is superior to exercise alone by a standardized mean difference (SMD) of 0.81 (95% CI: 0.18 to 1.45, p = 0.012), 0.78 (95% CI: 0.25 to 1.30, p = 0.001) and 0.62 (95% CI: 0.04 to 1.20, p = 0.035) on the WOMAC composite scale; and WOMAC function and pain subscale scores respectively. Moderate heterogeneity exists in all cases. Overall, prolotherapy conferred a positive and significant beneficial effect in the treatment of knee OA. Adequately powered, longer-term trials with uniform end points are needed to better elucidate the efficacy of prolotherapy.

Assessing ureteral patency using 10% dextrose cystoscopy fluid: evaluation of urinary tract infection rates.

BACKGROUND: Intravenous indigo carmine has routinely been used to confirm ureteral patency after urogynecologic surgery. Recent discontinuation of the dye has altered clinical practice. In the absence of indigo carmine, we have used 10% dextrose in sterile water (D10) as cystoscopic fluid to evaluate ureteral patency. Glucosuria has been associated with urinary tract infection (UTI) in vivo and significantly enhanced bacterial growth in vitro. The concern is that the use of D10 would mimic a state of glucosuria albeit transient and increase the risk of postoperative UTI. OBJECTIVES: The objectives of this study were to compare the rates of postoperative UTI and lower urinary tract (LUT) injuries between patients who underwent instillation of D10 vs normal saline at the time of intraoperative cystoscopy after urogynecological surgery. STUDY DESIGN: This was a retrospective cohort study of all women who underwent cystoscopic evaluation of ureteral patency at the time of urogynecological surgery from May through December 2014 at a tertiary care referral center. We compared patients who received D10 cystoscopy fluid vs those who used normal saline. Outcomes included UTI and diagnosis of ureteral or LUT injuries. UTI was diagnosed according to Centers for Disease Control and Prevention guidelines by symptoms alone, urine dipstick, urinalysis, or urine culture. Descriptive statistics compared the rates of UTI between the 2 groups, and a multivariable model was fit to the data to control for potential confounders and significant baseline differences between the groups. RESULTS: A total of 303 women were included. D10 was used in 113 cases and normal saline (NS) was used in 190. The rate of UTI was higher in the D10 group than the NS group: 47.8% (95% confidence interval [CI], 38.3-57.4) vs 25.9% (95% CI, 19.8-32.8, P < .001). After adjusting for age, pelvic organ prolapse stage, use of perioperative estrogen, days of postoperative catheterization, menopausal status, diabetes mellitus, and history of recurrent UTI, the UTI rate remained significantly higher with the use of D10 (adjusted odds ratio, 3.4 [95% CI, 1.6-7.5], P = .002) compared with NS. Overall, 3 cases of transient ureteral kinking (1.0%) and one cystotomy (0.3%) were identified intraoperatively. However, ureteral and LUT injuries were not different between groups. No unidentified injuries presented postoperatively. CONCLUSION: Although the use of D10 cystoscopy fluid has been successful in identifying ureteral patency in the absence of indigo carmine, it is associated with an increased rate of postoperative UTI compared with NS.

Hypo and hyperglycemia among tramadol overdose patients in Loghman Hakim Hospital, Tehran, Iran.

Tramadol is a synthetic and centrally active analgesic. Hypoglycemia as another possible major side effect among abusers has not been known well. Our objective is evaluation of the Blood Glucose Level (BGL) among tramadol-overdosed patients. This prospective cross-sectional study was performed from Feb to June 2013; BGL was measured at the time of admission, 8 and 12 hours later. All patients with hypoglycemia received infusion of 0.5-1 gr/kg of hypertonic dextrose and their BGL was checked every hour until normal BGL. Patients' demographic, clinical and paraclinical data were collected. Totally, 128 patients with a mean (SD) age of 24.5 (6.9) years were recruited; 127 (99.2%) were male. Seizure occurred in 59.4% cases. Mean ± SD admission BGL was 94.88 ± 21.5mg/dL. Fourteen patients experienced hypoglycemia within 12 hours period. Hyperglycemia was experienced in 8 patients (6.25%) on admission day. There was no significant relation between the dose of tramadol and BGL. In conclusion, hypoglycemia must be considered as an important side effect of tramadol-overdose. It is suggested that serial BGL monitoring in cases of Tramadol-overdose should be done for early recognition of hypoglycemia and its timely management. Also hyperglycemia may be revealed.

Polidocanol versus hypertonic glucose for sclerotherapy treatment of reticular veins of the lower limbs: study protocol for a randomized controlled trial.

BACKGROUND: The prevalence of chronic venous disease is high and occurs more frequently in females. According to the clinical, etiological, anatomical, and pathological classification (CEAP) definition, the reticular veins are included in the C1 class and are mainly associated with aesthetic complaints. Several invasive techniques are used for treatment, including mini phlebectomy, laser ablation, and radiofrequency ablation. However, a wide range of sclerosing agents may serve as minimally invasive alternatives, promoting chemical sclerosis of the vein wall. Although this technique is routinely performed around the world, there is no consensus on the most efficacious and safe chemical agent to be used. METHODS/DESIGN: Inclusion criteria are women between 18 and 69 years old with at least 10 cm long reticular veins in the lower limbs, on the outer side of the leg/thigh. Patients with CEAP 2 to 6, or with allergies, pregnancy, performing breastfeeding, or with any dermatologic or clinical problems will be excluded. Patients with venous ultrasound mapping showing involvement of saphenous trunks and/or a deep venous system will also be excluded. Patients will be randomized into two groups, one receiving 75% pure glucose and the other group receiving 0.2% polidocanol diluted in 70% glucose. Just one limb and one session per patient will be performed. The sclerosing agent volume will not exceed 5 mL. Clinical follow-up will include visits on days 7 and 60, always with photographic documentation. DISCUSSION: This project aims to enroll 96 patients and subject them to a double-blind treatment after the randomization process. The design is intended to evaluate efficacy through a primary end point and safety through a secondary end point. Forty-eight patients have currently been enrolled. Preliminary results for these patients showed that 25 received treatment, 2 were excluded, and 22 returned after 7 days and showed no greater adverse events. To date, establishing efficacy criteria has not been possible, and no patients have reached the 60-day return point. These data may help doctors choose the best chemical agent for the treatment of reticular veins. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02054325, 3/02/2014.