食管静脉曲张套扎术和β-受体阻滞剂预防肝硬化初次出血的Meta分析

目的评价食管静脉曲张套扎术(EVL)和β-受体阻滞剂(BB)预防肝硬化初次静脉破裂出血的有效性和安全性。方法计算机检索Cochrane临床对照试验资料库(2006年第4期)、MEDLINE(1966年至2006年11月)、EMBASE(1985年至2006年11月)和中国期刊全文数据库(1994—2006年),并辅以手工检索有关EVL和BB预防食管静脉曲张初次破裂出血的随机对照临床试验,按Cochrane协作网推荐的方法进行Meta分析。结果共纳入8个随机对照试验(RCT)。Meta分析结果显示,EVL和BB比较,EVL可降低肝硬化初次静脉破裂出血的发生率[相对危险度(RR)=0.63,95%可信区间(CI):0.46~0.85;P=0.003;相对危险度减少(RRR)=0.37,需要治疗的患者数(NNT)为12例]和严重副反应发生率(RR=0.23,95%CI:0.12~0.43;P<0.01;RRR=0.77,NNT为8例);但二者对总病死率的影响差异无显著性意义(RR=1.03,95%CI:0.81~1.31;P=0.82)。结论预防肝硬化初次静脉破裂出血EVL比BB更有效和安全。     

Endoscopic variceal band ligation compared with propranolol for prophylaxis of first variceal bleeding

Administration of nonselective beta-blockers in prophylaxis of first variceal bleeding is not suitable for all patients. Thus, we evaluated endoscopic variceal band ligation (EVBL) in primary prevention of bleeding in patients with cirrhosis and large esophageal varices. A total of 73 consecutive patients with liver cirrhosis and large esophageal varices without a history of gastrointestinal bleeding were randomized to receive either EVBL or propranolol and were followed for up to 18 months. Forty patients underwent EVBL and 33 patients received propranolol. Variceal bleeding occurred in 2 patients in the EVBL (5%) and in 2 patients in the propranolol group (6%, NS). The 18 month actuarial risk for first variceal bleed was 5% in the EVBL (95% CI, 0-12%) and 20% in the propranolol group (95% CI, 0-49%, NS). The actuarial probability of death at 18 months of follow-up was 5% (95% CI, 0-11%) in the EVBL group and 7% (95% CI, 0-17%, NS) in the propranolol arm. In conclusion, EVBL was an effective and safe alternative to propranolol in primary prophylaxis of bleeding in patients with large esophageal varices.     

内镜套扎与普萘洛尔预防肝硬化食管静脉曲张首次出血效能的Meta分析

目的比较内镜下套扎术（EVL）和普萘洛尔预防肝硬化食管静脉曲张首次出血的疗效和安全性。方法计算机检索1999至2012年12月31日PubMed、EBMBASE、万方数据库中关于EVL和普萘洛尔预防肝硬化食管静脉曲张首次出血的随机对照试验,同时追索纳入文献的参考文献。使用RevMan 5.1专业Meta分析软件对治疗后首次出血率,出血病死率,总病死率和不良反应发生率进行Meta分析。结果纳入6个随机对照试验,包括EVL组280例和普萘洛尔组301例患者。文献的Cochrane质量评价均为B级,属于较高质量文献。Meta分析结果显示,EVL在预防肝硬化食管静脉曲张患者的首次出血率、出血病死率、总病死率和不良反应发生率分别为16.4%、4.3%、22.5%和25.0%,与普萘洛尔组的21.6%（P=0.07）、6.3%（P=0.27）、20.9%（P=0.56）和31.9%（P=0.33）相比均无显著性差异;漏斗图存在不对称的现象,提示可能存在发表性偏倚;敏感性分析表明纳入研究具有稳定性。结论EVL与普萘洛尔在预防肝硬化食管静脉曲张破裂的效能无显著性差异。     

Endoscopic ligation vs. nadolol in the prevention of first variceal bleeding in patients with cirrhosis

BACKGROUND: The value of band ligation for prevention of the first episode of variceal bleeding has not been fully evaluated. This study compared the efficacy and safety of band ligation vs. treatment with a beta-blocker for the prophylactic prevention of first bleeding in patients with cirrhosis and high-risk esophageal varices. METHODS: A total of 100 patients with cirrhosis and endoscopically determined high-risk esophageal varices but no history of bleeding were randomized to band ligation (50 patients) or treatment with nadolol (50 patients). In the ligation group, two to 4 elastic bands were deployed during each session. Ligation was repeated at intervals of 3 to 4 weeks until variceal obliteration was achieved. In the nadolol group, the dose of the drug, administered once daily, was sufficient to reduce the pulse rate by 25%. RESULTS: In the ligation group, variceal obliteration was achieved in 41 patients (82%), at a mean of 2.7 (1.1) ligation sessions. In the nadolol group, the mean daily dose of nadolol administered was 60 (20) mg. During follow-up (median approximately 22 months), 10 patients (20%) in the ligation group and 16 (32%) in the nadolol group had upper-GI bleeding (p=0.23). Esophageal variceal bleeding occurred in 5 patients (10%) in the ligation group and 9 (18%) in the nadolol group (p=0.31). By multivariate Cox analysis, Child-Pugh class was the only factor predictive of variceal bleeding. Minor complications were noted in 9 patients (18%) in the ligation group and 4 (8%) in the nadolol group (p=0.35). No serious complication was encountered. Twelve patients in the ligation group and 11 in the nadolol group died (p=0.62). One patient in the ligation group and 3 in the nadolol group died from uncontrollable variceal hemorrhage. CONCLUSIONS: Variceal ligation is as effective and as safe as treatment with nadolol for prevention of first variceal bleeding in patients with cirrhosis.     

Endoscopic variceal ligation versus propranolol in prophylaxis of first variceal bleeding in patients with cirrhosis

BACKGROUND AND AIM: To compare the efficacy and safety of endoscopic variceal ligation (EVL) with propranolol in prophylaxis on the rate of first esophageal variceal bleeding in patients with cirrhosis. METHODS: A prospective, randomized trial was conducted in 100 cirrhotic patients with no history of previous upper gastrointestinal bleeding and with esophageal varices endoscopically judged to be at high risk of hemorrhage. The end-points of the study were bleeding and death. RESULTS: Life-table curves showed that prophylactic EVL and propranolol were similarly effective for primary prophylaxis of variceal bleeding (11/50 [22%]vs 12/50 [24%]; P = 0.68) and overall mortality (14/50 [28%]vs 12/50 [24%]; P = 0.49). The 2-year cumulative bleeding rate was 18% (9/50) in the EVL group and 16% (8/50) in the propranolol group. The 2-year cumulative mortality rate was 28% (14/50) in the EVL group and 24% (12/50) in the propranolol group. Comparison of Kaplan-Meier estimates of the time to death of both groups showed no significant difference in mortality in both groups (P = 0.86). Patients undergoing EVL had few treatment failures and died mainly of hepatic failure. In the propranolol group, the mean daily dosage of the drug was 68.2 +/- 32.8 mg, which was sufficient to reduce the pulse rate by 25%. 20% of patients withdrew from propranolol treatment due to adverse events. CONCLUSIONS: Prophylaxis EVL is as effective and as safe as treatment with propranolol in decreasing the incidence of first variceal bleeding and death in cirrhotic patients with high-risk esophageal varices.     

Endoscopic variceal ligation for primary prophylaxis of oesophageal variceal bleed: preliminary report of a randomized controlled trial

BACKGROUND: Prevention of variceal bleeding, a major cause of morbidity and mortality, is an important goal in the management of patients with portal hypertension (PHT). Although propranolol has been found useful in preventing the first episode of variceal bleeding (primary prophylaxis) in cirrhotic PHT, it has limitations which include side effects, contraindications, non-compliance and failure in some patients. Endoscopic variceal ligation (EVL) has not been used for primary prophylaxis. METHODS: Thirty cirrhotic patients with PHT, grade III to IV oesophageal varices, hepatic venous pressure gradient > or = 12 mmHg and no prior history of upper gastrointestinal bleeding were randomized to receive propranolol (to reduce their pulse rate by 25% from baseline, n = 15) and EVL (weekly to fortnightly until variceal eradication, n = 15). The two groups were comparable. All the patients in EVL group had variceal eradication during 3.8 +/- 2.2 sessions. RESULTS: There was no major complication or interval bleeding. During a follow-up period of 17.6 +/- 4.7 months, varices recurred in three, two of which bled (successfully treated by EVL). In contrast, during this period of follow up one patient in the propranolol group had variceal bleeding (P=NS). Side effects of propranolol included symptomatic bradycardia requiring reduction of dose in one of 15 patients. CONCLUSIONS: Although sample size in this study is small, it seems that EVL may be a good option for primary prophylaxis for variceal bleeding in patients with cirrhotic PHT; further studies on a larger number of patients and longer follow up are required.     

Endoscopic variceal ligation plus propranolol versus endoscopic variceal ligation alone in primary prophylaxis of variceal bleeding

BACKGROUND AND AIMS: The role of propranolol in addition to EVL in the prevention of first variceal bleed has not been evaluated. This prospective randomized controlled trial compared endoscopic variceal ligation (EVL) with propranolol and EVL alone in the prevention of first variceal bleed among patients with high-risk varices. PATIENTS AND METHODS: One hundred and forty-four consecutive patients with high-risk varices were randomly allocated to EVL plus propranolol (Gr I, n = 72) or EVL alone (Gr II, n = 72). EVL was done at 2-wk interval till obliteration of varices. In Gr I, incremental dosage of propranolol (sufficient to reduce heart rate to 55 beats/min or 25% reduction from baseline) was administered and continued after obliteration of varices. The endpoints of the study were bleeding and death. RESULTS: The two groups of patients had comparable baseline characteristics; follow-up (Gr I: 13.1 +/- 11.5 months, Gr II: 11.2 +/- 9.9 months), number of cirrhotic and noncirrhotic portal hypertension patients [Gr I 64 (88.6%) and 8 (11.4%), Gr II 63 (87.5%) and 9 (12.5%)], and frequency of Child's A (15 vs 18), B (38 vs 35), and C (19 vs 19). The mean daily propranolol dose achieved in Gr I was 95.6 +/- 38.6 mg. Eleven patients had bleeds, 5 in Gr I and 6 in Gr II. All patients bled before the obliteration of varices, the actuarial probability of first bleed at 20 months was 7% in Gr I and 11% in Gr II (p= 0.72). Six patients died in the combination and 8 in EVL group. All deaths in Gr I were due to nonbleed-related causes, while in Gr II, 2 deaths were bleed related, the actuarial probability of death at 20 months was 8% and 15%, respectively (p= 0.37). The probability of bleed-related death was comparable (p= 0.15). At the end of follow-up, 4 patients in Gr I and 11 in Gr II had recurrence of varices (p= 0.03). Side effects on propranolol were seen in 22% patients, in 8% it had to be stopped. There were no serious complications of EVL. CONCLUSIONS: Both EVL plus propranolol and EVL alone are effective in primary prophylaxis of bleed from high-risk varices. Addition of propranolol does not decrease the probability of first bleed or death in patients on EVL. However, the recurrence of varices is lower if propranolol is added to EVL.     

Cost-effectiveness analysis of variceal ligation vs. beta-blockers for primary prevention of variceal bleeding

Although both beta-blockade (BB) and endoscopic variceal ligation (EVL) are used for primary prevention of variceal bleeding (VB) in patients with cirrhosis with moderate to large esophageal varices (EVs), the more cost-effective option is uncertain. We created a Markov decision model to compare BB and EVL in such patients, examining both cost-effectiveness (cost per life year [LY]) and cost-utility (cost per quality-adjusted life year [QALY]). Outcomes included cost per LY, cost per QALY, proportions of persons with VB, TIPS, and all-cause mortality. EVL and BB were compared using the incremental cost-effectiveness ratio (ICER) and incremental cost-utility ratio (ICUR). When considering only LYs, initial EVL exceeds the benchmark of 50,000 dollars/LY, with an ICER of 98,407 dollars. However, when quality of life (QoL) is considered, EVL is cost-effective compared to BB (ICUR of 25,548 dollars/QALY). In sensitivity analysis, EVL is cost-effective if the yearly risk of EV bleeding is > or = 0.26 (base case 0.15), the relative risk of bleeding on BB is > or = 0.69 (base case 0.58), or if the relative risk of bleeding with EVL is < 0.27 (base case 0.35). The ICUR favored EVL unless the relative risk of bleeding on BB is < 0.46, the relative risk of bleeding with EVL is > 0.46, or the time horizon is < or = 24 months. Whether EVL is "cost-effective" relative to BB therapy for primary prevention of EV bleeding depends on whether LYs or QALYs are considered. If only LYs are considered, then EVL is not cost-effective compared to BB therapy; however, if QoL is considered, then EVL is cost-effective.     

Endoscopic variceal ligation plus nadolol and sucralfate compared with ligation alone for the prevention of variceal rebleeding: a prospective, randomized trial

Both beta-blockers and endoscopic variceal ligation (EVL) have proven to be valuable alternatives to sclerotherapy in the prevention of variceal rebleeding. Sucralfate is a mucosal protector. The effects of combinations of beta-blocker, band ligation, and sucralfate (triple therapy) remain unknown. A total of 122 patients with a history of esophageal variceal bleeding were randomized to receive EVL only (group A, 62 patients) or triple therapy (group B, 60 patients). The procedure for the triple therapy included ligation with the addition of sucralfate granules until variceal obliteration. In addition, nadolol was administered during the course of the study or until death. After a median follow-up of 21 months, recurrent upper gastrointestinal bleeding developed in 29 patients (47%) in group A and 14 patients (23%) in group B (P =.005). Recurrent bleeding from esophagogastric varices occurred in 18 patients in group A and 7 patients in group B (P =.001). Twenty-one patients in group A (50%) and 12 patients (26%) in group B experienced variceal recurrence after variceal obliteration (P <.05). Treatment failure occurred in 11 patients (18%) in group A and in 4 patients (7%) in group B (P =.05). Twenty patients from group A and 10 patients from group B died (P =.08); 9 and 4 of these deaths, respectively, were attributed to variceal hemorrhage (P =.26). The combination of ligation, nadolol, and sucralfate (triple therapy) proved more effective than banding ligation alone in terms of prevention of variceal recurrence and upper gastrointestinal rebleeding as well as variceal rebleeding.     

Variceal band ligation and variceal band ligation plus sclerotherapy in the prevention of recurrent variceal bleeding in cirrhotic patients: a randomized, prospective and controlled trial

BACKGROUND: The combination treatment of band ligation plus sclerotherapy has been proposed to hasten variceal eradication. The aim of this study was to assess the efficacy of band ligation alone versus band ligation plus sclerotherapy in the prevention of recurrent variceal bleeding. METHODS: Eighty cirrhotic patients were randomized to group I (band ligation) with 41 patients or to group II (band ligation plus sclerotherapy) with 39 patients in whom polidocanol (2%) was injected 1 to 2 cm proximal to each band. RESULTS: At baseline, both groups were similar with regard to clinical, demographic and laboratory data. Mean follow-up time (standard error) for group I was 336.5 +/- 43.4 days and for group II 386.1 +/- 40.1 days (p = 0.4). No statistical differences were observed between group I and group II in relation to recurrence of bleeding (31.7% vs. 23%, p = 0.38), treatment failure (24.4% vs. 12. 8%, p = 0.18), death (39% vs. 30.8%, p = 0.44) and variceal eradication (65.8% vs. 74.4%, p = 0.40). Group II had a significantly higher number of complications than group I, 30.8% versus 7.3%, respectively (p = 0.05). The number of bleeding related deaths was higher in group I than in group II (22% vs. 10.3%, respectively; p = 0.15). CONCLUSIONS: No significant difference was observed between band ligation and band ligation plus sclerotherapy in prevention of recurrent variceal bleeding. Furthermore, there was a higher incidence of complications in the latter group.     

肝硬化食管静脉曲张破裂出血序贯治疗的临床应用价值

目的 评价曲张静脉套扎术(EVL)+不同硬化剂曲张静脉硬化术(EVS)序贯治疗肝硬化食管静脉曲张破裂出血的疗效及安全性.方法 回顾性总结314例肝硬化食管静脉曲张破裂出血内镜治疗患者的临床资料,包括单纯EVL治疗者112例(EVL组)、单纯鱼肝油酸钠硬化治疗者48例(EVS1组)、单纯聚桂醇硬化治疗者40例(EVS2组)、套扎+鱼肝油酸钠硬化序贯治疗者26例(EVLS1组)、套扎+聚桂醇硬化序贯治疗者88例(EVLS2组),统计各组曲张静脉治疗有效率、静脉曲张复发率、并发症发生率并进行对比分析.结果 EVL组、EVS1组、EVS2组、EVIS1组、EVLS2组曲张静脉治疗有效率比较差异均无统计学意义[85.7％ (96/112)、83.3％ (40/48)、92.5％ (37/40)、92.3％(24/26)、94.3％ (83/88),P＞0.05],但EVLS1组和EVLS2组曲张静脉完全消失率均明显高于其他3组[88.5％(23/26)和87.5％(77/88)比58.0％(65/112)、62.5％(30/48)、70.0％(28/40),P＜0.05],而EVLS1组与EVLS2组比较差异无统计学意义(P＞0.05).EVS1组再出血率最高(18.8％,9/48) (P ＜0.05),其次是EVL组(11.6％,13/112),均高于EVS2组、EVLS1组和EVLS2组[7.5％(3/40)、7.7％ (2/26)、6.8％ (6/88),P＜0.05],后3组再出血率相似(P＞0.05).治疗后随访6 ～18个月,EVL组静脉曲张复发26例(23.2％,26/112),EVS1组复发8例(16.7％,8/48),EVS2组复发6例(15.0％,6/40),EVLS1组复发4例(15.4％,4/26),EVLS2组复发9例(10.2％,9/88);EVL组复发率最高(P＜0.05),EVLS2组复发率最低(P＜0.05),EVS1组、EVS2组和EVLS1组复发率相似(P＞0.05).EVS1组总体并发症发生率(32.2％,49/152)明显高于其他4组(P＜0.05),而EVL组(14.5％,32/220)、EVLS2组(19.6％,22/112)、EVLS1组(22.7％,25/110)、EVLS2组(15.8％,34/229)4组间比较差异无统计学意义(P＞0.05).结论 EVL+鱼肝油酸钠EVS或+聚桂醇EVS序贯治疗肝硬化食管静脉曲张破裂出血是安全而有效的,尤以EVL+聚桂醇EVS序贯治疗效果显著,有可能成为治疗食管静脉曲张出血并防止再出血的最佳选择.     

Primary prophylaxis of variceal hemorrhage: a randomized controlled trial comparing band ligation,propranolol, and isosorbide mononitrate

BACKGROUND & AIMS: This randomized controlled trial compared variceal band ligation (VBL), propranolol (PPL), and isosorbide-5-mononitrate (ISMN) in the prevention of first esophageal variceal bleed. METHODS: Over a 6-year period, 172 patients with cirrhosis, grade II or III esophageal varices that had never bled, were recruited; 44 into VBL, 66 into PPL, and 62 into ISMN. Baseline patient characteristics: age, 55 +/- 11 years; Child-Pugh score, 8 +/- 2; 65% alcohol-induced cirrhosis; follow-up period, 19.7 +/- 17.6 months (range, 0.13-72.1 months), were comparable in the 3 groups. RESULTS: On intention-to-treat analysis, variceal bleeding occurred in 7% of patients randomized to VBL, 14% to PPL, and 23% to ISMN. The 2-year actuarial risks for first variceal bleed were 6.2% (95% confidence interval [CI], 0.0%-15.0%) for VBL, 19.4% (95% CI, 0.1%-32.4%) for PPL, and 27.7% (95% CI, 14.2%-41.2%) for ISMN. A significant number of patients reported side effects with drug treatment (45% PPL and 42% ISMN vs. 2% VBL; P = 0.00), resulting in withdrawal from treatment in 30% of PPL and 21% of ISMN patients. There were no statistically significant differences in mortality rates in the 3 groups. In as-treated analysis, there was a statistically significant difference in actuarial risk for bleeding at 2 years between VBL and ISMN (7.5%, 95% CI, 2.5%-10.6% vs. 33.0%, 95% CI, 15%-49%, respectively, log rank test P = 0.03) but not between VBL and PPL. CONCLUSIONS: VBL was equivalent to PPL and superior to ISMN in preventing first variceal bleed. The side-effect profile for pharmacotherapy was considerable.     

Vasopressin/nitroglycerin infusion vs. esophageal tamponade in the treatment of acute variceal bleeding: a randomized controlled trial

Vasopressin infusion and esophageal tamponade are still widely used to arrest variceal bleeding, but no objective evidence exists on the superiority of either of the two procedures. In this study, 108 cirrhotic patients bleeding from varices were included in a prospective, randomized trial to investigate the comparative effectiveness and safety of balloon tamponade (using the Sengstaken-Blakemore tube for esophageal varices and the Linton-Nachlas tube for gastric varices) (n = 52) and intravenous vasopressin infusion (0.4 to 0.8 mu/min) plus intravenous nitroglycerin infusion (40 to 400 micrograms/min) (n = 56). Both treatments were maintained for 24-hr. The hemostatic efficacy according to the intention to treat was 86.5% for tamponade and 66% for pharmacological therapy (p less than 0.01). No significant differences were found with respect to rebleeding during the first 72 hr after treatment, mortality rate or side effects. These results suggest that esophageal tamponade is more effective than vasopressin/nitroglycerin infusion in the treatment of variceal bleeding in cirrhotic patients.     

Carvedilol vs endoscopic variceal ligation for primary and secondary prevention of variceal bleeding: Systematic review and metaanalysis

BACKGROUND Variceal hemorrhage is associated with high mortality and is the cause of death for 20–30% of patients with cirrhosis. Nonselective β blockers(NSBBs) or endoscopic variceal ligation(EVL) are recommended for primary prevention of variceal bleeding in patients with medium to large esophageal varices.Meanwhile, combination of EVL and NSBBs is the recommended approach for the secondary prevention. Carvedilol has greater efficacy than other NSBBs as it decreases intrahepatic resistance. We hypothesized that there was no difference between carvedilol and EVL intervention for primary and secondary prevention of variceal bleeding in cirrhosis patients.AIM To evaluate the efficacy of carvedilol compared to EVL for primary and secondary prevention of variceal bleeding in cirrhotic patients METHODS We searched relevant literatures in major journal databases(CENTRAL,MEDLINE, and EMBASE) from March to August 2018. Patients with cirrhosis and portal hypertension, regardless of aetiology and severity, with or without a history of variceal bleeding, and aged ≥ 18 years old were included in this review.Only randomized controlled trials(RCTs) that compared the efficacy of carvedilol and that of EVL for primary and secondary prevention of variceal bleeding and mortality in patients with cirrhosis and portal hypertension were considered, irrespective of publication status, year of publication, and language.RESULTS Seven RCTs were included. In four trials assessing the primary prevention, no significant difference was found on the events of variceal bleeding(RR: 0.74,95%CI: 0.37-1.49), all-cause mortality(RR: 1.10, 95%CI: 0.76-1.58), and bleedingrelated mortality(RR: 1.02, 95%CI: 0.34-3.10) in patients who were treated with carvedilol compared to EVL. In three trials assessing secondary prevention, there was no difference between two interventions for the incidence of rebleeding(RR:1.10, 95%CI: 0.75-1.61). The fixed-effect model showed that, compared to EVL,carvedilol decreased all-cause mortality by 49%(RR: 0.51, 95%CI: 0.33-0.79), with little or no evidence of heterogeneity.CONCLUSION Carvedilol had similar efficacy to EVL in preventing the first variceal bleeding in cirrhosis patients with esophageal varices. It was superior to EVL alone for secondary prevention of variceal bleeding in regard to all-cause mortality reduction.     

心得安对食管曲张静脉套扎后再出血的影响

目的:观察心得安对食管曲张静脉套扎后再出血的影响.方法:7 8 例门脉高压性食管静脉曲张(esophageal varices, EV)患者, 分成单独套扎组(39例, 作为对照组)和心得安组(39例, 套扎后给予心得安, 10 mg, 3次/d, po). 比较两组套扎后12 mo内再出血率, 同时12 mo后复查胃镜,比较两组患者门脉高压性胃病及胃底曲张静脉发生率.结果:套扎12 mo后再出血率心得安组明显低于对照组(38.70% vs 54.54%, P<0.05). 心得安组门脉高压性胃病发生率、胃底静脉发生率,食管静脉再发率均明显低于对照组(32.25% vs57.57%, 25.80% vs 42.42%, 29.03% vs 39.39%,均P<0.05).结论:心得安可降低食管曲张静脉套扎后再出血, 其原因是心得安能够降低套扎后的门脉高压性胃病和食管、胃底静脉曲张的发生.     

Endoscopic Nd:YAG laser therapy for active esophageal variceal bleeding. A randomized controlled study

A randomized controlled double-blind study was undertaken to assess the efficacy and safety of endoscopic neodymium:yttrium aluminum garnet (Nd:YAG) laser therapy for active esophageal variceal bleeding. Ten patients were randomized to the laser treatment group and 10 to a control group that received sham endoscopy and standard medical therapy. Initial hemostasis was achieved in seven laser-treated patients but in 0 of 10 controls receiving sham treatment (p less than 0.002). However, four of the seven who were initially controlled with laser therapy had rebleeding 12 to 48 hours later; thus, three of 10 laser patients had lasting hemostasis. The mean blood transfusion requirements were similar in both groups (laser = 7.3 units; control = 7.8 units). Six of the 10 laser-treated patients were discharged from the hospital and four died. There were seven hospital deaths in the control group and three patients were discharged (p = 0.22). In two patients in the treatment group, laser therapy increased bleeding. There were no perforations.