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PubMed2006

The use of trichloroacetic acid in the treatment of acute external otitis.

The purpose of this study was to evaluate the effectiveness of 5% trichloroacetic acid (TCA) in the treatment of acute external otitis (AEO) in comparison with a standard clinical treatment. All patients who consecutively presented in our emergencies with AEO during the summer months of the previous year were included in the study. They were randomly divided into two groups: the study group included 117 patients treated with TCA and the control group included 98 patients treated with ear drops containing antibiotic and corticosteroid. Occasionally, an antibiotic was administered orally for 7 days, in severe cases of AEO. All patients were evaluated on days 1, 3, 5, 7 and 10, whereas another review appointment was given 20 days later. Outcome measures included evaluation of efficacy using a six-step infection score and tolerability by visual analogue scale. Additionally, adverse reactions, complications and recurrencies were recorded. Treatment was successful for all patients of the study group, whereas 8 failures were found in the control group. The infection score improved faster in the study group than in the control group, resulting in an earlier clinical cure (mean 4.1 and 8.6 days, respectively). Tolerability was significantly better in the study group, on all points of evaluation. Complications and adverse reactions were minimal on both groups. Our results show that TCA is a very effective and nontoxic agent for the treatment of AEO. Rapid pain relief and prevention of recurrencies are its main advantages.

Acute Disease↗
PubMed1993

Use of interferons in atopic (IgE-mediated) diseases.

The purpose of the present study was to evaluate the possible therapeutic effects of interferon alpha and gamma in the management of atopic dermatitis (AD) and hyperimmunoglobulin E syndrome (HIES). A total of three patients with severe AD/HIES were studied. Two patients with AD (patients no. 1 and 2) were treated initially with IFN-gamma (0.05 mg/m2, thrice weekly). Although initial improvement was observed in both patients, due to the incomplete resolution of the disease in patient no. 1 (severity score decreased from 14 to 6), IFN-gamma was replaced by IFN-alpha (3 x 10(6) U/m2, thrice weekly) which offered further improvement (severity score decreased to 3). Patient no. 2 had a recurrence of the disease activity at the fourth week, which did not respond to an increased dose of IFN-gamma (0.1 mg/m2), hence the medication was changed to IFN-alpha (0.5 x 10(6) U/m2, thrice weekly). Following an additional 20 weeks therapy with IFN-alpha, the lesions improved dramatically and reached complete remission (severity score decreased from 12 to 0). A third patient with HIES was treated with IFN-gamma (0.05 mg/m2, thrice weekly), following which the disease severity score improved from 11 to 3 in 20 weeks. This preliminary study supports the therapeutic effect of IFNs in patients with atopic diseases. The sequential or combined usage of IFN-alpha and IFN-gamma may offer additional therapeutic benefit. The data further suggest that non-IgE-related mechanism(s) may also play an important role in this treatment modality.

Adult↗
PubMed1999

Detection of the proto-oncogene eIF4E in larynx and hypopharynx cancers.

BACKGROUND: The proto-oncogene eIF4E has been found to be elevated in head and neck squamous cell carcinomas. In an earlier prospective study overexpression of eIF4E, detected by Western blot analysis, in histologically normal surgical margins correlated with an increased local-regional recurrence rate during a 1-year follow-up. OBJECTIVE: To test the reverse hypothesis that absence of overexpression of eIF4E in the surgical margins is a predictor for long-term survival in patients with squamous cell carcinoma of the head and neck. DESIGN: A retrospective analysis was performed on 31 patients who underwent surgery for squamous cell carcinoma of the larynx or hypopharynx. Immunohistochemical analysis was used to detect eIF4E on paraffin embedded sections of the tumor and the histologically negative surgical margins. RESULTS: All 31 patients overexpressed eIF4E in the tumors. Thirteen patients had no detectable level of eIF4E in the margins, and only 1 had a local-regional recurrence. The average disease-free interval in this group of patients was 82.08 months. The remaining 18 patients all overexpressed eIF4E in the surgical margins (eIF4E score range, 5-80). Twelve (67%) of these patients developed a recurrence; the average disease-free interval was 31.95 months. Cox regression analysis showed that eIF4E in the margin (P= .01), nodes (P= .06), site (P= .02), and age (P= .02) had significant effects on the disease-free interval. The Kaplan-Meier survival curves were significantly different for eIF4E-positive and eIF4E-negative margins (P = .002). CONCLUSIONS: eIF4E in the surgical margins is an independent prognostic factor and its absence in surgical margins may predict long-term survival. Detecting eIF4E in the margins may improve survival by determining which patients would benefit from further resection or adjuvant therapy.

Adult↗
PubMed2004

A randomised controlled trial comparing abdominal and vaginal prolapse surgery: effects on urogenital function.

OBJECTIVE: To compare the effects of vaginal hysterectomy (combined with anterior and/or posterior colporraphy) and abdominal sacro-colpopexy (with preservation of the uterus) on urogenital function. DESIGN: Randomised trial. SETTING: Three teaching hospitals in The Netherlands. POPULATION: Eighty-two patients undergoing surgical correction of uterine prolapse stages II-IV. METHODS: Participating patients completed the urogenital distress inventory (UDI), before and at six weeks, six months and one year after surgery, to measure discomfort of prolapse and micturition symptoms. Domain scores of the UDI (ranging from 0 to 100, higher scores indicating more discomfort) were compared between groups at all time points. Findings at pelvic examination, number of doctor visits within the first year after surgery because of pelvic floor symptoms and performed or planned surgery of recurrent genital prolapse were also compared. MAIN OUTCOME MEASURE: Domain scores of the UDI at one year after surgery. RESULTS: At one year after surgery, scores on the discomfort/pain domain (mean difference 7.1, 95% confidence interval [CI] 1.1-13.2), overactive bladder domain (mean difference 8.7, 95% CI 0.5-16.9) and obstructive micturition domain (mean difference 10.3, 95% CI 0.6-20.1) of the UDI were significantly higher in the abdominal group than in the vaginal group. Findings at pelvic examination were similar in both groups. Doctor visits because of pelvic floor symptoms were more frequent in the abdominal group than in the vaginal group. Re-operation was performed or planned in 9 of the 41 patients who underwent abdominal surgery and in 1 of the 41 patients who underwent vaginal surgery (odds ratio [OR] = 11.2, 95% CI 1.4-90.0). CONCLUSIONS: Our findings suggest that vaginal hysterectomy with anterior and/or posterior colporraphy is preferable to abdominal sacro-colpopexy with preservation of the uterus as surgical correction in patients with uterine prolapse stages II-IV.

Colpotomy↗
PubMed2007

Paliperidone extended-release tablets for prevention of symptom recurrence in patients with schizophrenia: a randomized, double-blind, placebo-controlled study.

We evaluated the efficacy of paliperidone extended-release (ER), an investigational psychotropic agent, in delaying symptom recurrence in adult patients with schizophrenia and its safety and tolerability. In this randomized, double-blind, placebo-controlled, multicenter study, patients' symptoms were stabilized during an 8-week run-in and a 6-week stabilization phases using open-label, flexibly dosed paliperidone ER (3-15 mg once daily, starting dose = 9 mg). The primary efficacy variable was the time of first recurrence of schizophrenia symptoms, which included predefined changes in symptom scores, psychiatric hospitalization, self-injury, and suicidal or aggressive behavior during the double-blind phase (paliperidone ER or placebo treatment). Based on positive efficacy, the study was terminated at the preplanned interim analysis (43 recurrence events). The interim analysis (primary analysis) included 113 patients (mean age = 41 years; 51% men, 85% white). In the intent-to-treat group, 14 paliperidone ER-treated patients (25%) experienced a recurrence event versus 29 (53%) for placebo. Time-to-recurrence was significantly different, favoring the paliperidone ER group (P = 0.005, log-rank test): 25% quantile of time-to-recurrence was 83 days (paliperidone ER) versus 23 days (placebo). Final analyses (n = 205) were confirmatory. During initial open-label treatment with paliperidone ER, symptoms improved significantly. This improvement was maintained with continued treatment, as were functioning and quality-of-life measures. Treatment-emergent adverse events rates were similar: 35% for paliperidone ER and 40% for placebo. Paliperidone ER treatment versus placebo significantly delayed time-to-recurrence in patients with schizophrenia, maintained symptom stability and measures of functioning, and was generally well tolerated in this patient population.

Adult↗
PubMed1993

Central neurocytoma: proliferative assessment by nucleolar organizer region staining.

Proliferative potential of four cases of central neurocytoma were assessed by a silver colloid staining technique for argyrophilic protein associated with nucleolar organizer regions (AgNORs). All but one tumor had an Ag-NOR score of less than 2 and were regarded as a benign entity. However, one tumor tissue from a patient suffering from a recurrent central neurocytoma after 13 years from the first operation possessed a 2.06 AgNOR score, which is not significantly different from others. It is considered that central neurocytoma is an essentially benign neoplasm, even though the tumor is recurrent. The present study revealed the usefulness of AgNOR staining for a retrospective assessment of the proliferative potential of central neurocytomas.

Adult↗
PubMed2004

Adverse prognostic significance of capsular incision with radical retropubic prostatectomy.

PURPOSE: The prognostic significance of capsular incision (CPI) at radical retropubic prostatectomy remains to be defined. To evaluate this we compared prostate specific antigen recurrence for with CPI to that with established pathological groups. MATERIALS AND METHODS: From January 1998 to December 2000, 409 men underwent radical retropubic prostatectomy at our medical center. CPI was defined as a positive posterior, lateral or posterolateral surgical margin without documented extraprostatic extension (EPE). Excluding patients with preoperative androgen ablation, positive lymph nodes or seminal vesicle involvement there were 129 with organ confined disease and negative surgical margins (pT2/-M), 18 with CPI, 29 with EPE and negative surgical margins (pT3a/-M), and 24 with EPE and positive surgical margins (pT3a/+M). We compared time to biochemical recurrence among these 4 groups using Kaplan-Meier estimates. Cox proportional hazard regression was performed to determine the HR of CPI vs the other groups, while controlling for age, prostate specific antigen, tumor volume and Gleason score. RESULTS: The 3-year likelihood of freedom from biochemical recurrence in the CPI group was 65%, for pT2/-M it was 96%, for pT3a/-M it was 91% and for pT3a/+M it was 58%. The adjusted HR with the 95% CI showed that the risk of biochemical recurrence with CPI was 8.4 times higher than that with pT2/-M (p = 0.002), 5.9 times higher than that with pT3a/-M (p = 0.046) and the same as that with pT3a/+M (p = 0.840). CONCLUSIONS: Isolated posterior, lateral and posterolateral CPI by our definition occurs not uncommonly and it may represent true incision of the capsule and/or difficulty in diagnosing EPE due to a lack of extraprostatic tissue in the surgical specimen. However, the prognostic significance of CPI as defined appears similar to that of pT3a with positive margins.

Adenocarcinoma↗
PubMed2003

MIB1 as a possible predictor of recurrence in low-grade endometrial stromal sarcoma of the uterus.

OBJECTIVE: Immunohistochemical analysis of MIB1, p53, estrogen, and progesterone receptors can provide prognostic information in endometrial adenocarcinoma. Since predictors of recurrence for low-grade endometrial stromal sarcoma (LESS) are still unknown, a battery of immunostains was performed to find markers, which might be useful to predict prognosis. METHODS: Eleven patients with an average age of 43.8 years (range 27-76) were identified with stage I LESS. Immunostains, including MIB1, p53, ER, and PR, were evaluated by two pathologists, independently. RESULTS: All tumors were positive for ER and PR; 1/11 was positive for p53; MIB1 ranged from 0 to 20% positive tumor nuclei. Mitotic counts ranged from 0 to 7/10 hpf. Two patients developed recurrences. One had a pelvic recurrence 7 years after diagnosis. This tumor had a mitotic count of 1/10 hpf, MIB1 expression in 10% of nuclei, and focal p53 expression. A second patient developed pulmonary metastases 10.8 years after diagnosis; the tumor showed a mitotic count of 7/10 hpf and MIB1 expression in 20% of nuclei, but was negative for p53. There was a significant difference in MIB1 reactivity scores between patients who did or did not develop recurrence (P = 0.0303). A marginally significant association was detected between MIB1 (P = 0.0896) or p53 (P = 0.0833) positivity and length of recurrence-free survival. CONCLUSION: Although MIB1 and p53 appear to be useful prognostic markers, a larger study would be necessary to confirm their validity.

Adult↗
PubMed2004

External beam radiation therapy after radical prostatectomy: efficacy and impact on urinary continence.

INTRODUCTION AND OBJECTIVES: The efficacy of adjuvant and salvage external beam radiation (AXRT+SXRT) for prostate cancer after radical prostatectomy (RP) has been debated because of the inability to rule out systemic occult metastasis, uncertainty that radiation eradicates residual local disease and the potential of exacerbating impotency and incontinence. To characterize the effectiveness and treatment morbidity a retrospective review was performed. METHODS: In all, 38 patients received AXRT and 91 received SXRT. The SXRT group was stratified by PSA level, age, race, pathologic stage, margin status, worst Gleason sum, radiation dose and pelvic field. Complications evaluated were impotence and incontinence. Median follow-up was 60.2 months. RESULTS: The 5-y disease-free survival (DFS) rate was 61.3% for AXRT and 36.3% for SXRT. Multivariate analysis of the SXRT cohort showed Gleason score, pathologic stage and pre-XRT PSA to be predictors of disease recurrence. After XRT 26% had worsened continence. CONCLUSIONS: Patients who recur after RP whose pathologic stage is pT2 or pT3c, Gleason score of 8 or higher or pre-XRT PSA is >2.0 ng/dl may have microscopic metastatic disease and a decreased chance of cure with SXRT alone. Continence was further impaired after XRT.

Aged↗
PubMed1987

Laminectomy with and without spinal fusion.

This retrospective study evaluates two groups of patients surgically treated for a symptomatic, myelographically proven, herniated nucleus pulposus with a follow-up period from 3.5 to 16 years. One hundred thirty-four patients were treated with laminectomy, discectomy, and fusion (LDF) between the years 1972 and 1978; 49 returned for follow-up examination. Two hundred patients had laminectomies and discectomies between the years 1968 and 1981; 40 returned for follow-up evaluation. Two of the disc patients had a repeat laminectomy for recurrent disc herniation, thus totaling 42 laminectomies. Each patient was scored on a scale from zero to 100. The LDF cases had an average score of 70 points. The disc cases had an average score of 69 points. Three of the LDF cases (6%) and eight of the disc cases (19%) had had a second operation. Laminectomy patients have a significantly higher reoperation rate than patients who have had spinal fusion along with laminectomy; however, the authors were unable to evaluate the results in the two groups by the overall score.

Female↗
PubMed1994

[Can early recurrent hemorrhage in gastroduodenal ulcer be predicted?].

OBJECTIVE: To evaluate clinical, biological and endoscopic predictive factors of early recurrent bleeding from gastric or duodenal ulcers. PATIENTS AND METHODS: Seventy six patients (26 females and 50 males) with a mean age of 65.9 years (SD = 17.2) were included in a prospective study. Among the 76 patients, there were 39 NSAIDs users (51.3%). An endoscopy was performed systematically until 12 hours after admission. Treatment modalities were identical for all patients. The predictive value of 11 factors was evaluated through an univariate and multivariate analysis. RESULTS: Three factors had independent significant predictive value: a) the number of blood units used to treat a shock and to increase the haemoglobin level up to 100 g/L (P < 0.05); b) "high endoscopic risk" of recurrent bleeding including Forrest Ia, IIa and IIb ulcers (P < 0.05); c) a non steroidal anti-inflammatory treatment was associated with no recurrent bleeding contrary to the other factors (P < 0.05). Based on a second multivariate analysis including clinical factors only, a predictive score was calculated: 5 + number of blood units -5 x (NSAID = 0/1). The cut off point with maximum discrimination was 6 (specificity = 79.6%; sensitivity = 77.2%). CONCLUSION: A combination of clinical and endoscopic factors is useful to predict ulcer recurrent bleeding. Our clinical predictive score is interesting because of its simplicity. Its predictive value is of interest but have to be evaluated in another sample of patients.

Adult↗
PubMed1981

Cross-sectional clinical evaluation of recurrent enamel caries, restoration of marginal integrity, and oral hygiene status.

Both marginal quality and oral hygiene status have strong effects on the risk of recurrent caries. Although there was no statistically significant interaction between these two parameters in this study, the influence of each variable was dependent on its severity. There is a difference between the behavior or the likelihood of recurrent caries on occlusal surfaces as compared with smooth surfaces. On the smooth surfaces, there is a continued increased risk with decreasing marginal quality; the occlusal surfaces, however, show no change in vulnerability beyond a modified marginal quality score of 3. Variation in oral hygiene had a more pronounced effect on the probability of recurrent caries of restorations with moderate margin scores than it did on restorations with either very poor or very good cavosurface margins. This work further emphasizes the importance of technically good restorative care at the operative visit, which, coupled with conscientious oral hygiene, should have a positive effect on increasing the longevity of restorations and decreasing the need for replacement.

Adolescent↗
PubMedDate not supplied

Treatment of idiopathic clubfoot utilizing botulinum A toxin: a new method and its short-term outcomes.

A pivotal point in most clubfoot management protocols is Achilles tendon lengthening or tenotomy to address hindfoot deformity. The effectiveness of botulinum A toxin (BTX-A) in attenuating the function of the triceps surae muscle complex as an alternative to tenotomy was investigated. Fifty-one patients with 73 idiopathic clubfeet were recruited. Outcome measures included surgical rate, Pirani clubfoot score, ankle dorsiflexion with knee in flexion and extension, and recurrences. Patients were divided according to age: group 1 (<30 days old) and group 2 (>30 days and <8 months old). Ankle dorsiflexion in knee flexion and extension remained above 20 degrees and 15 degrees, respectively, and Pirani scores below 0.5 following BTX-A injection for both groups. One of the 51 patients required limited posterior release and 9 patients required repeat manipulation and casting plus or minus BTX-A injection. The use of BTX-A as an adjunctive therapy in the noninvasive approach of manipulation and casting in idiopathic clubfoot is a safe and effective treatment.

Botulinum Toxins, Type A↗
PubMed2002

In-patient management of diabetes mellitus and patient satisfaction.

AIMS: To devise a system for assessing in-patient glycaemic control and care satisfaction in diabetic patients admitted to hospital for reasons other than their diabetes. METHODS: Consecutive January to March 2001 case-notes were reviewed. Admissions with acute metabolic complications, acute myocardial infarction and pregestational or gestational diabetes were excluded. Glycaemic control, frequency of blood monitoring and management of hyperglycaemia were recorded. The diabetes treatment satisfaction questionnaire was used to assess preadmission satisfaction with care. Post-admission a 12-stem questionnaire was used to assess satisfaction with in-patient diabetes management. RESULTS: Hypoglycaemia was common. Although none developed a hyperglycaemic emergency, high blood glucose was prevalent and, frequently, persistent hyperglycaemia or recurrent hypoglycaemia was not acted on appropriately. The overall score for in-patient satisfaction with treatment was fair (4.1 +/- 1.8 on a six-point scale; 6 = very satisfied and 1 = very dissatisfied). Scores were higher among patients on surgical wards than on medical wards (P = 0.008), but satisfaction did not vary when patients were stratified according to sex, age and mode of treatment. CONCLUSION: Current systems are not achieving satisfactory in-patient glycaemic control and there is poor satisfaction with medical in-patient diabetes care. Following changes intended to produce improvements, this assessment system can be used recurrently to monitor in-patient care and satisfaction.

Adolescent↗
PubMed2001

Isolated local recurrence is rare after radical prostatectomy in men with Gleason 7 prostate cancer and positive surgical margins: therapeutic implications.

PURPOSE: We determined whether the high biochemical failure rate in men with Gleason score 7 disease and positive surgical margins after radical retropubic prostatectomy is secondary to distant metastasis or to local tumor recurrence that could be eliminated by immediate adjuvant radiation therapy. MATERIALS AND METHODS: Between 1982 and 1997, 112 men with Gleason score 7 disease and positive surgical margins but no seminal vesicle or lymph node involvement underwent radical retropubic prostatectomy without immediate adjuvant radiation or hormonal therapy. Median followup was 8 years (range 1 to 16) and 45 men (40%) were followed 10 years or more. Kaplan-Meier actuarial survival estimates were used to determine the actuarial 5 and 10-year post-prostatectomy, and 5-year post-radiation recurrence rates. RESULTS: The actuarial 5 and 10-year post-prostatectomy biochemical, local and distant recurrence rates were 40% and 52%, 6% and 6%, and 7% and 16%, respectively. For 20 men who received radiation therapy for isolated prostate specific antigen elevation actuarial 5-year post-radiation biochemical recurrence-free rate was 34%. For 5 men who received radiation therapy for local recurrence actuarial 5-year post-radiation biochemical recurrence-free rate was 20%. CONCLUSIONS: Isolated clinical local recurrence is rare during long-term followup of men with Gleason score 7 disease and positive surgical margins at radical prostatectomy. Radiation therapy given at prostate specific antigen elevation poorly controlled the disease. Because patients with biochemical failure rarely had local recurrence at long-term followup, they most likely harbored subclinical distant metastasis. These data suggest that immediate adjuvant radiation therapy will not have a major impact on outcome because most men with Gleason score 7 disease and positive surgical margins in whom treatment fails most likely had distant metastasis at surgery. To improve the outcome in cases of Gleason score 7 disease and positive surgical margins a systemic approach to adjuvant therapy is necessary.

Aged↗
PubMed2004

Permanent iodine 125 brachytherapy in patients with progressive or recurrent glioblastoma multiforme.

This study reports the initial experience at the University of California San Francisco (UCSF) with tumor resection and permanent, low-activity iodine 125 (125I) brachytherapy in patients with progressive or recurrent glioblastoma multiforme (GM) and compares these results to those of similar patients treated previously at UCSF with temporary brachytherapy without tumor resection. Thirty-eight patients with progressive or recurrent GM were treated at UCSF with repeat craniotomy, tumor resection, and permanent, low-activity 125I brachytherapy between June 1997 and May 1998. Selection criteria were Karnofsky performance score > or =60, unifocal, contrast-enhancing, well-circumscribed progressive or recurrent GM that was judged to be completely resectable, and no evidence of leptomeningeal or subependymal spread. The median brachytherapy dose 5 mm exterior to the resection cavity was 300 Gy (range, 150-500 Gy). One patient was excluded from analysis. Median survival was 52 weeks from the date of brachytherapy. Age, Karnofsky performance score, and preimplant tumor volume were all statistically significant on univariate analyses. Multivariate analysis for survival showed only age to be significant. Median time to progression was 16 weeks. Both univariate and multivariate analysis of freedom from progression showed only preoperative tumor volume to be significant. Comparison to temporary brachytherapy patients showed no apparent difference in survival time. Chronic steroid requirements were low in patients with minimal postoperative residual tumor. We conclude that permanent 125I brachytherapy for recurrent or progressive GM is well tolerated. Survival time was comparable to that of a similar group of patients treated with temporary brachytherapy.

Adolescent↗
PubMed2006

Prostate specific antigen recurrence rates are low after radical retropubic prostatectomy and positive margins.

PURPOSE: Treatment in patients with a positive surgical margin after radical retropubic prostatectomy is controversial. Options are observation, radiation therapy and early hormone therapy. Making the appropriate choice should be based on an understanding of the risk of recurrence without treatment. MATERIALS AND METHODS: We reviewed the records of 1,383 patients after radical retropubic prostatectomy was performed by a single surgeon. All specimens were analyzed by a single pathologist. Of the patients 936 met criteria for analysis. RESULTS: Mean followup in these 936 patients was 45.8 months (minimum 12). The overall PSA biochemical recurrence rate was 11.5% (108 of 936 cases). Of the 936 patients 350 (37%) had tumor at an inked margin. These patients had a recurrence rate of 19% (67 of 350), while patients with negative margins had a recurrence rate of 7% (41 of 586). This difference was statistically significant (p <0.01). Multivariate HR analysis revealed that significant risk factors for recurrence in the 936 patients were PSA greater than 20 ng/ml, clinical stage T2 or greater, Gleason 7 or greater, seminal vesicle involvement, extraprostatic extension, a visual estimate of prostate cancer volume of greater than 9.1% and positive surgical margins. Statistically significant risk factors for recurrence in patients with a positive margin on multivariate HR analysis were PSA greater than 20 ng/ml, Gleason score 7 or greater and seminal vesicle involvement. CONCLUSIONS: Although the positive margin rate in this series was 37%, the recurrence rate in these patients was only 19%. It is important to consider other factors, such as PSA, Gleason score, seminal vesicle involvement and extraprostatic extension, when making treatment decisions.

Humans↗
PubMed2004

Venlafaxine versus placebo in the preventive treatment of recurrent major depression.

BACKGROUND: Major depression is often chronic and recurrent, yet most long-term therapeutic trials are not adequately designed to assess antidepressant efficacy in recurrence prevention. Long-term efficacy and safety of prophylactic venlafaxine treatment were evaluated in outpatients with recurrent major depression. METHOD: Patients with a history of recurrent DSM-III-R major depression received open-label treatment with venlafaxine, 100 to 200 mg/day, for 6 months. Those who responded to treatment (Hamilton Rating Scale for Depression [HAM-D(21)] score < or = 12, day 56) and remained relapse-free (no more than 2 HAM-D(21) scores > 10 and no Clinical Global Impressions-Severity of Illness [CGI-S] score > or = 4, months 2-6) either continued taking venlafaxine, 100 to 200 mg/day, or were switched in a double-blind fashion to placebo for 12 months. The primary efficacy outcome was the number of patients experiencing a recurrence of major depression (CGI-S score > or = 4). The cumulative probability of recurrence was calculated using the Kaplan-Meier method of survival analysis. Data were collected from November 1992 through December 1995. RESULTS: Of the 235 patients who enrolled in the recurrence-prevention period, 225 (N = 109, venlafaxine; N = 116, placebo) provided efficacy data. Survival analysis determined a 22% cumulative probability of recurrence in venlafaxine-treated patients after 12 months compared with 55% for the placebo group (p <.001). More than twice as many placebo-treated patients (48%) as venlafaxine-treated patients (21%) discontinued treatment because of lack of efficacy (p <.001). CONCLUSION: Twelve-month maintenance venlafaxine treatment was significantly more efficacious than placebo in preventing major depression recurrence in patients who had been successfully treated with venlafaxine for 6 months.

Adult↗