scispace - formally typeset
Search or ask a question

Showing papers on "Randomized controlled trial published in 1986"


Journal ArticleDOI
TL;DR: Two disorder-relevant treatments were developed: a patient-centered behavioral treatment and a psychoeducational family treatment among schizophrenic patients receiving maintenance neuroleptic treatment.
Abstract: • Relapse rates averaging 41% in the first year after discharge among schizophrenic patients receiving maintenance neuroleptic treatment led to the development of two disorderrelevant treatments: a patient-centered behavioral treatment and a psychoeducational family treatment. Following hospital admission, 103 patients residing in high expressed emotion (EE) households who met Research Diagnostic Criteria for schizophrenia or schizoaffective disorder were randomly assigned to a two-year aftercare study of (1) family treatment and medication, (2) social skills training and medication, (3) their combination, or (4) a drug-treated condition. First-year relapse rates among those exposed to treatment demonstrate a main effect for family treatment (19%), a main effect for social skills training (20%), and an additive effect for the combined conditions (0%) relative to controls (41%). Effects are explained, in part, by the absence of relapse in any household that changed from high to low EE. Only the combination of treatment sustains a remission in households that remain high in EE. Continuing study, however, suggests a delay of relapse rather than prevention.

899 citations


Journal ArticleDOI
01 Nov 1986-BMJ
TL;DR: A randomised trial of the treatment of hypertension in 884 patients aged 60 to 79 years at the onset showed a reduction of 18/11 mm Hg in blood pressure over a mean follow up period of 4.4 years.
Abstract: A randomised trial of the treatment of hypertension in 884 patients aged 60 to 79 years at the onset showed a reduction of 18/11 mm Hg in blood pressure over a mean follow up period of 4.4 years. The principal antihypertensive agents were atenolol and bendrofluazide. There was a reduction in the rate of fatal stroke in the treatment group to 30% of that in the control group (95% confidence interval 11-84%, p less than 0.025). The rate of all strokes (fatal and non-fatal) in the treatment group was 58% of that in the control group (95% confidence interval 35-96%, p less than 0.03). The incidence of myocardial infarction and total mortality was unaffected by treatment. Questionnaires completed by the patients and their relatives failed to identify any differences in symptoms that were likely to be due to treatment.

720 citations


Journal ArticleDOI
TL;DR: The standard way to assess medical technologies is to conduct a randomized clinical trial as mentioned in this paper, where patients are randomly assigned to groups receiving alternative treatments, and outcomes are monitored over a long period of time.
Abstract: The standard way to assess medical technologies is to conduct a randomized clinical trial. Patients are randomly assigned to groups receiving alternative treatments, and outcomes are monitored over a long period of time. For example, some victims of left main coronary artery disease may undergo coronary artery bypass surgery, and others may receive medical treatment with nitroglycerine and beta blockers. Comparison of five-year mortality and morbidity in the two groups helps to determine the relative appropriateness of the two procedures. In addition, information about quality of life and cost can also be collected and compared.

674 citations


Journal ArticleDOI
TL;DR: Results of the randomized trial conducted at the Mayo Clinic showed that offering both procedures to high-risk outpatients every 4 months conferred no mortality advantage over standard medical practice that included recommended annual testing.
Abstract: The National Cancer Institute has sponsored three randomized controlled trials of screening for early lung cancer in large, high-risk populations to determine whether lung cancer detection can be improved by adding sputum cytological screening every 4 months to chest roentgenography done either yearly or every 4 months; and lung cancer mortality can be significantly reduced by this type of screening program, followed by appropriate treatment. Results of the three trials suggest that sputum cytology alone detects 15% to 20% of lung cancers, almost all of which are squamous cancers with a favorable prognosis; and chest roentgenography may be a more effective test for early-stage lung cancer than previous reports have suggested. Nevertheless, results of the randomized trial conducted at the Mayo Clinic showed that offering both procedures to high-risk outpatients every 4 months conferred no mortality advantage over standard medical practice that included recommended annual testing.

535 citations


Journal ArticleDOI
TL;DR: Double-blind randomized trials are used in which a single patient undergoes a series of pairs of treatments, consisting of one active and one placebo or alternative treatment per pair, with the order determined by random allocation.
Abstract: Although the treatment of an individual patient in routine clinical practice has been likened to an experiment, the method is so susceptible to bias that we have come to demand multi-patient, double-blind, randomized controlled trials on matters of efficacy. Unfortunately, such trials have not or cannot be carried out for many clinical disorders; even when they have been executed their results may be difficult to extrapolate to individual patients. To resolve this problem, we have begun to use double-blind randomized trials in which a single patient undergoes a series of pairs of treatments, consisting of one active and one placebo or alternative treatment per pair, with the order determined by random allocation. Appropriate treatment targets (signs, symptoms, or laboratory tests) are used as the measure of efficacy, and the trial is continued until efficacy is established or disproved. We describe such a trial, which resulted in a dramatically beneficial modification of treatment in a patient with partially reversible airflow limitation. We have established a clinical service that facilitates the widespread use of the method in our community.

495 citations


Journal ArticleDOI
TL;DR: Out of 253 patients fulfilling criteria for a first episode of schizophrenic illness, 120 entered a randomised placebo-controlled trial of maintenance neuroleptic medication on discharge; they were followed to relapse or loss to follow-up, for two years or to the end of the study.
Abstract: Out of 253 patients fulfilling criteria for a first episode of schizophrenic illness, 120 entered a randomised placebo-controlled trial of maintenance neuroleptic medication on discharge; they were followed to relapse or loss to follow-up, for two years or to the end of the study. Of those on active medication, 46% relapsed, as did 62% of those on placebo; the most important determinant of relapse was duration of illness prior to starting neuroleptic medication. This finding might be because extended duration of symptoms before admission is more likely to be present in illnesses which in any case will have poor prognosis, or because susceptibility to relapse is reduced by early institution of treatment. The study provides no data on which a decision between these alternative explanations can be based.

450 citations


Journal ArticleDOI
TL;DR: It is concluded that psychiatric consultation in the care of patients with somatization disorder reduced subsequent health care expenditures without inducing changes in health status or patients' satisfaction with their health care.
Abstract: The per capita expenditure for health care of patients with multiple physical symptoms but no apparent physical disease (somatization disorder) is up to nine times the average per capita amount. We conducted a randomized controlled trial to determine whether psychiatric consultation would reduce the medical costs of these patients, without effecting a substantial change in patient outcome. Thirty-eight patients were randomly assigned to treatment or control groups and studied prospectively for 18 months. Treatment consisted of a psychiatric consultation and suggestions on management given to primary physicians. After nine months, the control group was crossed over to receive treatment with the same intervention. After the psychiatric consultation, the quarterly health care charges in the treatment group declined by 53 percent (P less than 0.05). In contrast, the charges in the control group showed wide variations but no overall change. The quarterly charges in the control group were significantly higher than those in the treatment group (P less than 0.05). After the control group was crossed over to receive treatment, their quarterly charges declined by 49 percent (P less than 0.05). The reductions in expenditures in both groups were due largely to decreases in hospitalization. We conclude that psychiatric consultation in the care of patients with somatization disorder reduced subsequent health care expenditures without inducing changes in health status or patients' satisfaction with their health care.

429 citations


Journal ArticleDOI
TL;DR: Because the clinics in a multiclinic randomized clinical trial represent neither fixed stratification effects nor random classificatory effects, the appropriate analysis of data from such a trial has been the subject of controversy and debate.

399 citations


Journal ArticleDOI
TL;DR: Results confirm the hypothesis that the favorable effect of auranofin on clinical synovitis is accompanied by improvements across a range of outcomes relevant to the patient's quality of life.

351 citations


Journal ArticleDOI
TL;DR: The design and results of each of these studies are reviewed, to assess the consistency of the findings, and to integrate and quantify the overall changes in major cardiovascular morbidity and mortality that have resulted from drug treatment of hypertension in these trials.

341 citations


Journal ArticleDOI
TL;DR: The Diabetes Education Study (DIABEDS) was a randomized, controlled trial of the effects of patient and physician education and its effects on patient knowledge, skills, self-care behaviors, and relevant physiologic outcomes were described.
Abstract: The Diabetes Education Study (DIABEDS) was a randomized, controlled trial of the effects of patient and physician education. This article describes a systematic education program for diabetes patients and its effects on patient knowledge, skills, self-care behaviors, and relevant physiologic outcomes. The original sample consisted of 532 diabetes patients from the general medicine clinic at an urban medical center. Patients were predominantly elderly, black women with non-insulin-dependent diabetes mellitus of long duration. Patients randomly assigned to experimental groups (N = 263) were offered up to seven modules of patient education. Each content area module contained didactic instruction (lecture, discussion, audio-visual presentation), skill exercises (demonstration, practice, feedback), and behavioral modification techniques (goal setting, contracting, regular follow-up). Two hundred seventy-five patients remained in the study throughout baseline, intervention, and postintervention periods (August 1978 to July 1982). Despite the requirement that patients demonstrate mastery of educational objectives for each module, postintervention assessment 11-14 mo after instruction showed only rare differences between experimental and control patients in diabetes knowledge. However, statistically significant group differences in self-care skills and compliance behaviors were relatively more numerous. Experimental group patients experienced significantly greater reductions in fasting blood glucose (-27.5 mg/dl versus -2.8 mg/dl, P less than 0.05) and glycosylated hemoglobin (-0.43% versus + 0.35%, P less than 0.05) as compared with control subjects. Patient education also had similar effects on body weight, blood pressure, and serum creatinine. Continued follow-up is planned for DIABEDS patients to determine the longevity of effects and subsequent impact on emergency room visits and hospitalization.

Journal ArticleDOI
TL;DR: Patients with stroke and evidence of depression are likely to benefit from treatment with trazodone, according to Barthel activities of daily living scores.
Abstract: Twenty-seven inpatients participating in a stroke rehabilitation program were randomized to receive either placebo or trazodone hydrochloride (Desyrel) beginning a mean (+/- SEM) of 44 +/- 4 days after stroke. The target dosage was 200 mg/d. Patients with either a clinical diagnosis of depression or abnormal Zung depression scores showed a consistent trend toward greater improvement in Barthel activities of daily living (ADL) scores with trazodone than with placebo. An abnormal dexamethasone suppression test result was associated with significant improvement in the Barthel ADL scores of patients receiving trazodone (38 +/- 6 vs 20 +/- 6 for placebo). Patients with stroke and evidence of depression are therefore likely to benefit from treatment with trazodone.

Journal ArticleDOI
15 Sep 1986-Cancer
TL;DR: The authors conclude that TPN may be useful when used preoperatively in patients with gastrointestinal tract cancer and underscores the importance of demonstrating significant benefits in randomized trials before TPN is used routinely in these patients.
Abstract: Twenty-eight prospective randomized controlled clinical trials evaluating the use of total parenteral nutrition (TPN) in cancer patients were identified through a search of major indexing sources. The data were pooled across studies to increase the ability to detect therapeutic effects. The impact of publication bias and the quality of reporting each trial were used to critically assess the conclusions drawn from the pooled analysis. The authors conclude that TPN may be useful when used preoperatively in patients with gastrointestinal tract cancer. It appears to be beneficial in reducing major surgical complications (pooled P = 0.01) and operative mortality (pooled P = 0.02). No statistically significant benefit from TPN could be demonstrated in survival, treatment tolerance, treatment toxicity, or tumor response in patients receiving chemotherapy or radiotherapy. An increase in the risk of developing an infection in chemotherapy patients given TPN (pooled P less than 0.0001) underscores the importance of demonstrating significant benefits in randomized trials before TPN is used routinely in these patients.

Journal ArticleDOI
TL;DR: The results suggest that prompt use of glucocorticoids in the emergency treatment of severe asthma can prevent significant morbidity, reduce the number of hospitalizations, and effect substantial savings in health care costs.
Abstract: Ninety-seven acutely ill patients with bronchial asthma were enrolled in a double-blind, placebo-controlled, randomized trial of intravenous methylprednisolone (125 mg), given on presentation in the emergency room in addition to standard emergency treatments for asthma. Subjective and spirometric indexes of the severity of the asthma were similar on entry into the study in all patients, but only 9 of 48 patients (19 percent) treated with methylprednisolone required hospital admission, as compared with 23 of 49 patients (47 percent) in the control group (P less than 0.003). Our results suggest that prompt use of glucocorticoids in the emergency treatment of severe asthma can prevent significant morbidity, reduce the number of hospitalizations, and effect substantial savings in health care costs.

Journal ArticleDOI
TL;DR: Only in the maximum intervention group was a significant improvement in knowledge of asthma shown, and these simple informational education programmes were ineffective when applied to a general practice population.

Journal ArticleDOI
TL;DR: There was evidence that quality has improved over time and that the increasing tendency of involving a biostatistician in the research team was positively associated with the improvement of the internal validity but not with the external.
Abstract: The methodology of randomized control trials (RCTs) of the primary treatment of early breast cancer has been reviewed using a quantitative method. Sixty-three RCTs comparing various treatment modalities tested on over 34,000 patients and reported in 119 papers were evaluated according to a standardized scoring system. A percentage score was developed to assess the internal validity of a study (referring to the quality of its design and execution) and its external validity (referring to presentation of information required to determine its generalizability). An overall score was also calculated as the combination of the two. The mean overall score for the 63 RCTs was 50% (95% confidence interval [CI] = 46% to 54%) with small and nonstatistically significant differences between types of trial. The most common methodologic deficiencies encountered in these studies were related to the randomization process (only 27 of the 63 RCTs adopted a truly blinded procedure), the handling of withdrawals (only 26 RCTs in...

Journal ArticleDOI
TL;DR: It is concluded that the administration of desmopressin acetate can be recommended to reduce blood loss in patients undergoing complex cardiac operations and the beneficial effect of the drug on hemostasis after cardiopulmonary bypass may be related to its effect on von Willebrand factor.
Abstract: Bleeding after cardiopulmonary bypass remains a cause for concern, requiring reexploration of the chest in approximately 3 percent of patients who have had operations on the heart. We examined the possibility that this problem might be alleviated by desmopressin acetate (DDAVP), which increases the plasma level of von Willebrand factor and improves hemostasis in mild hemophilia and other conditions associated with defective platelet function. In a double-blind, prospective, randomized trial, we studied the effect of intraoperative desmopressin acetate in 70 patients undergoing various cardiac operations requiring cardiopulmonary bypass. Patients undergoing uncomplicated primary coronary-artery bypass grafting were not included. The drug significantly reduced mean operative and early postoperative blood loss (1317 +/- 486 ml in the treated group vs. 2210 +/- 1415 ml in the placebo group); of the 14 patients whose 24-hour blood loss exceeded 2000 ml, 11 had received the placebo. Plasma levels of von Willebrand factor were higher after desmopressin acetate than after placebo. Patients with the most bleeding had relatively low levels of von Willebrand factor before operation, suggesting a role for this factor in the hemorrhagic tendency induced by extracorporeal circulation. There were no untoward side effects of desmopressin acetate. We conclude that the administration of desmopressin acetate can be recommended to reduce blood loss in patients undergoing complex cardiac operations. The beneficial effect of the drug on hemostasis after cardiopulmonary bypass may be related to its effect on von Willebrand factor.

Journal ArticleDOI
TL;DR: Results of this study do not support the use of intravenous heparin to treat patients who have had acute partial stroke.
Abstract: In a double-blind, placebo-controlled trial, 225 patients with acute partial stable thrombotic stroke were randomly assigned to receive continuous intravenous heparin therapy or placebo for 7 days for the prevention of stroke progression or death. No statistically significant difference between the two groups was found in degree of neurologic change; incidence of stroke progression after 7 days; or functional activity level of survivors at 7 days, 3 months and at 1 year after treatment. Compared with controls, a statistically significant greater number of patients in the group receiving heparin died in the year after the stroke. These deaths occurred 3 to 12 months after the initial stroke and probably were not related to treatment. Results of this study do not support the use of intravenous heparin to treat patients who have had acute partial stroke.

Journal ArticleDOI
TL;DR: Alternative radiologic techniques are compared by performing a randomized, controlled trial in which hand films of rheumatoid arthritis patients were read by several skilled observes, and critical selection of the method of assessing study endpoint is of great importance.
Abstract: Radiologic assessment of progressive joint destruction in rheumatoid arthritis is generally considered to be the ultimate standard for evaluation of treatment. We compared alternative radiologic techniques by performing a randomized, controlled trial in which hand films of rheumatoid arthritis patients were read by several skilled observes. The number of joints evaluated (34 versus 18) was found to make relatively little difference, but the number of readers and their experience level was critical. Films should be read in pairs. Joint space narrowing and erosion scores were shown to contribute independent information. Use of recommended techniques can reduce the number of patients required and, thus, can reduce the cost of a clinical trial by more than half and can substantially increase the sensitivity and efficiency of a trial. Therefore, critical selection of the method of assessing study endpoint is of great importance.

Journal ArticleDOI
TL;DR: The study indicates that an asthma-specific computer game can significantly affect knowledge and behavior and may potentially affect morbidity in childhood asthma.
Abstract: To affect asthma-related knowledge, behavior, and morbidity, researchers tested a new educational intervention for children with asthma: an asthma-specific computer game called Asthma Command, which was specifically designed for this study. Sixty-five children with moderately severe asthma were randomly assigned to one of two groups, and 54 completed the study. Both groups were seen approximately six times during the 1 year of the study. Control subjects (n = 29) played routine computer games. Experimental subjects (n = 25) played Asthma Command. Compared with children in the control group, experimental subjects showed improvement in knowledge about asthma (P less than .001), behavior related to the management of asthma (P less than .008), and a trend toward the reduction of acute visits due to asthma (P less than .13). Children in the experimental group also scored higher on the assessment of behaviors related to the management of asthma that were specifically addressed by the intervention provided by Asthma Command (P less than .01). Differences between the control and experimental groups showed a greater improvement in the experimental group in 21 (84%) of the 25 outcome variables in the study (P = .004, Sign test). The study indicates that an asthma-specific computer game can significantly affect knowledge and behavior and may potentially affect morbidity in childhood asthma.

Journal ArticleDOI
24 Jan 1986-JAMA
TL;DR: A randomized trial of a mailed continuing education program on hypertension for primary care physicians showed no lasting effect on physician knowledge and no influence on performance in lowering the blood pressures of patients referred from screening.
Abstract: Evidence is sparse concerning the value of the "educational" materials that physicians receive in the mail We conducted a randomized trial of a mailed continuing education program on hypertension for primary care physicians Although formal pretesting documented that the program led to significant improvements in physician knowledge over the short term, the current study showed no lasting effect on physician knowledge (mean scores on an end-of-study questionnaire were 50% and 52% for study and control physicians, respectively) and no influence on performance in lowering the blood pressures of patients referred from screening (mean blood pressure drop for study patients, 122/104 mm Hg vs 130/106 mm Hg for control patients) The chance that we missed a difference in diastolic blood pressure as great as 3 mm Hg is less than 5% Resources spent on instructional materials mailed to physicians may be wasted ( JAMA 1986;255:501-504)

Journal ArticleDOI
04 Jan 1986-BMJ
TL;DR: High dose steroid treatment was ineffective in ischaemic stroke, and the data suggest that further evaluation by a larger multicentre trial is not justified.
Abstract: Steroid treatment is widely used in acute cerebral infarction yet its value is controversial. High dose dexamethasone (480 mg over 12 days) was given in a double blind, randomised controlled trial to 113 consecutive eligible patients with acute cerebral infarction admitted to an acute stroke unit. Those with stroke for more than 48 hours, known embolic sources, diabetes, and infection were excluded. Death and quality of survival were recorded over 21 days. The active drug group (54 patients) matched the placebo group (59 patients) for age, initial stroke score, delay in beginning treatment, and other relevant variables. The two groups did not differ significantly in death rate or quality of survivorship. The small difference in mortality between the two groups may have represented a marginal therapeutic effect, which might reach significance in a larger sample. The widespread use of steroids in response to such a marginal therapeutic gain would expose large numbers of patients with stroke to more serious hazards of steroid treatment and convert patients who would otherwise have died into neurovegetative survivors. High dose steroid treatment was ineffective in ischaemic stroke, and the data suggest that further evaluation by a larger multicentre trial is not justified.


Journal ArticleDOI
16 May 1986-JAMA
TL;DR: It is concluded that a geriatric consultation team contributes substantial additional input into the care of older patients and relatively high compliance can be achieved with recommendations made by a geriatrics consultation team, thereby overcoming the first barrier to the establishment of such a service.
Abstract: As part of a prospective, randomized, controlled study of the effectiveness of a geriatric consultation team, we examined compliance by the house staff with recommendations made by the team. Recommendations were formulated for 185 patients, aged 75 years or older, who were randomized into intervention (n = 92) and control (n=93) groups. In the control group, only 27.1% of the actions that would have been recommended by the team were implemented independently by the house staff. Problems commonly neglected included polypharmacy, sensory impairment, confusion, and depression. In the intervention group, overall compliance was 71.7%. Highest compliance occurred for recommendations addressing instability and falls (95.0%) and discharge planning (94.3%). We conclude that a geriatric consultation team contributes substantial additional input into the care of older patients. Furthermore, relatively high compliance can be achieved with recommendations made by a geriatric consultation team, thereby overcoming the first barrier to the establishment of such a service. (JAMA1986;255:2617-2621)

Journal ArticleDOI
TL;DR: It is concluded that although net differences in risk factors between the two groups had been reduced during the three years after the regular intervention period, the significant difference in coronary events and sudden death was maintained.

Journal ArticleDOI
TL;DR: After three weeks' treatment the traditional-acupuncture group showed significantly greater benefit in terms of subjective scores of breathlessness and six-minute walking distance than the placebo group.

Journal Article
TL;DR: Both drugs were effective in two thirds of the patients and appeared about equal in most outcome measures, except for a significantly higher dropout rate for patients with mood-incongruent psychotic features who were assigned to the lithium group.
Abstract: The comparative usefulness of carbamazepine and lithium carbonate in the acute and prophylactic management of DSM-III diagnosed major affective, schizoaffective, or schizophreniform psychoses was investigated in a 3-year, prospective double-blind randomized trial with 83 in- and outpatients. The incidence of side effects was similar in both treatment groups, and side effects generally responded well to dosage reduction. Both drugs were effective in two thirds of the patients and appeared about equal in most outcome measures, except for a significantly higher dropout rate for patients with mood-incongruent psychotic features who were assigned to the lithium group. Both drugs appeared more effective in preventing excited rather than depressive symptoms.

Journal ArticleDOI
TL;DR: The results of this study indicate that stress management techniques may have therapeutic benefits for IBD patients.
Abstract: This randomized controlled trial was designed to determine whether practising stress management techniques would decrease activity and promote psychosocial functioning in inflammatory bowel disease patients. Eighty ambulatory adults received a pre-intervention interview, at which time baseline data about disease activity and psychosocial functioning were collected. They were then randomly assigned to either the intervention or control group. The intervention group received six classes on stress management which included autogenics, personal planning skills and communication techniques. All 80 subjects were followed up at 4-month intervals for 1 year by interviewers who were blind to group designation. The data collection instruments, which were used at all assessment points, comprised three questionnaires: the Crohn's Disease Activity Index (CDAI) and the Inflammatory Bowel Disease (IBD) Stress Index. These instruments produced scores which decreased with improvement in physical and psychosocial well-being. At all assessment points, both the CDAI and IBD Stress Index scores dropped significantly (P less than 0.05) from baseline in the treatment group. However, there was no significant change in the scores of the control group throughout the study year. There were no significant changes in medications at any assessment point in either group that could account for changes in the scores. The results of this study indicate that stress management techniques may have therapeutic benefits for IBD patients.

Journal ArticleDOI
TL;DR: The early physical therapy program investigated in this study was not efficacious in altering the pattern of motor development in those high-risk infants participating in the trial.
Abstract: A prospective, randomized, controlled trial was conducted to assess the effects of early physical therapy on infants at risk for neurologic sequelae and to evaluate the impact of such early treatment on the prevention or minimization of future handicaps. A cohort of 134 infants who had received care in two Montreal inborn neonatal intensive care units was identified prospectively. Infants were stratified according to prognosis and birth weight and were randomly assigned to either an experimental or control group. Babies assigned to the experimental group received early physical therapy, whereas those allocated to the control group received conventional follow-up care. Outcome measures were administered by independent evaluators at 12 months and included measures of neurologic status, motor and overall development, and physical growth. No statistically significant differences on any of the measured outcomes at 12 months were found between the experimental and control groups. Infants weighing less than 750 g at birth, regardless of group assignment, consistently demonstrated significant delays in their growth and development when compared with their heavier peers. The early physical therapy program investigated in this study was not efficacious in altering the pattern of motor development in those high-risk infants participating in the trial.

Journal ArticleDOI
TL;DR: All future trials of chemotherapy should involve a randomized comparison with a group of patients receiving radiation and/or surgery alone, and chemotherapy has no place in the routine management of primary head and neck cancer.
Abstract: Numerous single-arm studies have shown that chemotherapy may produce a high rate of response and rapid shrinkage of tumor when used before radiation and/or surgery in patients with squamous-cell carcinoma of the head and neck. Despite this high rate of tumor response, randomized controlled trials do not indicate any consistent improvement in survival for patients receiving chemotherapy as compared with patients receiving local treatment alone. This population of patients often has poor performance status, and chemotherapy invariable adds some toxicity. Also, studies in animals suggest that some types of chemotherapy given before local radiation or surgery might increase the probability of distant metastases. Apart from pilot studies of feasibility, all future trials of chemotherapy should involve a randomized comparison with a group of patients receiving radiation and/or surgery alone. At present, chemotherapy has no place in the routine management of primary head and neck cancer.