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Objective To compare the efficacy of surgery with disc prosthesis versus non-surgical treatment for patients with chronic low back pain. Design A prospective randomised multicentre study. Setting Five university hospitals in Norway. Participants 173 patients with a history of low back pain for at least one year, Oswestry disability index of at least 30 points, and degenerative changes in one or two lower lumbar spine levels (86 patients randomised to surgery). Patients were treated from April 2004 to September 2007. Interventions Surgery with disc prosthesis or outpatient multidisciplinary rehabilitation for 12-15 days. Main outcome measures The primary outcome measure was the score on the Oswestry disability index after two years. Secondary outcome measures were low back pain, satisfaction with life (SF-36 and EuroQol EQ-5D), Hopkins symptom check list (HSCL-25), fear avoidance beliefs (FABQ), self efficacy beliefs for pain, work status, and patients’ satisfaction and drug use. A blinded independent observer evaluated scores on the back performance scale and Prolo scale at two year follow-up. Results The study was powered to detect a difference of 10 points on the Oswestry disability index between the groups at two years. At two years there was a mean difference of −8.4 points (95% confidence interval −13.2 to −3.6) in favour of surgery. In the analysis of prespecified secondary outcomes, there were significant differences in favour of surgery for low back pain (mean difference −12.2, −21.3 to −3.1), patients’ satisfaction (63% (n=46) v 39% (n=26)), SF-36 physical component score (mean difference 5.8, 2.5 to 9.1), self efficacy for pain (mean difference 1.0, 0.2 to 1.9), and the Prolo scale (mean difference 0.9, 0.1 to 1.6). There were no significant differences in return to work, SF-36 mental component score, EQ-5D, fear avoidance beliefs, Hopkins symptom check list, drug use, and the back performance scale. One serious complication of leg amputation occurred during surgical revision of a polyethylene dislodgement. The drop-out rate was 20% (34) and the crossover rate was 6% (5). Conclusions Surgical intervention with disc prosthesis for chronic low back pain resulted in a significantly greater improvement in the Oswestry score compared with rehabilitation, but this improvement did not clearly exceed the prespecified minimally important clinical difference between groups of 10 points, and the data are consistent with a wide range of differences between the groups, including values well below 10 points. The potential risks of surgery and the substantial amount of improvement experienced by a sizeable proportion of the rehabilitation group also have to be incorporated into overall decision making. Trial registration NCT 00394732.

Objectives. The main purpose of the study was to assess a possible association between haematocrit (Hct) and long-term cardiovascular disease (CVD) mortality. Design. An extensive examination programme was carried out in 2014 men, defined as apparently healthy, during the period 1972 to 1975, including Hct measurements in a 25% random subsample. Sequential, cause-specific mortality was followed prospectively over a period of 16 years. Setting. The survey was conducted at Medical Department B, Rikshospitalet, Oslo, Norway. Subjects. The participants represented 86% of all eligible apparently healthy men working in five preselected companies in Oslo. Interventions. No intervention was given by the study group during follow-up. Main outcome measures. Complete, cause-specific mortality figures after 8–16 years were obtained from the Norwegian Central Bureau of Statistics. Results. Hct measures were obtained in 488 men (24.2%). Mean Hct was 47.2% (sd 2.9%). After correcting for differences in age, plasma cholesterol, systolic blood pressure, erythrocyte sedimentation rate and smoking habits (Cox proportional hazards model), an increase in Hct by 2 SDS was associated with an increase in CVD mortality by a factor ranging between 2.9 at 10, and 1.9 at 16 years (P < 0.05). A similar increased risk was observed earlier during follow-up but the number of deaths was too small for meaningful statistical analysis. No association was found between Hct and non-CVD mortality. Conclusions. Our data show that increased Hct is associated with an increased risk of dying from CVD—independent of conventional CVD risk factors.

Data concerning the natural history of asymptomatic coronary artery disease (CAD) has been limited to epidemiologic rather than angiographic studies, thus leading to uncertainty as to whether warning symptoms and signs will identify subjects with silent myocardial ischemia before morbid events. To address this issue, 50 apparently healthy men with angiographically proven CAD and asymptomatic exercise-induced ST depression have been followed prospectively for 15 years in the Oslo Ischemia Study. Fourteen men died. The initial presenting clinical event in these 14 men was chest pain in 4 (30%)--but in only 1 case was it recognized as typical angina--silent myocardial infarction in 5 (35%) and sudden death in 5 (35%). Thirty-six men survived, with 19 developing symptoms. Overall, chest pain was the first clinical event in 22 of the total of 33 men with symptoms (66%), whereas myocardial infarction occurred in 6 (18%) and sudden death in 5 (16%). Although chest pain occurred in 22 men, it was clinically diagnosed as typical angina pectoris in only 6. These observations suggest that there is an absence of clear-cut ischemic symptoms in many asymptomatic patients before morbid events.

Despite many studies suggesting that poor physical fitness is an independent risk factor for death from cardiovascular causes, the matter has remained controversial. We studied this question in a 16-year follow-up investigation of Norwegian men that began in 1972.Our study included 1960 healthy men 40 to 59 years of age (84 percent of those invited to participate). Conventional coronary risk factors and physical fitness were assessed at base line, with physical fitness measured as the total work performed on a bicycle ergometer during a symptom-limited exercise-tolerance test.After an average follow-up time of 16 years, 271 men had died, 53 percent of them from cardiovascular disease. The relative risk of death from any cause in fitness quartile 4 (highest) as compared with quartile 1 (lowest) was 0.54 (95 percent confidence interval, 0.32 to 0.89; P = 0.015) after adjustment for age, smoking status, serum lipids, blood pressure, resting heart rate, vital capacity, body-mass index, level of physical activity, and glucose tolerance. Total mortality was similar among the subjects in fitness quartiles 1, 2, and 3 when the data were adjusted for these same variables. The adjusted relative risk of death from cardiovascular causes in fitness quartile 4 as compared with quartile 1 was 0.41 (95 percent confidence interval, 0.20 to 0.84; P = 0.013). The corresponding relative risks for quartiles 3 and 2 (as compared with quartile 1) were 0.45 (95 percent confidence interval, 0.22 to 0.92; P = 0.026) and 0.59 (95 percent confidence interval, 0.28 to 1.22; P = 0.15), respectively.Physical fitness appears to be a graded, independent, long-term predictor of mortality from cardiovascular causes in healthy, middle-aged men. A high level of fitness was also associated with lower mortality from any cause.

Physical work load was assessed by doctors and patients to have contributed to the health problems leading to sickness certification in 48.4% of 1413 patients certified sick by 118 general practitioners in Buskerud county, Norway (1986). Correspondingly, psychological factors were considered contributory in 32.1%. The potential for prevention of health problems underlying sickness certificates was reported in 37.1%. As expected, the frequency of sickness certification in which physical work load and psychological factors were considered to have contributed varied with the patients' occupation, type of work, and health problem. Physical work load was assessed as contributory particularly in patients with musculoskeletal/connective tissue diseases whose work involved much walking and lifting (93.2%) or was physically strenuous (94.0%). Psychological factors were assessed as contributory in a high percentage of cases whose work was mostly sedentary. The findings indicate that the potentials for prevention as assessed by doctors and patients were highest when the health problems underlying sickness certification were associated with musculoskeletal/connective tissue diseases. The results indicate a potential for prevention and limitation of sickness certification which may be utilized by a better collaboration between community medicine and occupational health services.

1. To assess the long-term effectiveness of a comprehensive cardiac rehabilitation programme on quality of life and survival in patients with a large spectrum of cardiovascular diseases (myocardial infarction, acute coronary syndrome, percutaneous transluminal coronary angioplasty and coronary artery bypass grafting). 2. To establish the degree of correlation between expected improvement of health-related quality of life and improvement in physical function attributable to rehabilitation in the intervention group, in comparison with similar changes in the conventional care group. Randomized, controlled, parallel-group design (intervention/conventional care). Akershus County, southeast of Oslo City, Norway. 500 patients, men and women, aged 40-85 years, who have sustained at least one of the above-mentioned cardiovascular diseases. 8 weeks of supervised, structured physical training of three periods of 20 min per week, targeting a heart rate of 60-70% of the individual's maximum; home-based physical exercise training with the same basic schedule as in the supervised period; quantification of patients' compliance with the exercise programme by the use of wristwatches, information stored in the watch memory being retrieved once a month during the 3-year follow-up period; and life-style modification with an emphasis on the cessation of smoking and on healthy nutrition and weight control.

Forty-five insulin-dependent diabetics were randomized to 1 yr treatment with either continuous subcutaneous insulin infusion (CSII), multiple insulin injections (MI), or continued conventional treatment. The CSII group used regular insulin only, the MI group used 4-6 premeal injections of regular insulin and intermediate insulin at night, and the conventional group used two daily injections of combined regular and intermediate insulin. Only highly purified porcine insulin was used. Near normoglycemia was obtained during CSII and MI but not during conventional treatment. Antibodies against insulin were measured in serum samples by measuring the binding of iodinated porcine insulin to serum after removal of free and antibodybound insulin from the samples by acid charcoal. The percent binding of 125I-labeled insulin increased significantly during MI and CSII, in contrast to conventional treatment. Nineteen patients had sufficient binding capacity for Scatchard analysis. In the CSII and MI groups, high- or low-affinity antibodies or both were induced. When insulin was administered subcutaneously during MI or CSII for 1 yr, the insulin antibody production increased, in contrast with conventional treatment.

The ovarian morphology in 149 patients with the clinical syndrome of polycystic ovaries (group I) is described. The ovaries from 10 age-matched women (group II) with no signs of ovarian disorder were investigated as a reference material. The number of cysts documented for group I was twice that of the reference group and the ovarian volume three times that of the normals. No significant difference in follicle number was seen between the two groups. The tunica albuginea was thicker in group I with more pronounced atretic changes. The duration of symptoms for group I correlated significantly with body mass index, thickening of tunica, degree of stromal hyperplasia and the calculated means of ovarian volume. A correlation was also seen between ovarian volume, degree of follicular atresia and stromal hyperplasia, as well as between the thickness of the tunica albuginea, number of follicles and degree of follicular atresia.

The efficacy of transdermal scopolamine, oral meclizine, and placebo in protection against motion sickness was compared in a double-blind crossover study. Thirty-six healthy subjects were exposed to motion three times for 90 min in a ship-motion simulator. Transdermal applications were made and tablets were taken at least 12 and 2 hr before exposure to motion. Transdermal scopolamine provided better protection than placebo or meclizine. Dryness of mouth was the only side effect reported more frequently for one regimen, transdermal scopolamine.

SUMMARY The problem of constructing dichotomous keys with maximum probability of right determination is discussed. Under some assumptions it is shown that keys in which all taxa are gathered on the last two levels have this property. The discussions also indicate that keys generally should be made as ‘short’as possible.

To assess the degree of familial clustering and the mode of inheritance of the polycystic ovarian syndrome (PCO), the prevalence of PCO-related symptoms among first- and second-degree relatives of 132 PCO patients and 71 controls was studied using questionnaire data. 19.7% of male first-degree relatives of PCO patients were reported to have early baldness or excessive hairiness, as opposed to 6.5% of relatives of controls. For female first-degree relatives, the percentages for PCO-related symptoms were 31.4 and 3.2, respectively, in the two groups. In a subgroup of 52 families of PCO patients where one of the parents was reported to have symptoms, 35% of brothers and 58% of sisters had symptoms. Although autosomal dominant inheritance could be excluded as an explanation for PCO in the whole data set, the findings were consistent with this mode of inheritance for a sizeable fraction of families. X-linked dominant inheritance of PCO could be discarded.

Ninety-two nonpsychotic inpatients took part in an exploratory study to assess the therapeutic effect of aerobic exercise intervention. All patients were hospitalized for 8 weeks and took part in aerobic exercise for at least 1 h five times a week. Degree of general mental distress was measured by the Symptom Rating Test (SRT); physical work capacity (PWC) was calculated from a submaximal bicycle ergometer test. Three patients dropped out. In every diagnostic category there was significant increase in PWC. Patients with alcohol abuse or dependence had the greatest reductions in symptom scores at the hospital, followed by those with unipolar depressive and anxiety disorders. Eighty-four per cent responded to a 1-year follow-up investigation by mailed questionnaires. The best long-term outcome was found in patients with alcohol abuse and dependence and unipolar depressive disorders. Sixty-five per cent of respondents exercised regularly, and regular exercise habits were most strongly associated with low SRT...

SummaryObjectiveTo compare the efficacy of patient education and supervised exercise with that of patient education alone for the management of pain in patients with hip osteoarthritis (OA).DesignSingle blind randomized clinical trial.SettingRecruitment of patients from hospitals, primary health care and advertisement, Oslo, Norway.Participants109 patients with radiographic and symptomatic hip OA with mild to moderate symptoms.InterventionsPatient education (PE). Patient education and supervised exercise (PE+SE).Primary outcome measureThe pain subscale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC pain).ResultsNo significant between group differences were found for WOMAC pain over the 16-month follow-up. Significant improvements were found for the secondary outcome WOMAC physical function (P=0.011) in the group receiving PE+SE compared to the group receiving PE only. No significant differences were found for WOMAC stiffness, the SF-36 subscales or the activity scale. The effect sizes (95% confidence interval) for WOMAC pain were −0.26 (0.11, −0.64), −0.35 (0.07, −0.77), and −0.30 (0.15, −0.75), and for WOMAC physical function −0.29 (0.09, −0.67), −0.48 (−0.06, −0.91), and −0.47 (−0.02, −0.93) at 4, 10 and 16 months, respectively, in favor of the group receiving both PE and SE. All patients attended the three-session PE program, and 75% performed ≥16 sessions of the 12-week SE program.ConclusionThe study could not demonstrate a significant difference in pain reduction over time between PE+SE vs PE alone. Adding SE to PE may improve physical function, but the magnitude of possible benefit is unknown as the 95% confidence intervals around the mean difference were wide.Trial registrationClinical Trials NCT00319423.

A motion sickness plaster releasing a powerful antisialogogic agent, scopolamine, was tested in a double blind clinical trial for its effect on salivary parameters in 14 healthy young men. The agent caused a decline in salivary flow rates, which was most pronounced during unstimulated conditions. Salivary pH and buffer capacity were also reduced. Salivary levels of Streptococcus mutans and lactobacilli showed a tendency to increase during 2 days on the antisialogogic agent, but the effect on S. mutans levels was not statistically significant.

Forty-five diabetic patients, 18 to 45 years of age, with mild or no retinopathy, were randomly assigned to continuous subcutaneous insulin infusion (CSII), multiple injections (Mls), and conventional insulin treatment (CIT). The effects of near-normoglycemia (CSII and MI) on oscillatory potentials (electroretinography [ERG]) and macular recovery time (nyctometry) were studied prospectively for 41 months. Before randomization, the amplitudes of oscillatory potentials were negatively correlated to age (P = 0.002) and positively correlated to the diameter of retinal veins (P less than 0.05). Men had shorter macular recovery time than women (P = 0.03). Nyctometry and oscillatory potentials were not related to mean blood glucose values, glycosylated hemoglobin (HbA1), retinopathy, blood pressure levels, or duration of diabetes. Changes in metabolic control (MI and CSII; P less than 0.01) and in microaneurysms and hemorrhages (CSII and CIT) during the study did not affect oscillatory potentials or nyctometry. Soft exudates (15 patients) and proliferative retinopathy (1 patient) transiently developed with MI and CSII regimens. No changes in oscillatory potentials or nyctometry were observed and no pretreatment characteristics of these parameters predicted the occurrence of these ischemic lesions. At the stage of proliferation, however, lowered amplitudes of oscillatory potentials and lengthened macular recovery time were observed.

• Forty-five diabetic patients were randomized and treated with continuous subcutaneous insulin infusion (CSII), multiple insulin injections (MI), or conventional insulin treatment (CIT) for 41 months. Near-normoglycemia was obtained with CSII and MI but not with CIT. A transient increase in microaneurysms and hemorrhages was seen at three months in CSII-treated patients. After 41 months, a moderate progression in microaneurysms and hemorrhages was registered, as assessed from fundus photographs, in all treatment groups. Fluorescein angiograms indicated a tendency (not statistically significant) to retarded progression of retinopathy in MI- and CSII-treated patients compared with CIT-treated patients. Soft exudates developed after three to six months of rapid tightening of metabolic control in 50% of patients on CSII and MI regimens. Those patients who had soft exudates had a slower progression of retinopathy three years later than those who did not develop soft exudates. Transient progression of retinopathy may be related to fluctuations in blood glucose levels, although a favorable effect of long-term improved metabolic control was not documented.

Mild background retinopathy was studied prospectively during long-term strict blood glucose control in insulin-dependent diabetes mellitus. Forty-five subjects (21 women and 24 men with a mean age of 26.3 years and a mean duration of diabetes of 12.8 years) were randomly assigned to continuous subcutaneous insulin infusion, multiple injections, and conventional two-injection treatment. Eyes were examined two months before treatment, at the beginning of treatment, and after three, six, and 12 months. A progressive deterioration was found in the two-injection group during the study, but no significant changes were found in patients receiving multiple injections. A transient deterioration occurred after three months of continuous subcutaneous insulin infusion. Soft exudates appeared in 50% of the patients on the two intensified regimens, but no exudates were found in patients given conventional treatment. The morphologic changes seemed to be related to a large and rapid decrease in mean blood glucose or to an increased frequency of hypoglycemia, or both.

A positive exercise ECG test in a middle-aged man without confounding disease is a strong indicator of occult coronary heart disease. In the years following a positive lest mortality increases moderately, but CHD events vary considerably compared with subjects having normal exercise tests. If a second exercise test is positive in the same subjects years later, this signifies a disease which is prone to progress in a very severe way in the ensuing years. A first normal test followed by a second pathologic test has an intermediate prognostic significance compared with two normal tests years apart. The clinical course indicates that preventive measures should be taken after observing a positive exercise test, and even more importantly if two positive tests are observed years apart.

The intensity profiles of the central light streak on various sized retinal vessels were measured by a computerized high quality scanning microphotometer. From the fundus photographs in 40 young men 240 arteries and 240 veins were analysed, and light streaks were found on 171 arterial and 170 venous sites. Differences in reflected intensities between arteries and veins and between small and large vessels were studied. In the whole range of vessels measured (50-200 microns) significantly higher intensities were found on arteries compared to veins (P less than 0.01). Large vessels (100-200 microns) reflected the light more intensely than small vessels (50-99 microns) (P less than 0.001). Variations in haemodynamics of flow and in physical properties of the streaming erythrocytes might account for the reflectivity differences between arteries and veins.

Forty men with mild to moderate hypertension were given one of two dietary supplements for 6 weeks: 20 capsules of fish oil (MaxEPA) or placebo (olive and corn oil). The MaxEPA supplement provided about 7 g omega-3-fatty acids pr day, whereas the placebo contained about 7 g omega-6-fatty acids and only 0.2 g omega-3-fatty acids. A clinical insignificant reduction in blood pressure was noted in both groups. In the fish oil group, the serum triglyceride levels fell by 30%. A decrease in the ratio total cholesterol/high density lipoprotein (HDL-) cholesterol was noted in both groups, most pronounced in the placebo group. No significant effect on total serum cholesterol level was observed during this study.

Background The aim of the present study was to compare the prevalence of periodontitis and alveolar bone loss among individuals with psoriasis and a group of randomly selected controls. Methods Fifty individuals with psoriasis and 121 controls completed a structured questionnaire, and were examined clinically and radiographically. Oral examination included numbers of missing teeth, probing pocket depth (PPD), clinical attachment level (CAL), presence of dental plaque and bleeding on probing, as well as alveolar bone loss from radiographs. Questionnaires requested information on age, gender, education, dental care, smoking habits, general diseases and medicament use. For adjustment for baseline differences between psoriasis individuals and controls the propensity score based on gender, age and education was computed using multivariate logistic regression. A subsample analysis for propensity score matched psoriasis individuals (n = 50) and controls (n = 50) was performed. Results When compared with controls, psoriasis individuals had significantly more missing teeth and more sites with plaque and bleeding on probing. The prevalence of moderate and severe periodontitis was significantly higher among psoriasis individuals (24%) compared to healthy controls (10%). Similarly, 36% of psoriasis cases had one or more sites with radiographic bone loss ≥3 mm, compared to 13% of controls. Logistic regression analysis showed that the association between moderate/severe periodontitis and psoriasis remained statistically significant when adjusted for propensity score, but was attenuated when smoking was entered into the model. The association between psoriasis and one or more sites with bone loss ≥3 mm remained statistically significant when adjusted for propensity score and smoking and regularity of dental visits. In the propensity score (age, gender and education) matched sample (n = 100) psoriasis remained significantly associated with moderate/severe periodontitis and radiographic bone loss. Conclusions Within the limits of the present study, periodontitis and radiographic bone loss is more common among patients with moderate/severe psoriasis compared with the general population. This association remained significant after controlling for confounders.

Background Few studies have examined how various lifestyle factors in midlife predict longevity, and none of these studies have examined the impact of physical fitness. The present study aimed to examine longevity in relation to smoking, overweight and physical fitness. Methods We prospectively studied longevity (defined as reaching at least 85 years of age) in relation to smoking status, body mass index and physical fitness in 821 healthy men between 51 and 59 years of age. Of these, 369 were smokers, 320 were overweight, and 31 were obese. The associations were adjusted for age, systolic blood pressure and cholesterol level, using multivariate logistic regression analysis. Deaths were registered until the 31st of December, 2006. Physical fitness was measured as the total work performed in a maximal exercise tolerance bicycle test. Results 252 men survived to the age of 85 years (30.7%). Smoking status was significantly and independently related to longevity; 37.2% of the non-smokers survived to the age of 85, and 22.8% of the smokers. Among non-smokers, overweight and physical fitness were significantly and independently related to longevity after adjustment for age, blood pressure and cholesterol level, but not among smokers. Among non-smokers with high physical fitness, 48.8% reached the age of 85 years, compared to 27.9% among non-smokers with low physical fitness. Conclusion Lifestyle variables appear to be strong and independent predictors of longevity in initially healthy middle-aged men. The probability of longevity may be a useful concept when informing the general public about the benefits of a healthy lifestyle.

In a clinical single case study the object is to decide whether a certain treatment has an intended effect on a certain patient. It is pointed out that the design should only be used in clinical situations where several rather strong assumptions are fulfilled. However, in these situations the design may be of significant value.