Hip fracture prevention with a multifactorial educational program in elderly community-dwelling Finnish women.

UNLABELLED: Guidelines suggest identification of women at fracture risk by bone density measurement and subsequently pharmacotherapy. However, most women who sustain a hip fracture do not have osteoporosis in terms of bone density. The present non-pharmacological intervention among elderly women unselected for osteoporosis reduced hip fracture risk by 55 % providing an alternative approach to fracture prevention. INTRODUCTION: Hip fractures are expensive for society and cause disability for those who sustain them. We studied whether a multifactorial non-pharmacological prevention program reduces hip fracture risk in elderly women. METHODS: A controlled trial concerning 60- to 70-year-old community-dwelling Finnish women was undertaken. A random sample was drawn from the Population Information System and assigned into the intervention group (IG) and control group (CG). Of the 2,547 women who were invited to the IG, 1,004 (39 %) and of the 2,120 invited to the CG, 1,174 (55 %) participated. The IG participated in a fracture prevention program for 1 week at a rehabilitation center followed by review days twice. The CG received no intervention. During the 10-year follow-up, both groups participated in survey questionnaire by mail. Outcome of interest was occurrence of hip fractures and changes in bone-health-related lifestyle. RESULTS: During the follow-up, 12 (1.2 %) women in the IG and 29 (2.5 %) in the CG sustained a hip fracture (P = 0.039). The determinants of hip fractures by stepwise logistic regression were baseline smoking (odds ratio (OR) 4.32 (95 % confidence interval [CI] 2.14-8.71), age OR 1.15/year (95 % CI 1.03-1.28), fall history OR 2.7 (95 % CI 1.24-5.9), stroke history OR 2.99 (95 % CI 1.19-7.54) and participating in this program OR 0.45 (95 % CI 0.22-0.93). Starting vitamin D and calcium supplement use was more common in the IG compared with the CG. CONCLUSIONS: The results suggest that this non-pharmacological fracture prevention program may reduce the risk of hip fractures in elderly Finnish women.

Genetically defined adult-type hypolactasia and self-reported lactose intolerance as risk factors of osteoporosis in Finnish postmenopausal women.

OBJECTIVE: To study the relationships of molecularly defined lactose malabsorption (LM) and self-reported lactose intolerance (LI) to bone mineral density (BMD) and fractures among Finnish postmenopausal women. DESIGN: A cross-sectional study of two cohorts. SETTING: Helsinki University Central Hospital. SUBJECTS: One cohort was population-based and comprised 453 women, aged 62-78 (mean 69) y. Another comprised 52 women, aged 69-85 (mean 75) y, with osteoporotic fractures and 59 control women, aged 69-83 (mean 74) y, without osteoporosis. METHODS: A single nucleotide polymorphism of the lactase (LCT) gene at chromosome 2q21-22 was studied. It shows complete association with intestinal disaccharidase activity, with the genotype CC(-13 910) meaning adult-type hypolactasia (primary LM) and the genotypes CT(-13 910) and TT(-13 910) lactose absorption. BMD of the heel was measured by dual-energy X-ray absorptiometry (DXA). RESULTS: In the population-based cohort, 16.0% of women had self-reported LI but only 15.3% of them had the CC(-13 910) genotype. Calcium intake from dairy products (P = 0.10) and BMD, adjusted for age, weight, height, exercise, smoking, and estrogen use (P = 0.71) were similar for the genotypes. Women with self-reported LI had reduced calcium intake from dairy products (P < 0.0001) but they were more frequent users of calcium supplements than lactose-tolerants (P < 0.0001). Adjusted BMD was similar for lactose intolerant and tolerant women (P = 0.60). Of 104 women with previous fracture in the population-based cohort, 13.5% had the CC(-13 910) genotype, which did not differ from the prevalence of 19.3% among 347 women without fractures (P = 0.29). The frequency of the CC(-13 910) genotype (23.1%) for 52 women with established osteoporosis was similar as for 59 control women (15.3%) (P = 0.19). CONCLUSION: Molecularly defined LM and self-reported LI are not risk factors for osteoporosis, if calcium intake from diet and/or supplements remains sufficient. Our study confirms the poor correlation between self-reported LI and LM established by different techniques.

Gamma irradiation and ethylene oxide in the sterilization of native reindeer bone morphogenetic protein extract.

BACKGROUND AND AIMS: For human use, it is necessary to sterilize bone morphogenetic proteins (BMPs), in order to reduce the risk of infections and associated complications. We compared the effects of ethylene oxide and gamma irradiation in the sterilization of native reindeer BMP extract with regard to bone induction in the Balb/C mouse thigh muscle pouch model. MATERIALS AND METHODS: BMP extract, sterilized with ethylene oxide gas (Steri-Vac 4XL, temperature 29 degrees C, exposure time 4 h, ethylene oxide concentration 860 mg/l), or gamma irradiation at doses of 3.15 MRad was administered in implants containing 5 or 10 mg of BMP extract with collagen carrier. Non-sterilized collagen implants served as controls. New bone formation was evaluated based on the incorporation of Ca45 and radiographically three weeks after implantation. RESULTS: The collagen was not able to induce new bone visible in radiographs. The mean Ca45 incorporation in the gamma sterilized group containing 5 mg of BMP extract was 30% (p = 0.04) and that containing 10 mg of BMP extract was 60% (p = 0.02) higher than seen in the corresponding ethylene oxide sterilized groups. The mean new bone areas were 45% higher in the gamma sterilized groups than in the corresponding ethylene oxide sterilized groups, but the differences were not significant. The mean optical density of new bone in the gamma sterilized group containing 5 mg of BMP extract was 75% (p = 0.00) and in that containing 10 mg of BMP extract was 70% (p = 0.00) higher than seen in the corresponding ethylene oxide sterilized groups. CONCLUSION: Native reindeer BMP extract is more sensitive to the effects of ethylene oxide gas sterilization than gamma irradiation. These results suggest that gamma irradiation is recommendable for the sterilization of BMP extracts.

The effect of different mineral frames on ectopic bone formation in mouse hind leg muscles induced by native reindeer bone morphogenetic protein.

INTRODUCTION: Bone morphogenetic proteins (BMPs) require carrier material for slow release and framing material for osteoconduction. MATERIALS AND METHODS: The effect of a frame on early bone formation induced by partially purified native reindeer BMP in composite implants containing 3 mg of BMP, type IV collagen and tricalcium phosphate (TCP/Col/BMP) or hydroxyapatite (HA/Col/BMP) or biphasic tricalcium phosphate-hydroxyapatite (TCP/HA/Col/BMP) or biocoral (NC/Col/BMP) was evaluated using a mouse hind leg muscle pouch model. Collagen with native reindeer BMP (Col/BMP) and corresponding implants without native reindeer BMP served as controls. Evaluation was done by incorporation of 45Ca, radiographically and histologically 3 weeks after the implantation. RESULTS: None of the implants without native reindeer BMP were able to induce new bone visible on radiographs. The area of new bone formation in the Col/BMP (p=0.026) and TCP/HA/Col/BMP (p=0.012) groups was significantly greater than in the TCP/Col/BMP group. The optical density of the new bone area was significantly greater in the TCP/HA/Col/BMP group than in the TCP/Col/BMP (p=0.036) or Col/BMP (p=0.02) groups. 45Ca incorporation was many times greater in all the groups containing native reindeer BMP than in the corresponding groups without BMP. In the Col/BMP (p=0.046) and TCP/HA/Col/BMP (p=0.046) groups, 45Ca incorporation was significantly greater than in the TCP/Col/BMP group. No significant differences were found in any parameters between HA/Col/BMP and NC/Col/BMP groups and the other BMP-containing groups. CONCLUSIONS: Hydroxyapatite, biocoral and biphasic tricalciumphosphate-hydroxyapatite are equally good as framing material for native reindeer BMP, while tricalciumphosphate is somewhat worse. Osteoinduction of native reindeer BMP works well with collagen alone.

Influence of ethylene oxide sterilization on the activity of native reindeer bone morphogenetic protein.

We studied the effects of ethylene oxide sterilization (Steri-Vac 4XL, temperature 29 degrees C, exposure time 4 h 10 min, ethylene oxide concentration 860 mg/l) on the osteoinductivity of partially purified native reindeer bone morphogenetic protein (BMP) in a hind leg muscle pouch model of male NMRI mice. BMP was administered in implants containing 3 mg in a collagen carrier. Implants without sterilization and without BMP served as controls. New bone formation was evaluated based on the calcium yield, radiographic and histological examination 3 weeks after implantation. The implants without BMP were not able to induce new bone visible in radiographs. In the sterilized BMP group, the mean area of new bone was 35% ( p=0.004) and density 32% ( p=0.000) smaller than in the nonsterilized group. Calcium yield was 20% lower in the sterilized group than in the nonsterilized group, but this difference was not significant ( p=0.22). It was many times lower in the group without BMP than in the above-mentioned groups ( p=0,001). We conclude that ethylene oxide gas sterilization reduces the bone-forming activity of native reindeer BMP by one third.

Health-related quality of life in a randomised placebo-controlled trial of sibutramine in obese patients with type II diabetes.

OBJECTIVE: We evaluated the effects of 12-month treatment with sibutramine 15 mg daily compared with placebo on health-related quality of life (HRQL) in obese type II diabetes patients. We examined the associations between the changes in HRQL and in weight, glycaemic control, and haemodynamic variables. We also explored the predictive value of HRQL and its changes early during treatment. DESIGN: A randomised clinical trial. The subjects were enrolled in a 2-week single-blind run-in period with a modestly hypocaloric diet (700 kcal daily deficit) and then randomised to receive either sibutramine 15 mg (n=114, 60% female) or placebo (n=122, 58% female) once daily with the hypocaloric diet for 12 months. SUBJECTS: Obese (mean BMI 36 kg/m(2) and age 54 y) type II diabetes patients untreated with antidiabetic medications. MEASUREMENTS: The main outcome measures included body weight and HRQL (the RAND 36-Item Health Survey 1.0). RESULTS: The mean weight loss was greater in the sibutramine group (-7.1 kg) than in the placebo group (-2.6 kg, P<0.001). The baseline HRQL was relatively high. There were no significant differences between the treatment groups in glycaemic control or in any of the RAND-36 scales during the study. The scores on physical functioning (PF) and health change (HC) since last year improved in both groups and this improvement was related to weight loss. When HRQL changes were examined in categories of weight loss, the scores on PF and HC increased with >/=5% weight loss, but the scores on vitality (V) and general health (GH) increased only after >/=15% weight loss. Decrease in HbA1c was associated with increases in the scores of PF, GH, V, mental health, and HC. In the sibutramine group, the increase in diastolic blood pressure was associated with the decrease in the scores of PF, physical role functioning, emotional role functioning (ERF), social functioning (SF), and bodily pain. High baseline scores on ERF and SF, and low scores on V predicted weight loss at 12 months. Also, increasing scores on PF and V during the first 3 months predicted weight loss at 12 months. The sum of four dichotomised HRQL variables (baseline ERF >/=75=1 and <75=0; baseline SF>/=80=1 and <80=0; 3-month change in PF>0=1 and 0=1 and /=5% weight loss, but >/=15% weight loss was needed to achieve a cluster of HRQL improvements. The decrease in HbA1c was associated with many HRQL benefits. Poor baseline HRQL and the improvement observed in the first months of treatment may prove to be useful in predicting success in long-term weight loss.

New bone formation induced by injection of native reindeer bone morphogenetic protein extract.

BACKGROUND AND AIMS: Bone morphogenetic proteins (BMPs) are usually administered with a solid framing material during open surgery. In some instances, percutaneous administration of injectable BMP would be preferable. We tested the new bone-forming activity of injectable native reindeer BMP extract in the Balb/C mouse thigh muscle pouch model. MATERIALS AND METHODS: The injectable implants contained 6 mg of native reindeer BMP extract and either physiological saline (NaCl/BMP) or collagen (Gel/BMP). Corresponding implants without BMP served as controls. New bone formation was evaluated based on incorporation of Ca45 and radiographically three weeks after the injection into the mouse thigh muscles. RESULTS: None of the injections without BMP were able to induce new bone visible in radiographs, whereas the injections with BMP induced new bone effectively. There were no significant differences in the area of new bone (p = 0.247) and its density (p = 0.739) between the NaCl/BMP and Gel/BMP groups. Ca-45 incorporation was multifold in the NaCl/BMP and Gel/BMP groups compared to the controls (p = 0.000). No significant differences in Ca-45 incorporation (p = 0.739) between the NaCl/BMP and Gel/BMP groups were observed. CONCLUSION: Our results suggest that BMP can be administered percutaneously, and that collagen and physiological saline are equally good carriers of injectable implants of native reindeer BMP.

Health-related quality of life in obese outpatients losing weight with very-low-energy diet and behaviour modification--a 2-y follow-up study.

OBJECTIVE: To study health-related quality of life (HRQL) in a clinically selected sample of obese outpatients. DESIGN: A single-strand before and after study with 2-y follow-up after treatment comprising 10 weeks on very-low-energy diet (VLED) and 4 months of behaviour modification in groups. SUBJECTS: A total of 126 (mean (s.d.) age 48.2 (11.1) y and body mass index 42.8 (6.2) kg/m(2) obese patients (63% women) referred for treatment in an obesity clinic. MEASUREMENTS: Weight and HRQL using questionnaires (RAND 36-Item Health Survey 1.0 and Obesity-related Psychosocial problems scale (OP-scale)). RESULTS: A total of 100 patients (61% women) completed the treatment and 67 (71% women) completed the 2-y follow-up. The mean (s.d.) weight loss was 12.5 (5.6)% at the end of group therapy, 6.0 (7.1)% at 1 y, and 2.6 (7.5)% at 2 y. At baseline, the mean (s.d.) score for the OP-scale was 61.9 (24.6). The mean scores on every RAND-36 scale were markedly lower than in the Finns without chronic conditions. All the scales in HRQL improved markedly during the treatment. During the follow-up, all the scales started to return towards baseline levels, and at 2 y only obesity-related psychosocial problems and physical functioning were still improved relative to baseline. In categories of weight change at 2 y (>or=10% weight loss, 0-9.9% weight loss, weight gain), obesity-related psychosocial functioning, physical functioning, and general health showed dose-response improvement with increasing weight loss. A >or=10% weight loss at 2 y after treatment was associated with clear improvement in obesity-related psychosocial problems, physical functioning, physical role functioning, bodily pain, general health, mental health, and vitality. A 0-9.9% weight loss was associated with improvement in obesity-related psychosocial problems and physical functioning. Weight gain was associated with improvement in obesity-related psychosocial problems and social functioning. The study population was too small to examine possible gender differences. CONCLUSIONS: Treatment with VLED and behaviour modification produces marked short-term weight loss and clear improvement in all aspects of HRQL. At 2 y after treatment, the average maintained weight loss is modest. However, 1/3 of patients maintained a >or=5% weight loss. Improvement in obesity-related psychosocial problems and physical functioning is associated even with less than 10% of maintained weight loss. Since the pattern of HRQL changes only partly followed the pattern of weight change as expected, other factors, such as the therapeutic effect of participating in the weight loss programme or increase in physical activity, may affect HRQL responses.

Health-related quality of life in obese outpatients losing weight with very-low-energy diet and behaviour modification: a 2-y follow-up study.

OBJECTIVE: To study health-related quality of life (HRQL) in a clinically selected sample obese outpatients. DESIGN: A single-strand before and after study with 2-y follow-up after treatment comprising 10 weeks on very-low-energy diet (VLED) and 4 months of behaviour modification in groups. SUBJECTS: A total of 126 patients (mean (s.d.) age 48.2 (11.1) y and body mass index (BMI) 42.8 (6.2) kg/m(2) (63% women)) referred for treatment in an obesity clinic. MEASUREMENTS: Weight and HRQL using questionnaires (RAND 36-Item Health Survey 1.0 and Obesity-related Psychosocial problems-scale). RESULTS: In all, 100 patients (61% women) completed the treatment and 67 (71% women) completed the 2-y follow-up. The mean (s.d.) weight loss was 12.5 (5.6)% at the end of group therapy, 6.0 (7.1)% at 1 y, and 2.6 (7.5)% at 2 y. At baseline, the mean (s.d.) score for OP-scale was 61.9 (24.6). The mean scores on every RAND-36 scale were markedly lower than in the Finns without chronic conditions. All the scales in HRQL improved markedly during the treatment. During the follow-up, all the scales started to return back towards baseline levels and at 2 y, only obesity-related psychosocial problems and physical functioning were still improved relative to baseline. In categories of weight change at 2 y (> or =10% weight loss, 0-9.9% weight loss, weight gain), obesity-related psychosocial functioning, physical functioning, and general health showed dose-response improvement with increasing weight loss. A > or =10% weight loss at 2 y after treatment was associated with clear improvement in obesity-related psychosocial problems, physical functioning, physical role functioning, bodily pain, general health, mental health, and vitality. A 0-9.9% weight loss was associated with improvement in obesity-related psychosocial problems and physical functioning. Weight gain was associated with improvement in obesity-related psychosocial problems and social functioning. The study population was too small to examine possible gender differences. CONCLUSIONS: Treatment with VLED and behaviour modification produces marked short-term weight loss and clear improvement in all aspects of HRQL. At 2 y after treatment, the average maintained weight loss is modest. However, one-third of patients maintain > or =5% weight loss. Improvement in obesity-related psychosocial problems and physical functioning is associated even with &<10% of maintained weight loss. Since the pattern of HRQL changes did only partly follow the pattern of weight change as expected, other factors, such as the therapeutic effect of participating in the weight loss programme or increase in physical activity, may affect HRQL responses.

Health-related quality of life in WHO class II-III obese men losing weight with very-low-energy diet and behaviour modification: a randomised clinical trial.

OBJECTIVE: To study health-related quality of life responses to marked weight loss in WHO Class II-III (body mass index (BMI) > or = 35 kg/m2) obese men. DESIGN: An 8 month randomised clinical trial with a 4 month weight loss programme (10 weeks on a very-low-energy diet (VLED) and 17 behaviour modification visits) in the treatment group and no intervention in the control group. SUBJECTS: Nineteen men (mean age 45.9 y, mean BMI 39.3 kg/m2) in the treatment group and 19 men (47.2 y, 39.4 kg/m2) in the control group. MEASUREMENTS: Weight and questionnaires measuring health-related quality of life (RAND 36-Item Health Survey 1.0 and obesity-related psychosocial problems scale). RESULTS: In the treatment group, the mean (s.d.) weight loss was 17.0 (7.4)% at the end of the 4 month therapy. At the end of follow-up, nearly 6 months after the end of VLED in the treatment group, the average maintained weight loss was 13.9 (7.8)% of baseline weight. The control group was weight stable throughout the study. During treatment, there was only transient improvement in general health, bodily pain, mental health, emotional role functioning and vitality (all increases in the scores were not statistically significant). Improvements in physical functioning, social functioning and obesity-related psychosocial problems were maintained until the end of follow-up. The treatment group also reported improvement in perceived health in the past year. There was only minor fluctuation in questionnaire scores in the control group. CONCLUSION: The short-term and maintained health-related quality of life effects of weight loss may differ. Marked weight loss in WHO Class II-III obese men leads to improvements in physical functioning, social functioning, obesity-related psychosocial problems, and perceived health; these improvements were maintained at 4 month post-intervention follow-up.

Very low energy diets in the treatment of obesity.

Very low energy diets (VLEDs) are defined as diets which contain energy levels of less than 3.4 MJ (800 kcal) per day and contain daily allowances of all essential nutritional requirements. These diets have been in clinical use for more than 20 years. They are used as the only source of nutrition for 8-16 weeks, which usually achieves a weight loss of 1.5-2.5 kg per week. Before using this type of diet a medical investigation is necessary to evaluate contraindications and to check medication use during the diet. To facilitate maintenance, cognitive behavioural counselling should always be included in a weight reduction programme using a very low energy diet. VLEDs have no serious harmful effects and can safely be used in patients with various chronic diseases. Programmes using VLEDs produce better short-term weight loss than programmes without the diet. However, in randomized controlled trials VLED-based programmes have not achieved significantly better long-term maintenance than conventional programmes. VLEDs are used when rapid weight loss is necessary because of an obesity-related disease. In other patients with obesity it is an alternative to other conservative approaches for treatment of obesity. In type 2 diabetes it may improve long-term glucose metabolism better than conventional weight reducing diets. Some studies suggest that after a VLED-based programme long-term maintenance is better among men than women. This possible gender difference is an important topic for further research.

Absence of cardiac valve dysfunction in obese patients treated with sibutramine.

OBJECTIVE: Serotonin-releasing agents prescribed as weight-loss medications have been implicated as a cause of acquired aortic and mitral valve abnormalities. Sibutramine hydrochloride (MERIDIA) is a serotonin and norepinephrine reuptake inhibitor with proven efficacy of weight reduction. The purpose of this study was to determine the incidence of cardiac valve disease in sibutraminetreated patients. RESEARCH METHODS AND PROCEDURES: Obese patients with type 2 diabetes mellitus enrolled in an ongoing double-blind, placebo-controlled, parallel-arm, 12-month study of sibutramine (followed by a 12-month open label extension) underwent transthoracic echocardiographic imaging and color Doppler interrogation for assessment of cardiac valve anatomy and function. RESULTS: A total of 210 patients were evaluated. Of these, 133 were receiving sibutramine (72 in the double-blind period), and 77 were receiving placebo. The mean+/-Standard Deviation age was 54+/-9 years, and the mean duration of treatment was 229+/-117 days (approximately 7.6 months). The prevalence of left-sided cardiac valve dysfunction was low and similar for the two treatment groups (sibutramine 3/133, or 2.3%; placebo 2/77, or 2.6%). All five cases were cases of aortic insufficiency; four were mild, one was severe (in a placebo patient). All three sibutramine cases were patients over age 50; two had a history of systemic hypertension. CONCLUSION: The prevalence of left-sided cardiac valve dysfunction was not higher than background in obese patients treated with sibutramine for an average of 7.6 months.

Maintenance programmes after weight reduction--how useful are they?

Maintenance programmes lasting one or two years or even longer are generally recommended to improve long-term outcome after weight reduction. They may not be practical for several reasons: it is not known whether they really improve long term outcome or only delay relapse; they may lessen patients' motivation to take full responsibility for their life-style changes; and they need extra resources. Some series on treatment of obesity and experience with successful maintainers suggest that satisfactory long-term outcome can also be achieved without long maintenance programmes. We believe that weight reduction programmes lasting 4-6 months can be developed to ensure better maintenance. The programmes should adopt a patient centred approach, support patients' full responsibility for life-style changes, and use principles and methods acceptable for most obese people.

Weight loss with very-low-calorie diet and cardiovascular risk factors in moderately obese women: one-year follow-up study including ambulatory blood pressure monitoring.

OBJECTIVE: The beneficial effects of weight loss with a very-low-calorie diet (VLCD) on cardiovascular risk factors have been reported at the end of energy restriction. As the effects, especially on blood pressure, may not remain constant during weight maintenance, we studied the longer-term effects of weight loss on 24h ambulatory blood pressure (ABP), lipids, glucose and insulin. DESIGN: Prospective study of a 17-week weight loss programme containing an eight-week VLCD period and follow-up visit at one-year. SUBJECTS: Twenty-nine moderately obese, normotensive or mildly hypertensive women. The mean +/- s.d. body mass index (BMI) was 36.0 +/- 2.6 kg/m2 and mean age 40.3 +/- 8.3 y. RESULTS: In the last week of the VLCD, the mean (s.d.) weight loss was 12.4 +/- 3.3 kg (P < 0.001), at the end of the programme 15.1 +/- 4.4 kg (P < 0.001 vs baseline), and at one-year follow-up 10.7 +/- 7.6 kg (P < 0.001 vs baseline). Mean 24 h ABP decreased 8.0/4.6 mmHg (P < 0.001 for both) on the last week of the VLCD, at the end of the programme, the systolic ABP decrease was 4.7 mmHg (P < 0.01 vs baseline) and diastolic 2.1 mmHg (not statistically significant (NS) vs baseline). At one-year follow-up, the mean systolic ABP decrease was 4.1 mmHg (P < 0.01 vs baseline) and mean diastolic 3.0 mmHg (P < 0.05 vs baseline). Sodium excretion decreased 55 mmol/24 h in the last VLCD week (P < 0.01) and returned to baseline after that. At the one-year follow-up, beneficial changes, compared with baseline, were observed in mean serum glucose (-0.28 mmol/l, P < 0.05), triglyceride (-0.35 mmol/l, P < 0.01) and HDL cholesterol (+0.16 mmol/l, P < 0.001). CONCLUSIONS: This weight loss programme with a VLCD enabled obese subjects to lose weight and decrease cardiovascular risks. Despite some regain in weight during follow-up, the beneficial effects were overall maintained over the year. Sodium intake tended to increase during follow-up. Information on sodium restriction should be included in weight loss programmes.

Comparison of behavior therapy with and without very-low-energy diet in the treatment of morbid obesity. A 5-year outcome.

BACKGROUND: Very-low-energy diets (VLEDs) together with behavior therapy (BT) are widely used in the treatment of morbid obesity, but there is no evidence of their long-term effectiveness as compared with behavior therapy alone. METHODS: Fifty-nine morbidly obese patients (25 men and 34 women; mean weight, 132.8 +/- 20.7 kg; mean age, 43.1 +/- 9.2 years) were treated with combined therapy of VLED and BT or BT alone. No maintenance program was used. Eighty-seven percent of eligible patients were contacted 4.8 to 6.2 years after the program. RESULTS: During treatment, 56% of patients dropped out of the VLED + BT group and 28% from the BT group (P = .03). High scores on the Symptom Checklist-90R before treatment predicted dropout from the VLED+BT group, but not from BT. At the end of therapy, mean weight change was -22.9 kg in the VLED+BT group and -8.9 kg in the BT group (P < .001). The overall weight change from pretreatment to the 5-year follow-up was greater in the VLED+BT group than in the BT group (-16.9 kg vs -4.9 kg, respectively; P = .03). Men succeeded better in the VLED+BT group than in BT. Among the dropouts, the mean weight change from baseline was +5.2 kg in the VLED+BT group and +13.0 kg in the BT group. CONCLUSIONS: Our data suggest that in the treatment of morbid obesity, VLED combined with BT may produce a better 5-year maintenance than BT alone, especially among men. A satisfactory weight loss can be achieved without a maintenance program.

Effects of lisinopril or lisinopril/hydrochlorothiazide compared with adjusting of previous medication and intensifying non-pharmacological treatment in patients with mild to moderate hypertension.

The objective of this study was to compare the effectiveness of three treatment methods available for treatment of previously medicated patients with mild to moderate hypertension. The comparison was made between adjusting or increasing previous medication and switching the previous drug treatment to lisinopril (CAS 76547-98-3) or lisinopril hydrochlorothiazide (CAS 58-93-5) therapy and in both of these treatment groups the effect of additional intensified health education was tested. An open, randomised, controlled multi-centre study lasting 36 weeks involving 189 doctors and 69 nurses was carried out in 155 centres of primary health care and occupational health care system in Finland. The study population consisted of 1156 patients, age 30-70 years, (mean DBP 95-115 mmHg in the last three to five measurements during follow-up). The number of patients achieving target pressure (DBP < 90 mmHg) at the end of the study, defined daily doses (DDD) of antihypertensive drugs and side-effects in different treatment groups were regarded as the main outcome measures of the study. After exclusions and drop-outs the final analysis was carried out with 900 patients, 419 women (46.6%) and 481 men (53.4%). Patients receiving lisinopril treatment achieved target pressure significantly more often (p < 0.001) than those continuing their previous or adjusted medication at 36 weeks (59.2 and 55.5% vs 40.3 and 42.7%). Only a small additional but statistically non-significant blood pressure lowering effect was achieved with intensified non-pharmacological treatment at weeks 12 and 24, but this difference had disappeared at week 36. The mean DDDs of different antihypertensive drugs did not differ between groups except for female patients on previous or adjusted medication not receiving health education, the mean DDD being significantly (p < 0.05) higher at weeks 24 and 36 in this group. The profile of adverse effects at the end of the study clearly favoured patients on lisinopril treatment except for cough which was reported in 18% of patients vs 10% in the control groups. 81 patients on lisinopril treatment were withdrawn from the study because of cough. The results showed that hypertensive patients with poor treatment control benefit from all three approaches. A greater proportion of patients on lisinopril treatment achieved target pressure and also experienced fewer side effects than those continuing on adjusted previous medication. Intensified personal health education given once a month during six months had only a small additional beneficial effect on reaching the target pressure and this effect was lost in three months after the health education period.

Use of very low-calorie diet in preoperative weight loss: efficacy and safety.

We report the efficacy of a very low-calorie diet (VLCD)-based weight reduction program in patients with morbid obesity whose elective surgery had been postponed because of being overweight. The safety of weight loss on the immune system will also be evaluated. Thirty patients (mean age, 50 years; weight, 125 kg; BMI, 44 kg/m2) were treated. The program consisted of a 7-week to 24-week VLCD period, supported by individual sessions with a therapist, and of a refeeding period of 1 month before surgery. Two patients discontinued, and the mean weight loss of the remaining 28 patients was 19.6 kg (15% of initial weight). In 23 patients, weight loss was 10% or more of the initial weight. After weight loss, 15 patients underwent surgery, 4 patients did not need an operation, and the remaining 9 patients were not operated on for various reasons. The numbers of circulating leukocytes, neutrophils, basophils, monocytes, CD3+, CD4+, CD8+, and natural killer cells did not change significantly by the ninth week on VLCD or by the end of the program. However, there was a significant (p < 0.05) decrease in the immunoglobulinM serum concentration during the program. In conclusion, a VLCD program is suitable for preoperative weight reduction in morbid obesity and seems not to compromise the immune system.

Two year maintenance of weight loss after a VLCD and behavioural therapy for obesity: correlation to the scores of questionnaires measuring eating behaviour.

OBJECTIVE: To investigate changes in weight, Three Factor Eating Questionnaire and Binge eating scores during a two-year period from the start of a VLCD (Nutrilett) and behavioural modification therapy for obesity. DESIGN: Prospective study of a 17-weeks weight loss programme with one- and two-year follow-up visits. SUBJECTS: 62 healthy, overweight subjects without previous eating disorders. The mean (+/- SD) age 41 +/- 8 years and BMI 36.4 +/- 2.6 kg/m2. MAIN OUTCOME MEASURES: Weight loss, Binge eating scale, Bulimic Investigatory Test and Three Factor Eating Questionnaire before and after therapy and at 1 and 2 year control visits. RESULTS: The mean weight loss (+/- SD) at the end of the treatment was 14.9 +/- 4.6 kg (n = 59) and at the two-year control 5.8 +/- 7.6 kg (n = 57). After two years 20 (32%) patients had a weight loss of more than 10% (good result), 24 patients a weight loss of 0-10% of their initial weight (partial result) and 13 patients weighed more than before therapy (poor result). The mean binge eating, disinhibition and hunger scores decreased in all patients by the end of the therapy. At the end of two years these improvements in the scores were maintained in patients with a good result but the scores returned to the pretreatment levels in the patients with partial or poor result. The mean restraint scores increased in all patients after treatment and were maintained in those with a good or partial result. CONCLUSIONS: VLCD combined with behaviour modification is a useful mode of therapy for obesity with low drop-out rate and majority (71%) of patients below pretreatment weight at the two-year control. One third of the patients succeeded to maintain positive changes in the scores measuring eating behaviour which was associated with sustained weight loss.

Long-term Results of Gastroplasty for Morbid Obesity: Binge-Eating as a Predictor of Poor Outcome.

We investigated the long-term results after vertical banded gastroplasty (VBG) for morbid obesity and evaluated some predictors of poor outcome. Twenty-seven morbidly obese patients (mean BMI 50 kg/m(2)) who underwent VBG a mean of 5.4 years earlier were studied. The mean weight loss was 31 kg or 40.5% of excess weight. Ten patients (37%) were within 50% of their ideal weight. The patients were classified as bingers (n = 10) and non-bingers (n = 17) according to the modified Binge Eating Scale. One-year postoperative weight losses were 55% and 57% respectively of excess weight, but at the time of the study weight losses were 24% and 50% of excess weight (p = 0.04) in the bingers and non-bingers, respectively. The mean weight regain was 23 kg in the bingers vs 8 kg in the non-bingers, p = 0.01. Two bingers had excellent weight loss results, but otherwise an unsuccessful outcome. Weight reduction did not correlate with age, sex or age of onset of obesity. These results show that binge-eating strongly predicts poor weight loss maintenance after gastroplasty in the long-term, though initial weight reduction is good. We suggest that binge-eating should be evaluated before gastroplasty and taken into consideration in the design of treatment.

Sleep apnoea and daytime sleepiness in acromegaly: relationship to endocrinological factors.

Sleep history and pituitary function were studied and sleep polygraphy performed in 11 acromegalic patients before and after pituitary surgery. Excessive daytime sleepiness or habitual snoring or both together, as well as an elevated fasting level of serum GH occurred in all the patients. In five men but in none of the women an abnormal number of episodes of sleep apnoea were observed. Pituitary adenomectomy improved the apnoea frequency in one patient, whereas in the others the abnormality was still present 1 year later. After operation the fasting level of serum GH became normal in eight patients, two of them with persisting sleep apnoea. The sleep apnoea syndrome is common and clinically important in acromegaly. Its early diagnosis using polygraphic monitoring is emphasized, as it is a treatable disorder.