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PubMed2005

Do support groups help people with chronic fatigue syndrome and fibromyalgia? A comparison of active and inactive members.

OBJECTIVE: To examine the benefits and problems of a chronic fatigue syndrome (CFS) and fibromyalgia (FM) support organization as reported by its participants. METHODS: Active members (n = 32) and inactive members or dropouts (n = 135) of a regional support organization for people with CFS and FM completed a 26 item questionnaire by telephone interview or by self-completion and postal return. RESULTS: The most frequently endorsed benefits of membership were illness legitimization (67.8%), finding out helpful new information (66.4%), and feeling understood by others (62.2%). Lower frequency endorsements were given to: helped to find (35.0%) or deal with (38.5%) doctors, and helped to improve my illness (36.4%). The most frequently reported reasons for dropping out were inconvenient location (37.8%) or time (37.0%), too much negative talk or complaining (33.3%), too sick to attend (28.8%), and illness or coping improvement (29.6% each). The active-member group showed significantly higher (p < 0.04) symptom severity scores and less illness improvement (p < 0.01) in comparison to the inactive/dropout group. CONCLUSION: This cross-sectional study suggests that support groups for CFS are viewed as helpful by participants on a number of illness related issues. On the other hand, active members reported greater symptom severity and less illness improvement than inactive members or dropouts.

Adult↗
PubMed1991

Exposing patients with chronic, stable, exertional angina to placebo periods in drug trials.

Because the safety of withholding standard therapy and enrolling patients with stable angina in placebo-controlled trials is not known, we identified all events leading to dropout from trials of 12 antianginal drugs submitted in support of new drug applications to the US Food and Drug Administration. Persons who dropped out of the trials were classified as cause due to adverse cardiovascular events or other causes without knowledge of drug assignment. There were 3161 subjects who entered any randomized, double-blind phase of placebo-controlled protocols; 197 (6.2%) withdrew because of cardiovascular events. There was no difference in risk of adverse events between drug and placebo groups. A prospectively defined subgroup analysis showed that groups who received calcium antagonists were at an increased risk of dropout compared with placebo groups (P = .04), primarily because of a disproportionate number of adverse events in studies of one drug. In conclusion, there were few adverse experiences associated with short-term placebo use. Withholding active treatment does not increase the risk of serious cardiac events.

Adrenergic beta-Antagonists↗
PubMedDate not supplied

Daily insemination with cryopreserved donor semen is more effective than alternate-day insemination.

A group of 177 consecutive treatment series using daily insemination has been compared with 211 consecutive treatment series using alternate-day insemination. The incidence of female infertility factors, the dropout rate per cycle, and the pregnancy rate per cycle were compared. No significant differences in distribution of female infertility factors or dropout rate were found. In contrast, the pregnancy rate by life-table analysis was significantly different between the two groups, the average monthly fecundability being 1.6 times as high in the daily insemination group. It is argued that after insemination, cryopreserved semen retains its fertilizing capacity no longer than 24 hours.

Adult↗
PubMed1990

[Comparison of chlorthalidone and sustained-action nifedipine in the treatment of mild to moderate arterial hypertension].

The effectiveness and safety of sustained action nifedipine (NF) were compared to those of chlorthalidone (CL) in two groups of 35 and 37 patients with mild to moderate hypertension followed up for 4 months. There was a significant reduction in blood pressure (BP) after 15 days of therapy. The degree of control was acceptable with both drugs. A second drug was required in 20% patients of the NF group and in 30.8% of CL group. The therapeutic goal (BP less than 160/95) was achieved in 86.7% of patients in CL group and in 48.4% of those in NF group. We found 48.8% of dropouts in the NF group and none in CL group. There was a significant increase in blood glucose in CL group and a reduction of uric acid and an increase of HDL-cholesterol in NF group. Both drugs are useful to treat hypertension, although NF has the drawback of a high dropout rate and CL induces abnormalities in biochemical parameters.

Aged↗
PubMed1990

[Insulin-sulfonylurea combination therapy in secondary therapy failure with sulfonylurea compounds. Randomized study between evening and morning intermediary insulin administration using the Novo Pen semi-automatic insulin injector].

In 28 type II diabetics with secondary failure of sulfonylurea treatment, the efficacy and safety of combined therapy with insulin and glibenclamide were investigated. Patients were randomized in two groups and treated for 16 weeks either with insulin Novo Protaphan HM Penfill (100 IU/ml "bed time") and 10 mg of glibenclamide in the morning (group A), or with insulin Novo Actraphan HM Penfill 100 IU/ml in the morning combined with two 5 mg doses of glibenclamide at lunchtime and in the evening (group B). Subsequently a dropout trial of sulfonylurea was performed in half of the patients. Mean blood glucose levels were lowered in the whole group of patients from 13.5 +/- 1.8 mmol/l to 8.8 +/- 2.3 mmol/l after 8 weeks and 8.7 +/- 1.8 mmol/l after 16 weeks, and the HbAlc from 10.1 +/- 1.2% to 8.4 +/- 1.0% and 7.8 +/- 1.0% respectively. After a glibenclamide dropout period of one or two weeks in 14 of the patients, the mean blood glucose level rose significantly by 2.8 +/- 2.6 mmol/l. Only 2 patients did not show this increase. The mean insulin consumption was 13 +/- 3 IU after 8 weeks and 14 +/- 5 IU after 16 weeks respectively, and the incidence of hypoglycemia one in 12 weeks of treatment. The combination of glibenclamide and insulin (administered with the Novo Pen injector) is a safe and effective form of therapy in secondary failure of sulfonylurea, and is well accepted due to the mild start into insulin therapy.

Adult↗
PubMed1990

Deaths due to accidents and violence in two recent trials of cholesterol-lowering drugs.

The Helsinki Heart Study and the Lipid Research Clinics Coronary Primary Prevention Trial both reported higher rates of deaths due to homicides, suicides, and accidents in the groups receiving cholesterol-lowering agents compared with the groups receiving placebos. We examined these deaths in the active treatment arms of the two trials to determine if there were some readily explainable causes or if the cholesterol-lowering agents might be a factor. Our examination showed that the two homicides were victims, not offenders, and one had stopped treatment because of myocardial infarction 1 year before his death. Five of the eight suicides had dropped out of the trials and had not taken the cholesterol-lowering drugs for periods of months to years prior to committing suicide. Of the 10 deaths due to accidents, two were dropouts from the trials, three others had high blood alcohol concentrations detectable at autopsy, and another three reported a history of psychiatric symptoms and/or treatment prior to entry. When dropouts and known risk factors for these deaths such as alcohol intoxication and psychiatric histories are considered, little evidence remains to support the hypothesis that cholesterol-lowering drugs are causally associated with deaths due to homicides, suicides, and accidents in these trials.

Accidents↗
PubMed1990

Azathioprine and methotrexate as combination chemotherapy in rheumatoid arthritis.

Azathioprine or methotrexate (MTX) are each established, and comparably effective, therapies for rheumatoid arthritis (RA). An ongoing, still double blind, 3-arm, 24-week study comparing azathioprine or MTX, or azathioprine and MTX in RA is described. With 146 (of 210 total) patients enrolled, it is apparent that all 3 treatment groups demonstrate clinically significant improvement at Week 24. One treatment arm (Group 1) showed a greater degree of improvement in raw mean scores for most outcome variables. Another treatment arm (Group 2) had an adverse effect dropout rate exceeding the sum of adverse effect dropouts from Group 1 and Group 2. Most adverse effects were due to gastrointestinal intolerance.

Arthritis, Rheumatoid↗
PubMed1990

[The value of alizapride in the treatment of vomiting in infants and children].

An open, three-day trial was carried out in 49 infants and children with vomiting related to an acute gastrointestinal or ENT infection (63.3% of cases), a gastroesophageal reflux (20.4%), or an attack of malaria (14.3%). Mean age of patients was 21.9 months. Number of episodes of vomiting exceeded six per day in 89.8% of patients. Alizapride (Plitican) was given as oral drops in a dosage of 3 mg/kg/d. Five patients were prematurely withdrawn from the trial for clinical deterioration requiring discontinuation of enteral nutrition. Under treatment, vomiting resolved completely in 35 patients, i.e. 71.4% of the initial study group. Six patients exhibited incomplete improvement of vomiting and eight (including the 5 dropouts) continued to have a significant number of episodes of vomiting. Overall effectiveness evaluated on the frequency of episodes of vomiting, weight changes, and the investigator's clinical judgement was considered as excellent or good in 81.6% of cases. No significant adverse effects were recorded but the product's bitter taste was involved in the persistence of vomiting in one of the dropouts and in the development of moderate nausea in another patient who was able to continue treatment. The therapeutic value of alizapride, evaluated using an analog scale, proved significant in this indication.

Antiemetics↗
PubMed1987

Ketanserin in intermittent claudication: effect on walking distance, blood pressure, and cardiovascular complications.

In a 7-center Scandinavian double-blind placebo-controlled study of 179 patients with intermittent claudication, the effect of the serotonin antagonist ketanserin was evaluated on walking distance, brachial and ankle blood pressure, and symptoms. For all centers together, pain-free walking distance was significantly increased after 6 months with both ketanserin (+65%; 71 patients) and placebo (+42%; 78 patients), with no significant difference. However, there was large variability among centers. Classification of "responders" (doubling of walking distance) and patients who deteriorated (decrease of walking distance or dropout for inefficacy) showed significantly more patients responding and significantly fewer patients deteriorating with ketanserin than with placebo. Systemic blood pressure was significantly decreased by ketanserin in hypertensive, but not normotensive, patients, while ankle pressure was unaffected. The incidence and nature of side effects were equal with ketanserin and placebo, but there were more side effects causing dropout in the ketanserin group. An unexpected and possibly important observation was the occurrence of six serious cardiovascular events (myocardial infarction, cerebrovascular complications, and development of rest pain) in the placebo group but none in ketanserin-treated patients. Moreover, there were four additional similar complications in the placebo run-in period. Ketanserin appears to be beneficial in a subgroup of patients with intermittent claudication. A fortuitous finding of this study is that ketanserin might possess a protective effect against thrombovascular complications in patients with intermittent claudication.

Adult↗
PubMed1989

Functional restoration with behavioral support. A one-year prospective study of patients with chronic low-back pain.

Patients with chronic disabling low-back pain have poor prospects of returning to work. The authors tested a treatment program of functional restoration with behavioral support through 1 year prospective observation of patients disabled for an average of 19 months without evidence of surgically correctable disease. Ninety patients were studied: 59 program graduates, five program dropouts, 17 patients denied program authorization by their insurance carriers, and six crossover patients. Three patients were admitted but refused to participate in the treatment program. Initial demographic, physical, and self-assessment attributes were similar for all four groups. At year's end, 81% of program graduates, 40% of the dropouts, and 29% of those denied the program had returned to work. All six crossover patients were working 6 months after treatment. Program graduates showed significant improvements in self-assessed pain, disability, and depression, and in physical capacities after 3 weeks of treatment. These improvements were maintained through the year except for partial decreases in frequent lifting, cycling endurance, and isokinetic trunk extension strength. Functional restoration with behavioral support is an effective treatment for patients with chronic, disabling low-back pain, as measured by self-assessments, physical capacities, and return to work.

Back Pain↗
PubMed1989

[Effect of compliance on treatment with autogenic training].

Autogenic therapy courses for patient with psychosomatic psychoneurotic disorders show a high dropout rate. A study among 38 ambulant patients analysed factors of the patients have influence on their compliance. Generally the dropout group, independent of the diagnosis, shows less striking deviations. Under autogenic therapy the compliance-positive group achieves a constructive change towards normality. Realisation of autogenic therapy is achieved by patients with more intensive psychoneurotic disorders. They experience a more distinct physical answer by the basic training. It is shown that it is easier for the compliant patient to learn the autogenic therapy, which is understood as conditional response. With reference to the experience in drug compliance the results recommend that autogenic therapy should be accompanied by a compliance therapy.

Arousal↗
PubMed1987

A comparison of buspirone, diazepam, and placebo in patients with chronic anxiety states.

Buspirone is an antianxiety compound that has been extensively evaluated in clinical trials: it has proved superior to placebo and comparable to diazepam in the treatment of patients with generalized anxiety disorder. In this study, 33 outpatients with generalized anxiety disorder were entered into a crossover study of 3 weeks each of placebo, buspirone 10 to 30 mg daily, and diazepam 10 to 30 mg daily. Psychiatrist and patient ratings were made, together with psychological tests and EEG and skin conductance measures before and after each treatment. Of the nine dropouts, six were on buspirone at the time of dropout. For the remaining 24 patients, the mean daily doses attained of buspirone and diazepam were both 20 mg. On most clinical ratings diazepam was superior to buspirone and placebo, which did not differ. Diazepam produced minor psychomotor changes and the expected major effects on the EEG. Buspirone was without effect. Side effects on buspirone were mainly nausea and giddiness and on diazepam, drowsiness. The lack of efficacy of buspirone is discussed in terms of the previous benzodiazepine exposure--23/24 patients had had previous exposure and only 10 were able to tolerate a pretrial placebo washout period. The implications are considerable for the introduction of any new antianxiety agent not cross-tolerant with the benzodiazepines into a chronically anxious group of patients with previous long-term benzodiazepine therapy.

Adult↗
PubMed1987

Neurological manifestations of the post-polio syndrome.

Patients with late effects of poliomyelitis, i.e., PPS, are being seen at an ever increasing frequency by general physicians, neurologists, and orthopedists. An appropriate time interval for the onset of late manifestations has elapsed since the major epidemics of poliomyelitis in the 1940s and 1950s. Post-polio neurological manifestations primarily include new weakness, atrophy, muscle pain, and fasciculations. Fortunately, the weakness is of a very slow, progressive nature. Abnormal laboratory studies include routine EMG, demonstrating chronic denervation; SFEMG, demonstrating increased fiber density, increased jitter, and blocking; and muscle biopsy most often revealing fiber-type grouping of chronic denervation and small isolated angular (or angulated) fibers and group atrophy in some series, both suggestive of active denervation. Unfortunately, both EMG and muscle biopsy studies suffer from a lack of specificity as they do not appear to distinguish asymptomatic from symptomatic (new weakness, PPMA) patients with prior poliomyelitis. Although the cause of PPMA is unknown, electrophysiological (SFEMG) and muscle biopsy studies suggest that the process involves a loss or dropout of axon terminals of reinnervated motor units. The axons terminal dropout could be due to dysfunction in the cell soma, the axon, or the terminals themselves. Whether motor neuron exhaustion, a persistent viral infection, or immune-mediated mechanisms play a role in the pathogenesis of the late weakness is unclear at present and will require further investigation. Treatment at this time is of a supportive nature. A major controversy involves the role of strengthening exercises in these patients since experimental animal studies suggest that excessive exercise of denervated muscles leads to increased weakness. Clearly, a better understanding of PPS and PPMA will allow more effective management of these patients' problems and might also provide insight into other motor neuron and neuromuscular junction diseases.

Aging↗
PubMed1982

Macroelectromyography in reinnervation.

Macroelectromyography is used to study the electrical activity of the entire motor unit. The amplitude of the motor unit action potential (MUP), recorded from a bared cannula, is dependent on the number and size of muscle fibers in the motor unit. In most situations of reinnervation the local fiber density (FD) as recorded with single fiber EMG, and the total motor unit size as indicated by the macro-EMG amplitudes, are increased, that is, denser motor units with a total increase in their number of fibers. In some situations, increased FD, but normal macro-MUPs are seen, which may reflect localized reinnervation in one area of the motor unit and a dropout of fibers in another area without on overall increase in number of muscle fibers in the motor unit. Rarely, a combination of increased macro-MUP amplitude and normal FD are seen, which may indicate a dropout of small motor units. By combining SFEMG and macro-EMG, new information is obtained concerning the reinnervating motor unit.

Amyotrophic Lateral Sclerosis↗
PubMed1984

Factors related to adherence to an exercise program for healthy adults.

Healthy men (N = 33) and women (N = 73) participated in a 6-month exercise program three mornings per week, and their attendance scores (percent of total classes attended) were related to a variety of physiological, anthropometric, psychological, and demographic variables which were studied. These subjects were also grouped by adherence patterns; 18% attended less than 10% of the classes (early dropouts = EDO), 40% attended between 10 and 50% of the classes (nonadherers = NAd), and 42% attended more than 50% (adherers = Ad). Correlation coefficients between all of the variables and attendance were low. However, certain patterns did emerge. Those who continued the program more than 10% of the sessions tended to be the more physically fit women and less physically fit men. The EDO men and women were more likely to 1) have less stability in the community (less time at present address or occupation), 2) be single, and 3) have no children. Self-motivation scores (SMI) for EDO men were significantly lower, but the correlation between SMI and attendance for all subjects was only r = 0.052. "Blue-collar" men had a greater-than-expected dropout rate; however, educational level did not affect adherence. Health care behavior (including smoking) and previous exercise patterns did not affect attendance. Eleven variables that were related to adherence were selected for further study. The predictive values and sensitivities for these variables ranged from 47-85% and 15-62%, respectively. Using criteria of multiple positive scores did not improve the ability to predict attendance behavior. It was concluded that for healthy volunteers, participant characteristics are not good predictors of compliance to an exercise regimen.

Adult↗
PubMed1983

The role of the doctor-nurse team in control of hypertension in family practice in Israel.

In the 1960s and early 1970s, only 9.4% of all hypertensives in Israel were under control, due to a low rate of detection, a high dropout rate and a low rate of patient compliance. In the past seven years, a program of screening and careful follow-up of hypertensives in over 400 community clinics has been introduced, based on the active participation of clinic nurses in addition to that of family doctors. This program has been associated with a large increase in the number of detected hypertensives, a fall in the dropout rate, and a decrease in patient waiting time. In one study of 5,541 hypertensives treated initially by a doctor alone, and then by the doctor-nurse team, the number of treated hypertensives who were under control increased from 42.1 to 84.6%. The improvement in hypertension control has paralleled the reduction in cardiovascular disease in Israel.

Family Practice↗
PubMed1982

[Leg disorders--disorders of blood supply. The effect of Essaven ultra in chronic venous insufficiency].

An open controlled study was performed over a period of 8 weeks to evaluate the effect of Essaven ultra capsules versus placebo in a total of 60 patients suffering from chronic venous insufficiency. Statistical analysis was performed on 29 patients on the active drug (one dropout) and on 25 patients on placebo (5 dropouts). Apart from patients' statements circumference measurements taken of 3 leg segments were used to assess the results of the treatment. In the patients on the active drug there were significant reductions of circumference in the three leg segments (ankle, calf and knee joint) while, in part of the patients on placebo, leg circumference was significantly increased. In the group on active treatment subjective symptoms were also significantly improved in comparison with the controls. The test drug was very well tolerated.

Anthropometry↗
PubMedDate not supplied

Quality of life during sequential hormone replacement therapy -- a placebo-controlled study.

OBJECTIVE -- The purpose of the study was to determine the efficacy of sequential 17 beta-estradiol and norethindrone acetate (Trisequens) in the relief of vasomotor symptoms by comparing the quality of life data from questionnaires, number and severity of symptoms, and the dropout rate versus placebo treatment. STUDY DESIGN -- Women 40 to 60 years old, who spontaneously complained of menopausal symptoms, were randomly allocated to four consecutive cycles with Trisequens (n = 40) or placebo (n = 42). Analysis of variance and two-tailed tests (P < .05) for all comparisons were used. RESULTS -- The mean number of pretreatment vasomotor symptoms per day was 7 (1.3 severe) for Trisequens and 6 (1.8 severe) for placebo, whereas posttreatment a reduction to 1.3 (0.1 severe) versus 4.2 (1.8 severe), respectively, was observed. Quality of life scores, utilizing the Kupperman Scale, 3-Factor Green Index, and Beck Depression Inventory all produced statistically significant differences (P = 0.0015, 0.0037, 0.0026, 0.0003, 0.0242, respectively). The dropout rate difference between groups was significant (P = 0.028): 12 from the Trisequens group and 23 from the placebo group. CONCLUSION -- Trisequens significantly improves vasomotor symptoms. Quality of life rating scales provide additional data to support the utility of sequential estrogen/progestin treatment for menopause therapy.

Adult↗