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PubMed2000

Group behaviour therapy programmes for smoking cessation.

BACKGROUND: Group therapy offers individuals the opportunity to learn behavioural techniques for smoking cessation, and to provide each other with mutual support. OBJECTIVES: The aims of this review were to determine the effects of smoking cessation programmes delivered in a group format compared to self-help materials, or to no intervention; to compare the effectiveness of group therapy and individual counselling; to determine the effect of adding group therapy to advice from a health professional or nicotine replacement and to determine the rate at which offers of group therapy are taken up. SEARCH STRATEGY: We searched the Cochrane Tobacco Addiction Group trials register. SELECTION CRITERIA: We considered randomised trials which compared group therapy with self-help, individual counselling, another intervention or usual care or waiting list control. We also considered trials which compared two group programmes with manipulation of the group interaction and social support components. We included those trials with a minimum of two group meetings, and follow-up of smoking status at least six months after the start of the programme. We excluded trials in which group therapy was provided to both active therapy and placebo arms of trials of pharmacotherapies, unless they had a factorial design. DATA COLLECTION AND ANALYSIS: We extracted data in duplicate on the type of subjects, the nature of the groups and the controls, the outcome measures, method of randomisation, and completeness of follow-up. The main outcome measure was abstinence from smoking after at least six months follow-up in patients smoking at baseline. We used the most rigorous definition of abstinence in each trial, and biochemically validated rates where available. Subjects lost to follow-up were counted as smokers. Where possible, we performed meta-analysis using a fixed effects model. MAIN RESULTS: Thirteen studies compared a group programme with a self-help programme. There was an increase in cessation with the use of a group programme (odds ratio 2.10, 95% confidence interval 1.64 to 2.70). Group programmes were more effective than no intervention or minimal contact interventions (odds ratio 1.91, 95% confidence interval 1.20 to 3. 04). There was no evidence from two trials that group therapy was more effective than a similar intensity of individual counselling. There was no evidence that manipulating the social interactions between participants in a group programme had an effect on outcome. There was limited evidence that the addition of group therapy to other forms of treatment, including advice from a health professional or nicotine replacement produced extra benefit. There was variation in the extent to which those offered group therapy accepted the treatment. REVIEWER'S CONCLUSIONS: There is evidence that groups are better than self-help, and other less intensive interventions. There is not enough evidence on their effectiveness compared to intensive individual counselling.

Behavior Therapy↗
PubMed2000

Music therapy for dementia symptoms.

BACKGROUND: While music/music therapy does not represent a treatment of dementia, its use is based on a possible beneficial effect on symptoms including social, emotional and cognitive skills and for decreasing behavioral problems of individuals with dementias. Thus, there are clear implications for patients' and caregivers' quality of life. However, quantification and documentation of the evidence of this effect is necessary. Professional music therapists are accountable for providing efficient, beneficial treatment. Further, music therapists are responsible for assessing, designing and implementing music therapy treatments, monitoring client progress, and reformulating their practice according to data collected and new advancements in the field. If they wait until sufficient valid, empirical data on all aspects of a disability or music response are available before attempting to design a therapy session, they may well reach retirement age before even one client can be served. On the other hand, promulgating the efficacy of music therapy in general, or of specific music therapy techniques, in the absence of any substantiation other than intuition or tradition borders on professional recklessness. OBJECTIVES: To gather and evaluate the evidence for the effectiveness of music therapy for dementia symptoms. SEARCH STRATEGY: All available sources of references were searched for randomised controlled trials of music therapy used as an intervention in dementia. The search terms included 'controlled trial or study, music*, therapy, dement*, Alzheimer*, cognitive impairment.' SELECTION CRITERIA: The reviewers assessed the methodological quality of the studies available for inclusion. The criteria used are presence and adequacy of a control condition, independent assessment of patients' performance (ie standardized ratings carried out by a person other than the music therapist) and the number of participants (no fewer than three). DATA COLLECTION AND ANALYSIS: No randomised controlled trials, or trials with quantitative data suitable for analysis were found. MAIN RESULTS: The research into music therapy to date has lacked methodological design rigour. However, the research evidence available provides sufficient grounds on which to justify further investigations into the use of music therapy in dementia patients. In this context, the reviewers discuss some of the issues and research from the studies that were considered for inclusion. REVIEWER'S CONCLUSIONS: This review was not able to identify reliable empirical evidence on which to justify the use of music therapy as a treatment for dementia. However, the evidence available suggests that music therapy may be beneficial in treating or managing dementia symptoms, and the predominant conclusion of this review is the highlighting of the need for better designed studies of the intervention.

Alzheimer Disease↗
PubMed2000

Validation therapy for dementia.

BACKGROUND: Validation therapy is a "therapy for communicating with old-old people who are diagnosed as having Alzheimer's disease and related dementia". The approach was developed by Naomi Feil between 1963 and 1980. She classifies individuals with cognitive impairment as having one of four stages on a continuum of dementia: these stages are Malorientation, Time Confusion, Repetitive Motion and Vegetation. The benefits of Validation therapy for patients are reported by Feil as restoration of self worth, minimisation of the the degree to which patients withdraw from the outside world, promotion of communication and interaction with other people, reduction of stress and anxiety, stimulation of dormant potential, help in resolving unfinished life tasks, facilitation of independent living for as long as possible. These benefits are highly desirable and Validation therapy but there is a need to show them on the basis of substantive research yielding strong evidence across a number of well designed studies. The potential number of people that might benefit from the implementation of Validation therapy is considerable given the increasing incidence of dementia. OBJECTIVES: To evaluate the effectiveness of using validation therapy with people diagnosed as having senile dementia of the Alzheimer's type, other forms of dementia, or cognitive impairment. SEARCH STRATEGY: The Cochrane Controlled Trials Register was searched by the Cochrane Dementia and Cognitive Impairment Group Coordinator and relevant references were forwarded to the primary reviewer. The reviewers carried out independent searches of the following electronic databases - MEDLINE, EMBASE, Eureka, CINAHL, PSYCLIT, RLIN, SIGLE and SOCIOFILE. The following key terms were used in searches; validation-therapy, dementia, cognitive impairmnent, communication, and random*-control*. An author search using Feil and Naomi was also carried out. Personal contact was made with the Validation Institute, Cleveland, Ohio USA and unpublished studies were sought by direct contact with the relevant authors, or institutions. Key individuals who might provide further information regarding validation therapy were contacted. SELECTION CRITERIA: All randomised controlled trials (RCTs) and quasi-randomised controlled trials examining Validation therapy as an intervention for dementia were considered for inclusion in review. The criteria for inclusion/exclusion comprised systematic assessment of the quality of study design and the risk of bias, using a standard data extraction form. Outcome measures of cognitive and/or behavioural change were required. DATA COLLECTION AND ANALYSIS: Data were extracted independently by both reviewers, using a previously tested data extraction form. Authors were contacted for data not provided in the papers. Psychological scales measuring cognitive and behavioural changes were examined. Subcategory analysis was performed due to the diversity of the scales and the inability to combine data across studies. MAIN RESULTS: Only three studies were identifed that potentially met the inclusion criteria and only two small studies were able to be obtained. The Peoples 1982 study was not obtainable through a British Library loan because the cost was prohibitive. Data from 2 studies were entered using MetaView - Robb 1986, Toseland et al 1997, incorporating data on a total of 87 patients (32 in the experimental group, and 55 in the control groups (usual care 34 and social contact 21)). It was not possible to pool the data from the two included studies, and therefore, subcategory analyses were carried out. The analysis of the data failed to reveal statistically significant results although there were trends toward favouring validation therapy for some outcomes. (ABSTRACT TRUNCATED)

Alzheimer Disease↗
PubMed2001

Recurrence of symptomatic ventricular arrhythmias in patients with implantable cardioverter defibrillator after the first device therapy: implications for antiarrhythmic therapy and driving restrictions. CARE Group.

OBJECTIVES: The purpose of this study was to investigate whether clinical or electrophysiologic characteristics could predict initial and subsequent implantable cardioverter defibrillator (ICD) therapy. BACKGROUND: Identification of markers to predict subsequent ICD therapy and symptoms after the first event could affect patient management. METHODS: We analyzed baseline and follow-up data on 125 ICD patients followed for 408+/-321 days. Medications and ICD programming were not changed after first ICD therapy. RESULTS: Implantable cardioverter defibrillator therapy occurred in 58 patients (46%). Clinical features were as follows: mean left ventricular ejection fraction (LVEF) 29%+/-15%; coronary artery disease 84%; presenting arrhythmia with sustained monomorphic ventricular tachycardia (SMVT) in 68%. In a multivariate analysis the relative risk for ICD therapy in patients presenting with SMVT versus cardiac arrest (CA) was 2.57 (range, 1.32 to 5.01), and for patients with LVEF < or =25%, 1.95 (1.11 to 3.45), respectively (p < 0.05). Implantable cardioverter defibrillator therapy was not predicted by any other variable. Forty-six patients had second ICD therapy. Mean time to second ICD therapy was only 66+/-93 days compared with 138+/-168 days for first ICD therapy (p < 0.05). No predictor for second ICD therapy was found. Regarding symptoms, impaired consciousness during initial ICD therapy was predicted only by SMVT cycle length <250 ms at electrophysiologic testing. In contrast, symptoms were similar between first and second ICD therapy (p = 0.0001). Of note, ventricular tachycardia cycle length preceding first and second ICD therapy was similar (r = 0.76, p = 0.001). CONCLUSIONS: First ICD therapy tends to occur in patients presenting with SMVT and LVEF < or =25%. Subsequent therapy occurs sooner and is unpredictable, suggesting that antiarrhythmic drug therapy should be considered after the first symptomatic ICD therapy. Symptoms during first ICD therapy predict subsequent symptoms, and patients presenting with SMVT and asymptomatic first ICD therapy are at very low risk for future syncopal ICD therapy.

Aged↗
PubMed2002

Alternative therapy use in HIV-infected patients receiving highly active antiretroviral therapy.

The extent of use of alternative therapies, psychosocial and disease-specific variables predictive of alternative therapy use, and factors motivating the use of alternative therapies in HIV-infected patients receiving highly active antiretroviral therapy (HAART) have not been well defined. Types of alternative therapies used, demographic and medical data, coping (Billing and Moos inventory of coping with illness styles), social support (Irwing and Sarason questionnaire), sense of personal control (Pearlin's Mastery scale), quality of life (Medical Outcome Study scale), health beliefs, and adherence rate were prospectively assessed in 118 HIV-infected patients receiving HAART. Of 38% (45/118) of the patients who used alternative therapies, 56% (25/45) began using alternative therapies since the initiation of HAART. While Caucasian patients were more likely to use alternative therapies than all other patients (P = 0.015), new users of alternative therapies were more likely to be African-American (P = 0.022). Alternative therapy users reported less satisfaction with their emotional support (P = 0.027), and had greater psychological distress (P = 0.048), but were more likely to utilize problem-focused coping (P = 0.015). Patients who used alternative therapies were less likely to believe that HAART was beneficial (P = 0.06). Physicians were unaware of patients' alternative therapy use in 40% (18/45) of all patients who used alternative therapies, in 67% of herbal therapy users, and in 100% of dietary supplement users. Adherence to antiretroviral therapy, CD4 count, and HIV-RNA level were neither predictive nor affected by alternative therapy use. Despite scepticism about the benefits of HAART, resort to alternative therapies did not undermine adherence with antiretroviral therapy. Although able actively to cope with their illness, users of alternative therapies had greater psychological distress and were less satisfied with their emotional support. Interventions aimed at promoting their psychological well-being and enhancing the emotional support should be considered in these patients.

Adaptation, Physiological↗
PubMed1996

The effects of sequence and type of chemotherapy and radiation therapy on cosmesis and complications after breast conservation therapy.

PURPOSE: Chemotherapy plays an increasingly important role in the treatment of both node-negative and node-positive breast cancer patients, but the optimal sequencing of chemotherapy and radiation therapy is not well established. The purpose of this study is to evaluate the interaction of sequence and type of chemotherapy and hormonal therapy given with radiation therapy on the cosmetic outcome and the incidence of complications of Stage I and II breast cancer patients treated with breast-conserving therapy. METHODS AND MATERIALS: The records of 1053 Stage I and II breast cancer patients treated with curative intent with breast-conserving surgery, axillary dissection, and radiation therapy between 1977-1991 were reviewed. Median follow-up after treatment was 6.7 years. Two hundred fourteen patients received chemotherapy alone, 141 patients received hormonal therapy alone, 86 patients received both, and 612 patients received no adjuvant therapy. Patients who received chemotherapy +/- hormonal therapy were grouped according to sequence of chemotherapy: (a) concurrent = concurrent chemotherapy with radiation therapy followed by chemotherapy; (b) sequential = radiation followed by chemotherapy or chemotherapy followed by radiation; and (c) sandwich = chemotherapy followed by concurrent chemotherapy and radiation followed by chemotherapy. Compared to node negative patients, node-positive patients more commonly received chemotherapy (77 vs. 9%, p < 0.0001) and/or hormonal therapy (40 vs. 14%, p < 0.0001). Among patients who received chemotherapy, the majority (243 patients) received concurrent chemotherapy and radiation therapy with two cycles of cytoxan and 5-fluorouracil (5-FU) administered during radiation followed by six cycles of chemotherapy with cytoxan, 5-fluorouracil and either methotrexate (CMF) or doxorubicin(CAF). For analysis of cosmesis, patients included were relapse free with 3 years minimum follow-up. RESULTS: The use of chemotherapy had an adverse effect on cosmetic outcome compared to no chemotherapy, which was of borderline significance at 3 years (92% excellent or good cosmetic outcome vs. 96% respectively, p = 0.057); however, cosmesis was not different at 5 years (91 vs. 93% respectively, p = 0.67). Cosmesis was not significantly different between patients treated sequentially and those treated concurrently (3 year: 87 vs. 93% respectively, p = 0.33), nor was it different between patients who received CMF vs. CAF (3 year: 92 vs. 93% respectively, p = 0.89). Hormonal therapy did not influence cosmetic outcome (p = 0.78). The incidence of Grade 4 or 5 arm edema (> or = 2 cm difference in arm circumference) was 2% without chemotherapy vs. 8% with chemotherapy (p = 0.00002). However, the incidence of arm edema was not affected by sequencing or type of chemotherapy (all p > or = 0.52). Patients treated sequentially had a 10% incidence of Grade 4 or 5 arm edema vs. 7% in the patients treated concurrently (p = 0.52). The incidence was 7 vs. 9% in patients treated with CMF vs. CAF (p = 0.73). The incidence of clinical pneumonitis and rib fracture was not influenced by use of chemotherapy, sequence of chemotherapy or use of hormonal therapy (all p > or = 0.06). CONCLUSIONS: Chemotherapy can be given concurrently with radiation therapy in the treatment of Stage I and II breast cancer with breast-conserving therapy without seriously compromising cosmetic outcome or incidence of complications compared to patients receiving other sequences of chemotherapy. Hormonal therapy did not affect cosmesis or complications. The chemotherapeutic regimen of cytoxan and 5-FU concurrent with radiation therapy followed by more chemotherapy is one reasonable option for breast conservation therapy in patients requiring chemotherapy.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2000

Cognitive behaviour therapy for schizophrenia.

BACKGROUND: Although medication is the mainstay of treatment for schizophrenia, always, some sort of informal or formal talking therapy is indicated. In cognitive behavioural therapy (CBT) links are made between the person's feelings and patterns of thinking which underpin their distress. OBJECTIVES: To review the effects of cognitive behaviour therapy (CBT) for those with schizophrenia compared to standard care, specific medication and non-intervention; also to review the effects of CBT for those with schizophrenia who are concurrently receiving standard care compared to no additional intervention to standard care, specific medication, additional drug interventions to standard care and other additional psychosocial interventions to standard care. SEARCH STRATEGY: Electronic searches of Biological Abstracts (1980-1998), CINAHL (1982-1998), The Cochrane Library (Issue 2, 1998), The Cochrane Schizophrenia Group's Register of Trials (August 1998), EMBASE (1980-1998), MEDLINE (1966-1998), PsycLIT (1887-1998), SIGLE (1990-1998), and Sociofile (1980-1998) were undertaken. All references of articles selected were searched for further relevant trials. SELECTION CRITERIA: Randomised trials of cognitive behaviour therapy for people with a diagnosis of schizophrenia, possible schizophrenia or mental illnesses where specific diagnoses have not been employed. Outcomes such as death, metal state, relapse, psychological well-being and acceptability of treatment were sought. DATA COLLECTION AND ANALYSIS: Studies were reliably selected and assessed for methodological quality. Data were extracted by two reviewers working independently. Dichotomous data were analysed on an intention-to-treat basis and continuous data with 70% completion rate are presented. MAIN RESULTS: Four small trials were identified. All presented data suggested that there was a difference favouring CBT plus standard care over standard care alone in terms of reducing relapse rates (short term OR 0.31 CI 0.1-0.98; medium term OR 0.38 CI 0.17-0.83; long term OR 0.46 CI 0.26-0.83, NNT 6 CI 3-30). These findings were supported within the trials by scale-derived data. CBT, however, did not keep more people in care than a standard approach and there is no data relating to the effect of CBT on compliance with medication. One study also presented data on the effects of CBT when compared to supportive psychotherapy. No effect statistically significantly favoured either group but all were suggestive that the trial may have been underpowered to find an effect in favour of CBT. REVIEWER'S CONCLUSIONS: The results of well conducted and reported ongoing trials are eagerly awaited. Currently, for those with schizophrenia willing to receive CBT, access to this treatment approach is associated with a substantially reduced risk of relapse. However, at present CBT is a fairly scarce commodity, often provided by highly skilled and experienced therapists. Therefore, its application in day to day practice may be restricted by the availability of suitable practitioners. Similarly, the present data provides little indication of how effective CBT procedures might be when they are applied by less experienced practitioners.

Cognitive Behavioral Therapy↗
PubMed2003

Factors associated with complementary therapy use in people living with HIV/AIDS receiving antiretroviral therapy.

OBJECTIVES: This study examined the extent to which people living with HIV/AIDS (PLWHIV) taking combination antiretroviral therapy used complementary therapy, and the relationship of their reported symptoms to the use of complementary therapy and health-related outcomes. DESIGN: A descriptive design was used in which data were obtained from individual interviews and medical records. SETTINGS: PLWHIV were identified through flyers distributed in five HIV clinics in urban and suburban locations in a Western state of the United States. SUBJECTS: The sample consisted of 182 people living with HIV/AIDS, self-identified as white (24.12%), black (44%), and Hispanic (31.88%) with a mean age of 38 (range, 22-66) years. The majority (n = 160; 87.91%) was using as least one category of complementary therapy. Approximately 56% were experiencing symptoms from HIV or their treatment, and 51% discussed their complementary therapy therapies with their health care providers. OUTCOME MEASURE: Three categories of complementary therapy--physical/body-mind therapies, religion, herbs and supplements--and two health-related outcomes--CD4 count and viral load--were explored. RESULTS: Complementary therapy use was associated with higher education, being Christian, white or black, and working part or full time. Significantly more PLWHIV with symptoms used physical/body-mind therapies than those without symptoms. No differences were found between users and nonusers of complementary therapy with respect to CD4 count and viral load. The use of herbs/supplements was significantly associated with the use of protease inhibitors. Among the categories of complementary therapy, religion, especially prayers, were most frequently used. CONCLUSIONS: A substantial proportion of PLWHIV reported using complementary therapy, most predominantly religion (specifically prayers). Further study is recommended to explore the PLWHIV's perceived benefits of using complementary therapy, and to examine the effect of complementary therapy on the patients' symptoms and disease progression. Health care providers need to be alert to potentials of interactions between combination antiretroviral therapies and specific complementary therapy in PLWHIV.

Adult↗
PubMed2006

Levofloxacin-based triple therapy versus bismuth-based quadruple therapy for persistent Helicobacter pylori infection: a meta-analysis.

BACKGROUND: Levofloxacin-based triple therapy has been suggested as an alternative salvage therapy to bismuth-based quadruple therapy for persistent Helicobacter pylori (H. pylori) infection. METHODS: A search of PUBMED, EMBASE, EBM Review databases and abstracts from recent Digestive Disease Week, United European Gastroenterology Week, and European Helicobacter Study Group conferences was performed. Randomized controlled trials (RCTs) comparing levofloxacin-based triple salvage therapy (levofloxacin + amoxicillin + PPI) to bismuth-based quadruple salvage therapy (bismuth + tetracycline + metronidazole + PPI) were selected for meta-analysis. Additionally, all prospective trials evaluating this levofloxacin-based triple therapy as salvage therapy were pooled to analyze optimal levofloxacin treatment duration and dosing. All selected trials confirmed prior treatment failure and post-salvage treatment eradication. RESULTS: Four RCTs compared a 10-day regimen of levofloxacin-based triple therapy to 7-day bismuth-based quadruple therapy (n = 391 patients). Levofloxacin-based triple therapy was superior to quadruple therapy (RR = 1.41 [95% CI: 1.25-1.59]). Levofloxacin-based triple therapy was better tolerated than quadruple therapy with a lower incidence of side effects (RR = 0.51 [95% CI: 0.34-0.75]) and side effects prompting discontinuation of therapy (RR = 0.30 [95% CI: 0.10-0.89]). Eleven trials (n = 547 patients) evaluating levofloxacin-based triple therapy demonstrated higher eradication rates with 10-day versus 7-day regimen (87%[95% CI: 82%-92%]vs 68%[95% CI: 62%-74%]) yet eight trials (n = 477 patients) demonstrated no difference with 500 mg daily versus 250 mg b.i.d. dosing of levofloxacin (81%[95% CI: 78%-89%]vs 84%[95% CI: 66%-97%]). CONCLUSIONS: A 10-day course levofloxacin triple therapy is more effective and better tolerated than 7-day bismuth-based quadruple therapy in the treatment of persistent H. pylori infection.

Amoxicillin↗
PubMed2004

A randomized clinical trial of manipulative therapy and interferential therapy for acute low back pain.

STUDY DESIGN: A multicenter assessor-blinded randomized clinical trial was conducted. OBJECTIVES: To investigate the difference in effectiveness of manipulative therapy and interferential therapy for patients with acute low back pain when used as sole treatments and in combination. SUMMARY OF BACKGROUND DATA: Both manipulative therapy and interferential therapy are commonly used treatments for low back pain. Evidence for the effectiveness of manipulative therapy is available only for the short-term. There is limited evidence for interferential therapy, and no study has investigated the effectiveness of manipulative therapy combined with interferential therapy. METHODS: Consenting subjects (n = 240) recruited following referral by physicians to physiotherapy departments in the (government-funded) National Health Service in Northern Ireland were randomly assigned to receive a copy of the Back Book and either manipulative therapy (MT; n = 80), interferential therapy (IFT; n = 80), or a combination of manipulative therapy and interferential therapy (CT; n = 80). The primary outcome was a change in functional disability on the Roland Morris Disability Questionnaire. Follow-up questionnaires were posted at discharge and at 6 and 12 months. RESULTS: The groups were balanced at baseline for low back pain and demographic characteristics. At discharge all interventions significantly reduced functional disability (Roland Morris scale, MT: -4.53; 95% CI, -5.7 to -3.3 vs. IFT: -3.56; 95% CI, -4.8 to -2.4 vs. CT: -4.65; 95% CI, -5.8 to -3.5; P = 0.38) and pain (McGill questionnaire, MT: -5.12; 95% CI, -7.7 to -2.5 vs. IFT: -5.87; 95% CI, -8.5 to -3.3 vs. CT: -6.64; 95% CI, -9.2 to -4.1; P = 0.72) and increased quality of life (SF-36 Role-Physical, MT: 28.6; 95% CI, 18.3 to 38.9 vs. IFT: 31.4; 95% CI, 21.2 to 41.5 vs. CT: 30; 95% CI, 19.9 to 40; P = 0.93) to the same degree and maintained these improvements at 6 and 12 months. No significant differences were found between groups for reported LBP recurrence, work absenteeism, medication consumption, exercise participation, or healthcare use at 12 months (P > 0.05). CONCLUSIONS: For acute low back pain, there was no difference between the effects of a combined manipulative therapy and interferential therapy package and either manipulative therapy or interferential therapy alone.

Adult↗
PubMed1999

Concurrent use of simvastatin and estrogen--progestin therapy compared with each therapy alone for hypercholesterolemia in postmenopausal women.

OBJECTIVE: Substantial improvements in lipoprotein-lipid profiles have previously been shown with both simvastatin and combined estrogen-progestin therapy in postmenopausal hypercholesterolemic women. Since little is known about the impact of the concomitant use of these therapies, the effects of concurrent hormone therapy and simvastatin in hypercholesterolemic postmenopausal women have been evaluated. METHODS: Twenty-three postmenopausal women with fasting serum total cholesterol levels greater than 250 mg/dl received, in a randomized cross-over design, simvastatin (10 mg daily) for 8 weeks or postmenopausal hormone therapy (up to 1.25 mg of conjugated equine estrogens plus 5 mg of medroxyprogesterone acetate daily) for 8 weeks, with an 8-week wash-out interval between the two treatment periods. In a third, non-randomized treatment period after a second wash-out interval, each woman received a combination of simvastatin and postmenopausal hormone therapy in the same dosage regimens as above. Fasting blood was sampled monthly from baseline to measure total cholesterol, high- and low-density lipoprotein (HDL and LDL) cholesterol, triglycerides and lipoprotein(a). RESULTS: For total cholesterol, the mean decreases with hormone therapy, simvastatin and combination therapy were 12% (95% confidence interval 6-17%), 26% (20-31%) and 28% (24-31%), respectively, and for LDL cholesterol 21% (14-27%), 37% (30-44%) and 46% (41-51%), respectively. Simvastatin was more effective than hormone therapy (p < 0.001), while the effect of the combined therapy was even greater (total cholesterol, p = 0.012; LDL cholesterol, p < 0.001). The level of HDL cholesterol increased similarly with each treatment: 4% (-3-11%), 6% (2-10%) and 7% (2-13%), respectively. Triglyceride levels increased with hormone therapy and decreased with simvastatin (p < 0.001), while there was little change with the combination (effect of combined therapy vs. simvastatin, p = 0.002; vs. hormone therapy, p < 0.001). Both hormone therapy and combined therapy reduced lipoprotein(a) similarly (-23% and -14%, respectively, p = 0.078). Simvastatin had no effect on lipoprotein(a) levels. CONCLUSION: For postmenopausal women with hypercholesterolemia, use of a statin in combination with continuous combined oral estrogen and progestin therapy can result in a more cardioprotective lipoprotein-lipid profile than that achieved with either therapy used alone.

Anticholesteremic Agents↗
PubMed1999

Intravenous and oral mono- or combination-therapy in the treatment of severe infections: ciprofloxacin versus standard antibiotic therapy. Ciprofloxacin Study Group.

Five hundred and forty patients with severe infection were enrolled in a multicentre, prospective, randomized, non-blinded study to compare the efficacy and safety of i.v. ciprofloxacin with i.v. standard therapy. Five hundred and thirty-one patients received at least one dose of study drug for pneumonia (310), septicaemia (112) or skin and skin structure infection (109). Intravenous ciprofloxacin (400 mg, every 8 h) or i.v. ciprofloxacin (400 mg, every 8 h) plus a beta-lactam were compared with a standard monotherapy (beta-lactam) or combination (aminoglycoside plus a beta-lactam) therapy. Patients were treated parenterally for a minimum of 2 or 3 days, then at the discretion of the investigator could be switched to oral therapy (ciprofloxacin 750 mg, every 12 h or a standard oral therapy). Patients were randomized in the ratio of 2:1 for the ciprofloxacin and standard therapy treatment groups and stratified to monotherapy if the APACHE II score was < or = 20 or to combination therapy if the APACHE II score was 21-29. Three hundred and ninety-five (74%) patients were valid for the efficacy analysis: these comprised 242 pneumonia (167 ciprofloxacin and 75 standard therapy), 70 septicaemia (47 ciprofloxacin and 23 standard therapy), and 83 skin infections (56 ciprofloxacin and 27 standard). The primary efficacy variable was clinical response and the secondary efficacy assessment was bacteriological response at the end of therapy (2 or 3 days after treatment). The mean duration of therapy for patients receiving only i.v. monotherapy or combination therapy was shorter (9-10 days) than for patients receiving sequential i.v./p.o. therapy (14-17 days). At the end of therapy, overall clinical resolution/improvement (success) for monotherapy was 138/166 (83%) for the ciprofloxacin group, compared with 74/87 (85%) for standard-treated patients (95% CI = -11.5% to 7.6%), and for combination therapy the response was 43/51 (84%) for the ciprofloxacin group and 14/20 (70%) for standard-treated patients (95% CI = -6.3% to 34.9%). For pneumonia, the most frequent infection treated, clinical success rates following monotherapy were 85% for ciprofloxacin and 83% for standard-treated patients and 83% for ciprofloxacin compared with 69% for standard-treated patients in the combination therapy group. Bacteriological eradication/presumed eradication following monotherapy was 85/102 (83%) for ciprofloxacin and 31/46 (67%) for standard-treated patients (95% CI = 1.6% to 30.3%), and that for combination therapy was 29/36 (81%) for ciprofloxacin and 7/10 (70%) for standard-treated patients (95% CI = -18.3% to 39.5%). Drug-related adverse events, primarily diarrhoea and nausea, were reported in 22% of ciprofloxacin-treated patients and 20% of standard-treated patients. In summary, ciprofloxacin administered alone or in combination was found to be effective in treating a wide range of severe infections.

Administration, Oral↗
PubMed2001

Perceptions about complementary therapies relative to conventional therapies among adults who use both: results from a national survey.

BACKGROUND: Little is known about perceptions of complementary and alternative medical (CAM) therapy relative to conventional therapy among patients who use both. OBJECTIVE: To document perceptions about CAM therapies among persons who use CAM and conventional therapies. DESIGN: Nationally representative, random-household telephone survey. SETTING: The 48 contiguous U.S. states. PARTICIPANTS: 831 adults who saw a medical doctor and used CAM therapies in 1997. MEASUREMENTS: Perceptions about helpfulness and patterns of CAM therapy use relative to conventional therapy use and reasons for nondisclosure of CAM therapies. RESULTS: Of 831 respondents who saw a medical doctor and used CAM therapies in the previous 12 months, 79% perceived the combination to be superior to either one alone. Of 411 respondents who reported seeing both a medical doctor and a CAM provider, 70% typically saw a medical doctor before or concurrent with their visits to a CAM provider; 15% typically saw a CAM provider before seeing a medical doctor. Perceived confidence in CAM providers was not substantially different from confidence in medical doctors. Among the 831 respondents who in the past year had used a CAM therapy and seen a medical doctor, 63% to 72% did not disclose at least one type of CAM therapy to the medical doctor. Among 507 respondents who reported their reasons for nondisclosure of use of 726 alternative therapies, common reasons for nondisclosure were "It wasn't important for the doctor to know" (61%), "The doctor never asked" (60%), "It was none of the doctor's business" (31%), and "The doctor would not understand" (20%). Fewer respondents (14%) thought their doctor would disapprove of or discourage CAM use, and 2% thought their doctor might not continue as their provider. Respondents judged CAM therapies to be more helpful than conventional care for the treatment of headache and neck and back conditions but considered conventional care to be more helpful than CAM therapy for treatment of hypertension. CONCLUSIONS: National survey data do not support the view that use of CAM therapy in the United States primarily reflects dissatisfaction with conventional care. Adults who use both appear to value both and tend to be less concerned about their medical doctor's disapproval than about their doctor's inability to understand or incorporate CAM therapy use within the context of their medical management.

Adult↗
PubMed2004

[Naikan therapy for prolonged depression: psychological changes and long-term efficacy of intensive Naikan therapy].

OBJECTIVE: Many studies have shown that a considerable number of patients with prolonged depression are refractory to drug therapy or supportive psychotherapy. A few studies have shown the short-term effectiveness of intensive Naikan therapy for prolonged depression, but the long-term effects have not been reported. For other psychotherapies also, few studies have demonstrated their long-term effectiveness for prolonged depression. The purpose of the present study was to assess the long-term efficacy of intensive Naikan therapy for patients with prolonged depression and to investigate the factors contributing to its efficacy. METHOD: At Tottori University Hospital, 23 inpatients with prolonged depression were treated with intensive Naikan therapy. The age, sex, age at onset, number of depressive episodes, duration of the present episode, diagnosis and family history were investigated. The Tokyo University Egogram (TEG), Yatabe-Guiltora personality inventory (YG test) and Rosenzweig picture-frustration (PF) study were conducted before and after intensive Naikan therapy to investigate psychological changes. The long-term efficacy (average: 24.5 +/- 10.6 months) of intensive Naikan therapy for prolonged depression was assessed with Global Assessment of Functioning scale (GAF). "Improvement" was defined as a post-therapy GAF score of 61 or higher. The Hamilton Depression Rating Scale (HAM-D) was applied to confirm the GAF results. Whether the patient achieved awareness of other's viewpoint, awareness of egocentricity, feeling of love, breaking out from self and sense of fulfillment after intensive Naikan therapy was investigated. RESULTS: Fifteen patients (65.2%) showed improvement in GAF and HAM-D (improved group) and eight patients showed no improvement (non-improved group). The average GAF score changed from 46.1 (before Naikan therapy) to 81.8 (at outcome assessment) in the improved group and from 45.3 to 52.8 in the non-improved group. The improved group had significantly shorter average duration of the present depressive episode and significantly less depressive episodes compared to the non-improved group. Only the improved group showed significantly lower scores on the critical parent (CP) scale of TEG, cyclic tendency (C) on the YG test and extraggression (E-A) in PF study. In the improved group, significantly more patients achieved deep insight (Naikan); and significantly more patients achieved awareness of other's viewpoint, awareness of egocentricity, feeling of love, breaking out from self and sense of fulfillment after intensive Naikan therapy. CONCLUSIONS: Our results suggested that intensive Naikan therapy for prolonged depression was equally as effective as Morita therapy, interpersonal therapy or group psychotherapy, and the effects of intensive Naikan therapy continued for a long term. Attainment of deep Naikan brought psychological changes in patients showing improvement, motivating them to continue Naikan therapy in daily life. We consider that this is the key factor that maintains the long-term efficacy of intensive Naikan therapy.

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PubMed2006

Consensus statement on negative pressure wound therapy (V.A.C. Therapy) for the management of diabetic foot wounds.

UNLABELLED: In 2004, a multidisciplinary expert panel convened at the Tucson Expert Consensus Conference (TECC) to determine appropriate use of negative pressure wound therapy as delivered by a Vacuum Assisted Closure device (V.A.C. THERAPY, KCI, San Antonio, Texas) in the treatment of diabetic foot wounds. These guidelines were updated by a second multidisciplinary expert panel at a consensus conference on the use of V.A.C. THERAPY, held in February 2006, in Miami, Florida. This updated version of the guidelines summarizes current clinical evidence, provides practical guidance, offers best practices to clinicians treating diabetic foot wounds, and helps direct future research. The Miami consensus panel discussed the following 12 key questions regarding V.A.C. THERAPY: (1) How long should V.A.C. THERAPY be used in the treatment of a diabetic foot wound? (2) Should V.A.C." THERAPY be applied without debriding the wound? (3) How should the patient using V.A.C. THERAPY be evaluated on an outpatient basis? (4) When should V.A.C. THERAPY be applied following revascularization? (5) When should V.A.C. THERAPY be applied after incision, drainage, and debridement of infection? (6) Should V.A.C. THERAPY be applied over an active soft tissue infection? (7) How should V.A.C. THERAPY be used in patients with osteomyelitis? (8) How should noncompliance to V.A.C. THERAPY be defined? (9) How should V.A.C. THERAPY be used in combination with other modalities? (10) Should small, superficial wounds be considered for V.A.C. THERAPY? (11) How should success in the use of V.A.C. THERAPY be defined? (12) How can one combine effective offloading and V.A.C. THERAPY?

Algorithms↗