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1.
J Am Geriatr Soc ; 48(10): 1183-94, 2000 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-11037003

RESUMO

OBJECTIVES: To evaluate the efficacy, the dose-dependence, and the durability of the effect of the ginkgo biloba special extract EGb 761 (ginkgo) in older people with dementia or age-associated memory impairment. DESIGN: A 24-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter trial. SETTING: Homes for the elderly in the southern part of the Netherlands. PARTICIPANTS: Older persons with dementia (either Alzheimer's dementia or vascular dementia; mild to moderate degree) or age-associated memory impairment (AAMI). 214 Participants were recruited from 39 homes for the elderly. INTERVENTION: The participants were allocated randomly to treatment with EGb 761 (2 tablets per day, total dosage either 240 (high dose) or 160 (usual dose) mg/day) or placebo (0 mg/d). The total intervention period was 24 weeks. After 12 weeks of treatment, the initial ginkgo users were randomized once again to either continued ginkgo treatment or placebo treatment. Initial placebo use was prolonged after 12 weeks. MEASUREMENTS: Outcomes were assessed after 12 and 24 weeks of intervention. Outcome measures included neuropsychological testing (trail-making speed (NAI-ZVT-G), digit memory span (NAI-ZN-G), and verbal learning (NAI-WL)), clinical assessment (presence and severity of geriatric symptoms (SCAG), depressive mood (GDS), self-perceived health and memory status (report marks)), and behavioral assessment (self-reported level of instrumental daily life activities). RESULTS: An intention-to-treat analysis showed no effect on each of the outcome measures for participants who were assigned to ginkgo (n = 79) compared with placebo (n = 44) for the entire 24-week period. After 12 weeks of treatment, the combined high dose and usual dose ginkgo groups (n = 166) performed slightly better with regard to self-reported activities of daily life but slightly worse with regard to self-perceived health status compared with the placebo group (n = 48). No beneficial effects of a higher dose or a prolonged duration of ginkgo treatment were found. We could not detect any subgroup that benefited from ginkgo. Ginkgo use was also not associated with the occurrence of (serious) adverse events. CONCLUSIONS: The results of our trial suggest that ginkgo is not effective as a treatment for older people with mild to moderate dementia or age-associated memory impairment. Our results contrast sharply with those of previous ginkgo trials.


Assuntos
Doença de Alzheimer/tratamento farmacológico , Demência Vascular/tratamento farmacológico , Flavonoides/uso terapêutico , Transtornos da Memória/tratamento farmacológico , Fármacos Neuroprotetores/uso terapêutico , Extratos Vegetais , Vasodilatadores/uso terapêutico , Atividades Cotidianas , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Doença de Alzheimer/etiologia , Demência Vascular/etiologia , Método Duplo-Cego , Feminino , Flavonoides/farmacologia , Avaliação Geriátrica , Ginkgo biloba , Humanos , Masculino , Transtornos da Memória/etiologia , Fármacos Neuroprotetores/farmacologia , Testes Neuropsicológicos , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do Tratamento , Vasodilatadores/farmacologia
2.
Eur J Radiol ; 36(1): 32-5, 2000 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-10996756

RESUMO

PURPOSE: To assess the willingness of radiologists to change their practice when the results of a randomized clinical trial (RCT) on the use of antispasmodic drugs in barium enema are presented. MATERIALS AND METHODS: During the years 1994 and 1995 two postal questionnaires were sent to 481 practicing radiologists who were all members of the Netherlands Society of Radiology. In the first questionnaire the respondents were asked to give the characteristics of their practices in performing daily barium enema. The data from this questionnaire was used as a reference. The second questionnaire was sent to the respondents together with an abstract on the randomized clinical trial supporting the use of antispasmodic drugs in barium enema. We also indicated a preference for Buscopan over Glucagon as the antispasmodic drug. The willingness to change prescription habits was measured by comparing the data of the two questionnaires. RESULTS: Of 481 practicing radiologists, 312 responded to the first questionnaire and gave information of their prescription habits (response rate 64%). These 312 responders were sent an abstract of the RCT and were asked to fill out a second questionnaire to determine their willingness to change their practice. Two hundred and sixty-seven radiologists responded (response rate 86%). A significant number of 119 (51%) were willing to increase the use of antispasmodic drugs. A significant number of 128 (55%) chose to increase the use of Buscopan, while a significant number of 81 (32%) were willing to decrease the use of Glucagon. CONCLUSION: Direct exposure to the results of an RCT recommending the use of antispasmodic drugs in barium enema, especially Buscopan, is likely to increase its use by practicing radiologists.


Assuntos
Sulfato de Bário , Meios de Contraste/administração & dosagem , Enema , Parassimpatolíticos/uso terapêutico , Padrões de Prática Médica , Radiologia , Atitude do Pessoal de Saúde , Sulfato de Bário/administração & dosagem , Brometo de Butilescopolamônio/uso terapêutico , Distribuição de Qui-Quadrado , Fármacos Gastrointestinais/uso terapêutico , Glucagon/uso terapêutico , Humanos , Antagonistas Muscarínicos/uso terapêutico , Países Baixos , Estudos Prospectivos , Inquéritos e Questionários
3.
Cochrane Database Syst Rev ; (2): CD000518, 2000.
Artigo em Inglês | MEDLINE | ID: mdl-10796385

RESUMO

BACKGROUND: Balneotherapy (hydrotherapy or spa therapy) for patients with arthritis is one of the oldest forms of therapy. One of the aims of balneotherapy is to soothe the pain and as a consequence to relieve patients' suffering and make them feel well. OBJECTIVES: To perform a systematic review to assess the effects of balneotherapy for rheumatoid arthritis and osteoarthritis. SEARCH STRATEGY: Using the Cochrane search strategy, studies were found by screening: 1) The Medline CD-ROM database from 1966 to June 1999 and 2) the database from the Cochrane Field 'Rehabilitation and Related Therapies', which contains also studies published in journals not covered by Medline. Also, 3) reference checking and 4) personal communications with authors was carried out to retrieve eligible studies. To perform an adequate assessment of the methodological quality the languages of the publications had to be: Dutch, English, French or German. Date of the most recent literature search: June, 1999 SELECTION CRITERIA: Studies were eligible if they were randomized controlled trials (RCT) comparing balneotherapy with any intervention or with no intervention. Patients included had rheumatoid arthritis (RA), osteoarthritis (OA) or some other form of arthritis. Trials incorporating patients with definite or classical rheumatoid arthritis (RA) as defined by the American Rheumatism Association Criteria (ARA) (Ropes 1958) (these criteria have changed over time) or by the criteria of Steinbrocker (1949) were regarded as a separate group. At least one of the WHO/ILAR core set of endpoints for RA clinical trials had to be the main outcome measures. DATA COLLECTION AND ANALYSIS: A criteria list used to assess the methodological quality was the one developed at the Department of Epidemiology at the Maastricht University, called "the Maastricht list". The quality scores and data abstraction of the studies were carried out independently by two reviewers (HdV, RdB). Disagreements were solved by consensus. MAIN RESULTS: Ten trials with 607 patients were included in this review. Most trials reported positive findings, but were methodologically flawed to some extent. A 'quality of life' outcome was reported by two trials. Just one of the randomized trials mentioned an intention-to-treat analysis and only three performed a comparison of effects between groups. Pooling of the data was not performed, because of heterogeneity of the studies, multiple outcome measurements, and, apart from two studies, the overall data presentation was too scarce to enable pooling of the data. REVIEWER'S CONCLUSIONS: One cannot ignore the positive findings reported in most trials. However the scientific evidence is weak because of the poor methodological quality, the absence of an adequate statistical analysis, and the absence, for the patient, of most essential outcome measures (pain, quality of life), Therefore, the noted "positive findings" should be viewed with caution. Because of the methodological flaws an answer about the efficacy of balneotherapy cannot be provided at this time. Flaws found in the reviewed studies could be avoided in future trials.


Assuntos
Artrite Reumatoide/terapia , Balneologia , Hidroterapia , Osteoartrite/terapia , Humanos
4.
Ann Rheum Dis ; 58(9): 530-40, 1999 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-10460185

RESUMO

OBJECTIVE: To assess the efficacy of bipolar interferential electrotherapy (ET) and pulsed ultrasound (US) as adjuvants to exercise therapy for soft tissue shoulder disorders (SD). METHODS: Randomised placebo controlled trial with a two by two factorial design plus an additional control group in 17 primary care physiotherapy practices in the south of the Netherlands. Patients with shoulder pain and/or restricted shoulder mobility, because of a soft tissue impairment without underlying specific or generalised condition, were enrolled if they had not recovered after six sessions of exercise therapy in two weeks. They were randomised to receive (1) active ET plus active US; (2) active ET plus dummy US; (3) dummy ET plus active US; (4) dummy ET plus dummy US; or (5) no adjuvants. Additionally, they received a maximum of 12 sessions of exercise therapy in six weeks. Measurements at baseline, 6 weeks and 3, 6, 9, and 12 months later were blinded for treatment. OUTCOME MEASURES: recovery, functional status, chief complaint, pain, clinical status, and range of motion. RESULTS: After written informed consent 180 patients were randomised: both the active treatments were given to 73 patients, both the dummy treatments to 72 patients, and 35 patients received no adjuvants. Prognosis of groups appeared similar at baseline. Blinding was successfully maintained. At six weeks seven patients (20%) without adjuvants reported very large improvement (including complete recovery), 17 (23%) and 16 (22%) with active and dummy ET, and 19 (26%) and 14 (19%) with active and dummy US. These proportions increased to about 40% at three months, but remained virtually stable thereafter. Up to 12 months follow up the 95% CI for differences between groups for all outcomes include zero. CONCLUSION: Neither ET nor US prove to be effective as adjuvants to exercise therapy for soft tissue SD.


Assuntos
Doenças do Tecido Conjuntivo/terapia , Terapia por Estimulação Elétrica/métodos , Dor de Ombro/terapia , Terapia por Ultrassom/métodos , Adulto , Idoso , Terapia Combinada , Terapia por Exercício , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Prognóstico , Ombro , Método Simples-Cego , Resultado do Tratamento
5.
J Manipulative Physiol Ther ; 22(3): 144-8, 1999.
Artigo em Inglês | MEDLINE | ID: mdl-10220712

RESUMO

BACKGROUND: Activities and their importance for daily living vary widely between patients. Patient-specific measurement of functional status means that the evaluation is focused on activities that an individual patient selected as main complaints. OBJECTIVE: To develop and to evaluate a patient-specific approach for measuring functional status in low back pain. STUDY DESIGN: A cohort of 150 patients was measured at baseline and 12 weeks later. METHODS: The feasibility of the patient-specific approach was evaluated in patients with nonspecific low back pain. We used effect size statistics to evaluate responsiveness in terms of sensitivity to change and specificity to change. RESULTS: The selection procedure for the main complaint was feasible but labor intensive. The patient-specific approach was able to detect changes in complaints that were highly relevant for the patients. The patient-specific approach appeared to be more sensitive to change but less specific to change compared with other instruments. CONCLUSIONS: On the basis of this study it would be valuable to apply the patient-specific approach in future studies, also with the aim of further evaluation. In the meantime a number of practical problems of the method need to be resolved.


Assuntos
Atividades Cotidianas , Dor Lombar/fisiopatologia , Medição da Dor , Satisfação do Paciente , Adulto , Estudos de Coortes , Feminino , Humanos , Masculino , Sensibilidade e Especificidade , Inquéritos e Questionários
6.
Arzneimittelforschung ; 48(10): 1033-6, 1998 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-9825123

RESUMO

The maintenance of double-blind conditions in placebo-controlled trials depends on the quality of the placebo preparation. The placebo should match the active substance-containing preparation as closely as possible, but it must not contain any substances that might themselves be pharmacologically active. Active substances characterized by a particular colour, taste, smell or other easily perceptible properties constitute a challenge to researchers. The way of developing a placebo that matches a phytopharmaceutical to a satisfactory extent is described and discussed.


Assuntos
Fármacos do Sistema Nervoso Central/uso terapêutico , Protocolos Clínicos/normas , Método Duplo-Cego , Flavonoides/uso terapêutico , Transtornos da Memória/tratamento farmacológico , Placebos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Idoso , Relação Dose-Resposta a Droga , Ginkgo biloba , Humanos , Transtornos da Memória/etiologia , Extratos Vegetais/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto/normas
7.
J Clin Epidemiol ; 51(4): 335-41, 1998 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-9539890

RESUMO

This study investigates aspects of the reliability of the Maastricht criteria list for quality assessment in systematic reviews, and whether blinded reviewing is necessary to prevent review bias. We used the data set of 12 articles from a systematic review concerning the efficacy of balneotherapy in patients with arthritis. Twenty reviewers participated of which two reviewers, who have been involved in developing the Maastricht criteria list, acted as reference standard. Half of all assessments were performed blindly. A high level of agreement was found between the reviewers and a high level of correlation with the reference standard. The quality scores between the blinded and unblinded assessment did not differ much. Based on the results we conclude that the Maastricht criteria list is a reliable instrument in quality assessment of clinical trials. Within the limits of this study we found no evidence that blinding is necessary to prevent review bias.


Assuntos
Artrite/terapia , Balneologia , Variações Dependentes do Observador , Garantia da Qualidade dos Cuidados de Saúde/métodos , Literatura de Revisão como Assunto , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Padrões de Referência , Reprodutibilidade dos Testes
8.
J Rheumatol ; 24(10): 1964-71, 1997 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-9330940

RESUMO

OBJECTIVE: To review English, French, German, and Dutch language studies of the effectiveness of balneotherapy. Balneotherapy (hydrotherapy or spa therapy) is one of the oldest forms of therapy for patients with arthritis. One of the aims of balneotherapy is to relieve pain. METHODS: We performed a systematic review that included randomized and nonrandomized studies. Quality scores of the studies were determined using a criteria list. RESULTS: Most studies report positive findings, but all studies showed methodological flaws. A quality of life measurement was never reported as an outcome measure. None of the randomized clinical trials included intention-to-treat analysis or comparison of effects between groups. CONCLUSION: Because of the methodological flaws a conclusion about the efficacy of balneotherapy cannot be provided from studies we reviewed. We conclude that most flaws found could be avoidable in future research.


Assuntos
Artrite Reumatoide/terapia , Artrite/terapia , Balneologia , Ensaios Clínicos como Assunto , Humanos , Avaliação de Resultados em Cuidados de Saúde , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
9.
Spine (Phila Pa 1976) ; 22(11): 1235-41, 1997 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-9201862

RESUMO

STUDY DESIGN: An intraobserver and interobserver study on the reproducibility of data was performed. OBJECTIVES: This study investigates the variability in the interpretation of lumbar spine radiographs by chiropractors working in private practice. SUMMARY OF BACKGROUND DATA: In chiropractic practice radiographs are used often, but this use is currently under debate. Therefore, there is a need for further study of the value of diagnoses made by radiographs by chiropractors. An acceptable intra- and interobserver agreement in radiograph reading is a prerequisite for a useful application of radiographs as a diagnostic tool in daily practice and in research. METHODS: Four chiropractors read 100 blinded sets of standard, erect anteroposterior and lateral lumbar radiographs independently. The same set was read in two separate sessions with a 2-month interval. The first session revealed the interobserver agreement. The comparison of the ratings by the same assessor in the two sessions indicated the intraobserver agreement. The assessors used a specially developed criteria list with emphasis on "nonspecific" radiographic findings. The prevalence of some important categories was increased artificially. Agreement was expressed in percentage agreement and generalized kappa, combining the results of all four assessors. RESULTS: Most kappas ranged from 0.40 to 0.75, representing fair to good agreement. In general, intraobserver agreement was better than interobserver agreement. The low kappas that were found may be explained partially by the high-agreement-low-kappa paradox as a result of a low prevalence. CONCLUSION: The kappas and percentage agreement were acceptable, although not excellent. These results will be beneficial for future research on the value of radiograph diagnosis of nonspecific findings for delivery of safe and effective chiropractic therapy.


Assuntos
Quiroprática , Vértebras Lombares/diagnóstico por imagem , Adulto , Humanos , Variações Dependentes do Observador , Radiografia , Reprodutibilidade dos Testes , Doenças da Coluna Vertebral/diagnóstico por imagem , Doenças da Coluna Vertebral/epidemiologia
10.
J Clin Epidemiol ; 48(12): 1453-60, 1995 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-8543959

RESUMO

The objective of this study was to assess the effects of ascorbic acid supplementation, 500 mg twice daily in the treatment of pressure ulcers as an adjunct to standardized treatment. The design consisted of a multicenter blinded randomized trial. The control group received 10 mg of ascorbic acid twice daily. Patients from 11 nursing homes and 1 hospital participated. Main outcome measures included wound survival, healing rates of wound surfaces, and clinimetric changes over 12 weeks. Eighty-eight patients were randomized. Intention-to-treat analysis showed that the wound closure probability per unit time (i.e., the closure rate) was not higher in the intervention group than in the control group (Cox hazard ratio of 0.78 [90% precision interval, 0.44-1.39]). Mean absolute healing rates were 0.21 and 0.27 cm2/week in the intervention and control group, respectively (PI of the adjusted difference: -0.17 to 0.13). Relative healing rates and healing velocities did not show favorable results of ascorbic acid supplementation, either. A panel scored slides of the ulcers with a report mark between 1 (bad) and 10 (excellent). The improvement was 0.45 and 0.72 points per week in the intervention and control group, respectively (PI of the adjusted difference: -0.50 to 0.20). With another clinimetric index we could not show any differences, either. These data do not support the idea that ascorbic acid supplementation (500 vs. 10 mg twice daily) speeds up the healing of pressure ulcers.


Assuntos
Ácido Ascórbico/uso terapêutico , Úlcera por Pressão/tratamento farmacológico , Quimioterapia Adjuvante , Método Duplo-Cego , Humanos , Análise Multivariada , Países Baixos/epidemiologia , Úlcera por Pressão/epidemiologia , Modelos de Riscos Proporcionais , Resultado do Tratamento , Cicatrização
11.
J Manipulative Physiol Ther ; 18(3): 141-7, 1995.
Artigo em Inglês | MEDLINE | ID: mdl-7790793

RESUMO

OBJECTIVE: To present the design of a trial on the efficacy of lumbar traction. DESIGN: Randomized clinical trial. PATIENTS: Patients with a minimum of 6 wk, nonspecific low back pain. INTERVENTION: High-dose, motorized, continuous traction with a force between 35% and 50% of the total body weight was compared with sham or low-dose traction with a force between 0 and 20% of body weight. The sham traction was given with a specially developed brace that becomes tighter in the back during traction. This is experienced by patients as if traction were exerted. OUTCOME MEASURES: Primary measures were the patient's global impression of the effect and the severity of three main complaints. Secondary effect measures were functional status, pain, range of motion, work absence and recurrences. The effect measures were rated before randomization and 4 wk, 12 wk and 6 months later. CONCLUSION: There have been a number of earlier trials on the efficacy of lumbar traction; they suffer, however, from severe methodological flaws. This trial aimed to avoid these shortcomings.


Assuntos
Dor Lombar/terapia , Tração/métodos , Análise de Variância , Método Duplo-Cego , Humanos , Projetos de Pesquisa , Resultado do Tratamento
12.
Int J Epidemiol ; 22(5): 798-803, 1993 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-8282457

RESUMO

The effect of sexual behavior on the risk for cervical dysplasia was evaluated in a case-control study. Cases (n = 257) had a histologically confirmed diagnosis of cervical dysplasia. Controls (n = 705) were sampled from the general population. A postal questionnaire was used to obtain information about, among other things, age at first sexual intercourse, number of sexual partners, current frequency of intercourse and contraceptive use. Information was also collected about other risk factors for cervical dysplasia, in order to adjust for possible confounding. We observed higher risks for cervical dysplasia (mild, moderate and severe) with increasing number of sexual partners. This effect appeared to be dependent on smoking behaviour. For women who reported more than six sexual partners, the adjusted odds ratio (aOR) was 9.1 (95% CI: 3.5-23.7) for non-smokers, and 26.4 (95% CI: 11.8-58.8) for women who smoked > or = 20 cigarettes per day. The effects of age at first sexual intercourse and current frequency of intercourse disappeared after adjustment for other risk factors. Use of oral contraceptives for > 10 years increased the risk (aOR = 2.3; 95% CI: 1.2-4.6). Thus, the number of sexual partners, especially in combination with smoking behaviour, appeared to be the most important risk factor for cervical dysplasia.


Assuntos
Coito , Parceiros Sexuais , Displasia do Colo do Útero/epidemiologia , Adjuvantes Imunológicos/uso terapêutico , Adulto , Idoso , Carotenoides/uso terapêutico , Estudos de Casos e Controles , Anticoncepcionais Orais , Feminino , Humanos , Modelos Logísticos , Pessoa de Meia-Idade , Países Baixos/epidemiologia , Razão de Chances , Fatores de Risco , Fumar/epidemiologia , Displasia do Colo do Útero/etiologia , Displasia do Colo do Útero/terapia , beta Caroteno
13.
J Manipulative Physiol Ther ; 16(4): 211-9, 1993 May.
Artigo em Inglês | MEDLINE | ID: mdl-8340715

RESUMO

OBJECTIVE: To study the efficacy of manual therapy and physiotherapy in subgroups of patients with persistent back and neck complaints. The second objective was to determine the correlation between three important outcome measures used in this trial. DESIGN: Randomized clinical trial (subgroup analysis). SETTING: Primary health care in the Netherlands. PATIENTS: Two hundred fifty-six patients with nonspecific back and neck complaints of at least 6 wk duration who had not received physiotherapy or manual therapy in the past 2 yr. INTERVENTIONS: At the discretion of the manual therapists, physiotherapists and general practitioners. Physiotherapy consisted of exercises, massage and physical therapy (heat, electrotherapy, ultrasound, shortwave diathermy). Manual therapy consisted of manipulation and mobilization of the spine. Treatment by the general practitioner consisted of drugs (e.g., analgesics), advice about posture, home exercises and (bed)rest. Placebo treatment consisted of detuned shortwave diathermy (10 min) and detuned ultrasound (10 min). MAIN OUTCOME MEASURES: Changes in severity of the main complaint and limitation of physical functioning measured on 10-point scales by a blinded research assistant and global perceived effect measured on a 6-point scale by the patients. RESULTS: Improvement in the main complaint was larger with manual therapy (4.3) than with physiotherapy (2.5) for patients with chronic conditions (duration complaint of 1 yr or longer). Also, improvement in the main complaint was larger with manual therapy (5.5) than with physiotherapy (4.0) for patients younger than 40 yr (both were measured after 12-mo follow-up). Labeling of patients by the treating manual therapists as "suitable" or "not suitable" for treatment with manual therapy did not predict differences in outcomes. Generally, there was a moderate to strong correlation between the three outcome measures, although a considerable number of patients gave a relatively low score for perceived benefit, while the research assistant gave a high improvement score for the main complaint and physical functioning. CONCLUSIONS: The subgroup analysis suggests better results of manual therapy compared to physiotherapy in chronic patients (duration of present complaints of 1 yr or longer) and in patients younger than 40 yr old). Differences for other subgroups were less clear. The explorative findings of these subgroup analyses have to be investigated in future research.


Assuntos
Dor nas Costas/terapia , Quiroprática , Modalidades de Fisioterapia , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pescoço , Avaliação de Resultados em Cuidados de Saúde , Prognóstico , Análise de Regressão
14.
BMJ ; 304(6827): 601-5, 1992 Mar 07.
Artigo em Inglês | MEDLINE | ID: mdl-1532760

RESUMO

OBJECTIVE: To compare the effectiveness of manipulative therapy, physiotherapy, treatment by the general practitioner, and placebo therapy in patients with persistent non-specific back and neck complaints. DESIGN: Randomised clinical trial. SETTING: Primary health care in the Netherlands. PATIENTS: 256 patients with non-specific back and neck complaints of at least six weeks' duration who had not received physiotherapy or manipulative therapy in the past two years. INTERVENTIONS: At the discretion of the manipulative therapists, physiotherapists, and general practitioners. Physiotherapy consisted of exercises, massage, and physical therapy (heat, electrotherapy, ultrasound, shortwave diathermy). Manipulative therapy consisted of manipulation and mobilisation of the spine. Treatment by general practitioners consisted of drugs (for example, analgesics), advice about posture, home exercises, and (bed)rest. Placebo treatment consisted of detuned shortwave diathermy (10 minutes) and detuned ultrasound (10 minutes). MAIN OUTCOME MEASURES: Changes in severity of the main complaint and limitation of physical functioning measured on 10 point scales by a blinded research assistant and global perceived effect measured on a 6 point scale by the patients. RESULTS: Many patients in the general practitioner and placebo groups received other treatment during follow up. Improvement in the main complaint was larger with manipulative therapy (4.5) than with physiotherapy (3.8) after 12 months' follow up (difference 0.9; 95% confidence interval 0.1 to 1.7). Manipulative therapy also gave larger improvements in physical functioning (difference 0.6; -0.1 to 1.3). The global perceived effect after six and 12 months' follow up was similar for both treatments. CONCLUSIONS: Manipulative therapy and physiotherapy are better than general practitioner and placebo treatment. Furthermore, manipulative therapy is slightly better than physiotherapy after 12 months.


Assuntos
Dor nas Costas/terapia , Manipulação Ortopédica , Pescoço , Manejo da Dor , Modalidades de Fisioterapia , Adulto , Dor nas Costas/reabilitação , Doença Crônica , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Dor/reabilitação
15.
J Manipulative Physiol Ther ; 15(1): 16-23, 1992 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-1531487

RESUMO

In a blinded randomized clinical trial, we compared the effectiveness of manual therapy, physiotherapy, (continued) treatment by the general practitioner (GP), and a placebo therapy (detuned ultrasound and detuned short wave diathermy) for patients (n = 256) with chronic nonspecific back and neck complaints. The physical outcome measures (spinal mobility and physical functioning) are presented for 3, 6 and 12 wk follow-up. Manual therapy showed a faster and larger improvement in physical functioning compared to the other three therapies. The changes in spinal mobility among the four study groups appear to be small and show no consistent pattern.


Assuntos
Dor nas Costas/terapia , Manipulação Ortopédica , Modalidades de Fisioterapia/métodos , Adulto , Método Duplo-Cego , Feminino , Humanos , Masculino , Pescoço , Avaliação de Resultados em Cuidados de Saúde , Cooperação do Paciente , Amplitude de Movimento Articular
16.
Spine (Phila Pa 1976) ; 17(1): 28-35, 1992 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-1531552

RESUMO

In a randomized trial, the effectiveness of manual therapy, physiotherapy, continued treatment by the general practitioner, and placebo therapy (detuned ultrasound and detuned short-wave diathermy) were compared for patients (n = 256) with nonspecific back and neck complaints lasting for at least 6 weeks. The principle outcome measures were severity of the main complaint, global perceived effect, pain, and functional status. These are presented for 3, 6, and 12 weeks follow-up. Both physiotherapy and manual therapy decreased the severity of complaints more and had a higher global perceived effect compared to continued treatment by the general practitioner. Differences in effectiveness between physiotherapy and manual therapy could not be shown. A substantial part of the effect of manual therapy and physiotherapy appeared to be due to nonspecific (placebo) effects.


Assuntos
Dor nas Costas/reabilitação , Manipulação Ortopédica , Pescoço , Modalidades de Fisioterapia , Adulto , Analgésicos/uso terapêutico , Anti-Inflamatórios não Esteroides/uso terapêutico , Dor nas Costas/epidemiologia , Diatermia , Feminino , Humanos , Masculino , Massagem , Efeito Placebo , Terapia por Ultrassom
17.
BMJ ; 303(6813): 1298-303, 1991 Nov 23.
Artigo em Inglês | MEDLINE | ID: mdl-1836153

RESUMO

OBJECTIVE: To assess the efficacy of spinal manipulation for patients with back or neck pain. DESIGN: Computer aided search for published papers and blinded assessment of the methods of the studies. SUBJECTS: 35 randomised clinical trials comparing spinal manipulation with other treatments. MAIN OUTCOME MEASURES: Score for quality of methods (based on four main categories: study population, interventions, measurement of effect, and data presentation and analysis) and main conclusion of author(s) with regard to spinal manipulation. RESULTS: No trial scored 60 or more points (maximum score 100) suggesting that most were of poor quality. Eighteen studies (51%) showed favourable results for manipulation. In addition, five studies (14%) reported positive results in one or more subgroups. Of the four studies with 50-60 points, one reported that manipulation was better, two reported that manipulation was better in only a subgroup, and one reported that manipulation was no better or worse than reference treatment. Eight trials attempted to compare manipulation with some placebo, with inconsistent results. CONCLUSIONS: Although some results are promising, the efficacy of manipulation has not been convincingly shown. Further trials are needed, but much more attention should be paid to the methods of study.


Assuntos
Dor nas Costas/terapia , Quiroprática , Manipulação Ortopédica , Pescoço , Manejo da Dor , Doença Aguda , Método Duplo-Cego , Humanos , Metanálise como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Doenças da Coluna Vertebral/terapia
18.
J Clin Epidemiol ; 44(3): 273-83, 1991.
Artigo em Inglês | MEDLINE | ID: mdl-1999687

RESUMO

In order to gain insight into the causality of the relation between beta-carotene and cancer, we performed a randomized placebo-controlled trial in which the effect of beta-carotene on the regression and progression rates of cervical dysplasia were examined. The experimental group (n = 137) received a supplemental dose of 10 mg of beta-carotene daily for 3 months. The control group (n = 141) received placebo capsules. As the outcome parameter, two definitions of regression and progression were used, which were based on the degree of dysplasia before and after the medication period. The number of patients who showed progression was too small to allow conclusions. No effect of beta-carotene on the regression percentages was observed: OR = 0.68 (95% CI: 0.28-1.60) using the broad definition; and OR = 1.22 (95% CI: 0.43-3.41) with the strict definition. A secondary analysis, in which the effect of the total intake of beta-carotene (diet + medication) on the regression percentages of cervical dysplasia was studied, did not show a positive effect either. The paper discusses to what extent issues in the study design may have masked a potential effect and how our results affect the evidence for a causal relation between beta-carotene and cancer.


Assuntos
Carotenoides/uso terapêutico , Displasia do Colo do Útero/tratamento farmacológico , Adulto , Idoso , Feminino , Humanos , Pessoa de Meia-Idade , Cooperação do Paciente , Prognóstico , Projetos de Pesquisa , Inquéritos e Questionários , beta Caroteno
19.
J Clin Epidemiol ; 44(4-5): 439-47, 1991.
Artigo em Inglês | MEDLINE | ID: mdl-2010788

RESUMO

In a randomized, double-blind trial the effectiveness of 6 months' use of a Chinese herb extract (Dabao) as a hair-restorer was studied on 396 males with alopecia androgenetica. The effect was evaluated by nonvellus hair counts, participants' opinions and a panel's judgement of a photo-report. Twenty-three participants withdrew prematurely from the study. In both the Dabao and placebo groups an increase in the amount of hair was observed; 133 and 109 hairs on a 5 cm2 marked area, a difference of 24 hairs (p = 0.03, one-sided). Participants as well as the panel reached a similar conclusion. Regarding cosmetic effect, 42% of the participants in the Dabao group and 37% in the placebo group reported positive results. The average panel score for the cosmetic result on a scale of -10 to +10 was 0.46 in the Dabao and 0.21 in the placebo group, a difference of 0.24 (p = 0.04, one-sided). It appears from our study that, although the cosmetic effect over 6 months is modest, Dabao does have a certain effect on the growth of nonvellus hair.


Assuntos
Alopecia/tratamento farmacológico , Medicamentos de Ervas Chinesas/uso terapêutico , Cabelo/crescimento & desenvolvimento , Administração Tópica , Adulto , Método Duplo-Cego , Medicamentos de Ervas Chinesas/administração & dosagem , Humanos , Masculino , Pessoa de Meia-Idade , Cooperação do Paciente
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