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Evaluating the efficacy of reflexology for the management of chronic low back pain
Abstract
The use of complementary and alternative medicine (CAM) for the management of chronic low back pain (CLBP) continues to rise. However, questions regarding the efficacy of many CAM therapies for CLBP remain unresolved. The present study investigated the effectiveness of reflexology for CLBP. A pragmatic randomised controlled trial was conducted. N = 243 patients were random-ised to one of three groups: reflexology, relaxation, or non-intervention (usual care). All completed a questionnaire booklet before and after the treatment phase, and at six months follow up. This measured their general health status, pain, functioning, coping strategies and mood. After adjusting for pre-treatment scores repeated measures ANCOVA found no significant differences between the groups pre and post treatment on the primary outcome measures of pain and functioning. There was a main effect of pain reduction , irrespective of group. Trends in the data illustrated the pain reduction was greatest in the reflexology group. Thus, the current study does not indicate that adding reflexology to usual GP care for the management of CLBP is any more effective than usual GP care alone.
... Badania Movaghar i wsp. oceniających wpływ refleksologii na redukcję przewlekłego bólu kręgosłupa, wskazują na istotne zmniejszenie się dolegliwości bólowych [20][21][22]. Poole i wsp. również badali efekt terapeutyczny stosowania refleksoterapii u osób cierpiących na bóle kręgosłupa. ...
... również badali efekt terapeutyczny stosowania refleksoterapii u osób cierpiących na bóle kręgosłupa. W ich opinii refleksologia jest dodatkową metodą w terapii bólów krzyża i nie biorą pod uwagę stosowania jej jako samodzielnej terapii [22]. Badania kliniczne potwierdzają, że zastosowanie zabiegów refleksoterapii skutkowało poprawą stanu zdrowia badanych oraz zmniejszeniem przez nich dawek przyjmowanych leków [23]. ...
... They also point to the need for further research to evaluate the efficacy of this method in the treatment of pain in the case of geriatric patients and patients suffering from pain due to chronic conditions [19]. Research carried out by Movaghar et al., regarding the evaluation of the effect of reflexology treatments on the reduction in chronic pain of the spinal column, indicate a significant decrease in pain intensity [20][21][22]. Poole et al. also investigated the therapeutic effect of reflexology in patients with spinal pain. In their opinion, reflexology is an auxiliary method in the treatment of back pain and it should not be treated as an independent form of therapy [22]. ...
Background: Osteoarthritis (OA) is one of the most common joint disorders and affects a significant percentage of the elderly. Reflexology is a therapeutic method of applying appropriate compression technique to pressure points located, for instance, on feet. The aim of this study was to evaluate the impact of foot reflexology treatment on pain and vitality level in persons with osteoarthritis. Material and Methods: The study was conducted on a group 20 individuals (16 women and 4 men) aged 41-76, who suffered from osteoarthritis. Two questionnaires (surveys), i.e. the NRS scale and the WOMAC questionnaire, were the research tools applied in the study. The study was conducted prior to the therapy and after a series of 8 sessions. Results: After the treatment, the researchers observed an improvement in average results obtained in the WOMAC questionnaire. Moreover, the respondents reported a reduction in pain intensity and improvement in functionality. The applied treatment effectively reduced the intake of pain medications by the surveyed individuals (p = 0.006). The respondents also reported improvement in the quality of sleep. Conclusions: According to the individuals surveyed, reflexology is an effective analgesic method, as a notable reduction in pain severity was observed. Reflexology increases the activity of patients and reduces the intake of pain medications.
... They reported that the pain intensity score decreased to an average extent in the experimental group [9]. Poole et al (2001) also studied the patients with chronic low back pain to investigate the effect of reflexology. In their study titled "evaluating the efficacy of reflexology for the management of low back pain", they suggested that reflexology is a supplementary procedure for the management of low back pain [10]. ...
... Poole et al (2001) also studied the patients with chronic low back pain to investigate the effect of reflexology. In their study titled "evaluating the efficacy of reflexology for the management of low back pain", they suggested that reflexology is a supplementary procedure for the management of low back pain [10]. Bennedbaek et al (2001) studied 63 patients with low back pain and colic. ...
... However, they did not affirm the definite efficacy of the reflexology and reported an average reduction in the patients' chronic low back pain. Poole et al (2001) studied the patients with chronic low back pain to investigate the effect of reflexology. They suggested that reflexology is a supplementary procedure for the management of low back pain [10]. ...
Introduction: Over 80% of people experience low back pain at least once in their life, which may turn into chronic low back pain over time. Since most of the patients tend to take non-aggressive and non-medicinal treatments with low health risks and complications, this study aims at investigating the effect of foot reflexology as a safe, refreshing treatment on the reduction of chronic low back pain. Previous studies by foreign scholars have confirmed that reflexology may reduce chronic low back pain; however, few domestic studies have examined this issue. Therefore, the main objective of the present study was to answer the question whether foot reflexology affects the reduction of chronic low back pain. Material and Methods: The study takes on a practical and quasi-experimental design. The participants were 24 male patients with chronic low back pain as diagnosed by physicians and criteria of research. The subjects were randomly assigned into one of the two equal groups: people of experimental or control group. As a pre-test, Pain intensity using the VAS (visual analog scale) was measured and the reflexology on the experimental protocol was applied. While the treatment was being performed on the experimental group, the control group received no therapeutic treatment and were engaged in their routines. To process the raw data, SPSS software, version 18 was used. Subsequently, dependent t-test (inter-group comparison) and P-values were used to interpret the data and examine the significance of research hypotheses. Besides, one-way ANOVA and LSD test were used to compare the means of the groups. Results: The findings of the study confirmed the efficacy of foot reflexology in reducing chronic low back pain (P<0.005) and indicated a significant difference between the mean pain intensity in the experimental group as measured by VAS index before and after the foot reflexology treatment (P<0.005). Accordingly, the mean low back pain in experimental group was 5.95 in the pretest and 4.05 in the posttest, which indicated 31% pain reduction. Discussion and Conclusion: According to the positive outcomes of this procedure, it is concluded that reflexology can be regarded as a non-aggressive, supplementary procedure in treating patients with chronic low back pain.
... It has been reported as helpful in conditions including multiple sclerosis, anxiety [34], and childbirth [35]. However, Poole, et al. [36], found insufficient evidence for using reflexology in low back pain sufferers and White AR (2000) and White AR, Williamson, and Ernst (2000) disputed claims for health promotion [37][38] considering 'diagnoses' no better than chance in identifying medical conditions in one blinded study [39]. ...
It is known that many patients with obstructive pulmonary diseases use a number of complementary and alternative medicines (CAM). There has been a great deal of interest into the CAM recently, with the House of Lords select committee for science and technology's report suggesting randomised-controlled trials are the best means of researching the area. There is very little research into the effects of reflexology specifically on the effects it has on COPD. As such a randomised-controlled trial was set up to examine the effects of reflexology treatments on COPD. Results were qualitative and quantitative and showed that there are a number of areas of possible benefit for patients with COPD, but a larger scale study with a longer time frame is needed for a full evaluation of these effects.
To investigate current management of low back pain (LBP) by reflexologists.
A postal survey of reflexologists (n=500) sampled from the International Institute of Reflexology. The questionnaire used investigated a range of areas including: professional details, reflexology training and practice, views and experiences of reflexology, reflexology and LBP, and views on other complementary therapies.
Response rate was 49.6% (n=248). The majority of respondents were female (95%), and were primarily employed within another profession such as nursing or teaching. Respondents perceived reflexology to have a positive effect on relieving LBP (94.3%) and to provide more benefit than simply relaxation. Practitioners also commented on other treatment effects, e.g. improving sleep patterns, decreasing anxiety and stress. It was reported that other healthcare practitioners, including general practitioners, referred patients to reflexologists for treatment.
Respondents considered reflexology to be an effective therapy for LBP. Further work is warranted to investigate the potential role of such treatment in the management of this prevalent and intractable condition.
A prior national survey documented the high prevalence and costs of alternative medicine use in the United States in 1990.
To document trends in alternative medicine use in the United States between 1990 and 1997.
Nationally representative random household telephone surveys using comparable key questions were conducted in 1991 and 1997 measuring utilization in 1990 and 1997, respectively.
A total of 1539 adults in 1991 and 2055 in 1997.
Prevalence, estimated costs, and disclosure of alternative therapies to physicians.
Use of at least 1 of 16 alternative therapies during the previous year increased from 33.8% in 1990 to 42.1% in 1997 (P < or = .001). The therapies increasing the most included herbal medicine, massage, megavitamins, self-help groups, folk remedies, energy healing, and homeopathy. The probability of users visiting an alternative medicine practitioner increased from 36.3% to 46.3% (P = .002). In both surveys alternative therapies were used most frequently for chronic conditions, including back problems, anxiety, depression, and headaches. There was no significant change in disclosure rates between the 2 survey years; 39.8% of alternative therapies were disclosed to physicians in 1990 vs 38.5% in 1997. The percentage of users paying entirely out-of-pocket for services provided by alternative medicine practitioners did not change significantly between 1990 (64.0%) and 1997 (58.3%) (P=.36). Extrapolations to the US population suggest a 47.3% increase in total visits to alternative medicine practitioners, from 427 million in 1990 to 629 million in 1997, thereby exceeding total visits to all US primary care physicians. An estimated 15 million adults in 1997 took prescription medications concurrently with herbal remedies and/or high-dose vitamins (18.4% of all prescription users). Estimated expenditures for alternative medicine professional services increased 45.2% between 1990 and 1997 and were conservatively estimated at $21.2 billion in 1997, with at least $12.2 billion paid out-of-pocket. This exceeds the 1997 out-of-pocket expenditures for all US hospitalizations. Total 1997 out-of-pocket expenditures relating to alternative therapies were conservatively estimated at $27.0 billion, which is comparable with the projected 1997 out-of-pocket expenditures for all US physician services.
Alternative medicine use and expenditures increased substantially between 1990 and 1997, attributable primarily to an increase in the proportion of the population seeking alternative therapies, rather than increased visits per patient.
Chronic low-back pain is a common clinical complaint, and patient dropout can be a major complication to treatment. The authors examined the variables predicting dropout from a 12-week outpatient clinical trial on the treatment of chronic low-back pain. Findings underscore the importance of carefully evaluating the patient's pain severity, attitudes about pain symptoms, and expectations and goals for treatment. Attempts should be made to correct misconceptions and unrealistic expectations regarding the nature of the pain condition, treatment options, likely outcomes, the role of self-regulation training, and family support. (PsycINFO Database Record (c) 2012 APA, all rights reserved)
Trials of healthcare interventions are often described as either explanatory or pragmatic. Explanatory trials generally measure efficacy-the benefit a treatment produces under ideal conditions, often using carefully defined subjects in a research clinic. Pragmatic trials measure effectiveness-the benefit the treatment produces in routine clinical practice.An explanatory approach recruits as homogeneous a population as possible and aims primarily to further scientific knowledge. By contrast, the design of a pragmatic trial reflects variations between patients that occur in real clinical practice and aims to inform choices between treatments. To ensure generalisability pragmatic trials should, so far as possible, represent the patients to whom the treatment will be applied. The need for purchasers and providers of health care to use …
A 36-item short-form (SF-36) was constructed to survey health status in the Medical Outcomes Study. The SF-36 was designed for use in clinical practice and research, health policy evaluations, and general population surveys. The SF-36 includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. The survey was constructed for self-administration by persons 14 years of age and older, and for administration by a trained interviewer in person or by telephone. The history of the development of the SF-36, the origin of specific items, and the logic underlying their selection are summarized. The content and features of the SF-36 are compared with the 20-item Medical Outcomes Study short-form.
To describe the characteristics of patients using non-orthodox health care and their pattern of use of conventional health care with respect to a particular problem.
Postal survey of all 2152 practitioners of acupuncture, chiropractic, homeopathy, naturopathy, and osteopathy identified from 11 national professional association registers. Patients attending a representative sample of 101 responding practitioners completed questionnaires covering demographic characteristics, presenting problems, and use of the health service.
Practices of practitioners of non-orthodox health care in England, Scotland, and Wales.
Qualified, non-medical practitioners of non-orthodox health care working in Great Britain and 2473 patients who had attended one of the sampled practitioners in an allocated time period between August 1987 and July 1988.
An estimated 1909 practitioners were actively practising one of the study treatments in Great Britain in 1987. Of the estimated 70,600 patients seen by this group of practitioners in an average week, most (78%) were attending with a musculoskeletal problem. Two thirds of the patients were women. Only 2% were aged under 16, but 15% were aged 65 or over. One in three patients had not received previous conventional care for their main problem; 18% were receiving concurrent non-orthodox and conventional care. Twenty two per cent of the patients reported having seen their general practitioner for any reason in the two weeks before the surveyed consultation.
Patients of non-orthodox health care, as provided by this group of practitioners, had not turned their backs on conventional health care. Non-orthodox treatment was sought for a limited range of problems and used most frequently as a supplement to orthodox medicine.
To determine whether reflexology therapy--the application of manual pressure to reflex points on the ears, hands, and feet that somatotopically correspond to specific areas of the body--can significantly reduce premenstrual symptoms compared to placebo treatment.
Thirty-five women who complained of previous distress with premenstrual syndrome (PMS) were randomly assigned to be treated by ear, hand, and foot reflexology or to receive placebo reflexology. All subjects completed a daily diary, which monitored 38 premenstrual symptoms on a four-point scale. Somatic and psychological indicators of premenstrual distress were recorded each day for 2 months before treatment, for 2 months during reflexology, and for 2 months afterward. The reflexology sessions for both groups were provided by a trained reflexology therapist once a week for 8 weeks, and lasted 30 minutes each.
Analysis of variance for repeated measures demonstrated a significantly greater decrease in premenstrual symptoms for the women given true reflexology treatment than for the women in the placebo group.
These clinical findings support the use of ear, hand, and foot reflexology for the treatment of PMS.
A systematic review of randomized controlled trials.
To assess the effectiveness of the most common conservative types of treatment for patients with acute and chronic nonspecific low back pain.
Many treatment options for acute and chronic low back pain are available, but little is known about the optimal treatment strategy.
A rating system was used to assess the strength of the evidence, based on the methodologic quality of the randomized controlled trials, the relevance of the outcome measures, and the consistency of the results.
The number of randomized controlled trials identified varied widely with regard to the interventions involved. The scores ranged from 20 to 79 points for acute low back pain and from 19 to 79 points for chronic low back pain on a 100-point scale, indicating the overall poor quality of the trials. Overall, only 28 (35%) randomized controlled trials on acute low back pain and 20 (25%) on chronic low back pain had a methodologic score of 50 or more points, and were considered to be of high quality. Various methodologic flaws were identified. Strong evidence was found for the effectiveness of muscle relaxants and nonsteroidal anti-inflammatory drugs and the ineffectiveness of exercise therapy for acute low back pain; strong evidence also was found for the effectiveness of manipulation, back schools, and exercise therapy for chronic low back pain, especially for short-term effects.
The quality of the design, execution, and reporting of randomized controlled trials should be improved, to establish strong evidence for the effectiveness of the various therapeutic interventions for acute and chronic low back pain.
To investigate the claim that 90% of episodes of low back pain that present to general practice have resolved within one month.
Prospective study of all adults consulting in general practice because of low back pain over 12 months with follow up at 1 week, 3 months, and 12 months after consultation.
Two general practices in south Manchester. 490 subjects (203 men, 287 women) aged 18-75 years.
Proportion of patients who have ceased to consult with low back pain after 3 months; proportion of patients who are free of pain and back related disability at 3 and 12 months.
Annual cumulative consultation rate among adults in the practices was 6.4%. Of the 463 patients who consulted with a new episode of low back pain, 275 (59%) had only a single consultation, and 150 (32%) had repeat consultations confined to the 3 months after initial consultation. However, of those interviewed at 3 and 12 months follow up, only 39/188 (21%) and 42/170 (25%) respectively had completely recovered in terms of pain and disability.
The results are consistent with the interpretation that 90% of patients with low back pain in primary care will have stopped consulting with symptoms within three months. However most will still be experiencing low back pain and related disability one year after consultation.
To introduce the UK SF36 Version II (SF36-II), and to (a) gain population norms for the UK SF36-II in a large community sample as well as to explore the instrument's internal consistency reliability and construct validity, and (b) to derive the Physical Component Summary (PCS) and Mental Component Summary (MCS) algorithms for the UK SF36-II.
Postal survey using a questionnaire booklet, containing the SF-36-II and questions on demographics and long term illness.
The sample was drawn from General Practitioner Records held by the Health Authorities for Berkshire, Buckinghamshire, Northamptonshire, and Oxfordshire.
The questionnaire was sent to 13,800 randomly selected subjects between the ages of 18-64 inclusive.
Scores for the eight dimensions of the UK SF36-II and the PCS and MCS summary scores.
The survey achieved a response rate of 64.4% (n = 8889). Internal consistency of the different dimensions of the questionnaire were found to be high. Normative data for the SF-36 are reported, broken down by age and sex, and social class. Factor analysis of the eight domains produced a two factor solution and provided weights for the UK SF36-II.
The SF36-II domains were shown to have improved reliability over the previous version of the UK SF36. Furthermore, enhancements to wording and response categories reduces the extent of floor and ceiling effects in the role performance dimensions. These advances are likely to lead to better precision as well as greater responsiveness in longitudinal studies.
This paper reports the results of a 'cost-of-illness' study of the socio-economic costs of back pain in the UK. It estimates the direct health care cost of back pain in 1998 to be pound1632 million. Approximately 35% of this cost relates to services provided in the private sector and thus is most likely paid for directly by patients and their families. With respect to the distribution of cost across different providers, 37% relates to care provided by physiotherapists and allied specialists, 31% is incurred in the hospital sector, 14% relates to primary care, 7% to medication, 6% to community care and 5% to radiology and imaging used for investigation purposes. However, the direct cost of back pain is insignificant compared to the cost of informal care and the production losses related to it, which total pound10668 million. Overall, back pain is one of the most costly conditions for which an economic analysis has been carried out in the UK and this is in line with findings in other countries. Further research is needed to establish the cost-effectiveness of alternative back pain treatments, so as to minimise cost and maximise the health benefit from the resources used in this area.
To test the effects of foot reflexology on anxiety and pain in patients with breast and lung cancer.
Quasi-experimental, pre/post, crossover.
A medical/oncology unit in a 314-bed hospital in the southeastern United States.
Twenty-three inpatients with breast or lung cancer. The majority of the sample were female, Caucasian, and 65 years or older; had 12 or fewer years of education and an annual income of $20,000 or more; and were receiving regularly scheduled opioids and adjuvant medications on the control and intervention day.
Procedures included an intervention condition (foot reflexology to both feet for 30 minutes total by a certified reflexologist) and a control condition for each patient (with at least a two-day break). No changes were made in patients' regular schedule or medications.
Anxiety and pain.
Following the foot reflexology intervention, patients with breast and lung cancer experienced a significant decrease in anxiety. One of three pain measures showed that patients with breast cancer experienced a significant decrease in pain.
The significant decrease in anxiety observed in this sample of patients with breast and lung cancer following foot reflexology suggests that this may be a self-care approach to decrease anxiety in this patient population.
Professionals and lay people can be taught reflexology. Foot reflexology is an avenue for human touch, can be performed anywhere, requires no special equipment, is noninvasive, and does not interfere with patients' privacy.
Objectives:
To introduce the UK SF36 Version II (SF36-II), and to (a) gain population norms for the UK SF36-II in a large community sample as well as to explore the instrument's internal consistency reliability and construct validity, and (b) to derive the Physical Component Summary (PCS) and Mental Component Summary (MCS) algorithms for the UK SF36-II.
Design:
Postal survey using a questionnaire booklet, containing the SF-36-II and questions on demographics and long term illness.
Setting:
The sample was drawn from General Practitioner Records held by the Health Authorities for Berkshire, Buckinghamshire, Northamptonshire, and Oxfordshire.
Sample:
The questionnaire was sent to 13,800 randomly selected subjects between the ages of 18-64 inclusive.
Outcome measures:
Scores for the eight dimensions of the UK SF36-II and the PCS and MCS summary scores.
Results:
The survey achieved a response rate of 64.4% (n = 8889). Internal consistency of the different dimensions of the questionnaire were found to be high. Normative data for the SF-36 are reported, broken down by age and sex, and social class. Factor analysis of the eight domains produced a two factor solution and provided weights for the UK SF36-II.
Conclusion:
The SF36-II domains were shown to have improved reliability over the previous version of the UK SF36. Furthermore, enhancements to wording and response categories reduces the extent of floor and ceiling effects in the role performance dimensions. These advances are likely to lead to better precision as well as greater responsiveness in longitudinal studies.
Chronic low-back pain is a common clinical complaint, and patient dropout can be a major complication to treatment. The authors examined the variables predicting dropout from a 12-week outpatient clinical trial on the treatment of chronic low-back pain. Findings underscore the importance of carefully evaluating the patient's pain severity, attitudes about pain symptoms, and expectations and goals for treatment. Attempts should be made to correct misconceptions and unrealistic expectations regarding the nature of the pain condition, treatment options, likely outcomes, the role of self-regulation training, and family support.
The objective of this pilot study is to identify if reflexology and foot massage (FM) affect the physiology of the body by measuring baroreceptor reflex sensitivity (BRS) using phase IV of the Valsalva manoeuvre, blood pressure (BP) and sinus arrhythmia (SA). The reflexology (n = 10) and FM groups (n = 10) showed significantly greater reductions in BRS compared to the control group (n = 4). Analysis of the mean differences between groups showed a greater difference in BRS between reflexology or FM and the control group than between reflexology and FM. This study found no significant difference in resting BP after intervention. The frequency of SA after reflexology and FM increased by 43.9% and 34.1% respectively. Further thoughts from the results of this study suggest a ‘neuro theory’ whereby reflexology and FM alter the BRS by stimulating the sensory nervous system in the feet.
Despite the amount that has been written about research methodologies for evaluating medical interventions (conventional and non-conventional), there remains a need to clarify which specific research designs are most appropriate and under what circumstances. This paper, the first of two, discusses a number of substantial problems with using a classical randomized controlled clinical trial design for assessing complex interventions, such as many complementary therapies, and identifies a set of design challenges that arise from these problems. In particular, we recognize the need to retain randomization in the research design. Despite the practical difficulties that can arise, the arguments for randomization are compelling. However, we argue for the use of randomization in a way that maximizes the proportion of the population that is included in the evaluation and builds on patients' preferences as much as possible. Additionally, we argue for a design that leaves practitioners free to give individualized treatments as appropriate and enables them to develop their relationship with each patient without constraint. In effect, we want to be able to evaluate the therapy or service delivered under ‘normal’ service conditions as near as is possible. Our second paper argues that the search for appropriate methods need not be a ‘one horse race’ and describes two trial designs that appear to meet these challenges without sacrificing methodological rigour.
Recently, there has been growing interest in the development of methods for recording disability as an outcome measure to monitor treatment effectiveness in chronic pain patients. Where these methods have relied on self-report, further information is needed about the validity and reliability of the results. Three such studies are reported on the Oswestry Low Back Pain Disability Questionnaire (ODQ. These involved comparing actual performance on lifting, sitting and walking tasks with reported limitation on the relevant subsections of the ODQ. The results were able to show encouraging validity and reliability. A factor-analytic study was also undertaken, which determined that there were two distinct factors of disability measured by this instrument. A small cohort of patients were followed up after a pain rehabilitation programme and reductions in disability were found to be reliably measured by the ODQ. The relationships between reported disability and the emotional and cognitive context in which the pain is experienced are discussed.
Objectives: Reflexology has become one of the most frequently used treatment modalities within complementary medicine. This level of popularity makes it desirable for healthcare professionals to understand the essential facts about it. The aim of this article is therefore to review the existing literature on reflexology and compile the facts. Particular emphasis is put on clinical trials.
Methods: Two independent, computerised literature searches were performed. All articles with factual information were included. Various other sources of information were used as well. Particular emphasis was on data relating to prevalence, effectiveness, safety and costs. For reviewing the effectiveness of reflexology, only controlled clinical trials were considered for a systematic review.
Results: The prevalence of reflexology is variable. Only few controlled clinical trials on the subject have been published. Collectively they do not support the motion that reflexology is associated with specific therapeutic effects. The data on safety and costs are similarly insufficient.
Conclusion: Reflexology is popular, yet little factual information exists about it. On the basis of the existing data, it seems possible, even probable, that its perceived benefit is brought about by non-specific effects.
Research in unconventional medicine requires a number of different questions to build up a “mosaic” of evidence. Choice of research design depends on the question being asked and is independent of the therapy under investigation. Despite the doubts of some practitioners, randomized trials are of value for determining certain questions in alternative medicine.
The effectiveness of relaxation techniques in the management of chronic pain was determined in this systematic review of published randomized controlled trials. Reports were sought by searching MEDLINE, psycLIT, CINAHL, EMBASE and the Oxford Pain Relief Database. Studies were included in this review if they were randomized controlled trials of relaxation techniques in chronic pain. Studies which investigated the effects of relaxation in combination with other interventions were not considered. Nine studies involving 414 patients met the predefined inclusion criteria and are critically appraised in this review. Meta-analysis was not possible, due to lack of quantitative data in the primary studies. Studies involved patients with a range of chronic pain conditions. The McGill Pain Questionnaire was the most common pain outcome used. Whilst four studies were able to show a significant difference for the pain outcomes in favour of relaxation for the pre- and post-treatment assessments, few statistically significant differences were reported in favour of relaxation when between treatment comparisons were used. Only three studies reported statistically significant differences in favour of relaxation (judged as a significant difference for at least 1 of the pain outcomes) compared to the other treatment groups. In rheumatoid arthritis the McGill Pain Questionnaire scores were significantly lower for patients receiving relaxation compared to those who were in the routine treatment control group. In ulcerative colitis significant differences were reported for six of seven different pain outcome measures in favour of progressive muscle relaxation compared to patients in the waiting list control group. In one of the two cancer pain studies, relaxation taught by nurses produced significantly lower pain sensation scores compared to the control group. Two studies reported significant differences in favour of the experimental control groups rather than for relaxation. There is insufficient evidence to confirm that relaxation can reduce chronic pain. Many of the studies both positive and negative suffer methodological inadequacies. Recommendations for future research into the effectiveness of relaxation techniques for chronic pain are made.
This study examined the factor structure of the Beck Depression Inventory—II (BDI-II) in a sample of 127 individuals referred by their primary care physicians. Using exploratory factor analysis with oblique rotation, a 2-factor model appeared to be the most parsimonious representation of the data. The rotated factors accounted for approximately 53% of the variance. Consistent with previous research, the first factor was interpreted as a somatic–affective dimension and the second factor reflected a cognitive dimension. The correlation between these 2 factors was .79. It appears possible to divide the BDI-II into subscales to facilitate interpretation in medical patients.
The effectiveness of relaxation techniques in the management of chronic pain was determined in this systematic review of published randomized controlled trials. Reports were sought by searching MEDLINE, psycLIT, CINAHL, EMBASE and the Oxford Pain Relief Database. Studies were included in this review if they were randomized controlled trials of relaxation techniques in chronic pain. Studies which investigated the effects of relaxation in combination with other interventions were not considered. Nine studies involving 414 patients met the predefined inclusion criteria and are critically appraised in this review. Meta-analysis was not possible, due to lack of quantitative data in the primary studies. Studies involved patients with a range of chronic pain conditions. The McGill Pain Questionnaire was the most common pain outcome used. Whilst four studies were able to show a significant difference for the pain outcomes in favour of relaxation for the pre- and post-treatment assessments, few statistically significant differences were reported in favour of relaxation when between treatment comparisons were used. Only three studies reported statistically significant differences in favour of relaxation (judged as a significant difference for at least 1 of the pain outcomes) compared to the other treatment groups. In rheumatoid arthritis the McGill Pain Questionnaire scores were significantly lower for patients receiving relaxation compared to those who were in the routine treatment control group. In ulcerative colitis significant differences were reported for six of seven different pain outcome measures in favour of progressive muscle relaxation compared to patients in the waiting list control group. In one of the two cancer pain studies, relaxation taught by nurses produced significantly lower pain sensation scores compared to the control group. Two studies reported significant differences in favour of the experimental control groups rather than for relaxation. There is insufficient evidence to confirm that relaxation can reduce chronic pain. Many of the studies both positive and negative suffer methodological inadequacies. Recommendations for future research into the effectiveness of relaxation techniques for chronic pain are made.
It is the thesis of this paper that most therapeutic trials are inadequately formulated, and this from the earliest stages of their conception. Their inadequacy is basic, in that the trials may be aimed at the solution of one or other of two radically different kinds of problem; the resulting ambiguity affects the definition of the treatments, the assessment of the results, the choice of subjects and the way in which the treatments are compared. It often occurs that one type of approach is ethically less defensible than the other, or may even be ruled out altogether on ethical grounds. We postpone consideration of this aspect of the question until a later section.
Thirty patients with proved bronchial asthma receiving treatment with inhaled steroid in dosages of less than 1,000 micrograms daily were subdivided at random into two groups of 15 patients. One group received foot zone therapy and the other merely uniform clinical care but without "placebo foot zone therapy". The "active" group received a total of ten foot zone therapy sessions of one hour at intervals of one week. The asthmatic symptoms, consumption of medicine and the objective pulmonary function parameters were followed-up during the subsequent six months. Decrease in consumption of beta-2-agonists and increase in peak-flow levels were observed in the group which had received foot zone therapy, but the same changes were observed in the control group. The authors do not find that this investigation demonstrates that foot zone therapy is of effect on the disease bronchial asthma. They conclude, however, that the favourable effect in both of the groups are due to increased care and control which occurred in both patient groups.
In recent years, employers, insurers, and government purchasers have paid increased attention to the measurement of patient outcomes and health status. Such interest is stimulated less by policy or quality concerns than by the need to reduce health care expenditures. Any expected benefits which might accrue from health status measurement will require active participation by community hospitals and their affiliated physicians. St. Vincent Hospital and Medical Center in Portland, Oregon has begun hospital-wide use of outcomes measurement systems. This study presents case studies of outcomes measurement for low back pain and total hip replacement, summarizes the hospital's objectives in implementing such measures, and identifies several strategies for successful adoption of health status measures in community practice.
The questionnaire is divided into ten sections selected from a series of experimental questionnaires designed to assess limitations of various activities of daily living. The chosen sections were those found to be most relevant to the problems suffered by people with low back pain. Each section contains six statements. A study of 25 patients with primary low back pain has already been mentioned. Their symptoms tended to resolve quickly and changes in their mean disability score can be seen over the first three weeks after referral to the spinal disorders department. The disability score was also used to demonstrate that there was no difference in the severity of symptoms in two sub-groups of patients in the same study. All new patients referred to the department complete the questionnaire when they first attend. The disability score is used as a guide to a patient's treatment programme. It cannot be used in isolation since it makes no allowance for the demands of a patient's job, his age or psychological make-up. However, it does ensure that important aspects of disability which are often forgotten are recorded in the patient's notes. Later, changes in the score may be used in monitoring the subsequent progress of the patient through treatment.
The authors developed and validated a measure of health outcome for patients with low back pain.
A questionnaire was developed incorporating the type of questions asked when taking a clinical history. After testing on a sample of 568 patients, three questions were discarded from the questionnaire. The final questionnaire was found to be reliable and valid in the sense that patients' scores correlated highly with their scores on a general health profile and with GP perceptions of severity. Health status in patients with low back pain was significantly impaired when compared with the general population.
A clinically based questionnaire, together with a general measure of health, can provide a valid and reliable package for the routine assessment of perceived health in patients with low back pain.
Over 250 patients from three complementary medicine practices—acupuncture, osteopathy and homoeopathy-completed a questionnaire rating 20 potential reasons for seeking complementary treatment. The reasons that were most strongly endorsed were ‘because I value the emphasis on treating the whole person’; ‘because I believe complementary therapy will be more effective for my problem than orthodox medicine’; ‘because I believe that complementary medicine will enable me to take a more active part in maintaining my health’; and ‘because orthodox treatment was not effective for my particular problem’.
Five factors were identified, in order of importance: a positive valuation of complementary treatment, the ineffectiveness of orthodox treatment for their complaint, concern about the adverse effects of orthodox medicine, concerns about communication with doctors and, of less importance, the availability of complementary medicine. Groups were compared, using analysis of covariance to control for demographic differences between the three patient groups.
Osteopathy patients' reasons indicated they were least concerned about the side effects of orthodox medicine and most influenced by the availability of osteopathy for their complaints. Homoeopathy patients were most strongly influenced by the ineffectiveness of orthodox medicine for their complaints, a fact which was largely accounted for by the chronicity of their complaints. Results are discussed in terms of the limited research in this area. Future studies should separate the reasons for beginning complementary treatment from the reasons for continuing it. It is possible, for instance, that the failure of orthodox medicine is the strongest motive for seeking complementary treatment but that, once treatment has been experienced, other more positive factors become more important.
This study sought to update national estimates of the use of alternative therapies, to improve the quality of those estimates, and to examine differences between users and nonusers of alternative medicine. Data were analyzed from the general probability sample (N = 3450) of the 1994 Robert Wood Johnson Foundation National Access to Care Survey. The results indicate that nearly 10% of the U.S. population, almost 25 million persons, saw a professional in 1994 for at least one of the following four therapies: chiropractic, relaxation techniques, therapeutic massage, or acupuncture. Even though users of alternative therapies made almost twice as many visits to conventional (or orthodox) medical providers as nonusers made, the former still reported much higher levels of unmet need for medical care. The growing emphasis on market-driven health care and consumer choice suggests that alternative therapies could have a larger role in the health-care system of the future.
To determine the current status for the association of chronic pain and depression and to review the evidence for whether depression is an antecedent or consequence of chronic pain (CP).
A computer and manual literature review yielded 191 studies that related to the pain-depression association. These reports were reviewed and sorted into seven categories relating to the topic of this paper. Eighty-three studies were then selected according to inclusion criteria and subjected to a structured review.
Any medical treatment setting including pain treatment as inclusion criteria for selection of studies.
Any patients with any type of chronic pain.
The reviewed studies were consistent in indicating that there is a statistical relationship between chronic pain and depression. For the relationship between pain and depression, there was greater support for the consequence and scar hypotheses than the antecedent hypothesis.
Depression is more common in chronic pain patients (CPPs) than in healthy controls as a consequence of the presence of CP. At pain onset, predisposition to depression (the scar hypothesis) may increase the likelihood for the development of depression in some CPPS. Because of difficulties in measuring depression in the presence of CP, the reviewed studies should be interpreted with caution.
In recent years, multidisciplinary pain programs were seen to successfully treat patients by basing treatment on a combination of physical exercise and psychological interventions. However, in spite of their effectiveness, it still remains to be clarified exactly which features of these programs were responsible for patient improvement. Cognitive-behavioral models posit that improvement is due, in part, to changes in patient coping strategies. Nonetheless, as reflected by the conflicting opinions present in the literature, it is questionable whether a so-called 'cognitive shift' is an accurate indicator for return to work of disabled patients. Ninety patients with chronic low back pain took part in a multidisciplinary treatment program. Therapeutic environment reinforces wellness behavior and enhances the patients' sense of control over their pain and resulting disability. The main therapeutic target point was to facilitate return to work. Ways of coping were measured by a well studied coping inventory in the German language (FEKB). Factor analysis revealed three factors: 'catastrophizing', 'search for information' and 'cognitive control'. In addition, assessment included measurements of pain intensity, depression, disability, flexibility of the lumbar spine, and different performance parameters. All of them were measured prior to and at the end of treatment, and following intervals of 6 and 12 months after discharge from program. Measurements showed significant changes over time, but more importantly, nearly all results were seen to stabilize at the 6- and 12-month evaluation following treatment. The coping strategies demonstrated little or poor change. In addition, coping measures and change in coping behavior showed poor prognostic relevance. But other psycho-social parameters like self-evaluation of potential return-to-work, application for pension, the length of pre-absence from work, and a decrease in subjective disability following treatment were effective indicators for 'back-to-work'. Other objective parameters, such as medical history, physical impairment and general physical variables were seen to have little predictive value in determining a return to work. The results suggest that the primary target point for further investigation is the analysis of the patients' beliefs about their pain. Our results indicate that future research must be attentive to the complex interactions between environmental factors and the coping demands posed by the specific nature of pain problems.
Public interest in complementary therapies continues to grow and many nurses and midwives are incorporating complementary therapies such as reflexology, aromatherapy and massage into their clinical practice. However, there are concerns regarding the use of such therapies when their effectiveness has not been clearly demonstrated. This article is a review of the literature relating to the effectiveness of reflexology. Anecdotal evidence is described and concerns relating to the literature's reliance on personal beliefs and experiences are presented. The need for research evidence to demonstrate effectiveness is highlighted. A critical review of published research studies is presented which focuses in particular on methodological issues such as the use of the randomized controlled trial to determine the effectiveness of complementary therapies such as reflexology.
This paper introduces the use of complementary therapies within midwifery practice, and particularly focuses on reflexology. Case reports illustrate instances in which reflexology has been successful for childbearing women. Some of the issues pertinent to midwives are explored.
Randomized, controlled trial.
To evaluate a four-session self-management group intervention for patients with pain in primary care, led by trained lay persons with back pain. The intervention was designed to reduce patient worries, encourage self-care, and reduce activity limitations.
Randomized trials of educational interventions suggest that activating interventions may improve back pain outcomes. Expert opinion increasingly regards effective self-management of back pain as important in achieving good outcomes. In this study, an educational intervention designed to activate patients and support effective self-management was evaluated.
Six to 8 weeks after a primary care visit for back pain, patients were invited to participate in an educational program to improve back pain self-management. Those showing interest by returning a brief questionnaire became eligible for the study. Participants (n = 255) randomly were assigned to either a self-management group intervention or to a usual care control group. The effect of the intervention, relative to usual care, was assessed 3, 6, and 12 months after randomization, controlling for baseline values. The intervention consisted of a four-session group applying problem-solving techniques to back pain self-management, supplemented by educational materials (book and videos) supporting active management of back pain. The groups were led by lay persons trained to implement a fully structured group protocol. The control group received usual care, supplemented by a book on back pain care.
Participants randomly assigned to the self-management groups reported significantly less worry about back pain and expressed more confidence in self-care. Roland Disability Questionnaire Scores were significantly lower among participants in the self-management groups relative to the usual care controls at 6 months (P = 0.007), and this difference was sustained at 12 months at borderline significance levels (P = 0.09). Among self-management group participants, 48% showed a 50% or greater reduction in Roland Disability Questionnaire Score at 6 months, compared with 33% among the usual care controls.
Self-management groups led by trained lay persons following a structured protocol were more effective than usual care in reducing worries, producing positive attitudes toward self-care, and reducing activity limitations among patients with back pain in primary care.
To pilot procedures to be used in a randomized controlled trial of acupuncture for low back pain.
Uncontrolled clinical trial.
Primary care and acupuncture clinics in York, England.
20 patients with low back pain lasting 1 month or more.
10 sessions of individualized acupuncture from a traditional acupuncturist.
Change in Oswestry low back pain disability questionnaire; present pain intensity scale; effect on daily living scale, and SF-36 general health questionnaire at post-treatment and 6 months after the end of treatment.
14 patients completed follow-up. Patients had similar severity scores at baseline to those referred to an NHS outpatient clinic. Post-treatment, there were statistically significant improvements in Oswestry, present pain intensity, effect on daily living and the physical functioning, social functioning, bodily pain, vitality and mental health sub-scales of the SF36. Similar results were found at the six month follow-up. Oswestry scores showed reduced levels of pain at 6 months compared to than at post-treatment, falling approximately 40% from baseline.
Though the improvements in pain and quality in life may be due to the natural course of back pain, the promising responses justify further research. The procedures used in the study are appropriate for a randomized controlled trial. Drop-out could be reduced by more careful patient monitoring.
Background: The randomised controlled trial (RCT) is the most powerful research tool for evaluating health technologies. However, for most therapeutic activities with the NHS, reliable information from RCTs is not available. Objectives: To assemble and classify a comprehensive bibliography of factors limiting the quality, number and progress of RCTs. To collate and report the findings, identifying areas where firm conclusions can be drawn, and identifying areas where further research is required. Methods: A systematic review of the literature was undertaken, covering the period 1986- 96. The scope of the review was too broad to be comprehensive in all of the areas covered, rather it attempted to cover the diversity of factors limiting the quality, number and progress of RCTs. The issues considered were those of design, barriers to participation, conduct and structure, analysis, reporting and costs. Results and recommendations for practice. Design: Following a systematic review of existing evidence, a well-formulated question should be developed, specifying participants, interventions and outcomes. Wide patient eligibility criteria are generally preferred to give representativeness and good recruitment rates. However, a more homogeneous group may be preferable when evaluating expensive or hazardous interventions. Outcome measures need to be clinically and socially relevant, well-defined, valid, reliable, sensitive to important change and measured at appropriate times. There is evidence that the use of intermediate or surrogate outcomes has been misleading. The most frequent choice of study design is between a parallel group or a crossover design. Simultaneous investigations of two or more treatments are efficiently approached by using a factorial design. Simple parallel group designs with fixed sample sizes are most common but other designs should be considered. Protection from selection bias is provided by secure random allocation, using telephone- or computer-based randomisation, and by analysis based on the groups as allocated, thus ensuring that groups being compared differ only by chance. Performance bias can be minimised by blinding treatments (when possible) and by employing clearly described treatment policies. Detection bias may be avoided by blind outcome assessment and attrition bias by ensuring follow-up of all patients randomised. Pre- study size calculations should always be made and funding bodies, independent protocol review bodies and journal editors should all demand them. A sensitivity analysis should be considered, with indicative estimates rather than unrealistically precise numbers. Small trials should be reported as hypothesis forming. Barriers to participation: Barriers to clinician participation include: time constraints, lack of staff and training, concern about the impact on doctor-patient relationships, concern for patients, loss of professional autonomy, difficulty with consent procedures, lack of reward and recognition, and an insufficiently interesting question. Barriers to patient participation include: additional demands of the trial, patient preferences, concern caused by uncertainty and concerns about information and consent. To overcome barriers to clinician recruitment, a trial should address an important research question and the protocol and data collection should be as straightforward as possible, with demands on clinicians and patients kept to a minimum. Dedicated research staff may be required to support clinical staff and patients. The recruitment aspects of an RCT should be carefully planned and piloted. Conduct and structure: Many trials fail to start, mainly because of lack of funding or logistical problems. Of those that start, half have recruitment difficulties, leading to abandonment or reduced size and, hence, loss of statistical power. Recruitment problems may be reduced by piloting, using multiple recruitment strategies, making contingency plans in case recruitment is slow, and using recruitment coordinators. None of these approaches has been rigorously evaluated. Inadequate compliance with the study protocol can lead to false-negative or false-positive results. Some assessment of compliance (clinician and participant) should be made but may be difficult to measure. Quality control is important but too much may make RCTs prohibitively expensive and hinder recruitment. Trials need good organisational and administrative bases but there is little research evaluating the optimal structure. The precise roles of steering committees and data monitoring committees have been poorly evaluated. There is concern about bias in the design, conduct, analysis and reporting of commercially sponsored trials, and independent monitoring should be considered. Analysis: Intention-to-treat analysis is the method of choice to provide an unbiased estimate of treatment effects. In studies where the aims are more explanatory than pragmatic, consideration should be given to reporting analysis by treatment received as well as intention-to-treat. Study protocols should identify a predetermined primary outcome supplemented by secondary outcomes and a clear statistical plan. Any subgroup analyses that are proposed as hypothesis testing should be specified in the protocol and the study must be of sufficient size to detect such an interaction. All other subgroup analyses should be considered as hypothesis-generating. Reporting: The introduction of the Consolidation of Standards for Reporting Trials (CONSORT) guidelines should improve reporting of RCTs. Conclusions should be supported by the data presented. About 10% of trials remain unpublished while many others are only published in conference proceedings, particularly if they are small and show non-significant treatment effects: prospective registration of all RCTs is recommended. Multiple publication of a study is also a problem for studies showing significant results. Costs: Economic evaluations are reported in few RCTs, possibly because of difficulties in conducting such evaluations and the lack of generalisability from one healthcare context to another. Some components of an economic analysis are subject to uncertainty; statistical tests and confidence intervals should, therefore, be used. There has been little research into trial costs but costs of caring for patients in RCTs may be perceived as an unaffordable new service, delaying or preventing recruitment at some participation centres. Conclusions: The evidence available to guide may aspects of the design, conduct and analysis of RCTs is not always being applied. Recommendations for research: Further research is required, particularly in relation to: problems being experienced and solutions employed in current RCTs, the optimum structure, staffing and organisation for the conduct of large and small trials, the factors which influence the participation of clinicians and patient in trials.
Physical and psychosocial disability in patients with chronic pain have been shown to be associated with patients' pain-related beliefs, tendency to catastrophize, and pain coping strategy use. However, little is known about whether beliefs, catastrophizing, and coping strategies are independently associated with patient adjustment. Identification of specific beliefs, cognitive responses, and coping strategies strongly and independently associated with physical and psychosocial functioning would suggest the importance of targeting those variables for modification in treatment. One hundred sixty-nine patients entering a multidisciplinary pain treatment program completed measures of pain, beliefs, coping, catastrophizing, physical disability, and depression. Principal components analyses were used to create belief and coping components, which were then entered in multiple regression analyses predicting physical disability and depression. Belief scores significantly and independently predicted both physical disability and depression, after controlling for age, sex, pain intensity, catastrophizing, and coping. Coping scores significantly and independently predicted physical disability, but not depression, whereas catastrophizing independently predicted depression, but not physical disability. These findings suggest the importance of targeting specific pain-related beliefs and coping strategies, as well as catastrophizing, for modification in the treatment of patients with chronic pain.
The purpose of this study was to examine exercise compliance in patients with chronic low back pain (CLBP) after participation in an intensive spine rehabilitation program.
Exercise behaviors in 122 consecutive subjects with CLBP who completed a program of quota based exercise were examined. Frequency per week of performance of four exercise activities, Oswestry disability scores, and visual analog scale (VAS) scores were assessed at evaluation, 3-month, and 12-month follow-up by patient-completed questionnaires.
Percentage of patients responding to initial, 3-month, and 12-month questionnaires were 100%, 86%, and 71%, respectively. Frequencies of exercise behaviors were compared by Wilcoxon signed-rank test and were found to increase significantly between evaluation and 3 months (P < 0.000), and evaluation and 12-month follow-up (P < 0.000). The percentages of patients reporting three or more times weekly performance of the following activities at evaluation and at three month follow-up, respectively, were: 1) stretching for the back and legs, 35% and 93%; 2) aerobic exercise, 44% and 87%; 3) back-strengthening exercises, 15% and 82%; and, 4) weight training, 6% and 71%. Evaluation and follow-up Oswestry disability and visual analog scale (VAS) scores for back pain were compared using Student's t-test. Significant improvements (P < 0.000) were noted for each of these scales at 3-month follow-up that were maintained at 12-month follow-up.
It is concluded that exercise behaviors can be increased and maintained in CLBP patients without adversely affecting pain or function.
To conduct a systematic review of published research investigating the prevalence of complementary and alternative medicine (CAM) use in the general population.
A protocol was developed for a systematic review of survey literature identified using two bibliographic databases and citation tracking. The protocol specified criteria for: 1) database searches; 2) selection of studies for review; and 3) description of methodological and substantive aspects of the studies.
Twelve studies were reviewed. These estimated the prevalence of CAM use in Australia, Canada, Finland, Israel, the UK, and the USA. The most rigorous studies, conducted in Australia and the USA, showed that a high proportion of the population was using CAM. There was evidence from the USA that CAM use increased significantly among the general population during the 1990s.
CAM is used by substantial proportions of the general population of a number of countries, but differences in study design and methodological limitations make it difficult to compare prevalence estimates both within and between countries.
Using existing systems for appraising the efficacy of various therapies, regardless of their typology, the authors considered approximately 10 methods commonly used to evaluate quality of life. They provide guidelines on how to build another index for judging quality of life, taking into account the patient's conditions of life. These indexes share similar problems in finding objective measures for assessing personal situations without regard to patients' or observers' subjective impressions. Nevertheless, the authors demonstrate that for randomized controlled clinical trials and for meta-analyses this deficiency is also a problem, at least qualitatively, for scientific methods that are considered quite objective. Therefore, according to the methodological manifesto of the World Health Organization, the authors conclude by suggesting the simultaneous adoption, for complementary medicine studies, of some methods already known for their use in conventional medicine, despite general limited validity.
Many claims are made that complementary medicine use is a substantial and growing part of health-care behaviour. Estimates of practitioner visits in the USA and Australia indicate high levels of use and expenditure. No reliable population-based estimates of practitioner use are available for the UK.
In 1998, a previously piloted postal questionnaire was sent to a geographically stratified, random sample of 5010 adults in England. The questionnaire focuses on practitioner contacts, but also asked about the purchase of over-the-counter remedies. Additional information was requested on socio-demographic characteristics, perceived health, and recent NHS resource use. Information on use included reason for encounter, expenditure, insurance, and location of visit.
Population estimates (by age group and sex) of lifetime use and use in the past 12 months for acupuncture, chiropractic, homoeopathy, hypnotherapy, medical herbalism, osteopathy. Estimates for two additional therapies (reflexology and aromatherapy), and homoeopathic or herbal remedies purchased over-the-counter. Estimates of annual out-of-pocket expenditure on practitioner visits in 1998.
A crude response rate of 60% was achieved (adjusted response rate 59%). Responders were older and more likely to be female than non-responders. Usable responses (n = 2669) were weighted using the age/sex profile of the sample frame. From these adjusted data we estimate that 10.6% (95% CI 9.4 to 11.7) of the adult population of England had visited at least one therapist providing any one of the six more established therapies in the past 12 months (13.6% for use of any of the eight named therapies, 95% CI 12.3 to 14.9). If all eight therapies, and self-care using remedies purchased over the counter are included, the estimated proportion rises to 28.3% (95% CI 26.6 to 30.0) for use in the past 12 months, and 46.6% (95% CI 44.6 to 48.5) for lifetime use. All types of use declined in older age groups, and were more commonly reported by women than men (P < 0.01 for all comparisons). An estimated 22 million visits were made to practitioners of one of the six established therapies in 1998. The NHS provided an estimated 10% of these contacts. The majority of non-NHS visits were financed through direct out-of-pocket expenditure. Annual out-of-pocket expenditure on any of the six more established therapies was estimated at pound 450 million (95% CI 357 to 543).
This survey has demonstrated substantial use of practitioner-provided complementary therapies in England in 1998. The findings suggest that CAM is making a measurable contribution to first-contact primary care. However, we have shown that 90% of this provision is purchased privately. Further research into the cost-effectiveness of different CAM therapies for particular patient groups is now urgently needed to facilitate equal and appropriate access via the NHS.