expanding the evidence
Helen Poole and Peter Mackereth
Chapter contents
Introduction63
What is the current state of the evidence for reflexology?75
Ethical issues76
Conclusion77
References77
Further reading79
Useful resources79
ABSTRACT
Despite an increase in research into reflexology, evidence for its effectiveness remains limited. This chapter considers the need for research in reflexology and the questions to be asked. We briefly consider research ethics, describe some common research designs with their limitations, and provide an overview of more recent studies and their findings. Both authors have completed PhD studies investigating reflexology; these are briefly summarised along with others reported from 2000 to 2009 (seeTable 6.1).
Introduction
The first edition of Clinical Reflexology included a chapter which looked at some of the published research evidence for reflexology. Since then, more studies have been completed, further informing the evidence base for reflexology. It is necessary, first, to consider why research is important to reflexologists as well as the users and service purchasers, and to outline common research methods.
The Select Committee on Science and Technology (2000) report recommended that well-designed research trials be conducted on touch therapies such as reflexology, which claim to complement orthodox medicine and ‘clearly, to comfort’ many people. However, the Committee felt that attempts to integrate complementary and alternative medicine (CAM) therapies within UK health services are unlikely to succeed, despite increasing popularity with patients, whilst there remains a paucity of research and lack of practitioner regulation (House of Lords 2000), and ‘pump priming’ funding for CAM research by the NHS and Medical Research Council was recommended. The report also charged healthcare practitioners (doctors and nurses) with the lead role in advising the public about suitable CAM therapies. To rise to this challenge, the reflexology profession needs to become better regulated, and to produce evidence of safety and effectiveness of a credible calibre to inform healthcare practitioners and enable them, in turn, to advise the public.
Evidence-based medicine, or evidence-based practice, is not new, having evolved to ensure safe and effective care for patients, and is increasingly being adopted in all types of healthcare provision (Sackett et al. 1996). For example, the National Institute for Health and Clinical Excellence (NICE) produce evidence-based guidelines for a range of health technologies (including CAM, pharmaceutical, surgical, psychological and physical therapies) which are used for decision-making about NHS service provision and funding. Reflexologists need to provide evidence for their practice, but other non-reflexologist researchers will also be keen to explore effectiveness and safety of the therapy.
Research designs
When considering research, it is necessary to select the most appropriate research design to answer your particular research question. A comprehensive review of all research methodologies is beyond the scope of this chapter. We have chosen, instead, to summarise some of the main types of commonly used research designs and to discuss some of the criticisms of these methods (Table 6.1).
| Terms: PMR: Progressive muscle relaxation; HADS: Hospital Anxiety & Depression Scale; HCAMQ: Holistic Complementary & Alternative Medicine Questionnaire; SAI: State Anxiety Inventory; STAI: State Trait Anxiety Inventory; CES–D: Centre for Epidemiological Studies Depression Scale; SCL-90: Symptom Checklist-90 Revised. MBSRQ-MS: Multidimensional Body-Self Relations Questionnaire – modified for multiple sclerosis; IFST-MS: Inventory of Functional Status-Multiple Sclerosis; C-GHQ-12/28: (Chinese) General Health Questionnaire; SF-36: Short Form Health Status; HAT: Hostile Automatic Thoughts Scale; BP: Blood Pressure; HR: Heart Rate; WHQ: Women’s Health Questionnaire; MS: Multiple Sclerosis; PD: Parkinson’s Disease; VAS: Visual Analogue Scale; PMS: Pre Menstrual Syndrome; FLI: Functional Living Index – Cancer Scale; PS: Performance Scale; PSS: Perceived Stress Scale; Image–SP: Illness image self profile; DQ: discharge questionnaire; C-STAI: Chinese State-Trait Anxiety Inventory. Qol-Colostomy: Quality of Life Index for Colostomy; WHOQoL: World Health Organisation Quality of Life Scale; AIMS2: Arthritis Impact Measures. | ||||||
| Study | Purpose/condition | Method | Treatment/group | Outcome measures | Findings | Commentary |
|---|---|---|---|---|---|---|
| Grealish et al. 2000 | To assess the effects of foot massage on nausea, pain and relaxation in hospitalised patients with cancer | Crossover RCT n=87 | 1. 2 sessions of foot massage, and 2. Quiet resting | HR, Pain (VAS)Nausea (VAS)Self-report of relaxation (VAS) | Significant difference in all measures. Improving relaxation and reducing nausea and pain | No control for medication No exploration of lasting effects Numbers in each group not given. 10 min sessions only. Therapists were trained as reflexologists |
| Hodgson 2000 | To assess the effects of reflexology on quality of life of people in the palliative stage of cancer | Randomised controlled trialn=12 | 1. Reflexology 2. Foot massage | Quality of Life VAS | 2 in foot massage group (6) reported improvementsAll 6 in reflexology group had significant improvementVerbal reports of satisfaction and benefit | Same practitioner for both interventions. Difficulty with distinguishing between placebo and true reflexology. Small sample. Erroneous omissions of 5 out of 28 components in the VAS scale. No account made of cancer type |
| Stephenson et al. 2000 | To assess the effects of reflexology on pain and anxiety in patients with lung and breast cancer | Quasi-experimentalcrossover trialn=23 | 1. Reflexology 2. No intervention period | Pain (SF – MPQ)Anxiety (VAS) | Significant decrease in anxiety following reflexology for both groups. Significant decrease in pain for breast cancer group | Only 2 out of the 10 lung cancer patients reported pain compared to 11 out of 13 in the breast cancer group. Gender difference in the group and effects of pain relief makes it difficult to interpret results |
| White et al. 2000 | Investigation into the accuracy of reflexology charts as a diagnostic tool | Experimental study with 18 patients assessed by 2 practitioners | Assessment time 20 minutes | Comparison of the assessments made by both reflexologists | Ability to distinguish conditions very poor. No evidence of agreement between the practitioners | Assessment time limited to 20 minutes Not able to communicate to patients. Relied on palpation only. Does not reflect normal reflexology practice. Only 2 practitioners in the study (over 12 000 in UK) |
| Boyd et al. 2001 | Evaluation of reflexology provided to users of a mental health service | Qualitative studyn=6 | Semi-structured interviews | Thematic analysis of the interview data | Recurrent themes; improvements related to the reflexology, sense of relaxation, interest in self-care & felt cared for/ time for self | Small sample Practitioner as researcher may have influenced responses |
| Gambles et al. 2002 | An evaluation of a hospice-based reflexology service | Qualitative studyn=34 | Semi-structure questionnaires | Thematic analysis of the questionnaire data | Positive comments; improved well-being, comfort support, able to cope with symptoms and treatment | Hospice staff and therapist distributed the questionnaire No demographic details Sensitive approach taken given the vulnerability of service users in this setting |
| Smith 2002 | Evaluation of reflexology for patients with breast cancer undergoing radiotherapy | Randomised controlled trialn=150 | 1. Reflexology 2. Foot massage 3. Standard care only | POMS, Pearson-Byars Fatigue Check list, Lymphocyte activity | Significant differences for foot massage compared to standard care group in some subscale of the POMS & Fatigue ChecklistTrend for a possible effect on lymphocyte activity in reflexology group. | Researcher also the practitioner Used foot massage as a sham treatment |
| Tovey 2002 | Evaluation of the overall effectiveness of reflexology to improve symptoms for people with IBS | Single blind trial n=34 | 1. Reflexology 2. Foot massage | HADS, 5-point scale: abdominal pain, constipation/diarrhoea, bloatedness, overall health well-being, tiredness | No significant difference between groups with the IBS symptom scale Significant difference for reduction in anxiety for the reflexology group only | Lead reflexologist advised on the treatment protocol6 treatments given as per ‘normal practice’Small studyIBS subtypes not defined |
| Williamson et al. 2002 | To examine the effects of reflexology for menopausal symptoms | Randomised controlled trial n=76 | 1. Reflexology 2. Sham – foot massage only 3. Maintained usual care | WHQ subscales of Anxiety and Depression, Flushes and night sweats VAS | No significant differences between groups Small differences favouring reflexology in mean differences for anxiety and depression | MYMOP data invalidated by inconsistencies in its completion14 participants reported they knew they were receiving reflexology |
| Mollart 2003 | To explore the effects of two different reflexology techniques versus rest on ankle and foot oedema in late pregnancy | Single blind randomised controlled trial n=55 | Reflexology to zones other than lymphatic system (n=20)Reflexology to lymphatic zone (n=25)Rest (n=10) | Ankle and foot circumference measurements Participant questionnaire (stress, tension, anxiety, foot changes) | No significant differences in foot or ankle circumference between groups. Self-reported well-being statistically improved in lymphatic group and non-lymphatic group compared to rest | Self report to therapists may be biased |
| Stephenson et al. 2003 | To examine duration effects of reflexology in patients with cancer | Randomised, repeated measures experimental studyn=36 | Foot reflexology x 2 sessions, 2 hours apart No treatment, but offered reflexology session at end of study | Pain scores Medication use (opioids)recorded for 3 consecutive days | In reflexology group, pain scores lower 24 hours after the intervention though not statistically significant. And medication increased | Assistant collected data, not therapist An expectation effect may have occurred in the control group who were promised treatment at the end of the study |
| McNeill et al. 2006 | To investigate the association of antenatal reflexology with different outcomes in the intranatal period | Comparative retrospective cohort designn=150 | 1. Reflexology (n=50) 2. Control (n=100) | Mode of delivery, Type of onset of labour, duration of labour, use of analgesics | No significant differences in onset or duration of labour between groups Significantly lower use of Entonox in reflexology group | Authors note that standardised treatment and outcome measures would have improved the study quality |
| Wilkinson et al. 2006 | To examine the effects of reflexology for patients with chronic obstructive pulmonary disease | Randomised controlled trialn=20 | 1. Reflexology 2. Control | Lung function test, evaluation (Quality of Life), HADS, AQ20Diary CardsBP & HR | No significant changes in lung function, BP & HR No difference between groups on HADS, AQ20, Quality of Life Patients who received reported feeling better on the evaluation questionnaire | Difference in group characteristics at baseline could have impacted on the results Objective measures showed no differences yet patients self report did. Self report is subject to bias but could indicate patients experienced changes not detected by other measures due to small sample size |
| Quattrin et al. 2006 | To examine the effectiveness of reflexology in hospitalised cancer patients during chemotherapy | Randomised controlled trialn=30 | 1. Reflexology foot massage 2. Control group | STAI | Statistically significant reduction in reflexology group compared to control group | Small sample size. Only measured immediate/ next day effects Treatments provided by student nurses Patients not categorised by disease |
| Gunnarsdottir & Jonsdottir 2007 | Does the experimental design capture the effects of complementary therapy? : a study using reflexology for patients undergoing coronary artery bypass graft surgery | Randomised controlled experimentn= 11 | Reflexology Rest | STAI, BP, HR, respiratory rate | No significant differences between groups on STAI, BP, HR, respiratory rate | Small sample size with 2 dropping out of the study Measures may not have been sensitive to change – participants’ comments indicated a change in well-being. The SAI may not be culturally sensitive (Iceland) |
| McVicar et al. 2007 | To explore the effects on reflexology on anxiety, salivary cortisol, melatonin secretion, pulse rate and blood pressure | Randomised controlled trial with crossover designn=30 | 1. Reflexology 2. Control quiet resting | STAI, BP & HR, salivary cortisol & melatonin | No significant differences between groups on BP, HR, salivary cortisol & melatoninSignificant reduction in state anxiety following reflexology | High drop out rate with only 18 completing the studySitting may have been stressful for some individuals |
| Wyatt et al. 2007 | To evaluate patient characteristics to predict selection and maintenance of a complementary therapy | Non-randomised quasi-experimentn=96 | Patients could choose 1. Reflexology 2. Guided imagery 3. Guided imagery plus reflexology 4. Interview only | Quality of life Patient characteristics | Those who chose 1, 2, or 3 tended to be older and in worse health with higher anxiety, depression and poorer physical and emotional well-being | Patients without caregivers were restricted to guided imagery or interview |
| Stephenson et al. 2007 | Partner-delivered reflexology effects on cancer pain and anxiety | Randomised controlled trialn=86 | 1. Partner delivered reflexology 2. Control group | BPI, VAS | Reduction in pain and anxiety in partner-delivered reflexology group | The researcher provided the training and collected the data. Immediate effects could be transient |
| Poole et al. 2007 | Investigation of the effectiveness of reflexology on chronic low back pain | Randomised controlled trialn=243 | Reflexology (6 sessions)Relaxation (6 sessions)Usual care (GP) | Sf-36 Pain Oswestry Disability Questionnaire | No significant differences between groups | 5 reflexologists provided the treatment Trends in the data showed pain reduction greater in reflexology group |
| Brown & Lido 2008 | To evaluate reflexology as a means of pain relief and empowerment in patients with phantom limb pain | Same subject experimentn=10 | Same subjects had 6 sessions of reflexology, followed by 6 sessions of training, then 6 sessions self treatment | Pain diaries, HADS, lifestyle changes | Improvement in phantom limb pain and lifestyle Changes maintained at 12 months follow-up | Lack of control group limits conclusions of this small cohort study |
| Hodgson & Andersen 2008 | To examine the efficacy of reflexology in individuals with mild-to-moderate dementia | Crossover trialn=21 | 1. 4 weeks of reflexology followed by 4 weeks of friendly visits 2. The reverse | Salivary amylase, Nonverbal Pain checklist, Apparent Affect Rating Scale | Significant reduction in pain and salivary alpha-amylase when receiving reflexology compared to friendly visits | Small sample size Consent and feedback issues as participants had mild to moderate dementiaSame practitioner did both arms of the study |
| Quinn et al. 2008 | To investigate the effectiveness of reflexology in the management of low back pain | Randomised controlled trialn=15 | 1. Reflexology group 2. Sham group | Pain VAS, Roland-Morris disability questionnaire, Sf-36, McGill pain questionnaire | Pain VAS clinically significantly reduced in reflexology group. No other significant differences between groups. Both improved on Roland-Morris, McGill and some SF36 subscales | Small sample size – need larger numbers to draw any definite conclusionsSham group received foot massage |
| Mackereth et al., 2009 and Mackereth et al., 2009 | 1. To compare the effects of reflexology and progressive muscle relaxation training for people with MS 2. Analysis of worries and concerns expressed during reflexology | Crossover trialn=50 | 1. Reflexology 2. Progressive Muscle Relaxation Training (PMR) | 1. GHQ 28 SAI SF 36 Salivary cortisol, HR & BP 2. Analysis of audiotaped sessions (n=245 tapes) | 1. Only significant difference in state anxiety and cortisol levels favouring reflexology. Significant difference in systolic blood pressure favouring PMR 2. Reflexology created opportunities for disclosure of worries and concerns for 48 participants. Recurring themes identified. Differences noted in the subgroups (sex, disease groups) | 1. Evidence of carryover effect from one treatment to the other. Crossover design may not have been appropriate 2. Recordings a crude method of eliciting process/content of the sessions. Unbalanced number in the disease subgroups |
| Woodward et al. 2009 (in press) | To evaluate the effectiveness of reflexology in treating idiopathic constipation in women | Prospective single group test and retest trialn=19 | Reflexology (6 sessions – 45 minutes each) | Gut transit markers & X-ray, Bowel diary, HADS, Sf-36 HCAMQ | Improved colon transit times Significant positive change in attitudes towards CAM Improvements in HADS & 3 of the Sf-36 subscales (vitality, general and mental health) Reports of improvement in constipation for most participants (94%) | Small study. No comparative group Over 25% of bowel diaries incomplete Severity of symptoms varied widely in this small group Participants self selecting Unclear whether responses were linked to bowel changes or general health improvement |
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