Reflexology

Used to be known as zone therapy.

The House of Lords Select Committee on Complementary and Alternative Medicine described reflexology as follows:
A system of massage of the feet based on the idea that there are invisible zones running vertically through the body, so that each organ has a corresponding location in the foot. It has also been claimed to stimulate blood supply and relieve tension.
Therapeutic massage of the feet may go back to Ancient Egypt some 4,000 years ago, or even further back in China.¹ The concept of "zone therapy" appears to date back to the 16th century but did not gain much popularity until around the turn of the 20th century. It was still called zone therapy until physiotherapists objected to the term "therapy" and the term "reflexology was coined in 1961.

There has been considerable interest in "complementary and alternative medicine" with a House of Lords Select Committee Report in November 2000.²
In the UK, 47% of people have used complementary and alternative medicine (CAM) at some times in their lives and 10% use some form of CAM each year.³ Users tend to be older, female and over 90% is purchased outside of the NHS. At least 10% of hospital physicians also use CAM as part of their clinical practice,⁴ but offering reflexology is exceptional. A survey, conducted in 2001, estimated that one in two practices in England now offer their patients some access to CAMs.⁵ Of the various forms of CAMS, reflexology rates fairly lowly in terms of popularity and nearly all is obtained outside the NHS. The quantity and quality of evidence about it are poor. It is rarely performed by qualified health practitioners.

There is much less research on the proposed mechanism of action of reflexology than on acupuncture or manipulation. It is said that the areas activated by massage of the feet may have something in common with the lines of chi or qi in acupuncture.

The Prince of Wales Foundation for Integrated Health produced a series of conferences in 2003 and 2004 called "Searching for Evidence. Complementary therapies research". Reflexology did feature in this. Areas covered, with reference to reflexology included premenstrual syndrome, menopausal symptoms, pain, nausea and vomiting in early pregnancy, mental health in primary care and chronic fatigue syndrome. A striking observation about this selection of conditions is that every one may be expected to have a very high placebo response rate.
Every single topic was lauded as a great success. This in itself should raise concern amongst the objective. Many trials were not placebo controlled. For many individual trials there were results that were at variance with conclusions of Cochrane reviews. This does not apply for reflexology as there has never been a Cochrane review of reflexology.

York Centre for Reviews and Dissemination

The York Centre has produced one of the few, if not the only review of scientific publications about reflexology.⁶ The main reviewer was Professor Ernst from Exeter. Many in the CAM community see him as antagonistic to their cause. This he denies. He says that he is trying to validate CAM by putting it on the same evidence base as conventional medicine.
Only 7 trials were included, 5 of randomised design with a total of 214 participants overall. All of the studies had methodological flaws, including small sample size. A summary of the results is as follows:

• In the group receiving post-operative reflexology, use of adjuvant medication was reduced. There was no formal statistical evaluation.
• Significantly fewer PMS symptoms were observed in women receiving ear, hand, and foot reflexology compared with those receiving placebo reflexology for 2 months. The statistically significant difference persisted 2 months after cessation of therapy.
• Blood glucose levels and platelet aggregability in patients with type II diabetes were normalized in a group receiving daily foot reflexology for 30 days. No such effects were seen in those receiving no intervention.
• There were no significant changes in plasma cortisol levels as a result of reflexology foot massage of the pituitary-adrenal zones.
• Patients receiving daily foot reflexology for 8 days reported a reduction in anxiety levels while those receiving daily reassurance or no intervention did not report reduced levels.
• The intensity and duration of headaches were not significantly different between groups receiving regular foot reflexology plus oral placebo versus arm massage plus oral flunarizin at the end of the 2-3 month treatment period. Similar results were seen at 3 months follow-up.
• Those receiving either foot reflexology plus conventional care for asthma or conventional care alone had no difference in symptomatic improvement of asthma. Follow-up was at 6 months.

Control Interventions

The "gold standard" of clinical investigation is the double blind, placebo, randomised controlled trial. Practitioners of CAM have long argued that their therapies are tailored for the individual and so they cannot be subjected to placebo control. This is untrue. Herbal remedies and homeopathy can easily be subjected to placebo control but it is more problematical for physical interventions. The more we know about the potency of the placebo response the more impressive it appears. Some may argue that it does not matter if part or all of the response is placebo mediated so long as the patient gets better and no harm is done (primum non nocere). However, if the study is designed to demonstrate that the intervention is effective and not entirely a placebo response, then an adequate control is essential.
Where controls have been used, the usual technique is to insist that subjects have not previously experienced reflexology and the intervention involves pressure and massage of the feet but not in the correct manner as taught to exponents. However, there is a problem if the correct application of the procedure is not as important as has been taught. The dummy intervention may have a degree of effectiveness and this will improve the outcome in the placebo group, making any improvement in the intervention group less impressive. There is a good analogy with acupuncture where there is evidence that superficial needling or slight misplacing of the needles may have more than placebo effect.
As the York review was based on a paper in the European Journal of General Practice in 1997, it is worth looking at a much more recent paper in the British Journal of General Practice in 2002.⁷ The aim was to assess the value of reflexology for irritable bowel syndrome. There was tight definition of the condition being treated, using the Rome criteria. The condition was stable at the time. A sham treatment was used as control. Valid end points were used for assessment and the patients, but not the practitioner, were blind as to intervention. There was no significant difference between treatment and control groups. The methodology of this study was very much better than so many others had been. It was a pity that it was stopped just short of the number needed to have an 80% chance of demonstrating that if a true difference does exist at the 0.05 level of probability, it will be manifest. This is what is necessary to demonstrate lack of efficacy.
Another more recent paper came from Indianapolis and reviewed the literature with regard to CAM treatment of menopausal symptoms. No benefit was found for reflexology.⁸

In the UK, the cost of one reflexology session is usually between £14 and £35.⁶ The usual duration of treatment is 6 to 8 sessions that could cost as much as £240. If patients consult with chronic conditions that require repeated attention throughout the year, an expenditure of £1,000 per patient per year would not be exceptional.

The House of Lords Select Committee was very keen on professional regulation of CAM to set standards for education, registration and standards of behaviour and care. It was especially critical of reflexology for having 13 different bodies to represent it in the UK. It said that these divisions are unhelpful to public, practitioners and government. So far only chiropractors and osteopaths have statutory regulation. Herbal medicine and acupuncture are next for statutory regulation. There are an estimated 50,000 CAM practitioners compared with 38,000 GPs in the UK.

• Reflexology is of moderate popularity compared with other CAM treatments.
• It is impossible to give a firm indication of whether it is effective or not because the quantity of research has been so limited and the quality of research has been so poor. Poor methodology involves not just lack of adequate control but failure to determine a valid objective and form of measurement from the outset, inadequate randomization and under-powered studies with small numbers.
• It is most unlikely to do any significant harm.
• What evidence there is, remains unimpressive with regard to efficacy of this intervention. Any PCT or practice based commissioning body who chose to offer the service would be very vulnerable to criticism of poor stewardship of funds.