A pilot study of the efficacy of reflexology in treating idiopathic constipation in women

A pilot study of the efficacy of reflexology in treating idiopathic constipation in women

Sue Woodward

Background

There has been an increase in interest in complementary therapies in recent years with evidence that the use of complementary therapies has grown dramatically in the last 20 years. It is estimated that in the UK around 2 million people are using a range of complementary therapies on a regular basis (Watkins, 1997). In general there has been significantly less scientific study of most complementary therapies when compared with conventional medicine and therefore the evidence for the effectiveness of many therapies remains unproven.

The need for sound research into the efficacy of complementary therapies is recognised and it has been reported that a lack of evidence supporting the effectiveness of these therapies is the single most important factor affecting NHS funding of them (National Association of Health Authorities and Trusts, 1993). If reflexology is to be accepted as a discipline within conventional healthcare circles, then there needs to be a sound evidence-base supporting the efficacy of the therapy. Although the research is extremely limited, there have been some recent trials of the effectiveness of reflexology for multiple sclerosis (Siev-Ner et al, 2003), menopausal symptoms (Williamson et al, 2002), asthma (Brygge et al, 2001), ankle and foot oedema in pregnancy (Mollart 2003) and mood and symptom rating in advanced cancer (Ross et al, 2002).

Idiopathic constipation is defined as “an infrequent or incomplete evacuation not caused by disease or medication” (Horton N, p251) and is a common problem in the UK female population. Although reflexologists often claim, in their promotional literature and reflexology texts, that reflexology can be beneficial in the treatment of constipation; there are an extremely limited number of studies investigating the effectiveness of reflexology for the treatment of constipation (e.g. Eriksen, 1995; Yang et al, 1994). Of these, most are conducted on a small scale and are not controlled studies.

Methodological issues in Complementary and Alternative Medicine (CAM) research

Appropriate methodology for assessing Complementary therapies has been the subject of much debate. While it is acknowledged that randomised controlled trials are the “gold standard” in evaluating the efficacy of many treatments, a case has also been made for the use of pragmatic trials, which seek to answer questions as to whether patients benefit from a particular therapy (Richardson, 2000). This form of research design would allow patients to be treated individually as they would be in routine clinical practice and seeks to capitalise on the placebo effect that may contribute to a therapeutic response. It has been suggested, following a systematic review, that use of strategies to enhance such expectations and beliefs in the benefits of treatments is justified (Crow et.al., 1999). Reflexologists aim to treat clients suffering from specific conditions, but within a holistic context, where the client’s own healing potential may be triggered, leading to alleviation of symptoms (O’Hara, 2002). For these reasons, and the exploratory nature of this trial, a pragmatic approach will be taken.

Aims and Objectives of the research

This study is a pilot study and hence hypotheses are being explored, rather than tested at this stage. It is envisaged that results will inform the development and undertaking of a larger scale evaluation of reflexology as an intervention for this client group.

The research aims to determine:

The value of providing reflexology as an intervention for women with idiopathic constipation.
The potential impact of this therapy for the bowel physiology and biofeedback service.

Research Questions

Does a course of reflexology treatment relieve the symptoms of idiopathic constipation in women?
Does the frequency of bowel motions increase following a course of reflexology?
Does reflexology enhance patients’ subjective well-being and perceived quality of life?
Do attitudes towards reflexology impact on the effectiveness of this treatment?

Experimental Design and methods

Study design:

Prospective one-group exploratory test-retest pilot study.

Sample:

20 female patients who present to a nurse led Biofeedback service with idiopathic constipation will be recruited to this study. The sample size is appropriate for a pilot trial and will be achievable given the number of patients referred to the service with this symptom. For patients to participate, the following eligibility criteria will have to be met:

Patient is female and aged 18 years or over

Patient has a confirmed diagnosis of idiopathic constipation, based on the Rome II criteria (Thompson et al, 1999).

Patient will not be receiving biofeedback treatment for the duration of the study

Patient is not receiving treatment from any other complementary therapist or agrees not to alter their current treatment regime in any way for the duration of the trial

Patient has given verbal consent over the telephone to be sent further participant information.

The following exclusion criteria will also be applied:

Any patient who on first assessment has symptoms requiring urgent medical assessment or treatment.

Any patient presenting with conditions that would form contra-indications to a reflexology treatment, i.e. pregnancy, history of deep vein thrombosis.

Protocol:

Patients referred to the biofeedback service and put on the waiting list following Consultant Nurse or Gastroenterologist triage (currently four to five months from referral to initial assessment once placed on the waiting list) will be telephoned by the researcher. A checklist will be used by the researcher to screen for symptoms indicating need for urgent clinical referral. Anyone identified as needing an urgent clinical referral will be excluded from the study and an urgent referral will be made to the next available Consultant Nurse or Gastroenterologist appointment. Participants may also be drawn from patients who have undergone a course of biofeedback treatment, which has failed. These patients would be offered the opportunity to participate at their final biofeedback appointment, at which point they would normally have been discharged.

The nature and brief outline of the study will be explained at this time and patients will be asked if they are willing to participate and screened to identify if they meet the inclusion criteria for the study. Patients willing to take part will then meet with a researcher at a convenient time and at this initial meeting, written consent will be obtained from each participant. Baseline questionnaires and investigations will be administered before the intervention commences. The baseline questionnaires will be sent to the patient by post and they would be asked to bring the completed questionnaires with them to the initial appointment. The patient will also be sent and asked to ingest gut transit markers prior to the initial appointment and a single abdominal Xray on that day (gut transit studies, which would otherwise be done on the day of the first biofeedback appointment) will be taken prior to the commencement of the intervention.

Prior to the commencement of the intervention a general health history would be taken from the patient, as would be the case in any “normal” reflexology consultation. If any symptoms of concern, unrelated to their current bowel problem, were identified at this stage, then the patient would be advised to seek a consultation with their General Practitioner.

Intervention:

All participating patients will receive the intervention. This will consist of a course of 6 reflexology treatments at weekly intervals, each lasting 35-45 minutes. This treatment will be evaluated under “normal” service conditions, leaving the practitioner free to give individualised patient treatments (Fitter and Thomas, 1997). The reflexology treatment will be given using reflex areas on the patients’ bare feet, as defined in a standardised chart produced by the Association of Reflexologists (AoR). The patient will be lying in a recliner chair and soft background music will be played, to facilitate a relaxing environment. The treatment will commence with the right foot and will be preceded by a few minutes foot massage. Pressure will then be applied in a standardised sequence to all the reflex zones on the right foot, using a “hooking” technique with the thumb and fingers. If any reflex zones are unable to be used on the foot due to a specific foot condition (e.g. athlete’s foot, verucca) then the corresponding reflex zone on the hand would be used (as would be the case in a routine reflexology consultation). The treatment would then be repeated on the left foot.

During the treatment it is normal for the practitioner to converse with the patient, giving a brief overview of the background to reflexology, the potential benefits and evidence-base for the therapy and answering any specific questions about the treatment. The patient would “normally” lead conversation and if a patient simply wanted to relax and close their eyes then the practitioner will encourage this.

Following the treatment the patient would be sat up slowly and offered a drink of water. They would be advised to drink 1 and a half to 2 litres of water within the next 24 hours and would be warned of possible side-effects such as potential worsening of symptoms or a so-called “healing crisis”, that they may experience an increase in frequency of bladder emptying, that they may feel particularly energised or conversely may feel tired, and that if they had any concerns before the next appointment they could contact the researcher. Patients would be encouraged not to engage in strenuous activity following the treatment so that the relaxed state could continue.

Patients would also be given general health advice relating to their presenting problem, such as ensuring an adequate fibre and fluid intake as part of a healthy balanced diet and ensuring they take adequate exercise. This advice be similar to that given as part of a normal reflexology consultation, but would not include specific advice that would be considered part of a biofeedback treatment plan.

Data Collection:

Outcome measures will be administered at baseline (before the intervention commences) and again following the sixth treatment and after the completion of the intervention. To determine the impact of reflexology on constipation, patients will be assessed before and after the intervention using a standard assessment proforma (St Marks NHS Trust), currently in use in the NHS Nurse-led Biofeedback service, through which a standard history will be gathered. Patients will be required to undergo gut transit studies and will be asked to complete a bowel diary for one week before the intervention commences and again following the sixth treatment.

To assess the possible psychological impact of the intervention participants will be asked to complete the Hospital Anxiety and Depression Scale (HAD) and the Short form 36 (SF36) at baseline and again following the sixth treatment. To assess the impact of attitudes on outcome participants will be asked to complete the Holistic Complementary and Alternative Medicine Questionnaire (HCAMQ) before the intervention commences and again following the sixth treatment (Hyland et al, 2003). In this pragmatic trial, contextual factors are optimised to approximate actual practice so that the role expectations play in treatment outcome can be evaluated (Richardson, 2000).

Patients who are decline to participate will also be asked to complete the HCMAQ to determine if there was a major difference in attitudes towards complementary and alternative medicine between participants and non-participants.

Data Analysis:

Following descriptive tests, the quantitative data attained will be imported into SPSS and analysed using appropriate parametric and non-parametric tests depending on the data generated. If there is a suggestion of efficacy (i.e. increased bowel frequency, decreased gut transit time or improved patient perception of symptoms and quality of life), effect size will be evaluated after the data has been completely collected to facilitate a power calculation of the required sample size for proceeding to a randomised controlled trial.

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