Positive Health Online

A Pilot Study: British Flower & Vibrational Essences Association - BFVEA

Pilot Study Lead - Sheila Hicks Balgobin MBACP IFPA BFVEA

Abstract

In partnership with the Bach Centre and the Twelve Healers Trust, a pilot study, led by The British Flower & Vibrational Essences Association (BFVEA), examined what impact, if any, essence therapy (ET) had on emergency (police, fire brigade, ambulance, paramedics) and health service workers suffering from stress. The study was free for emergency and health workers to participate in and took place over a six-month period. Participants were randomly allocated to one of two groups: (i) individualized Bach Remedy therapy and (ii) Bach Rescue Remedy® only. This latter group acted as a control. Severe challenges in recruiting participants were encountered and the resulting sample size was far smaller than intended. Notwithstanding this, the results indicate that Bach Flower Essences could play a useful role in supporting emergency and health workers manage work-related stress. 73% of participants who completed the study showed good reduction in their stress levels as shown by lower post treatment scores on the 34-question CORE-OM instrument. It is hoped that the encouraging beginnings reported here can be built upon in the future in studies with larger sample sizes.

Method

Recruitment of Participants

The study intended to recruit health and emergency workers via their employers / occupational health departments. Despite significant effort the necessary permissions and assistance were not forthcoming - due, we understand, to scepticism about the value of flower essence therapy. A self-referral process was therefore then employed using personal networks. The study was also broadened to include partners of health and emergency service workers (who often experience vicarious stress from living with a partner who experiences significant work-related stress).

Study Design

Flower and vibrational essences are now produced across the world; there are probably many thousands of different essences. This study chose to focus on one range - the original 38 individual and 1 composite essence of the Bach range (Bach 1949). In keeping with the philosophy and ethics of complementary medicine in general, and flower essence therapy in particular, it was deemed inappropriate to allocate participants to either a treatment or non-treatment control group. We therefore designed the study to compare the effects of individualized flower essence therapy - from the 38 individual Bach Remedies (the treatment group) against generic non-individualized flower essence therapy (the ‘control’ group) using the composite Bach Rescue Remedy®. This was a multi-centre study involving seven flower essence practitioners across the UK.

Due to the anticipated small size of this pilot study the two cohorts could not be matched in terms of age, gender or severity of symptoms. Rather, participants were randomly allocated to either the individualized treatment group (wherein practitioners selected the essences used according to individual needs) or to the generic treatment group (Rescue Remedy© only) which acted as the control.

There was no pre-assessment stage and hence any participant self-referring with ‘stress’ was accepted into the study. No diagnoses were made; hence self-reports of work and / or life-related stress were taken as the baseline for the study.

The 34-item Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) instrument was employed at the beginning and end of the study to assess the extent of change. The shorter CORE-10 instrument was used during the study to track progress and provide feedback to participants. CORE-OM was chosen because it is a validated pan-theoretical measure of psychological distress covering four domains of functioning:

• Subjective well-being (4 items);
• Problems/symptoms (12 items);
• Life functioning (12 items);
• Risk/harm (6 items).

The study was conducted over a six-month period between June and December 2014, with each participant being invited to have at least one monthly consultation. Ten participants utilized all six consultations, one participant attended three out of six planned consultations and one attended two out of six planned consultations.

Results

Sample Size and Composition

Despite significant efforts only 12 participants were recruited. Of these, complete data is only available for 11 participants. The sample comprised seven women and five men. Ages ranged from 29 to 53, with a median age of 42. Seven reported that they were not currently taking prescribed medication for any psychological problems. Three did not provide this information. One participant had been prescribed amitriptyline (a tricyclic antidepressant) by her GP.

Occupations were:

• 5 serving police officers;
• 3 paramedics;
• 2 fire fighters;
• 1 nurse;
• 1 partner of a police officer.

Identified Problems and Concerns

At the initial consultation participants’ problems and concerns were identified using the CORE-OM therapy assessment form. Data is available for 11 of the 12 participants. The major presenting problem was anxiety / stress, with seven participants (64% of the sample) reporting recurring / continuous anxiety/stress as shown in Table 1:

The CORE-OM questionnaire comprises 34 items each of which is scored on a five-point scale (from 0 = Not at all to 4 = Most or all of the time). The maximum total CORE-OM score is therefore 136 and the minimum is 0.

The extent to which a client’s total CORE-OM score is associated with a ‘clinical population’ is determined by comparing the score with a national ‘clinical cut-off’ score of 10 which is calculated by multiplying the mean total score by ten (CORE-OM website). 25% of the sample population had an initial score above the clinical cut off value (i.e. 10). However, none of the initial scores were particularly high (the highest score being 50). Thus, the sample represents a population exhibiting low levels of distress as measured by the CORE-OM. Having said this, all participants were experiencing subjective levels of stress and welcomed the opportunity to address this using flower essence therapy.

As noted earlier, the CORE-OM assesses levels of distress across four discrete domains:

• Subjective well-being (4 items);
• Problems/symptoms (12 items);
• Life functioning (12 items);
• Risk/harm (6 items).

[Refer to Full Report for Core-OM questionnaires].

The mean scores per domain are shown in Table 2.

Table 2 shows that the highest levels of distress were in the symptoms and functioning domains. Unsurprisingly, these levels of distress were not sufficient to be having a significant impact on participants’ sense of well-being, given their relatively low values. Moreover, none of our participants reported being at risk from harming themselves or others.

Changes to CORE-OM Scores

Of the 11 participants for whom we have complete data, nine showed a decrease between their initial and final CORE-OM scores. The remaining two participants showed an increase of 2 and 16 points respectively, the latter believing the increase was due to a significant deterioration in their work situation. Figure 1 shows the change in CORE-OM scores for each participant:

Figure 1 suggests that the positive changes for participants 1-8 are probably significant. While the sample is too small to utilize statistical tests with any degree of confidence, the group mean values are 20.82 (initial) and 9.45 (final) giving a t-test value of 2.37. This indicates that the differences between the initial and final means are significant at the 95% level, and encourages further research with a larger sample size.

Individualised Treatment vs. Rescue Remedy©

Seven participants were randomly allocated to the individualized treatment group and five to the Rescue Remedy© control group. Six complete data sets are available for the former. Figures 2 and 3 show the changes in Core OM score for the individualised treatment and Rescue Remedy© control groups:

Although the sample size is too small to conduct any reliable statistical analysis, it is instructive to look at the differences between the individualized treatment and Rescue Remedy© control groups. The mean scores per group are shown in Table 3:

The t test shows that the changes between the initial and final CORE-OM scores for the individualized treatment group are statistically significant at the 95% confidence level. In contrast the differences for the Rescue Remedy© control group are not significant. We stress that these statistical values are for illustrative purposes only due to the very small sample sizes involved. However, if these results were replicated with a larger sample (n>30) it would indicate that individualized treatment of work-related stress is superior to generic treatment using only Rescue Remedy©.

Benefits of Therapy

The CORE-OM form also allows data to be captured at the final consultation regarding participants’ subjective experience regarding the benefits of their therapy. The categories available are:

• Personal insight/understanding (labelled Insight in Figure 4 below);
• Expression of feelings/problems (Expression);
• Exploration of feelings/problems (Exploration);
• Coping strategies/techniques (Coping);
• Access to practical help (Access);
• Control/planning/decision making (Control);
• Subjective well-being (Well-being);
• Symptoms (Symptoms);
• Day to day functioning (Functioning);
• Personal relationships (Relationships).

The extent to which benefits of therapy were reported are shown in Figure 4:

These are very encouraging results, indicating that flower essence therapy benefits a wide range of aspects of living. Importantly, the two participants whose CORE-OM scores increased between the initial and final evaluations reported positive benefits of therapy, indicating that quantitative measures (such as the CORE-OM) on their own do not capture the full extent of therapeutic value. Benefits were reported across the two groups - individualized and Rescue Remedy© control as shown in Figure 5:

The differences between the two groups are difficult to comment on given the small sample sizes involved. It does appear that more benefits were reported by the control group who only took Recue Remedy©, even though the differences between the initial and final CORE-OM scores for this control group do not appear to be statistically significant. It could be that the differences seen in Figure 5 are within the limits of random fluctuation (which would be expected to flatten out in a larger sample) or that the practitioners in this study provided more pastoral care to their control group participants because they felt that Recue Remedy© alone was not a sufficient intervention (indeed, several of the practitioners voiced their disquiet at not being able to provide individualised treatment to the control group - see Appendix B  Practitioners’ Reflections in the Full Report). Further research (including a double blind protocol) is clearly needed to explore these issues further.

Discussion

The Context: Previous Essence Therapy Research

A Nelson & Co (2006) reviewed a number of studies focusing on flower essences the most relevant of which are discussed below:

Weisglas - 1979

This study evaluated the effectiveness of Bach Flower Remedies (BFR) on creativity and 'well-being'. 39 volunteers were recruited into a randomized controlled trial, with 31 completing the study. Volunteers were randomized into one three groups: (i) placebo, (ii) treatment group using 4 BFRs, and (iii) treatment group using 7 BFRs. The Adjective Check-list was employed test for changes in creativity. The Lüscher Colour Test was used to examine changes in well-being. The placebo response was further evaluated by exploring how participants’ belief systems affected outcomes. Improvements in well-being and enhancement of creativity were seen in the treatment groups compared to placebo, with these changes being larger in the group receiving a mix of only 4 BFRs. Weisglas also reported that the remedies acted independently of participants’ belief systems - suggesting that the impact of flower essences goes beyond the placebo effect.

Von Rühle - 1995

Von Rühle explored the efficacy of BFR in a group of primiparie pregnant women all of whom were at least 5 days overdue. 24 overdue women were randomized into one of three parallel groups: (i) individualized BFR, (ii) 'attention' only and (iii) no intervention. The outcomes measured included: time to birth, type of birth, medication use around the time of birth, anxiety during birth and general feelings of well-being. Anxiety was measured using the State-Trait Anxiety Index (STAI) instrument.

No significant differences were reported between the three groups on all measures except medicine usage. The difference in medicine usage (i.e. orthodox medicines to control pain and nausea) was significantly less (p=O.032) for the group receiving BFR compared to the other two groups. Indeed, seven of the eight subjects in the BFR group used no medication at all. Furthermore, these mothers were reported to have delivered with less assistance. This may suggest that they experienced less anxiety during childbirth, although this was not supported by the STAI results.

Campinini - 1997

This study comprised 115 patients (of which 91 completed) who suffered either anxiety (including stress) or depression. Patients received individualized mixes of up to five remedies. They were followed up with fortnightly assessments over several months and outcomes were reported as either 'nil', 'partial' or 'complete' recovery. 89 patients made a partial to complete recovery. The majority of those that made a partial to full recovery did so within the first 18 weeks of the trail. Trust in the remedy system was also explored. It would be reasonable to assume that if the effects of BFR were purely placebo, then favourable responses would be expected to be higher amongst ‘believers’ compared to ‘skeptics’. This hypothesis did not appear to be supported - of the 11 patients who were assessed as 'nil' response, ten were 'believers'.

Armstrong and Ernst - 1999

One hundred university students experiencing examination stress volunteered and were randomized to one of two groups: (i) treatment with Five Flower Essence[1] and (ii) matched placebo. The study was conducted under double-blind conditions. Levels of exam stress were measured using the Speilberger State Trait Anxiety Inventory. Participants were asked to take the remedy (or placebo) from eight days before their examinations. No significant difference was found between the treatment and control groups regarding the primary outcome (i.e. anxiety or exam stress). The authors did report that participants in the study smoked less and consumed less alcohol, although no information was provided on intergroup differences.  While being a rigorous study it is clear that few, if any, flower essence practitioners would ‘prescribe’ the rescue combination for exam stress (except perhaps immediately before or during an exam). Thus, the negative findings of this study cannot be generalized to flower essence therapy in the broad sense.

Walach et al - 2001

61 volunteers were recruited (of which 55 completed) into this randomized, double blind and controlled, partial crossover, trial. All volunteers were otherwise healthy students about to sit examinations. The test group received a BFR formula containing 10 essences (far more than many flower essence practitioners would prescribe) and used the essence mix for several weeks leading up to their exams. The control group was given placebo and the same prescribing instructions. No significant differences were detected between the treatment and control group, although both showed a significant decrease in test anxiety.

Cram - 2001

This was a non-randomized ‘within-subject’ trial involving 12 patients with moderate to major depression. 11 patients had been receiving psychotherapy and eight were being treated with antidepressants (for an average of 17 months) with most having had depression for more than five years. In the first month of the trial patients were assessed and continued to receive their 'usual' care. During the second month flower remedies were added to the patients' usual care, with the choice of flower remedies being individualized to each subject. Treatment continued for a further two months. Patients were assessed using the Hamilton Depression Score (HAM D) and the Beck Depression Inventory (BDI). Mean BDI decreased from a baseline value of approximately 20 to 11, and HAM D from baseline average 21 to 10 at three months, indicating that the addition of flower remedies to the ‘usual’ care regime led to demonstrable improvements.

Mehta - 2002

This pilot study examined the use of BFRs as an adjunctive therapy in children suffering Attention Deficit/Hyperactivity Disorder (ADHD). Ten partially hospitalized children aged between five and 12 years were randomized to receive either BFR or placebo (five children in each group). The children continued to receive their standard medication during the study and improvement was assessed using the Childhood Attention Profile (CAP) and Columbia Impairment Scale (CIS) measures. Assessments were recorded at 3 weeks and 3 months. At completion, three in the BFR group were no longer in need of partial hospitalization and were no longer taking any medication for their ADHD. They were all described as 'functioning well'. Three in the placebo group had moved to inpatient hospitalization. The remaining children in each group remained on medication and were described as being of 'intermediate levels of functioning'. Mean CAP and CIS scores had decreased in both groups by the second follow-up. However, only CAP scores were significant at the p=0.05 level. The difference between the groups' CAP scores were 4.4 at baseline, which increased to 7.0 at three weeks (p=0.03) and 7.2 at three months (p=0.03). The study suggests a positive role for BFR in addition to standard treatment in children diagnosed with ADHD.

Pintov et al - 2005

This study evaluated Five Flower Essence in 40 children (aged 7-11 years) suffering Attention Deficit and Hyperactivity Disorder (ADHD). 20 children were randomized each to treatment and placebo groups. The children were asked to take their prescribed remedy four times a day for three months. By the end of the study 17 children (9 in the treatment group and 8 in the placebo group) had dropped out due to the "difficulty in following the program". Assessments were made by teacher or parent-completed questionnaires - at baseline and at monthly intervals. There was no significant difference in outcome between the two groups, but there were obvious improvements in both groups over the test period.

The Current Study

While small in scope, the study indicates that both individualized Bach Flower remedy treatment and Bach Rescue Remedy© can have a positive effect on helping emergency and health workers with work-related stress issues. The results indicate, however, that individualized treatment is superior to Rescue Remedy© as would be expected from flower essence treatment philosophy. The results presented here warrant further research with a much larger sample, and one that includes participants with higher scores on the CORE-OM instrument. We are aware that the therapeutic alliance formed between the participants and their practitioners is a confounding variable. How much of the improvement or deterioration seen was due to the flower essences and/or the therapeutic alliance is unknown and worthy of further investigation.

Conclusion

The review above of some of the most important studies into the efficacy of BFR and flower essence therapy is far from conclusive - some results are encouraging, others not. While the randomized clinical trial (RCT) is the Gold Standard for clinical research, some (see e.g. Weatherley-Jones, 2005) have argued that it has severe weaknesses in relation to holistic approaches, such as homeopathy and flower remedies, due to the individualized nature of prescribing which is a cornerstone of holistic philosophy. Indeed, the current study provides some evidence that individualized treatment is superior to generic treatment - although it cannot clarify to what extent the therapeutic gains reported result from the flower essences, the therapeutic relationship, placebo or a complex interaction between these factors. There is clearly a need for an agreed methodology which meets the criteria of clinical research but is also congruent with the underlying philosophy of flower essence therapy. Notwithstanding this, the current pilot study does, we believe, represent a useful addition to the flower essence literature.

Notes

1. Five Flower Essence contains the same five essences as Bach Rescue Remedy

References

CORE-OM. How is CORE used? Retrieved from www.coreims.co.uk/About_Core_System_How_Used.html

Armstrong NC & Ernst E. A randomized, double-blind, placebo-controlled trial of Bach Flower Remedy. Perfusion 11: 440-6. 1999.

Bach E. The Twelve Healers And Other Remedies. Rochford, England, The CW Daniel Company Ltd (first published 1933). 1949.

Campanini M. Terapia con i fiori di Bach: risultati di un monitoraggio su 115 pazienti (Bach flower therapy: results of a monitored study of 115 patients). La Medicina Biologica 3: 37-43. 1997.

Cram JR. Flower essence therapy in the treatment of major depression: preliminary findings. International Journal of Healing and Caring 1:1-18. 2001.

Mehta SK. Oral flower essences for ADHD. Am Ac of Child and Adolescent Psychiatry, 41(8): 895. 2002.

A Nelson and Co Ltd Bach Flower Remedies: An Appraisal of the Evidence Base. Retrieved from www.bachcentre.com/centre/research.pdf  May 2006.

Pintov S, Hochman M, Livine A, Heyman E & Lahat E. Bach flower remedies used for attention deficit hyperactivity disorder in children - A prospective double blind controlled study. European Journal of Paediatric Neurology 9: 395–8. 2005.

Von Rühle G. Pilot study on the use of Bach flower essences in primiparae with post-date pregnancy. Erfahrungsheilkunde 44: 854-60. 1995.

Walach H, Rilling C,& Engelke U. Efficacy of Bach-flower remedies in test anxiety: a double-blind, placebo-controlled, randomized trial with partial crossover. J Anxiety Dlsorders 15(4):  359-66. 2001.

Weatherley-Jones E. Homeopathy: A complementary view. Trends in pharmacological studies 26(11): 545-6. 2005.

Weisglas MS. Personal growth and conscious evolution through Bach flower essences. Unpublished PhD Thesis. 1979.

Appendix A - CORE Questionnaires

To view the complete set of Core Questionnaires Appendices please refer to the full Report: http://bachcentre.com/other/news/2015_08_research.php   www.bachcentre.com/centre/research_2015_08.pdf

Appendix B - Practitioner Reflections

To view the Practitioner Reflections Appendices please refer to the full Report at: http://bachcentre.com/other/news/2015_08_research.php   www.bachcentre.com/centre/research_2015_08.pdf

Acknowledgements

The Researchers would like to express their gratitude to the many individuals and organizations that supported this pilot study:

• The British Flower & Vibrational Essences Association (BFVEA) for their support and assistance in all phases of the pilot study;
• Judy Howard of the Dr Edward Bach Centre and Julian Barnard of the Twelve Healers Trust, for their sponsorship of the pilot study;
• Stefan Ball of the Dr Edward Bach Centre, for his advice and assistance with both funding and practitioner recruitment;
• David Corr and Jan Stewart, former chairs of BFVEA and experienced researchers, who provided oversight;
• Dawn White, BFVEA Webmaster, for assistance with promotion of the pilot;
• Beryl Nelson, Bach practitioner and database manager for the pilot;
• The various practitioners – Bach and BFVEA practitioners alike - who provided both the staffing, advice and support throughout the pilot study;
• And most importantly, the clients who participated in the study.

Further Information

To view the complete set of Core Questionnaires and Practitioner Reflections Appendices please refer to the full Report uploaded: http://bachcentre.com/other/news/2015_08_research.php   www.bachcentre.com/centre/research_2015_08.pdf

Acknowledgement Citation

A shortened version of this article is being published by BFVEA in their Winter 2015/16 edition of Essence.