Isolating the inherent value of the therapeutic relationship: a double-blind placebo controlled trial

 By Jane Ellwood RNLD MIFPA 

There has been much published in clinical and scientific academia acknowledging the effect of the therapist to client relationship as an unwanted influence on study results (Hartfelt, 1999; Regré, et al. (2003); Unde, et al. 2001). This invites an important variable for discussion: How important is the Therapeutic Effect in influencing treatment outcome in complementary therapies? Most trials to date have concentrated on removing the influence of the therapist from clinical data as it regarded as a corrupting influence (Deutlich, 1999; Taik, 1989). This trial seeks to invert this established assumption by separating the Therapeutic Effect and isolating it to ascertain its significance as an equally, if not more important contribution to clinical outcome. 

For the purpose of this trial we used Kryke's MDSMS conversion to convert clinical observations into Therapeutic Effect (Kryke 2000). It is the first time that this particular model has been applied to a complementary therapy intervention. We look at 5 groups of 10 client subjects, each being treated by aromatherapy for the superficial baceolus infection staphylobaceolus bacillus.

Only one group received bona fide treatment from qualified therapists, the remaining 4 groups supporting at various levels of control. In order to eliminate all possible scrutiny, the concept of the placebo therapist was introduced and included the use of a double-dummy placebo (Pleaz, et al. 2003). 

The baceolus bacterium was selected for its natural affinity with treatment protocols (Wonderworth, et al. 1989). It has proved receptive to both conventional medication and complementary interventions (Broadview, 1998), remaining consistent and stable throughout (Ickan et al. 2001). The criteria for its isolation in this particular study as a topical agent was viewed to meet with all possible variable and influencing factors (Hyme, 2001), making it the most suitable organism for its suitability, enabling the therapeutic effect to be isolated as a single unit. 

The concept of the placebo therapist is relatively new in complementary medicine (Watt, 2003); nevertheless, its recent use has shown promising progress towards isolating the treatment process from the therapeutic agent (Newtry, 2003). This trial offered the added opportunity to test its efficiency in a rigorous scientific environment. Placebo therapists were selected for their lack of natural talent, absence of basic social skills, poor personal hygiene and distinct lack of a sense of humour. 

In order to further minimise variables, 10 of the 20 qualified therapists were asked to pretend that they were not qualified. Likewise, 10 of the 20 placebo therapist were instructed to pretend that they knew what they were talking about. This gave us 5 groups of 10 therapists, each with one client subject. 

Group A: Therapists fully qualified and competent to practice (abbr. TFQCP).

Group B: Matched placebo - fully qualified but pretending to be incompetent (abbr. FQPI). 

Group C: Inactive placebo - no qualifications whatsoever *. (abbr. NQW). 

Group D: Double dummy placebo - no qualifications but pretending to be competent (abbr. NQBP2BC). 

Group E: Negative control - an extra control group of inert therapists (abbr. NC). * 

As a further safeguard, placebo therapists were instructed to insult their subjects at 5-minute intervals during the treatment session in order interrupt the formation of any genuine therapeutic relationship (Mann et al. 1998; Manning 1990). 

Method 

All groups correlated to the definitive Eliminating Outcome Variable Scale of Practitioner Positivistic Influence (EOVSPPI) (based on a mean score of minus equals negative plus equals positive) taking a mean score of 0 (zero) as an acceptable variable for client subject/therapist compatibility. All subjects were currently receiving conventional treatment for a superficial baceolus infection of chronic duration prior to selection. Conventional treatment was ceased 10 days prior to trial onset with all client subjects experiencing continuation of their symptoms at day 1. Client subjects were blinded as to which group they had been assigned. 

Throughout the duration of treatment, the course of the baceolus infection was graded using Mezarré's Dermal Symptomatic Manifestation Scale (MDSMS), which translates Area (infected) (Ai), Appearance (Ap), Irritation (Ir) and Perceived Inconvenience (PI) into numerical representation. As both irritation (Ir) and Perceived Inconvenience (PI) are both subjective in analysis, it was considered necessary to introduce a further sub-category to the Area:Appearance (Ar:Ap) ratio. Therefore category Ar:Ap was subdivided into the further criteria of colour (Co) in order to maintain a fifty percent ratio of subjective to objective data (Co:Ar:Ap). 

A standard deviation (SD) was acceptable at +/- 5. All client subjects were initially assessed at a normalised baseline score of Ir+PI+Ar+Ap+Co = 50 in order to accommodate ease of scoring for both improvement and deterioration throughout the trial period. 

The MDSMS factor was then converted into Therapeutic Effect using Kryke's Translating MDSMS factor into Therapeutic Effect conversion scale (Kryke, 2000). 

Essential oil: Lusum Apralis var. fructus (Blue Gill) - selected for its proven anti-baceolus activity (Toidi, 2000). 

Dilution: 5% L. Apralis in aqueous base (fontis ct.fon). 

Route - transcutaneous via prodo. 

Duration and frequency - 30 minute massage, once daily for 5 days. 

Results 

Table showing MDSMS factor scores for Groups A to E

Kryke's conversion scale was then used to isolate Therapeutic Effect (TE). The scores were calculated as the mean for each group i.e. total MDSMS factor x 0.1 

Graph showing MDSMS factor scores translated into Kryke's scale of Therapeutic Effect (TE) using Kryke's Translating MDSMS factor into Therapeutic Effect conversion scale 

No data was available for Group E (see notes below). 

Observations and discussion 

Client subjects in Group A (therapists fully qualified and competent to practice) obtained the most symptomatic relief, obtaining an MDSMS factor of 31 (SD +/- 5) translated into the mean of T = 81 giving a TE score of 74. Even with being more generous with the SD factor, no other client subject group manifested with any significant proximity to such a similarly positive outcome. 

Client subjects in Group D (therapists with no qualifications but pretending to be competent) did initially make some significant healing progress. This was probably due to client subjects being taken in by good deceptive practises before realising. 

Client subjects in Group B (fully qualified therapists pretending to be incompetent) did (surprisingly) experience a better MDSMS factor that the other 3 controlling groups C, D, and E. This would support a further hypothesis that despite particular attentive efforts to conform to strict protocol guidelines, you cannot hide natural talent (Fortatté, et al. 2001). 

Therapists in Group E failed to make appointments with their client subjects.

Clients in Groups B, C, and D showed generally higher numerical scores for irritancy (Ir) assessment compared with the other indices: the highest Ir score on Day 4 correlated with the use of some particularly offensive insults (data not shown). 

Some clients found their experiences with the placebo therapists positively rewarding despite the rigorous selection process involved. This was possibly due to a paradoxical synergy between the placebo therapist and the client subject. However, even with this unexpected and unusual variable, overall score was not significantly compromised. 

Conclusion 

We have seen the Therapeutic Effect successfully isolated in order to illustrate the powerful influence of the complementary therapist in facilitating health and well-being. This study should help us to reflect and reaffirm our values as holistic practitioners. It hopes to redirect the phyto-scientific, and at times, the over-analytical approach to aromatherapy without regard for the more spiritual and holistic dimensions to the healing process. Indeed, it helps us realise that the essential synergy and essences of all our work here are the humanistic qualities and holistic skills of the Aromatherapist. 

References 

Broadview, U.R.A. (1998) The baceolus bacterium: an alternative approach. Journal for Applied Complementary Therapists 17(2): 44-48 

Deutlich, S.O. (1999) Removing the therapeutic influence on clinical data: a review of the literature. London: Jollywell Readme Books Limited 

Fortatté, T.I.T. Pat-Miback, U. (2001) Governing principles of a hierarchal relationship. Journal of Applied Peer Pressure 58(3): 159-167 

Hartfelt, A. (1999) Self examination: a new concept for integration. Independent Journal of Progressive Values 19(8): 11-18 

Hyme, U.M. (2001) Isolating topical agents: a model for defining methodical and mythological methods. Oxford: Overate Books 

Ickan, T.A., Kit T., Cann, U. (2001) Measuring stability of the baceolus bacterium in both the complementary and conventional environment. Integrated and International Journal of Integration. 7(6): 29-41 

Kryke, S. (2000) Isolating the Therapeutic Effect using Mezarré's Dermal Symptomatic Manifestation Scale as a model for comparison. Wigan: Peer Publications 

Mann, U., Knight, T. (Eds) (1998) Placebo verses placebo: the comparison of two approaches to achieving definitive targets and their influence on clinical outcome. Journal of Like-minded Related Illnesses 12(6): 18-22 

Manning, B (1990) Graded Insults for the Placebo Therapist. Oxford: The Friendly Press Company Limited 

Newtry, M.E. (2003) Introducing the placebo therapist as an inherent component of the scientific control mechanism. Advanced Journal of Inactive Parts 1(4): 145-156 

Regré, T.S., Nauty, M.E. (2003) Regressive behaviour: nature or nurture? London: Pushover Publishers 

Pleaz, E,. Getwell, L. (2003) The positive role of intuition in the cognitive demise of the treatment plan. Journal of Applied Cognitive Thinking 15(3): 56-59 

Taik, I.N. (1989) Isolating the therapist effect by removing the humanistic element of the treatment process. Journal of Advanced Inactive Parts 4(1) 56-60 

Toidi, U. (2000) Endogenous antibaceolus peptide activity of the essential isolates of the Lusum Flower (Blue Gill) in atopic baceolus infection. International Journal of Infiltrated Earth Sciences 3(5): 214-218 

Unde, R., Hann, D (2001) Safe hands to practise?. Baltimore: Orless University Press 

Watt, U. (2003) The relatively new concept of the placebo therapist in complementary medicine. Journal of Relatively New Concepts 14(6) 34-38

Wonderworth, I., Itsworth I.T. (1989) Minimising variant deviations in the isolation of the dermal baceolus bacterium: methodological grading of the evidence in complementary therapies. Associated Journal of Advanced Antagonistics 17(5): 45-51 

Acknowledgements 

The author would like to thank Dr Chris Parkinson for his helpful and unhelpful comments during the preparation of this manuscript. Thanks also to Ann Thorpe for help in pointing out the blatantly obvious.

© Jane Ellwood
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