Dyer et al. (2013): Is reflexology as effective as aromatherapy massage for symptom relief in an adult outpatient oncology population?

Reference ↗
Title	Is reflexology as effective as aromatherapy massage for symptom relief in an adult outpatient oncology population?
Topic	Reflexology
Author	Dyer, J, Thomas, K, Sandsund, C, Shaw, C
Year	2013
Journal	Complementary Therapies in Clinical Practice
DOI	http://dx.doi.org/10.1016/j.ctcp.2013.03.002

Brief summary

In this comparative study, 115 patients with different types of cancer were randomly assigned to a group that received either aromatherapy massage or reflex therapy. Various quality of life parameters were recorded in both groups, including the participants' self-reporting of the negative effects of cancer on them and how these had changed as a result of treatment with aromatherapy massage/reflex therapy. It was shown that there was a significant positive development in the assessed quality of life in both arms. However, there was no difference between the groups. This study therefore shows that reflex therapy is not inferior to aromatherapy massage in terms of improving the quality of life measured here, but it is not superior either. Aromatherapy massage itself is not an established therapy that can be assumed to have an effect beyond a placebo effect. The authors also mention that there is insufficient evidence of the effectiveness of aromatherapy massage.

In dieser Vergleichsstudie wurden 115 Patienten verschiedener Krebserkrankungen zufällig in eine Gruppe eingeteilt, die entweder Massagen mit Aromatherpie oder Reflextherapie erhalten haben. In beiden Gruppen wurden verschiedene Parameter der Lebensqualität erhoben, darunter konnten die Teilnehmer selbst angeben, welche negativen Auswirkungen die Krebserkrankung auf sie hat und wie sich diese durch die Behandlung mit Aromatherpie-Massage/ Reflextheapie verändert haben. Dabei konnte gezeigt werden, dass es in beiden Armen eine bedeutsame positive Entwicklung der erhobenen Lebensqualität gab. Allerdings gab es keinen Unterschied zwischen den Gruppen. Diese Studie zeigt also, dass die Reflextherapie der Aromatherapie-Massage in Bezug auf die Verbesserung der hier gemessenen Lebensqualität nicht unterlegen, aber auch nicht überlegen ist. Die Aromatherapie-Massage ist selbst keine etablierte Therapie, von der man ausgehen kann, dass ihr Effekt über ein Placeboeffekt hinausgeht. Auch die Autoren erwähnen, dass es keinen ausreichenden Nachweis über die Wirksamkeit der Aromatherapie-Massage gibt.

Study Design

Prospective / Retrospective Prospective: forward-looking, examples include clinical trials, cohort studies, and long-term observational studies;</br>Retrospective: backward-looking, relying on existing data, examples include case-control studies and retrospective cohort studies	Prospective
Monocentric / Multicentric Monocentric: conducted in one center/ hospital; </br>Multicentric: conducted in multiple centers/ hospitals	Monocentric
Blinding No: Open, all parties are aware of group assignments;</br>Single: one party is unaware of group assignments (generally participants);</br>Double: two parties are unaware of group assignments (generally the participants and the researchers); </br>Triple: concealing group assignment from additional parties	No
Is randomized	Yes
Cross-over Participants alternate between different treatment groups or conditions over a specified period, allowing each participant to serve as their own control	No
Number of arms	2

Study characteristics

Inclusion criteria	Patients over 18 years old, with a diagnosis of cancer, attending the hospital as NHS out- patients, wishing to access complementary therapy treatment and able to attend the hospital for four, one-hour sessions.
Exclusion criteria	Those already receiving (or who had received in the past two months or who were intending to receive during the period of the study) either aromatherapy massage or reflexology from any practitioner and those unable to receive the intervention due to contraindications or precautions for either therapy.
N randomized	115
Analysis PP: Per Protocol analysis, i.e. only participants included who adhered to the study protocol.</br>ITT: Intention-to-treat analysis, i.e. all randomized participants included regardless of any drop-outs or changes in assignment.</br>mITT: modified Intention-to-treat analysis can refer to analyses in which participants with missing outcome data are excluded or it can refer to analyses in which only participants who received at least one treatment dose are included. In this case, participants dropped out of the study prematurely for reasons unrelated to the treatment.	PP Analysis
Specifications on analyses	One-tailed independent samples t-test
Countries of data collection	United Kingdom - Great Britain
LoE Level of evidence	1b Oxford 2009
Outcome timeline Data collection times	T0: 1st intervention T1: 2nd intervention T2: 3rd intervention T3: 4th intervention

Characteristics of participants

Setting Refers to cancer therapy setting.</br>- Curative therapy: aims to completely eradicate a disease and achieve a full recovery; </br>- Neo-adjuvant therapy: form of curative therapy, given before the primary treatment for cancer (usually surgery); </br>- Adjuvant therapy: form of curative therapy, given after the primary treatment for cancer (usually surgery); </br>- Palliative therapy: focuses on providing relief from symptoms and improving the quality of life for patients, without necessarily targeting the underlying disease; </br>- Active surveillance: involves close monitoring of disease progression without any intervention (typically used for prostate cancer);</br>- No therapy setting: Patients who completed therapy/are currently not in cancer treatment, cancer survivors.	Curative
Types of cancer "Other Cancers" means that only a subpopulation was specified, but further unspecified cancer types were included	Breast Cancer, Gastrointestinal Cancers, Gynecologic Cancers - Ovarian Cancer, Hematologic Cancers, Head and Neck Cancers, Lung Cancer, Brain and Central Nervous System (CNS) Cancers, Skin Cancer, Other Cancers, Unspecified Sarcoma, Genitourinary Cancers
Cancer stages Early Stage: generally refers to cancer that is localized to the area where it started, mostly stages I and II;</br>Advanced Stage: cancer that has spread beyond its original site, mostly stages III and IV, with stage IV indicating distant metastasis	NI
Specifications on cancer stages	NI
Comorbidities	NI
Current cancer therapies	NI
Specifications on cancer therapies	NI
Previous cancer therapies	NI
Gender	Mixed
Gender specifications	93 % female
Age groups	Adults (18+)
Age groups specification	Mean (SD): Arm A: 53.76 (11.36); Arm B: 54.72 (11.12)

Arms

Arm type Active control: group receives active treatment; </br>Passive control: for example treatment as usual, waiting control, no treatment	Placebo
Number of participants (arm) N randomized	58
Drop-out Number of participants who left the study for any reason or did not provide information on every data collection date	N=4
Drop-out reasons	No subdivision between arms: 2nd intervention: Caring for family member (n=1); too difficult to attend appointments (n=2); caring for a friend (n=1) 3rd intervention: Withdrew: for further medical treatment (n=1); RIP (n=1) 4th intervention: Withdrew: unable to attend (n=1); Did not attend (n=1); admitted as inpatient (n=1); caring for a friend (n=1); felt too unwell to continue (n=1
Intervention	Aromatherapy massage
Dosage and regime	4 sessions for 1 h each, spread over an average of 10 weeks
One-time application	No
Duration in days For long-term interventions, the number of days is an estimation.</br>A value of -999 indicates that the exact duration cannot be extracted from the study due to ambiguous or incomplete information. See Outcome timeline or Dosage and regime for further information.	70
Side effects / Interactions	NI

Arm type Active control: group receives active treatment; </br>Passive control: for example treatment as usual, waiting control, no treatment	Intervention
Number of participants (arm) N randomized	57
Drop-out Number of participants who left the study for any reason or did not provide information on every data collection date	N=7
Drop-out reasons	No subdivision between arms: 2nd intervention: Caring for family member (n=1); too difficult to attend appointments (n=2); caring for a friend (n=1) 3rd intervention: Withdrew: for further medical treatment (n=1); RIP (n=1) 4th intervention: Withdrew: unable to attend (n=1); Did not attend (n=1); admitted as inpatient (n=1); caring for a friend (n=1); felt too unwell to continue (n=1
Intervention	Reflex therapy
Dosage and regime	4 sessions, no information regarding duration of therapy
One-time application	No
Duration in days For long-term interventions, the number of days is an estimation.</br>A value of -999 indicates that the exact duration cannot be extracted from the study due to ambiguous or incomplete information. See Outcome timeline or Dosage and regime for further information.	70
Side effects / Interactions	NI

Outcomes

Well-being

Outcome type As specificed by the authors	Primary
Outcome specification	Overall well-being scores and levels of relaxation. Before the first and after the last session: main complaints according to own statement
Type of measurement	MYCaW (Measure Yourself Concerns and Wellbeing)
Results during intervention - Results during intervention means that the time of data collection is during or shortly after the period of the intervention (e.g. on the last day or a few days after). The results therefore still relate to the direct effects of the intervention.</br>- Results after intervention means there is a longer break between the time of data collection and the end of the intervention, e.g. more than a week. The results relate more to long-term effects.</br>- If a categorization in Results during vs. after intervention is not possible (e.g. survival data), the results are summarized under Results after intervention under the headline "Overall".	NA
Results after intervention - Results during intervention means that the time of data collection is during or shortly after the period of the intervention (e.g. on the last day or a few days after). The results therefore still relate to the direct effects of the intervention.</br>- Results after intervention means there is a longer break between the time of data collection and the end of the intervention, e.g. more than a week. The results relate more to long-term effects.</br>- If a categorization in Results during vs. after intervention is not possible (e.g. survival data), the results are summarized under Results after intervention under the headline "Overall".	Mean difference 0.453 (SE = 0.323) in favor of aromatherapy, but this is significantly less than one point on the scale (p=0.046).

Risk of Bias Assessment: Cochrane RoB tool 2.0
Bias arising from the randomization process	?
Bias due to deviation from intended intervention (assignment to intervention)	?
Bias due to deviation from intended intervention (adhering to intervention)	NA
Bias due to missing outcome data	?
Bias in measurement of the outcome	?
Bias in selection of the reported result	?
Other sources of bias	?
Overall RoB judgment	?

Well-being

Outcome type As specificed by the authors	Secondary
Outcome specification	Secondary complaints according to self-report
Type of measurement	MYCaW (Measure Yourself Concerns and Wellbeing)
Results during intervention - Results during intervention means that the time of data collection is during or shortly after the period of the intervention (e.g. on the last day or a few days after). The results therefore still relate to the direct effects of the intervention.</br>- Results after intervention means there is a longer break between the time of data collection and the end of the intervention, e.g. more than a week. The results relate more to long-term effects.</br>- If a categorization in Results during vs. after intervention is not possible (e.g. survival data), the results are summarized under Results after intervention under the headline "Overall".	NA
Results after intervention - Results during intervention means that the time of data collection is during or shortly after the period of the intervention (e.g. on the last day or a few days after). The results therefore still relate to the direct effects of the intervention.</br>- Results after intervention means there is a longer break between the time of data collection and the end of the intervention, e.g. more than a week. The results relate more to long-term effects.</br>- If a categorization in Results during vs. after intervention is not possible (e.g. survival data), the results are summarized under Results after intervention under the headline "Overall".	Significant and clinically relevant improvement in both arms (reflex therapy: M= -1.44 [95%CI: -1.90, -0.97]; p= NI; aroma massage: M= -1.98 [95%CI: -2.49,-1.47]; p= NI), but no significant arm differences (M= 0.54 ([95%CI: -0.14, 1.22]; p= NI)

Risk of Bias Assessment: Cochrane RoB tool 2.0
Bias arising from the randomization process	?
Bias due to deviation from intended intervention (assignment to intervention)	?
Bias due to deviation from intended intervention (adhering to intervention)	NA
Bias due to missing outcome data	?
Bias in measurement of the outcome	?
Bias in selection of the reported result	?
Other sources of bias	?
Overall RoB judgment	?

Well-being

Outcome type As specificed by the authors	Secondary
Outcome specification	Fundamental well-being
Type of measurement	MYCaW (Measure Yourself Concerns and Wellbeing)
Results during intervention - Results during intervention means that the time of data collection is during or shortly after the period of the intervention (e.g. on the last day or a few days after). The results therefore still relate to the direct effects of the intervention.</br>- Results after intervention means there is a longer break between the time of data collection and the end of the intervention, e.g. more than a week. The results relate more to long-term effects.</br>- If a categorization in Results during vs. after intervention is not possible (e.g. survival data), the results are summarized under Results after intervention under the headline "Overall".	NA
Results after intervention - Results during intervention means that the time of data collection is during or shortly after the period of the intervention (e.g. on the last day or a few days after). The results therefore still relate to the direct effects of the intervention.</br>- Results after intervention means there is a longer break between the time of data collection and the end of the intervention, e.g. more than a week. The results relate more to long-term effects.</br>- If a categorization in Results during vs. after intervention is not possible (e.g. survival data), the results are summarized under Results after intervention under the headline "Overall".	Significant and clinically relevant improvement over time in both arms (reflexology: M= -0.70 [95% CI: -1.16, -0.24]; aromatherapy massage: M= -1.16 [95% CI: -1.15, -0.80]), but no sig. arm differences (M= 0.45 [95% CI: -0.12, 1.03]; p=NI).

Risk of Bias Assessment: Cochrane RoB tool 2.0
Bias arising from the randomization process	?
Bias due to deviation from intended intervention (assignment to intervention)	?
Bias due to deviation from intended intervention (adhering to intervention)	NA
Bias due to missing outcome data	?
Bias in measurement of the outcome	?
Bias in selection of the reported result	?
Other sources of bias	?
Overall RoB judgment	?

Relaxation

Outcome type As specificed by the authors	Secondary
Outcome specification	Before and after the 4 sessions: Change in values before and after treatment at the respective 4 points in time
Type of measurement	VAS (Visual Analogue Scale)
Results during intervention - Results during intervention means that the time of data collection is during or shortly after the period of the intervention (e.g. on the last day or a few days after). The results therefore still relate to the direct effects of the intervention.</br>- Results after intervention means there is a longer break between the time of data collection and the end of the intervention, e.g. more than a week. The results relate more to long-term effects.</br>- If a categorization in Results during vs. after intervention is not possible (e.g. survival data), the results are summarized under Results after intervention under the headline "Overall".	NA
Results after intervention - Results during intervention means that the time of data collection is during or shortly after the period of the intervention (e.g. on the last day or a few days after). The results therefore still relate to the direct effects of the intervention.</br>- Results after intervention means there is a longer break between the time of data collection and the end of the intervention, e.g. more than a week. The results relate more to long-term effects.</br>- If a categorization in Results during vs. after intervention is not possible (e.g. survival data), the results are summarized under Results after intervention under the headline "Overall".	No significant difference between the arms (p= 0.489)

Risk of Bias Assessment: Cochrane RoB tool 2.0
Bias arising from the randomization process	?
Bias due to deviation from intended intervention (assignment to intervention)	?
Bias due to deviation from intended intervention (adhering to intervention)	NA
Bias due to missing outcome data	?
Bias in measurement of the outcome	?
Bias in selection of the reported result	?
Other sources of bias	?
Overall RoB judgment	?

Relaxation

Outcome type As specificed by the authors	Secondary
Outcome specification	Change in values across all 4 time points, arm comparison
Type of measurement	VAS (Visual Analogue Scale)
Results during intervention - Results during intervention means that the time of data collection is during or shortly after the period of the intervention (e.g. on the last day or a few days after). The results therefore still relate to the direct effects of the intervention.</br>- Results after intervention means there is a longer break between the time of data collection and the end of the intervention, e.g. more than a week. The results relate more to long-term effects.</br>- If a categorization in Results during vs. after intervention is not possible (e.g. survival data), the results are summarized under Results after intervention under the headline "Overall".	NA
Results after intervention - Results during intervention means that the time of data collection is during or shortly after the period of the intervention (e.g. on the last day or a few days after). The results therefore still relate to the direct effects of the intervention.</br>- Results after intervention means there is a longer break between the time of data collection and the end of the intervention, e.g. more than a week. The results relate more to long-term effects.</br>- If a categorization in Results during vs. after intervention is not possible (e.g. survival data), the results are summarized under Results after intervention under the headline "Overall".	No significant difference between the arms (p= 0.408)

Risk of Bias Assessment: Cochrane RoB tool 2.0
Bias arising from the randomization process	?
Bias due to deviation from intended intervention (assignment to intervention)	?
Bias due to deviation from intended intervention (adhering to intervention)	NA
Bias due to missing outcome data	?
Bias in measurement of the outcome	?
Bias in selection of the reported result	?
Other sources of bias	?
Overall RoB judgment	?

Well-being

Outcome type As specificed by the authors	Secondary
Outcome specification	Percentage of patients who have an improvement on at least one scale of the MYCaW, arm comparison
Type of measurement	MYCaW (Measure Yourself Concerns and Wellbeing)
Results during intervention - Results during intervention means that the time of data collection is during or shortly after the period of the intervention (e.g. on the last day or a few days after). The results therefore still relate to the direct effects of the intervention.</br>- Results after intervention means there is a longer break between the time of data collection and the end of the intervention, e.g. more than a week. The results relate more to long-term effects.</br>- If a categorization in Results during vs. after intervention is not possible (e.g. survival data), the results are summarized under Results after intervention under the headline "Overall".	NA
Results after intervention - Results during intervention means that the time of data collection is during or shortly after the period of the intervention (e.g. on the last day or a few days after). The results therefore still relate to the direct effects of the intervention.</br>- Results after intervention means there is a longer break between the time of data collection and the end of the intervention, e.g. more than a week. The results relate more to long-term effects.</br>- If a categorization in Results during vs. after intervention is not possible (e.g. survival data), the results are summarized under Results after intervention under the headline "Overall".	Arm A: 82% to 91% on the various scales, Arm B = 68% to 86% on the various scales. No significant arm differences

Risk of Bias Assessment: Cochrane RoB tool 2.0
Bias arising from the randomization process	?
Bias due to deviation from intended intervention (assignment to intervention)	?
Bias due to deviation from intended intervention (adhering to intervention)	NA
Bias due to missing outcome data	?
Bias in measurement of the outcome	?
Bias in selection of the reported result	?
Other sources of bias	?
Overall RoB judgment	?

Well-being

Outcome type As specificed by the authors	Secondary
Outcome specification	Qualitative responses of the patients analysed by framework analysis
Type of measurement	MYCaW (Measure Yourself Concerns and Wellbeing)
Results during intervention - Results during intervention means that the time of data collection is during or shortly after the period of the intervention (e.g. on the last day or a few days after). The results therefore still relate to the direct effects of the intervention.</br>- Results after intervention means there is a longer break between the time of data collection and the end of the intervention, e.g. more than a week. The results relate more to long-term effects.</br>- If a categorization in Results during vs. after intervention is not possible (e.g. survival data), the results are summarized under Results after intervention under the headline "Overall".	NA
Results after intervention - Results during intervention means that the time of data collection is during or shortly after the period of the intervention (e.g. on the last day or a few days after). The results therefore still relate to the direct effects of the intervention.</br>- Results after intervention means there is a longer break between the time of data collection and the end of the intervention, e.g. more than a week. The results relate more to long-term effects.</br>- If a categorization in Results during vs. after intervention is not possible (e.g. survival data), the results are summarized under Results after intervention under the headline "Overall".	The most common answer to the question “What was the most important thing for you?” was “Relaxation and time for myself” in both arms

Risk of Bias Assessment: Cochrane RoB tool 2.0
Bias arising from the randomization process	?
Bias due to deviation from intended intervention (assignment to intervention)	?
Bias due to deviation from intended intervention (adhering to intervention)	NA
Bias due to missing outcome data	?
Bias in measurement of the outcome	?
Bias in selection of the reported result	?
Other sources of bias	?
Overall RoB judgment	?

Funding and Conflicts of Interest

Funding	A grant from the Royal Marsden Hospital Charity Panel pro- vided the funding for the Data Manager who manages data for studies conducted by the Therapies Department (CP08201). There was no other funding for this study.
Conflicts of Interest	The authors have no conflicts of interest related to this work.

Further points for assessing the study

Sample

Power analysis performed	?
- Sample size corresponds to power analysis	?
- Reasons for insufficient sample size based on power analysis	?
If no power analysis performed: at least moderate sample size (n >= 30 per arm)	?
Ethnicity mentioned	?

Alternative Explanation

Other explanations for an effect besides the investigated intervention	?
- Possibility of attention effects	?
- Possibility of placebo effects	?
- Other reasons	?

Statistics

Correct use of parametric and non-parametric tests Testing for normal distribution only necessary if parametric tests are used, NI: use of parametric tests without report of normal distribution testing	?
Correction for multiple testing	?
Measurement of compliance	?
Consistent reporting in numbers (figures, flowchart, abstract, results)	?
Comprehensive and coherent reporting	?
Cross-over	?
- Sufficient washout period	?
- Tested for carry-over effects	?
- Tested for sequence effects	?

Interpretation of results

Effect sizes reported (clinical vs. statistical significance)	?
Side effects systematically recorded	?
Side effects considered in result interpretation	?
Ethics votum	?