Brief summary
In this study, 90 patients with various metastatic cancers were randomly assigned to one of two arms. In one arm, the patients' partners (or family members or friends) were trained in the method of reflexology so that they could apply it to the patient (a single session at home). In the other arm, the partners were asked to read something of the patient's choice aloud. In both arms, patients were surveyed about their pain and anxiety before and after the partner's intervention. Both arms reported similar levels before the intervention. After the intervention, patients who had received reflexology reported significantly lower levels of pain and anxiety compared to the other arm. The greatest benefit was seen in patients who had reported high pain levels before the reflexology. This suggests a short-term effect of reflexology that goes beyond the effect of attention (through reading aloud). However, a placebo effect cannot be ruled out, as the patients were aware that they were receiving special treatment. Additionally, physical touch or massage could also explain the effect. To demonstrate that reflexology has a specific effect, it would be necessary to compare it with a regular foot massage. Furthermore, the study has a methodological flaw: patients were questioned about their pain using several questionnaires, but only one questionnaire is presented in the evaluation. This suggests that only selected results were presented in the publication, and results indicating the ineffectiveness of reflexology may have been omitted. The first author of the study is a trained reflexologist herself and collected the study data. This could indicate a conflict of interest.
In dieser Studie wurden 90 Patienten mit verschiedenen metastasierten Krebserkrankungen zufällig in eine von zwei Gruppen eingeteilt. In der einen Gruppe wurden die Partner (oder Familienangehörige oder Freunde) der Patienten in der Methode der Reflextherapie unterrichtet, damit sie diese beim Patienten durchführen konnten (eine einzelne Sitzung im häuslichen Umfeld). In der anderen Gruppe sollten die Partner dem Patienten etwas seiner Wahl vorlesen. In beiden Gruppen wurden die Patienten vor und nach der Intervention durch den Partner bezüglich ihrer Schmerzen und Angst befragt. Beide Gruppen machten vor der Intervention vergleichbare Angaben. Nach der Intervention gaben die Patienten, die eine Reflextherapie bekommen hatten, deutlich niedrigere Werte für Schmerzen und Angst an, als die andere Gruppe. Am meisten profitierten die Patienten, die vor der Reflextherapie hohe Werte für Schmerzen angegeben hatten. Dies spricht für einen kurzfristigen Effekt der Reflextherapie, der über den Effekt von Aufmerksamkeit (durch Vorlesen) hinausgeht. Allerdings ist ein Placeboeffekt nicht auszuschließen, da die Patienten wussten, dass sie eine besondere Behandlung bekommen. Zudem könnte auch die körperliche Berührung oder Massage den Effekt erklären. Um zu zeigen, dass die Massage der Reflexzonen eine besondere Wirkung hat, müsste man die Reflextherapie mit einer gewöhnlichen Fußmassage vergleichen. Des Weiteren hat die Studie einen methodischen Mangel: Die Patienten wurden mit mehreren Fragebögen zu ihren Schmerzen befragt. In der Auswertung wird allerdings nur ein Fragebogen dargestellt. Dies lässt vermuten, dass in der Veröffentlichung nur ausgewählte Ergebnisse präsentiert wurden und Ergebnisse, die auf die Nichteffektivität von Reflextherapie hindeuten, weggelassen wurden. Die Erstautorin der Studie ist selbst ausgebildete Reflextherapeutin und hat die Daten der Studie selbst erhoben. Hier könnte ein Interessenskonflikt vorliegen.
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
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Prospective
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| Monocentric / Multicentric Monocentric: conducted in one center/ hospital; </br>Multicentric: conducted in multiple centers/ hospitals
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Multicentric
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| 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
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No
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| Is randomized
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Yes
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| Cross-over Participants alternate between different treatment groups or conditions over a specified period, allowing each participant to serve as their own control
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No
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| Number of arms
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2
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Study characteristics
| Inclusion criteria
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Presence of any type of metastatic cancer and a pain score of 2 or higher on the 0–10 pain scale during the current hospitalization. Additional criteria for the patient-partner dyad were being 21 years of age or older; living together as spouses or domestic partners, family members, or friends; English speaking; living within a 75- to 100-mile radius of the hospital; partner availability for 30 minutes from 2–10 pm; and willingness to participate as evidenced by verbalizing understanding and signing an informed consent form.
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| Exclusion criteria
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Patients were excluded if they had had surgery in the previous six weeks or had open skin wounds on the feet, foot tumors or foot metastases, radiation to the feet, radiation to the site of pain, or more than 50% loss of feeling because of peripheral neuropathy. Patients with symptoms of deep vein thrombosis required a medical consultation prior to study participation or prior to continuation in the study if symptoms developed during the study.
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| N randomized
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90
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| 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.
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NI
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| Specifications on analyses
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Arms were compared with t tests and chi-square tests
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| Countries of data collection
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United States
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| LoE Level of evidence
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1b Oxford 2009
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| Outcome timeline Data collection times
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NI
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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.
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Curative
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| Types of cancer "Other Cancers" means that only a subpopulation was specified, but further unspecified cancer types were included
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Lung Cancer, Breast Cancer, Colorectal Cancer, Head and Neck Cancers, Hematologic Cancers - Lymphoma (Hodgkin and Non-Hodgkin)
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| 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
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NI
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| Specifications on cancer stages
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NI
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| Comorbidities
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NI
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| Current cancer therapies
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Chemotherapy, Radiation therapy
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| Specifications on cancer therapies
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Chemptherapy/Radiation therapy/OP (at least 6 weeks before or after surgery)
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| Previous cancer therapies
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NI
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| Gender
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Mixed
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| Gender specifications
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51 % female
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| Age groups
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Adults (18+)
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| Age groups specification
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Mean = 58.3
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Arms
| Arm type Active control: group receives active treatment; </br>Passive control: for example treatment as usual, waiting control, no treatment
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Intervention
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| Number of participants (arm) N randomized
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42
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| Drop-out Number of participants who left the study for any reason or did not provide information on every data collection date
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N = 3
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| Drop-out reasons
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Unable to receive the intervention because they were too ill
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| Intervention
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Reflexotherapy
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| Dosage and regime
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Reflexotherapy of the Ingram method by a partner/family member who has received 15-30 minutes of instruction from a certified reflex therapist
Duration: 1x 30 minutes;
And usual care
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| One-time application
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No
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| 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.
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-999
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| Side effects / Interactions
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NI
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| Arm type Active control: group receives active treatment; </br>Passive control: for example treatment as usual, waiting control, no treatment
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Placebo
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| Number of participants (arm) N randomized
|
44
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| Drop-out Number of participants who left the study for any reason or did not provide information on every data collection date
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N = 1
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| Drop-out reasons
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Unable to answer the preintervention visual analog scale and was too agitated to answer any postintervention questions
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| Intervention
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Reading
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| Dosage and regime
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Reading aloud by a partner/family member/friend (reading of own choice)
Duration: 1x 30 minutes;
And usual care
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| One-time application
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No
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| 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.
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-999
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| Side effects / Interactions
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NI
|
Outcomes
Pain
| Outcome type As specificed by the authors
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Primary
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| Outcome specification
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NA
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| Type of measurement
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BPI-SF (Brief Pain Inventory - Short Form)
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| 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".
|
Adjusted mean differences pre/post (SD), p-value, effect size ε^2):
Sig. better values in intervention than placebo (intervention: 1.1(NI), placebo: 0.1 (NI); p=0.001; ε^2=0.12 )
Subgroup analysis: Sig. better values in intervention than placebo for all patients with pain > 5 (intervention: 2.7 (NI), placebo: 0.5 (NI); p=0.007; ε^2=0.23)
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| 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".
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NA
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| Risk of Bias Assessment: Cochrane RoB tool 2.0
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| Bias arising from the randomization process
|
?
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| Bias due to deviation from intended intervention (assignment to intervention)
|
?
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| Bias due to deviation from intended intervention (adhering to intervention)
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NA
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| Bias due to missing outcome data
|
?
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| Bias in measurement of the outcome
|
?
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| Bias in selection of the reported result
|
?
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| Other sources of bias
|
?
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| Overall RoB judgment
|
?
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Pain
| Outcome type As specificed by the authors
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Secondary
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| Outcome specification
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NA
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| Type of measurement
|
SF-MPQ (Short-Form McGill Pain Questionnaire)
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| 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".
|
?
|
| 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".
|
NA
|
| 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
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| Bias due to missing outcome data
|
?
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| Bias in measurement of the outcome
|
?
|
| Bias in selection of the reported result
|
?
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| Other sources of bias
|
?
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| Overall RoB judgment
|
?
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Anxiety
| Outcome type As specificed by the authors
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Primary
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| Outcome specification
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NA
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| Type of measurement
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VAS (Visual Analogue Scale)
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| 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".
|
Adjusted mean differences pre/post (SD), p-value, effect size ε^2:
Sig. better scores in intervention than placebo (intervention: 3.1(n.s.), placebo: 1.3 (n.s.); p=0.001; ε^2= 0.13)
Subgroup analysis: Sig. better values in intervention than placebo for all patients with anxiety > 5 (intervention: 5.0 (n.a.), placebo: 2.5 (n.a.); p=0.006; ε^2=0.15)
|
| 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".
|
NA
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| 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
|
No information were given by the authors.
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| Conflicts of Interest
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No information were given by the authors.
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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
|
?
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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
|
?
|
Additional Notes
