Methodology as Means of Supporting Non-Medical Therapy

Non-medical Therapies

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If you have breast cancer, chances are you’ve heard about non-medical ways to treat your cancer or symptoms. Well-meaning friends and family may suggest vitamins, herbs, special diets or other treatments.1 While the decision is ultimately yours, it’s important to talk with your doctor and thoroughly research any non-standard treatment you are considering. Here are a few points to consider:Methodology as Means of Supporting Non-Medical Therapy

Complementary or Alternative? Complementary therapies refer to methods used along with your regular medical care.1 Alternative therapies are used instead of medical treatment.1 It can be confusing, as not everyone uses these terms the same way.1 Make sure you know the difference. Most complementary therapies are used to help you feel better.1 Examples include acupuncture to reduce pain or peppermint tea to relieve nausea.1 Alternative therapies, which have not been proven safe or effective in clinical trials, may be offered as cures and are used instead of standard medical treatments.1
What’s safe? Many complementary methods are helpful, while some are harmless but haven’t been proven effective.1 Others may be harmful or interfere with your medical treatment, so be sure to check with your medical team before beginning complementary therapy.1 Alternative treatments, however, are often downright dangerous. Some have life-threatening side effects or delay you from getting crucial medical treatments.1
How do I learn more? The best sources of information, along with your doctor, are reputable organizations, such as the American Cancer Society® and the National Cancer Institute. Avoid unproven websites, and use internet groups for support rather than specific medical advice. Beware of anyone who promises to cure your cancer, suggests you forgo regular medical treatment or asks you to travel to another country.1 Don’t be afraid to discuss non-medical treatments with your medical team. Your doctors are there to help you and can advise you about safely using some nontraditional methods.Methodology as Means of Supporting Non-Medical Therapy

Non-pharmacological pain management approaches may contribute to effective analgesia and are often well accepted by patients. While possibly not effective as stand-alone treatments for pain, the combination of non-pharmacological techniques with pharmacological approaches may improve pain management outcomes for patients. [1] In groups that are particularly vulnerable to side effects from a pharmacological approach there is benefit to using these non-medication approaches. [2-5] However, there is limited research and low quality evidence in this area, which makes specific recommendations difficult. [6,7] Studies examining non-pharmacological approaches often produce variable results due to a lack of standardisation in intervention implementation. [8,9] Very few studies specifically target the same outcome, and few target pain in palliative care.

Psychological Interventions
The role of psychological interventions in the management of pain in a palliative setting are generally seen as adjunctive to other therapeutic interventions. They are often implemented as part of the holistic palliative approach for individual patients, rather than specifically for pain management. Common psychological approaches include patient and carer education, stress reduction, distraction and cognitive-behavioural interventions.Methodology as Means of Supporting Non-Medical Therapy

A recent review of interventions designed to improve pain management knowledge among palliative care patients and carers found that targeted patient education on pain management does improve adherence to a pain plan and improves patient satisfaction. [10] A systematic review examining patient education targeting people with cancer shows that educational interventions can have a modest but clinically significant impact on pain, and that this is an underutilised strategy. [11]

Strategies targeting stress reduction are used to reduce pain and these include relaxation techniques and hypnosis. A systematic review reporting on the use of hypnosis in pain management did find hypnosis had an analgesic effect but this was dependant on the suggestibility of the patient and the specific technique used by the therapist. [12] Another review examining the use of hypnosis to reduce procedure related pain in children and adolescents with cancer suggested it may be beneficial, but the evidence is of low quality. [3] There is no specific research examining the effectiveness of hypnosis on terminally ill cancer patients.Methodology as Means of Supporting Non-Medical Therapy

Attentional strategies, such as music therapy have been studied and a systematic review of music therapy in cancer pain suggests that it may be beneficial. [14] Another systematic review suggested music therapy was useful in managing pain in terminally ill patients, although the evidence base remains limited in quality. [15]

Cognitive behavioural interventions are well established in chronic pain management. [16] Specific evidence establishing its use in managing pain in the palliative care context is lacking. A recent systematic review examining cognitive behavioural therapy and mindfulness found both may be useful in reducing pain in chronic pain conditions. [16] Mindfulness has also been found to be useful in reducing cancer pain. [17] There is some evidence that both mindfulness and cognitive behavioural therapy may benefit from being delivered in a group situation, particularly for older people. [4] However, there is limited evidence to support these interventions in a palliative care setting, particularly in managing pain.

Transcutaneous Electrical Nerve Stimulation
The role of transcutaneous electrical nerve stimulation (TENs) has been studied in acute [18] and neuropathic pain, [19] and in cancer pain. [20] A systematic review of TENs and cancer pain was unable to establish evidence to support its use. [21] Two other systematic reviews agreed that the quality of evidence for using TENS to manage cancer pain was low, but suggested there may be some slight benefit to using this treatment approach. [7,20] A review specifically focused on palliative care patients was unable to recommend the use of TENs in this group. Methodology as Means of Supporting Non-Medical Therapy

Acupuncture
There have been several systematic reviews examining acupuncture in pain management and the results have been generally poor. There is no evidence to support the use of acupuncture to manage pain in renal disease, [2] or in palliating cancer pain. [22] There is low quality evidence to support its use in children [23] and in some peripheral neuropathies. [24] There is also low quality evidence that acupuncture may improve analgesia in cancer pain when combined with pharmacological treatments. [1]

Physical and Manual Therapies
Massage has been the subject of a systematic review and, despite methodological problems with the studies included, it appears that massage may potentially have a positive effect on symptoms in advanced cancer including pain. [25] There is limited evidence to support its use in a palliative care setting. [7,26]

Reflexology has been studied in many conditions, including for palliation of cancer, [27] and in breast cancer. [28] Whilst some studies yielded positive results, the methodological quality was poor, the risk of bias high, and the studies small. A systematic review concluded that there is no evidence that reflexology is an effective treatment for any of the conditions studied. Methodology as Means of Supporting Non-Medical Therapy

Other Interventions
Other non-pharmacological interventions which were considered for pain management in a palliative care context included Reiki. There is low quality evidence to support the use of Reiki therapy in palliative care. [26]

Practice Implications
The role of non-pharmacological approaches in pain management is evolving, and some non-pharmacological and complementary therapies have an increasingly important contribution to make to holistic patient care alongside analgesics.
There is evidence to support the use of patient education, cognitive behavioural therapy (CBT), relaxation, and music.
There is limited evidence to support the use of TENS and acupuncture in some conditions.
For this reason, research on non-pharmacological approaches to pain management is very important, so that patients are provided with information that ensures them the most effective options for treating their pain. It is essential that patients assessed with significant pain in palliative care who are using complementary therapies should also be treated with appropriate analgesics and adjuvants, using an evidence-based approach.

What is non-pharmacological pain management?
Non-pharmacological pain management is the management of pain without medications. This method utilizes ways to alter thoughts and focus concentration to better manage and reduce pain. Methods of non-pharmacological pain include:

Education and psychological conditioning
Not knowing what to expect with cancer treatment is very stressful. However, if you are prepared and can anticipate what will happen, your stress level will be much lower.Methodology as Means of Supporting Non-Medical Therapy

To decrease your anxiety about cancer treatment, consider the following:

Ask for an explanation of each step of a procedure in detail, utilizing simple pictures or diagrams when available.
Meet with the person who will be performing the procedure and write down answers to questions.
Tour the room where the procedure will take place.
Ask what you can expect as an outcome of the treatment.
Hypnosis
With hypnosis, a psychologist or doctor guides you into an altered state of consciousness. This helps you to focus or narrow your attention to reduce discomfort.

Methods for hypnosis include:

Imagery: Guiding you through imaginary mental images of sights, sounds, tastes, smells, and feelings can help shift attention away from the pain.
Distraction: Distraction is usually used to help children, especially babies. Using colorful, moving objects or singing songs, telling stories, or looking at books or videos can distract preschoolers. Older children and adults find watching TV or listening to music helpful. Use distraction appropriately, and not in place of an explanation of what to expect.
Relaxation/guided imagery: Guiding you through relaxation exercises such as deep breathing and stretching can often reduce discomfort
Other non-pharmacological pain management may utilize alternative therapies such as comfort therapy, physical and occupational therapy, psychosocial therapy/counseling, and neurostimulation to better manage and reduce pain. Examples of these non-pharmacological pain management techniques include the following:

Comfort therapy
Comfort therapy may involve the following:

Companionship
Exercise
Heat/cold application
Lotions/massage therapy
Meditation
Music, art, or drama therapy
Pastoral counseling
Positioning
Physical and occupational therapy
Physical and occupational therapy may involve the following:Methodology as Means of Supporting Non-Medical Therapy

Aquatherapy
Tone and strengthening
Desensitization
Psychosocial therapy/counseling
Psychosocial therapy/counseling may involve the following:

Individual counseling
Family counseling
Group counseling
Neurostimulation
Neurostimulation may involve the following:

Transcutaneous electrical nerve stimulation (TENS)
Acupuncture
Acupressure

Non-Pharmacological Interventions (NPIs) are science-based and non-invasive interventions on human health. They aim to prevent, care, or cure health problems. They may consist in products, methods, programs or services whose contents are known by users. They are linked to biological and/or psychological processes identified in clinical studies. They have a measurable impact on health, quality of life, behavioral and socioeconomic markers. Their implementation requires relational, communicational and ethical skills.” (Plateforme CEPS, 2017).Methodology as Means of Supporting Non-Medical Therapy

Increasingly, NPIs are integrating digital health solutions (web-based interface, e-Health apps for mobile devices, electronic pill box, serious games, etc.) as well as technology solutions (motion sensors, e-cigarette, etc.). They do not include surgery, radiation therapy, gene therapy or drug treatments, which are also called conventional therapies in this blog.

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“NPIs are complementary to biological or surgical treatments” (Ninot, 2019). They often potentiate their action (for example, improving adherence). They rarely are alternatives to them. They involve the active participation of patients, who often adopt new health behaviors.

The effects of NPIs on people’s health and quality of life are direct (via identified mechanisms and processes) and occur in the midterm (1-6 months); they are observable (exceeding a single satisfaction instance), significant (greater than placebo effects) and verified (proven by clinical trials). The demonstration of their efficacy relies on the principles of Evidence-Based Medicine, as implemented in randomized controlled trials and meta-analyses, the most rigorous and reliable research protocols available today (Ninot, 2019).

Hence, NPIs should therefore not be confused with general health promotion programs within the broader contexts of home improvement, environmental or social reorganization or legislative regulation. They do not fall within the scope of cosmetics either, whose purpose is purely aesthetic. Lastly, they are designed to benefit patients directly, not their loved ones or their support networks, be they personal or professional.Methodology as Means of Supporting Non-Medical Therapy

The other names of NPIs
NPIs are known under several designations, which vary according to countries, healthcare, educational and social service specializations. Those appellations include:
– Adjuvant treatments,
– Behavioral interventions,
– Behavioral medicines,
– Complementary and alternative medicines (CAM),
– Complementary therapies,
– Complementary treatments,
– Health services,
– Integrative medicines,
– Medical devices,
– Natural health products,
– Non-drug therapies,
– Non-pharmaceutical interventions,
– Non-pharmacological treatments,
– Primary (secondary or tertiary) prevention programs,
– Supportive cares,
– Technical and technological health supports,
– Traditional medicines.

Since NPI legislation and regulation (e.g., FDA, EMA) have not been finalized yet, and since neither the French Health Authority (Haute Autorité de Santé) and the World Health Organization have issued specific vocabulary recommendations, the area of NPIs remains ill-defined. It ranges from therapy to prevention, from products to services, from medical prescriptions to recommendations by health professionals. Proving their efficacy in improving people’s health and quality of life may provide the foundation for their historical legitimacy. The wold market of NPIs is estimated between 360 and 4200 billions of dollars (Global Wellness Institute, 2018).Methodology as Means of Supporting Non-Medical Therapy

NPIs are not alternatives to conventional biomedical treatments; instead, they most often complement.
Categories of NPIs
According to the French Health Authority (Haute Autorité de Santé, HAS), NPIs fall into 3 categories. The French Health Authority has issued a searchable report on this subject in 2011 (see also Ninot, 2014). (1) Kinesiology interventions fall into two sub-categories. The first one comprises all the procedures involving therapeutic gestures applied to the body (massage, physiotherapy, osteopathy, chiropractic, acupuncture, etc.). The other involves the individual or group practice of physical activity (yoga, tai chi, nordic walking, adapted physical activity, etc.). (2) Nutritional interventions comprise two sub-categories: diets (diets, dietary advice, etc.) and dietary supplements (mushroom, vitamin, antioxidant food supplements). (3) Psycho-education interventions are also divided into two sub-categories: educational therapy (patient monitoring programs, serious games, etc.) and psychotherapy (cognitive behavioral therapy, mindfulness, meditation, discussion groups, hypnosis, etc.).Methodology as Means of Supporting Non-Medical Therapy

The French Academic and Collaborative Platform, Plateforme CEPS, proposes 5 categories, and 19 subcategories to list NPIs:
(1) psychological health interventions include art therapies, health education programs, zootherapies, and psychotherapies,
(2) physical health interventions include physical activity programs, hortitherapies, physiotherapies, manual therapies, and thermal cares,
(3) nutritional health interventions include food supplements and nutritional therapies,
(4) digital health interventions include ehealth devices, therapeutic games, and virtual reality therapies,
(5) other non-pharmacological health interventions include phytotherapies, ergonomic tools, wave therapies, lithotherapies, and cosmetic therapies.

NPI-ontology-CEPSPlatform-2017

Goals of NPIs
NPIs seek to address, reduce or stabilize an individual’s health problem (symptom or disease) or to eliminate a modifiable risk factor (prodrome or high-risk disease-causing behavior). Thus, depending on context, the aim of NPIs is to have a preventive (primary, secondary or tertiary), therapeutic, curative or palliative effect. Professionals offer them to patients in order to:
– Improve quality of life,
– Alleviate the symptoms,
– Enhance the effects of conventional treatments,
– Prevent the emergence of new diseases,
– Increase life expectancy,
– Cure a disease,Methodology as Means of Supporting Non-Medical Therapy
– Limit unplanned health expenses (treatments, hospitalization, etc.),
– Reduce productivity losses (sick leave, welfare, etc.).

Offering NPIs: prescription or over-the-counter?
Both professionals and users wonder about the best way to distribute/procure NPIs. Their questions include:
– What class (i.e., processes or action mechanisms, method, technique, theory)?
– What “dosage” (i.e., nature, dose, length, intensity, frequency, place of administration, supervision mode)?
– What therapeutic indications?
– What contraindications?
– What precautions?
– What side effects?
– What training for professionals?

The Bottom Line
NPIs are currently associated with two fallacies. The first fallacy is that their efficacy is “self-evident”, and therefore does not require scientific or clinical proof. It assumes that if their benefits are “obvious” and have been known “since the dawn of time”, “there is no need to prove the efficacy of non-pharmacological interventions, which are merely routine hygiene measures.” The second fallacy states that NPIs do not belong to the domain of healthcare products and services. Naysayers claim that NPIs belong instead to the wellness or the entertainment industry, where user satisfaction is paramount. Unfortunately, such biases slow the development of research aiming to provide evidence of the efficacy of NPIs, and are therefore detrimental to their credibility (Ninot, 2013).Methodology as Means of Supporting Non-Medical Therapy

“A knowledge-based policy is the key to integrate Traditional an Complementary Medicine into national health systems. Research should be prioritized and supported in order to generate knowledge. While there is much to be learned from controlled clinical trials, other evaluation methods are also valuable. These include outcome and effectiveness studies, as well as comparative effectiveness research, patterns of use, and other qualitative methods. There is an opportunity to take advantage of, and sponsor such “real world experiments” where different research designs and methods are important, valuable and applicable. The importance of embracing various kinds of contributory research methods and designs in the effort to build a broad evidence base to inform national policy and decision making has been underlined by the National Institute for Health and Care Excellence (NICE), as well as others” (WHO, 2013, p.39).

The blog invites to think that any NPI must go beyond the observation of the benefit of a few cases. It must go through the contribution of safety and effectiveness evidence on the health and quality of life from rigorous clinical studies.

“Non-pharmacological interventions (NPIs) must make the demonstration that they are beneficial to people’s health and quality of life.”Methodology as Means of Supporting Non-Medical Therapy
What it means for Health Professionals
Non-pharmacological interventions (NPIs) are not substitutes for conventional treatments. Neither do they fall into the alternative medicine category. They often complete official biological treatments. In several medical specializations, they are considered “adjuvant” (pejoratively understood as nonessential) or hygiene (pejoratively understood as harmless) treatments. In fact, NPIs are full-fledged treatments, whose interactions with other treatments should be known. They have been the subject of extensive clinical studies. Therefore, similar to drug treatments, NPIs should be prescribed by physicians. Indeed, physicians are trained and qualified to target specific health issues, selecting the best solutions from an arsenal of available interventions. They know the action mechanisms of NPIs, and can anticipate potential interactions with other treatments. They prioritize risks and benefits. They customize the “dose” to each patient, recommend procedures to follow, orient patients within local networks of skilled professionals, and order full check-ups when necessary.Methodology as Means of Supporting Non-Medical Therapy

What it means for Researchers
Checking the indications for a medication on the package insert is now a reflex for most users, who can readily identify a drug’s therapeutic category, therapeutic indications, contraindications, precautions and adverse/side effects. Dosage recommendations are also available (administration mode, dose, length, frequency). These criteria were standardized and regulated (Boutron et al., 2012). But few professionals are able to provide this level of detail on NPIs, because no standardized assessment and surveillance framework is available at this time. This leaves the door open to speculation and misconceptions such as fake medicines or parallel medicines (Ninot, 2013).Methodology as Means of Supporting Non-Medical Therapy

What it means for Policymakers
In the last 20 years, interventional studies have shown the positive effects of NPIs on people’s health and their positive impact on social and economic markers. Some studies have highlighted quality of life improvements and increases in survival without disability. The generalization and reimbursement of NPIs are now required. Methodology as Means of Supporting Non-Medical Therapy

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