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Traditional medicine is the sum of knowledge, skills, and practices that are based on theories, beliefs, and experiences of different cultures used in the maintenance of health. Rituals and shamanistic ceremonies guiding the use of herbal drugs with mind-altering properties are considered mandatory for ...

Traditional medicine is the sum of knowledge, skills, and practices that are based on theories, beliefs, and experiences of different cultures used in the maintenance of health. Rituals and shamanistic ceremonies guiding the use of herbal drugs with mind-altering properties are considered mandatory for maintaining the quality, safety and efficacy of the therapeutic experiences. Although science recognizes the therapeutic role of the placebo effect and the meaning response, the power of rituals in the context of mental health and the consumption of mind-altering drugs has rarely been assessed. We aim to provide a platform for the presentation of first-hand clinical experiences and experts’ contributions on practices used or inspired by traditional medicines related to the improvement of mental health.

The focus on testing pure compounds and botanical drugs derived from indigenous pharmacopoeias follows the idea that local medicines become meaningful only when pharmacologically assessed and often disregards the importance of indigenous recipes and the cultural context. While useful in the context of drug development, this can hamper the successful integration of indigenous practices into modern contexts, such as for instance that of psychedelic-assisted therapy. Currently there is an increasing interest towards new therapies for mental problems using indigenous psychedelic drugs. Therefore, the assessment of the traditional pharmaceutical recipes and the role of the set and setting representing the overall context are crucial. The interdisciplinary challenge posed by this relatively new field of research (despite seminal work dating back many decades) will be tackled by giving priority to studies adopting schemes for assessing the mind-set of users, rituals and ceremonies. Studies should, moreover, evaluate the treatment outcome by means of standardized protocols measuring different parameters related with mental health such as anxiety, depression, or psychological flexibility, but also spiritual wellbeing and overall quality of life. There is no constriction towards specific disciplinary methodologies.

Contributions are invited from a broad range of disciplines and fields of research including, but not limited to, medical anthropology, ethnopharmacology and ethnomedicine, psychopharmacology, neuroscience, psychology, sociology, history, and philosophy, as well as from conventional or complementary therapists with clinical expertise related to the proposed research topic and addressing:

• Herbal medicines and modern drugs of natural origin used in the context of mental health
• Pharmacology of traditional recipes including psychoactive drugs; pharmacology of the placebo effect/meaning response
• Efficacy of rituals and ceremonies (responses to non-biological factors in therapy)
• Traditional and modern practices in mental health

Topic Editors Matteo Politi and Fernando Mendive receive research funding from Takiwasi Centre, a not-for-profit organization. Topic Editor Luis Luna is the Founder and Director of Wasiwaska, also a not-for-profit Research Center for the Study of Psychointegrator Plants, Visionary Art and Consciousness [hyperlinked]. There is no funding of this Research Topic, and all other Topic Editors declare no competing interests with regard to the Research Topic subject.

All manuscripts must comply with the four pillars of best practice in Ethnopharmacology.

1) Pharmacological Requirements:
a) Traditional context - The traditional context must be described in the introduction.
b) Credible experimental models - methods must be state of the art, or a credible alternative. The following have specific requirements:
- FRAP, ABTS, DPPH, and Trolox equivalent antioxidant capacity assays are not accepted.
- in silico studies are not accepted as a main method.

- Disc diffusion experiments must be followed by in vitro or in vivo experiments.
- Specificity must be assessed to rule out general toxic effects, e.g. by including parallel cytotoxicity testing (cf. Cos et al. 2006)
- The mechanism of action must be assessed in sufficient detail (for crude extracts, the effects of contaminants should also be addressed).

- Experiments on the rat hind paw oedema model are not acceptable unless they are part of a larger pharmacological – phytochemical study.

Docking studies:
- These will not be accepted unless followed by benchwork confirming affinity.
- A proposed mechanism of action is required.

In silico network pharmacology studies
-Network pharmacology studies must critically assess the evidence to evaluate the potential pharmacological effects of a preparation / herbal (medical) product.
- The identification of the compounds must be sound. This information may be derived from the existing literature or from benchwork. It is essential that the quantities of the compounds in the preparation or plant are stated and are high enough to be of pharmacological relevance.
- The bioavailability of the compounds must be assessed.
- Ubiquitous or very widely known compounds are highly unlikely to be ‘active’.
- Transcriptomic data need to be validated using RT-PCR, and proteomic data with Western blots.

Single dose studies:
- These are not accepted unless they focus on a species / compound not yet studied in detail, and can be justified on specific ethical grounds

c) Dose - ranges must be therapeutically relevant:
- Implausibly high doses will not be considered.
- Both positive and negative controls are essential.
- Multiple doses are strongly recommended, as single dose studies are rarely accepted - only in some specific complex models.

2. Composition Requirements:
Whether the material under investigation is a crude plant extract, a multi-herbal preparation, a single compound from a commercial source or extracted from plant, chemical and botanical composition must be explicitly stated.
a) Chemical:
- The concentrations of the dominating compounds must be listed, including dominant impurities if these compounds have been identified in previous studies. Stating the class of compounds present (such as “alkaloids”) is insufficient. We will usually ask for a HPLC or UPLC to establish the compounds present to ensure replicability, if this is not possible a credible alternative can be used.
- Referring to a previously used preparation in the literature is not acceptable, unless it has come from the same preparation or has the same batch number.
- For purchased compounds, purity (%) and the supplier name must be included.
- For extracted compounds, purity (%) and the method used to determine the purity must be stated.
- The structure of active compounds should be included as figures.

b) Botanical:
- Species names must be fully validated and should be described in their full taxonomy, using the Kew Medicinal plant names service.
- Samples must be deposited in a recognised herbarium, and accessible if necessary. To find out if your institution is indexed, please use the NYBG Steere Herbarium Search tool
- Voucher numbers from the herbarium must be included in the Methods.
- Coordinates of plant picking should also be included, or the commercial source of a preparation, which must include a batch number and details on the preparation’s composition.

3. Basic Experimental and Ethical Requirements:
a) The study must contribute substantially to the existing literature. How it does so must be explicitly stated. The most up-to-date surrounding literature should be discussed, including related compounds, to demonstrate the contribution of the study to the field.
b) Compliance with all international ethical standards is essential. The Convention on Biological Diversity and the Nagoya Protocol are of particular relevance. This includes that research in the field should benefit the original users and consider their traditions.
c) The use of animals must be justified. If a material is well-characterised, and its properties well-known, performing another in vivo study is considered an unethical use of animals. A thorough knowledge of the literature is essential to avoid this mistake. Conversely, if a material is not well characterised, initial experiments in cell-based models are necessary to justify moving onto animal experiments.
d) The effects of traditional medicinal preparations must be testable in scientific terms. We acknowledge the importance of the understanding of medicinal preparations in their cultural context, and it may be that the treatment of symptoms as defined by traditional practices forms a basis for such investigations. However, pharmacological studies generally do not provide evidence for such uses, but rather for the established therapeutic targets of the model. Experimental outcomes should be linked to and described in these terms. For example, a series of in vitro tests will not demonstrate relevant evidence that will contribute to a physiological understanding of traditional therapeutic concepts, e.g. “dispelling wind” or “dampness” in Traditional Chinese Medicine. A justification must therefore be given for choosing a certain model to test a certain preparation.

4. Article-type Specific Requirements:

- Data must be substantial and original.
- The study must be discussed in the context of previous studies carried out in the region. How the study contributes to the development of the field must be made explicit.
- Must comply to the ConsEFS standards, including any updates.

- The objective of the review must be clearly defined.
- They must provide a specific, critical assessment of the literature. The scientific quality of the original articles must be critically assessed. This includes the experimental design, and reliability of the studies.
- The traditional use must be linked to scientific evidence.
- Future needs and priorities must be clearly defined.

- To assure the quality of the studies included, we ask for the inclusion of a summary table (templates available on the Ethnopharmacology About page).
- We ask that a chemical analysis is included, taken from one of the included studies. The chemical composition of the study material must be well defined. If the composition is poorly characterized, this must be highlighted.
- Quality control measures taken, as defined by a pharmacopoeia, must also be included.
- If the included studies do not use full botanical taxonomic names, this should be highlighted, as must any naming inconsistency between studies.

Keywords: Herbal medicine, traditional knowledge, psychoactive drugs, psychedelics, set and setting, ritual efficacy

Important Note: All contributions to this Research Topic must be within the scope of the section and journal to which they are submitted, as defined in their mission statements. Frontiers reserves the right to guide an out-of-scope manuscript to a more suitable section or journal at any stage of peer review.

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