Complementary therapies for chronic plaque psoriasis

Complementary therapies for chronic plaque psoriasis

(Protocol)

Monson CA, Silva V, Andriolo RB, Kozasa EH, Sabbag CY, Paula CAD, Tweed JA, Fernandes

Moça Trevisani V

This is a reprint of a Cochrane protocol, prepared and maintained by The Cochrane Collaboration and published in The CochraneLibrary 2014, Issue 7

http://www.thecochranelibrary.com

Complementary therapies for chronic plaque psoriasis (Protocol)

Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

http://www.thecochranelibrary.com

T A B L E O F C O N T E N T S

1HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9ADDITIONAL TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

22APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

iComplementary therapies for chronic plaque psoriasis (Protocol)


[Intervention Protocol]

Complementary therapies for chronic plaque psoriasis

Carlos A Monson1 , Valter Silva2, Régis B Andriolo3, Elisa Harumi Kozasa4, Cid Yazigi Sabbag5 , Carlos Alberto de Paula6, John ATweed6, Virginia Fernandes Moça Trevisani7

1Brazilian Cochrane Centre, São Paulo, Brazil. 2Internal Medicine and Therapeutics, Universidade Federal de São Paulo, São Paulo,Brazil. 3Department of Public Health, Universidade do Estado do Pará, Belém, Brazil. 4Instituto do Cérebro - Instituto Israelita deEnsino e Pesquisa Albert Einstein, Universidade Federal de São Paulo, São Paulo, Brazil. 5Psoriasis Ambulatory Hospital Ipiranga, SãoPaulo, Brazil. 6c/o Cochrane Skin Group, The University of Nottingham, Nottingham, UK. 7Rheumatology/Internal Medicine andTherapeutics, Universidade Federal de São Paulo, São Paulo, Brazil

Contact address: Carlos A Monson, Brazilian Cochrane Centre, Rua Pedro de Toledo, 598, Vila Clementino, São Paulo, CEP 04039-001, Brazil. [email protected].

Editorial group: Cochrane Skin Group.Publication status and date: New, published in Issue 7, 2014.

Citation: Monson CA, Silva V, Andriolo RB, Kozasa EH, Sabbag CY, Paula CAD, Tweed JA, Fernandes Moça Trevisani V. Com-plementary therapies for chronic plaque psoriasis. Cochrane Database of Systematic Reviews 2014, Issue 7. Art. No.: CD011243. DOI:10.1002/14651858.CD011243.


A B S T R A C T

This is the protocol for a review and there is no abstract. The objectives are as follows:

To assess the effects of complementary medicine for the treatment of chronic plaque psoriasis.

B A C K G R O U N D

Description of the condition

Psoriasis is a complex skin disease that may affect any part of thebody, but the most common places are the knees, elbows, andscalp. However, lesions may occur in other areas, such as the nails,joints, and mouth (Camisa 2003; Gonzaga 1996). Both men andwomen over a wide age range can be affected. With a worldwideprevalence, white people are more commonly seen to be at risk thanany other ethnicity, and in the UK, about 2% of the populationare affected (Habif 2001; Raychaudhuri 2001).It is unknown why psoriasis occurs, but it appears that the immunesystem is involved (Christophers 1996; Griffiths 2007), and pso-riasis is associated with markers of systemic inflammation (suchas increased levels of C-reactive protein, and tumour necrosis fac-

tor), which increase the chances of heart disease, such as myocar-dial infarction, in affected people (Gelfand 2006). Psoriasis itselfis not infectious (Roenigk Jr 1990), but some lesions may incursecondary infection, which may complicate treatment (Mallbris2009). Psoriasis is often found in families, but may skip a genera-tion, and many genes have been linked to it (Borska 2009; Elder2009).Many factors are thought to trigger the condition, including skininjury, a sore throat, chest infection, sunburn, certain drug treat-ments, increased intake of alcohol (Morse 1985), weather changes,and stress. Stress seems to be one of the most important factors(Farber 1993; Fortune 2002; Selye 1950; Raychaudhuri 2001;Weiss 2006; Zachariae 1973), which may also influence the clin-ical course of the disease. Prior psychological trauma can triggeran exacerbation of the disease (Rapp 1997; Raychaudhuri 2001;Wright 1994).

1Complementary therapies for chronic plaque psoriasis (Protocol)


mailto:[email protected]

Psoriasis in any of its forms often produces physical discomfort inthe form of itching, pain, and skin blemishes (Fitzpatrick 1993).Many people with psoriasis experience embarrassment, find it af-fects their daily life, experience anxiety and mood disorders aboutthe uncertainty of how the disease will progress or how the condi-tion will react to new treatments (Stein 2005), and have feelingsof emotional distress at seeing their skin degenerating (Camisa2003). However, others find it no more than a slight irritation.Emotional distress can cover a range of experiences. Because thecondition is chronic, the time needed to treat the condition maybe long (Bergstrom 2003), and there may be a fear of being unableto cover the cost of treatments (Bottomley 2007; Schoffski 2007;Weiss 2006). Also, specific treatments may be needed, such aslithium for emotional disorders (Basavaraj 2010). Some peoplefeel shame in front of other people (Savin 1970) and fear rejection.The latter is manifested by people with the condition avoidingpublic places, such as swimming pools, the beach, the gym, andrestaurants (Ramsay 1988), and being aware that many people aretrying not to touch them, e.g. suffering rejection by barbers or atbeauty salons (Camisa 2003). They may be angry because theymay feel discriminated against in employment (Schmitt 2006).Depression at not being sexually attractive (Bolgert 1955) maythen lead to worry in a relationship about bearing children, becauseof the risk of genetic transmission (McEvoy 1989).The great variability of clinical forms of the disease, the unpre-dictability of its progress, and the way an individual’s personalitycan have an effect on its progression illustrate the complexitiesinvolved in treating this disease (Sato 2004). There is a globalconsensus that psoriasis in its more severe form is an incurablechronic condition that is difficult to treat. There is a consensusamong experts that psoriasis usually does not take away the lifeof a person, but severely affects the quality of life (Camisa 2003;Kurd 2010; Rossi 2011). As emotional fragility can be seen inmost people with psoriasis, there is a constant need to search forstrategies to improve the quality of life of those with this condition(Raychaudhuri 2001).

Description of the intervention

Throughout the world, people spend large amounts of moneyeach year on complementary medical interventions, while manyquestions concerning these therapies remain unanswered. Com-plementary and alternative medicine (CAM) consists of groups ofmedical and healthcare systems, practices, and products that areoften considered outside conventional medical practice. Accord-ing to the Cochrane Complementary and Alternative Medicine(CAM) Field, the number of those who use these therapies hasbeen growing steadily (Cochrane CMF 2013).The use of complementary and alternative medicines is commonamong people with skin diseases, specifically those with psoria-sis (Schoffski 2007). Most people with psoriasis seek the opinionof their dermatologist about the existence of new treatments and

complementary or alternative treatments that may provide pallia-tive relief. Some of these therapies are able to help people achievesome relief, allowing them to cope with their condition (Feldman1997); however, in reality, we still do not have precise informationon their effectiveness, efficacy, and safety.To help ensure consistent classification of these interventions, theUSA’s National Institutes of Health (NIH) has created the Na-tional Center for Complementary and Alternative Medicine (NC-CAM), which has determined criteria for the definition and clas-sification of complementary and alternative medicine. Thus, theterm ’complementary medicine’ refers only to the use of inter-ventions in addition to conventional medicine. The term ’alterna-tive medicine’ refers to treatments used in place of conventionalmedicine, whereas the term ’integrative medicine’ describes a com-bination of conventional medicine and complementary and alter-native medicine (CAM) when there is evidence of effectiveness,efficiency, and safety (NCCAM 2013). The NCCAM has dividedCAM into the following categories:

• natural products;• mind and body practices; and• other CAM Practices (e.g. movement therapies, traditional

healers, manipulation of various energy fields, and whole medicalsystems) (NCCAM 2013; Uman 2004).

(See a glossary of CAM interventions adapted from NLM 2013in Table 1.)Additionally, many practitioners are not medically qualified andhave little knowledge of the biomedical sciences, although some dotake diplomas in their area of treatment. Some are medically qual-ified practitioners who have studied, for example, in hypnother-apy, acupuncture, and homeopathy. The selection of a competenthealthcare practitioner is an important decision and can be essen-tial to ensuring the best possible care (NCCAM 2013).

How the intervention might work

Studies have shown that stress management has helped to in-crease the efficacy of treatments in many people with psoriasis(Kabat-Zinn 1998), because stress appears to play an importantpart in a vicious circle of interactions that lead to worsening pso-riatic skin (Mohum 2006; Zachariae 1996). Although the intrin-sic mechanisms of action of the CAM systems are not well un-derstood, improvement in mental health may help (Bonadonna2003), because when added to conventional treatments, resultshave been acceptable (NCCAM 2013; Tierney Jr 2007).Complementary and alternative medicines are mistakenly consid-ered to be innocuous because they are regarded as ’natural prod-ucts’. However, they are complex substances with active chemicalingredients and therefore have pharmacokinetic and pharmacody-namic effects like any other drug. These effects, which may often beunknown, may turn out to be dangerous and unsafe (Kabat-Zinn1998).



The concept of what complementary or alternative practice meansis often completely dependent upon the cultural context of dif-ferent countries. The definition of complementary and alternativepractices includes all such practices and ideas that are outside thedomain of conventional medicine in most countries and consid-ered by its users as preventing or treating illness, or promotinghealth or well-being (Gaston 1991).

Why it is important to do this review

Although there are many publications on CAMs, importantknowledge about their effectiveness, efficiency, and safety have notbeen fully mapped. The body of clinical trial literature surround-ing the use of complementary and alternative medicine for psori-asis is large, but has several limitations (Smith 2009).We plan to review the evidence for the possible potential benefitsof complementary interventions, classified according to the cri-teria of the National Center for Complementary and AlternativeMedicine (NCCAM 2013), which is aimed at treating chronicplaque psoriasis.

O B J E C T I V E S

To assess the effects of complementary medicine for the treatmentof chronic plaque psoriasis.

M E T H O D S

Criteria for considering studies for this review

Types of studies

All randomised controlled trials (RCTs) evaluating the effectsof complementary and alternative medicine, classified accord-ing to the National Center for Complementary and Alterna-tive Medicine/National Institutes of Health (NCCAM/NIH)(NCCAM 2013), for the treatment of chronic plaque psoriasis.

Types of participants

We will include people of any age with a diagnosis of chronicplaque psoriasis.

Types of interventions

We will consider complementary medicine interventions in anyform used in conjunction with conventional treatments forchronic plaque psoriasis. We will also include studies that applyalternative medicine, especially with regard to studies conductedwithin the criteria for categorisation of NCCAM/NIH (NCCAM2013). Chinese medicines will make the present review as com-prehensive as possible.We might include the following possible general comparisons.

1. complementary medicine interventions versus conventionalmedical practice, e.g. meditation plus PUVA (a combination ofpsoralen and ultraviolet A) versus PUVA;

2. complementary medicine interventions versus alternativemedicine interventions, e.g. acupressure plus PUVA versusacupressure herbal Chinese medicine;

3. complementary medicine interventions versuscomplementary medicine interventions, e.g. acupressure plusPUVA versus meditation plus PUVA;

4. alternative medicine interventions versus conventionalmedical practice, e.g. homeopathy versus PUVA; or

5. alternative medicine interventions versus alternativemedicine interventions, e.g. Tai Ji versus hypnosis.For inclusion in the review, at least one arm of the RCT will needto include a CAM intervention.A glossary of potential CAM interventions, adapted from NLM2013, is available in Table 1.

Types of outcome measures

Primary outcomes

1. Changes in disease status assessed by signs (e.g. planimetricmethod, Camisa 2003; Psoriasis Area and Severity Index (PASI),Fredriksson 1978) and symptoms (e.g. Symptom Severity Scale(SSS), Hughes 1981; Self Administered Psoriasis Area andSeverity Index (SAPASI), Feldman 1996) of disease or any toolavailable.

2. Adverse effects or events (e.g. life-threatening adverse events(LTAE), Naranjo 1981).

Secondary outcomes

1. Changes in conventional medicine interventions assessed bylower doses of drug, reduced ultraviolet light exposures, orincreased intervals between relapses.

2. Changes in participant status assessed by psychosocialchanges (e.g. Psoriasis Disability Index (PDI), Finlay 1987;happiness, anxiety, emotional distress, behavioural changes,sexuality, or intimacy); quality of life (e.g. Dermatology LifeQuality Index (DLQI), Mazzotti 2003; 36-item short-formhealth survey (SF-36), Tasai 1997; UK Sickness Impact Profile



(SIP), Finlay 1990); and treatment satisfaction (through usingany tool available).

Search methods for identification of studies

We aim to identify all relevant RCTs, regardless of language or pub-lication status (published, unpublished, in press, or in progress).

Electronic searches

We will search the following databases for relevant trials:• the Cochrane Skin Group Specialised Register;• the Cochrane Central Register of Controlled Trials

(CENTRAL) in The Cochrane Library;• PubMed using the CAM subset;• MEDLINE via OVID (from 1946);• Embase via OVID (from 1974);• AMED via OVID (Allied and Complementary Medicine

Database, from 1985);• PsycInfo via OVID (from 1806);• CINAHL (Cumulative Index to Nursing and Allied Health

Literature) via EBSCO (from 1981);• Salford Database of Psoriasis trials;• ISI Web of Science; and• HealthSTAR.

We have devised a search strategy for RCTs for PubMed, which isdisplayed in Appendix 1. This will be used as the basis for searchstrategies for the other databases listed.

Trials registers

We will search the following trials registers.• The metaRegister of Controlled Trials (www.controlled-

trials.com).• The US National Institutes of Health Ongoing Trials

Register (www.clinicaltrials.gov).• The Australian New Zealand Clinical Trials Registry (

www.anzctr.org.au).• The World Health Organization International Clinical

Trials Registry platform (www.who.int/trialsearch).• The EU Clinical Trials Register (

www.clinicaltrialsregister.eu/).

Searching other resources

References from published studies

We will check the bibliographies of included studies and reviewarticles for additional references to relevant trials.

Unpublished literature

We will contact the authors of included studies and ask them aboutother published and unpublished RCTs.

Conference proceedings

We will handsearch the following conference proceedings from2011 to date when they have not already been handsearched bythe Cochrane Skin Group.

• World Psoriasis & Psoriatic Arthritis Conference• Annual Meeting of the American Academy of Dermatology• Annual Meeting of the European Society for

Dermatological Research• World Congress of Dermatology• Annual Meeting of the British Society for Investigative

Dermatology• Annual Meeting of the Society for Investigative

Dermatology

Adverse effects

We will not perform a separate search for adverse effects of com-plementary therapies for chronic plaque psoriasis. However, wewill examine data on adverse effects from the included studies weidentify.

Data collection and analysis

We plan to include at least one ’Summary of findings’ table inour review. In this, we will summarise the primary outcomes forthe most important comparison. If we feel there are several majorcomparisons or that our findings need to be summarised for dif-ferent populations, we will include further ’Summary of findings’tables.We will perform the data collection and analysis according to therecommendations in the Cochrane Handbook for Systematic Reviewsof Interventions (Higgins 2011).

Selection of studies

Two review authors (CM and EK) will independently screen titlesand abstracts of trials from literature searches for inclusion in thereview and code them as “retrieve” (eligible, potentially eligible,or unclear) or “do not retrieve”. We will obtain full text of thosecoded “retrieve”, and two review authors (CM and EK) will in-dependently screen the full text to identify studies for inclusion.We will resolve disagreements by discussion; however, if we do notreach consensus, a third author (CS) will make the judgment.We will record reasons for the exclusion of any ineligible studiesin the ’Characteristics of excluded studies’ tables.We will carry out the selection process in sufficient detail to com-plete a flow diagram.



http://www.controlled-trials.com/

http://www.controlled-trials.com/

http://www.clinicaltrials.gov/

http://www.anzctr.org.au/

http://www.who.int/ictrp/search/en/

http://www.who.int/ictrp/search/en/

http://www.clinicaltrialsregister.eu/

Data extraction and management

Two review authors (CM and EK) will independently conductdata extraction from the primary studies, and if necessary, they willconsult a third reviewer (CS or VS) to resolve any disagreements.We will modify the standard Cochrane Skin Group data extractionform to meet the needs of this systematic review.

Assessment of risk of bias in included studies

Two authors (CM and EK) will independently assess the risk ofbias for each included trial using the criteria described in theCochrane Handbook for Systematic Reviews of Interventions (Chan2005; Higgins 2011). A third author (CS or VS) will resolve anydisagreement. We will assess the risk of bias according to the fol-lowing domains:

1. random sequence generation (selection bias);2. allocation concealment (selection bias);3. blinding of participants and personnel (performance bias);4. blinding of outcome assessment (detection bias);5. incomplete outcome data (attrition bias);6. selective reporting (reporting bias); and7. other bias (other sources of bias related to a particular trial

design, e.g. cross-over or cluster-randomised, or specificcircumstances, e.g. interventions mixed).We will classify the risk of bias as low risk of bias, high risk of bias,or unclear risk of bias.

Measures of treatment effect

Considering the objective, criteria for considering studies, out-comes for this review, and also the recommendation in theCochrane Handbook for Systematic Reviews of Interventions (Chan2005; Higgins 2011), we plan to use the following types of mea-surements of treatment effect.

Continuous data: outcome measures evaluated by

numerical quantity

We will combine the results using the mean difference (MD) formeasures using the same scale or the standardised mean difference(SMD) when different scales are used to evaluate the same out-come. This type of measure may be found for signs assessed byPASI, for example.

Dichotomous data: outcome measures evaluated as binary

responses

We will show the summarised results as risk ratios (RR) consideringthe types of included studies criteria, i.e. RCTs. We will calculatethe number needed to treat (NNT) from the RR if estimatedeffects are statistically significant. These type of data may be foundfor changes in conventional medicine interventions assessed bylower doses of drug, for example.

Ordinal data: outcome measures evaluated by several

ordered categories, e.g. trichotomous (mild, moderate, or

severe)

If a shorter ordinal scale is used, we will analyse in meta-analysesas dichotomous data, but if a longer scale is used, we will analyseas continuous data in meta-analyses. These type of data may befound for psychosocial changes, such as depression, for example.

Counts and rates: outcome measures based on the number

of events experienced by each individual

If a meta-analysis is appropriate, we may use the rate ratio, i.e. rateof events in the two groups by dividing one by the other. This typeof data may be found for adverse effects or events, for example.

Time-to-event data: measures the time until an event occurs

We may use the hazard ratio (HR) to measure this type of time-to-event outcome. This type of data may be found for increasedinterval between relapses, for example.If we find more than one study that analyses the same outcome, wewill conduct a meta-analysis. All statistical parameters will use 95%confidence intervals (CI). However, where data are not availablefor meta-analysis or are considered inappropriate, we will assessthe evidence systematically and describe it.

Unit of analysis issues

Given the nature of the disease and variety of interventions, wecan expect the following units of analysis.

• Parallel RCTs: The unit of analysis will be based on theindividual participant (unit to be randomly assigned forinterventions to be compared).

• Cross-over RCTs: In cross-over designs, we will onlyinclude the phase one data to avoid a carry-over effect.

• Cluster RCTs: If we include cluster-randomised trials, theunit of analysis will be the group that was allocated theintervention.

• Multiple treatment: If we include multiple interventiongroups within a RCT and more than two groups are relevant, wewill create single pair-wise comparisons to analyse it as a parallelRCT where possible.

• Multiple body parts receiving different interventions: If weinclude RCTs where chronic plaque psoriasis or body parts arerandomised to the allocated intervention, which have similaritiesto a cross-over RCT, we will extract and analyse all relevant dataif possible.

• Multiple body parts receiving the same intervention: If weinclude RCTs where participants are randomised to receive thesame intervention, but multiple chronic plaque psoriasis or bodyparts receive the same intervention, and a separate judgement ismade for each body part, which have similarities to a cluster



RCT, the unit of analysis will be the group of multiple chronicpsoriasis or body parts that was allocated the intervention.

Dealing with missing data

If the included studies have missing data, we will manage thisby following the strategies detailed in the Cochrane Handbook forSystematic Reviews of Interventions (Higgins 2011).

1. As a first step, we will try to contact the authors by sendingat least two emails to request additional information (e.g.incomplete reporting, lack of intention-to-treat analysis,summary data missing for an outcome, randomisation processnot described, or any other necessary data). If we obtain noanswer, we will report and discuss this in the text.

2. We will describe any methods used to cope with missingdata.

3. We will perform sensitivity analyses to test the robustness ofthese assumptions.

4. We will discuss the impact of missing data on the results ofthe review.

5. We will use available case analysis as our primary analysis.The available case analysis will use data on known results for aparticular outcome. A potential source of heterogeneity may bethe variation in the amount of missing data.

6. We will use intention-to-treat analysis (ITT) withimputation as our secondary analysis: ITT assessment will useanalysis of the total number of randomised participants whetheror not the original authors analysed them in this way. It may benecessary to impute dichotomous outcome data. The mostcommon way is to assume that all the missing participantsexperienced the event or all did not. An alternative is to imputedata according to the event rate in a control group or accordingto event rates in the participants who complete in the groups.We will base the choice of methodology on clinical judgment insome cases.

Assessment of heterogeneity

We will assess the level of diversity among studies using I² statis-tic. We will describe this as percentage of variability in effect esti-mates resulting from heterogeneity. We will consider heterogene-ity substantial if the I² statistic is > 50%, considering, in addition,magnitude and direction of effects and strength of evidence forheterogeneity (e.g. P value from the Chi² test).If substantial heterogeneity exists among studies, our strategies foraddressing it will follow the recommendations in the CochraneHandbook for Systematic Reviews of Interventions (Higgins 2011).Considering the complexities and degree of incompleteness inCAM interventions, where it makes sense, we will try to explorethis with subgroup analysis of study characteristics and advise cau-tion in the interpretation of our results.

Assessment of reporting biases

We will try to contact the authors by email if there is insufficientinformation to assess report bias. We will also contact the trialauthors to clarify the information if there are mismatches betweenstudy protocols and reports.We will perform a funnel plot asymmetry test if we include 10or more RCTs in the meta-analysis to have power in the test todistinguish chance from real asymmetry.

Data synthesis

We will meta-analyse RCTs if the pooled estimates for the out-comes is possible. When the heterogeneity is not substantial (I²statistic < 50%), we will use a fixed-effect meta-analysis. When-ever heterogeneity is substantial (I² statistic > 50%), we will use arandom-effects meta-analysis.In cases where the combination of data is not possible to performmeta-analyses, we will present a description of individual studies.

Subgroup analysis and investigation of heterogeneity

If possible and whenever it makes sense, we will conduct subgroupanalyses to explore possible sources of heterogeneity due to par-ticipants, interventions, or methods:

Participant characteristics

• Severity of psoriasis (e.g. light, moderate, severe)• Age groups (e.g. children (until 18 years old), adults

(between 18 to 65 years old), and the elderly (more than 65 yearsold))

• Setting (e.g. hospital, home care)• Ethnicity• Associated chronic conditions

Type and characteristics of CAM interventions

• Natural products• Mind and body practices• Other CAM practice

We will also assess duration of the treatments.We will assess statistical differences in subgroup analyses by overlapof confidence intervals and by performing the test for subgroupdifferences available in Review Manager (RevMan).

Sensitivity analysis

We plan to explore how the results of the meta-analysis changeunder different assumptions by conducting sensitivity analyses toassess the robustness of the results, describing and comparing themwith the overall findings. Moreover, we will conduct sensitivityanalyses looking at the following aspects of methods:



1. study design (e.g. parallel, cross-over, cluster); and2. methodological quality (e.g. effects of missing data;

blinding; intention-to-treat; risk of bias: low, high, or unclear).

A C K N O W L E D G E M E N T S

We would like to thank Finola Delamere and Laura Prescott fromthe Cochrane Skin Group for their support when writing this

protocol, and we are grateful for peer review comments madeby Bob Dellavalle, Juping Chen, Matthew Grainge, and PhilippaMiddleton. We would also like to thank Liz Doney for the searchstrategy development.

The Cochrane Skin Group editorial base wishes to thank RobertDellavalle who was the Cochrane Dermatology Editor for thisprotocol; Matthew Grainge and Philippa Middleton who were theStatistical and Methods Editors, respectively; the clinical referee,Juping Chen; and the consumer referee, Maria Grogan.

R E F E R E N C E S

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∗ Indicates the major publication for the study

A D D I T I O N A L T A B L E S

Table 1. Glossary of CAM interventions (adapted from NLM 2013: U.S. National Library of Medicine. E02.190 - Comple-

mentary Therapies. In: MeSH Tree Structures - 2013)

MeSH (tree number) Definition and other important information

Complementary therapies (E02.190) Therapeutic practices which are not currently considered an in-tegral part of conventional allopathic medical practice. Theymay lack biomedical explanations but as they become better re-searched some (PHYSICAL THERAPY MODALITIES; DIET;ACUPUNCTURE) become widely accepted whereas others (hu-




mentary Therapies. In: MeSH Tree Structures - 2013) (Continued)

mors, radium therapy) quietly fade away, yet are important his-torical footnotes. Therapies are termed as Complementary whenused in addition to conventional treatments and as Alternativewhen used instead of conventional treatmentAdditional tree number: noneSynonyms: Therapies, Complementary; Therapy, Complemen-tary; Complementary Medicine; Medicine, Complementary; Al-ternative Medicine; Medicine, Alternative; Alternative Therapies;Therapies, Alternative; Therapy, Alternative

Acoustic stimulation (E02.190.888.030) Use of sound to elicit a response in the nervous systemAdditional tree number: E02.037, E05.723.136Synonyms: Stimulation, Auditory; Auditory Stimulation; Stim-ulation, Acoustic

Acupressure (E02.190.599.092) A type of massage in which finger pressure on specific body sites isused to promote healing, relieve fatigue, etc. Although the anatom-ical locations are the same as the ACUPUNCTURE POINTSused in ACUPUNCTURE THERAPY (hence acu-), no needleor other acupuncture technique is employed in acupressure. Shi-atsu is a modern outgrowth that focuses more on prevention thanhealingAdditional tree number: E02.779.867.171Synonyms: Shiatsu; Shiatzu; Zhi Ya; Chih Ya

Acupuncture analgesia (E02.190.044.105) Analgesia produced by the insertion of ACUPUNCTURE nee-dles at certain ACUPUNCTURE POINTS on the body. This ac-tivates small myelinated nerve fibers in the muscle which transmitimpulses to the spinal cord and then activate three centers - thespinal cord, midbrain and pituitary/hypothalamus - to produceanalgesiaAdditional tree number: E03.091.048Synonyms: Analgesia, Acupuncture; Acupuncture Anesthesia;Anesthesia, Acupuncture

Acupuncture points (E02.190.044.555.035) Designated locations along nerves or organ meridians for insertingacupuncture needlesAdditional tree number: noneSynonyms: Acupuncture Point; Point, Acupuncture; Points,Acupuncture; Acupoints; Acupoint

Acupuncture therapy (E02.190.044) Treatment of disease by inserting needles along specific pathwaysor meridians. The placement varies with the disease being treated.It is sometimes used in conjunction with heat, moxibustion, acu-pressure, or electric stimulationAdditional tree number: noneSynonyms: Therapy, Acupuncture





Acupuncture, ear (E02.190.044.133, E02.190.204.500) Acupuncture therapy by inserting needles in the ear. It is used tocontrol pain and for treating various ailmentsAdditional tree number: noneSynonyms: Acupunctures, Ear; Ear Acupunctures; Auricu-lar Acupuncture; Ear Acupuncture; Acupuncture, Auricular;Acupunctures, Auricular; Auricular Acupunctures

Anthroposophy (E02.190.088) Knowledge of the nature of man. A spiritual and mystical doctrinethat grew out of theosophy and derives mainly from the philoso-phy of Rudolph Steiner, Austrian social philosopher (1861-1925)Additional tree number: K01.844.058Synonyms: none

Aromatherapy (E02.190.525.061, E02.190.755.100, E02.

190.888.061)

The use of fragrances and essences from plants to affect or altera person’s mood or behavior and to facilitate physical, mental,and emotional well-being. The chemicals comprising essential oilsin plants has a host of therapeutic properties and has been usedhistorically in Africa, Asia, and India. Its greatest application is inthe field of alternative medicineAdditional tree number: F04.754.035Synonyms: Aromatherapies; Aroma Therapy; Aroma Therapies;Therapies, Aroma; Therapy, Aroma

Art therapy (E02.190.888.124) The use of art as an adjunctive therapy in the treatment of neu-rological, mental, or behavioral disordersAdditional tree number: E02.831.100, F04.754.070Synonyms: Therapy, Art; Art Therapies; Therapies, Art

Auriculotherapy (E02.190.204) Treatment of pain, drug addictions, or other ailments by stimu-lating the various points on the external ear (EAR AURICLES).It is based on the ancient Chinese practices of EAR ACUPUNC-TURE, but sometimes magnets and other modes of stimulationare usedAdditional tree number: noneSynonyms: Auriculotherapies

Autogenic training (E02.190.525.217.100) Technique based on muscle relaxation during self-hypnotic exer-cises. It is used in conjunction with psychotherapyAdditional tree number: F04.754.103Synonyms: Autogenic Trainings; Training, Autogenic; Trainings,Autogenic

Autosuggestion (E02.190.525.217.771.100) Suggestion coming from the subject himselfAdditional tree number: F04.754.424.771.299Synonyms: Autosuggestions





Biofeedback, psychology (E02.190.525.123) The therapy technique of providing the status of one’s own AU-TONOMIC NERVOUS SYSTEM function (e.g., skin tempera-ture, heartbeats, brain waves) as visual or auditory feedback in or-der to self-control related conditions (e.g., hypertension, migraineheadaches)Additional tree number: F02.830.131, F04.754.137.301, F04.754.308.500, L01.143.283.425.624.500Synonyms: Biofeedbacks, Psychology; Psychology Biofeedback;Psychology Biofeedbacks; Psychophysiologic Feedback; Feedback,Psychophysiologic; Feedback, Psychophysiological; Biofeedback;Biofeedbacks; Biofeedback (Psychology); Biofeedbacks (Psychol-ogy); Myofeedback; Myofeedbacks; False Physiological Feed-back; False Physiological Feedbacks; Feedback, False Physiologi-cal; Feedbacks, False Physiological; Physiological Feedback, False;Physiological Feedbacks, False; Bogus Physiological Feedback;Bogus Physiological Feedbacks; Feedback, Bogus Physiological;Feedbacks, Bogus Physiological; Physiological Feedback, Bogus;Physiological Feedbacks, Bogus

Breathing exercises (E02.190.525.186) Therapeutic exercises aimed to deepen inspiration or expirationor even to alter the rate and rhythm of respirationAdditional tree number: E02.779.474.124Synonyms: Exercise, Breathing; Respiratory Muscle Training;Muscle Training, Respiratory; Training, Respiratory Muscle;Qigong; Qi Gong; Gong, Qi; Ch’i Kung; Kung, Ch’i

Color therapy (E02.190.888.249) A form of phototherapy using color to influence health and totreat various physical or mental disorders. The color rays may be inthe visible or invisible spectrum and can be administered throughcolored lights or applied mentally through suggestionAdditional tree number: E02.774.215, F04.754.215Synonyms: Therapy, Color; Chromatotherapy; Chromotherapy

Dance therapy (E02.190.888.374) The use of dancing for therapeutic purposesAdditional tree number: E02.779.474.186, E02.831.230, F04.754.278Synonyms: Therapy, Dance; Dance Therapies; Therapies, Dance

Diffuse noxious inhibitory Control (E02.190.262) A physiological process by which the perception of pain at a localarea of the body is inhibited by a second painful stimulus admin-istered at a distal body siteAdditional tree number: E03.091.322Synonyms: none

Eclecticism, historical (E02.190.755.624) A system of medicine, most popular in the 19th century, thatadvocates the use of indigenous plants in the treatment of specificsigns and symptomsAdditional tree number: E03.091.322





Synonyms: Historical Eclecticism

Electroacupuncture (E02.190.044.244) A form of acupuncture with electrical impulses passing throughthe needles to stimulate NERVE TISSUE. It can be used forANALGESIA; ANESTHESIA; REHABILITATION; and treat-ment for diseasesAdditional tree number: E02.186.250, E02.342.543, E02.779.468.399, E03.091.823.500, E03.155.519Synonyms: none

Faith healing (E02.190.901.155) The use of faith and spirit to cure diseaseAdditional tree number: noneSynonyms: Healing, Faith; Prayer Healing; Healing, Prayer

Holistic health (E02.190.321) Health as viewed from the perspective that humans and otherorganisms function as complete, integrated units rather than asaggregates of separate partsAdditional tree number: K01.752.667.710, N01.400.350Synonyms: Health, Holistic; Wholistic Health; Health, Wholis-tic; Medicine, Holistic; Medicine, Wholistic; Wholistic Medicine;Holistic Medicine; Holistic Therapies; Wholistic Therapies

Homeopathy (E02.190.388, E02.190.901.249) A system of therapeutics founded by Samuel Hahnemann (1755-1843), based on the Law of Similars where “like cures like”. Dis-eases are treated by highly diluted substances that cause, in healthypersons, symptoms like those of the disease to be treatedAdditional tree number: noneSynonyms: Homoeopathy

Horticultural therapy (E02.190.438) A therapeutic approach in which horticultural artefacts are uti-lized in improving an individual’s social, emotional, educational,psychological, and physical well-beingAdditional tree number: F04.754.392Synonyms: Horticultural Therapies; Therapies, Horticultural;Therapy, Horticultural

Hypnosis (E02.190.525.217) A state of increased receptivity to suggestion and direction, initiallyinduced by the influence of another personAdditional tree number: F04.754.424Synonyms: Hypnoses; Mesmerism

Imagery (psychotherapy) (E02.190.525.249) The use of mental images produced by the imagination as a formof psychotherapy. It can be classified by the modality of its con-tent: visual, verbal, auditory, olfactory, tactile, gustatory, or kines-thetic. Common themes derive from nature imagery (e.g., forestsand mountains), water imagery (e.g., brooks and oceans), travelimagery, etc. Imagery is used in the treatment of mental disordersand in helping patients cope with other diseases. Imagery often





forms a part of HYPNOSIS, of AUTOGENIC TRAINING, ofRELAXATION TECHNIQUES, and of BEHAVIOR THER-APYAdditional tree number: F04.754.462Synonyms: Imageries (Psychotherapy); Imagery; Guided Im-agery; Imagery, Guided; Directed Reverie Therapy; DirectedReverie Therapies; Reverie Therapies, Directed; Reverie Therapy,Directed; Therapies, Directed Reverie; Therapy, Directed Reverie

Kinesiology, applied (E02.190.599.186) The study of muscles and the movement of the human body. Inholistic medicine it is the balance of movement and the interac-tion of a person’s energy systems. Applied kinesiology is the namegiven by its inventor, Dr. George Goodheart, to the system of ap-plying muscle testing diagnostically and therapeutically to differ-ent aspects of health careAdditional tree number: E02.779.867.344Synonyms: Applied Kinesiology

Laughter therapy (E02.190.525.311) Therapeutic use of humor and laughter to improve emotional wellbeing in order to facilitate improvement in healthAdditional tree number: noneSynonyms: Therapy, Laughter

Magic (E02.190.901.411) Beliefs and practices concerned with producing desired resultsthrough supernatural forces or agents as with the manipulation offetishes or ritualsAdditional tree number: I01.076.201.450.897.439Synonyms: Magics

Manipulation, chiropractic (E02.190.599.233) Procedures used by chiropractors to treat neuromusculoskeletalcomplaintsAdditional tree number: noneSynonyms: Chiropractic Manipulation; Spinal Adjustment, Chi-ropractic; Adjustment, Chiropractic Spinal; Adjustments, Chi-ropractic Spinal; Chiropractic Spinal Adjustment; ChiropracticSpinal Adjustments; Spinal Adjustments, Chiropractic; Chiro-practic Adjustment; Adjustment, Chiropractic

Manipulation, osteopathic (E02.190.599.280) Musculoskeletal manipulation based on the principles of OSTEO-PATHIC MEDICINE developed in 1874 by Dr Andrew TaylorStillAdditional tree number: E02.779.867.444Synonyms: Osteopathic Manipulative Treatment; OsteopathicManipulative Treatments; Treatment, Osteopathic Manipulative;Treatments, Osteopathic Manipulative; Osteopathic Manipula-tion





Massage (E02.190.599.500) Group of systematic and scientific manipulations of body tissuesbest performed with the hands for the purpose of affecting thenervous and muscular systems and the general circulationAdditional tree number: E02.779.867.522Synonyms: Zone Therapy; Therapies, Zone; Zone Therapies;Therapy, Zone; Reflexology; Rolfing; Bodywork; Bodyworks;Craniosacral Massage; Massage, Craniosacral

Medicine, African traditional (E02.190.488.505, E02.190.

901.433)

A system of traditional medicine which is based on the beliefs andpractices of the African peoples. It includes treatment by medicinalplants and other materia medica as well as by the ministrations ofdiviners, medicine men, witch doctors, and sorcerersAdditional tree number: I01.076.201.450.654.505Synonyms: Traditional Medicine, African; Medicine, TraditionalAfrican; Traditional African Medicine; African Medicine, Tradi-tional; African Traditional Medicine; Medicine, African; AfricanMedicine; African Witch Doctor; African Witch Doctors; Doctor,African Witch; Doctors, African Witch; Witch Doctors, African;Witch Doctor, African

Medicine, Arabic (E02.190.488.510) Traditional Arabic and Islamic Medicine (TAIM) is one of com-plete systems of herbalist medicine of ancient world, and usesplant species from Mediterranean region. The remedies are ad-ministered in forms of standard decoction prepared by boilingplant parts in hot water, infusion in water or oil or inhalation ofessential oils. It is also taken as juice, syrup, roasted material, freshsalad or fruit, macerated plant parts, oil, milky sap, poultice andpasteAdditional tree number: I01.076.201.450.654.510, K01.400.552.643Synonyms: Arabic Medicine

Medicine, Ayurvedic (E02.190.488.515) The traditional Hindu system of medicine which is based on cus-toms, beliefs, and practices of the Hindu culture. Ayurveda means“the science of Life”: veda - science, ayur - lifeAdditional tree number: I01.076.201.450.654.515Synonyms: Ayurvedic Medicine; Siddha Medicine; Medicine,Siddha; Hindu Medicine; Medicine, Hindu

Medicine, Chinese traditional (E02.190.488.585.520) A system of traditional medicine which is based on the beliefs andpractices of the Chinese cultureAdditional tree number: I01.076.201.450.654.558.520Synonyms: Traditional Chinese Medicine; Chinese Medicine,Traditional; Chung I Hsueh; Hsueh, Chung I; Zhong Yi Xue;Chinese Traditional Medicine; Traditional Medicine, Chinese

Medicine, East Asian traditional (E02.190.488.585) Medical practice or discipline that is based on the knowledge,cultures, and beliefs of the people in EAST ASIA





Additional tree number: I01.076.201.450.654.558Synonyms: Medicine, Oriental Traditional; Oriental TraditionalMedicine; Medicine, Traditional, East Asia; Traditional Medicine,Oriental; Traditional East Asian Medicine; Traditional Far East-ern Medicine; Traditional Medicine, East Asia; East Asian Tradi-tional Medicine; Oriental Medicine, Traditional; Medicine, Tra-ditional Oriental; Traditional Oriental Medicine; Traditional Ori-ental Medicines; East Asian Medicine; East Asian Medicines;Medicine, East Asian; Oriental Medicine; Medicine, Oriental;Medicine, East Asia; Asia Medicines, East; East Asia Medicine;East Asia Medicines; Medicines, East Asia; Medicine, Far East;East Medicine, Far; East Medicines, Far; Far East Medicine; FarEast Medicines; Medicines, Far East

Medicine, Kampo (E02.190.488.585.600) System of herbal medicine practiced in Japan by both herbal-ists and practitioners of modern medicine. Kampo originated inChina and is based on Chinese herbal medicine (MEDICINE,CHINESE TRADITIONAL)Additional tree number: I01.076.201.450.654.558.600Synonyms: Kanpo Medicine; Medicine, Kanpo; Kanpo; Kampo;Kampo Medicine

Medicine, Korean traditional (E02.190.488.585.700) Medical practice or discipline that is based on the knowledge,cultures, and beliefs of the people of KOREAAdditional tree number: I01.076.201.450.654.558.700Synonyms: Korean Traditional Medicine; Traditional Medicine,Korea

Medicine, Mongolian traditional (E02.190.488.585.850) Medical practice indigenous to the peoples of Mongolia, devel-oped over many years according to their culture, beliefs, and tra-ditionsAdditional tree number: I01.076.201.450.654.558.750Synonyms: Medicines, Mongolian Traditional; Mongolian Tra-ditional Medicine; Mongolian Traditional Medicines; TraditionalMedicine, Mongolian; Traditional Medicines, Mongolian; Mon-golian Medicine; Medicine, Mongolian; Medicines, Mongolian;Mongolian Medicines; Mongolian Folk Medicine; Folk Medicine,Mongolian; Folk Medicines, Mongolian; Medicine, MongolianFolk; Medicines, Mongolian Folk; Mongolian Folk Medicines

Medicine, traditional (E02.190.488) Systems of medicine based on cultural beliefs and practiceshanded down from generation to generation. The concept in-cludes mystical and magical rituals (SPIRITUAL THERAPIES); PHYTOTHERAPY; and other treatments which may not beexplained by modern medicineAdditional tree number: I01.076.201.450.654Synonyms: Traditional Medicine; Folk Remedies; Folk Remedy;Remedies, Folk; Remedy, Folk; Home Remedies; Home Remedy;Remedies, Home; Remedy, Home; Medicine, Primitive; Primitive





Medicine; Medicine, Folk; Folk Medicine; Medicine, Indigenous;Indigenous Medicine; Ethnomedicine

Medicine, Unani (E02.190.488.510.500) A modified Greco-Arabic medical system flourishing today asunani medicine. It was the product of Arab physicians and schol-ars captivated by Greek philosophy, science, and medicine. It ispracticed today in India and Pakistan, largely as a type of herbalmedicineAdditional tree number: I01.076.201.450.654.510.500, I01.076.201.450.654.745, K01.400.552.643.500Synonyms: Unani Medicine

Meditation (E02.190.525.374, E02.190.901.455) A state of consciousness in which the individual eliminates envi-ronmental stimuli from awareness so that the mind can focus on asingle thing, producing a state of relaxation and relief from stress.A wide variety of techniques are used to clear the mind of stressfuloutside interferences. It includes meditation therapyAdditional tree number: F04.754.137.750.500Synonyms: Transcendental Meditation; Meditation, Transcen-dental

Mental healing (E02.190.525.500, E02.190.901.500) The use of mind to cure disease, particularly physical illnessAdditional tree number: noneSynonyms: Healing, Mental

Meridians (E02.190.044.555) Classical loci in ACUPUNCTURE. They are main and collateralchannels, regarded as a network of passages, through which vitalenergy (Qi) circulates and along which acupoints (ACUPUNC-TURE POINTS) are distributed. The meridians are a series of14 lines upon which more than 400 acupoints are located on thebodyAdditional tree number: I01.076.201.450.654.558.520.300.500Synonyms: Ching Lo; Jing Luo; Luo, Jing; Jingluo

Mesotherapy (E02.190.506) The application of medicine, vitamins, extracts, or other bioactivesubstances for a localized effect via multiple subcutaneous injec-tions or perfusion of substances into the various layers of the skinbelow the EPIDERMISAdditional tree number: E02.218.660, E02.319.267.530.620.785Synonyms: none

Mind-body therapies (E02.190.525) Treatment methods or techniques which are based on the knowl-edge of mind and body interactions. These techniques can be usedto reduce the feeling of tension and effect of stress, and to enhancethe physiological and psychological well-being of an individualAdditional tree number: noneSynonyms: Mind Body Therapies; Mind-Body Therapy; Ther-





apies, Mind-Body; Therapy, Mind-Body; Mind-Body Medicine;Mind Body Medicine

Moxibustion (E02.190.044.588) The burning of a small, thimble sized, smoldering plug of driedleaves on the SKIN at an ACUPUNCTURE point. Usually theplugs contain leaves of MUGWORT or moxaAdditional tree number: noneSynonyms: Moxabustion

Musculoskeletal manipulations (E02.190.599) Various manipulations of body tissues, muscles and bones byhands or equipment to improve health and circulation, relieve fa-tigue, promote healingAdditional tree number: E02.779.867Synonyms: Manipulations, Musculoskeletal; Manual Therapies;Manual Therapy; Therapies, Manual; Therapy, Manual; Manip-ulation Therapy; Manipulation Therapies; Therapies, Manipula-tion; Manipulative Therapies; Manipulative Therapy; Therapies,Manipulative; Therapy, Manipulative; Therapy, Manipulation

Music therapy (E02.190.888.500) The use of music as an adjunctive therapy in the treatment ofneurological, mental, or behavioral disordersAdditional tree number: E02.831.440, F04.754.549Synonyms: Therapy, Music

Naturopathy (E02.190.655) A drugless system of therapy, making use of physical forces suchas air, light, water, heat, massage. Treatments are often diet- andnutrition-oriented with attention given to the patient’s personalhistory and lifestyleAdditional tree number: noneSynonyms: Medicine, Naturopathic; Naturopathic Medicine

Neurofeedback (E02.190.525.123.500) A technique to self-regulate brain activities provided as a feedbackin order to better control or enhance one’s own performance,control or function. This is done by trying to bring brain activitiesinto a range associated with a desired brain function or statusAdditional tree number: F02.830.131.500, F04.754.137.301.750, F04.754.308.500.750, L01.143.283.425.624.500.500Synonyms: Neurofeedbacks; Brainwave Biofeedback; Biofeed-back, Brainwave; Biofeedbacks, Brainwave; Brainwave Biofeed-backs; Alpha Feedback; Alpha Feedbacks; Feedback, Alpha;Feedbacks, Alpha; Electromyography Feedback; EEG Feedback;EEG Feedbacks; Feedback, EEG; Feedbacks, EEG; Electroen-cephalography Biofeedback; Biofeedback, Electroencephalogra-phy; Biofeedbacks, Electroencephalography; Electroencephalog-raphy Biofeedbacks; Alpha Biofeedback; Alpha Biofeedbacks;Biofeedback, Alpha; Biofeedbacks, Alpha; Brainwave Feedback;Brainwave Feedbacks; Feedback, Brainwave; Feedbacks, Brain-wave





Occultism (E02.190.901.650) From the Latin word occultus meaning “clandestine”, “hidden”,“secret”, “knowledge of the hidden”. In common English usage,occult refers to “knowledge of the paranormal”, as opposed to“knowledge of the measurable”, usually referred to as science. Oc-cultism is the study of occult practices, including (but not limitedto) magic, alchemy, extra-sensory perception, astrology, spiritual-ism, and divination and is conceived of as the study of the innernature of things. Interpretation of occultism and its concepts canbe found in the belief structures of religions such as Gnosticism,Hermeticism, Theosophy, Wicca, Thelema, Satanism, and neo-paganism (Mircea 1976)Additional tree number: K01.672Synonyms: Occultisms

Organotherapy (E02.190.701) Historically, the treatment of disease by the administration ofanimal organs or their extracts (after Brown-Sequard). At presentsynthetic preparations substitute for the extracts of a glandAdditional tree number: E02.095.682Synonyms: Organotherapies

Phytotherapy (E02.190.755) Use of plants or herbs to treat diseases or to alleviate painAdditional tree number: noneSynonyms: Herb Therapy; Herbal Therapy

Play therapy (E02.190.888.625) A treatment technique utilizing play as a medium for expressionand communication between patient and therapistAdditional tree number: F04.754.664Synonyms: Play Therapies; Therapies, Play; Therapy, Play; Sand-play Therapy; Sandplay Therapies; Therapies, Sandplay; Therapy,Sandplay; Sandplay; Sandplays

Psychodrama (E02.190.525.781) Primarily a technique of group psychotherapy which involves astructured, directed, and dramatized acting out of the patient’spersonal and emotional problemsAdditional tree number: F04.754.864.581.679Synonyms: Drama Therapy; Therapy, Drama; Dramatherapy

Psychophysiology (E02.190.525.812) The study of the physiological basis of human and animal behaviorAdditional tree number: F02.830, F04.096.795, H01.158.782.795Synonyms: Physiological Psychology; Psychology, Physiologi-cal; Physiologic Psychology; Physiologic Psychologies; Psycholo-gies, Physiologic; Psychology, Physiologic; Mind-Body Relations(Physiology); Mind Body Relations (Physiology); Mind-BodyRelation (Physiology); Relation, Mind-Body (Physiology); Rela-tions, Mind-Body (Physiology); Mind-Body Relationship (Phys-iology); Mind Body Relationship (Physiology); Mind-Body Re-lationships (Physiology); Relationship, Mind-Body (Physiology);





Relationships, Mind-Body (Physiology)

Radiesthesia (E02.190.901.740) Therapeutic cult concerned with intangible energies surroundingthe living body and based on the detection of these intrinsic ra-diations by dowsing, or divining, or the use of more elaborateinstruments (radionics)Additional tree number: noneSynonyms: none

Reflexotherapy (E02.190.799) Treatment of some morbid condition by producing a reflex action,as in the household treatment of nosebleed by a piece of ice appliedto the cervical spineAdditional tree number: noneSynonyms: Reflex Therapy; Therapy, Reflex

Rejuvenation (E02.190.822) The phenomenon of youthfulness, vitality, and freshness being re-stored. This can apply to appearance, TISSUES, organ functions,or other areasAdditional tree number: E02.849Synonyms: none

Relaxation therapy (E02.190.525.875) Treatment to improve one’s health condition by using techniquesthat can reduce PHYSIOLOGICAL STRESS; PSYCHOLOGI-CAL STRESS; or bothAdditional tree number: F04.754.137.750Synonyms: Therapy, Relaxation; Relaxation Techniques; Relax-ation Technics

Role playing (E02.190.525.781.653) The adopting or performing the role of another significant indi-vidual in order to gain insight into the behavior of that personAdditional tree number: F04.754.864.581.679.653Synonyms: Playing, Role; Playings, Role; Role Playings

Sensory art therapies (E02.190.888) Therapies using arts or directed at the sensesAdditional tree number: noneSynonyms: Art Therapies, Sensory; Therapies, Sensory Art

Shamanism (E02.190.488.830, E02.190.901.788) An intermediate stage between polytheism and monotheism,which assumes a “Great Spirit”, with lesser deities subordinated.With the beginnings of shamanism there was the advent of themedicine man or witch doctor, who assumed a supervisory relationto disease and its cure. Formally, shamanism is a religion of Ural-Altaic peoples of Northern Asia and Europe, characterized by thebelief that the unseen world of gods, demons, ancestral spirits is re-sponsive only to shamans. The Indians of North and South Amer-ica entertain religious practices similar to the Ural-Altaic shaman-ism. The word shaman comes from the Tungusic (Manchuria andSiberia) saman, meaning Buddhist monk. The shaman handlesdisease almost entirely by psychotherapeutic means; he frightens





away the demons of disease by assuming a terrifying mienAdditional tree number: I01.076.201.450.654.830Synonyms: none

Speleotherapy (E02.190.894) The use of CAVES, mines, or other subterranean environmentsin treatment of diseases. Speleotherapy is used in some Centraland Eastern European countries to treat CHRONIC OBSTRUC-TIVE AIRWAY DISEASEAdditional tree number: noneSynonyms: Speleotherapies

Spiritual therapies (E02.190.901) Mystical, religious, or spiritual practices performed for health ben-efitAdditional tree number: noneSynonyms: Therapies, Spiritual; Spiritual Healing

Suggestion (E02.190.525.217.771) The uncritical acceptance of an idea or plan of actionAdditional tree number: F04.754.424.771Synonyms: Suggestions

Tai Ji (E02.190.525.890) One of the MARTIAL ARTS and also a form of meditative ex-ercise using methodically slow circular stretching movements andpositions of body balanceAdditional tree number: E02.779.474.913, I03.450.642.845.560.500Synonyms: Tai-ji; Tai Chi; Chi, Tai; Tai Ji Quan; Ji Quan, Tai;Quan, Tai Ji; Taiji; Taijiquan; T’ai Chi; Tai Chi Chuan

Therapeutic touch (E02.190.525.906, E02.190.901.830) Placing of the hands of the healer upon the person to be curedwith the intent of spiritual energetic healingAdditional tree number: noneSynonyms: Touch, Therapeutic; Reiki; Laying-on-of-Hands

Tissue therapy (E02.190.701.884) Historically, tissue transplantation, especially of refrigerated tis-sue (after Filatov). It was theorized that nonspecific substances,capable of initiating restorative processes, formed in tissues whenrefrigerated. Cell therapy (after Niehans) refers to implantationof tissue by injection. Originally this involved fresh cells but laterfrozen or lyophilized cellsAdditional tree number: E02.095.682.884Synonyms: Therapy, Tissue; Biogenic Stimulators; BiogenicStimulator; Stimulator, Biogenic; Stimulators, Biogenic; CellTherapy; Therapy, Cell

Witchcraft (E02.190.901.968) An act of employing sorcery (the use of power gained from theassistance or control of spirits), especially with malevolent intent,and the exercise of supernatural powers and alleged intercoursewith the devil or a familiarAdditional tree number: I01.076.201.450.897.439.925





Synonyms: Sorcery; Sorceries

Yoga (E02.190.525.937, E02.190.901.984) A major orthodox system of Hindu philosophy based on Sankhya(metaphysical dualism) but differing from it in being theistic andcharacterized by the teaching of raja-yoga as a practical methodof liberating the self. It includes a system of exercises for attainingbodily or mental control and well-being with liberation of the selfand union with the universal spiritAdditional tree number: E02.779.474.937, K01.844.799.867Synonyms: none

A P P E N D I C E S

Appendix 1. PubMed (draft) search strategy

#7 Search #6 Limits: Complementary Medicine

#6 Search #1 and #5

#5 Search #2 or #3 or #4

#4 Search “palmoplantar* pustulosis”

#3 Search “pustulosis palmaris et plantaris”

#2 Search (“Arthritis, Psoriatic”[Mesh]) OR “Psoriasis”[Mesh] or psoria*

#1 Search ((randomized controlled trial[Publication Type] OR controlled clinical trial[Publication Type]) OR randomized[Title/Abstract]) OR placebo[Title/Abstract] OR “clinical trials as topic”[MeSH Terms:noexp] OR randomly[Title/Abstract] ORtrial[Title] NOT (animals[MeSH Terms] NOT (humans[MeSH Terms]) AND animals[MeSH Terms])



C O N T R I B U T I O N S O F A U T H O R S

CM was the contact person with the editorial base.

CM co-ordinated the contributions from the co-authors and wrote the final draft of the protocol.

CM, VS, and RA worked on the methods sections.

CM, EK, CS, VT, and VS drafted the clinical sections of the background and responded to the clinical comments of the referees.

VS and RA responded to the methodological and statistical comments of the referees.

JT contributed to writing the protocol.

CP was the consumer co-author and checked the protocol for readability and clarity. He also ensured that the outcomes are relevant toconsumers.

CM is the guarantor of the final review.

Disclaimer

The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the NIHR, NHS, or theDepartment of Health, UK.

D E C L A R A T I O N S O F I N T E R E S T

Carlos Alberto Monson: Nothing to declare.

Valter Silva: Nothing to declare.

Régis B Andriolo: Nothing to declare.

Elisa Harumi Kozasa: Nothing to declare.

Cid Yazigi Sabbag: Nothing to declare.

Carlos Alberto de Paula: Nothing to declare.

John A Tweed: Nothing to declare.

Virginia Fernandes Moça Trevisani: Nothing to declare.

S O U R C E S O F S U P P O R T

Internal sources

• No sources of support supplied



External sources

• The National Institute for Health Research (NIHR), UK.The NIHR, UK, is the largest single funder of the Cochrane Skin Group.



Complementary therapies for chronic plaque psoriasis

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