Therapeutic touch for healing acute wounds

  • Review
  • Intervention

Authors


Abstract

Background

Therapeutic Touch (TT) is an alternative therapy that has gained popularity over the past two decades for helping wounds to heal. Practitioners enter a meditative state and pass their hands above the patient's body to find and correct any imbalances in the patient's 'life energy' or chi. Scientific instruments have been unable to detect this energy. The effect of TT on wound healing has been expounded in anecdotal publications.

Objectives

To identify and review all relevant data to determine the effects of TT on healing acute wounds.

Search methods

In January 2014, for this fifth update, we searched The Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE; and EBSCO CINAHL.

Selection criteria

All randomised or quasi-randomised controlled trials, which compared the effect of TT with a placebo, another treatment, or no treatment control were considered. Studies which used TT as a stand-alone treatment, or as an adjunct to other therapies, were eligible.

Data collection and analysis

One author (DO'M) determined the eligibility for inclusion of all trials in the review. Both authors conducted data extraction and evaluation of trial validity independently. Each trial was assessed using predetermined criteria.

Main results

No new trials were identified for this update. Four trials in people with experimental wounds were included. The effect of TT on wound healing in these studies was variable. Two trials (n = 44 & 24) demonstrated a significant increase in healing associated with TT, while one trial found significantly worse healing after TT and the other found no significant difference. All trials are at high risk of bias.

Authors' conclusions

There is no robust evidence that TT promotes healing of acute wounds.

Résumé scientifique

Le toucher thérapeutique pour guérir les plaies aiguës

Contexte

Le toucher thérapeutique (TT) est une thérapie alternative qui a gagné en popularité au cours des deux dernières décennies pour aider à guérir les plaies. Les praticiens entrent dans un état de méditation et passent leurs mains au-dessus du corps du patient pour trouver et corriger les déséquilibres dans « l'énergie vitale » ou le « chi » du patient. Les instruments scientifiques ont été incapables de détecter cette énergie. L'effet du TT sur la cicatrisation des plaies a été exposé dans des publications anecdotiques.

Objectifs

Identifier et examiner toutes les données pertinentes afin de déterminer les effets du TT sur la guérison des plaies aiguës.

Stratégie de recherche documentaire

En janvier 2014, pour cette cinquième mise à jour, nous avons effectué des recherches dans le registre spécialisé du groupe Cochrane sur les plaies et contusions ; le registre Cochrane des essais contrôlés (CENTRAL) (Bibliothèque Cochrane) ; Ovid MEDLINE ; Ovid MEDLINE In-Process & Other Non-Indexed Citations ; Ovid EMBASE et EBSCO CINAHL.

Critères de sélection

Tous les essais contrôlés randomisés ou quasi randomisés ayant comparé l'effet du TT à un placebo, à un autre traitement ou à un témoin sans traitement ont été pris en compte. Les études qui ont utilisé le TT comme traitement unique, ou comme complément à d'autres thérapies, étaient éligibles.

Recueil et analyse des données

Un auteur (DO'M) a déterminé l'éligibilité pour l'inclusion de tous les essais dans la revue. Deux auteurs ont extrait des données et évalué la validité des essais de façon indépendante. Chaque essai a été évalué en utilisant des critères prédéterminés.

Résultats principaux

Aucun nouvel essai n'a été identifié pour cette mise à jour. Quatre essais chez des personnes présentant des plaies expérimentales ont été inclus. L'effet du TT sur la cicatrisation des plaies, dans ces études, était variable. Deux essais (n = 44 et 24) ont démontré une augmentation significative de la guérison associée au TT, tandis qu'un essai a conclu à une aggravation significative de la cicatrisation après le TT et le dernier n'a constaté aucune différence significative. Tous les essais présentaient un risque de biais élevé.

Conclusions des auteurs

Il n'existe aucune preuve solide que le TT favorise la cicatrisation des plaies aiguës.

Notes de traduction

Traduction réalisée par le Centre Cochrane Français

アブストラクト

急性創傷治癒に対するセラピューティックタッチ

背景

セラピューティックタッチ(TT)は、この20年の間に広まった代替療法で、創傷治癒の促進に用いられている。実践者は瞑想状態に入り、患者の体に手をかざして患者の「生命のエネルギー」、つまり気の不均衡を発見し修正する。科学機器では、このエネルギーを検出できていない。TTの創傷治癒に対する有効性は、事例報告で詳細に説明されている。

目的

急性創傷の治癒におけるTTの有効性を明らかにするために、関連性のあるすべてのデータを特定し評価すること。

検索戦略

この5回目の更新では、2014年1月にCochrane Wounds Group Specialised Register、Cochrane Central Register of Controlled Trials(CENTRAL)(コクラン・ライブラリ)、Ovid MEDLINE、Ovid MEDLINE(In-Process & Other Non-Indexed Citations)、Ovid EMBASEおよびEBSCO CINAHLを検索した。

選択基準

TTの効果と、対照群のプラセボ、他の療法または無治療とを比較したランダム化比較試験、準ランダム化比較試験をすべて対象とした。TTを単独で実施した試験、他の療法の補助療法として用いた試験をともに適格とした。

データ収集と分析

1人の著者(DO’M)がレビューの全試験の適格性を決定した。2人の著者が独立してデータを抽出し、試験の妥当性を評価した。各試験は、あらかじめ定めた判断基準を用いて評価した。

主な結果

今回の更新では新たな試験は見つからなかった。実験的創傷を有する患者を登録した試験4件を採用した。これらの試験で示されたTTの有効性には、ばらつきが認められた。2件の試験(n=44および24)が、TTに関連して治癒が有意に促進したことを示した一方、別の1件ではTT実施後に治癒が有意に遅れ、残る1件は有意差が示されなかった。いずれの試験もバイアスのリスクは高いと判定した。

著者の結論

TTが急性創傷治癒を促進することを裏づける確固たるエビデンスはない。

訳注

《実施組織》厚生労働省「「統合医療」に係る情報発信等推進事業」(eJIM:http://www.ejim.ncgg.go.jp/)[2015.12.27]《注意》この日本語訳は、臨床医、疫学研究者などによる翻訳のチェックを受けて公開していますが、訳語の間違いなどお気づきの点がございましたら、eJIM事務局までご連絡ください。なお、2013年6月からコクラン・ライブラリーのNew review, Updated reviewとも日単位で更新されています。eJIMでは最新版の日本語訳を掲載するよう努めておりますが、タイム・ラグが生じている場合もあります。ご利用に際しては、最新版(英語版)の内容をご確認ください。

Plain language summary

Therapeutic touch therapy for healing acute wounds.

Therapeutic touch is an alternative therapy that is gaining popularity as a wound treatment. Practitioners enter a meditative state and pass their hands above the patient's body to find and correct any imbalances in the patient's 'life energy' or chi. Scientific instruments have been unable to detect this energy. The review found contradictory evidence about the effects of therapeutic touch. Some trials showed a benefit while others suggested that the process slowed the rate of healing. The review concluded that trials do not show therapeutic touch to be beneficial in healing wounds from minor surgery and that the trials are at high risk of bias.

Résumé simplifié

Thérapie par le toucher thérapeutique pour guérir les plaies aiguës.

Le toucher thérapeutique est une thérapie alternative qui gagne en popularité en tant que traitement des plaies. Les praticiens entrent dans un état de méditation et passent leurs mains au-dessus du corps du patient pour trouver et corriger les déséquilibres dans « l'énergie vitale » ou le « chi » du patient. Les instruments scientifiques ont été incapables de détecter cette énergie. La revue a mis en évidence des preuves contradictoires sur les effets du toucher thérapeutique. Certains essais ont montré un bénéfice tandis que d'autres ont suggéré que le processus ralentissait la vitesse de la guérison. La revue a conclu que les essais ne montrent pas de bénéfice du toucher thérapeutique dans la cicatrisation des plaies issues d'une chirurgie mineure et que les essais présentent un risque élevé de biais.

Notes de traduction

Traduction réalisée par le Centre Cochrane Français

Laički sažetak

Pomaže li bioenergija u liječenju akutnih rana?

Liječenje bioenergijom je sve popularniji tretman alternativne medicine. Bioenergičar pri izvođenju tog tretmana ulazi u meditativno stanje i polaže ruke poviše bolesnikova tijela kako bi pronašao i popravio neravnotežu „životne energije“ ili chi-ja pacijenta. Tu energiju nije moguće izmjeriti znanstvenim instrumentima. U ovom Cochrane sustavnom pregledu, istražena je učinkovitost terapije bioenergijom kod liječenja akutnih rana. Uspoređena su istraživanja koja su promatrala efekt bioenergije i bioenergijske terapije s placebom ili nekom drugim terapijom. Neka od uključenih istraživanja pokazala su korist bioenergije u liječenju, dok su druga ukazala na usporenje ozdravljenja pri njenom korištenju. S obzirom na kontradiktorne dokaze o učincima te terapije i visokom riziku od pristranosti kod istraživanja koja su potvrdila pozitivni učinak bioenergije, zaključeno je da terapija bioenergijom ne pomaže u liječenju akutnih rana.

Bilješke prijevoda

Hrvatski Cochrane ogranak.
Prevela: Ana-Marija Rožić

平易な要約

急性創傷治癒に対するセラピューティックタッチ療法

セラピューティックタッチは創傷の治療法として人気が高まっている代替療法である。実践者は瞑想状態に入り、患者の体に手をかざして患者の「生命のエネルギー」、つまり気の不均衡を発見し修正する。科学機器では、このエネルギーを検出できていない。レビューからは、セラピューティックタッチの効果について相反するエビデンスが認められた。有益性を示す試験がある一方、この処置によって治癒が遅れる可能性を示唆する試験も認められた。このレビューでは、小手術による創傷の治癒に対して、セラピューティックタッチの有益性は示されていないと結論づけられた。さらに、試験のバイアスのリスクは高いと判定した。

訳注

《実施組織》厚生労働省「「統合医療」に係る情報発信等推進事業」(eJIM:http://www.ejim.ncgg.go.jp/)[2015.12.27]《注意》この日本語訳は、臨床医、疫学研究者などによる翻訳のチェックを受けて公開していますが、訳語の間違いなどお気づきの点がございましたら、eJIM事務局までご連絡ください。なお、2013年6月からコクラン・ライブラリーのNew review, Updated reviewとも日単位で更新されています。eJIMでは最新版の日本語訳を掲載するよう努めておりますが、タイム・ラグが生じている場合もあります。ご利用に際しては、最新版(英語版)の内容をご確認ください。

Laienverständliche Zusammenfassung

Therapeutische Berührung zur Heilung akuter Wunden

Die therapeutische Berührung (Therapeutic Touch, TT) ist eine Behandlungsweise aus der Alternativmedizin, die zunehmend auch zur Wundbehandlung eingesetzt wird. Die behandelnden Therapeuten versetzen sich ein einen meditativen Zustand und bewegen ihre Hände über dem Körper des Patienten, um Blockaden im Fluss der Lebensenergie bzw. des Chi des Patienten aufzuspüren und zu harmonisieren. Mit wissenschaftlichen Geräten war diese Energie nicht feststellbar. Der Review ergab widersprüchliche Ergebnisse hinsichtlich der Wirkung der therapeutischen Berührung. Einige Studien verzeichneten einen positiven Nutzen, während andere Anlass zu der Vermutung gaben, diese Therapie verzögere den Heilungsprozess. Der Review kam zu dem Schluss, dass eine verbesserte Wundheilung nach kleinen chirurgischen Eingriffen durch therapeutische Berührung in den Studien nicht nachgewiesen werden konnte, und dass die Studien einem hohen Bias-Risiko unterlagen.

Anmerkungen zur Übersetzung

B. Bayerlein, freigegeben durch Cochrane Schweiz.

Background

Therapeutic Touch (TT) is an alternative nursing intervention first developed in the 1970s by Dora Kunz, a lay healer, and Dolores Krieger, RN, PhD, then a nursing professor at New York University (Krieger 1997). Faster wound healing continues to be frequently cited as an effect of TT (Burr 2005; Engebretson 2007; Herdtner 2000; Smith 2003; Umbreit 2000), even when concerns are acknowledged about the validity of some studies (Leskowitz 2007). Interest in alternative methods of wound care is growing, but requires more well-designed research and systematic review to ensure only effective and safe therapies are promoted (Leach 2004; Papantonio 1998).

TT is a method of detecting and balancing nonphysical 'life energy', also called prana or chi. A balanced flow of life energy between the environment and the body is assumed to underlie good health (Krieger 1997). Imbalances and blockages in the energy field lead to illness and ill-health. Life energy has not been detected with scientific instruments. Practitioners state they sense the energy field after entering a meditative state called 'being centered.' One study found that TT practitioners could not reliably detect human energy fields with statistical reliability (Rosa 1998). This study has been replicated (Long 1999). The negative studies have been denounced by TT practitioners as flawed and biased (Blank 1998; Carpenter 1998; Collins 1998; Freinkel 1998; Howell 1998; Ireland 1998; Jarski 1998; Lee 1998; Manos 1998; Palmer 1998; Schmidt 1998; Streltzer 1998).

When receiving TT, patients are encouraged to relax while sitting or lying, and remain clothed. When 'centered', practitioners pass their hands 2 to 4 inches above the patient's body. For this reason, TT is also called Non-Contact Therapeutic Touch (NCTT). Physical contact is not necessary with TT, although it is sometimes incorporated into the practice. Practitioners assess the patient's energy field, looking for imbalances. Congested areas of the energy field are removed by 'unruffling', in which practitioners move their hands gently down the length of the patient's body. The treatment phase follows where practitioners consciously facilitate the direction of life energy from the universal energy field to the patient. When the field is balanced, or after approximately 10-20 minutes, the therapy is usually concluded (Krieger 1997).

TT has gained widespread support within nursing, especially in the US. It is one of a number of 'energy healing' therapies being provided in hospitals and other healthcare settings (DiNucci 2005). In North America, TT is reported to be taught at 75 schools and universities and practiced at 95 health care facilities (Krieger 1997). Training is available from practitioners, and through the Nurse Healers-Professional Associates, Inc. The American Nurses Association, American Holistic Nurses Association, and the National League for Nursing promote TT to various extents through accredited workshops and publications. In the United Kingdom, TT is gaining popularity through the work of the Didsbury Trust (Sayre-Adams 1995). Courses in TT are taught in over 70 countries. Professional standards or certification programs are not available for TT (Meehan 1998).

The North American Nursing Diagnosis Association has accepted 'energy field disturbance' as a nursing diagnosis, for which TT is the only treatment recommended (Carpenito 1995). Anecdotal reports claim that TT is effective for a wide variety of conditions (DiNucci 2005). A number of researchers have received US federal grants to study the effectiveness of TT in particular settings, such as with burn patients (Turner 1998). Its clinical efficacy is said to be supported by controlled trials in four main areas. These are the reduction of situationally induced anxiety (assumed to occur via a relaxation response), relief of pain, hastening of wound healing, and boosting of the immune system (Engebretson 2007; Krieger 1997).

TT's growing popularity is at least due in part to claims made regarding its efficacy. Krieger states that over 20 years of clinical research supports the claims made concerning TT (Krieger 1993). Others claim that TT 'is among the most well-researched of the alternative touch healing techniques' (Thorpe 1994). In contrast, two narrative reviews of the research found little evidence to support these claims (Claman 1994; Clark 1984). Two meta-analyses of TT research for any indication found much variability and methodological problems in the studies, though an overall effect was calculated (Peters 1999; Winstead-Fry 1999).

Krieger states that TT is most effective in reducing anxiety, relieving pain, and promoting healing. Most research has been conducted on the first two effects using a variety of conditions and measuring numerous outcomes. This particular review will focus on TT's effect on acute wound healing. This will include recent surgical interventions as opposed to trauma wounds which have failed to heal and become chronic wounds. The studies already identified in this area are similar, quantitative, and may be amenable to meta-analysis. A number of narrative reviews of this research have been published, but no systematic review or meta-analysis (Daley 1997; Finch 1997; Kenosian 1995; Rosenbaum 2012; Wirth 1995; Wirth 1996b).

Objectives

To identify and review RCT and quasi RCT evidence on the effects of Therapeutic Touch on acute wound healing.

Methods

Criteria for considering studies for this review

Types of studies

All randomised or quasi-randomised controlled trials comparing Therapeutic Touch (TT) with sham TT, another treatment, or a no treatment control. Studies which used TT as a stand-alone treatment, or as an adjunct to other therapies, were eligible:

  • TT compared with sham TT

  • TT compared with other treatment

  • TT compared with no treatment

  • TT plus wound care interventions compared with wound care interventions alone.

Quasi-randomised trials (for example using alternate allocation to groups) were subjected to sub-group analysis.

Types of participants

Any person with acute wounds after trauma, surgery, or who have a wound which has been experimentally induced. The latter are usually induced using biopsy instruments to give uniform wounds.

Types of interventions

All interventions in which Non-Contact Therapeutic Touch was administered were considered. Trials evaluating all forms of touch therapy that do not involve direct skin to skin contact were included.

Types of outcome measures

Any quantifiable means of measuring wound healing rates or degrees of healing, such as the changes in area, volume, depth or circumference of the wound, or time to heal.

Search methods for identification of studies

The search methods used in the previous update of this review can be found in Appendix 1.

In January 2014, for this fifth update, we searched the following electronic databases:

  • The Cochrane Wounds Group Specialised Register (searched 28 January 2014);

  • The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 12);

  • Ovid MEDLINE (1946 to January Week 3 2014);

  • Ovid MEDLINE (In-Process & Other Non-Indexed Citations, January 23, 2014);

  • Ovid EMBASE (1974 to 2014 January 24);

  • EBSCO CINAHL (1982 to January 24, 2014).

The following search strategy was used in the Cochrane Central Register of Controlled Trials (CENTRAL):
#1 MeSH descriptor Acute Disease explode all trees
#2 MeSH descriptor Wounds and Injuries explode all trees
#3 (#1 AND #2)
#4 MeSH descriptor Surgical Wound Infection explode all trees
#5 MeSH descriptor Surgical Wound Dehiscence explode all trees
#6 MeSH descriptor Wounds, Penetrating explode all trees
#7 MeSH descriptor Lacerations explode all trees
#8 MeSH descriptor Burns explode all trees
#9 MeSH descriptor Skin Transplantation explode all trees #10 MeSH descriptor Fractures, Open explode all trees
#11 ((traumatic NEXT wound*) or (acute NEXT wound*)):ti,ab,kw
#12 ((surgical NEXT wound*) or (incised NEXT wound*)):ti,ab,kw
#13 acute NEXT ulcer*:ti,ab,kw
#14 (burn or burns or burned or scald*):ti,ab,kw
#15 ((thermal or blast or crush or avulsion) NEXT injur*):ti,ab,kw
#16 (laceration* or gunshot or (gun NEXT shot) or stab or stabbing or stabbed):ti,ab,kw
#17 ((donor NEXT site*) or (skin NEXT graft*)):ti,ab,kw
#18 experimental NEXT wound*:ti,ab,kw
#19 ((mechanical NEXT trauma) or polytrauma):ti,ab,kw #20 ((open NEXT fracture*) or (compound NEXT fracture*)):ti,ab,kw
#21 (#3 OR #4 OR #5 OR #6 OR #7 OR #8 OR #9 OR #10 OR #11 OR #12 OR #13 OR #14 OR #15 OR #16 OR #17 OR #18 OR #19 OR #20)
#22 MeSH descriptor Therapeutic Touch explode all trees
#23 MeSH descriptor Relaxation Techniques explode all trees
#24 non-contact NEAR/5 therap*:ti,ab,kw
#25 non-contact NEAR/5 heal*:ti,ab,kw
#26 therapeutic NEXT touch*:ti,ab,kw
#27 (#22 OR #23 OR #24 OR #25 OR #26)
#28 (#21 AND #27)

The search strategies for Ovid MEDLINE, Ovid EMBASE and EBSCO CINAHL can be found in Appendix 2, Appendix 3 and Appendix 4 respectively. The Ovid MEDLINE search was combined with the Cochrane Highly Sensitive Search Strategy for identifying randomised trials in MEDLINE: sensitivity- and precision-maximizing version (2008 revision); Ovid format (Lefebvre 2011). The EMBASE and CINAHL searches were combined with the trial filters developed by the Scottish Intercollegiate Guidelines Network (SIGN 2011). There were no restrictions on the basis of language.

Data collection and analysis

Selection of studies

Titles and abstracts of reports identified in the review were assessed by one author (DO'M). Their relevance and design were assessed according to the selection criteria. Complete copies of those articles and studies which appeared to satisfy these criteria were obtained.

Full papers were checked to identify those eligible for inclusion, and these were checked independently by a second author (RA). A data extraction sheet was used to extract and summarize the details of the studies. If data were missing from any reports, attempts were made to contact the authors to obtain the missing information. Data from studies that were published in duplicate were included only once.

Data extraction and management

Data extraction was undertaken independently by both authors and then compared. Disagreements were resolved by discussion. An editor of the Cochrane Wounds Group was available to act as arbitrator in the event agreement could not be reached but this was not necessary. When necessary information was missing, authors were contacted.

Each study was originally appraised according to a standard checklist developed from the Cochrane Handbook to assess study validity. Data were collected on:

  • inclusion and exclusion criteria

  • baseline comparability of treatment groups for important variables

  • adequacy of experimental intervention, by comparison with usual practice procedures

  • adequacy of control treatment, by comparison with the duration and frequency of the experimental intervention

  • allocation concealment

  • randomisation method

  • blinding of recipients of therapy

  • blinding of outcome assessors of therapy

  • extent of loss to follow-up, and reasons for this

  • documentation of co-interventions.

Further patient data extracted and presented in an evidence table included:

  • details on the type of wound

  • age and gender of patients

  • reason for and number of withdrawals and drop-outs

  • year of the study

  • country of the study

  • manner of recruitment

  • adverse effects.

Treatment data extracted included:

  • precise type of treatment used

  • training and experience of the practitioners

  • duration of treatment

  • frequency of treatments

  • total number of treatments

  • method of assessment of healing.

Assessment of risk of bias in included studies

For the previous update of this review, one review author assessed each included study using the Cochrane Collaboration tool for assessing risk of bias (Higgins 2011). This tool addresses six specific domains, namely sequence generation, allocation concealment, blinding, incomplete outcome data, selective outcome reporting and other issues (e.g. baseline comparability; fraud).

Blinding and completeness of outcome data will be assessed for each outcome separately. We completed a risk of bias table for each eligible study. We presented the assessment of risk of bias using a 'risk of bias summary figure', which presents all of the judgments in a cross-tabulation of study by entry. This display of internal validity indicates the weight the reader may give the results of each study.

Results

Description of studies

We have undertaken five update searches for this review resulting in a total of 102 citations, none of which met the inclusion criteria. Two of these citations were narrative reviews previously identified and cited (Daley 1997; DiNucci 2005). Two studies published in Portuguese were excluded on the basis of their English abstracts, they involved non-human subjects, one using guinea pigs (Savieto 2004a) and the other rats (Savieto 2004b). The fifth update identified a recent literature review of complementary therapies for wound healing which included did not identify any additional studies of TT beyond those included here (Rosenbaum 2012).

The original search strategies identified seven articles selected as potentially relevant. One of these, Wirth 1992, was a secondary publication of an earlier study (Wirth 1990). In one trial the researchers gave a narrative description of their findings but reported no data (Wirth 1994b). This study was excluded because it did not meet the inclusion criteria for the review. Letters were written in 1988 and 2000 to Daniel Wirth at the Healing Sciences Research International, but no reply was obtained. Another study did not report wound healing as an outcome and was also excluded (Turner 1998). Hence, four studies were included in this review (Wirth 1990; Wirth 1993; Wirth 1994a; Wirth 1996a).

All of the studies were conducted by the same principal researcher. They all involved relatively small numbers of subjects; sample sizes ranged from 15 to 44). All subjects received experimental full thickness dermal wounds on the lateral deltoid from an experienced physician using a skin biopsy instrument. The wounds were 5 mm in diameter in the first study (Wirth 1990), and 4 mm in all subsequent studies. All wounds were washed with an antibacterial solution and bandaged with either an occlusive (Wirth 1990; Wirth 1993; Wirth 1996a) or non-occlusive dressing (Wirth 1994a).

All trials included use of dressings by all subjects. One excluded trial (Wirth 1994b) also used biofeedback, progressive muscle relaxation and guided imagery with all subjects. In addition, each group was given a different combination of three other therapies: LeShan therapy, intercessory prayer and Reiki. Brief overviews of these therapies are given here, but detailed descriptions can be found elsewhere (O'Mathuna 2007). All subjects used biofeedback for 10 minutes, progressive muscle relaxation for 15 minutes and guided imagery for 45 minutes in sessions carried out every second day. The biofeedback involved using a hand-held thermometer to consciously increase the subject's hand temperature. Progressive muscle relaxation is a method of tensing and relaxing muscles around the body to learn to consciously induce relaxation. Guided imagery is a method of relaxing which involves mentally picturing peaceful scenes while listening to instructions on an audiotape. LeShan therapy allegedly allows healers to achieve a heightened sense of consciousness which energizes another person's natural healing capacity. Intercessory prayer in a health context usually involves asking God or a divine being for healing. The precise nature of the prayer was not specified in this study. Reiki is another 'life energy' therapy that looks similar to TT except that physical contact also occurs and spiritual beings are consulted for guidance during the therapy.

The outcomes measured in every study were the number of completely healed wounds in each group. The wounds were evaluated by one or more experienced physicians who were usually blinded to the nature of the study and the group to which each subject belonged. On preselected days, the physicians determined whether or not each wound was fully healed. In the first study (Wirth 1990), wound area was also calculated, but all subsequent studies reported only numbers of wounds 'fully healed' or 'not healed'.

Risk of bias in included studies

Wirth 1990 - 44 healthy male subjects in two arms. Inclusion and exclusion criteria listed - no. Sample size calculation described - no. Method of sequence generation - unclear. Allocation concealment - unclear. Baseline comparability of groups - age only. Blinded outcome assessment - yes. Subjects, researchers, and physicians evaluating wounds were blinded. Appropriate outcome measures were reported, although wound sizes were small (5 mm) and measurement highly prone to error. Analysis by intention to treat - not applicable as there were no drop outs.

Wirth 1993 - 24 healthy subjects in two arms. Inclusion and exclusion criteria listed - no. Sample size calculation described - no. Method of sequence generation - unclear. Allocation concealment - unclear. Baseline comparability of groups - age only. Blinded outcome assessment - yes. Subjects, researchers, and physicians evaluating wounds were blinded. Selective reporting is suggested because the pre-specified outcomes were six criteria for the evaluation of wound healing. Few of these were reported due to lack of data and the main outcome reported was the number of wounds either fully healed or not, which was not a pre-specified primary outcome. Appropriate outcome measures were reported, although wound sizes were small (4 mm) and measurement highly prone to error. Analysis by intention to treat - not applicable as there were no drop outs.

Wirth 1994a - 15 healthy subjects in two arms who crossed over to different interventions (total of four different protocols). Data were only used to the point of cross over because wound healing in cross over trials is not a stable phenomenon. Inclusion and exclusion criteria listed - no. Sample size calculation described - no. Method of sequence generation - unclear. Allocation concealment - unclear. Baseline comparability of groups - age only. Blinded outcome assessment - yes. Subjects and physicians evaluating wounds were blinded. Appropriate outcome measures were reported. Analysis by intention to treat - not applicable as there were no drop outs.

Wirth 1996a - 38 healthy subjects in two arms. Inclusion and exclusion criteria listed - no. Sample size calculation described - no. Method of sequence generation - unclear. Allocation concealment - unclear. Baseline comparability of groups - age only. Blinded outcome assessment - yes. Subjects, researchers, and physicians evaluating wounds were blinded. Appropriate outcome measures were reported. Analysis by intention to treat - not conducted as data for the six withdraws is not reported. Withdrawals - six reported but no reasons given.

The risk of bias in these four included studies by Wirth is moderate to high when considered solely from a methodological perspective (see Figure 1 and Figure 2 for the 'risk of bias summary figure and graph'). The trials are described in detail, with innovative (but complex) methodologies used to ensure blinding. The reports suffer from not describing the methods of randomisation or allocation concealment.

Figure 1.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Figure 2.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

However, the value of this series of studies is overshadowed by allegations against the principal researcher (Wirth) and some of his co-researchers (Flamm 2005). One issue arises from concerns that participants in some of the studies may have been biased by prior involvement in earlier studies or by financial remuneration (see Characteristics of included studies). Wirth's former colleagues have specifically identified concerns about these wound healing studies (Solfvin 2005). They have appealed publicly to him to resolve the uncertainty around all his research, recommending that "Wirth’s studies not be considered as scientifically valid until Wirth responds directly to these concerns" (Solfvin 2005). At the same time, the experimental protocols of these studies appear valid and the studies have not been withdrawn from publication. However, until the concerns about these four trials by Wirth are addressed, this uncertainty introduces additional, high risk of bias which must be considered when guiding practice based on their findings.

Effects of interventions

After screening the results of the search five citations to four trials were identified and included in this review. The following are the main results of these (see Characteristics of included studies for additional information).

Wirth 1990 compared TT with sham TT (both groups had film dressings). Treatment occurred daily for 16 days. In the intervention group 57% of the wounds healed completely (13/23), compared with 0/23 in the control group (RR 27.00, 95% CI: 1.70 to 428.90, Analysis 1.1). This shows a statistically significant effect in favour of TT.

Wirth 1993 compared TT with sham TT (both groups had occlusive dressings). Treatment occurred daily for 10 days. In the intervention group 83% of the wounds healed completely (10/12), compared with 4/12 (33%) in the control group (RR 2.50, 95% CI: 1.08 to 5.79, Analysis 1.1). This shows a statistically significant effect in favour of TT.

Wirth 1994a compared TT with sham TT (both groups had nonocclusive dressings). Treatment occurred daily for 10 days. Concurrent interventions for all subjects were guided imagery, biofeedback, and visualisation. Concurrent interventions for subjects in the two treatment protocols were Reiki, LeShan, and intercessory prayer. In the intervention group 7% of the wounds healed completely (1/15), compared with 7/15 (47%) in the control group (RR 0.14, 95% CI: 0.02 to 1.02, Analysis 1.1). This indicates no significant difference, however the authors report a statistically significant effect using Fisher's exact test (Fisher's exact test A=4, df=1, 2 sided p = 0.035). The difference in results between the Fisher's Exact and the risk ratio used by RevMan indicates that the result is highly sensitive to choice of test and should be regarded as not significant.

Wirth 1996a compared TT with sham TT (both groups had occlusive dressings). Treatment occurred daily for 10 days. In the intervention group none of the wounds healed completely (0/16), compared with 4/16 (25%) in the control group (RR 0.11, 95%CI: 0.01 to 1.91). This result is not statistically significant.

There was evidence of statistical heterogeneity between the studies (I2 = 79%) and other minor differences in wound dressings used and duration of intervention. Pooling the studies using a random effects model showed no statistically significant difference in complete healing (RR 1.03, 95% CI 0.12 to 8.60)(Analysis 1.1). In general, the study quality was poor leading to concerns about the validity of the results. While all studies were reported as randomised, the method of sequence generation was not described, nor was allocation concealment discussed. Inclusion and exclusion criteria were not described to explain how subjects were chosen from all those who volunteered (44 of 175 in Wirth 1990 and 38 of 54 in Wirth 1996a). No baseline comparison data were reported between the groups except that the groups did not differ significantly by age distribution. In all studies, the subjects and wound assessors were blinded, although in Wirth 1996a it is not explicitly stated that the assessor was blinded. Intention to treat was not mentioned in any study, but was not applicable in the three studies with no withdraws. Of the 38 subjects in Wirth 1996a, 4 withdrew from the treatment group and 2 from the control (16 percent loss). No reasons were given for the withdrawals.

Discussion

The pooled results of the four included trials do not provide evidence of a benefit of therapeutic touch in the healing of biopsy wounds. The concerns about the conduct of these trials reflect negatively on any potential value these studies may have. Taken as published, however, a variety of interventions were used for comparison in the trials which made generalising the results difficult. Although statistically significant benefit was demonstrated for therapeutic touch in the first two studies, the two later studies showed no statistically significant benefit and all studies were at high risk of bias.

TT was studied as part of a portfolio of complementary therapies in Wirth 1994a, while it was the sole intervention in the three other trials. The very complicated design of Wirth 1994a, where several different interventions were used in different combinations, makes attribution of any effect to TT impossible. Subjects crossed over between different groups, as a result data was only included up to the point of crossover. All of these factors led to complicated protocols with few subjects experiencing any one set of conditions.

The creative design of these studies, done in an attempt to reduce biases, led to important differences between the study intervention and that administered in practice. In the studies, treatment was administered for 5 minutes, which is shorter than the more usual 15 to 20 minutes (Krieger 1997). Practitioners usually assess the patient's whole body (or energy field) while in the studies the wound area was isolated. Treatment through one-way mirrors and using video cameras is not usual practice. Different physical materials were placed between the practitioners of therapeutic touch and the subjects. Whether or not this influences the effectiveness of the procedure is controversial among therapeutic touch practitioners. The researchers did not carry out tests to validate the assumptions they made about the impact of these materials.

There were several other methodological problems with the studies. Participants in two studies (Wirth 1993; Wirth 1994a) were selected from a group meeting to practice progressive relaxation and visualisation techniques. These subjects may have responded differently to the study intervention due to their interest in complementary therapies, making the results less generalizable. It should also be noted that all the studies were conducted by the same principal researcher.

Although the early studies supported the efficacy of TT for wound healing, in later studies the control group did better, though the differences were not significant. The authors of the most recent study (Wirth 1996a) concluded that their study was the first randomised double-blind trial to demonstrate an inhibitory response because the healer was in a 'highly stressed or physically or emotionally unbalanced state'. The greater healing found in the control group of an earlier study was explained as possibly due to a cancellation effect between TT and the other complementary therapies (Wirth 1994a). Rather than generating such new hypotheses, the data point to the role of chance in producing different results from four small studies.

Some ethically questionable approaches were used in some of these studies. Potential subjects in all the studies were not informed that they would be receiving one or more therapies. Instead, the researchers told the subjects that the study would measure the bioelectrical energy released from the site of the biopsy. They were told that the study was double-blinded and that all the details would be revealed upon conclusion of the study. This approach was taken to minimise placebo and suggestion effects. However, such an approach is questionable given the controversial nature of therapeutic touch (and the Reiki, LeShan and prayer therapies used in Wirth 1994a). In a study of therapeutic touch with bone marrow transplant recipients, one third of the subjects withdrew from the study (Smith 2003). One reason given was conflict between people's religious beliefs and TT, leading those researchers to conclude that TT 'is a more controversial therapy that probably requires greater preparation and explanation.' Failure to reveal that the therapy will be given, or to explain anything about its nature, does not meet the usual standards for informed consent (O'Mathuna 1998).

A second concern with these wound studies involves the inducements subjects received to become involved. Wirth 1994b offered free training in biofeedback and visualisation for stress reduction, a medical examination, and nutritional counselling. The researchers noted that the subjects enrolled primarily to obtain these free services. The most recent study in this series (Wirth 1996a) was conducted in Mexico and the subjects enrolled primarily for the monetary compensation (amount not reported). The compensation may have encouraged subjects to overcome their apprehension of the clinical setting and biopsy procedure, and to risk the potential adverse effects of TT (O'Mathuna 1998). Such inducements are controversial, especially when the procedure being tested will not be readily available to the population in which the study is conducted (O'Mathuna 2002). The risk of bias inherent in these studies makes any findings questionable.

Authors' conclusions

Implications for practice

There is insufficient evidence for the effectiveness of TT for healing acute wounds. Two trials reported a significant benefit with TT and two found a non significant trend to reduced healing with TT, when all trials were pooled there was no significant difference in complete healing. All trials used patients undergoing a biopsy from healthy skin and the findings may not be generalisable to other wound types.

Implications for research

Further research into the effects of TT on acute wound healing is unlikely to be a good use of resources.

Acknowledgements

The authors would like to thank the Cochrane Wounds Group referees (Sandra King, Trudie Young), Editors (Gillian Cranny, Nicky Cullum & Andrea Nelson) and Managing Editor (Sally Bell-Syer) for their comments to improve the review. The updated searches were carried out by Ruth Foxlee, Trial Search Coordinator. The authors would like to thank the editorial base of the Wounds Group for assisting with all updates of this review.

Data and analyses

Download statistical data

Comparison 1. Therapeutic Touch vs Control
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 wounds healed completely4132Risk Ratio (M-H, Random, 95% CI)1.03 [0.12, 8.60]
Analysis 1.1.

Comparison 1 Therapeutic Touch vs Control, Outcome 1 wounds healed completely.

Appendices

Appendix 1. Search strategies for the fourth update

For the fourth update, searches were carried out in the following databases:

  • Cochrane Wounds Group Specialised Register (Searched 31/3/10)

  • The Cochrane Central Register of Controlled Trials (CENTRAL) - The Cochrane Library 2010 Issue 1

  • Ovid MEDLINE - 2007 to March Week 3 2010

  • Ovid MEDLINE - In-Process & Other Non-Indexed Citations (Searched 30/3/10)

  • Ovid EMBASE - 2007 to 2010 Week 11

  • EBSCO CINAHL - 2007 to March 26 2010

The following search strategy was used in the Cochrane Central Register of Controlled Trials (CENTRAL):
#1 MeSH descriptor Acute Disease explode all trees
#2 MeSH descriptor Wounds and Injuries explode all trees
#3 (#1 AND #2)
#4 MeSH descriptor Surgical Wound Infection explode all trees
#5 MeSH descriptor Surgical Wound Dehiscence explode all trees
#6 MeSH descriptor Wounds, Penetrating explode all trees
#7 MeSH descriptor Lacerations explode all trees
#8 MeSH descriptor Burns explode all trees
#9 MeSH descriptor Skin Transplantation explode all trees #10 MeSH descriptor Fractures, Open explode all trees
#11 ((traumatic NEXT wound*) or (acute NEXT wound*)):ti,ab,kw
#12 ((surgical NEXT wound*) or (incised NEXT wound*)):ti,ab,kw
#13 acute NEXT ulcer*:ti,ab,kw
#14 (burn or burns or burned or scald*):ti,ab,kw
#15 ((thermal or blast or crush or avulsion) NEXT injur*):ti,ab,kw
#16 (laceration* or gunshot or (gun NEXT shot) or stab or stabbing or stabbed):ti,ab,kw
#17 ((donor NEXT site*) or (skin NEXT graft*)):ti,ab,kw
#18 experimental NEXT wound*:ti,ab,kw
#19 ((mechanical NEXT trauma) or polytrauma):ti,ab,kw #20 ((open NEXT fracture*) or (compound NEXT fracture*)):ti,ab,kw
#21 (#3 OR #4 OR #5 OR #6 OR #7 OR #8 OR #9 OR #10 OR #11 OR #12 OR #13 OR #14 OR #15 OR #16 OR #17 OR #18 OR #19 OR #20)
#22 MeSH descriptor Therapeutic Touch explode all trees
#23 MeSH descriptor Relaxation Techniques explode all trees
#24 non-contact NEAR/5 therap*:ti,ab,kw
#25 non-contact NEAR/5 heal*:ti,ab,kw
#26 therapeutic NEXT touch*:ti,ab,kw
#27 (#22 OR #23 OR #24 OR #25 OR #26)
#28 (#21 AND #27)

Appendix 2. Ovid MEDLINE search strategy

1 exp Acute Disease/ (179226)
2 exp "Wounds and Injuries"/ (683628)
3 and/1-2 (9899)
4 exp Surgical Wound Infection/ (27605)
5 exp Surgical Wound Dehiscence/ (6117)
6 exp Wounds, Penetrating/ (29923)
7 exp Lacerations/ (1692)
8 exp Burns/ (47250)
9 exp Skin Transplantation/ (30605)
10 exp Fractures, Open/ (4281)
11 (traumatic wound$ or acute wound$).ti,ab. (921)
12 (surgical wound$ or incised wound$).ti,ab. (4159)
13 acute ulcer$.ti,ab. (671)
14 (burn or burns or burned or scald$).ti,ab. (44555)
15 ((thermal or blast or crush or avulsion) adj injur$).ti,ab. (7448)
16 (laceration$ or gunshot or gun shot or stab or stabbing or stabbed).ti,ab. (17331)
17 (donor site$ or skin graft$).ti,ab. (20750)
18 experimental wound$.ti,ab. (363)
19 (mechanical trauma or polytrauma).ti,ab. (2806)
20 (open fracture$ or compound fracture$).ti,ab. (3036)
21 or/3-20 (190699)
22 exp Therapeutic Touch/ (641)
23 exp Relaxation Techniques/ (6948)
24 therapeutic touch.ti,ab. (381)
25 non-contact therap$.ti,ab. (6)
26 non-contact heal$.ti,ab. (1)
27 or/22-26 (7709)
28 21 and 27 (36)
29 randomized controlled trial.pt. (359010)
30 controlled clinical trial.pt. (86881)
31 randomi?ed.ab. (310448)
32 placebo.ab. (141107)
33 clinical trials as topic.sh. (166531)
34 randomly.ab. (186021)
35 trial.ti. (111455)
36 or/29-35 (844137)
37 exp animals/ not humans.sh. (3865236)
38 36 not 37 (776037)
39 28 and 38 (12)

Appendix 3. Ovid EMBASE search strategy

1 exp Wound/ (171121)
2 exp Acute Disease/ (101054)
3 1 and 2 (667)
4 exp Surgical Infection/ (26052)
5 exp Wound Dehiscence/ (10184)
6 exp Penetrating Trauma/ (9621)
7 exp Laceration/ (5961)
8 exp Burn/ (58989)
9 exp Skin Transplantation/ (50161)
10 exp Open Fracture/ (4417)
11 (traumatic wound$ or acute wound$).ti,ab. (1267)
12 (surgical wound$ or incised wound$).ti,ab. (5566)
13 acute ulcer$.ti,ab. (923)
14 (burn or burns or burned or scald$).ti,ab. (60085)
15 ((thermal or blast or crush or avulsion) adj injur$).ti,ab. (9718)
16 (laceration$ or gunshot or gun shot or stab or stabbing or stabbed).ti,ab. (22587)
17 (donor site$ or skin graft$).ti,ab. (27164)
18 experimental wound$.ti,ab. (440)
19 (mechanical trauma or polytrauma).ti,ab. (4059)
20 (open fracture$ or compound fracture$).ti,ab. (4013)
21 or/3-20 (220234)
22 exp Therapeutic Touch/ (34423)
23 exp Relaxation Training/ (8420)
24 therapeutic touch.ti,ab. (441)
25 non-contact therap$.ti,ab. (10)
26 non-contact heal$.ti,ab. (1)
27 or/22-26 (41987)
28 21 and 27 (285)
29 Randomized controlled trials/ (45578)
30 Single-Blind Method/ (18881)
31 Double-Blind Method/ (122381)
32 Crossover Procedure/ (39650)
33 (random$ or factorial$ or crossover$ or cross over$ or cross-over$ or placebo$ or assign$ or allocat$ or volunteer$).ti,ab. (1343387)
34 (doubl$ adj blind$).ti,ab. (150245)
35 (singl$ adj blind$).ti,ab. (14637)
36 or/29-35 (1409792)
37 exp animals/ or exp invertebrate/ or animal experiment/ or animal model/ or animal tissue/ or animal cell/ or nonhuman/ (20931447)
38 human/ or human cell/ (15267952)
39 and/37-38 (15221293)
40 37 not 39 (5710154)
41 36 not 40 (1217838)
42 28 and 41 (43)

Appendix 4. EBSCO CINAHL search strategy

S29 S22 and S28
S28 S23 or S24 or S25 or S26 or S27
S27 TI non-contact heal* or AB non-contact heal*
S26 TI non-contact therap* or AB non-contact therap*
S25 TI therapeutic touch or AB therapeutic touch
S24 (MH "Relaxation Techniques+")
S23 (MH "Therapeutic Touch")
S22 S1 or S2 or S3 or S4 or S5 or S6 or S7 or S8 or S9 or S10 or S11 or S12 or S13 or S14 or S15 or S16 or S17 or S18 or S19 or S20 or S21
S21 TI ( open fracture* or compound fracture* ) or AB ( open fracture* or compound fracture* )
S20 TI ( mechanical trauma or polytrauma ) or AB ( mechanical trauma or polytrauma )
S19 TI experimental wound* or AB experimental wound*
S18 TI ( donor site* or skin graft* ) or AB ( donor site* or skin graft* )
S17 TI ( laceration* or gunshot or gun shot or stab or stabbing or stabbed ) or AB ( laceration* or gunshot or gun shot or stab or stabbing or stabbed )
S16 TI ( thermal injur* or blast injur* or crush injur* or avulsion injur* ) or AB ( thermal injur* or blast injur* or crush injur* or avulsion injur* )
S15 TI ( burn or burns or burned or scald* ) or AB ( burn or burns or burned or scald* )
S14 TI acute ulcer* or AB acute ulcer*
S13 TI ( surgical wound* or incised wound* ) or AB ( surgical wound* or incised wound* )
S12 TI ( traumatic wound* or acute wound* ) or AB ( traumatic wound* or acute wound* )
S11 (MH "Fractures, Open")
S10 (MH "Graft Donor Site")
S9 (MH "Skin Transplantation")
S8 (MH "Burns+")
S7 (MH "Tears and Lacerations")
S6 (MH "Wounds, Penetrating+")
S5 (MH "Surgical Wound Dehiscence")
S4 (MH "Surgical Wound Infection")
S3 S1 and S2
S2 (MH "Wounds and Injuries+")
S1 (MH "Acute Disease")

What's new

DateEventDescription
22 April 2014New search has been performedFifth update, new search, no new studies identified.
22 April 2014New citation required but conclusions have not changedConclusions not changed

History

Protocol first published: Issue 4, 1998
Review first published: Issue 4, 2003

DateEventDescription
25 April 2012New citation required but conclusions have not changedFourth update. The authors' conclusions remain unchanged.
2 June 2010New search has been performedFor this third update, a new search was conducted. No new studies were identified. Risk of bias tables were completed. The authors' conclusions remain unchanged.
23 July 2008AmendedConverted to new review format.
26 November 2007New search has been performedFor this second update, a new search strategy was used and carried out in November 2007. No new studies were identified.The authors' conclusions remain unchanged.
16 January 2006New search has been performedFor the first update, new searches were carried out in January 2006. Two new studies were excluded from the review. The authors' conclusions remain unchanged.
19 August 2003New citation required and conclusions have changedSubstantive amendment. This review, with 4 included trials, was originally published in The Cochrane Library, Issue 4, 2003.

Contributions of authors

DO'M developed the protocol for this review and conducted the initial literature search. Relevant studies were determined by DO'M and data extracted. Data was extracted independently by RLA and compared. First draft of the review was written by DO'M followed by revision and additions by RLA. The updates were conducted by DO'M who is guarantor of the review.

Declarations of interest

None

Sources of support

Internal sources

  • Mount Carmel College of Nursing, USA.

  • Faculty of Health and Community Care, University of Central England, UK.

  • School of Nursing, Dublin City University, Ireland.

External sources

  • The National Institue for Health Research (NIHR) is the sole funder of the Cochrane Wounds Group, UK.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Wirth 1990

MethodsRandomised, double-blind, placebo-controlled study.
Participants44 healthy male students, 21 to 32 years old (mean 26 years).
InterventionsGroup 1: 5 minutes TT daily for 16 days.
Subject passed arm through a screen and could not see what happened to it.
Group 2: 5 minutes sham TT - subject sitting in a room.
All subjects received a full thickness 5 mm wound using a skin biopsy instrument. The wound was covered with a polyurethane dressing (Tegaderm) which was changed at day 8 and 16. In each group, half received the wound in their right arm and half in the left.
OutcomesAfter 8 days, 3 of 23 wounds treated in Group 1 were completely healed; 0 of 21 in Group 2 (p<0.001).
After 16 days, 13 of 23 (57%) wounds treated in Group 1 were completely healed; 0 of 21 in Group 2 (p<0.001).
Mean wound area in Group 1 was 3.9 mm² (SD 2.958); in Group 2 it was 19.34 mm² (SD 4.469)
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskStated to be "randomized" but no details given
Allocation concealment (selection bias)Unclear riskNo details given
Blinding (performance bias and detection bias)
participants
Low riskParticipants, experimenter and outcome assessors blinded.
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo drop-outs
Selective reporting (reporting bias)Low riskAll primary outcomes reported
Other biasHigh riskConcerns have been raised that this trial (of a series) may be at risk of fraud

Wirth 1993

MethodsRandomised, double-blind, placebo-controlled study
Participants24 healthy subjects drawn from people practicing progressive relaxation and visualization. Aged 35 to 63 years (mean 47 years). Gender not reported. All given 4 mm skin biopsy wound
InterventionsGroup 1: 5 minutes TT daily for 10 days.
Practitioners were behind a one-way mirror.
Group 2: Subject sat in the room with no therapist behind the one-way mirror.
The 4 mm skin biopsy wound was covered with a polyurethane dressing which was changed at days five and 10.
OutcomesAfter five days, seven of 12 wounds treated with in Group 1 were completely healed; 0 of 12 in Group 2 (p<0.006).
After 10 days, 10 of 12 wounds treated in Group 1 were completely healed; 4 of 12 in Group 2 (p<0.041).
Mean wound area in Group 1 was 3.9 mm² (SD 2.958); in Group 2 it was 19.34 mm² (SD 4.469)
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskStated "randomly assigned," but no details given.
Allocation concealment (selection bias)Unclear riskNo details given
Blinding (performance bias and detection bias)
participants
Low riskParticipants, experimenter and outcome assessors blinded.
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo drop-outs
Selective reporting (reporting bias)High riskSix outcomes were examined as evidence of wound healing, but most were not reported due to a lack of data for each assessment. The results were based on whether the wounds were fully healed or not, which was not a pre-specified primary outcome.
Other biasHigh riskConcerns have been raised that this trial (of a series) may be at risk of fraud

Wirth 1994a

MethodsRandomised, double-blind, within-subject cross-over study
Participants15 healthy subjects from Wirth et al 1993.
InterventionsPart A (10 days).
Group 1: Even-numbered days: subjects used biofeedback to increase hand temp. and send healing energy to wounds and told TT would be given through a one-way mirror, but no TT given. On odd-numbered days: 1 hour group guided imagery using audiotape and receiving LeShan and Intercessory Prayer. During this, each subject received TT for 6 min. TT practitioners received Reiki/massage also.
Group 2: Control
Even-numbered days, subject used biofeedback to increase hand temp only. Odd-numbered days, listened to relaxation tape in presence of therapists with no experience of TT moving their hands over subjects.
Part B.
7 days after Part A finished, subjects cross-over with one exception: each subject used the same audiotape used in Part A.
All 4 mm skin biopsy wounds treated with antibacterial solution and covered with nonocclusive dressing (Band-Aid).
OutcomesAfter 10 days of treatment, one of 15 wounds was healed, compared to seven of 15 in control group (p < 0.01).
Comparing Part A treatment and Part B control (same subjects), one of eight were healed after treatment and five of eight after control (p < 0.04).
NotesVery large number of variables included.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskStated "randomly assigned" but no details given.
Allocation concealment (selection bias)Unclear riskNo details given
Blinding (performance bias and detection bias)
participants
Unclear riskParticipants blinded but had participated in previous studies in this series. The physician outcome assessors were not blinded. The participants in this study had participated in Wirth 1993 and would have been familiar with the study design.
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo drop-outs
Selective reporting (reporting bias)Low riskAll primary outcomes were reported
Other biasHigh riskConcerns have been raised that this trial (of a series) may be at risk of fraud.

Wirth 1996a

MethodsRandomised, double-blind study.
Participants38 healthy volunteers from 54 respondents to advertisements.
InterventionsGroup 1. 5 minutes TT daily for 10 days.
Practitioners were behind a one-way mirror, within 6 inches of the subjects.
Group 2. Subject sat in the room with no therapist behind the one-way mirror. The wounds were 4 mm skin biopsy wounds covered with an occlusive dressing, changed at day 5 and 10.
OutcomesAfter 10 days, none of 16 wounds receiving TT were fully healed, while four of 16 were healed in the control group (P = 0.05).
NotesInclusion criteria not given. Four withdrew from treatment group and two from control - no reasons given.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskStated "randomly assigned," but no details given.
Allocation concealment (selection bias)Unclear riskNo details given
Blinding (performance bias and detection bias)
participants
Unclear riskThe participants and experimenter were blinded but unclear if the outcome assessor was.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNumber of subjects randomly assigned to each group was not reported (n = 38 total). Four dropped out of the treatment group and 2 from the control group. Results were given for 16 people in each group. Suggests uneven distribution to groups initially or possible movement between groups after drop-outs.
Selective reporting (reporting bias)Low riskAll primary outcomes reported
Other biasHigh riskConcerns have been raised that this trial (of a series) may be at risk of fraud. In addition, the participants were given monetary compensation which the authors suggested could have influenced the outcomes.

Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion
Savieto 2004aAnimal study.
Savieto 2004bAnimal study.
Turner 1998Study was retrieved using search criteria, but did not include wound healing as an outcome. Outcomes were pain and anxiety.
Wirth 1994bAfter 10 days of daily treatment there were insufficient numbers of fully healed wounds to warrant statistical comparisons. The researchers reported no data.

Ancillary