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Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet]. York (UK): Centre for Reviews and Dissemination (UK); 1995-.

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Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet].

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Bach flower remedies for psychological problems and pain: a systematic review

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Review published: .

CRD summary

This review of Bach flower remedies concluded that they were no more effective than placebo for psychological problems and were probably safe, although this was uncertain due to poor-quality evidence. The conduct of this review was good and the author's conclusions seem reliable, but the risk of language and publication bias needs to be considered

Authors' objectives

To assess whether Bach flower remedies were safe and efficacious for treatment of psychological problems and pain.

Searching

MEDLINE, EMBASE, AMED and The Cochrane Library were searched from inception to June 2008. Search terms were reported. Reference lists of reviews and letters to the editor were searched. Only studies published in English or German were included.

Study selection

Randomised controlled trials (RCTs) and prospective controlled observational studies (for efficacy) or uncontrolled and retrospective observational studies with at least 30 participants (for safety) were eligible for inclusion. Studies had to compare Bach flower remedies against placebo in patients with pain and/or psychological symptoms in any setting and report pain reduction, symptom improvement and adverse events.

Studies that assessed efficacy of Bach flower remedies were conducted in UK, Germany, Israel and USA in students with examination anxiety or children with attention-deficit hyperactivity disorder (ADHD). Where reported, mean ages were 25.6 to 28 years for students and seven to 11 years for children. Treatment duration ranged from three hours to three months. Outcome measures were the State-Trait Anxiety Inventory (STAI) or S-anxiety subscale scores, Conner's scores or German Test Anxiety Inventory (TAI-G) score.

Studies were selected by two reviewers independently. Disagreements were resolved by consensus or involvement of a third reviewer.

Assessment of study quality

Risk of bias for RCTs was assessed using criteria from the Cochrane Collaboration and classed as high, low or unclear. This covered the generation of the randomisation sequence, allocation concealment, baseline comparability of groups, blinding, completeness of outcome data and reporting and loss to follow-up. For observational studies, the assessment covered selection of cases and controls or cohorts, adjustment for confounders, methods of outcome assessment, length of follow-up and methods of statistical analysis. Studies with a fatal flaw for any item were classed as high risk of bias. Evidence for key questions was rated using the GRADE profile.

Risk of bias assessment was performed by one reviewer and checked by a second. Disagreements were resolved by discussion or referral to a third party.

Data extraction

Mean reductions in outcomes for each group and corresponding p-values were extracted where possible.

Data extraction was performed by one reviewer and checked by a second. Disagreements were resolved by discussion or referral to a third party. Authors were contacted for further information if necessary.

Methods of synthesis

Results were presented in a narrative synthesis.

Results of the review

Six studies were included: four RCTs (n=312) for assessment of efficacy and two RCTs (n=161) and two case series (n=156) for adverse events. Five studies were classed as high risk of bias and one as low risk.

Efficacy: Three studies assessed the effects of Bach flower remedies compared with placebo on exam anxiety. None reported any statistically significant differences between treatment groups. One study treated children aged from six to 11 with a confirmed diagnosis of ADHD and reported statistically significant improvements in mean Conner's score for both Bach flower remedies and placebo groups over three months of treatment, but no evidence of a difference between them.

Adverse events: Two of the six studies did not report on adverse events. One RCT and one case series reported that there were no adverse events. One RCT reported one adverse event (details not given). One RCT reported six adverse events, three in the Bach flower remedies group (headaches, skin eruptions) and three in the placebo group (vomiting, hay fever and a depressive mood).

Authors' conclusions

The current evidence indicated that Bach flower remedies were not more efficacious than a placebo intervention for psychological problems but were probably safe. Due to a lack of methodologically sound trials, this statement was associated with a high level of uncertainty.

CRD commentary

This review stated inclusion criteria with sufficient detail to enable independent replication. The search covered a number of relevant databases. The restiction to studies published in English or German increased risks of language and publication biases, which meant that some studies may have been missed. All the review methods were performed by one reviewer and checked by another, which reduced risks of mistakes and reviewer bias. Study validity was assessed using recommended methods and different items were used for randomised controlled trials and observational study designs. Risk of bias results were reported, but full details of all quality items were not reported for all studies. The conduct of this review was good and the author's conclusions are appropriate and reliable, but the risk of language and publication bias needs to be considered.

Implications of the review for practice and research

Practice: The authors did not state any implications for practice.

Research: The authors stated that future trials should use appropriate randomisation and blinding, have an adequate sample size, minimise loss to follow-up, use patient-relevant endpoints, have sufficient length of follow-up and allow for flexibility in personalising Bach flower remedies therapy.

Funding

Not stated, but the review was conducted to provide evidence to an Austrian state insurance company.

Bibliographic details

Thaler K, Kaminski A, Chapman A, Langley T, Gartlehner G. Bach flower remedies for psychological problems and pain: a systematic review. BMC Complementary and Alternative Medicine 2009; 9:16. [PMC free article: PMC2695424] [PubMed: 19470153]

Indexing Status

Subject indexing assigned by NLM

MeSH

Anxiety /therapy; Attention Deficit Disorder with Hyperactivity /therapy; Complementary Therapies /adverse effects; Flowers; Humans; Mental Disorders /therapy; Pain Management; Plant Preparations /therapeutic use; Plants; Randomized Controlled Trials as Topic

AccessionNumber

12009107352

Database entry date

21/07/2010

Record Status

This is a critical abstract of a systematic review that meets the criteria for inclusion on DARE. Each critical abstract contains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment on the reliability of the review and the conclusions drawn.

Copyright © 2014 University of York.
Bookshelf ID: NBK76723

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