Bach-Flower Remedies (BFRs) are often confused with homeopathics. Like them, they contain no active molecule; unlike them, they are not potentised nor used according to the ‘like cures like’ assumption. Both have in common that they are as popular as implausible.
Few studies have tested BFRs; my own systematic review of controlled clinical trials was published in 2010:
Bach flower remedies continue to be popular and its proponents make a range of medicinal claims for them. The aim of this systematic review was to critically evaluate the evidence for these claims. Five electronic databases were searched without restrictions on time or language. All randomised clinical trials of flower remedies were included. Seven such studies were located. All but one were placebo-controlled. All placebo-controlled trials failed to demonstrate efficacy. It is concluded that the most reliable clinical trials do not show any differences between flower remedies and placebos.
Now a new study has emerged. This trial from the Department of Pedodontics and Preventive Dentistry, DY Patil University – School of Dentistry, Navi Mumbai, Maharashtra, India, compared the effects of Bach Flower Therapy (BFT) and music therapy (MT) on the dental anxiety in paediatric patients. A total of 120 children (aged 4-6 years) were selected and randomly allocated to one of three groups:
- BFT group: Children from this group were administered orally four drops of “rescue remedy” diluted in 40 mL of water 15 min before the treatment. Children were asked to wear headphones without playing any music during the dental treatment
- MT group: Children from this group were provided with a headphone, and Indian classical instrumental music (Raag Sohni played by Pandit Shiv Kumar Sharma on santoor) was played during the scheduled dental treatment. Children were also given 40 mL plain water to drink 15 min before the treatment
- Control group: Children from this group were given 40 mL plain water 15 min before the treatment. During the treatment, children were asked to wear the headphone without playing any music.
All children received oral prophylaxis and fluoride treatment (no further details provided). Dental anxiety was evaluated using
- North Carolina Behavior Rating Scale (NCBRS), the primary outcome measure,
- Facial Image Scale (FIS),
- and physiological parameters.
Significantly better behaviour was seen in children from the BFT group as compared to the control group (P = 0.014). FIS scores measured postoperatively did not show significant differences among the groups.
Children from the BFT and MT groups showed a significant decrease in the pulse rates intraoperatively from the preoperative period. Intraoperative systolic blood pressure in children from the MT group was significantly lower than both the BFT and the control groups. Diastolic blood pressure significantly increased in the control group intra-operatively, whereas other groups showed a decrease.
The authors concluded that the results of this study demonstrate significant effects of both single dose of BFT and exposure to MT, on reduction of dental anxiety in children aged between 4 and 6 years.
I find these findings most puzzling (like all BFRs, Rescue Remedies do not contain a single active molecule that could explain them) and strongly recommend that we wait until we have an independent replication before accepting these results as trustworthy.
4 Responses to A new study of Bach ‘Rescue Remedy’ yields significant effects on dental anxiety
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Maybe they were playing Bach in both arms.? Which would be the most soothing piece of Bach you can think of?
One might as well conclude that classical Indian music causes more stress than BFR. The treatment (application of Fluoride) is not stressful anyway.
The operators wouldn’t be blinded. They’d know which kids were listening to music and which weren’t.
Just to come back on what Catherine has said above, applying fluoride varnish to kids can be hard work but, as she says, it is essentially atraumatic for the kids. You’re going to get very noisy data out of this.
Happily I was able to get to the original paper by following your link, and there was no paywall.
There was no significant difference in anxiety levels between the three groups when scored by questionnaire. There was a significant difference when blinded observers scored the behaviour of the children as seen on video recordings, although the authors didn’t explain how the scoring system worked so I have no idea of the size of the difference.
When it came to physiological parameters (pulse rate, systolic and diastolic blood pressure), they took the mean (not the median) of the measurements within each group before, during and after the procedure, and found a statistically significant, albeit small, difference between these mean values, concluding that this was evidence of a beneficial effect of Bach Flower Remedies. The did not look at individual changes in these measurements, which would have been much more informative (of perhaps they did, and decided not to publish them). Did the BP go up in some individuals and down in others? We don’t know.
The reason for preferring median rather than mean values in this type of study is that the mean can be unduly affected by a single individual with outlying results. For instance, if one individual in the Bach Flower Remedies group had a particularly high pulse rate at the beginning, but subsequently fell to normal, this could skew the results.
So – inapropriate statistical analysis found a small effect. What are we to conclude?