Anxiolytic Effect of Rescue Remedy for Psychiatric Patients: A Double-blind, Placebo-controlled, Randomized Trial
Bach flower remedies are available over the counter and mostly used as self-help intervention for anxiety. Consumers strongly believe in their therapeutic effect, and flower remedies are readily available from a wide range of providers that economically thrive on these consumers' therapeutic preference.
The physician Dr Edward Bach (1886-1936) was convinced that flowers and leaves of some selected plants generate healing qualities by placing them into crystal plates with clear spring water near the place of harvesting, exposing them to the sun and, above that, homeopathically diluted.1 These remedies do not fulfill the criteria for drugs and do not contain pharmacologically relevant amounts of the flowers they originate from. There are only a few controlled clinical trials about Bach flower remedies.2 Rühle3 performed a clinical trial by measuring the time to birth at 24 pregnant women with overdue births, without a placebo group. The remedy group needed significantly less (P = 0.032) medication. Armstrong and Ernst4 conducted a randomized, placebo-controlled double-blind study to evaluate the effect of rescue remedy on healthy university students sitting examinations. The study by Wallach et al5 examined the effect of rescue remedy in 51 healthy students sitting examinations and separated into rescue remedy and placebo groups and crossover treatment. There was no difference between the groups in both studies. Cram6 performed an open-label study for depressive patients with a crossover design. There was no placebo group, and so its results could therefore be due to a placebo response. In view of the increased use of Bach flower remedies, the objective of this study was to evaluate the effects of rescue remedy on psychiatric patients with anxiety as the main symptom. Participants were hospitalized and conditions of outpatients of the Department of Psychiatry and Psychotherapy, who gave confirmed consent, were diagnosed as an anxiety disorder, depression or, depressive symptoms during a nonacute schizoaffective psychosis. The Ethics Committee of the University of Bochum approved of the study. All kinds of organically caused anxiety were excluded.
The point of departure of the anxiety occurrence was determined by expert rating of the standardized Association for Methodology and Documentation in Psychiatry system, the symptom checklist 90 revised (SCL-90R), and the visual analogue scale (VAS), according to the adjective checklist of Janke and Debus. The VAS contained 15 items, which the patient could rate by marking the line between 2 extreme conditions. In conclusion, it can be stated that for placebo and verum group, the aspects age, sex, psychiatric diagnosis, and severity of symptoms of the main symptom (anxiety) at the beginning of the study showed no significant difference. Rescue remedy was originally ordered at Dr Edward Bach Centre; the placebo remedies were prepared by the hospital pharmacist and contained water and 27% alcohol. It was not possible to differentiate the remedies by taste. Concomitant medication was documented and stable during the study.
The participants were treated for 3 days in the same way, as self-medicating at the onset of anxiety. The remedies were given to the patient in a strictly recommended way to exclude any effect by the nurse. The patient gave a short rating on the visual analogue scale about his anxiety and mood before and 30 minutes after having taken the drops with water.
The primary outcome criterion was the change of item 15 "anxiety" of the VAS. We appointed only one primary outcome to avoid multiple testing and alpha adjusting.
Ninety-eight patients gave informed consent and were included into the study. Valid data were available from 87 patients, 42 patients for the placebo, and 45 for the verum condition.