Reviewed: Gromball J, Beschorner F, Wantzen C, Paulsen U, Burkart M. Hyperactivity, concentration difficulties and impulsiveness improve during seven weeks’ treatment with valerian root and lemon balm extracts in primary school children. Phytomed. 2014;21(8-9):1098-1103.
Children with mild or fluctuating levels of intensity in attention deficits, hyperactivity, or impulsiveness may not meet the diagnostic criteria for attention deficit hyperactivity disorder (ADHD). These children do not qualify for prescription pharmaceuticals to treat their symptoms; however, there remains an urgent need to reduce the burden of care presented by these challenging conditions. In clinical trials, it has been demonstrated that valerian (Valeriana officinalis, Caprifoliaceae) root extract and lemon balm (Melissa officinalis, Lamiaceae) aerial extract can help alleviate insomnia and restlessness. The purpose of this prospective, multi-center, open-label study was to evaluate the effectiveness of a valerian and lemon balm preparation in treating children who exhibit symptoms of ADHD but who do not fulfill the diagnostic criteria for ADHD.
Primary school children aged six to 11 years with hyperactivity and concentration difficulties — but who did not meet the ADHD criteria listed in the Diagnostic and Statistical Manual of Mental Disorders, 4th ed. (DSM-IV), or the International Statistical Classification of Diseases and Related Health Problems, 10th ed. (ICD-10), and not taking stimulating drugs (e.g., methylphenidate) — participated in this study conducted in 27 pediatric practices throughout Germany. Patients took two coated tablets of Sandrin® (Dr. Willmar Schwabe GmbH & Co. KG; Karlsruhe, Germany) twice daily for seven weeks. Those with any of the contraindications listed in the product monograph were excluded from the study. The daily dosage of the fixed combination, as analyzed according to official European Pharmacopoeia monographs, supplied 640 mg per day of the quantified dry extract WS®1014 from valerian root (drug/extract ratio 3-6:1, 62% ethanol m/m) and 320 mg per day of the quantified lemon balm dry extract WS®1303 (drug/extract ratio 4-6:1, 30% ethanol m/m).
At baseline, two weeks, and seven weeks, both parents and physicians rated the child’s behavior over the preceeding seven days with regard to the following symptoms: concentration problems, hyperactivity, impulsiveness, impaired social behavior, difficulties falling asleep or sleeping through the night, morning fatigue, attention deficits, nervousness, anxiety, and behavior apart from school and family environments. There were also questions concerning the burden of the child’s symptoms on the family members. The enrolled patients had displayed symptoms for a mean of 24.3 months (with a range of one month to four years). Prior to the study, 16.6% of the patients had been prescribed other treatments. The physicians rated compliance as “very good” or “good” in 74.9% of patients.
According to the authors, 169 patients were evaluated, 152 patients were completely documented, and “treatment was terminated prematurely in 16 patients, mainly because of insufficient compliance (6), low efficacy (5), problems with intake (3) and/or other reasons (multiple responses allowed). 77 patients terminated therapy after the final examination (29 because symptoms had improved or vanished, 29 because of insufficient efficacy, 10 for poor compliance).” The authors do not account for the discrepancy (n=11) between the number of enrolled patients and their report of post-treatment terminations and continuations.
After seven weeks of treatment, the physician ratings indicated a significant improvement in ability to concentrate, hyperactivity, impulsiveness, social behavior, difficulty falling asleep, difficulty sleeping through the night, and morning fatigue compared with baseline (P < 0.0001 for all). The parent ratings of symptom severity decreased from a mean overall score of 3.2 at baseline to 2.7 at the end of the study. Specifically, there was a significant improvement compared with baseline in the following areas: problems in leisure time, problems with friends, difficulties in everyday life, burden on child, burden on parents/family, and problems in school (P < 0.0001 for all).
At baseline, 58% of parents perceived their child’s behavior as a “heavy” or “very heavy” burden, which decreased to 18% after seven weeks of treatment. The symptom with the highest severity score at baseline was distractibility, which significantly decreased after seven weeks of treatment (P<0.0001). Treatment satisfaction was rated as “very good” or “good” by 62% of the physicians and 58% of the parents. Treatment tolerability was rated as “very good” or “good” by 96.9% of the physicians and 95.1% of the parents. There were three adverse side effects (ASEs) reported (eye blinking tics, moderate tiredness, and irritability) in two patients. All of these ASEs were judged by the physicians to be “unlikely” related to treatment.
The authors conclude that the Sandrin preparation is a safe and effective treatment for primary school children with hyperactivity and concentration difficulties but who do not meet ADHD diagnostic criteria. An important limitation of this study is that there was no control group; the reported benefits may have been due to a placebo effect. However, the results support the safety of this herbal combination for children. Another limitation is that the seven-week study duration is relatively short; it is unknown if any of the reported benefits would persist with chronic treatment. The study was sponsored by the manufacturer of the extracts, Dr. Willmar Schwabe GmbH & Co. KG; two of the authors (Paulsen and Burkart) are employees of the company.
—Heather S. Oliff, PhD