gms | German Medical Science

Background: Mental health issues (MHIs) are commonly treated with synthetic compounds such as antidepressants, anxiolytics and other psychotropic drugs, which can cause adverse events (AEs) as well as compliance issues [1]. In contrast Herbal Medicinal Products (HMPs) are well tolerated and also exert therapeutic benefits. Therefore, they could offer an alternative for prescription and self-medication [2]. However, very little is known about the actual use of HMPs in treatment of MHIs. In order to find out why users choose HMPs for the treatment of their MHI-associated symptoms we evaluated various factors related to the treatment habits and the perceived effectiveness and tolerability.

Materials and Methods: We analyzed a data subset (n=1504) from the pharmaco-epidemiological database PhytoVIS, which contains Real-World Data (RWD) in form of Patient-Reported Outcomes (PROs). All patients used HMPs (mainly derived from Valeriana officinalis L., Lavandula angustifolia Mill., Ginkgo biloba L. and Hypericum perforatum L.) for the treatment of MHIs. We categorized the cases into the indication groups (1) sleep disorders (n=656), (2) stress, restlessness and nervousness (n=444), (3) dysphoric or depressive symptoms (n=157), (4) cognitive impairment (n=203) and (5) symptoms of anxiety (n=44). The analysis focused on treatment habits such as the reason for application (acute symptoms/chronic symptoms or preventive purposes), frequency of application (daily or as needed), duration of application, and the type of HMPs (Herbal Medicines (HMs) or Herbal Teas (HTs)). Furthermore, the perceived effectiveness (very good, moderate-distinct, minimal-mild, unchanged or worsened) and tolerability (no AEs, no significant AEs, significant AEs, AEs outweigh the perceived effectiveness) rated on Likert-scales were analyzed. Descriptive statistical methods were applied using IBM SPSS Statistics.

Results: We found differences in the application pattern depending on the type of MHI:

While acute symptoms were the main reason for the use of HMPs for patients with symptoms of anxiety (69.8%), stress, restlessness, and nervousness (63.7%) and sleep disorders (53.7%), chronic symptoms were the main cause for patients with depressive symptoms (50.3%) and cognitive impairment (40.7%).

Interestingly, over a third of patients with cognitive impairment used HMPs for preventive purposes (37.6%).

Daily use of HMPs was preferred particularly among patients with cognitive impairment (over 95%) and dysphoric or depressive symptoms (over 90%).

Patients mainly used HMPs on an as-needed-basis for sleep disorders (40.6%), stress, restlessness and nervousness (32.0%) or symptoms of anxiety (29.5%).

Regarding the duration of use, the vast majority of patients - regardless of the indication - used HMPs for longer than 30 days or for a longer undefined duration particularly patients with cognitive impairment (85.8%) and those with dysphoric or depressive symptoms (72.7%).

Differences were also observed concerning the type of drug preparation:

The vast majority of patients preferred HMs to HTs, especially for the treatment of cognitive impairment (99.0%) and dysphoric or depressive symptoms (96.2%). Looking at the gender distribution in our sample, men preferred HMs (over 86%), while women opted slightly more frequently for HTs regarding sleep disorders and stress, restlessness and nervousness.

Generally, the tolerability of HMPs was very good with an excellent benefit-risk ratio. Over 93% of all patients perceived a therapeutic benefit from HMPs while only few had unchanged or worsened symptoms. Around 86% did not perceive any AEs and only less than 3% reported significant AEs. AEs reported were e.g. gastrointestinal symptoms, dizziness, headaches or skin rashes. All of them have not been life-threatening.

Conclusion: The results provide a valuable insight into the actual treatment habits of users of HMPs. When treating MHIs with HMPs patients show a strong preference for HMs over HTs. The majority of patients used HMPs over a longer period of time, regardless of the indication or whether it was used daily or as needed. Patients with acute symptoms treated predominantly “as needed” (sleep disorders, stress, restlessness and nervousness and anxiety symptoms), while chronic symptoms, such as cognitive impairment and dysphoric or depressive symptoms were primarily treated daily and over a long time period. The latter observation indicates a high level of compliance, which could be attributed to the favorable tolerability and perceived effectiveness of HMPs.

Taken together, patients with MHIs have applied HMPs in different ways as either permanent treatment, prophylaxis or symptom relief with remarkable treatment outcomes.

Patients’ compliance was excellent, which is probably due to the rare occurrence of serious undesirable side effects.

Therefore, we suggest HMPs as a valuable alternative to synthetic drugs.