Depression is very common among mental illnesses. Unipolar depression is the third leading cause of so-called Disability Adjusted Life Years (DALY), years of life associated with health limitations and disability. Efficacies have been demonstrated for tricyclic antidepressants, SSRIs, SNRIs, and MAO inhibitors. Because it is better tolerated, St. John’s wort offers a good alternative for mild to moderate depression. Health care research in this area was presented at the 28th Swiss Annual Conference on Phytotherapy in Baden.
Prof. Reinhard P. T. Rychlik, MD, PhD, of the Ruhr University in Bochum, Germany, sees health services research as research conducted under everyday conditions, but using valid methods, that can complement clinical studies in that it confirms clinical evidence in everyday life. Randomized, controlled, double-blind trials (RCTs) can describe the pure efficacy of an intervention under controlled conditions and thus have high internal validity but lower external validity. When it comes to the actual effect (“effectiveness”) of an intervention under real-life practice conditions, health services research with its higher external validity can fill the evidence gap.
Proven efficacy in meta-analysis and RCT
A meta-analysis from 2008 [1] concluded for St. John’s wort extracts that they
- Placebo are superior in patients with unipolar depression
- are comparably effective as standard synthetic antidepressants
- cause fewer side effects than standard antidepressants.
Gastpar et al. compared Hypericum extract STW 3-VI with citalopram and placebo in terms of efficacy and tolerability in a phase III study [2] in 388 outpatients diagnosed with moderate depression requiring treatment in 2006. They were able to show that STW 3-VI was significantly superior to placebo after six weeks (p<0.0001) and comparably effective (“non-inferior”) to the SSRI citalopram. The validity of the study results was also evident in the significant superiority of citalopram over placebo. As expected, tolerability was significantly better with STW 3-VI than with citalopram.
Supply research confirms results
“In our study, the primary objective was to compare the everyday effectiveness of STW 3-VI (900 mg, q.d.) and SSRI. Data were collected on efficacy, quality of life, tolerability, compliance, and the relevant direct and indirect costs under the respective therapy for moderate depression,” Prof. Rychlik introduced the second part of his presentation.
This was a six-month, non-interventional, observational study based on documentation of 669 outpatients by 77 centers. The diagnosis was moderate depression (ICD-10 F 32.1, F 33.1) and depressive disorders/episodes (F 32.9, F 32.8, F 33.9). Data collection points were at the beginning of observation (visit 1), after approximately three to four weeks (V2), three months (V3) and six months (V4). Treatment outcome was assessed using the Quick Inventory of Depressive Symptomatology (QIDS), a validated questionnaire assessing depression severity adapted from the Hamilton Scale (HAM-D). The QIDS has advantages for use in daily practice because it is available as both a third-party and self-assessment instrument (QIDS-C and QIDS-SR) and is easy to use (only 9 of 16 questions to be evaluated; for symptom complexes, only the highest score in each case counts). Another parameter was quality of life, assessed using the cross-disease self-report instrument “SF-36 v2 Health Survey” (SF 36). Also performed were cost-utility and cost-effectiveness analyses of the two treatment alternatives.
Results: For both treatment groups, symptoms improved during the observation period (difference between groups n.s., p=0.202). Tolerability in the STW-3-VI group was better than in the SSRI group (p<0.001). Patients in the STW-3 VI group showed better compliance. The cost-utility analysis showed that STW 3-VI therapy resulted in lower costs and a higher quality-adjusted life-year (QALY) score and thus an overall better cost-utility ratio compared with SSRI. QIDS-C and QIDS-SR were used for the cost-effectiveness analysis. One calculated a higher cost-effectiveness for the STW-3-VI approach due to the lower costs and despite marginally worse effects.
Conclusion: “Our observational study demonstrated non-inferiority of Hypericum extract to SSRIs in efficacy, but superiority to placebo. Thus, for outpatients with moderate depression, it is a therapeutically equivalent substance with a lower side effect rate, better tolerability and higher patient compliance. In addition, STW 3-VI is cost superior to the SSRI studied. Overall, we were able to confirm the results from clinical studies in everyday care,” Prof. Rychlik concluded his presentation.
Source: “St. John’s wort: health care research follows double-blind studies”, 28th Swiss Annual Conference on Phytotherapy, November 21, 2013, Baden.
Literature:
- Linde K, et al: St John’s wort for major depression. Cochrane Database Syst Rev 2008 Oct 8; (4): CD000448. doi: 10.1002/14651858.CD000448.pub3.
- Gastpar M, et al: Comparative efficacy and safety of a once-daily dosage of hypericum extract STW3-VI and citalopram in patients with moderate depression: a double-blind, randomised, multicentre, placebo-controlled study. Pharmacopsychiatry 2006 Mar; 39(2): 66-75.
The Hypericum extract STW 3-VI is commercially available in Switzerland under the name Deprivita®.
InFo Neurology & Psychiatry 2014; 12(1): 38-40.
