Hypericum extract versus imipramine or placebo in patients with moderate depression: randomised multicentre study of treatment for eight weeks   Commentary: Has hypericum found its place in antidepressant treatment?

Abstract

Objectives To assess the efficacy and safety of hypericum extract (STEI 300, Steiner Arzneimittel, Berlin) compared with imipramine and placebo in patients in primary care with a current episode of moderate depression. Design Randomised, double blind, multicentre, parallel group trial for 8 weeks. Setting Trained panel of 18 general practitioners from four German states: Bavaria, Berlin, Rhineland Palatinate, and Saxony. Participants 263 patients (66 men, 197 women) with moderate depression according to ICD-10 (international classification of diseases, 10th revision) codes F32.1 and F33.1. Interventions 1050 mg hypericum extract (350 mg three times daily), 100 mg imipramine (50 mg, 25 mg, and 25 mg daily), or placebo three times daily. Main outcome measures Change from baseline score on the 17 item version of the Hamilton depression scale, the Hamilton anxiety scale, the clinical global impressions scale, Zung's self rating depression scale, and SF-36, and adverse events profile. Results Hypericum extract was more effective at reducing Hamilton depression scores than placebo and as effective as imipramine (mean − 15.4 (SD 8.1), − 12.1 (7.4), and -14.2 (7.3) respectively). Comparable results were found for Hamilton anxiety and clinical global impressions scales and were most pronounced for the Zung self rating depression scale. Quality of life was more improved in the standardised mental component scale of the SF-36 with both active treatments than with placebo but in the physical component scale was improved only by hypericum extract compared with placebo. The rate of adverse events with hypericum extract was in the range of the placebo group but lower than that of the imipramine group (0.5, 0.6, and 1.2 events per patient respectively). Conclusions At an average dose of 350 mg three times daily hypericum extract was more effective than placebo and at least as effective as 100 mg imipramine daily in the treatment of moderate depression. Treatment with hypericum extract is safe and improves quality of life.

Efficacy and Tolerability of Tricyclic Antidepressants and SSRIs Compared With Placebo for Treatment of Depression in Primary Care: A Meta-Analysis

“…There were 890 participants in SSRI studies, 596 in TCA studies, and 1,267 patients on placebo (Table 1). [16][17][18][19][20][21][22][23][24][25][26][27][28][29][30] Of the 5 possible SSRIs available, 2 studied sertraline, 3 studied escitalopram (a precursor of citalopram), and 1 studied citalopram. Of the TCAs available, 2 studied dothiepin, 4 studied amitriptyline, 2 studied mianserin, and 3 studied imipramine.…”

“…We also performed a funnel plot analysis to check for publication bias. There were a number of defi nitions for outcomes we described as "improvement": 4 defi nitions used ≤50% reduction in the Montgomery-Asberg Depression Rating Scale (MADRS), [16][17][18][19] ≤50% reduction in Hamilton Depression Rating Scale (HAMD), 20 ≤7 on the HAMD scale, 21 and ≤4 points on HAMD 22 ; and 3 defi nitions used global evaluation of improvement.…”

Alternative Medicine Use by Individuals with Major Depression

“…Some stud ies have dem on strated that St John's wort ef fectively treats mi nor and mild de pres sion and some times has fewer side ef fects than an ti de pres sant treat ment (13)(14)(15). Perceived ef fi cacy may be a mo ti va tion for vis it ing AM…”

“…Ad di tionally, AM approaches have not been tested suf fi ciently (12). Some stud ies as sert that AM may be as ef fec tive as con ven tional an ti depres sant treat ment among pa tients with mild and mod er ate de pres sion (13)(14)(15). A re cent ran dom ized, dou ble-blind, placebo-con trolled clin i cal trial found that a widely used herbal prod uct, St John's wort (Hypericum perforatum), was not effec tive for treat ment of ma jor de pres sion (16).…”

The 2 “Es” of Research: Efficacy and Effectiveness Trials

“…Needless to say, efficacy studies try very hard to avoid these pitfalls, using various techniques. From the provider's perspective, these techniques include having therapists attend training sessions so that they can learn to perform the therapy systematically (9), using treatment manuals that detail what should and should not be done during the sessions (10), taperecording the sessions so that they can later be checked for adherence to the treatment protocol (11), having fixed dosing regimens or algorithms in drug trials (12), or having a fixed number of therapy sessions (13). Some surgical trials even go so far as to drop surgeons or centres that have high perioperative mortality or infection rates (14).…”