Paper

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

BMJ 1999; 319 doi: 10.1136/bmj.319.7224.1534 (Published 11 December 1999)
Cite this as: BMJ 1999;319:1534

This article has a correction

Please see: Hypericum extract versus imipramine or placebo in patients with moderate depression: randomised multicentre study of treatment for eight weeks

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.

Key messages

  • Hypericum extract (STEI 300) was effective after 4, 6 and 8 weeks of treatment in patients with moderate depression

  • Simultaneous analysis confirmed hypericum extract to be at least as efficacious as imipramine 100 mg daily after eight weeks of treatment

  • Besides better antidepressive efficacy both hypericum extract and imipramine improved quality of life

  • Patients tolerate hypericum extracts much better than they do tricyclics and therefore by improving patients' compliance hypericum extracts are promising drugs for long term treatment

Footnotes

    • Accepted 31 August 1999

    Hypericum extract versus imipramine or placebo in patients with moderate depression: randomised multicentre study of treatment for eight weeks

    1. Michael Philipp, professor of psychiatrya,
    2. Ralf Kohnen, professor of psychologyb,
    3. Karl-O Hiller, senior research fellow (kohiller.steiner{at}t-online.de)c
    1. a Bezirkskrankenhaus Landshut, D-84034 Landshut, Germany
    2. b Imerem Institute for Medical Research Management and Biometrics, D-90478 Nuremberg, Germany
    3. c Steiner Arzneimittel, D-12207 Berlin, Germany
    4. a Centre for Complementary Medicine Research, Department of Internal Medicine II, Technische Universität München, Munich, Germany
    5. b Department of Psychiatry and Psychotherapy, Albert-Ludwigs- Universität, 79104 Freiburg, Germany
    1. Correspondence to: K-O Hiller
    • Accepted 31 August 1999

    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.

    Key messages

    • Hypericum extract (STEI 300) was effective after 4, 6 and 8 weeks of treatment in patients with moderate depression

    • Simultaneous analysis confirmed hypericum extract to be at least as efficacious as imipramine 100 mg daily after eight weeks of treatment

    • Besides better antidepressive efficacy both hypericum extract and imipramine improved quality of life

    • Patients tolerate hypericum extracts much better than they do tricyclics and therefore by improving patients' compliance hypericum extracts are promising drugs for long term treatment

    Footnotes

    • Funding Steiner Arzneimittel, Berlin, Germany.

    • Competing interests KOH is an employee of Steiner Arzneimittel. RK is head of a contract research organisation (IMEREM), which is engaged in several clinical trials with hypericum extract for different pharmaceutical companies.

    • Accepted 31 August 1999

    Commentary: Has hypericum found its place in antidepressant treatment?

    1. Klaus Linde, senior researcher (Klaus.Linde{at}lrz.tu-muenchen.de)a,
    2. Michael Berner, clinical psychiatristb
    1. a Bezirkskrankenhaus Landshut, D-84034 Landshut, Germany
    2. b Imerem Institute for Medical Research Management and Biometrics, D-90478 Nuremberg, Germany
    3. c Steiner Arzneimittel, D-12207 Berlin, Germany
    4. a Centre for Complementary Medicine Research, Department of Internal Medicine II, Technische Universität München, Munich, Germany
    5. b Department of Psychiatry and Psychotherapy, Albert-Ludwigs- Universität, 79104 Freiburg, Germany
    1. Correspondence to: K Linde

      Footnotes

      • Competing interests MB has received sponsorship from Schwabe in the past, manufacturer of a hypericum extract.

      • website extra The sample size calculation and a chart showing the flow of participants through the trial appear on the BMJ's website www.bmj.com

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