Hypericum perforatum to Improve Postoperative Pain Outcome After Monosegmental Spinal Sequestrectomy (HYPOS): Results of a Randomized, Double-Blind, Placebo-Controlled Trial.

Introduction: Patients undergoing lumbar spine surgery often suffer from severe radicular postoperative pain leading to the prescription of high-dose opioids. In Integrative Medicine, Hypericum perforatum is known as a remedy to relieve pain caused by nerve damage. Objectives: This trial investigated whether homeopathic Hypericum leads to a reduction in postoperative pain and a decrease in pain medication compared with placebo. Design: Randomized double blind, monocentric, placebo controlled clinical trial. Settings/Location: Department of Neurosurgery, Community Hospital Herdecke. Subjects: Inpatients undergoing lumbar sequestrectomy surgery. Interventions: Homeopathic treatment versus placebo in addition to usual pain management. Outcomes Measures: Primary endpoint was pain relief measured with a visual analog scale. Secondary endpoints were the reduction of inpatient postoperative analgesic medication and change in sensory and affective pain perception. Results: Baseline characteristics were comparable between the groups. Pain perception between baseline and day 3 did not significantly differ between the study arms. With respect to pain medication, total morphine equivalent doses did not differ significantly. However, a statistical trend and a moderate effect (d = 0.432) in the decrease of pain medication consumption in favor of the Hypericum group was observed. Conclusion: This is the first trial of homeopathy that evaluated the efficacy of Hypericum C200 after lumbar monosegmental spinal sequestrectomy. Although no significant differences between the groups could be shown, we found that patients who took potentiated Hypericum in addition to usual pain management showed lower consumption of analgesics. Further investigations, especially with regard to pain medication, should follow to better classify the described analgesic reduction. Clinical Trial Registration Number: German Clinical Trials Register No: DRKS00007913.

Hypericum perforatum to improve post-operative Pain Outcome after monosegmental Spinal microdiscectomy (HYPOS): a study protocol for a randomised, double-blind, placebo-controlled trial.

BACKGROUND: Spinal disc herniation is a frequently occurring degenerative disease of the spine. Many patients undergoing surgery suffer from radicular pain, known as memory pain, beginning from the third post-operative day. This results in the prescription of high-dose opioid medications. In homeopathy, Hypericum perforatum is known as a remedy for unbearable, shooting or jabbing pain especially when neural damage is involved. Reduction of pain after application of H. perforatum has been observed in previous studies. This study is aimed to investigate whether homeopathic H. perforatum in a potentisation of C200 leads to the reduction of post-operative pain and a decrease of pain medication compared to placebo. METHODS/DESIGN: This is a monocentric, double-blind, randomised placebo-controlled trial conducted at the Department of Neurosurgery at the Community Hospital Herdecke, Germany. One hundred study participants are being recruited from inpatients undergoing elective, monosegmental, lumbar microdiscectomy surgery. Patients are randomly allocated to receive homeopathic treatment or placebo in addition to usual pain management after surgery. The primary clinical outcome is pain reduction after 3 days of inpatient care as measured by pain reduction of subjective pain on a 100-mm Visual Analogue Scale (VAS) at the third post-operative day. Statistical analysis will be carried out by means of a covariance model with adjustment for baseline values and patient expectation for all randomised patients. DISCUSSION: This study is the first trial of classical homeopathy that will evaluate the efficacy of homeopathic H. perforatum after monosegmental spinal microdiscectomy. We intend to clarify the potential of homoeopathic H. perforatum to reduce surgery-associated pain. TRIAL REGISTRATION: German Clinical Trials Register, ID: DRKS00007913 . Registered on 17 October 2014. EudraCT - Nr: 2013-001383-31. Data sets from the German Clinical Trials Register (DRKS, Deutsches Register Klinischer Studien) are updated every 4 weeks automatically to the International Clinical Trials Registry Platform of World Health Organisation: http://apps.who.int/trialsearch/ . Responsibilities Sponsor: Witten/Herdecke University Alfred-Herrhausen-Straße 50 58,448 Witten Deputy of the sponsor: Dr. Wolfgang Eglmeier (Head of Centre for Clinical Trials Witten/Herdecke) Alfred-Herrhausen-Straße 50 58,448 Witten E-mail: wolfgang.eglmeier@uni-wh.de Principal investigator: Prof. Dr. med. Wolfram Scharbrodt Community Hospital Herdecke Department for Neurosurgery Gerhard-Kienle-Weg 4 58,313 Herdecke w.scharbrodt@gemeinschaftskrankenhaus.de Project coordination: Christa Raak Faculty for Health (Department for Integrative and Anthroposophic Medicine) University Witten/Herdecke gGmbh Gerhard-Kienle-Weg 4 58,313 Herdecke christa.raak@uni-wh.de Project manager/data analysis/biometry: Prof. Dr. Thomas Ostermann Faculty for Health (Department for Psychology and Psychotherapy) University Witten/Herdecke gGmbh Alfred-Herrhausen-Straße 50 58,448 Witten thomas.ostermann@uni-wh.de.