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Hypericum perforatum to improve post-operative Pain Outcome after monosegmental Spinal microdiscectomy (HYPOS): a
Christa Raak1, Wolfram Scharbrodt2, Bettina Berger3
1Institute of Integrative Medicine, Witten/Herdecke University, 58313 Herdecke, Germany. christa.raak@uni-wh.de.
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.
Insights
This study investigates if homeopathic Hypericum perforatum (H. perforatum) can reduce post-operative pain and opioid use after spinal disc surgery. The trial aims to determine the efficacy of H. perforatum compared to a placebo in managing surgical pain.
Area of Science:
- Neurosurgery
- Integrative Medicine
- Homeopathy
Background:
- Spinal disc herniation is a common degenerative spine condition.
- Post-operative radicular pain (
- memory pain
- ) is a frequent complication, often requiring high-dose opioid analgesics.
- Homeopathic Hypericum perforatum (H. perforatum) is traditionally used for nerve-related pain.
Purpose of the Study:
- To evaluate the efficacy of homeopathic H. perforatum (C200) in reducing post-operative pain following lumbar microdiscectomy.
- To assess the potential of H. perforatum to decrease the need for opioid pain medication compared to placebo.
Main Methods:
- A monocentric, double-blind, randomized placebo-controlled trial.
- 100 inpatients undergoing elective, monosegmental, lumbar microdiscectomy.
- Participants received either homeopathic H. perforatum or placebo alongside standard pain management.
- Primary outcome: pain reduction measured by Visual Analogue Scale (VAS) on the third post-operative day.
Main Results:
- Results are pending as this is a trial description.
- The study is designed to provide data on pain reduction and medication needs.
Conclusions:
- This is the first trial assessing classical homeopathy with H. perforatum post-spinal microdiscectomy.
- The study aims to clarify the potential of H. perforatum in managing surgery-associated pain.
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