Harpagophytum Procumbens Clinical Trials
Harpagophytum Procumbens Clinical Trials
Harpagophytum Procumbens Clinical Trials
J Pharm Pharmacol. 2014 Aug 31. doi: 10.1111/jphp.12242. [Epub ahead of print]
J Nat Med. 2010 Apr;64(2):219-22. doi: 10.1007/s11418-010-0395-8. Epub 2010 Feb 23.
J Ethnopharmacol. 2012 Oct 11;143(3):755-71. doi: 10.1016/j.jep.2012.08.013. Epub 2012 Aug 21.
OBJECTIVES:
Potential interactions between herbal medicinal products and the cytochrome (CYP) P450 system are an important safety concern. We set out to
develop a screening panel for assessing such interactions and use it to evaluate the interaction potential of devil's claw.
METHODS:
The panel consisted of luminescence-based inhibition assays for CYP1A2, 2C9, 2C19, 2D6 and 3A4, and a reporter gene (luciferase) assay for
pregnane X receptor (PXR) activation and CYP3A4 induction. Caftaric acid and chlorogenic acid, two compounds with strong fluorescence quenching
properties, were used to demonstrate the assay's resistance to interference. We tested 10 commercial devil's claw preparations as well as harpagoside
and harpagide, two important constituents of devil's claw.
KEY FINDINGS:
Five preparations were found to weakly inhibit CYP3A4 (IC50 124.2-327.6 g/ml) and five were found to weakly activate PXR (EC50 10.21-169.3
g/ml). Harpagoside and harpagide did not inhibit CYP3A4. In agreement with published data, bergamottin, a natural product known to interact with
CYP3A4, was shown to inhibit CYP3A4 with an IC50 of 13.63 m and activate PXR with an EC50 of 6.7 m.
CONCLUSIONS:
Devil's claw preparations are unlikely to have a clinically relevant effect on CYP function. The assay panel proved effective in
screening devil's claw preparations, demonstrating its suitability for use with plant extracts. It showed superior sensitivity and resistance to interference.
OBJECTIVES:
The aim of the study was to evaluate the clinical relevance of the efficacy of a marketed complex of 3 plant extracts-H procumbens, C longa, and
bromelain (AINAT, 650 mg)-in the treatment of degenerative joint pain.
METHODS:
A multicenter, observational, prospective, open-label survey was conducted in 8 rheumatology centers. The study included 2 groups, 1 group with
participants suffering from chronic osteoarthritis (OA) pain and 1 group suffering from acute OA pain.
SETTING:
The research team carried out the study under daily practice conditions.
PARTICIPANTS:
A total of 42 patients (36 women; mean age = 67 y) suffering from acute or chronic, degenerative spine or joint pain participated.
INTERVENTION:
Two 650-mg capsules of AINAT were administered 3 /d to patients with acute pain and 2 /d to patients with chronic pain.
OUTCOME MEASURES:
At baseline, and during a follow-up visit at 15 d for the acute pain group and 60 d for the chronic pain group, the research team obtained each
participant's global assessment (PGA) and each rheumatologist's global assessment (RGA), as well as each participant's pain score, using for each of
them a 100-mm visual analogue scale (VAS). The clinical relevance of the efficacy was evaluated by comparing the outcome measures at endpoint to
the values defining the patient acceptable symptom state (PASS) and by comparing the variations (in mm and %) between baseline and endpoint to
those defining the minimal clinically important improvement (MCII). Tolerance was also assessed by collecting adverse events at each visit and by
using a 4-point scale (very good to bad) at the endpoint.
RESULTS:
At baseline, the VAS pain score (standard deviation) was 69.1 mm (15.4) and 68.0 mm (18.2) for patients with acute and chronic pain, respectively. At
the endpoint, the scores decreased to 42.1 mm (21.1) and 37.8 mm (25.9), respectively. This reduction of pain, as a percentage as well as an absolute
value, corresponds to the required definition of MCII, particularly in patients with chronic joint pain. At the endpoint, most of the patients in both groups
reached the level of pain defined as the PASS. No withdrawals occurred due to treatment side effects.
CONCLUSION:
The improvement of joint pain was clinically relevant in patients treated with AINAT for both acute and chronic OA pain. Considering its excellent
tolerance profile, the tested complex of 3 plant extracts with antiinflammatory properties may be a valuable and safe alternative to NSAIDs in patients
suffering from degenerative joint diseases.
Phytother Res. 2012 Jun;26(6):806-11. doi: 10.1002/ptr.3636. Epub 2011 Nov 10.
Author information
Abstract
Harpagophytum procumbens (Hp) is often used in the supportive treatment of inflammatory and degenerative diseases of the skeletal system.
Although the clinical efficacy in osteoarthritis has been demonstrated in clinical trials, the molecular target(s) of Hp are unclear. This study quantified
the effects of the ethanol Hp extract (60% v/v ethanol, sole active ingredient of Pascoe-Agil), on the expression and release of the major proinflammatory mediators in LPS-stimulated human monocytes and the intracellular signalling pathways involved in inflammation. The Hp extract dosedependently inhibited the release of TNF as well as that of interleukin (IL)-6, IL-1 and prostaglandin E (PGE). The Hp prevented TNF and IL-6
mRNA expression in human monocytes and cyclooxygenase-2 (COX-2) in RAW 264.7 cells. Furthermore, the Hp extract inhibited LPS-stimulated AP1-mediated gene transcription activity and binding to the AP-1 response elements. The extract had no effect on the LPS-induced binding of nuclear
factor-B in RAW 264.7 cells, on LPS-induced degradation of IB or on LPS-induced activation of mitogen-activated protein kinases (MAPK),
p38MAPK and JNK in human monocytes. The data indicate that a standardized ethanol Hp extract inhibits induction of pro-inflammatory gene
expression, possibly by blocking the AP-1 pathway. This is novel evidence of a possible mechanism of action of this antiinflammatory drug.
may reduce pain but high costs and product quality issues limit its use. Several other supplements are promoted for treatingosteoarthritis, such as
methylsulfonylmethane, Harpagophytum procumbens (devil's claw), Curcuma longa (turmeric), and Zingiber officinale (ginger), but there is insufficient
reliable evidence regarding long-term safety or effectiveness.
Devil's Claw (Harpagophytum procumbens DC): an evidencebased systematic review by the Natural Standard Research
Collaboration.
Brendler T1, Gruenwald J, Ulbricht C, Basch E; Natural Standard Research Collaboration.
Author information
Abstract
An evidence-based systematic review including written and statistical analysis of scientific literature, expert opinion, folkloric precedent, history,
pharmacology, kinetics/dynamics, interaction, adverse effects, toxicology, and dosing.
METHODS:
Results specifically related to pain were retrieved from review articles of acupuncture, homeopathy, herbal remedies, and selected nutritional
supplements.
RESULTS:
Evidence exists to support the efficacy of reducing pain from osteoarthritis (OA) for acupuncture; devil's claw, avocado/soybean unsaponifiables,
Phytodolor and capsaicin; and chondroitin, glucosamine, and SAMe. Strong support exists for gamma linolenic acid (GLA) for pain of rheumatoid
arthritis (RA).
CONCLUSIONS:
Despite support for some of the most popular CAM therapies for pain from arthritis-related conditions, additional high quality research is needed for
other therapies, especially for herbals and homeopathy.
Wegener T.
Author information
Abstract
Herbal medicinal products with secondary tubers of Devil's Claw (Harpagophyti radix) are successfully used in degenerative rheumatism. The interest
in this herbal drug is documented by many controlled and uncontrolled clinical studies in the last few years. Efficacy was tested in patients with
degenerative rheumatism or low back pain. There was shown an improvement of motility and a reduction of pain sensation and a good tolerability
following an administration even for only few weeks.