Зинаксин

OBJECTIVE: Alternative medicine is used extensively by patients with chronic pain due to e.g., osteoarthritis. Only few of these drugs have be tested in a controlled setting and the present study was undertaken to examine the effect of ginger extract, one of the most popular herbal medications. DESIGN: Ginger extract was compared to placebo and Ibuprofen in patients with osteoarthritis of the hip or knee in a controlled, double blind, double dummy, cross-over study with a wash-out period of one week followed by three treatment periods in a randomized sequence, each of three weeks duration. Acetaminophen was used as rescue medication throughout the study. The study was conducted in accordance with Good Clinical Practice (European Guideline for GCP). RESULTS: A ranking of efficacy of the three treatment periods: Ibuprofen>ginger extract>placebo was found for visual analogue scale of pain (Friedman test: 24.65, P< 0.00001) and the Lequesne-index (Friedman test: 20.76, P< 0.00005). In the cross-over study, no significant difference between placebo and ginger extract could be demonstrated (Siegel-Castellan test), while explorative tests of differences in the first treatment period showed a better effect of both Ibuprofen and ginger extract than placebo (Chi-square, P< 0.05). There were no serious adverse events reported during the periods with active medications. CONCLUSION: In the present study a statistically significant effect of ginger extract could only be demonstrated by explorative statistical methods in the first period of treatment before cross-over, while a significant difference was not observed in the study as a whole. Copyright 2000 OsteoArthritis Research Society International.

Rheumatology, January 2002 Journal Scan

From
Arthritis and Rheumatism
November 2001 (Volume 44, Number 11)

Effects of a Ginger Extract on Knee Pain in Patients With Osteoarthritis
Altman RD, Marcussen KC
Arthritis and Rheumatism. 2001;44(11):2531-2538

There has been increasing interest in the use of herbal agents for the treatment of osteoarthritis. A recent article by Altman and Marcussen reported a randomized, double-blind, placebo-controlled trial of the use of a ginger extract for treatment of osteoarthritis of the knee. This study was well designed and carefully conducted, and it received extensive coverage in the general press and radio, leading to many phone calls from patients.
Although some press releases heralded this study as a "breakthrough" for nutraceuticals, the data indicated that the results of ginger over placebo were small and inconsistent according to both the author and the accompanying editorial.[1] Further, the results could have been due to instruction of the patients prior to the study about the pungent taste of ginger, which may have made a truly "blinded" study difficult.[1]

The main finding of the study was reduced pain while standing, which is not a well-standardized measurement. The more specific osteoarthritis measurement technique is the Western Ontario and McMaster University osteoarthritis index (WOMAC) of the knee,[2] and no significant differences between ginger and placebo were noted when measured by WOMAC. The absence of a significant improvement with ginger extends the previous double-blind study with similar results by Bliddal and colleagues.[3]

The recent studies on ginger continue the debate in the medical literature over the potential benefit of a group of naturally derived extracts termed nutraceuticals. Although a recent review suggests only scarce clinical evidence for the effects of these nutrients in patients with knee, hip, or hand osteoarthritis,[4] the media coverage of these agents remains wildly enthusiastic. Ginger and its extracts have been used for more than 500 years and are described in early Ayurvedic and Tibb systems of medicine to be useful in inflammation and rheumatism,[5] so it appears that the public assumes that they must have value to have survived in the medicinal arsenal for such a duration.

While the debate over efficacy continues, it is important to note that a number of herbal medicines inhibit platelet function and may be associated with bleeding during surgery. Patients often do not report use of these agents to physicians because they are either ashamed or do not recognize them as medications to be stopped prior to surgery or anticoagulation. Further, most have not been checked for interaction with other drugs.[6,7] Because the available studies of safety of herbal drugs have been short, it is important to remind patients that therapy for conditions such as osteoarthritis will require long-term therapy and monitoring to assess subtle toxic adverse effects, including drug interactions.


References


Marcus DM, Suarez-Almazor ME. Is there a role for ginger in the treatment of osteoarthritis? Arthritis Rheum. 2001;44:2461-2462.
McConnell S, Kolopack P, Davis AM. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): a review of its utility and measurement properties. Arthritis Rheum. 2001;45:453-461.
Bliddal H, Rosetzsky A, Schlichting P, et al. A randomized, placebo-controlled, cross-over study of ginger extracts and ibuprofen in osteoarthritis. Osteoarthritis Cartilage. 2000;8:9-12.
Hauselmann HJ. Nutripharmaceuticals for osteoarthritis. Best Pract Res Clin Rheumatol. 2001;15:595-607.
Srivastava KC, Mustafa T. Ginger (Zingiber officinale) in rheumatism and musculoskeletal disorders. Med Hypotheses. 1992;39:342-348.
Ernst E. Harmless herbs? A review of the recent literature. Am J Med. 1998;104:170-178.
Ernst E. Herb-drug interactions: potentially important but woefully under-researched. Eur J Clin Pharmacol. 2000;56:523-524.