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Thursday, April 1, 2010

Is Ginger effective in preventing Chemotherapy Induced Nausea and Vomiting (CINV)?

Is Ginger effective in preventing Chemotherapy Induced Nausea and Vomiting (CINV)?




THE EVIDENCE:

Ginger root (Zingiber officinale) has been used as a medicinal herb for at least 2,000 years. In Chinese, Indian, Middle Eastern and western herbal medicine, ginger is used mainly to treat digestive disorders such as nausea, vomiting and diarrhea.



A presentation by Ryan et al (1) at the 2009 ASCO Annual Meeting described positive results with the use of ginger in the prevention of acute nausea. A multi-site, randomized, placebo-controlled double-blind trial accrued 644 patients who had experienced nausea following any chemotherapy cycle and were scheduled to receive at least 3 additional cycles. Patients were randomized into 4 arms (placebo, ginger 0.5 g per day, ginger 1 g per day and ginger 1.5 g per day). Patients took three 250 mg capsules of ginger/placebo twice daily for 6 days starting 3 days before chemotherapy, for the next 2 cycles. All patients received 5-HT3 receptor antagonists on Day 1. Nausea was reported by the patients using a 7 point rating scale. All doses of ginger significantly reduced nausea (P = 0.003), with the largest reduction in nausea occurring with 0.5 g and 1 g daily doses of ginger. There was no difference between groups in the incidence of vomiting.



Two other references report efficacy of ginger in treating acute nausea induced by chemotherapy (2) (3). Pace (2) studied 41 leukemic patients receiving chemotherapy who were randomized to receive oral ginger or placebo in addition to prochlorperazine. The results showed a significant reduction in nausea in patients receiving ginger compared to those receiving placebo. Unfortunately, these results were only published in abstract form, the dose of ginger was not indicated, and no P values were reported. Sontakke et al (3) conducted a randomized, prospective, cross-over double-blind study of 50 patients receiving cyclophosphamide-containing chemotherapy regimens who had experienced at least two episodes of vomiting in the previous chemotherapy cycle. Patients were randomized to receive ginger (1 g orally pre-chemotherapy and 1 g orally 6 hours post-chemotherapy) or metoclopramide (20 mg IV pre-chemotherapy and 10 mg orally 6 hours post-chemotherapy) or ondansetron (4 mg IV pre-chemotherapy and 4 mg orally 6 hours post-chemotherapy). Patients were monitored for 24 hours, and nausea was graded as none, mild to moderate, or severe. The effect of ginger was found to be comparable to that of metoclopramide (complete control of nausea was achieved in 62% of patients who received ginger and 58% of patients who received metoclopramide). Ondansetron was found to be better than both agents, with complete control of nausea in 86% of patients (P < 0.01). This study also assessed acute vomiting. The difference between the anti-emetic effect of metoclopramide and ginger was not statistically significant but ondansetron was significantly better than metoclopramide and ginger (P < 0.01).



Two published studies failed to demonstrate a benefit in the use of ginger in acute nausea and/or vomiting and in delayed nausea and/or vomiting (4) (5). Manusirivithaya et al (4) conducted a randomized, double-blind crossover study in 48 gynecologic cancer patients receiving cisplatin-based chemotherapy. All patients received metoclopramide IV, dexamethasone IV and lorazepam po pre- and post- chemotherapy. Patients randomly received 1 g ginger orally daily for 5 days starting on the first day of chemotherapy, or placebo for day 1 and metoclopramide 40 mg orally daily on days 2 to 5. Assessment of nausea and vomiting was performed by the investigators for the first 24 hours and by the patients for days 2 – 5. The number of vomiting episodes was recorded, and a 10 cm visual analog scale was used to indicate the intensity of nausea. Adding 1 g of ginger to the standard antiemetic regimen in patients receiving 75 mg/m2 of cisplatin had no benefit in controlling acute cisplatin-induced nausea or vomiting. In the delayed phase, 1 g/day of ginger had a control of nausea and vomiting which was not statistically different than that achieved with 40 mg metoclopramide/day. Zick et al (5) performed a randomized, double-blind, placebo-controlled trial in 162 patients with cancer who had experienced CINV during at least one previous chemotherapy cycle. Study participants received 1 g ginger daily, 2 g ginger daily or placebo for 3 days. All patients received a 5-HT3 receptor antagonist and/or aprepitant. Prevalence and severity of nausea and vomiting was recorded in a patient diary (intensity was recorded using a 6 point Likert scale). There was no significant difference between either of the ginger doses compared to placebo in the prevalence of acute or delayed nausea or vomiting. Participants who received the high dose of ginger (2 g) had significantly more severe delayed nausea compared to both placebo and low-dose ginger. Significantly more severe delayed nausea occurred with both doses of ginger in patients prescribed aprepitant.



CONCLUSION:

Ginger is generally well-tolerated and not associated with significant toxicity. Ginger may interfere with blood clotting, and should not be taken by patients with bleeding disorders or patients taking anticoagulants. The trial by Zick et al (5) indicated that when ginger was co-administered with aprepitant, the severity of delayed nausea was increased. The authors suggested that ginger could decrease the absorption of aprepitant by increasing gastrointestinal motility.



It is difficult to compare results between trials due to the variation in the ginger doses and dosing schedules used, variation in the nausea rating scales used, and variation in the emetogenicity of the chemotherapy regimens. In the prevention of CINV, the standard of care for patients receiving moderately emetogenic and highly emetogenic chemotherapy protocols includes a 5-HT3 antagonist. The two trials which studied acute CINV and included a 5-HT3 antagonist in their regimens were those by Ryan et al (1) and Zick et al (5). These trials gave conflicting results with regards to efficacy of ginger in treating acute nausea. The conclusion which may be drawn (using the methods and positive results of Ryan et al) is that ginger may be effective in preventing ACUTE NAUSEA at a dose of 0.5 g or 1 g orally daily (divided into twice daily dosing) taken for 6 days, beginning 3 days before chemotherapy (1). Both trials failed to demonstrate prevention of acute vomiting by ginger. No trial demonstrated prevention of delayed nausea and/or vomiting by ginger.





References:



1. Ryan JL, Heckler C, Dakhil SR et al. Ginger for chemotherapy-related nausea in cancer patients: A URCC CCOP randomized, double-blind, placebo-controlled clinical trial of 644 cancer patients. Journal of Clinical Oncology, 2009 ASCO Annual Meeting Proceedings (Post Meeting Edition) 27(15S):9511.

2. Pace J. Oral ingestion of encapsulated ginger and reported self-care action for the relief of chemotherapy-associated N & E. Dissertations Abstracts International 1987;47:3297-B.

3. Sontakke S, Thawani V, Naik MS. Ginger as an antiemetic in nausea and vomiting induced by chemotherapy: A randomized, cross-over, double blind study. Indian Journal of Pharmacology 2003;35:32-36.

4. Manusirivithaya S, Sripramote M, Tangjitgamol T et al. Antiemetic effect of ginger in gynecologic oncology patients receiving cisplatin. Int J Gynecol Cancer 2004;14:1063-1069.

5. Zick SM, Ruffin MT, Lee J et al. Phase II trial of encapsulated ginger as a treatment for chemotherapy-induced nausea and vomiting. Support Care Cancer 2009;17:563-572.

6. http://www.umm.edu/altmed/articles/ginger-000246.htm


Submitted by: Frances Cusano (March 26, 2010)

1 comments:

Mike March 21, 2011 at 7:18 PM  

Well, ginger's ability to treat nausea is really impressive. Many researches show that ginger has been found effective for treating nausea caused by seasickness, morning sickness and chemotherapy also. But chemotherapy patients should not take ginger if their blood-clotting ability is impaired.
Try Reed’s Ginger Brew. It varies from 8 to 26 grams per bottle!

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Pharmacy History

"The earliest known compilation of medicinal substances was ARIANA the Sushruta Samhita, an Indian Ayurvedic treatise attributed to Sushruta in the 6th century BC. However, the earliest text as preserved dates to the 3rd or 4th century AD.
Many Sumerian (late 6th millennium BC - early 2nd millennium BC) cuneiform clay tablets record prescriptions for medicine.[3]

Ancient Egyptian pharmacological knowledge was recorded in various papyri such as the Ebers Papyrus of 1550 BC, and the Edwin Smith Papyrus of the 16th century BC.

The earliest known Chinese manual on materia medica is the Shennong Bencao Jing (The Divine Farmer's Herb-Root Classic), dating back to the 1st century AD. It was compiled during the Han dynasty and was attributed to the mythical Shennong. Earlier literature included lists of prescriptions for specific ailments, exemplified by a manuscript "Recipes for 52 Ailments", found in the Mawangdui tomb, sealed in 168 BC. Further details on Chinese pharmacy can be found in the Pharmacy in China article."

From Wikipedia: http://en.wikipedia.org/wiki/Pharmacy#History_of_pharmacy

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