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Re: Доказательная медицина о лечебном голодании.

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Сообщение от Вадим Асадулин
http://herbalgram.org/wholefoodsmark...iew.asp?a=2546
HerbalGram. 2003;59:23 American Botanical Council

Reviewed: Sallon S, Ben Arye E, Davidson R, Shapiro H, Ginsberg G, Ligumsky M. A novel treatment of constipation-predominant irritable bowel syndrome using Padma Lax, a Tibetan herbal formulation. Digestion 2002;65:161-171.

Irritable bowel syndrome (IBS) is a gastrointestinal disorder characterized by pain, disturbed defecation, bloatedness, and distention, which are unexplained by structural or biochemical abnormalities. According to three studies cited in this article under discussion, 15-20 percent of people worldwide suffer from IBS. Drugs, dietary modifications, behavioral treatments, and alternative therapies are current treatment strategies. Herbal remedies are growing in popularity, but the value of such treatments has not been well studied. Based on a Tibetan recipe traditionally used to treat constipation and aid in digestion, Padma�Lax is a complex formula of 15 herbs and minerals. This article reports on a pilot study evaluating the efficacy and safety of Padma Lax in patients with constipation-predominant IBS.

Eighty men and women (aged 20�81 years) with diagnosed constipation-predominant IBS participated in this randomized, double-blind, placebo-controlled study. All patients entered the 2-week run-in period where an initial gastroenterological screening, blood tests, and daily diaries were recorded for a baseline measurement. After the 2-week run-in, patients took 2 capsules of Padma Lax (n = 42) or an identical looking placebo (n = 38) for 12-weeks. Padma Lax (Padma AG, Schwerzenbach, Switzerland) 482 mg capsules contain: 12.5 mg Aloe standardized extract (Aloe vera (L.) Burm. f., Aloaceae and A. ferox Mill.), 10 mg calumba root (Jateorhiza palmata (Lam.) Miers, Menispermaceae), 10 mg condurango bark (Marsdenia cundurango Rchb. f., Apocynaceae), 52.5 mg frangula bark (Frangula alnus Mill., Rhamnaceae), 35 mg gentian root (Gentiana lutea L., Gentianaceae), 35 mg elecampane rhizome (Inula helenium L., Asteraceae), 35 mg chebulic myrobalan or tropical almond fruit (Terminalia chebula Retz. var. tormentella (Kurz) C.B. Clarke, Combretaceae), 3.5 mg long pepper (Piper longum L., Piperaceae), 52.5 mg cascara sagrada bark (Frangula purshiana (DC.) J.G. Cooper, Rhamnaceae; syn. Rhamnus purshiana DC.), 70 mg Chinese rhubarb root (Rheum palmatum L. var. tangaticum Regel, Polygonaceae), 1.75 mg nux vomica seed (Strychnos nux-vomica L., Loganiaceae), 70 mg ginger root (Zingiber officinale Roscoe, Zingiberaceae), 25 mg heavy kaolin (clay), 15 mg sodium bicarbonate, and 35 mg sodium sulfate.

Symptoms, stool consistency, bowel movement frequency, pain, urgency, incomplete evacuation, and abdominal distension were recorded.

Both groups increased their stool frequency throughout the study. However, by the end of three months, subjects receiving Padma Lax increased their mean stool frequency to 6 days per week compared to 5 days per week for placebo-treated subjects (P = .002). Severity of constipation improved in both groups, but was significantly better in patients treated with Padma Lax by the end of the study (P = .0001). After three months of treatment, there was a significant decline in the severity of abdominal pain in the Padma Lax-treated subjects (P = .05). Compared to baseline, subjects receiving Padma Lax experienced a significant decline in flatulence (P < .05) and abdominal distension (P < .01) after three months of treatment. At the end of the study, a general improvement in bowel habit was reported by 70 percent of Padma Lax subjects, compared to 11 percent of placebo subjects (P = .001). Of the 34 Padma Lax subjects who completed the study, 10 had mild side effects, including slight headache, nausea, and hoarseness. Seven subjects developed diarrhea, including one who additionally complained of a mild episode of dizziness, shortness of breath, and chest pain which resolved within 24 hours. Patients with diarrhea were permitted to decrease the dose to 1 capsule per day. There was no difference in final outcomes between patients who maintained the regimen of 2 capsules daily and those who lowered their dosage to 1 capsule per day.

IBS is a chronic condition with spontaneous fluctuations, so three months is the minimum time required to see an effect. During the first month of treatment, placebo and Padma Lax caused nearly the same amount of improvement. An effect at three months may indicate that the patients were receiving more benefit from Padma Lax therapy. Laboratory investigations showed no clinically relevant changes after three months for either the Padma Lax or placebo group in electrolyte levels, in liver and kidney function tests, or blood tests.

The manufacturer�s website notes that those who take the product without a doctor�s supervision should not take it more than 1�2 weeks, and that exceeding the recommended dose can lead to depletion of essential electrolytes, especially potassium, which can lead to health complications. Patients taking cardiac glycosides are cautioned to exercise particular care with stimulant laxatives. Further, taking laxatives beyond the recommended duration can damage intestinal mucosa and lead to dependency, a significant reduction in the ability to perform normal bowel functions without the use of laxatives. Laxative products should not be used for longer than 1 week, unless directed by a doctor.

It should also be noted that the American Herbal Products Association�s Botanical Safety Handbook states that the aloe species listed above are contraindicated in "� any inflammatory condition of the intestines � [including IBS]." That same source notes that products containing cascara sagrada bark, frangula bark, and/or rhubarb root should be labeled to caution consumers to follow directions carefully, and not to use if they have diarrhea, loose stools, or abdominal pain.

Padma Lax has been marketed in Switzerland for more than 30 years, the authors report, with no adverse effects reported to the Swiss health authorities.

�Heather S. Oliff, Ph.D.


The preceding Research Review is drawn from the 2,000 critical reviews available online to members of ABC at the Academic level and above. The full HerbClip Educational Mailing Service is distributed bimonthly and includes 12 critical reviews along with many of the original articles drawn from a variety of professional and mainstream sources. To receive the full service, contact Wayne Silverman, PhD, at 512/926-4900 ext. 120, or via email
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