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 No BM 2 days after Enema
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Sweetmaxine
Advanced Member

51 Posts

Posted - 06/15/2007 :  06:53:30  Show Profile
Hi everyone. It's great posting here and feeling free to talk about constipation and enemas. I recently bought the smooth flow higginson syringe and gave myself a very thorough enema with purified water and sea salt 2 days ago. I had an amazing cleanse and cleaned out what I think was most of the entire colon. ALOT came out and I was greatly relieved. Now however, 2 days have gone by and I have not had a bowel movement on my own. I don't want to use laxatives. I have been eating Activia and flaxseed, and bran and fruit and drinking plenty of water but I have not had a bowel movement since my enema on Wednesday. Should I do another enema? I really think I may have to resort to this since all other measures have not produced a bowel movement. Any suggestions?
thanks!

Dave
Advanced Member

422 Posts

Posted - 06/15/2007 :  07:25:46  Show Profile
I am no expert, but I think your situation may be due to a combination of couple of factors, Sweetmaxine. First, your enema may have been so complete that it left little in the colon for another BM. Also, I have read that too much fiber (bulk, roughage) actually is constipating, and your diet indicates that.
I would eat a more balanced diet today and wait until tomorrow to see what happens before taking another enema unless you are really uncomfortable.
Just a suggestion.
Dave
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Sweetmaxine
Advanced Member

51 Posts

Posted - 06/15/2007 :  08:30:41  Show Profile
Thanks Dave. Yes. I have heard that too much fiber can bloat and back you up. I also considered that my colon may take a while to get "primed" for another bm. Afterall, that was a very thorough enema I took. My stomach went from being bloated to FLAT afterward. Alot was in there. Well, I appreciate your advise and may wait for a while on the enema.
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Garym
Average Member

33 Posts

Posted - 06/15/2007 :  18:52:59  Show Profile
Thanks to both of you for this information. I did not realize that too much fiber could also cause constipation problems. What is the best way to get going again after a enema series? This always seems to be a challenge for me.

Gary
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Clint
Advanced Member

234 Posts

Posted - 06/15/2007 :  21:10:00  Show Profile
quote:
Originally posted by Garym

Thanks to both of you for this information. I did not realize that too much fiber could also cause constipation problems. What is the best way to get going again after a enema series? This always seems to be a challenge for me.

Gary


I have no problem going the very next day but on the second day, I usually can't go at all. By the third day, I'm up to speed again. I don't think it's a problem though because I'm not at all uncomfortable.
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Water Woman
Advanced Member

390 Posts

Posted - 06/15/2007 :  22:31:31  Show Profile
Sweetmaxine,
Because Kristina is busier than ever these days, I will tell you something that she believes it works. Aged Cascara Sagrada Bark.
OHN sells it. This is something to look into.
Here is a long post Kristina made about this.
I hope this helps.
Salute, (To your health)
Lisa

ts

Posted - 09/25/2006 : 21:20:38 Show Profile Email Poster Reply with Quote
I am working up a statement to make on Aged Cascara Sagrada bark. For now, I want to say a few words about constipation. Constipation is almost always related to low thyroid function. In hypothyroidism there is often a very high chronic level of adrenaline, and adrenaline lowers colonic mobility,(read constipation) and reduces the guts barrier function (read leaky gut). Those, combined with hypoglycemia,(which many, many people are struggling with) high histamine and serotonin and poor digestion, help to create a generalized inflammatory tendency throughout the entire body-headaches, muscle aches, fibromyalgia, arthritis and more. Then, besides the general endotoxemia and other systemic problems, the intestine will tend to react locally to allergens with swelling and spasms. If this situation is left untreated through lifestyle changes, it tends to result in colitis, irritable bowel syndrome, and intermittent diarrhea.

In good health,
Kristina Amelong, CNC,CT
Optimal Health Network
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Kristina
Administrator

354 Posts

Posted - 11/23/2006 : 17:56:20 Show Profile Email Poster Reply with Quote
Here is some research on Cascara Sagrada. In short, it is a safe, strengthening and healthful laxative:

From Materia medica- http://en.wikipedia.org/wiki/Cascara_Sagrada

CASCARA SAGRADA

Rhamnus purshiana - Family Rhamnaceae

Synonyms-Sacred Bark, California Buckthorn

Description-This tree is 5 - 8 m in height, and has reddish-brown bark, which is often covered with lichen. The leaves are alternate, dark green, elliptic to oblong - ovate, irregular, finely toothed, or often almost entire. In addition, they are rounded at the base and may be obtuse or acute at the apex. The small, greenish flowers grow in finely hirsute umbels and produce black, pea-size drupes.

Parts used-The aged, dried bark.

Constituents-The bark contains 6-9% anthraquinone glycosides, including A, B, C, D, E and F-cascarosides. The glycosides form chrysophanol and emodin complexes. The activity of Cascara is primarily due to the anthraquinones A,B,C and D-cascarosides (C-10 isomers of 8-0-B-D glucopyranosides of deoxybarbaloin and chrysophanol).(1) Cascara also contains smaller amounts of the bitter, less desirable anthracene compounds and aloins that account for the cathartic character of aloes and senna.(2) The cascarosides are found in a concentration of 6 to 9% O-glycosides and C-glycosides.(3,4) The European Pharmacopeia requires official Cascara to contain at least ``... 8% hydro-anthracene derivatives, calculated as cascaroside, of which not less than 60% consists of cascaroside A.``(5) It appears that the more irritative anthranols, dianthrones and anthranes are the likely intermediates of the anthraquinone cascarosides.(6,7) The study of these anthraquinone derivatives is complex as there may be derivatives (about a dozen in Cascara)(8) and their nature may change with age and during extraction.(9) Anthracene derivative plants have been important cathartics for hundreds of years.

Mode of Action-R. purshiana is a mild cathartic laxative(10,11) primarily used in the treatment of chronic constipation. Cascara also has tonic and stomachic properties.(15-19) In the control of habitual constipation it ``not only acts as a laxative but restores natural tone to the colon.(20) Cascara is recommended for piles as it forms a soft non-irritating stool(21) and is also suggested as a useful laxative for hemorrhoidal conditions.(22,23) Cascara is indicated as the cathartic of choice in the elderly and delicate(24) and is non-irritating. The use of Cascara has ``little tendency to produce secondary constipation.(25)

The action of Cascara Sagrada is primarily due to stimulation of increased colonic peristalsis.(26-29) Peristalsis is stimulated through the autonomic nervous system rather than through the local irritative mechanism as is sometimes proposed. The active principles are absorbed through the small intestine, enter the systemic circulation, and stimulate the Auerbach plexus thereby exciting peristalsis.(30) Cascara is mild in action and generally doesn`t cause griping. It is considered the least griping of the emodin cathartics.(31)

Therapeutic Action-Cathartic, bitter tonic, alterative, hepatic, stomachic, and febrifuge.

Energetics-Other-Holmes lists Cascara Sagrada as bitter, a bit astringent, cold and moist; with secondary qualities of stimulating, restoring, dissolving, cleansing sinking movement. It enters the Liver, Gall Bladder, Small Intestine, Stomach and Colon meridians; influencing the liver, gall bladder, stomach and small intestine. Its organism is warmth.(32) Tierra lists it as cold and bitter; influencing the spleen, stomach, liver and colon.(33)

Folklore-This herb has been applied traditionally as a laxative and also as a bitter tonic. It was also used for gallstones, liver ailments, hemorrhoids and the stimulation of digestion.(34) Cascara has been heavily recommended since the mid-1800`s by Eclectic physicians in North America.(35)

Well over a dozen Western North American Indian tribes used Cascara. Not surprisingly, they found its cathartic and laxative effect most useful.(36)

Dosage(37)

Capsules -1/4-3, 2-3 times daily


Cascara Sagrada powdered bark is listed as between 0.10 and 8.0 grams in the literature.(38)


Cascara produces its action 6-8 hours after ingestion(43)

Toxicity and Contraindications

ESCOP lists contraindications for intestinal obstruction and stenosis, atony, inflammatory disease of the colon ( e.g. Crohn`s disease, ulcerative colitis), appendicitis; abdominal pain of unknown origin; severe dehydration state with water and electrolyte depletion. It is also listed not to be used by children under the age of 10 years old(44) Western herbalists often use Cascara (since 19th century) for atony and in small doses for Crohn`s and colitis (under practitioner care). In complex formulas, Cascara is used in children as young as six, if under practitioner care.



Large doses can cause extensive diarrhea accompanied by nausea, vomiting and cramping. The cascarosides are ``generally considered to be safe drugs with a minimum of side effects...``(45) Toxicity appears to be an issue in excessively large doses which may cause irritation.(46)

The Merck Index lists the upper therapeutic dose as 8 grams. Cascarosides may enter a mother`s milk and act as a laxative for some children (many practitioners have noticed this) however, experimental data suggest it should have very little or no effect.. Long term use may induce chronic diarrhea or a pseudomelanin pigmentation of the colon and rectal mucosa.(47,48) This pigmentation is completely harmless and reversible in four to twelve months after use is discontinued.(49) Some authors note that excessive doses can result in cramping, vomiting, and nausea.(50,51) These side effects are generally countered by the addition of a carminative such as ginger or fennel. The younger the bark, the more pronounced the side effects. The ratio of anthrone to anthraquinone constituents changes as the bark is stored. The less predominant and more desirable anthraquinone cascarosides become more common through a slow process of hydrolysis of the constituent glycosides.(52,53) Grieve(54) states that ``the action of the bark becomes milder and less emetic by keeping. Matured bark, three years old, is preferred for pharmaceutical purposes``.

Experimental studies as well as centuries of experience has shown that there is no undesirable or damaging effect if Cascara is taken in moderate doses during pregnancy even though several pharmacopeia suggest it should not be used during the first trimester and others suggest at any time.(55)



Official Recognition and Medical References

Cascara Sagrada has had a long history of use as an official drug. The following are just some of the official preparations of Cascara used in the past.

EXTRACTUM CASCARAE B.P. 1914, U.S.P. 1905, Fr.Codex 1908, (56)

ELIXIR CASCARAE SAGRADAE B.P., 1934(57)

EXTRACTUM CASCARAE SAGRADAE LIQUIDUM B.P.,1934(58)

P.ITAL. 1909(59) Fr.Codex, 1908, GERMAN PHARM, 1910 (60)

EXTRACTUM CASCARAE LIQUIDUM MISCIBLE B.P.C. 1911(61)

EXTRACTUM CASCARAE SAGRADAE SICCUM B.P., 1934(62)

TINCTURA CASCARAE SAGRADAE Fr.Codex, 1908, Ital. Pharm 1909(63)

ESCOP 1996 & 1997

German Commision E 5.12.84

UK General sales list Schedule 1 table A

Belgium Accepted for specific indication No. 90/22 bis.

France Accepted for specific indication

PDR for Herbal medicine

Cascara Sagrada is also currently found in many prescription and ``over-the-counter`` laxative preparations including: Bicholax, Cas-Evac, Casylium, Kordremul with Cascara and many others.

References



1. Morton, J.F., Major Medicinal Plants: Botany, Culture and Uses, Charles C. Thomas Inc, Springfield IL, 1977, p. 201.

2. Leung, A.Y., Encyclopedia of common natural ingredients used in food, drugs, and cosmetics, John Wiley & Sons Inc., New York, 1980, p. 97.

3. Trease, G.E. and Evans, W.C., Pharmacognosy 11 ed., Bailliere Tindall, London, 1978, p. 385.

4. Trease, G.E. and Evans, W.C., Ibid.

5. European Pharmacopeia (Vol. 2), Council of Europe, Maisonneuve S.A., Sainte-Ruffine, France, 1971. p. 355.

6. Tyler, V.E. et al., Pharmacognosy (7th ed.), Lea & Febiger, Phila. PA, 1976. p. 78

7. Robinson, T., The Organic Constituents of Higher Plants (4th ed.), Cordus Press, North Amherst, Mass., 1980. p. 122.

8. Tyler, V.E. et al., Ibid.

9. Robinson, T., Ibid.

10. Remington`s Pharmaceutical Sciences (16th ed.), Mack Publ. Co., Easton PA, 1980. p. 742

11. Leung, A.Y., Ibid. .

12. Spoerke, D.G., Herbal Medications, Woodbridge Press Publ. Co., Santa Barbara CA, 1980, p. 50.

13. Squire, P.W., Squire`s Companion to the Latest Edition of the British Pharmacopeia, J & A Churchill, London, 1908, p. 337.

14. Wood, H.C. and Osol, A., Dispensatory of the United States of America 23rd Ed.,J.B. Lippincott, Montreal, P.Q., 1943. p. 283.

15. Gathercoal, E.N. and Wirth, E.H., Pharmacognosy, Lea & Febiger, Phila. PA, 1936, p. 459.

16. Textbook of Pharmacognosy, J. & A. Churchill Ltd., Rahway, N.J.,1976 p. 90.

17. Wren, R.C., Potter`s New Cyclopaedia of Botanical Drugs and Preparations, Health Science Press, Rustington, Sussex, U.K., 1975. p. 68.

18. Squire, P.W., Ibid.

19. Grieve, M., A Modern Herbal, Jonathan Cape, London, 1931, p.137.

20. Tyler, V.E. et al., Ibid.

21. Martindale: The Extra Pharmacopeia, The Pharmaceutical Press, London, 1941, p. 376.

22. The British Pharmaceutical Codex 1934. The Pharmaceutical Press, London, 1934, p. 290.

23. Morton, J.F., Ibid

24. Grieve, M., Ibid.

25. The Merck Index 5th ed., Merck & Co. Inc., Rahway NJ, 1940. p. 124.

26. Wood, H.C. and Osol, A., Ibid.

27. Martindale, Ibid.

28. Spoerke, D.G.,Ibid.

29. Leung, A.Y., Ibid.

30. Remington`s Pharmaceutical Sciences (16th ed.), Ibid.

31. Remington`s Pharmaceutical Sciences (16th ed.), Ibid.

32. Holmes, P., The Energetics of Western Herbs (2 vols.), Artemis Press, Boulder CO, 1989, p. 176-178.

33. Tierra, M., Planetary Herbology, Lotus Press, Santa Fe, NM, 1988, p. 167.

34. Willard, T.W., Textbook of Modern Herbology, c.w. Progressive Publishing Inc., Calgary, AB, Can., 1988, p. 220.

35. Crellin, p.137-138, Grieves, Ibid.

36. Moerman, D.E., Medicinal Plants of Native America, University of Michigan Museum of Anthropology, Technical Reports, Number 19, Ann Arbor, Michigan, 1986, Vol.1, p. 399.

37. Santillo, H., Natural Healing with Herbs, Hohm Press, Prescott Valley, AZ, p. 98.

38. The British Pharmaceutical Codex 1934. Ibid..

39. The Merck Index 5th ed., Ibid.

40. Wood, H.C. and Osol, A., Ibid.

41. The British Pharmaceutical Codex 1934. Ibid. Grieve, M., Ibid.

42. Remington`s Pharmaceutical Sciences (16th ed.), Ibid.

43. Williams, L.O., Drug and Condiment Plants, Agricultural Handbook 172, U.S.D.A., Washington, D.C., 1960, p. 74.

44. ESCOP, Rhamni purshiani, Cascara; July 1997

45. Leung, A.Y., Encyclopedia of common natural ingredients used in food, drugs, and cosmetics, Ibid., p. 97.

46. Wood, H.C. and Osol, A., Dispensatory of the United States of America 23rd ed., Ibid..

47. Remington`s Pharmaceutical Sciences (16th ed.), Ibid.

48.Morton, J.F., Major Medicinal Plants: Botany, Culture and Uses, Charles C. Thomas Inc, Springfield IL, 1977. p. 204

49 Williams, L.O., Drug and Condiment Plants, Agricultural Handbook 172, Ibid., p. 69.

50. Spoerke, D.G., Herbal Medications, Ibid., p, 51.

51.Morton, J.F., Major Medicinal Plants: Botany, Culture and Uses, Ibid.

52. Griffenberg, G.B. and Hawkins, L.L., Handbook of Non-Prescription Drugs (1973 ed.), American Pharmaceutical Assoc., Washington, D.C., 1973. p. 122.

53. Kinglet, R., Studies in the field of Drugs containing Anthracene Derivatives XVII. The quantitative determination of the anthracene derivatives of Rhamnus purshiana bark., Lloydia Vol. 31, No.1, p. 17 - 22, 1968, p. 17

54. Grieve, M., Ibid

55. ESCOP Ibid

56. Lucus, E.W. and Stevens, H.B., The Book of Pharmacopeias, J & H Churchill, London, 1915, p. 90.

57. The British Pharmaceutical Codex 1934. Ibid., p. 291.

58. The British Pharmaceutical Codex 1934. Ibid.

59. Lucus, E.W. and Stevens, H.B., The Book of Pharmacopeias, Ibid.

60. Lucus, E.W. and Stevens, H.B., The Book of Pharmacopeias, Ibid.

61. Lucus, E.W. and Stevens, H.B., The Book of Pharmacopeias, Ibid. p. 91

62. The British Pharmaceutical Codex 1934. Ibid.

63. Lucus, E.W. and Stevens, H.B., The Book of Pharmacopeias, Ibid., p. 383.

Edited by - Water Woman on 06/15/2007 22:35:02
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Dave
Advanced Member

422 Posts

Posted - 06/16/2007 :  04:30:11  Show Profile
The lesson I think we're agreeing on here is to let the body take charge of itself after a very productive enema or colonic session, perhaps with a little help from something like cascara sagrada. It's probably not harmful to "miss" a day after a good cleanse if you're feeling well otherwise.
Sweetmaxine, hope you have a natural movement today, without ruling out a little "helper' enema later on if needed.
Dave

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Kristina
Administrator

408 Posts

Posted - 06/16/2007 :  15:30:35  Show Profile
I would definitely keep a bottle of Cascara sagrada about the house. We are having a newsletter subscribers sale starting on Sunday, if you want to buy it and buy it at a discount.

It is also fine to do another enema.

If the bowels don't move the day after an enema, it is a sign that your digestive transit time is slow. You might consider a hair tissue mineral analysis to take a look at what factors are slowing down your overall digestion so that you might make other lifestyle changes.

In good health,
Kristina Amelong, CNC,CT
Optimal Health Network
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Dave
Advanced Member

422 Posts

Posted - 06/17/2007 :  05:38:44  Show Profile
An added thought: Primal Defense (sold by OHN and health stores) or other probiotics are a big help in restoring "good" bacteria, intestinal flora, that a large enema or colonic has flushed from the colon and getting the system back to normal. Eating yogurt is another option.
Dave

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Sweetmaxine
Advanced Member

51 Posts

Posted - 06/19/2007 :  10:26:15  Show Profile
Appreciate the info everyone. Be careful with Cascara; whether aged or new. No matter what grade it is, cascara is still a harsh bowel stimulant and can be habit forming and eventually stop working. I have suffered with chronic constipation for years mainly due to taking pain meds. These slow my digestive tract down. I don't have a thyroid problem. My thyroid is normal. I have a sluggish bowel due to pain meds. Still, I think it is time to go in have have my colon checked. I finally had a bm on Sunday but only after taking a small soapsuds enema. I went almost 4 days without a bm. When I finally went on Sunday, I had a lot of cramps and the stool came out soft and thinner than a normal size stool which worried me. Thin stools can be a sign of bowel tumors so I am paranoid about this and want to get checked. It's probably nothing but since my bm's have slowed to a crawl, and I can not have a bm without using an enema or a laxative such as cascara, it is time to get checked. I hope it is just my IBS flaring up and not cancer or anything.
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Water Woman
Advanced Member

390 Posts

Posted - 06/19/2007 :  11:50:17  Show Profile
I'm a bit confused if it is habit forming or not. Swichablesusie, a nurse, is not posting anymore, but when she did, she said it was habit forming. I asked Kristina about this, so please read these two post from another thread...

posted - 11/30/2006
Kristina,
This is very good information. Thank you.
So does this mean that Cascara is NOT addictive, and we don't need to be concerned about that?
Salute! (To your health)
Lisa


Posted - 11/30/2006 : 06:31:27 Show Profile Email Poster Reply with Quote
Yes, indeed, this does. However, it is best to optimize your colon health by making sure your thyroid is functioning optimally. The thyroid gland is a big player in colonic peristalsis. You can check out your thyroid health by having a hair analysis done through the Optimal Health Center or by having a blood test done at your doctor's office. If you do a blood test, make sure to have me or someone knowledgable about thyroid health read it, as the medical doctors have different ideas about what the numbers should look like.

In good health,
Kristina Amelong, CNC,CT
Optimal Health Network

Edited by - Water Woman on 06/19/2007 11:59:13
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Sweetmaxine
Advanced Member

51 Posts

Posted - 06/19/2007 :  13:35:48  Show Profile
Hi W/W. I am a registered nurse and worked with a gastroenterologist for a while who said he'd seen static colons with actual nerve damage in them in people who relied frequently on stimulant laxatives for a bowel movement. Cascara and others stimulate the bowel to contract. What this does over time is damage the nerves in the bowel so that they no longer sense when the bowel is full and needs to empty. Thus, using them over a long period of time, they become ineffective. Many people are fooled by the words "herbal" and "natural" mistaking them for being safe. They are not. In my professional medical opinion, the safest way to clean the colon is a plain water enema with a little sea salt to balance it. I hope I don't sound too pompous here...just years of experience talking. And by the way, I moved my bowels normally today. Guess I was over-worried for nothing. I think when one gets a thorough colon cleasing, it takes a while to build up waste in the colon again.
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Water Woman
Advanced Member

390 Posts

Posted - 06/19/2007 :  18:29:19  Show Profile
Lisa's question
So does this mean that Cascara is NOT addictive, and we don't need to be concerned about that?
Salute! (To your health)
Lisa

Kristina's Answer
Yes, indeed, this does.


It's nice to have a nurse on the forum again to get the medical profession side on things.
Boy, are you ever right about the word natural or herbal being misleading. Look at all the dangrous street drugs that are "natural."
Kristina says Cascara not habit forming as she clearly said on her post.
Kristina, with the medical profession feeling that way, do you still stand behind this product and still say it's not habit forming? Please don't get me wrong. I'm not criticizing you what so ever. It's just that we have two different answers here.
Is it at least safe using it in moderation? I'm sure many things are habit forming.
I do agree with Kristina about finding the cause of constipation such as thyroid function.
Salute, (To your health)
Lisa

Edited by - Water Woman on 06/20/2007 10:30:11
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Kristina
Administrator

408 Posts

Posted - 06/20/2007 :  18:44:50  Show Profile
Well, it has taken me awhile to put all this together, and I know it isn't as organized as we all would like it, but with two employees on vacation during the same week, it is the post I am going to make about this VERY important subject. Please do ask questions, criticize my argument and talk about your own experiences. I find this topic extremely exciting, especially given that Michael Moore's new movie, Sicko, is coming out in one and one half weeks!

My response:

The drug industry has been successfully getting expensive, often harmful, proprietary drugs substituted for cheap and effective generics, and the registered medical workers are the industry's claque. The story of Zelnorm and cascara-aloe a few years ago (some quotes below) is just one grim example. More than fifty years ago, the industry introduced a few talking points--people who are chronically constipated are likely to keep taking laxatives, and bowel irritation associated with constipation usually causes a defensive (antioxidant) brown pigmentation to form in the intestine. Therefore, they reasoned, traditional laxatives are habit forming and cause the bowel to turn brown. But experiments showed that their arguments were wrong. People kept using the cheap laxatives, so the argument escalated to the idea that aloe and cascara are carcinogenic. This idea popped into the FDA's mind just as mainline research in the cancer drug industry began showing that these chemicals had remarkable anticancer effects, and that the drug industry suppressed for a time.

In 1877, Cascara Sagrada was admitted to the U.S. Pharmacopoeia and is still included in the registry as an

official medicine. It was first marketed to the medical establishement by Parke-Davis who introduced it as a bitter fluid extract. The extract was first exported to Europe in 1883. In 1978, it became available pharmaceutically as a nauseous and bitter fluid extract for use in cases of chronic constipation.

The herb is popular for its ability to re l i e v e constipation and tonify the bowel. Perhaps its most valuable p roperty is that once Cascara Sagrada is used, re p e a t e d dosages of the herb are not necessary. In other words, the treatment not only alleviates constipation but prevents it as well. The Dispensatory of the United States r e c o rd s concerning the herb: "It often appears to restore tone to the relaxed bowel and in this way produces a permanent beneficial effect."1

Traditionally, small doses of the bark were also taken to ease digestion. Curre n t l y, Cascara Sagrada extracts are found in many over-the-counter preparations in this country. It is considered one of the best and safest laxatives available. The fact that it is not habit forming, like so many pharmaceutical laxatives, makes it even more valuable in cases of chronic constipation. Unfortunately, most people are unaware that Cascara is an excellent laxative option. It is not a household term and remains unknown to vast segments of our population, who continue to use laxatives which have undesirable side-effects.

1995 Copyright
Woodland Publishing Inc. P.O. Box 160 Pleasant Grove, UT 84062

As Zelnorm only received US FDA approval in July 2002, the medication has not been on the market long enough to determine safety or effectiveness for lifelong use. Zelnorm has not been shown to work in men with Irritable Bowel Syndrome. In 2005 the European Union refused to accept Zelnorm as a medication for Irritable Bowel Syndrome.
* Zelnorm - How well does it work?
* What is Zelnorm?
* Who should NOT take Zelnorm?
* Zelnorm clinical trials
* Controversy over Zelnorm approval
* Zelnorm side effects
* Zelnorm prices


Zelnorm - How well does it work? ~ In the clinical trials for this medication, IBS patients fared only a little better -- 5 percent to 11 percent better -- when taking Zelnorm than when taking dummy pills (placebos). The FDA has concluded that Zelnorm seems to work best during the first month of its use, before its effects wane after three months of treatment.
If you're considering taking this drug for Irritable Bowel Syndrome constipation, you'll probably find it very helpful to get feedback from other Zelnorm users on the Irritable Bowel Syndrome Message Boards.
What is Zelnorm? ~ Zelnorm (the generic name is tegaserod) is a drug manufactured by Novartis Pharmaceuticals, and available by prescription only, in the US, Canada, Australia, South Africa, and over 30 other countries (where it may be called Zelmac). Zelnorm is classified as a 5-HT4-receptor agonist, which means that it imitates the action of serotonin (a neurotransmitter) in your gut. Ninety-five percent of serotonin in the body is found in the gastrointestinal tract (the balance is found in the brain). In plain English, Zelnorm acts on nerve cells to speed the colon's movement of stools.
The recommended Zelnorm dosage is 6 mg tablets taken twice daily on an empty stomach, shortly before meals. Zelnorm is only meant to be used for 4 to 6 weeks. For patients who respond well to Zelnorm, an additional 4 to 6 week course can be considered. Zelnorm is not meant to be taken only as needed; it is a twice-daily maintenance drug. Zelnorm is meant to increase the movement of stools through the bowels, which relieves the IBS symptom of constipation, but Zelnorm does not cure IBS (nothing does). For those who are helped by Zelnorm, the drug can reduce abdominal pain and discomfort, bloating, and constipation. Once you stop taking Zelnorm your IBS constipation and other symptoms will likely return very shortly. For safe lifelong management and prevention of constipation and bloating due to Irritable Bowel Syndrome, the IBS diet and a soluble fiber supplement such as organic Acacia are healthy alternatives. Fennel is a safe herbal tea that can be extremely beneficial for bloating associated with IBS.
Who should NOT take Zelnorm? ~ Zelnorm is not recommended for use by pregnant or breast-feeding women, and it is absolutely not to be used by women with diarrhea. Zelnorm is not established as safe for children, and its use in children is not recommended. The drug should also not be used by women who have a kidney or liver disease; a bowel obstruction (intestinal blockage); symptomatic gallbladder disease; or abdominal adhesions. Zelnorm should not be used by patients who are allergic to any of its active or inactive ingredients, which include lactose (milk sugar).
Zelnorm clinical trials ~ The FDA based its decision to approve Zelnorm on the results of three randomized, double-blind, placebo-controlled clinical studies each lasting 12 weeks. In these clinical trials, the most common possible side effects of Zelnorm were: abdominal pain; headache; diarrhea; nausea; gas; back pain; indigestion; upper respiratory tract infection; flu-like symptoms; sinusitis; urinary tract infection. A slight increase in abdominal surgeries (particularly gall-bladder removal) among Zelnorm users was noted during one of the trials.
The FDA was expected to approve Zelnorm one whole year before it actually did. This anticipated approval was abruptly halted as a result of concerns about an increase in gallbladder and other abdominal operations among patients testing the drug. European regulators raised similar concerns. Post-approval, the FDA has ordered Novartis to study how patients fare as sales begin, and pledged to closely monitor any reports of side effects.

Controversy over Zelnorm approval ~ A consumer advocacy group has attacked the FDA's approval, claiming that officials were ignoring early signals of Zelnorm risks just as the agency earlier downplayed the bowel inflammations and other complaints that eventually derailed the IBS-diarrhea drug Lotronex. The advocacy group Public Citizen (a national non-profit organization that accepts no government or corporate money) contends that the approval of Zelnorm is a serious mistake by the FDA, and that there is no proof Zelnorm relieves constipation better than soluble fiber supplements. Drs. Elizabeth Barbehenn, Ph.D. and Sidney M. Wolfe, M.D. of Public Citizen claim Zelnorm is "a drug that is, at best, minimally effective and that may be causing substantial harm." Public Citizen's letter to the FDA regarding Zelnorm has been made publicly available.

Zelnorm side effects ~ During clinical trials, the following list of adverse events occurred more often in patients on Zelnorm than in patients on the placebo:
Body as a Whole: abdominal pain, chest pain, flushing, facial edema
Cardiovascular: hypertension, hypotension, angina pectoris, syncope, arrythmia
Central Nervous System: anxiety, vertigo
Female Reproductive: ovarian cyst, miscarriage, menorrhagia
Gastrointestinal: cholecystitis, appendicitis, bilirubinemia, gastroenteritis
Metabolic: increased creatine phosphokinase
Musculoskeletal: back pain, cramps
Neoplasms: breast cancer
Psychiatric: attempted suicide, impaired concentration, increased appetite, sleep disorder, sleep disorder, depression, anxiety
Respiratory: asthma
Skin: pruritis, increased sweating
Urinary: renal pain, polyuria
If you experience any side effects while taking Zelnorm, call your doctor. If you experience new or worsening abdominal pain not typical of your IBS, call your doctor.
Zelnorm Prices ~ In the US, Novartis estimates that Zelnorm tablets will sell for somewhere in the range of $3 to $4 each. The drug is expected to generate $1 billion in annual sales for Novartis.
Zelnorm Warnings Issued by FDA!
On April 29, 2005, the Food and Drug Administration (FDA) and Novartis notified healthcare professionals of revisions to the warnings and precautions sections of labeling for tegaserod maleate (Zelnorm). The warning refers to serious consequences of diarrhea (including hypovolemia, hypotension, and syncope) that occurred both during clinical trials and during marketed use, in some cases requiring hospitalization.
The warning refers to serious consequences of diarrhea (including hypovolemia, hypotension, and syncope) that occurred both during clinical trials and during marketed use, in some cases requiring hospitalization. Zelnorm is prescribed for the short-term treatment of women with irritable bowel syndrome whose primary bowel symptom is constipation.
According to the FDA, Zelnorm should be discontinued in patients who develop hypotension or syncope. It should not be initiated in patients who frequently experience or are currently experiencing diarrhea. The FDA recommends discontinuation of the drug in patients who develop symptoms of ischemic colitis such as rectal bleeding, bloody diarrhea, or new/worsening abdominal pain. These patients should be evaluated promptly and treatment with Zelnorm should not be resumed if a diagnosis of ischemic colitis is confirmed.
* * * * * * * * * *
On April 28, 2004, the Food and Drug Administration (FDA) announced the addition of serious new risk information to the health professional labeling for Zelnorm. The specific revisions include:
* a new warning about the serious consequences of diarrhea associated with the medication
* a new precaution about ischemic colitis and other forms of intestinal ischemia (reduced blood flow to the intestines)
* changes to the adverse reactions section describing post-marketing reports
* new information in the "Information for the Patient" leaflet
The new warning states: "Serious consequences of diarrhea, including hypovolemia, hypotension and syncope have been reported in the clinical studies and during marketed use of Zelnorm. In some cases, these complications have required hospitalization for rehydration. Zelnorm should be discontinued immediately in patients who develop hypotension or syncope. Zelnorm should not be initiated in patients who are currently experiencing or frequently experience diarrhea."
"The FDA currently has 21 reports of diarrhea so severe that it caused such complications as low blood pressure and fainting. Sixteen patients required hospitalization," said the FDA's Dr. Robert Justice.
The new precaution on ischemic colitis states: "Ischemic colitis, and other forms of intestinal ischemia, have been reported in patients receiving Zelnorm during marketed use of the drug. A causal relationship between Zelnorm use and these events has not been established. Placebo-controlled clinical trials of 7,000 patients for 3-month duration showed no cases of these events, and would suggest the rate of these events is low. Zelnorm should be discontinued immediately in patients who develop symptoms of ischemic colitis, such as rectal bleeding, bloody diarrhea or new or worsening abdominal pain. Patients developing these symptoms should be evaluated promptly and have appropriate diagnostic testing performed. Treatment with Zelnorm should not be resumed in patients who develop findings consistent with ischemic colitis."
"Since Zelnorm went on sale in 2002, the FDA has received 20 reports of ischemic colitis, plus three reports of a similar intestinal problem," Justice said. "Fourteen patients were hospitalized. Four died, although they had numerous other serious medical conditions."
Under the post marketing experience heading in the adverse reactions section, the labeling now states: "Voluntary reports of adverse events occurring with the use of Zelnorm include the following: ischemic colitis, mesenteric ischemia, gangrenous bowel, rectal bleeding, syncope, suspected sphincter of Oddi spasm, bile duct stone, and cholecystitis with elevated transaminases. Because these cases are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. No causal relationship between these events and Zelnorm use has been established. Hypokalemia secondary to diarrhea has also been reported."
The new patient information advises patients who get new or increased stomach pain or blood in their stools to stop taking Zelnorm right away and to immediately contact their doctor to determine if they may have a serious problem. In addition, the new labeling advises patients to stop taking Zelnorm and to call a doctor right away if they experience diarrhea that leads to lightheadedness, dizziness or fainting. In conjunction with today's FDA announcement, the manufacturer of Zelnorm, Novartis Pharmaceuticals Corporation of East Hanover, N.J., has issued a letter to health professionals to highlight the labeling changes.
For safe and effective non-drug approaches to managing IBS symptoms, check here to learn how the organic soluble fiber Acacia can help relieve constipation without risks or side effects, why fennel can be extremely beneficial for bloating, how peppermint can relieve and prevent abdominal pain, and how gut-directed hypnotherapy addresses the underlying pathology of bowel dysfunctions and relieves all IBS symptoms.
If you feel confident that your constipation and bloating are symptoms of Irritable Bowel Syndrome, information is key. Learn all you need to know about this disorder with The First Year: IBS, an essential guide to successfully managing Irritable Bowel Syndrome.
Zelnorm clinical information supplied by the Novartis Zelnorm Patient Prescribing Information drug insert.

[Federal Register: May 9, 2002 (Volume 67, Number 90)]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 310
[Docket No. 78N-036L]
RIN 0910-AA01
Status of Certain Additional Over-the-Counter Drug Category II and III Active Ingredients
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule stating that the stimulant laxative ingredients aloe (including aloe extract and aloe flower extract) and cascara sagrada (including casanthranol, cascara fluidextract aromatic, cascara sagrada bark, cascara sagrada extract, and cascara sagrada fluidextract) in over-the-counter (OTC) drug products are not generally recognized as safe and effective or are misbranded. This final rule is part of FDA's ongoing OTC drug product review.
DATES: This rule is effective November 5, 2002.


In good health,
Kristina Amelong, CNC,CT
Optimal Health Network
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