Laxsenn by Flora Manufacturing & Distributing Ltd

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Atopic dermatitis (eczema). It is unclear if topical fig fruit extract is beneficial in children with eczema. Details: Preliminary clinical research in children 4 months to 14 years of age with mild to moderate atopic dermatitis shows that topical application of a cream containing fig fruit extract 8% twice daily for 14 days reduces the severity of symptoms by 56% and itchiness by 64% when compared with baseline. Fig cream is as effective as a cream containing 1% hydrocortisone and more effective than placebo (99958).
• Constipation. It is unclear if oral fig fruit is beneficial for constipation. Details: A small clinical study in adults with constipation shows that taking fig fruit paste 300 grams daily for 8 weeks improves stool consistency by 58%, compared to a 27% improvement with placebo. Fig paste also modestly improves abdominal discomfort; however, it does not affect stool frequency, abdominal pain, effort, or relief (99956).
• Diabetes. It is unclear if oral fig leaf is beneficial for glycemic control in patients with type 1 diabetes. Details: A very small clinical crossover study in adults with type 1 diabetes shows that consuming a tea made from fig leaves modestly reduces postprandial, but not pre-prandial, glucose levels and also reduces insulin requirements when compared with consuming a non-fig tea (12578).
• Vitiligo. Although there has been interest in using oral fig for vitiligo, there is insufficient reliable information about the clinical effects of fig for this condition.
• Warts. It is unclear if topical fig latex is beneficial for warts in adults and children. Details: Preliminary clinical research in adults and children 5 years of age and older shows that applying fig latex directly to a common wart three times daily for at least 4 days is slightly less effective than cryotherapy for producing complete resolution of the wart after 2 weeks (99962).
• Wound healing. Although there has been interest in using topical fig for wound healing, there is insufficient reliable information about the clinical effects of fig for this purpose. More evidence is needed to rate fig for these uses.

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LIKELY EFFECTIVE

• Constipation. Taking senna orally is effective for the short-term treatment of constipation. Details: Senna is an FDA-approved nonprescription drug marketed for the short-term treatment of constipation in adults and children ages 2 years and older (15429,15433,15436,15441,15442,74545,74607,74609,74613,74615). Senna usually produces a laxative effect 6-10 hours after oral administration (15429,96559). However, in children ages 3-15 years, mineral oil and lactulose might be more effective (15434,15435). Taking senna with psyllium is also effective for the short-term treatment of constipation (8424,74593), with the combination increasing stool moisture to a greater degree than psyllium alone (8424). In patients with opioid or loperamide-induced constipation, taking senna appears to be as effective as lactulose, psyllium, and docusate for relieving constipation (15432,74586,74644,74650). Some population research has found that senna may be more effective than docusate, polyethylene glycol, and lactulose for preventing problematic constipation, the need for an enema, and abdominal imaging in pediatric cancer patients receiving opioids (92710). Senna also seems to be beneficial in chronic constipation. Clinical guidelines published by the American Gastroenterology Association and American College of Gastroenterology in 2023 give a conditional recommendation suggesting the use of senna over managing chronic idiopathic constipation without senna based on low-quality of evidence conducted over 4 weeks (112859). In geriatric patients, senna plus psyllium is more effective than lactulose for treating chronic constipation (15438,15439,15440). Also, a small study in middle-aged adults with chronic idiopathic constipation shows that taking senna (ALOSENN granules) 500 mg twice daily for 4 weeks seems to be similarly effective to taking magnesium oxide 500 mg three times daily (105959).

POSSIBLY EFFECTIVE

• Bowel preparation. Taking oral senna might be effective for bowel cleansing before colonoscopy. Details: A meta-analysis of 10 clinical trials in adults shows that taking senna alone or with other bowel preparations does not improve bowel cleansing before elective colonoscopy when compared with non-senna bowel preparations. However, in a subgroup analysis of 3 clinical studies, taking senna solution alone is about 2.5 times more likely to result in a clean bowel when compared with polyethylene glycol alone (112893). The interpretation of these findings is limited by varied senna dosages and regimens. Additionally, 2 clinical studies that were not included in this meta-analysis show that senna is as effective or more effective than polyethylene glycol for improving bowel cleanse quality (15431,40088). Conversely, other studies show that polyethylene glycol is superior to senna (40086,74587,74606,74636). It is also unclear if taking senna with polyethylene glycol improves bowel cleansing when compared with polyethylene glycol alone (74583,74585). Some clinical studies show that senna is as effective as castor oil and bisacodyl for bowel cleansing (74548,74603,74624). Although taking senna alone is less effective than sodium phosphate (15431,74567,74570,74653,92712), some evidence suggests that taking a combination of senna, sodium picosulfate, and polyethylene glycol is more effective than sodium phosphate for bowel cleansing prior to colonoscopy (74538). Limited research has also assessed the benefit of adding senna to a preparation regimen for small bowel capsule endoscopy; however, it is unclear whether the addition of senna improves endoscopy outcomes when compared with the preparation regimen alone (96557). There is insufficient reliable information available about the effectiveness of senna for its other uses.

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LIKELY SAFE ...when the fresh or dried fruit is used orally in amounts commonly found in foods.

POSSIBLY SAFE ...when fig fruit paste is consumed orally in amounts of up to 300 grams daily for up to 8 weeks (99956).

POSSIBLY UNSAFE ...when fig leaf decoctions are used topically. Fig leaf contains psoralens (12579,12581). There have been reports of photodermatitis with burn-like lesions and rashes after fig decoctions were applied prior to sun exposure (49962,49968,49973,49975,49981). There is insufficient reliable information available about the safety of fig leaf when used orally.

PREGNANCY AND LACTATION: LIKELY SAFE
when the fresh or dried fruit is used orally in amounts commonly found in foods. There is insufficient reliable information available about the safety of fig leaf or fruit used in medicinal amounts during pregnancy and lactation; avoid use.

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LIKELY SAFE ...when used orally and appropriately, short-term. Senna is an FDA-approved nonprescription drug (8424,15429,15431,15442,40086,40088,74535,74545,74548,74562)(74567,74570,74583,74585,74586,74587,74593,74603,74606,74607)(74609,74613,74615,74624,74636,74639,74644,74650,74653,92711)(92712).

POSSIBLY UNSAFE ...when used orally long-term or in high doses. Long-term, frequent use, or use of high doses has been linked to serious side effects including laxative dependence and liver toxicity (13057,13095).

CHILDREN: LIKELY SAFE
when used orally and appropriately, short-term. Senna is an FDA-approved nonprescription drug for use in children 2 years and older. (15429,15434,15435).

CHILDREN: POSSIBLY UNSAFE
when used orally long-term or in high doses. Long-term, frequent use, or use of high doses has been linked to serious side effects including laxative dependence and liver toxicity (13057,13095,105956).

PREGNANCY: POSSIBLY SAFE
when used orally and appropriately, short-term (15429,24480). POSSIBLY UNSAFE...when used orally long-term or in high doses. Long-term, frequent use, or use of high doses has been linked to serious side effects including laxative dependence and liver toxicity (13057,13095).

LACTATION: POSSIBLY SAFE
when used orally and appropriately, short term. Although small amounts of constituents of senna cross into breast milk, senna has been taken while breast-feeding with apparent safety. Senna does not cause changes in the frequency or consistency of infants' stools. (6026,15429,15436,15437,24482,24484,24485,24486,24487,74545).

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ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = B Theoretically, fig leaf might enhance the blood glucose lowering effects of hypoglycemic drugs.  Details A small clinical study in patients with type 1 diabetes shows that consuming a tea made from fig leaves modestly reduces postprandial glucose levels and insulin requirements (12578).

INSULIN Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = B Fig leaf may enhance the blood glucose lowering effects of insulin.  Details A small clinical study in patients with type 1 diabetes shows that consuming a tea made from fig leaves modestly reduces postprandial glucose levels and insulin requirements (12578).

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DIGOXIN (Lanoxin) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, senna might increase the risk of adverse effects when taken with digoxin.  Details Overuse/abuse of senna increases the risk of adverse effects from cardiac glycosides, such as digoxin, due to potassium depletion (15425).

DIURETIC DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, senna might increase the risk of hypokalemia when taken with diuretic drugs.  Details Overuse of senna might compound diuretic-induced potassium loss and increase the risk for hypokalemia (15425).

ESTROGENS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Theoretically, taking senna may interfere with the absorption of exogenous estrogens.  Details Some preliminary clinical evidence suggests that senna reduces the absorption of estradiol and decreases serum concentrations of estrone and estrone sulfate by decreasing intestinal transit time (74647,74651).

STIMULANT LAXATIVES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, senna might increase the risk for fluid and electrolyte loss when taken with other stimulant laxatives.  Details Senna is a stimulant laxative; concomitant use with other stimulant laxatives might compound fluid and electrolyte loss (19,15425).

WARFARIN (Coumadin) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, excessive use of senna might increase the effects of warfarin.  Details Senna has stimulant laxative effects and can cause diarrhea. Diarrhea can increase the effects of warfarin, increase international normalized ratio (INR), and increase the risk of bleeding. In one case report, excessive use of senna for 3 weeks resulted in diarrhea, bloody stools, and an elevated INR of 11.9 (16530).

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General ...Orally, the fresh or dried fig fruit is well tolerated in amounts commonly found in foods. A thorough evaluation of safety outcomes has not been conducted when fig fruit is used orally as medicine.
Topically, fig leaf may cause photodermatitis. There is limited reliable information available about the safety of fig fruit or latex when applied topically.
Serious Adverse Effects (Rare):
Orally: Allergy and, in rare cases, anaphylaxis.
Topically: The fig leaf may cause photodermatitis.

Dermatologic ...Topically, fig leaf might cause photodermatitis. The leaf contains psoralens (12579,12581). Many cases of photodermatitis from fig leaf have been reported (49962,49968,49973,49975,49981). In at least two cases, the burns were serious enough to require hospitalization. Severe anemia and sepsis developed in one patient (49962). Avoid excessive sunlight or ultraviolet light exposure while using products containing fig leaf.

Orally, fig fruit is unlikely to cause photodermatitis (12581).

Immunologic ...Orally, fig fruit can cause allergy and, in rare cases, anaphylaxis (8815,12580). Topically, exposure to fig fruit and leaves can cause contact dermatitis. In some cases, sun exposure can make contact dermatitis worse (12689,99961).

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General ...Orally, senna is generally well-tolerated when used short-term in appropriate doses.
Most Common Adverse Effects:
Orally: Abdominal pain and discomfort, cramps, diarrhea, flatulence, nausea, fecal urgency, and urine discoloration.
Serious Adverse Effects (Rare):
Orally: Skin eruptions.

Cardiovascular ...Excessive use can cause potassium depletion and other electrolyte abnormalities (15425). In theory, this could cause potentially dangerous changes in heart rhythm. A small decrease in heart rate was seen in one clinical study (74587).

Dermatologic ...In adults, there are rare case reports of skin eruptions associated with senna, including erythema multiforme, fixed drug eruption, lichenoid reaction, toxic epidermal necrolysis, urticaria, photosensitivity, and contact dermatitis (96558). Infants and young children given senna products have experienced contact reactions on the buttocks due to prolonged exposure to stool while wearing a diaper overnight. These reactions range from erythema with small blisters, to large fluid-filled blisters with skin sloughing, as occurs with second degree burns (96559). In a case series of children treated with senna for chronic constipation, burn-like reactions occurred in 2.2%, typically with higher doses (mean 60 mg/day, range 35.2 to 150 mg/day) (96558,96559). These reactions can be avoided by giving senna early in the day, so that bowel movements occur at a time when diapers can be changed quickly (96559).

Gastrointestinal ...Orally, senna can cause abdominal pain and discomfort, cramps, bloating, flatulence, nausea, fecal urgency, and diarrhea (15427,15434,15435,15436,15439,15440,15441,105955). Chronic use has also been associated with "cathartic colon," radiographically diagnosed anatomical changes to the colon such as benign narrowing, colonic dilation, and loss of colonic folds (15428). The clinical relevance of these findings is unclear. Chronic use can also cause pseudomelanosis coli (pigment spots in intestinal mucosa) which is harmless, usually reverses with discontinuation, and is not associated with an increased risk of developing colorectal adenoma or carcinoma (6138). The cathartic properties of senna leaf are greater than the fruit (15430). Thus, the American Herbal Products Association only warns against long-term use of senna leaf (12).

Hepatic ...Chronic liver damage, portal vein thrombosis, and hepatitis have been reported following oral use of senna alkaloids, such as in tea made from senna leaves (13057,13095,41431,74560,74564,74584,105956). There is a case report of hepatitis in a female who consumed moderate amounts of senna tea. The patient was a poor metabolizer of cytochrome P450 2D6 (CYP2D6). It's thought that moderate doses of senna in this patient led to toxic hepatitis due to the patient's reduced ability to metabolize and eliminate the rhein anthrone metabolites of senna, which are thought to cause systemic toxicity (13057). There is also a case of liver failure, encephalopathy, and renal insufficiency in a female who consumed 1 liter/day of senna tea, prepared from 70 grams of dried senna fruit, over 3 years (13095). In another case report, a 3-year-old female presented with hepatitis that led to pancytopenia after drinking tea made from 2-3 grams dry senna leaves three times or more weekly for over one year (105956).

Immunologic ...In one case report, a 19-year-old male developed anaphylaxis with dyspnea, facial edema, and hives. This reaction was determined to be caused by the senna content in a specific combination product (Delgaxan Plus, Pompadour Ibérica) that the patient ingested (105957).

Musculoskeletal ...Hypertrophic osteoarthropathy, finger clubbing, cachexia, and tetany have been reported from excessive oral senna use in humans (15426,74580,74582,74620,74625).

Renal ...Nephrocalcinosis has been reported as a result of oral senna overuse (74582).

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