Slumberol by Allergy Research Group

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Anxiety. Although there has been interest in using oral lotus stem for anxiety, there is insufficient reliable information about the clinical effects of lotus for this purpose.
• Bleeding. Although there has been interest in using oral lotus flowers and leaves for bleeding, there is insufficient reliable information about the clinical effects of lotus for this purpose.
• Cholera. Although there has been interest in using oral lotus flowers and leaves for cholera, there is insufficient reliable information about the clinical effects of lotus for this purpose.
• Cough. Although there has been interest in using oral lotus seeds for cough, there is insufficient reliable information about the clinical effects of lotus for this purpose.
• Diarrhea. Although there has been interest in using oral lotus flowers, leaves, rhizome, and seeds for diarrhea, there is insufficient reliable information about the clinical effects of lotus for this purpose.
• Halitosis. Although there has been interest in using oral lotus seeds for halitosis, there is insufficient reliable information about the clinical effects of lotus for this purpose.
• Hemorrhoids. Although there has been interest in using topical lotus seeds for hemorrhoids, there is insufficient reliable information about the clinical effects of lotus for this purpose.
• Insomnia. Although there has been interest in using oral lotus seeds for insomnia, there is insufficient reliable information about the clinical effects of lotus for this purpose.
• Leprosy. Although there has been interest in using oral lotus stem for leprosy, there is insufficient reliable information about the clinical effects of lotus for this purpose.
• Menorrhagia. Although there has been interest in using oral lotus seeds for menorrhagia, there is insufficient reliable information about the clinical effects of lotus for this purpose.
• Nausea and vomiting. Although there has been interest in using oral lotus stem for nausea and vomiting, there is insufficient reliable information about the clinical effects of lotus for this purpose.
• Obesity. It is unclear if oral lotus is beneficial in patients who are overweight. Details: Preliminary clinical research in overweight adults (BMI 24-28 kg/m2) shows that taking a lotus leaf extract, 1-2 grams orally daily for 12 weeks, modestly reduces total body fat when compared with no treatment. Preliminary subgroup analyses also suggests that it reduces visceral fat and waist circumference in males (110686).
• Pharyngitis. Although there has been interest in using oral lotus rhizome for pharyngitis, there is insufficient reliable information about the clinical effects of lotus for this purpose.
• Urinary retention. Although there has been interest in using oral lotus stem for urinary retention, there is insufficient reliable information about the clinical effects of lotus for this purpose. More evidence is needed to rate Lotus for these uses.

(Read more about LOTUS)

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.

(Read more about SENNA)

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Aging skin. Although there has been interest in using topical zizyphus for aging skin, there is insufficient reliable information about the clinical effects of zizyphus for this purpose.
• Anemia of chronic disease. Although there has been interest in using oral zizyphus for anemia of chronic disease, there is insufficient reliable information about the clinical effects of zizyphus for this purpose.
• Anxiety. Although there has been interest in using oral zizyphus for anxiety, there is insufficient reliable information about the clinical effects of zizyphus for this purpose.
• Asthma. Although there has been interest in using oral zizyphus for asthma, there is insufficient reliable information about the clinical effects of zizyphus for this purpose.
• Athletic performance. Although there has been interest in using oral zizyphus to improve athletic performance, there is insufficient reliable information about the clinical effects of zizyphus for this purpose.
• Cancer. Although there has been interest in using oral zizyphus for cancer, there is insufficient reliable information about the clinical effects of zizyphus for this purpose.
• Constipation. It is unclear if oral zizyphus fruit extract is beneficial in patients with constipation. Details: A small clinical study in patients with idiopathic constipation shows that taking zizyphus fruit extract 20-40 drops daily for 12 weeks improves bloating, abdominal pain, difficult evacuation, and quality of life when compared to baseline. Significant improvements in constipation-related symptoms were lacking in patient taking placebo drops (93316). The validity of these findings is limited by the lack of statistical comparison between groups.
• Coronavirus disease 2019 (COVID-19). Oral zizyphus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in adults hospitalized with confirmed COVID-19 shows that taking a combination product containing zizyphus, barley, and Assyrian plum 200 mL twice daily for 5 days in addition to standard therapy improves oxygen saturation levels and fatigue but does not improve cough severity or frequency, respiratory rate, or temperature when compared with control (112818). It is unclear if these effects are due to zizyphus, other ingredients, or the combination. It is also unclear if these changes are due to the product or the natural resolution of the condition.
• Diabetes. It is unclear if oral zizyphus fruit powder is beneficial in patients with type 2 diabetes. Details: A small clinical study in patients with type 2 diabetes shows that taking zizyphus fruit powder 30 grams daily for 12 weeks reduces measures of insulin resistance and improves measures of insulin sensitivity, but does not affect fasting blood glucose levels or glycated hemoglobin, when compared with placebo (104507).
• Diarrhea. Although there has been interest in using oral zizyphus for diarrhea, there is insufficient reliable information about the clinical effects of zizyphus for this purpose.
• Epilepsy. Although there has been interest in using oral zizyphus for epilepsy, there is insufficient reliable information about the clinical effects of zizyphus for this purpose.
• Hyperlipidemia. It is unclear if oral zizyphus fruit powder is beneficial in patients with hyperlipidemia. Details: A small clinical study in obese adolescents with hyperlipidemia shows that taking zizyphus fruit powder 5 grams three times daily for one month modestly lowers total cholesterol and low-density lipoprotein (LDL) cholesterol, but does not improve high-density lipoprotein (HDL) cholesterol, when compared with placebo (93317). However, a small clinical study in patients with type 2 diabetes shows that taking zizyphus fruit powder 30 grams daily for 12 weeks does not improve lipid levels when compared with placebo (104507).
• Hypertension. Although there has been interest in using oral zizyphus for hypertension, there is insufficient reliable information about the clinical effects of zizyphus for this purpose.
• Insomnia. It is unclear if oral zizyphus seed extract is beneficial in patients with insomnia. Details: A very small crossover trial in patients with chronic insomnia shows that taking zizyphus seed extract 2 grams one hour before bedtime for 4 weeks improves sleep quality as measured using the Pittsburgh Sleep Quality Index, but not when assessed on the Insomnia Severity Index, when compared with placebo. While patients self-reported significant improvements in total sleep time, sleep efficiency, and sleep onset latency with zizyphus, these findings were not consistent with data gathered from actigraphy wrist watches worn during the study (107921). Zizyphus has also been evaluated in combination with other ingredients. A clinical trial in healthy adults with mild insomnia shows that taking a specific product (LZ Complex3, Sanofi) containing zizyphus 4.5 grams, hops 500 mg, lactium 75 mg, magnesium oxide 52.5 mg, and vitamin B6 10 mg daily for 2 weeks does not improve sleep quality, daytime functioning, or physical fatigue when compared with placebo (95971). Liver disease. Although there has been interest in using oral zizyphus for liver disease, there is insufficient reliable information about the clinical effects of zizyphus for this purpose.
• Melasma. Oral zizyphus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in adults with hyperpigmentation of facial skin shows that taking a syrup containing extracts of zizyphus and several other herbal plants 7.5 mL twice daily for 8 weeks reduces the number of pigments, total area of pigmentation, and percentage area of pigmentation when compared with baseline and placebo (112816). However, it is unclear if these changes are clinically significant. In addition, it is unclear if these effects are due to zizyphus, other ingredients, or the combination.
• Neonatal jaundice. It is unclear if oral zizyphus fruit extract is beneficial for neonatal jaundice. Details: A small clinical study in hospitalized infants with jaundice who are also being treated with phototherapy shows that giving zizyphus fruit extract 1 mL/kg orally three times daily does not significantly reduce levels of bilirubin, but modestly reduces the duration of hospitalization by 0.2 days, when compared with placebo (93306).
• Peptic ulcers. Although there has been interest in using oral zizyphus for peptic ulcers, there is insufficient reliable information about the clinical effects of zizyphus for this purpose.
• Wound healing. Although there has been interest in using topical zizyphus for wound healing, there is insufficient reliable information about the clinical effects of zizyphus for this purpose. More evidence is needed to rate zizyphus for these uses.

(Read more about ZIZYPHUS)

LIKELY SAFE. ..when used orally in food amounts. The flowers, seeds, leaves, and rhizomes of lotus are all edible (95261). There is insufficient reliable information available about the safety of medicinal lotus.

PREGNANCY AND LACTATION:
Insufficient reliable information available on the medicinal use of lotus; avoid using.

(Read more about LOTUS)

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).

(Read more about SENNA)

LIKELY SAFE ...when zizyphus fruit is consumed in the amounts typically found in foods.

POSSIBLY SAFE ...when zizyphus fruit or seed is used orally and appropriately, short-term. Zizyphus fruit powder has been used with apparent safety at doses up to 30 grams daily for up to 12 weeks (93317,104507). Zizyphus fruit extract has been used with apparent safety at a dose of 20-40 drops daily for up to 12 weeks (93316). Zizyphus seed extract has been used with apparent safety at a dose of 2 grams daily for 4 weeks (107921). There is insufficient reliable information available about the safety of zizyphus when used topically.

PREGNANCY AND LACTATION: LIKELY SAFE
when zizyphus fruit is consumed in the amounts typically found in foods. There is insufficient reliable information available about the safety of zizyphus fruit in amounts greater than those found in foods; avoid using.

(Read more about ZIZYPHUS)

ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, concurrent use of lotus with other antiplatelet drugs might reduce platelet aggregation and increase the risk of bleeding.  Details Neferine and isoliensinine, constituents of lotus, have been shown to inhibit platelet aggregation, in vitro. These constituents can inhibit the production of pro-aggregating factors like prostaglandins (59994,60005).

ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, lotus might have additive effects with antidiabetes drugs and increase the risk of hypoglycemia.  Details Animal research shows that the ethanolic extract of lotus reduces blood glucose levels and potentiates the effects of injected insulin (60053). Monitor blood glucose levels closely. Dose adjustments might be necessary.

PENTOBARBITAL (Nembutal) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking lotus concomitantly with pentobarbital might increase sedation.  Details Animal research shows that lotus extract increases pentobarbitone-induced sleeping time (60051). It is not known if this occurs in humans or if this effect occurs with other barbiturates or sedatives.

(Read more about LOTUS)

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).

(Read more about SENNA)

ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, zizyphus might increase the risk of hypoglycemia when taken with antidiabetes drugs.  Details Animal research shows that zizyphus has hypoglycemic activity (87589,87591,87617,87637,87659,87671). However, a small clinical study shows that zizyphus fruit powder does not reduce fasting blood glucose levels in patients with type 2 diabetes (104507).

CNS DEPRESSANTS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, zizyphus might cause additive sedative effects when taken with CNS depressants.  Details Some animal research has found that various parts of zizyphus have sedative effects (87572,87644,87646,87658). However, other animal research shows that zizyphus plant extract does not alter sleep parameters when used in combination with pentobarbital (93308).

CYTOCHROME P450 1A2 (CYP1A2) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, zizyphus might decrease the levels and clinical effects of drugs metabolized by CYP1A2.  Details Animal research shows that zizyphus induces CYP1A2 enzymes (93311). However, this effect has not been reported in humans.

(Read more about ZIZYPHUS)

General ...Orally, adverse effects to lotus seem to be rare when taken in medicinal amounts; however, a thorough safety evaluation has not been conducted.

Immunologic ...Orally and topically, lotus root can cause allergic reactions such as urticaria and contact dermatitis. In a case report, a 6-year-old female developed urticaria after ingesting lotus root. She had also developed contact dermatitis on body areas that had been in contact with the lotus root (99738).

(Read more about LOTUS)

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).

(Read more about SENNA)

General ...Orally, zizyphus fruit extract and powder seem to be well tolerated.

Gastrointestinal ...Orally, zizyphus fruit extract was associated with three cases of mild diarrhea in newborn infants (93306). Zizyphus seed extract was associated with one case of dry mouth and one case of increased bowel movements in a small clinical study (107921).

Neurologic/CNS ...Orally, zizyphus seed extract was associated with two cases of headache in a small clinical study (107921).

(Read more about ZIZYPHUS)