Research - Menstruation
The effect of peppermint (Mentha piperita) capsules on the severity of primary dysmenorrhea
- Akram Heshmatia,
- Mahrokh Dolatianb, , ,
- Faraze Mojabc,
- Nozhat shakerid,
- Somayeh Nikkhahe,
- Zohreh Mahmoodif
Background and objectivesPrimary dysmenorrhea refers to painful menstrual cramps without an organic cause and is one of the most common problems for women during reproductive ages. Given the high prevalence of primary dysmenorrhea and its undesirable effects on the quality of life, and also given the evidence on the analgesic properties of peppermint capsules, the present study was conducted to investigate the effect of these capsules on the severity of primary dysmenorrhea in female students living in the dormitories of North Khorasan University of Shirvan, Iran in 2014–2015.
Materials and methodThis double-blind clinical trial was conducted on 102 eligible female students (aged 18–25) living in the dormitories of North Khorasan University of Shirvan from August 2014 to February 2015. The study subjects were initially matched in terms of the reported severity of primary dysmenorrhea and then divided into a peppermint capsule group (46 students) and a placebo group (44 students). The treatment group received three 330 mg peppermint capsules per day, and the placebo group received three identical placebo capsules containing starch, which were taken from the first to the third day of their menstrual cycle with identical administrations. The severity of pain was measured and compared before the intervention and over two successive cycles based on a visual analogue scale (0–10 cm). The data obtained was analyzed in SPSS-17 using the independent t-test and the ANOVA at the significance level of P < 0.05 .
ResultsNo significant differences were observed between the two groups in the mean duration and severity of pain before the intervention. After the intervention, a significant difference was observed between the groups in the severity of pain (P < 0.05), but no significant differences were observed in the duration of pain.
DiscussionPeppermint capsules appear to be capable of reducing the severity of primary dysmenorrhea through certain analgesic mechanisms. Further studies are recommended to be conducted in order to confirm the use of peppermint in the relief of primary dysmenorrhea.
Source : sci-hub via Journal of Herbal Medicine
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Topical Black Cumin as Effective as NSAID Gel in Treating Cyclic Mastalgia
Reviewed: Huseini HF, Kianbakht S, Mirshamsi MH, Zarch AB. Effectiveness of topical Nigella sativa seed oil in the treatment of cyclic mastalgia: a randomized, triple-blind, active, and placebo-controlled clinical trial [published online November 19, 2015].Planta Med. doi: 10.1055/s-0035-1558208.
Mastalgia, or breast pain, may interfere with quality of life and can occur as a non-cyclic phenomenon or as cyclic mastalgia, which occurs during the premenstrual phase of the cycle. Although there are a few standard treatments for severe mastalgia, including nonsteroidal anti-inflammatory drugs (NSAIDs), these common therapies can cause adverse side effects. Traditionally, black cumin (Nigella sativa, Ranunculaceae) seed and preparations thereof have been used both internally and externally as an analgesic, galactagogue, digestive stimulant, and antibacterial for a variety of ailments, including gastrointestinal problems, bacterial infections, dysmenorrhea, and hypertension. In Iranian traditional medicine, black cumin seed oil is used topically for mastalgia. This randomized, triple-blind, placebo-controlled trial compared the topical use of black cumin seed gel with diclofenac gel (an NSAID) and placebo.
The study included Iranian women (aged 25-45 years) with regular menstrual cycles who had cyclic mastalgia during at least three previous consecutive menstrual cycles, who experienced pain for at least seven days per month, and who had mastalgia severity scores greater than 4 on a visual analog scale (VAS; 0 = no pain to 10 = severe pain), requiring medical treatment. Those taking NSAIDs, hormones, or a hormone-based contraceptive, and those who had irregular menstrual cycles, cancer, a hysterectomy, or an oophorectomy (the surgical removal of ovaries) in the past were excluded. Patients who were pregnant, lactating, planning to become pregnant, or had severe health issues also were excluded.
Treatments consisted of cold-pressed black cumin seed oil gel (30% seed oil by weight; Barij Essence Pharmaceutical Company; Mashhad-e Ardahal, Iran), diclofenac gel (1% diclofenac by weight; Darou Pakhsh Pharmaceutical Company; Tehran, Iran), and placebo gel. The same gel base was used for all three treatments. Patients applied 2 g black cumin seed oil gel (equivalent to 600 mg of black cumin seed oil), 2 g diclofenac gel (equivalent to 20 mg of diclofenac), or 2 g placebo gel topically at the mastalgia site twice daily for two menstrual cycles.
The study’s primary endpoint was pain improvement based on VAS scores during three baseline cycles and two treatment cycles at the late luteal phase (post-ovulation). Patients also reported any adverse side effects (the secondary endpoint). Returned treatment containers and patient self-reporting were used to measure compliance. Fatty acid concentrations, as well as fixed and volatile compounds in the black cumin seed oil, were measured using gas chromatography-mass spectrometry.
From a total of 181 patients screened, 159 were randomly assigned to black cumin seed oil gel, diclofenac gel, or placebo gel (n = 53 for each). In the black cumin seed oil and diclofenac groups, one and two patients, respectively, were lost to follow-up for “personal reasons,” leaving a total of 156 for the analysis. Patients reportedly “fully complied” with the study protocol.
No significant differences were noted in baseline pain scores between groups. Following the second treatment cycle, those in the black cumin seed oil group experienced a significant decrease in pain scores compared to baseline (P < 0.001). A significant decrease in pain scores was also seen in those using diclofenac (P < 0.001). A nonsignificant reduction in pain scores between baseline and endpoint was observed in the placebo group (P > 0.05).
The pain scores of those in the black cumin seed oil and diclofenac groups during both treatment cycles were significantly less than those of the placebo group (P < 0.001 for both comparisons). Additionally, no significant differences were noted between scores of the black cumin seed oil and diclofenac groups after either treatment cycle. Patients (98% of the black cumin seed oil group and 95% of the diclofenac group) reported more than 50% pain relief, with relief occurring 10-15 minutes following topical application. None of the patients reported any adverse side effects.
In the phytochemical analysis, the unsaturated fatty acids linoleic acid (58.24%), oleic acid (22.58%), and palmitoleic acid (0.28%) were prominent fixed compounds in the black cumin seed oil. The phytochemicals -cymene (51.62%), thymoquinone (14.48%) and carvacrol (0.96%) were detected as volatile components.
In this study, both black cumin seed oil gel and diclofenac gel were effective in treating mastalgia compared with placebo. The data suggest that black cumin seed oil may be as effective as diclofenac, since no significant differences were noted between pain scores in treatment cycles of these groups. Since there were no adverse side effects reported during the treatment period, black cumin seed oil appears safe for use.
Thymoquinone and carvacrol have previously been shown to have analgesic effects, and may contribute to the pain-reducing effects seen with the topical application of black cumin seed oil gel. However, since these compounds were not directly tested, no conclusion can be drawn as to their bioactivity, and the pain modulation may be due to other undetected compounds. Further studies should investigate the potential mechanisms of action of black cumin seed oil.
The results of this trial suggest that topical black cumin may be a candidate for the list of evidence-based natural therapies for cyclic mastalgia, which includes chaste tree (Vitex agnus-castus, Lamiaceae) berry, evening primrose (Oenothera biennis, Onagraceae) seed oil, vitamin E, and molecular iodine.
—Amy C. Keller, PhD
Source : American Botanical Council
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The effect of Crocus sativus (saffron) on the severity of premenstrual syndrome
Soheila Pirdadeh Beiranvanda, , Nabiollah Shams Beiranvandb, , Zahra Behboodi Moghadamc, ,Mehdi Birjandid, , , Seddigheh Azharie, , Elham Rezaeif, , Ali Nazar Salehniag, , Somayyeh Beiranvandg,
Premenstrual syndrome is one of the most common problems for women during their reproductive age and has wider impacts affecting their family and their work. Herbal products are a suggested way of treating the syndrome. This research was carried out to identify whether saffron could have an effect on the severity of premenstrual syndrome among female students.
This randomized triple-blind controlled clinical trial was carried out with 78 students aged 18–35 years residing in university accommodation. The intervention group received capsules containing 30 mg of dried extract of saffron stigma once a day and the control group received placebo capsules for two menstrual cycles. The data gathering instrument consisted of questionnaire, the DASS21 scale, and premenstrual symptoms assessment form.
At the beginning of the study, the two groups did not differ significantly in terms of their mean severity of PMS (P = 0.81). At the end of the study, the changes of the mean severity of PMS were significantly different compared with those in the beginning:P < 0.001 for the intervention group, and p = 0.04 for the control group. In total, the two groups had significant differences in terms of changes in the mean severity of PMS over time (P < 0.001).
The results of this study suggest that saffron reduces the severity of PMS symptoms, but in order to prove its effectiveness for the treatment of this syndrome, further research is warranted.
Source : European Journal of Integrative Medicine
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Effect of rhubarb (Rheum emodi) in primary dysmenorrhoea: a single-blind randomized controlled trial
Hina Rehman1 / Wajeeha Begum1 / Farzana Anjum1 / Humyra Tabasum2 / Shabnam Zahid3
Background: The aim of this study was to investigate and evaluate the efficacy of Rheum emodi in the management of primary dysmenorrhoea.
Methods: A randomized, single-blind, standard controlled trial compared efficacy of R. emodi against mefenamic acid on diagnosed subjects of primary dysmenorrhoea for three consecutive cycles. Experimental group (n=30) received capsules of R. emodi powder two times a day, two days before the expected date of menstruation, and continued first three days of menstruation, while control group (n=15) participants received mefenamic acid capsules three times a day on the same protocol. The primary outcome measures were reduced in severity and duration of pain, assessed by visual analogue scale (VAS) and verbal multidimensional scoring system (VMSS), and secondary outcome measures were overall improvement of dysmenorrhoea and improved in quality of life (QOL). Statistical analysis was done by repeated measures analysis of variance and Chi-square/Fisher Exact test.
Results: The menstrual pain was significantly decreased in both groups after three-cycle intervention. Significant changes were observed in VAS (p<0.001) and VMSS (p<0.001) in the experimental group. There is a significant (p<0.001) reduction in duration of pain in both the groups. Associated symptoms and QOL were markedly improved after treatment (p<0.001).
Conclusions: It has been clear from the above result that R. emodi is an effective herb in alleviating symptoms of primary dysmenorrhoea. It can serve as an alternative treatment without any apparent side effects. These results deserve further investigations.
Source : Journal Complementary and Integrative Medicine
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Sugar-sweetened beverage consumption and age at menarche in a prospective study of US girls
- J.L Carwile1,
- W.C Willett1,2,3,
- D. Spiegelman1,3,4,
- E. Hertzmark3,4,
- J. Rich-Edwards1,3,5,
- A.L Frazier3,6 and
- K.B Michels1,3,7,*
STUDY QUESTION Is sugar-sweetened beverage (SSB) consumption associated with age at menarche?
SUMMARY ANSWER More frequent SSB consumption was associated with earlier menarche in a population of US girls.
WHAT IS KNOWN ALREADY SSB consumption is associated with metabolic changes that could potentially impact menarcheal timing, but direct associations with age at menarche have yet to be investigated.
STUDY DESIGN, SIZE, DURATION The Growing up Today Study, a prospective cohort study of 16 875 children of Nurses' Health Study II participants residing in all 50 US states. This analysis followed 5583 girls, aged 9–14 years and premenarcheal at baseline, between 1996 and 2001. During 10 555 person-years of follow-up, 94% (n = 5227) of girls reported their age at menarche, and 3% (n = 159) remained premenarcheal in 2001; 4% (n = 197) of eligible girls were censored, primarily for missing age at menarche.
PARTICIPANTS/MATERIALS, SETTING, METHODS Cumulative updated SSB consumption (composed of non-carbonated fruit drinks, sugar-sweetened soda and iced tea) was calculated using annual Youth/Adolescent Food Frequency Questionnaires from 1996 to 1998. Age at menarche was self-reported annually. The association between SSB consumption and age at menarche was assessed using Cox proportional hazards regression.
MAIN RESULTS AND THE ROLE OF CHANCE More frequent SSB consumption predicted earlier menarche. At any given age between 9 and 18.5 years, premenarcheal girls who reported consuming >1.5 servings of SSBs per day were, on average, 24% more likely [95% confidence interval (CI): 13, 36%; P-trend: <0.001] to attain menarche in the next month relative to girls consuming ≤2 servings of SSBs weekly, adjusting for potential confounders including height, but not BMI (considered an intermediate). Correspondingly, girls consuming >1.5 SSBs daily had an estimated 2.7-month earlier menarche (95% CI: −4.1, −1.3 months) relative to those consuming ≤2 SSBs weekly. The frequency of non-carbonated fruit drink (P-trend: 0.03) and sugar-sweetened soda (P-trend: 0.001), but not iced tea (P-trend: 0.49), consumption also predicted earlier menarche. The effect of SSB consumption on age at menarche was observed in every tertile of baseline BMI. Diet soda and fruit juice consumption were not associated with age at menarche.
LIMITATIONS, REASONS FOR CAUTION Although we adjusted for a variety of suspected confounders, residual confounding is possible. We did not measure SSB consumption during early childhood, which may be an important window of exposure.
WIDER IMPLICATIONS OF THE FINDINGS More frequent SSB consumption may predict earlier menarche through mechanisms other than increased BMI. Our findings provide further support for public health efforts to reduce SSB consumption.
Source : Journal Human Reproduction
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Ginger Rhizome Reduces Pain in Women with Moderate to Severe Dysmenorrhea
Shirvani MA, Motahari-Tabari N, Alipour A. The effect of mefenamic acid and ginger on pain relief in primary dysmenorrhea: a randomized clinical trial. Arch Gynecol Obstet. November 16, 2014; [epub ahead of print]. doi: 10.1007/s00404-014-3548-2.
Dysmenorrhea is the most common adverse symptom of menstruation and is the result of uterine contraction associated with an excess of prostaglandins within the uterus. Primary dysmenorrhea occurs in the absence of uterine pathology and is often treated with non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs are effective in approximately 70% of women with primary dysmenorrhea. The remaining 30% of women find these drugs either ineffective or accompanied by undesirable gastrointestinal side effects. The rhizome of ginger (Zingiber officinale, Zingiberaceae) has been found to be an anti-inflammatant, and previous studies suggest that ginger consumption reduces the severity of primary dysmenorrhea. In this randomized study, the effect of ginger rhizome was compared to mefenamic acid in women with primary dysmenorrhea.
Women ≥ 18 years old with moderate to severe dysmenorrhea were recruited from the dormitories at Mazandaran University in Babolsar, Iran. Women were excluded if they had an irregular menstrual cycle, exercised regularly, had secondary dysmenorrhea, had an intrauterine device, or were taking contraceptive medication. Patients were randomly assigned to either a ginger treatment group or a mefenamic acid treatment group. The ginger group took one 250 mg capsule of dried ginger rhizome (Zintoma; Goldaru Pharmaceutical Laboratory; Isfahan, Iran) every 6 hours during menstruation until pain relief occurred. The mefenamic acid group took one 250 mg capsule of mefenamic acid every 8 hours during menstruation until pain relief occurred. Patients recorded the most intense pain felt over the course of menstruation with a 100 mm visual analog scale (VAS). Date of each cycle, length of menstruation, and amount of bleeding were also recorded. Patients were allowed to use additional analgesics, if necessary, and were asked to record usage. Data were recorded for 2 menstrual cycles and analyzed with t-tests, chi-squared tests, and Fisher exact tests.
Each treatment group contained 61 patients. Pain associated with dysmenorrhea decreased significantly in both treatment groups over the study period (P < 0.05 for both). In the ginger treatment group, the level of pain went from 58.01 ± 14.52 to 38.19 ± 20.47, while the level of pain in the mefenamic acid group went from 55.03 ± 14.95 to 33.75 ± 17.71. There was no difference in pain reduction between the treatments. The number of days of menstruation was significantly greater in the ginger treatment group (6.67 ± 1.24) than in the mefenamic acid treatment group (6.21 ± 1.19) at the end of the study (P = 0.03). The patients in the ginger treatment group used more supplemental analgesics than the patients in the mefenamic acid treatment group, but this difference was not significant (P = 0.07). By the end of the study, approximately half of the patients in each group had moved from a classification of moderate/severe dysmenorrhea to a classification of mild dysmenorrhea. Fewer patients had severe dysmenorrhea in the mefenamic acid treatment group (n = 2) than in the ginger treatment group (n = 7) at the end of the study. Side effects of the treatments were not noted.
Both ginger rhizome and mefenamic acid reduced the pain associated with menstruation to a similar extent in women with moderate to severe dysmenorrhea. The greater use of supplemental analgesics, increased time of menstruation, and higher incidence of severe dysmenorrhea in the ginger treatment group suggests that mefenamic acid may be more effective for treating dysmenorrhea. Previous studies have found the effect of ginger supplementation on dysmenorrhea to be similar to NSAIDs, and that the effect is more pronounced if supplementation begins before menstruation. The ginger dosage used in previous studies was between 1000 and 2000 mg per day. This is similar to the maximum dosage (1000 mg/day) used in this study. Some studies have found that dosages higher than 2000 mg/day can lead to adverse effects. Ginger contains the compounds gingerol and gingerdione. These compounds are thought to lead to a decrease in inflammation and a concomitant decrease in prostaglandins. Ginger also contains salicylate which would serve directly as an analgesic. Further studies that begin ginger treatment before menstruation may show an even greater effect of ginger on dysmenorrhea.
–Cheryl McCutchan, PhD
Source : American Botanical Council - HerbClip
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Bian Zheng Lun Zhi as a Complementary and Alternative Treatment for Menstrual Cramps in Women with Dysmenorrhea: A Prospective Clinical Observation
Pin-Yi Lin,1 Yueh-Ting Tsai,1 Jung-Nien Lai,1,2 Chia-Hao Yeh,3 and Ruei-Chi Fang1
1Institute of Traditional Medicine, School of Medicine, National Yang-Ming University, No. 155, Section 2, Linong Road, Taipei City 112, Taiwan
2Department of Obstetrics and Gynecology, Taipei City Hospital, Yangming Branch, Taipei City 111, Taiwan
3Department of Chinese Medicine, Taipei City Hospital, Yangming Branch, Taipei City 111, Taiwan
Background. Limited scientific evidence supports the positive effects of traditional Chinese medicine (TCM) for treating dysmenorrhea. Thus, an observation period of 3 months could verify the ancient indication that TCM treatments effectively alleviate menstrual cramps in women with primary dysmenorrhea or endometriosis.
Methods. A prospective, nonrandomized study (primary dysmenorrhea and endometriosis groups) was conducted in women with dysmenorrhea for more than three consecutive menstrual cycles. All patients received TCM prescriptions based on bian zheng lun zhi theory 14 days before menstruation for a period of 12 weeks. Pain intensity was evaluated using a 10-cm visual analogue scale and two validated questionnaires (the Menstrual Distress Questionnaire and the World Health Organization Quality of Life questionnaire).
Results. Of the initial 70 intent-to-treat participants, the women with dysmenorrhea reported significant alleviation of cramps during menstruation after the 12-week TCM treatment. Mixed model analysis revealed that TCM prescriptions were more effective in alleviating fatigue, hot flashes, dizziness, painful breasts, excitement, and irritability in the primary dysmenorrhea group (n=36) than in the endometriosis group (n=34).
Conclusion. TCM prescriptions based on syndrome differentiation theory might be a potentially viable choice for treating painful menstruation and premenstrual symptoms after ruling out endometriosis.
Source Journal Evidence Based Complementary and Alternative Medicine
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An open-label pilot study to assess the effectiveness of krill oil with added vitamins and phytonutrients in the relief of symptoms of PMS
Michael P Wakeman
School of cancer Sciences, University of Birmingham,
Abstract: An open-label pilot study over 4months to evaluate the effectiveness of a compound formulation of ingredients, which individually have been demonstrated to be implicated in the pathogenesis of premenstrual syndrome to ameliorate the most troublesome symptoms of the condition. The supplement provided thiamine, riboflavin, pyridoxine, vitamin D, soy isoflavones, rosemary extract, and krill oil and was taken each day for the 3 months of the trial. Statistically significant effect was reported by the 29 women who completed the study in relief of anxiety, bloating, mood swings, breast tenderness, skin outbreaks, food cravings, fatigue, forgetfulness, insomnia, and headache after 3 months of treatment compared with baseline. This pilot study indicates the formulation to be effective, and a larger placebo-controlled trial is now planned.
Source : Nutrition and Dietary Supplements
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Approach to dysmenorrhoea in ancient ages and its current relevance
Hina Rehman, Wajeeha Begum, Farzana Anjum, Humyra Tabasum
Dysmenorrhoea, cyclic lower abdominal pain or pelvic pain which may radiate to back and thigh, is one of the most common gynaecologic condition experienced by menstruating women. The occurrence of painful menstruation is noticed by ancient times. Over the centuries, numerous authors have speculated on the particular cause of primary dysmenorrhoea; although false belief is still persists regarding pain and menstruation. The pain is often not completely relieved despite the use of medication in some women. It is necessary to understand the new available as well as traditionally documented therapeutic options for pain relief of dysmenorrhoea. The review will focus on ancient concepts of dysmenorrhoea in different era with available research studies on prescribed treatments in order to understand the alternative holistic approach
Source : International Journal of Herbal Medicine
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A randomized pilot study of acupuncture treatment for primary dysmenorrhea.
Kiran G, Gumusalan Y, Ekerbicer HC, Kiran H, Coskun A, Arikan DC.
Kahramanmaras Sutcu Imam University School of Medicine, Department of Obstetrics and Gynecology, Kahramanmaras, Turkey.
OBJECTIVE: To compare the therapeutic effect of acupuncture and non-steroidal anti-inflammatory drug (NSAID) therapy in primary dysmenorrhea patients.
STUDY DESIGN: Thirty-five young women with a diagnosis of primary dysmenorrhea were recruited for the study. Their dysmenorrhea severity was rated by visual analog scale (VAS) immediately prior to entry into the study. They were randomly divided into two groups; and the following month they were given NSAID (group 1, n=24) or acupuncture treatment (group 2, n=11). Pain was rated again using VAS during menstruation in both groups.
RESULTS: After one month's treatment, pain scores were significantly lower in both groups (p<0.05). Mean pain scores decreased by 52.2% and 69.5% in the NSAID and acupuncture groups, respectively.
CONCLUSION: Acupuncture was as effective as NSAID therapy for patients with primary dysmenorrhea. Since this was a pilot study with a small sample size and short follow-up period, larger studies are needed to clarify the effect of acupuncture in the treatment of primary dysmenorrhea.
Source : Eur J Obstet Gynecol Reprod Biol. 2013 Mar 19. pii: S0301-2115(13)00104-8. doi: 10.1016/j.ejogrb.2013.02.016
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Vitamin D Eases Menstrual Cramps
By John Gever,
Reviewed by Zalman S. Agus, MD; Emeritus Professor, Perelman School of Medicine at the University of Pennsylvania
Women with a history of severe menstrual cramps reported significantly less pain when they took an ultra-high dose of vitamin D five days before their next expected period, according to results of a small randomized trial.
Of 20 women taking the 300,000-IU dose of vitamin D, 15 reported pain scores at least two points lower than their average over a four-cycle baseline period, on a standard 10-point visual analog scale, reported Antonino Lasco, MD, of the University of Messina in Italy, and colleagues.
Only four of 20 participants assigned to placebo in the trial showed any improvement relative to baseline, the researchers indicated in a research letter appearing in the Feb. 27 issue of Archives of Internal Medicine.
Additionally, no patients in the vitamin D group reported using NSAID painkillers during the trial's treatment phase, whereas eight women in the placebo group took the medications at least once (P=0.003).
But in an accompanying commentary, two U.S. researchers pointed out that the vitamin D dose used in the study, even when averaged over two months, was still higher than the "tolerable upper limit" established last year by the Institute of Medicine.
Elizabeth R. Bertone-Johnson, ScD, of the University of Massachusetts in Amherst, and JoAnn E. Manson, MD, DrPH, of Brigham and Women's Hospital in Boston, recommended larger and longer trials not only to confirm the benefit of high-dose vitamin D, but also to determine how long it may last -- and, thus, how frequently the doses would have to be given.
Menstrual cramps and other symptoms of dysmenorrhea are caused by an excessive uterine production of prostaglandins, the authors noted in their letter. Cramps are usually managed with the use of nonsteroidal anti-inflammatory drugs (NSAIDs).
Lasco and colleagues sought to test vitamin D for menstrual cramps because vitamin D appears to affect pathways that also are involved in pain and in uterine physiology. In particular, it inhibits prostaglandin synthesis, and previous studies have shown that the enzyme that converts vitamin D into its active metabolites is expressed in the uterus.
Women complaining of at least four consecutive painful menstrual periods during the previous six months and who had serum levels of 25-hydroxyvitamin-D (25-OH-D) below 45 ng/mL (the lowest quartile of the normal range in the researchers' laboratory) were recruited for the trial. Those with previous or current use of an intrauterine device for contraception were excluded, but birth control by some other means was required during the baseline observation period.
Those assigned to the vitamin D group in the double-blinded trial received a single oral dose of 300,000 IU of cholecalciferol five days before they were expected to begin the next menstrual cycle.
Participants recorded menstrual pain on the 10-point scale for four cycles during the observation phase and for two cycles during the treatment phase. The primary outcome measure was the difference between the baseline average and the score during the second menstrual cycle post treatment.
Most patients in the placebo group had no change in scores relative to baseline. Four had a one-point decrease in pain; four others reported worsening by one or two points after treatment.
In the vitamin D group, every participant reported at least some improvement: five by one point, eight by two points, four by three points, two by four points, and one with a six-point improvement. Averages for the whole group were 5.85 at baseline and 3.50 at the second post-treatment cycle (P<0.001).
Lasco and colleagues indicated that there were no baseline differences between groups in age, body mass index, menstrual pain, or serum 25-OH-D.
In the accompanying commentary, Bertone-Johnson and Manson said the findings were plausible on the basis of known anti-inflammatory effects of vitamin D. These are not confined to the vitamin's suppression of prostaglandin production, but may also involve nuclear factor kappa-B and MAPK phosphatase-5 activity.
But the enormous dose used in the study was a concern. "Follow-up of participants in clinical trials of vitamin D must be extended to better evaluate adverse effects and compare risks and benefits," they wrote. Bertone-Johnson and Manson pointed particularly to a 2010 study that found increased fractures and falls in older women given annual 500,000-IU doses.
They argued that the 300,000-IU dose could be problematic if, in fact, the benefit only lasts two months and therefore must be repeated that often. Such a dose equates to about 5,000 IU/day -- well above the 4,000 IU/day that the IOM indicated was the maximum tolerable dose.
Future studies should also establish a cutoff for baseline serum level of 25-OH-D below which supplementation would most likely be beneficial, Bertone-Johnson and Manson suggested.
Source : MedPage Today
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Studies Assess Ginger for Treatment of Nausea During Pregnancy and Menstrual Pain
Reviewed: Ozgoli G, Goli M, Moattar F. Comparison of effects of ginger, mefenamic acid, and ibuprofen on pain in women with primary dysmenorrhea. J Altern Complement Med. 2009;15(2):129-132. Reviewed: Ozgoli G, Goli M, Simbar M. Effects of ginger capsules on pregnancy, nausea, and vomiting. J Altern Complement Med. 2009:15(3):243-246.
Researchers from Iran recently conducted 2 trials to evaluate the safety and effectiveness of ginger (Zingiber officinale, Zingiberaceae) for treating female reproductive complaints. The first study compared ginger preparations to non-steroidal anti-inflammatory drugs (NSAIDs) for relieving dysmenorrhea (painful or difficult menstruation). The second study evaluated ginger as a treatment for nausea and vomiting during pregnancy.
Dysmenorrhea is experienced by more than half of menstruating women. NSAIDs can be effective in relieving dysmenorrhea, but NSAIDs and other pain relievers commonly cause adverse side effects and are contraindicated in some people. Ancient medical texts refer to the use of ginger for relief of dysmenorrhea, but there are no published clinical trials to support its effectiveness. The researchers therefore conducted a study to compare the effects of ginger, mefenamic acid (a mild analgesic and fever-reducing NSAID used in some types of arthritis and for the relief of moderate short-term menstrual pain), and the NSAID ibuprofen on dysmenorrhea.
For the non-randomized, double-blind trial, the researchers recruited 150 female college students who were 18 years or older and had primary dysmenorrhea. The women completed a questionnaire that assessed menstrual characteristics and severity of pain. Those with moderate to severe dysmenorrhea were enrolled in the study and alternately allocated to 1 of 3 groups: the ginger group, the mefenamic acid group, or the ibuprofen group. Depending on their assigned group, the women were instructed to take either four 250-mg capsules of ginger rhizome powder (Zintoma; Goldaroo Company; Tehran, Iran), four 250-mg capsules of mefenamic acid (Ponstan; Razak Co.; Iran), or four 400-mg capsules of ibuprofen (Brufen; Roozdaru Co.; Iran) each day, beginning on the first day of their menstrual period and continuing for 3 days. After the 3 days, the women rated the severity of their dysmenorrhea, the degree of pain relief, and their satisfaction with the treatment. Only one menstrual cycle was studied.
All 150 women completed the study. There were no significant differences in baseline characteristics among the 3 groups. Dysmenorrhea severity decreased in all 3 groups (P values not reported) after 3 days. Severity of symptoms, improvement in pain relief, satisfaction with the treatment, and compliance with the capsules were not significantly different among the groups. None of the women reported any serious adverse side effects during the study.
The authors conclude that ginger is as effective as mefenamic acid and ibuprofen in decreasing menstrual pain. They also point out certain limitations of this study. The study subjects were alternately assigned to an experimental group rather than randomly assigned; however, baseline characteristics were similar among subjects in all 3 groups, and there is no indication of bias in group assignments. The study did not compare the effect of ginger on other menstrual symptoms, such as nausea, headaches, and fatigue. The scale used to rate dysmenorrhea severity was a verbal, 4-point scale, and the authors suggest that use of a 10-point visual analog scale or other standardized scale may detect more subtle differences in response among the experimental groups.
One issue the authors do not address is the dosage of comparator drugs used in this study. It is not clear if the doses selected for this study (1,600 mg ibuprofen and 1,000 mg mefenamic acid) are typical doses used for treatment of primary dysmenorrhea in the local population. In the United States, daily doses of 2,400-3,200 mg ibuprofen are commonly recommended for treatment of moderate or severe dysmenorrhea and may be more effective than the 1,600 mg dose of ibuprofen used in this study. The recommended dose for mefenamic acid is 1,500 mg per day. It is therefore unclear as to how much of a placebo-effect occurred in this study. It would have been better if a placebo group had been included for comparison. Another limitation is that the study was very brief; typically, dysmenorrhea studies are conducted over a 3 month period. In addition to correcting the limitations discussed by the authors, future trials should assess the safety and efficacy of ginger during several menstrual cycles, investigate a range of ginger doses, and include populations of women other than young college students.
The second study assessed the effects of 1,000 mg of ginger administered in capsule form on the severity of nausea and vomiting in pregnant women. Up to 90% of women experience nausea and vomiting during pregnancy. Little is known about the safety of antinausea drugs during pregnancy, so some pregnant women turn to herbs or other complementary therapies for relief. Ginger has long been used to relieve stomach upset in the traditional medicines of many cultures.
This single-blind, randomized, placebo-controlled trial was conducted at prenatal clinics and Isfahan Shahid Beheshti Hospital in Isfahan, Iran. Seventy healthy, pregnant women who were less than 20 weeks gestational age and who reported mild to moderate nausea with or without vomiting were enrolled in the trial. The women were randomly allocated to an experimental group or a matched control group. Women in the experimental group took four 250-mg capsules containing ginger root powder (Zintoma; Goldaroo Company; Tehran, Iran) daily for 4 days. Women in the control group took 4 placebo capsules containing lactose daily for 4 days. The women were instructed to take a capsule in the morning, at noon, in the afternoon, and at night.
Before starting the study, women rated the severity of their nausea and vomiting using a 10-point visual analog scale (VAS). The women were instructed to avoid fatty foods and to eat smaller, more frequent meals during the study. The women completed a questionnaire each day and recorded the severity of their nausea on the VAS twice a day (at noon and at bedtime). On the fifth day, the women were interviewed by a researcher to assess compliance with the dietary instructions and capsule use.
Of the 70 women who started the study, 67 completed the study (32 in the ginger group and 35 in the placebo group). There were no significant differences in nausea intensity between the 2 groups at baseline. Women in the ginger group reported significantly greater improvement in nausea than women in the placebo group (P < 0.05) during the 4-day trial. Nausea intensity declined in 84% of women in the ginger group and 56% of women in the placebo group (P < 0.05). The incidence of vomiting did not decrease significantly in the placebo group but decreased a significant 50% in the ginger group after 4 days (P < 0.05). None of the women reported any adverse side effects from the capsules. While compliance with the capsules was excellent in both groups, only about half of the women in each group reported complying with the dietary advice.
The authors conclude that daily treatment with 1,000 mg of ginger is a safe and effective way to decrease the intensity of nausea as well as the incidence of vomiting during pregnancy. However, the authors’ conclusions that 1,000 mg is the appropriate dose cannot be asserted given that this study was not a dose-ranging study. Also, the authors’ conclusion that this dose is safe cannot be asserted since there has been no long-term, follow-up studies of the infants, and, given the small sample size, only very large changes in pregnancy outcomes would have been seen.
The results of this study are consistent with 9 published randomized controlled trials, which have also evaluated the effectiveness of ginger for nausea and vomiting during pregnancy. In these trials, daily doses ranged from 1,000 mg to 1,500 mg and the ginger products included capsules containing ginger powder or ginger syrup, which is mixed with a beverage.
The authors point out that the short duration of this trial is a limitation. Another limitation that the authors did not discuss is whether the study was adequately blinded. Ginger capsules have a distinctive odor and flavor and it is possible that the people taking the placebo were aware that they had the placebo treatment. This could have contributed to the study outcome. Future trials should assess the safety and effectiveness of ginger over a longer period of time, should improve study blinding, and enroll pregnant women with severe nausea and vomiting to expand the understanding of this herb’s effectiveness during pregnancy.
—Heather S. Oliff, PhD
Source : American Botanical Council
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