Sattoe et al. BMC Nephrology 2013, 14:279http://www.biomedcentral.com/1471-2369/14/279 Effective peer-to-peer support for young peoplewith end-stage renal disease: a mixed methodsevaluation of Camp COOL Jane NT Sattoe1,2*, Susan Jedeloo1 and AnneLoes van Staa1,2 Background: The Camp COOL programme aims to help young Dutch people with end-stage renal disease (ESRD)develop self-management skills. Fellow patients already treated in adult care (hereafter referred to as ‘buddies')organise the day-to-day program, run the camp, counsel the attendees, and also participate in the activities. Theattendees are young people who still have to transfer to adult care. This study aimed to explore the effects of thisspecific form of peer-to-peer support on the self-management of young people (16–25 years) with ESRD whoparticipated in Camp COOL (CC) (hereafter referred to as ‘participants').Methods: A mixed methods research design was employed. Semi-structured interviews (n = 19) with initiators/staff,participants, and healthcare professionals were conducted. These were combined with retrospective and pre-postsurveys among participants (n = 62), and observations during two camp weeks.
Nep001 1.8eCAM Advance Access published February 2, 2009
eCAM 2009;Page 1 of 8 Acupuncture and Auricular Acupressure in RelievingMenopausal Hot Flashes of Bilaterally OvariectomizedChinese Women: A Randomized Controlled Trial Jue Zhou1,*, Fan Qu2,*, Xisheng Sang3, Xiaotong Wang4 and Rui Nan5 1Sino-Britain Joint Laboratory, College of Pharmaceutical Sciences, Zhejiang University, Hangzhou, Zhejiang310058, 2Women's Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang 310006, 3HeilongjiangUniversity of Chinese Medicine, Harbin, Heilongjiang, 150040, 4The First Affiliated Hospital, Liaoning University ofChinese Medicine, Shenyang, Liaoning, 110032, P. R. China and 5Colorado School of Traditional ChineseMedicine, 1441, York Street, Denver, CO 80206, USA The objective of this study is to explore the effects of acupuncture and auricular acupressure inrelieving menopausal hot flashes of bilaterally ovariectomized Chinese women. Between May2006 and March 2008, 46 bilaterally ovariectomized Chinese women were randomized into anacupuncture and auricular acupressure group (n ¼ 21) and a hormone replacement therapy(HRT) group (Tibolone, n ¼ 25). Each patient was given a standard daily log and was requiredto record the frequency and severity of hot flashes and side effects of the treatment felt daily,from 1 week before the treatment started to the fourth week after the treatment ended. Theserum levels of follicle stimulating hormone (FSH), LH and E2 were detected before and afterthe treatment. After the treatment and the follow-up, both the severity and frequency of hotflashes in the two groups were relieved significantly when compared with pre-treatment(P50.05). There was no significant difference in the severity of hot flashes between them aftertreatment (P40.05), while after the follow-up, the severity of hot flashes in the HRT group wasalleviated more. After the treatment and the follow-up, the frequency of menopausal hot flashesin the HRT group was reduced more (P50.05). After treatment, the levels of FSH decreasedsignificantly and the levels of E2 increased significantly in both groups (P50.05), and theychanged more in the HRT group (P50.05). Acupuncture and auricular acupressure can be usedas alternative treatments to relieve menopausal hot flashes for those bilaterally ovariectomizedwomen who are unable or unwilling to receive HRT.
Keywords: acupuncture – auricular acupressure – hormone replacement therapy (HRT) –hot flashes – menopausal Hot flashes are episodic and usually accompanied bynausea, dizziness, headache, palpitations, diaphoresis or Hot flashes occur in the vast majority of post-menopausal night sweats (3). Having hot flashes may decrease a women (1). An extensive questionnaire study of 506 woman's quality of life by decreasing the quality of sleep women found that 87% had daily hot flashes (2).
and aggravating fatigue and depression (4,5). Menopausalhot flashes make most of women seek medical care during *These authors contribute equally to this work.
the menopausal transition (2). Menopausal hot flashes are For reprints and all correspondence: Fan Qu, No. 604 Room in related to a psychological or mental disorder in meno- B Building, School of Medicine, Zhejiang University, 388 Yuhang Tang pausal women and the hormonal changes in these women Road, Hangzhou, Zhejiang 310058, P. R. China. Tel: þ86-13429119143;E-mail: [email protected] may be the underlying mechanism (6,7).
ß 2009 The Author(s).
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License licenses/by-nc/2.0/uk/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work isproperly cited.
Acupuncture and auricular acupressure in relieving menopausal hot flashes For those bilaterally ovariectomized pre-menopausal not manifest any perimenopausal symptoms before the women, the estradiol (E2) contents in their serum were bilateral ovariectomy and had not taken any drugs reduced by 80% (8). The abrupt decline in E2 usually containing hormones or affecting the cardiovascular leads to more frequent and severe menopausal symptoms, system during the previous 6 months; the level of especially hot flashes. Menopausal hot flashes are also thyroid-stimulating hormone (TSH) was normal and the related to enhanced norepinephrine (NE) activity in the E2 concentration was 550 pg/ml; a gynecologic examina- hypothalamus, resulting in an abrupt, transient, down- tion and laboratory tests showed that the patient did not ward resetting of the normal thermoregulatory response suffer from other organic diseases of the reproductive set point (9, 10). Most of the bilaterally ovariectomized system after the bilateral ovariectomy; written consent Chinese women have difficulty in stopping hormone was obtained from the subject stating that the subject replacement therapy (HRT) due to the severe menopausal would complete the study. To have been considered for symptoms. Although HRT historically has been used the study, patients must have met all criteria.
as the standard treatment for hot flashes (11), many Exclusion criteria were as follows: the subject was women choose not to initiate or adhere to HRT because under other medical treatment during the research period, of its potential health risks and side effects (12,13).
had metabolic, renal, anaphylactic or endocrine disease, In recent years, non-pharmacological alternative treat- or suffered from primary hypertension, primary hypoten- ments are being requested by more bilaterally ovariecto- sion, chronic anemia, tuberculosis, a mental disorder or mized women to relieve their menopausal symptoms, a chronic affection; the body mass index (BMI) of the especially menopausal hot flashes. A study has demon- subject was more than 24 or she was a cigarette smoker.
strated that acupuncture could induce accumulation of Patients were excluded from the study if they fit any of vaginal exfoliative cells, increase the weight of adrenal, the above criteria.
and raise the level of serum corticosterone in ovariecto- The women were informed of the short- and long-term mized model rats (14). It is deduced that estrogen levels benefits of HRT and were informed about the aim and may be elevated using acupuncture to create compensa- methodology of the study. Ethical approval and permis- tory hyperplasia of the adrenal cortex, thereby enhancing sion to conduct the study were obtained from the local the transferring of androgen into estrogen in peripheral ethical committee and the administration of the study tissues (14). In as early as 1995, the acupuncture's was based on international ethical guidelines. Voluntary efficacy in relieving menopausal symptoms has been participation was requested and informed consent was demonstrated (15). Alternative and complementary thera- pies, including acupuncture, have been used increasingly Subjects were randomized to either the acupuncture and auricular acupressure group or the HRT group (16–23), although one of them suggested that the used with the use of a randomization chart constructed in medical acupuncture was not any more effective for Microsoft Excel that randomized numbers into two reducing menopausal hot flashes than was the chosen groups. Having been divided, the acupuncture and auric- sham acupuncture (16). As hot flashes are the most ular acupressure group had 21 cases and HRT group common menopausal symptoms in bilaterally ovariecto- had 25. In the statistical analysis, 43 of the women were mized women, it is important to find effective, non- included. Three subjects were considered missing cases pharmacological treatments to relieve their menopausal during the study (Fig. 1). There was no significant differ- hot flashes. This study was designed to explore the effects ence in baseline characteristics between the two groups of acupuncture and auricular acupressure in relieving menopausal hot flashes of bilaterally ovariectomized Each patient was given a standard daily log and was Chinese women.
required to record the frequency and severity of hotflashes and side effects of the treatment felt daily, from1 week before the treatment started to the fourth week Subjects and Methods after the treatment ended. The patients were required torecord the items before going to bed in the evening.
The standard daily log was made in a structured way by Between May 2006 and March 2008, 46 bilaterally the hospitals and all the possible side effects of the ovariectomized Chinese women were recruited through treatment had been listed on it, which had been validated advertisement to complete 12 weeks of intervention with either acupuncture and auricular acupressure or Livial Each participant received a physical examination, a routine blood examination, a routine uronoscopy, a Inclusion criteria were as follows: the subject had liver function test and a renal function test, respectively, received a bilateral ovariectomy in the previous 2 years 1 day before the treatment started and 1 day after the and suffered from menopausal hot flashes; the patient did treatment ended.
Table 1. The baseline characteristics of the participants Assessed for eligibility
(n = 46)
Excluded (n = 0)
(n = 46)
Time since ovariectomy (years) Married/living as married Acupuncture & auricular
(n = 21)
(n = 25)
Received oral Livial (Tibolone)
Women with children one tablet a day (2.5mg/tab) for
Area of residence acupuncture and auricular
twelve consecutive weeks
for twelve consecutive weeks
excluded from analysis
Current employment status excluded from analysis
(n = 2)
Full-time employment (n = 1)
lost to follow-up (n = 1)
Part-time employment no explanation (n = 1)
no explanation (n = 1)
Registered unemployed Cause of ovariectomy Analysed (n = 19)
Analysed (n = 24)
Bilateral tubal-ovarian cyst Bilateral tubal-ovarian abscess Figure 1. Study design.
Malignant tumor of uterus and/or ovary Benign tumor of uterus Group and Administration Removing the need Acupuncture and Auricular Acupressure Group for contraception Each patient randomized into the acupuncture and Prophylactic ovariectomy auricular acupressure group received both acupuncture Bilateral severe ovarian and auricular acupressure treatments.
Cessation of menstruation The selected acupoints: Sanyinjiao (SP6), Fengchi (GB20), Hegu (LI4), Quchi (LI11), Guanyuan Duration of the menopausal hot flashes (year) The patient was in a comfortable, supine position.
After the skin was routinely disinfected and the acupointswere carefully localized, filiform 0.35 mm 40 mm ster- time and manipulated twice during that time using ilized, disposable needles (provided by Suzhou Hua Tuo a twirling technique in a small range. The manipulation Medical Instruments Co. Ltd, Suzhou, China) were lasted 30 s for each acupoint. The acupuncture treatment inserted using the double hand-needle insertion techni- consisted of two sessions each week for 12 consecutive que. The depth of insertion was adjusted based on the patient's body size and the permissible depth of insertionof the specific acupoint. A technique using lifting, thrust- The selected auricular acupoints: ing and twirling in a small range was performed until the sympathetic (AH6a), shenmen (TF4), adrenal gland appearance of De-qi, an obtained needle sensation, when (TG2p), subcortex (AT4), endocrine (CO18), kidney there emerge a soreness, numbness and a feeling of (CO10), heart (CO15) and liver (CO12).
distension around the point after the needle is inserted to After the above acupoints were sterilized with 75% a certain depth, and tenseness around the needle felt by alcohol, pieces of plaster with magnetic beads of proper the operator. Then, an even reinforcing-reducing techni- size and good quality were stuck to the acupoints, which que was applied. The needle was retained for 40 min each were then pressed slightly until the patient had an Acupuncture and auricular acupressure in relieving menopausal hot flashes aching pain, numbness, distention and a warm sensation.
The patients were asked to press the acupoints by acupressure group and the HRT group were determined.
themselves six times a day for a 3 min duration eachtime. It was explained that the strength of the pressingshould make the local auricle congestive, flushed, hot and achy. The auricular acupressure was alternativelyconducted on the two ears every 2 days. The plaster with The Baseline Characteristics magnetic beads was exchanged for a fresh set once There were no significant difference between the two groups' baseline characteristics (P40.05) (Table 1).
The acupuncture process adhered to the Standards for Reporting Interventions in Controlled Trials of Acu-puncture (STRICTA) criteria (24).
The Severity of Hot Flashes There was no significant difference between the two groups' severity of hot flashes before treatment. After the The patients were prescribed with oral Livial (Tibolone, 12 weeks of treatment, both groups' severity of hot made by Nanjing Oujianong Pharmaceutical Company flashes decreased significantly (P50.05) with no signifi- Limited, Nanjing, China), in the dosage of one tablet cant difference between the groups (P40.05). The 4-week a day (2.5 mg/tablet) for 12 consecutive weeks.
follow-up showed that both groups were alleviated signif- One day before the treatment and at the end of the icantly when compared with pre-treatment (P50.05) and treatment, the levels of follicle stimulating hormone HRT had greater effects (P50.05) (Table 2).
(FSH) and luteinizing hormone (LH) were measuredwith enzyme-linked immunosorbent assay (ELISA) and The Frequency of Hot Flashes the levels of E2 were measured with double antibioticELISA. All the reagents were provided by Lianxing There was no significant difference between the two Biological Technology Company, Tianjin, China.
groups before treatment. After the 12 weeks of treatment,the frequency of the menopausal hot flashes in bothgroups were reduced significantly (P50.05) and HRT had greater effects (P50.05) (Table 2). The 4-week The severity of hot flashes was defined as follows: mild— follow-up showed that the frequency of hot flashes in the a fleeting, warm sensation without sweating or disruption two groups both decreased significantly when compared of normal activities; moderate—a warm sensation asso- with pre-treatment (P40.05) and the patients in the HRT ciated with sweating, and disruption of normal activities; group were alleviated more (P50.05) (Table 2).
severe—a hot sensation associated with sweating and thediscontinuation of normal activities (16,19,23,25,26).
The Serum Levels of FSH, LH and E2 The score of the hot flash severity for a particular day is calculated by adding 1 the number of mild hot Before treatment, there was no significant difference flashes þ 2 the number of moderate hot flashes þ 3 in the serum levels of FSH, LH and E2 between the the number of severe hot flashes (16,19,23,25,26).
acupuncture and auricular acupressure group and the The frequency of hot flashes is the total number of HRT group. After treatment, the levels of FSH decreased the mild, moderate and severe hot flashes occurred significantly and the levels of E2 increased significantly in during 24 h.
both of the two groups and the levels of LH decreasedsignificantly in the HRT group (P50.05) (Table 2). Theserum levels of FSH, LH and E2 in the HRT group changed more (P50.05) (Table 2).
Results were analyzed by an independent universitystatistician using Statistical Package for Social Sciences (SPSS 13.0 for Windows), a computer software. Non-parametric Mann–Whitney tests were used to analyze the No side-effect was reported in either group during the inter-group and intra-group differences of the severity period of the research or in the follow-up phase.
and frequency of menopausal hot flashes. Analysis ofvariance (ANOVA) was used to compare the inter-group and intra-group differences of the serum levels of FSH,LH and E2. A 5% significance level (P50.05) and two- Although menopause is associated with changes in tailed tests were used for all hypothesis tests. Ninety- the hypothalamic and pituitary hormones that regulate five percent confidence intervals (CI) for the median Table 2. The severity and frequency of hot flashes and the serum levels of FSH, LH and E2 Acupuncture and auricular acupressure group (n ¼ 19) HRT group (n ¼ 24) Hot flash severity 14.71 3.81 (95% CI 12.96–16.52) 15.28 4.06 (95% CI 13.53–16.96) 3.86 0.84* (95% CI 3.40–4.45) 3.71 0.65* (95% CI 3.44–3.97) 4.45 0.90*,# (95% CI 3.92–4.95) 3.25 0.34* (95% CI 3.00–3.33) Hot flash frequency 14.21 2.42 (95% CI 13.37–15.88) 15.11 4.96 (95% CI 13.04–17.30) 10.32 3.13*,#(95% CI 8.80–12.32) 7.48 2.69* (95% CI 6.33–8.59) 7.69 1.48*,# (95% CI 7.12–8.63) 5.58 1.64* (95% CI 4.86–6.22) 51.5 13.9 (95% CI 46.7–58.7) 53.0. 14.3 (95% CI 46.9–59.0) 40.4 9.6*,# (95% CI 34.6–44.5) 22.7 5.1* (95% CI 20.6–24.8) 33.7 6.4 (95% CI 30.2–37.0) 32.9 7.1 (95% CI 29.9–35.9) 31.9 5.7# (95% CI 28.6–34.9) 15.6 4.8* (95% CI 13.6–17.6) 37.1 8.9 (95% CI 32.0–41.5) 39.4 7.0 (95% CI 36.4–42.3) 45.4 7.3*,# (95% CI 41.7–49.4) 71.5 13.4* (95% CI 65.8–77.1) FSH, follicle stimulating hormone; LH, luteinizing hormone; E2, estradiol; CI, Confidence intervals.
*P50.05, compared with pre-treatment in the same group.
#P50.05, compared with the HRT group.
event, but rather primary ovarian failure (27). As the elevated plasma LH due to ovariectomy (36); in addition, hypothalamic-pituitary-ovarian axis remains intact during acupuncture also restored the number of gonadotropin- the menopausal transition, FSH levels rise in response to releasing hormone (GnRH) neurons in the ovariecto- ovarian failure and the absence of negative feedback mized rats (35). In another study, acupuncture was found from the ovary (27). Atresia of the follicular apparatus, to improve the reproductive disorders induced by in particular the granulosa cells, results in the reduced ovariectomy in rats through modulating the blood E2 production of estrogen and inhibin, which leads to the levels (37). Acupuncture may improve the function of the reduced inhibin levels and the elevated FSH levels, a hypothalamic-pituitary-ovarian axis, increase blood adre- cardinal sign of menopause (27). Correlations between nogenous androgen level and facilitate its transformation endocrine levels and symptom severity ratings over time into estrogen by aromatic enzyme in the brain, liver and revealed that hot flash severity was significantly and fat tissues (38–40).
positively related to FSH (28). Investigations of hormo- The present study showed that acupuncture and auric- nal connections between hot flash severity and reproduc- ular acupressure significantly relieve the severity and tive hormones in Study of Women's Health Across the frequency of menopausal hot flashes. The levels of FSH Nation (SWAN), Melbourne Midlife Women's Health decreased significantly and the level of E2 increased Project (MMWHP) and Penn Ovarian Aging Study significantly in both of the two groups after treatment.
cohorts found that decreased serum E2 and increased As the increased levels of FSH and the lowered level of E2 serum FSH were associated with the increases in hot are mainly associated with hot flashes during the flash severity (29–31). In an analysis of SWAN data, menopausal transition (29–31), it may be partly through which modeled the effects of FSH and E2 (and other decreasing the levels of FSH and increasing the levels of reproductive hormones) together, Randolph and collea- E2 that acupuncture and auricular acupressure alleviate gues noted that FSH was associated with hot flash the severity and frequency of menopausal hot flashes of prevalence and frequency (7).
the bilaterally ovariectomized Chinese women. In com- It is well known that acupuncture is associated with parison with HRT, although acupuncture did not change homeostatic regulation, and possess effects such as hormone levels as significantly as HRT in this study, the buffering hormonal disturbance, modulating ovulation, bilaterally ovariectomized women's own functions may be as well as improving psychological or behavioral abnor- regulated with the use of acupuncture, while HRT restores mity (32–34). Acupuncture in specific acupoints has been the body's hormone level by exogenous hormones.
found to significantly increase blood concentrations of E2 The protocol of the acupuncture treatments comes from in the ovariectomized rats (35), while reducing the a combination of literatures and clinical experiences.
Acupuncture and auricular acupressure in relieving menopausal hot flashes There is no corresponding name to menopausal hot acupuncture treatment was also found to significantly flashes in ancient books of traditional Chinese medicine decrease the severity of hot flashes in symptomatic post- (TCM). Based on Zang-fu organs in TCM, disorders of menopausal women when compared with placebo acu- the kidney and liver are generally considered as the main puncture of equal duration (23). Another study showed pathogenesis. According to the principle of reinforcing that acupuncture and applied relaxation significantly the kidney and regulating the liver, the main acupoints reduced the number of menopausal hot flashes (22).
selected were Sanyinjiao (SP6), Fengchi (GB20), Hegu The present study showed that acupuncture and auricular (LI4), Quchi (LI11), Guanyuan (CV4), Dazhui (GV14), acupressure significantly relieve the severity and fre- Fuliu (KI7) and Zigong (EX-CA1). Among them, quency of menopausal hot flashes. However, as the Sanyinjiao (SP6), Fengchi (GB20), Hegu (LI4) and sample size of the present study was small and the sham- Quchi (LI11) have been selected as the main acupoints acupuncture was not used, the conclusion may be in most of the clinical researches on menopausal hot somewhat limited.
flashes (19,23). Sanyinjiao (SP6) is an important acupoint Although the double-blind randomized controlled trial to treat disorders of the spleen, liver and kidney (41).
(RCT) has been known as the gold standard in clinical It is able to soften and harmonize the Liver and to researches, the biggest challenges and the difficulties to benefit the kidney Qi, based on the ancient classics of the researchers in the fields of clinical acupuncture and acupuncture (42). Fengchi (GB20) works to regulate the moxibustion are the design of an ideal placebo-control function of liver and remove heat from the head and eye, method and the credibility and ethics behind sham based on the ancient acupuncture records and the acupuncture (47–52). An ideal acupuncture placebo that Meridian Theory of TCM (41). Hegu (LI4) functions to avoids the necessity of penetration of the skin and shows clear heat in the Upper and Middle Jiao (41). Quchi the same psychological impact has not yet been found.
(LI11) has been acknowledged to produce hypothermia in A study has shown that for non-drug interventions normal subject (42). Guanyuan (CV4) is an important including acupuncture, it was difficult to establish a acupoint on the Conception Vessel and functions to placebo or sham control that is both inert and indistin- reinforce kidney Qi and replenish Qi and blood (41).
guishable (53). It concluded that although randomized Sanyinjiao (SP6) and Guanyuan (CV4) have been found trials investigating the specific effects of acupuncture to increase the gonadal hormone levels (43). Dazhui have used a great variety of sham interventions as (GV14) has been found to produce hypothermia in controls, the sham interventions as ‘placebo' controls normal adult (44). Fuliu (KI7) can regulate kidney Qi seem misleading and scientifically unacceptable (53).
and sweating (41). Zigong (EX-CA1) is an important Another study demonstrated that the control interven- empirical one for treating female disorders (41).
tions were equally as effective as acupuncture in According to the theory of TCM, all channels of the alleviating pain in conditions that are predominantly body and all 12 meridians are closely connected with associated with affective components such as migraines the ear (45). The earliest record of ear acupuncture is or lower back pain, but not those with a more pro- in Huangdi Neijing (The Yellow Emperor's Classic ofInternal Medicine). In the famous Chinese medical nounced sensory component, such as osteoarthritis of classics, a great number of acupuncture treatments were the knee or lateral epicondylalgia (54). Some previous summarized, among which, there are the specific acu- research also showed that nearly 40% of the participants puncture points on the external ear for relief of certain in clinical research were able to detect a difference disorders. Auricular acupressure could associate the between the active and placebo needles at active points meridians of the body, regulate Qi and activate blood, (55). In a clinical study on the effect of acupuncture in regulate Zang-fu organs and promote good metabolism treating post-menopausal hot flashes, although they according to the Meridian Theory of TCM (45). There combined the use of placebo needles with sham points are 200 acupoints on the outer ear. Auricular acupres- in the placebo treatment, a difference in the patients' sure's effectiveness and non-invasiveness make it easily accepted by both patients and doctors (45,46). Auricular considered finding an optimal placebo for acupuncture acupressure works by stimulating the central nervous remained a challenge for future studies (23). In addition, system through the cranial and spinal nerves on the as most of the middle-aged Chinese people have had auricle of the ear. This stimulation results in increasing experiences receiving acupuncture treatments, it is even neurotransmitters within the pituitary and spinal cord of more difficult to simulate real acupuncture in clinical the central nervous system (45). All the auricular acu- researches. This is why the study did not attempt to use points selected in the study were associated with enforc- sham-acupuncture as a control. Although this may ing kidney Qi and regulating liver Qi.
introduce bias into trials, extensive details regarding the Acupuncture has been found to significantly reduce the baseline characteristics of the recruited women were severity of nocturnal hot flashes in post-menopausal collected before treatment and between the two groups, women (19). Standardized and individually tailored no significant difference in the patients' detailed baseline characteristics existed. Further research with larger 12. Connelly MT, Richardson M, Platt R. Prevalence and duration of postmenopausal hormone replacement therapy use in a managed samples needs to be conducted.
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Caucus on New and Underused Reproductive Health Technologies Misoprostol for maternal health oral misoprostol was associated with a significant reduction in the rate of postpartum hemorrhage Misoprostol can be used for a number of obstetric compared to women not using a uterotonic.3 A indications that address maternal health concerns. significant reduction in PPH was also observed with