Acupuncture in Menopause (AIM) study: a pragmatic, randomized controlled trial.
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ABSTRACT:
SUBMITTER: Avis NE
PROVIDER: S-EPMC4874921 | biostudies-literature | 2016 Jun
REPOSITORIES: biostudies-literature
Publications
Acupuncture in Menopause (AIM) study: a pragmatic, randomized controlled trial.
Avis Nancy E NE Coeytaux Remy R RR Isom Scott S Prevette Kristen K Morgan Timothy T
Menopause (New York, N.Y.) 20160601 6
<h4>Objective</h4>The aim of the study was to evaluate the short and long-term effects of acupuncture on vasomotor symptoms (VMS) and quality of life-related measures.<h4>Methods</h4>A total of 209 perimenopausal and postmenopausal women aged 45 to 60 years, experiencing four or more VMS per day, were recruited from the community and randomized to receive up to 20 acupuncture treatments within the first 6 months (acupuncture group) or the second 6 months (waitlist control group) of the 12-month ...[more]
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Project description:In this trial, patients who agreed to random assignment were allocated to a randomized acupuncture group (R-acupuncture group) or control group. Those who declined randomization were assigned to a nonrandomized acupuncture group (NR-acupuncture group). Patients in the R-acupuncture group and NR-acupuncture group received up to 21 acupuncture sessions during a period of 6 weeks plus routine care, while the control group received routine care alone. Cognitive function, activities of daily living, and quality of life were assessed by mini-mental state examination (MMSE), Activities of Daily Living Scale (ADL), and dementia quality of life questionnaire (DEMQOL), respectively. All the data were collected at baseline, after 6-week treatment, and after 4-week follow-up. No significant differences of MMSE scores were observed among the three groups but pooled-acupuncture group had significant higher score than control group. Compared to control group, ADL score significantly decreased in NR-acupuncture group and pooled-acupuncture group. For DEMQOL scores, no significant differences were observed among the three groups, as well as between pooled-acupuncture group and control group. Additional acupuncture to routine care may have beneficial effects on the improvements of cognitive status and activities of daily living but have limited efficacy on health-related quality of life in VaD patients.
| S-EPMC4606072 | biostudies-other
Project description:ObjectiveThe aim of this study was to conduct a pilot study for the feasibility of planning a definitive clinical trial comparing traditional acupuncture (TA) with sham acupuncture (SA) and waiting control (WC) on menopause-related vasomotor symptoms (VMS), quality of life, and the hypothalamic-pituitary-adrenal axis in perimenopausal and postmenopausal women.MethodsThirty-three perimenopausal and postmenopausal women with at least seven VMS daily were randomized to TA, SA, or WC. The TA and SA groups were given three treatments per week for 12 weeks. Outcomes included the number and severity of VMS, Menopause-Specific Quality of Life Questionnaire, Beck Depression Inventory, Spielberg State-Trait Anxiety Instrument, Pittsburgh Quality Sleep Index, 24-hour urine cortisol and metabolites, and adrenocorticotropic hormone stimulation testing.ResultsBoth the TA and SA groups demonstrated improved VMS trends compared with the WC group (Δ -3.5 ± 3.00 vs -4.1 ± 3.79 vs -1.2 ± 2.4, respectively; P = 20) and significantly improved Menopause-Specific Quality of Life Questionnaire vasomotor scores (Δ -1.5 ± 2.02 vs -1.8 ± 1.52 vs -0.3 ± 0.64, respectively; P = 0.04). There were no psychosocial group differences. Exit 24-hour urinary measures were lower in the TA versus the SA or WC group in total cortisol metabolites (4,658.9 ± 1,670.9 vs 7,735.8 ± 3,747.9 vs 5,166.0 ± 2,234.5, P = 0.03; respectively) and dehydroepiandrosterone (41.4 ± 27.46, 161.2 ± 222.77, and 252.4 ± 385.40, respectively; P = 0.05). The response data on adrenocorticotropic hormone stimulation cortisol also trended in the hypothesized direction (P = 0.17).ConclusionsBoth TA and SA reduce VMS frequency and severity and improve VMS-related quality of life compared with WC; however, TA alone may impact the hypothalamic-pituitary-adrenal axis. This association is viewed as preliminary and hypothesis generating and should be explored in a large clinical trial.
| S-EPMC3246091 | biostudies-literature
Project description:BackgroundAcupuncture is used by patients as a treatment for irritable bowel syndrome (IBS) but the evidence on effectiveness is limited. The purpose of the study was to evaluate the effectiveness of acupuncture for irritable bowel syndrome in primary care when provided as an adjunct to usual care.MethodsDesignA two-arm pragmatic randomised controlled trial.SettingPrimary care in the United Kingdom.Patients233 patients had irritable bowel syndrome with average duration of 13 years and score of at least 100 on the IBS Symptom Severity Score (SSS).Interventions116 patients were offered 10 weekly individualised acupuncture sessions plus usual care, 117 patients continued with usual care alone.MeasurementsPrimary outcome was the IBS SSS at three months, with outcome data collected every three months to 12 months.ResultsThere was a statistically significant difference between groups at three months favouring acupuncture with a reduction in IBS Symptom Severity Score of -27.43 (95% CI: -48.66 to -6.21, p=0.012). The number needed to treat for successful treatment (?50 point reduction in the IBS SSS) was six (95% CI: 3 to 17), based on 49% success in the acupuncture group vs. 31% in the control group, a difference between groups of 18% (95% CI: 6% to 31%). This benefit largely persisted at 6, 9 and 12 months.ConclusionsAcupuncture for irritable bowel syndrome provided an additional benefit over usual care alone. The magnitude of the effect was sustained over the longer term. Acupuncture should be considered as a treatment option to be offered in primary care alongside other evidenced based treatments.Trial registrationCurrent Controlled Trials ISRCTN08827905.
| S-EPMC3556159 | biostudies-literature
Project description:IntroductionAlthough acupuncture has been recommended for alleviating cancer pain by clinical guidelines, the level of the supporting evidence needs to be improved. A pragmatic randomised controlled trial (pRCT) in a hospital setting would provide real-world assessments of the overall clinical effects of acupuncture. This pilot trial aims to explore the feasibility and provide data for sample size calculations for a pRCT evaluating the effectiveness of acupuncture as an adjunctive therapy to routine medical care for cancer pain.Methods and analysisThirty patients with cancer admitted to the oncology department with moderate or severe pain will be recruited. Participants will be randomised at a ratio of 1:1 to the adjunctive acupuncture group or a control group which receives routine pain management without acupuncture. The standardised section of the acupuncture protocol will be developed based on the results of reviews of the literature, recommendations in clinical guidelines and interviews with clinical experts. The acupuncturist will be allowed to tailor the protocol according to the individual situation of each participant. Primary outcomes relevant to the feasibility of conducting a fully powered trial include: numbers and proportions of participants recruited, screened, consented and randomised; numbers and reasons for withdrawals and dropouts; numbers and types of adverse events; feasibility of implementing the trial procedures; evaluation of the comprehensiveness and ease-of-use of the case report form. Secondary outcomes are clinical measurements of the effectiveness of the treatment that are intended for use in the full-scale trial. Analysis of feasibility will be descriptive and pain intensity measures will be analysed using mixed-effects regression.Ethics and disseminationEthics approval was obtained from the Institutional Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine (approval no: Z2017-184-01) and RMIT University Human Research Ethics Committee (reference no: 21361). Results will be disseminated in a peer-reviewed journal, and trial participants will be informed via email and/or phone calls.Trial registration numberChiCTR1800017023.
| S-EPMC6629396 | biostudies-literature
Project description:Background Acupuncture is one of the most popular complementary and alternative treatments for knee osteoarthritis (KOA). There are many methods of acupuncture in the treatment of KOA, and the effects are different. According to our clinical observations and researches, it is found that manual acupuncture (MA), electro-acupuncture (EA), and warm acupuncture (WA) are used more frequently in the treatment of KOA, and the curative effects are satisfactory. However, there is currently a lack of efficacy comparison of efficacy between different acupuncture treatments, as well as a lack of standardized clinical research on the acupuncture treatment of KOA. Therefore, we will carry out a high-quality clinical randomized controlled trial to research the effect laws of MA, EA, and WA on KOA. Methods/design A total of 200 eligible participants with KOA will be randomly assigned to group A, B, C, or D in a ratio of 1:1:1:1. Patients in group A will receive MA, while those in group B, group C, and group D will be treated with EA, WA, and sham acupuncture (SA), respectively. Patients will be treated with acupuncture once a day, 30 min per session, 5 sessions per week for 4 weeks. The primary outcome is the change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at week 4. The secondary outcomes include WOMAC, visual analog scale (VAS), Arthritis Quality of Life Measurement Scale Simplified Scale (AIMS2-SF), Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI), and Credibility/Expectancy Questionnaire. The evaluation will be performed at baseline and weeks 4, 8, and 12 respectively after randomization. Discussion This is a randomized controlled trial. We will observe the clinical effect of MA, EA, and WA on KOA to research the effect laws of these three acupuncture treatments on KOA and set up standardized treatment programs for acupuncture for KOA. Trial registration China Clinical Trials Registry ChiCTR2100049526. Registered on August 2, 2021 Supplementary Information The online version contains supplementary material available at 10.1186/s13063-022-06653-7.
| S-EPMC9392363 | biostudies-literature
Project description:A large number of randomized trials on the use of acupuncture to treat chronic pain have been conducted. However, there is considerable controversy regarding the effectiveness of acupuncture. We designed a randomized trial involving patients with chronic neck pain (CNP) to investigate whether acupuncture is more effective than a placebo in treating CNP.A five-arm, parallel, single-blinded, randomized, sham-controlled trial was designed. Patients with CNP of more than 3 months' duration are being recruited from Guangdong Provincial Hospital of Chinese Medicine (China). Following examination, 175 patients will be randomized into one of five groups (35 patients in each group) as follows: a traditional acupuncture group (group A), a shallow-puncture group (group B), a non-acupoint acupuncture group (group C), a non-acupoint shallow-puncture group (group D) and a sham-puncture group (group E). The interventions will last for 20 min and will be carried out twice a week for 5 weeks. The primary outcome will be evaluated by changes in the Northwick Park Neck Pain Questionnaire (NPQ). Secondary outcomes will be measured by the pain threshold, the Short Form McGill Pain Questionnaire-2 (SF-MPQ-2), the 36-Item Short-Form Health Survey (SF-36) and diary entries. Analysis of the data will be performed at baseline, at the end of the intervention and at 3 months' follow-up. The safety of acupuncture will be evaluated at each treatment period.The purpose of this trial is to determine whether traditional acupuncture is more effective for chronic pain relief than sham acupuncture in adults with CNP, and to determine which type of sham acupuncture is the optimal control for clinical trials.Chinese Clinical Trial Registry: ChiCTR-IOR-15006886 . Registered on 2 July 2015.
| S-EPMC5504675 | biostudies-other
Project description:BackgroundAcupuncture is commonly used to treat migraine. We assessed the efficacy of acupuncture at migraine-specific acupuncture points compared with other acupuncture points and sham acupuncture.MethodsWe performed a multicentre, single-blind randomized controlled trial. In total, 480 patients with migraine were randomly assigned to one of four groups (Shaoyang-specific acupuncture, Shaoyang-nonspecific acupuncture, Yangming-specific acupuncture or sham acupuncture [control]). All groups received 20 treatments, which included electrical stimulation, over a period of four weeks. The primary outcome was the number of days with a migraine experienced during weeks 5-8 after randomization. Our secondary outcomes included the frequency of migraine attack, migraine intensity and migraine-specific quality of life.ResultsCompared with patients in the control group, patients in the acupuncture groups reported fewer days with a migraine during weeks 5-8, however the differences between treatments were not significant (p > 0.05). There was a significant reduction in the number of days with a migraine during weeks 13-16 in all acupuncture groups compared with control (Shaoyang-specific acupuncture v. control: difference -1.06 [95% confidence interval (CI) -1.77 to -0.5], p = 0.003; Shaoyang-nonspecific acupuncture v. control: difference -1.22 [95% CI -1.92 to -0.52], p < 0.001; Yangming-specific acupuncture v. control: difference -0.91 [95% CI -1.61 to -0.21], p = 0.011). We found that there was a significant, but not clinically relevant, benefit for almost all secondary outcomes in the three acupuncture groups compared with the control group. We found no relevant differences between the three acupuncture groups.InterpretationAcupuncture tested appeared to have a clinically minor effect on migraine prophylaxis compared with sham acupuncture.Trial registrationClinicaltrials.gov NCT00599586.
| S-EPMC3291669 | biostudies-literature
Project description:BackgroundPostprandial distress syndrome (PDS) has a considerable impact on quality of life. Our previous pilot trial suggested that acupuncture might be a potential treatment option for PDS. We will conduct this large trial to determine the efficacy of acupuncture versus sham acupuncture for PDS.Methods/designA total of 280 eligible patients who meet the Rome IV criteria for PDS will be randomly allocated to either the acupuncture group or the sham acupuncture group. Each patient will receive 12 sessions over four weeks. The primary outcomes will be the response rate of overall treatment effect (OTE) and the elimination rate of all three cardinal symptoms (postprandial fullness, upper abdominal bloating, and early satiation) at four weeks after randomization. Secondary outcomes will include assessments of the severity of dyspepsia symptoms and disease-specific quality of life at weeks 4, 8, and 16 after randomization. All patients who receive randomization will be included in the intent-to-treat analysis.DiscussionThe finding of this trial will provide high-quality evidence on the efficacy of acupuncture for treatment of PDS. Results of this research will be published in peer-reviewed journals.Trial registrationISRCTN Registry, ISRCTN12511434 . Registered on 31 March 2017.
| S-EPMC6339308 | biostudies-literature
Project description:BackgroundCisplatin is one of the most potent chemotherapeutic drugs used in head and neck cancer treatment; however, nephrotoxicity is the major side-effect limiting usage. Magnesium supplementation has been reported to reduce risk in non-controlled studies. We investigated whether preloading with magnesium prevents nephrotoxicity with a low-dose weekly cisplatin regimen.MethodsWe carried out a prospective pilot, single-blinded, randomized controlled trial to compare cisplatin-associated acute kidney injury (cis-AKI) and acute kidney disease (cis-AKD) between two groups: intravenous 0.9% NaCl 500 ml + KCL 20 mEq over 4 h pre-cisplatin 40 mg/m2 weekly for 7-8 weeks (control group) compared with additional 16 mEq magnesium added to the saline infusion (Mg group) in 30 head and neck cancer patients. Cis-AKI was defined as an increased serum creatinine (SCr) ≥ 0.3 mg/dl within 7 days and cis-AKD is an increased SCr ≥ 0.3 mg/dl between last SCr and baseline pre-chemotherapy SCr.ResultsThe overall cisplatin tumor response rate and survival were comparable between groups. The baseline characteristics were comparable between groups, although SCr was lower in the controls (0.70 ± 0.17 versus 0.87 ± 0.17 mg/dl, P = 0.01). The incidence of cis-AKI was similar (4.6% versus 1.3%); however, the incidence of cis-AKD was higher for the control group (46.7% versus 6.7%, hazard ratio = 0.082, 95% confidence interval 0.008-0.79, P = 0.03). The time to develop cis-AKD was significantly shorter in the control group (P = 0.007).ConclusionsThe magnesium-preloading regimen was safe and significantly showed a decreased incidence of cis-AKD. The encouraging results of our pilot study need to be confirmed in a large-scale randomized controlled trial.
| S-EPMC8717436 | biostudies-literature
Project description:Rigorous evaluation of eHealth interventions is acutely needed but can be challenging to execute in a cost- and time-efficient way. The purpose of this study is to describe a randomized controlled trial carried out as part of an approach that evaluates and informs product development throughout an intervention's life cycle. We present the methodological case of a pragmatic randomized controlled trial evaluating the effectiveness of the web-based intervention "Daily Challenge." We conducted the trial entirely online and leveraged existing resources to implement it quickly and within budget. One thousand five hundred three participants were recruited in 49 days (17.1 % of candidates assessed for eligibility). Then, 68.7 % of participants were reached for follow-up at 30 days and 62.5 % at 90 days. Data collection (baseline to 90-day follow-up) was completed within 5 months. Rigorous trials can be conducted efficiently and in a timely manner, enabling evaluation on a continuous basis. Development should include ongoing empirical input to inform product iterations.
| S-EPMC3771016 | biostudies-literature