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Additive Complex Ayurvedic Treatment in Patients with Fibromyalgia Syndrome Compared to Conventional Standard Care Alone: A Nonrandomized Controlled Clinical Pilot Study (KAFA Trial).

ABSTRACT: Background. Fibromyalgia (FMS) is a challenging condition for health care systems worldwide. Only limited trial data is available for FMS for outcomes of complex treatment interventions of complementary and integrative (CIM) approaches. Methods. We conducted a controlled, nonrandomized feasibility study that compared outcomes in 21 patients treated with Ayurveda with those of 11 patients treated with a conventional approach at the end of a two-week inpatient hospital stay. Primary outcome was the impact of fibromyalgia on patients as assessed by the FIQ. Secondary outcomes included scores of pain intensity, pain perception, depression, anxiety, and quality of sleep. Follow-up assessments were done after 6 months. Results. At 2 weeks, there were comparable and significant improvements in the FIQ and for most of secondary outcomes in both groups with no significant in-between-group differences. The beneficial effects for both treatment groups were partly maintained for the main outcome and a number of secondary outcomes at the 6-month followup, again with no significant in-between-group differences. Discussion. The findings of this feasibility study suggest that Ayurvedic therapy is noninferior to conventional treatment in patients with severe FMS. Since Ayurveda was only used as add-on treatment, RCTs on Ayurveda alone are warranted to increase model validity. This trial is registered with NCT01389336.

SUBMITTER: Kessler CS

PROVIDER: S-EPMC3773902 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature

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Additive Complex Ayurvedic Treatment in Patients with Fibromyalgia Syndrome Compared to Conventional Standard Care Alone: A Nonrandomized Controlled Clinical Pilot Study (KAFA Trial).

Kessler Christian S CS Ostermann Thomas T Meier Larissa L Stapelfeldt Elmar E Schütte Silvia S Duda Joachim J Michalsen Andreas A

Evidence-based complementary and alternative medicine : eCAM 20130901

Background. Fibromyalgia (FMS) is a challenging condition for health care systems worldwide. Only limited trial data is available for FMS for outcomes of complex treatment interventions of complementary and integrative (CIM) approaches. Methods. We conducted a controlled, nonrandomized feasibility study that compared outcomes in 21 patients treated with Ayurveda with those of 11 patients treated with a conventional approach at the end of a two-week inpatient hospital stay. Primary outcome was th ...[more]

PMID: 24073008

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Project description:Traditional Indian Ayurvedic medicine uses complex treatment approaches, including manual therapies, lifestyle and nutritional advice, dietary supplements, medication, yoga, and purification techniques. Ayurvedic strategies are often used to treat osteoarthritis (OA) of the knee; however, no systematic data are available on their effectiveness in comparison with standard care. The aim of this study is to evaluate the effectiveness of complex Ayurvedic treatment in comparison with conventional methods of treating OA symptoms in patients with knee osteoarthritis.In a prospective, multicenter, randomized controlled trial, 150 patients between 40 and 70 years, diagnosed with osteoarthritis of the knee, following American College of Rheumatology criteria and an average pain intensity of ?40 mm on a 100 mm visual analog scale in the affected knee at baseline will be randomized into two groups. In the Ayurveda group, treatment will include tailored combinations of manual treatments, massages, dietary and lifestyle advice, consideration of selected foods, nutritional supplements, yoga posture advice, and knee massage. Patients in the conventional group will receive self-care advice, pain medication, weight-loss advice (if overweight), and physiotherapy following current international guidelines. Both groups will receive 15 treatment sessions over 12 weeks. Outcomes will be evaluated after 6 and 12 weeks and 6 and 12 months. The primary endpoint is a change in the score on the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) after 12 weeks. Secondary outcome measurements will use WOMAC subscales, a pain disability index, a visual analog scale for pain and sleep quality, a pain experience scale, a quality-of-life index, a profile of mood states, and Likert scales for patient satisfaction, patient diaries, and safety. Using an adapted PRECIS scale, the trial was identified as lying mainly in the middle of the efficacy-effectiveness continuum.This trial is the first to compare the effectiveness of a complex Ayurvedic intervention with a complex conventional intervention in a Western medical setting in patients with knee osteoarthritis. During the trial design, aspects of efficacy and effectiveness were discussed. The resulting design is a compromise between rigor and pragmatism.NCT01225133.

Project description:Fibromyalgia (FM) is characterized by widespread muscle pain and soft tissue tenderness. However, a lack of definitive muscle pathology has made FM both a diagnostic and a treatment puzzle. Much of the evidence for pathology in FM lies in the central nervous system - in particular abnormal amplification of pain signals in the spinal cord - a manifestation of central sensitization. An emerging body of evidence posits that peripheral pain generated from the muscles and fascia may trigger and maintain central sensitization in FM. Since FM patients so frequently seek manual therapy to relieve muscle symptoms, the present study compared two different manual therapy techniques in a parallel study of women with FM. Eight subjects received myofascial release (MFR) while four subjects received Swedish massage, 90 min weekly for four weeks. Overall symptom burden and physical function were assessed by the Fibromyalgia Impact Questionnaire Revised (FIQ-R). A unique challenge for the manual therapist in treating conditions involving central sensitization is to determine if localized pain reduction can be achieved with targeted therapy in the context of ongoing widespread pain. Localized pain improvement was measured by a novel questionnaire developed for this study, the modified Nordic Musculoskeletal Questionnaire (NMQ). Between-group differences in FIQ-R did not reach statistical significance, but the total change scores on FIQ-R for the MFR group (mean = 10.14, SD = 16.2) trended in the hypothesized and positive direction compared to the Swedish massage group (mean = 0.33, SD = 4.93) yielding a positive Aikin separation test. Although overall modified NMQ scores improved in both groups there were no consistent focal areas of improvement for the Swedish massage group. In contrast, the MFR group reported consistent pain reductions in the neck and upper back regions on the NMQ. These data support the need for larger randomized controlled trials of MFR versus other massage techniques and support the assessment of localized pain reduction in future manual therapy studies in FM.

Project description:BackgroundPostoperative care is influenced by various factors such as compliance, comprehension, retention of instructions, and other unaccounted elements. It is imperative that patients adhere to the instructions and prescribed regimen for smooth and placid healing. ExoDont, an Android-based mobile health app, was designed to ensure a smooth postoperative period for patients after a dental extraction. Besides providing postoperative instructions at defined intervals, the app also sends drug reminders as an added advantage over other available, conventional methods.ObjectiveThe aim of this study was to compare the compliance rate of individuals with respect to the prescribed regimen and postoperative instructions. Additionally, we aimed to assess any changes in the postoperative complication rate of patients assigned to 3 categories: the verbal, verbal plus written, and ExoDont app-based delivery groups.MethodsWe conducted a pilot, nonrandomized, and prospective comparative study in which patients after tooth extraction were assigned to 3 groups-verbal (Group A), verbal plus written (Group B), and ExoDont app-based delivery (Group C)-based on the eligibility criteria, and a 1-week follow-up was planned to obtain the responses regarding compliance and postoperative complications from the participants.ResultsIn total, 90 patients were recruited and equally divided into 3 groups. Compliance to prescribed drug was found to be the highest in Group C, where of the 30 participants, 25 (83%) and 28 (93%) followed the entire course of antibiotics and analgesics, respectively. For postoperative instructions, higher compliance was observed in Group C in relation to compliance to diet restrictions (P=.001), not rinsing for 24 hours (P<.001), and warm saline rinses after 24 hours (P=.001). However, the difference was not significant for smoking restrictions (P=.07) and avoiding alcohol (P=.16). Moreover, the difference in postoperative complication rate was not statistically significant among the 3 groups (P=.31).ConclusionsAs evident from the results, it is anticipated that the ExoDont app will be helpful in circumventing the unaccounted possibilities of missing the prescribed dosage and postoperative instructions and ensuring the smooth recovery of patients after dental extraction. However, future studies are required to establish this app-based method of delivery of postoperative instructions as a viable option in routine clinical practice.

Project description:BackgroundSeverity of illness in COVID-19 is consistently lower in women. A focus on sex as a biological factor may suggest a potential therapeutic intervention for this disease. We assessed whether adding progesterone to standard of care (SOC) would improve clinical outcomes of hospitalized men with moderate to severe COVID-19.Research questionDoes short-term subcutaneous administration of progesterone safely improve clinical outcome in hypoxemic men hospitalized with COVID-19?Study design and methodsWe conducted a pilot, randomized, open-label, controlled trial of subcutaneous progesterone in men hospitalized with confirmed moderate to severe COVID-19. Patients were randomly assigned to receive SOC plus progesterone (100 mg subcutaneously twice daily for up to 5 days) or SOC alone. In addition to assessment of safety, the primary outcome was change in clinical status on day 7. Length of hospital stay and number of days on supplemental oxygen were key secondary outcomes.ResultsForty-two patients were enrolled from April 2020 to August 2020; 22 were randomized to the control group and 20 to the progesterone group. Two patients from the progesterone group withdrew from the study before receiving progesterone. There was a 1.5-point overall improvement in median clinical status score on a seven-point ordinal scale from baseline to day 7 in patients in the progesterone group as compared with control subjects (95% CI, 0.0-2.0; P = .024). There were no serious adverse events attributable to progesterone. Patients treated with progesterone required three fewer days of supplemental oxygen (median, 4.5 vs 7.5 days) and were hospitalized for 2.5 fewer days (median, 7.0 vs 9.5 days) as compared with control subjects.InterpretationProgesterone at a dose of 100 mg, twice daily by subcutaneous injection in addition to SOC, may represent a safe and effective approach for treatment in hypoxemic men with moderate to severe COVID-19.Trial registryClinicalTrials.gov; No.: NCT04365127; URL: www.clinicaltrials.gov.

Dataset Information

Additive Complex Ayurvedic Treatment in Patients with Fibromyalgia Syndrome Compared to Conventional Standard Care Alone: A Nonrandomized Controlled Clinical Pilot Study (KAFA Trial).

Publications

Additive Complex Ayurvedic Treatment in Patients with Fibromyalgia Syndrome Compared to Conventional Standard Care Alone: A Nonrandomized Controlled Clinical Pilot Study (KAFA Trial).

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