A randomized controlled pilot study of a proprietary combination versus sunscreen in melasma maintenance

Background: Melasma is the commonest cause of facial hypermelanosis in skin type IV-VI. First-line treatment includes a triple combination containing topical corticosteroid and hydroquinone which have side effects on prolonged use. Chemical peels are a second-line management option with the laser being used in refractory cases, but the worsening of hyperpigmentation in darker skin types can occur following laser therapy. Sunscreen is a must to prevent relapses. Aims and Objectives: (i) To compare the effects of treatment with a proprietary combination (phenyl ethyl resorcinol, nonapeptide-1, aminoethyl phosphinic acid, antioxidants and sunscreen) versus sunscreen alone in limiting or reducing, melasma and preventing recurrence as a maintenance regimen after the initial use of triple combination,(ii) to evaluate the safety of the formulation studied, and (iii) to study the improvement of the quality of life of the patients after using the study formulation versus placebo. Methods: It was a prospective double-blinded parallel-group randomized controlled pilot study. A total of 46 subjects were recruited by consecutive sampling methods and randomized to 23 each in case and control groups. The study period was eight months with three phases. Phase 1 constituted the application of triple combination for eight weeks by both groups followed by phase 2 with the case group applying proprietary medicine and the control group applying sunscreen. Phase 3 was a follow-up period to see the sustenance of results in both groups as well as any evidence of relapses. Sunscreen was applied in all three phases. Results: Case group in the study showed improvement in the melasma severity score and mean melanin index as measured by mexameter but it did not attain statistical significance as compared to the control group. The melasma area and severity index score showed a consistent reduction in the case group, whereas it increased in the control group from baseline. Limitations: Small sample size and a short follow-up period of our study were major limitations. Conclusion: The proprietary combination, which has sunscreen as one of its constituents, is more effective in maintaining remission after triple combination without any added inconvenience of application of two separate preparations as compared to sunscreen alone.

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A comparison between two educational methods in the rehabilitation of the microstomia in systemic sclerosis: a randomized controlled trial

Clinical Rehabilitation ◽

10.1177/0269215519858395 ◽

2019 ◽

Vol 33 (11) ◽

pp. 1747-1756

Author(s):

Claudia Uras ◽

Simona Mastroeni ◽

Stefano Tabolli ◽

Cinzia Masini ◽

Sabatino Pallotta ◽

...

Keyword(s):

Systemic Sclerosis ◽

Confidence Interval ◽

Statistical Significance ◽

Mouth Opening ◽

Controlled Study ◽

Control Group ◽

Educational Materials ◽

Face To Face ◽

Randomized Controlled

Objective: To test the effectiveness of an educational intervention including “face to face” training, compared to a standard information program, to reduce microstomia in women with systemic sclerosis. Design: Single-blind, two-arm, randomized controlled study with a 12-month follow-up period. Setting: Hospital wards of a large Italian dermatological reference center. Subjects: Female inpatients with diagnosis of systemic sclerosis. Interventions: For both groups an information brochure and an audio-visual DVD were developed specifically for the study. The control group was assigned to educational materials alone (i.e. brochures and DVD), while the experimental group, in addition to the same educational materials, received specific “face-to-face” interventions, repeated at each follow-up visit. Main measures: Primary outcome was measurement of the opening of the mouth. Secondary outcomes was the self-reported mouth disability. Results: The intention-to-treat analysis included 63 patients. Compared to the baseline measurement, we observed an increase of the mouth opening of 0.31 cm (95% confidence interval: 0.13–0.49), P = 0.003; in the control group, the increase was 0.13 cm (95% confidence interval: 0.01–0.25), P = 0.06. The difference in improvement between the two groups was not statistically significant ( P = 0.10); however, it reached statistical significance in the per-protocol analysis (39 patients, P = 0.02). Conclusion: Face-to-face nursing rehabilitation training seems to improve microstomia to a greater extent, when compared to a standard intervention based only on written and audio-visual materials.

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Ultra-short-wave diathermy shortens the course of moderate and severe COVID-19: a randomized controlled trial

10.1101/2021.01.28.21250163 ◽

2021 ◽

Author(s):

Liangjiang Huang ◽

Qian Li ◽

Sayed Zulfiqar Ali Shah ◽

Mohammad Nasb ◽

Chen Bin ◽

...

Keyword(s):

Clinical Trial ◽

Pulmonary Fibrosis ◽

Lung Injury ◽

Statistical Significance ◽

Small Sample ◽

Control Group ◽

Clinical Recovery ◽

Randomized Controlled ◽

Conversion Rates ◽

Negative Conversion

AbstractBackgroundCOVID-19 patients have severe lung injury. The USWD could play a supportive role in relieving lung injury and enhance clinical recovery.Methods and findingsThe design was a single-center, evaluator blinded; 2-arm parallel design superiority randomized controlled clinical trial. Moderate and severe coronavirus-2 (SARS-CoV-2) positive patients with acute respiratory syndrome, Fifty patients were randomized (USWD, 25; control, 25) between February 18/2020 and April 20/2020. There were male 22 (44.0%) and female 28 (56.0%) with mean (SD) age 53(10.69). Time to clinical recovery (USWD 36.84 vs control 43.56, P = 0.03) was significantly shortened with a between-group difference of 6.72 days. The median SIRS score at day 28 was 0 (0-1) in the USWD group, while 0 (0-2) in the control group (P = 0.011), and the seven-point scale at day 28 showed significant improvement in the USWD group (P = 0.003). While the rate of RNA negative conversion at day 7 (2/25 vs 7/25, p=0.054), day 14 (14/25 vs 18/25 p=0.239), day 21 (22/25 vs 18/25 p=0.279), and day 28 (25/25 vs 22/25 p=0.730) did not show statistical significance. Similarly, no significant differences were observed in the AI-assisted CT analysis. No treatment-associated adverse events or worsening of pulmonary fibrosis were found.ConclusionsAmong the 50 moderate and severe COVID-19 patients, the USWD as an adjunctive therapy to standard therapy could shorten the recovery course and enhance clinical improvement without aggravating pulmonary fibrosis. However, the study did not report statistical significance in the negative conversion rates of SARS-CoV-2 nucleic acid due to the small sample size and early termination, the findings of this study are limited.TRIAL REGISTRATIONChinese Clinical Trial Registry: ChiCTR2000029972, URL: http://www.chictr.org.cn/historyversionpuben.aspx?regno=ChiCTR2000029972

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Effectiveness of Text Messaging as an Incentive to Maintain Physical Activity after Cardiac Rehabilitation: A Randomized Controlled Pilot Study

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18126645 ◽

2021 ◽

Vol 18 (12) ◽

pp. 6645

Author(s):

Giulia Foccardi ◽

Marco Vecchiato ◽

Daniel Neunhaeuserer ◽

Michele Mezzaro ◽

Giulia Quinto ◽

...

Keyword(s):

Physical Activity ◽

Cardiac Rehabilitation ◽

Exercise Testing ◽

Text Messages ◽

Control Group ◽

Stand Test ◽

Randomized Controlled ◽

Sit To Stand ◽

Significant Difference

Although the efficacy of cardiac rehabilitation (CR) is proven, the need to improve patients’ adherence has emerged. There are only a few studies that have investigated the effect of sending text messages after a CR period to stimulate subjects’ ongoing engagement in regular physical activity (PA). A randomized controlled pilot trial was conducted after CR, sending a daily PA text message reminder to an intervention group (IG), which was compared with a usual care control group (CG) during three months of follow-up. Thirty-two subjects were assessed pre- and post-study intervention with GPAQ, submaximal iso-watt exercise testing, a 30 s sit-to-stand test, a bilateral arm curl test, and a final survey on a seven-point Likert scale. A statistically significant difference in the increase of moderate PA time (Δ 244.7 (95% CI 189.1, 300.4) minutes, p < 0.001) and in the reduction of sedentary behavior time (Δ −77.5 (95% CI 104.9, −50.1) minutes, p = 0.004) was shown when the IG was compared with the CG. This was associated with an improvement in heart rate, blood pressure, and patients’ Borg rating on the category ratio scale 10 (CR10) in iso-watt exercise testing (all p < 0.05). Furthermore, only the IG did not show a worsening of the strength parameters in the follow-up leading to a change of the 30 s sit-to-stand test with a difference of +2.2 (95% CI 1.23, 3.17) repetitions compared to CG (p = 0.03). The telemedical intervention has been appreciated by the IG, whose willingness to continue with regular PA emerged to be superior compared to the CG. Text messages are an effective and inexpensive adjuvant after phase 2 CR that improves adherence to regular PA. Further studies are needed to confirm these results in a larger patient population and in the long term.

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Effectiveness of Abdominal and Gluteus Medius Training in Lumbo-Pelvic Stability and Adductor Strength in Female Soccer Players. A Randomized Controlled Study

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18041528 ◽

2021 ◽

Vol 18 (4) ◽

pp. 1528

Author(s):

Héctor Guerrero-Tapia ◽

Rodrigo Martín-Baeza ◽

Rubén Cuesta-Barriuso

Keyword(s):

Repeated Measures ◽

Gluteus Medius ◽

Soccer Players ◽

Controlled Study ◽

Control Group ◽

Extrinsic Factors ◽

Randomized Controlled ◽

Limb Injuries ◽

Experimental Group

Background. Abdominal and lumbo-pelvic stability alterations may be the origin of lower limb injuries, such as adductor pathology in soccer players. Imbalance can be caused by both intrinsic and extrinsic factors. Methods: In this randomized controlled trial over 8 weeks, 25 female footballers were randomly allocated to an experimental group (isometric abdominal training and gluteus medius-specific training) or a control group (isometric abdominal training). Evaluations were performed at baseline, at the end of the intervention and after a 4-week follow-up period. The exercise protocol in common for both groups included three exercises: Plank, Lateral plank and Bird dog. Specific exercises for the gluteus medius were: Pelvic drop and Stabilization of the gluteus medius in knee valgus. Outcome measures were lumbar-pelvic stability and adductor strength. Results: After the intervention, there was an increase in lumbo-pelvic stability in both groups, being greater in the control group than in the experimental group (mean differences [MD]: 4.84 vs. MD: 9.58; p < 0.01) with differences in the analysis of repeated measures (p < 0.001), but not in group interaction (p = 0.26). Changes were found in adductor strength in the experimental group (MD: −2.48; p < 0.001 in the left adductor; MD: −1.48; p < 0.01 in right adductor) and control group (MD: −1.68; p < 0.001 in the left adductor; MD: −2.05; p < 0.001 in the right adductor) after the intervention, with differences in the analysis of repeated measures in left (p < 0.001) and right (p < 0.001) adductor strength. Conclusions: An abdominal and gluteal training protocol shows no advantage over a protocol of abdominal training alone for lumbo-pelvic stability and adductor strength, while improvements in both variables are maintained at four weeks follow-up.

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Efficacy of Mobile phone use on adherence to Nevirapine prophylaxis and retention in care among the HIV-exposed infants in prevention of mother to child transmission of HIV: a randomized controlled trial

BMC Pediatrics ◽

10.1186/s12887-021-02660-w ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Lilian M. N. Kebaya ◽

Dalton Wamalwa ◽

Nyambura Kariuki ◽

Bashir Admani ◽

Philip Ayieko ◽

...

Keyword(s):

Mobile Phone ◽

Infant Feeding ◽

Retention In Care ◽

Control Group ◽

Hiv Exposed Infants ◽

Randomized Controlled ◽

Phone Calls ◽

Hiv Exposed ◽

To Receive

Abstract Background HIV is a major contributor to infant mortality. A significant gap remains between the uptake of infant and maternal antiretroviral regimens and only a minority of HIV-exposed infants receives prophylaxis and safe infant feeding. Losses to follow-up of HIV-exposed infants are associated with shortcomings of facility-based PMTCT models with weak community support of linkages. Use of mobile phones offers an opportunity for improving care and promoting retention assessed by timely attendance of scheduled appointments for the mother-baby pairs and achievement of an HIV-free generation. The objective of this study was to compare self-reported adherence to infant Nevirapine (NVP) prophylaxis and retention in care assessed by timely attendance of scheduled appointments over 10 weeks in HIV exposed infants randomized to 2-weekly mobile phone calls (intervention) versus no phone calls (control). Methods In this open label randomized controlled study, one hundred and fifty HIV infected women drawn from 3 health facilities in Western Kenya and their infants were randomly assigned to receive either phone-based reminders on PMTCT messages or standard health care messages (no calls) within 24 h of delivery. Women in the intervention arm continued to receive fortnightly phone calls. At 6- and 10-weeks following randomization we collected data on infant adherence to Nevirapine, mode of infant feeding, early HIV testing and retention in care in both study arms. All analyses were intention to treat. Results At 6 weeks follow-up, 90.7% (n = 68) of participants receiving phone calls reported adherence to infant NVP prophylaxis, compared with 72% (n = 54) of participants in the control group (p = 0.005). Participants in the intervention arm were also significantly more likely to remain in care than participants in the control group [78.7% (n = 59) vs. 58.7% (n = 44), p = 0.009 at 6 weeks and 69.3% (n = 52) vs. 37.3% (n = 28), p < 0.001 at 10 weeks]. Conclusions These results suggest that phone calls are potentially an important tool to improve adherence to infant NVP prophylaxis and retention in care for HIV-exposed infants. Trial registration PACTR202007654729602. Registered 6 June 2018 - Retrospectively registered, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=3449

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Short-term balance training and acute effects on postural sway in balance-deficient older adults: a randomized controlled trial

BMC Sports Science Medicine and Rehabilitation ◽

10.1186/s13102-021-00251-x ◽

2021 ◽

Vol 13 (1) ◽

Author(s):

Niklas Sörlén ◽

Andreas Hult ◽

Peter Nordström ◽

Anna Nordström ◽

Jonas Johansson

Keyword(s):

Older Adults ◽

Postural Sway ◽

Intervention Group ◽

Community Dwelling ◽

Control Group ◽

Positive Effects ◽

Randomized Controlled ◽

Eyes Closed ◽

Balance Exercise

Abstract Background We aimed to determine the effectiveness of 4 weeks of balance exercise compared with no intervention on objectively measured postural sway. Methods This was a single-center parallel randomized controlled, open label, trial. A six-sided dice was used for allocation at a 1:1-ratio between exercise and control. The trial was performed at a university hospital clinic in Sweden and recruited community-dwelling older adults with documented postural instability. The intervention consisted of progressively challenging balance exercise three times per week, during 4 weeks, with follow-up at week five. Main outcome measures were objective postural sway length during eyes open and eyes closed conditions. Results Sixty-five participants aged 70 years (balance exercise n = 32; no intervention n = 33) were randomized. 14 participants were excluded from analysis because of early dropout before follow-up at week five, leaving 51 (n = 22; n = 29) participants for analysis. No significant differences were detected between the groups in any of the postural sway outcomes. Within-group analyses showed significant improvements in hand grip strength for the intervention group, while Timed Up & Go improvements were comparable between groups but only statistically significant in the control group. Conclusions Performing balance exercise over a four-week intervention period did not acutely improve postural sway in balance-deficient older adults. The lower limit in duration and frequency to achieve positive effects remains unclear. Trial registration Clinical trials NCT03227666, July 24, 2017, retrospectively registered.

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The Effect of Reflexology on Lactation in Women Who Had Cesarean Section: A Randomized Controlled Pilot Study

Complementary Medicine Research ◽

10.1159/000513924 ◽

2021 ◽

pp. 1-8

Author(s):

Sevde Aksu ◽

Pelin Palas Karaca

Keyword(s):

Pilot Study ◽

Cesarean Section ◽

Intervention Group ◽

Control Group ◽

Breast Pain ◽

Randomized Controlled ◽

Significant Difference ◽

The Right ◽

Documentation Tool ◽

And Control

Aim: The research was conducted as a randomized controlled pilot study to evaluate the effects of reflexology on lactation in mothers who delivered by cesarean section (CS). Methods: A single-blind randomized controlled experimental study was conducted with a total of 60 postpartum women in the reflexology application (n = 30) and control groups (n = 30). After the CS, the mothers in the control group were given approximately 3-h routine nursing care after recovering from the effects of anesthesia; the introductory information form was applied, and the Breastfeeding Charting System and Documentation Tool (LATCH) and visual analog scale (VAS) for the signs of the onset of lactation were implemented on the first and second days. Reflexology was applied to the women in the intervention group after an average of 3 h following the mother’s condition had become stable and she had recovered from the effects of anesthesia. Reflexology was applied a total of 20 min – 10 min for the right foot, 10 min for the left foot – twice a day with 8-h intervals on the first and second days after CS. After the last reflexology application, the LATCH and VAS for the signs of the onset of lactation were applied. Results: Of the women, 70% breastfed their babies within 60 min after delivery; 46.7% of the mothers received breastfeeding training and 81.7% needed support for breastfeeding after the CS. The LATCH breastfeeding scores of the women in the intervention group on both days were significantly higher compared to those of the women in the control group (p < 0.001). On the first day after the CS, apart from breast pain, there was no significant difference between the two groups in terms of breast heat and breast tension (p > 0.05). On the second day after the CS, apart from breast tension, there was no significant difference between the groups in terms of breast heat and breast pain (p < 0.05). In the study, women in the intervention group were found to have higher scores in terms of all three symptoms compared to the control group (p < 0.05). Conclusions: In the study, it was determined that LATCH scores and signs of the onset of breastfeeding increased in the mothers who received reflexology after CS.

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83 A Medication Self-Management Intervention to Improve Medication Adherence For Older People with Multimorbidity: A Pilot Study

Age and Ageing ◽

10.1093/ageing/afab030.44 ◽

2021 ◽

Vol 50 (Supplement_1) ◽

pp. i12-i42

Author(s):

C Yang ◽

Z Hui ◽

S Zhu ◽

X Wang ◽

G Tang ◽

...

Keyword(s):

Medication Adherence ◽

Pilot Study ◽

Older People ◽

Intervention Group ◽

Self Management ◽

Control Group ◽

Medication Knowledge ◽

Management Intervention ◽

Patient Reported

Abstract Introduction Medication self-management support has been recognised as an essential element in primary health care to promote medication adherence and health outcomes for older people with chronic conditions. A patient-centred intervention empowering patients and supporting medication self-management activities could benefit older people. This pilot study tested a newly developed medication self-management intervention for improving medication adherence among older people with multimorbidity. Method This was a two-arm randomised controlled trial. Older people with multimorbidity were recruited from a community healthcare centre in Changsha, China. Participants were randomly allocated to either a control group receiving usual care (n = 14), or to an intervention group receiving three face-to-face medication self-management sessions and two follow-up phone calls over six weeks, targeting behavioural determinants of adherence from the Information-Motivation-Behavioural skills model (n = 14). Feasibility was assessed through recruitment and retention rates, outcome measures collection, and intervention implementation. Follow-up data were measured at six weeks after baseline using patient-reported outcomes including medication adherence, medication self-management capabilities, treatment experiences, and quality of life. Preliminary effectiveness of the intervention was explored using generalised estimating equations. Results Of the 72 approached participants, 28 (38.89%) were eligible for study participation. In the intervention group, 13 participants (92.86%) completed follow-up and 10 (71.42%) completed all intervention sessions. Ten participants (71.42%) in the control group completed follow-up. The intervention was found to be acceptable by participants and the intervention nurse. Comparing with the control group, participants in the intervention group showed significant improvements in medication adherence (β = 0.26, 95%CI 0.12, 0.40, P < 0.001), medication knowledge (β = 4.43, 95%CI 1.11, 7.75, P = 0.009), and perceived necessity of medications (β = −2.84, 95%CI -5.67, −0.01, P = 0.049) at follow-up. Conclusions The nurse-led medication self-management intervention is feasible and acceptable among older people with multimorbidity. Preliminary results showed that the intervention may improve patients’ medication knowledge and beliefs and thus lead to improved adherence.

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Effects of Aerobic, Resistance, or Combined Exercise Training Among Older Adults with Subjective Memory Complaints: A Randomized Controlled Trial

Journal of Alzheimer s Disease ◽

10.3233/jad-210047 ◽

2021 ◽

pp. 1-17

Author(s):

Taeko Makino ◽

Hiroyuki Umegaki ◽

Masahiko Ando ◽

Xian Wu Cheng ◽

Koji Ishida ◽

...

Keyword(s):

Older Adults ◽

Exercise Training ◽

Controlled Trial ◽

Community Dwelling ◽

Control Group ◽

Subjective Memory ◽

Logical Memory ◽

Randomized Controlled ◽

Community Dwelling Older Adults

Background: Physical exercise is suggested to be effective for preventing cognitive decline in older adults, but the relative efficacy of different types of exercise have yet to be clarified. Objective: This single-blinded randomized controlled trial was designed to investigate the differential effects of aerobic exercise training (AT), resistance exercise training (RT), and combined exercise training (CT) on cognition in older adults with subjective memory complaints (SMC). Methods: Community-dwelling older adults with SMC (n = 415; mean age = 72.3 years old) were randomly assigned to one of the four groups: AT, RT, CT, or control group. The study consisted of two phases: a 26-week intervention and a 26-week follow-up. The participants were evaluated at baseline, 26 weeks (postintervention), and 52 weeks (follow-up). The primary outcome of this study was memory function, which was assessed using the Logical Memory II subtest of the Wechsler Memory Scale-Revised (WMS-R) score. The secondary outcomes included global cognitive function, verbal fluency, working memory, processing speed, and executive functions. Results: Intention-to-treat analysis by a mixed-effect model repeated measure showed that the AT group had significantly improved performance on the WMS-R Logical Memory II test (2.74 [1.82–3.66] points) than the control group (1.36 [0.44–2.28] points) at the postintervention assessment (p = 0.037). The effect was more pronounced in those without amnesia than those with amnesia. No significant improvement was observed in the RT and CT groups. Conclusion: This study suggests that AT intervention can improve delayed memory in community-dwelling older adults, particularly in individuals without objective memory decline.

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A Collaborative Deprescribing Intervention in a Subacute Medical Outpatient Clinic: A Pilot Randomized Controlled Trial

Metabolites ◽

10.3390/metabo11040204 ◽

2021 ◽

Vol 11 (4) ◽

pp. 204

Author(s):

Anissa Aharaz ◽

Jens Henning Rasmussen ◽

Helle Bach Ølgaard McNulty ◽

Arne Cyron ◽

Pia Keinicke Fabricius ◽

...

Keyword(s):

Pilot Study ◽

Controlled Trial ◽

Inappropriate Medication ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Patient Interviews ◽

Number Of Patients ◽

Multimorbid Patients ◽

And Control

Medication deprescribing is essential to prevent inappropriate medication use in multimorbid patients. However, experience of deprescribing in Danish Subacute Medical Outpatient Clinics (SMOCs) is limited. The objective of our pilot study was to evaluate the feasibility and sustainability of a collaborative deprescribing intervention by a pharmacist and a physician to multimorbid patients in a SMOC. A randomized controlled pilot study was conducted, with phone follow-up at 30 and 365+ days. A senior pharmacist performed a systematic deprescribing intervention using the Screening Tool of Older Persons’ potentially inappropriate Prescriptions (STOPP) criteria, the Danish deprescribing list, and patient interviews. A senior physician received the proposed recommendations and decided which should be implemented. The main outcome was the number of patients having ≥1 medication where deprescribing status was sustained 30 days after inclusion. Out of 76 eligible patients, 72 (95%) were included and 67 (93%) completed the study (57% male; mean age 73 years; mean number of 10 prescribed medications). Nineteen patients (56%) in the intervention group and four (12%) in the control group had ≥1 medication where deprescribing status was sustained 30 days after inclusion (p = 0.015). In total, 37 medications were deprescribed in the intervention group and five in the control group. At 365+ days after inclusion, 97% and 100% of the deprescribed medications were sustained in the intervention and control groups, respectively. The three most frequently deprescribed medication groups were analgesics, cardiovascular, and gastrointestinal medications. In conclusion, a collaborative deprescribing intervention for multimorbid patients was feasible and resulted in sustainable deprescribing of medication in a SMOC.

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