Individualized Homeopathic Medicines in Chronic Rhinosinusitis: Randomized, Double-Blind, Placebo-Controlled Trial

Abstract Background Chronic rhinosinusitis (CRS) is a common disorder, with up to an estimated 134 million Indian sufferers, and having significant impact on quality of life (QOL) and health costs. Despite the evidence favoring homeopathy in CRS being inadequate, it is highly popular. This trial attempts to study the efficacy of individualized homeopathy (IH) medicines in comparison with placebo in patients with CRS. Methods A double-blind, randomized (1:1), placebo-controlled, preliminary trial (n = 62) was conducted at the National Institute of Homoeopathy, West Bengal, India. Primary outcome measure was the sino-nasal outcome test-20 (SNOT-20) questionnaire; secondary outcomes were the EQ-5D-5L questionnaire and EQ-5D-5L visual analog scale scores, and five numeric rating scales (0–10) assessing intensity of sneezing, rhinorrhea, post-nasal drip, facial pain/pressure, and disturbance in sense of smell, all measured at baseline and after the 2nd and 4th months of intervention. Group differences and effect sizes (Cohen's d) were calculated on the intention-to-treat sample. Results Groups were comparable at baseline. Attrition rate was 6.5% (IH: 1, Placebo: 3). Although improvements in both primary and secondary outcome measures were higher in the IH group than placebo, with small to medium effect sizes, the group differences were statistically non-significant (all p > 0.05, unpaired t-tests). Calcarea carbonica, Lycopodium clavatum, Sulphur, Natrum muriaticum and Pulsatilla nigricans were the most frequently prescribed medicines. No harmful or unintended effects, homeopathic aggravations or any serious adverse events were reported from either group. Conclusion There was a small but non-significant direction of effect favoring homeopathy, which ultimately renders the trial as inconclusive. Rigorous trials and independent replications are recommended to arrive at a confirmatory conclusion. [Trial registration: CTRI/2018/03/012557; UTN: U1111–1210–7201].

Download Full-text

Efficacy of individualized homeopathic medicines in primary dysmenorrhea: a double-blind, randomized, placebo-controlled, clinical trial

Journal of Complementary and Integrative Medicine ◽

10.1515/jcim-2020-0512 ◽

2021 ◽

Vol 0 (0) ◽

Author(s):

Shubhamoy Ghosh ◽

Rai Khushboo Ravindra ◽

Amila Modak ◽

Shukdeb Maiti ◽

Arunava Nath ◽

...

Keyword(s):

Repeated Measures ◽

Rating Scales ◽

Controlled Trial ◽

Attrition Rate ◽

Effect Sizes ◽

Secondary Outcome ◽

Systematic Research ◽

Controlled Clinical Trial ◽

Serious Adverse Events ◽

Double Blind

Abstract Objectives Homeopathic treatment is claimed to be beneficial for primary dysmenorrhoea (PD); still, systematic research evidences remain compromised. This study was undertaken to examine the efficacy of individualized homeopathic medicines (IH) against placebo in the treatment of PD. Methods A double-blind, randomized, placebo-controlled trial was conducted at the gynecology outpatient department of Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, West Bengal, India. Patients were randomized to receive either IH (n=64) or identical-looking placebo (n=64). Primary and secondary outcome measures were 0–10 numeric rating scales (NRS) measuring intensity of pain of dysmenorrhea and verbal multidimensional scoring system (VMSS) respectively; all measured at baseline, and every month, up to 3 months. Group differences and effect sizes (Cohen’s d) were calculated on intention-to-treat (ITT) sample. Results Groups were comparable at baseline (all p>0.05). Attrition rate was 10.9% (IH: 7, placebo: 7). Differences between groups in both pain NRS and VMSS favoured IH over placebo at all time points (all p<0.001, unpaired t-tests and two-ways repeated measures analysis of variance) with medium to large effect sizes. Natrum muriaticum and Pulsatilla nigricans (n=20 each; 15.6%) were the most frequently prescribed medicines. No harms, serious adverse events and intercurrent illnesses were recorded in either of the groups. Conclusions Homeopathic medicines acted significantly better than placebo in the treatment of PD. Independent replication is warranted. Trial registration: CTRI/2018/10/016013.

Download Full-text

A Randomized, Double-Blind, Placebo-Controlled, Pilot Trial of Individualized Homeopathic Medicines for Cutaneous Warts

Homeopathy ◽

10.1055/s-0040-1722232 ◽

2021 ◽

Author(s):

Samit Dey ◽

Shifa Hashmi ◽

Sangita Saha ◽

Mahakas Mandal ◽

Abdur Rahaman Shaikh ◽

...

Keyword(s):

Controlled Trial ◽

Pilot Trial ◽

Attrition Rate ◽

Effect Sizes ◽

Secondary Outcome ◽

Group Differences ◽

Practice Research ◽

Double Blind ◽

Definitive Trial ◽

Cutaneous Warts

Abstract Background Though frequently used in practice, research studies have shown inconclusive benefits of homeopathy in the treatment of warts. We aimed to assess the feasibility of a future definitive trial, with preliminary assessment of differences between effects of individualized homeopathic (IH) medicines and placebos in treatment of cutaneous warts. Methods A double-blind, randomized, placebo-controlled trial (n = 60) was conducted at the dermatology outpatient department of D.N. De Homoeopathic Medical College and Hospital, West Bengal. Patients were randomized to receive either IH (n = 30) or identical-looking placebo (n = 30). Primary outcome measures were numbers and sizes of the warts; secondary outcome was the Dermatology Life Quality Index (DLQI) questionnaire measured at baseline, and every month up to 3 months. Group differences and effect sizes were calculated on the intention-to-treat sample. Results Attrition rate was 11.6% (IH, 3; placebo, 4). Intra-group changes were significantly greater (all p < 0.05, Friedman tests) in IH than placebo. Inter-group differences were statistically non-significant (all p > 0.05, Mann-Whitney U tests) with small effect sizes—both in the primary outcomes (number of warts after 3 months: IH median [inter-quartile range; IQR] 1 [1, 3] vs. placebo 1 [1, 2]; p = 0.741; size of warts after 3 months: IH 5.6 mm [2.6, 40.2] vs. placebo 6.3 [0.8, 16.7]; p = 0.515) and in the secondary outcomes (DLQI total after 3 months: IH 4.5 [2, 6.2] vs. placebo 4.5 [2.5, 8]; p = 0.935). Thuja occidentalis (28.3%), Natrum muriaticum (10%) and Sulphur (8.3%) were the most frequently prescribed medicines. No harms, homeopathic aggravations, or serious adverse events were reported. Conclusion As regards efficacy, the preliminary study was inconclusive, with a statistically non-significant direction of effect favoring homeopathy. The trial succeeded in showing that an adequately powered definitive trial is both feasible and warranted. Trial Registration CTRI/2019/10/021659; UTN: U1111–1241–7340

Download Full-text

Maternal–Infant Supplementation with Small-Quantity Lipid-Based Nutrient Supplements Does Not Affect Child Blood Pressure at 4–6 Y in Ghana: Follow-up of a Randomized Trial

Journal of Nutrition ◽

10.1093/jn/nxy285 ◽

2019 ◽

Vol 149 (3) ◽

pp. 522-531 ◽

Cited By ~ 2

Author(s):

Sika M Kumordzie ◽

Seth Adu-Afarwuah ◽

Rebecca R Young ◽

Brietta M Oaks ◽

Solace M Tamakloe ◽

...

Keyword(s):

Blood Pressure ◽

Birth Weight ◽

Controlled Trial ◽

Intervention Group ◽

Path Model ◽

Secondary Outcome ◽

Double Blind ◽

Blood Institute ◽

Nutrient Supplements ◽

Pregnancy And Postpartum

ABSTRACT Background In the International Lipid-Based Nutrient Supplements (iLiNS)-DYAD-Ghana trial, prenatal small-quantity lipid-based nutrient supplements (LNSs) had a positive effect on birth weight. Birth weight may be inversely related to blood pressure (BP) later in life. Objectives We examined the effect of the intervention on BP at 4–6 y of age, and maternal and child factors related to BP. Methods The iLiNS-DYAD-Ghana study was a partially double-blind, randomized controlled trial which assigned women (n = 1320) ≤20 weeks of gestation to daily supplementation with: 1) iron and folic acid during pregnancy and 200 mg Ca for 6 mo postpartum , 2) multiple micronutrients during pregnancy and postpartum, or 3) LNSs during pregnancy and postpartum plus LNSs for infants from 6 to 18 mo of age. At 4–6 y of age (n = 858, 70% of live births), we compared BP, a secondary outcome, between non-LNS and LNS groups and examined whether BP was related to several factors including maternal BP, child weight-for-age z score (WAZ), and physical activity. Results Non-LNS and LNS groups did not differ in systolic (99.2 ± 0.4 compared with 98.5 ± 0.6 mm Hg; P = 0.317) or diastolic (60.1 ± 0.3 compared with 60.0 ± 0.4 mm Hg; P = 0.805) BP, or prevalence of high BP (systolic or diastolic BP ≥90th percentile of the US National Heart, Lung, and Blood Institute reference: 31% compared with 28%; P = 0.251). BP at 4–6 y of age was positively related to birth weight; this relation was largely mediated through concurrent WAZ in a path model. Concurrent WAZ and maternal BP were the factors most strongly related to child BP. Conclusions Despite greater birth weight in the LNS group, there was no intervention group difference in BP at 4–6 y. In this preschool population at high risk of adult hypertension based on BP at 4–6 y, high maternal BP and child WAZ were key factors related to BP. This trial was registered at clinicaltrials.gov as NCT00970866.

Download Full-text

Vitamin–mineral treatment of attention-deficit hyperactivity disorder in adults: double-blind randomised placebo-controlled trial

The British Journal of Psychiatry ◽

10.1192/bjp.bp.113.132126 ◽

2014 ◽

Vol 204 (4) ◽

pp. 306-315 ◽

Cited By ~ 65

Author(s):

Julia J. Rucklidge ◽

Chris M. Frampton ◽

Brigette Gorman ◽

Anna Boggis

Keyword(s):

Attention Deficit Hyperactivity Disorder ◽

Active Treatment ◽

Attention Deficit ◽

Rating Scales ◽

Controlled Trial ◽

Severe Depression ◽

Group Differences ◽

Adhd Symptoms ◽

Double Blind ◽

Hyperactivity Disorder

BackgroundThe role of nutrition in the treatment of attention-deficit hyperactivity disorder (ADHD) is gaining international attention; however, treatments have generally focused only on diet restriction or supplementing with one nutrient at a time.AimsTo investigate the efficacy and safety of a broad-based micronutrient formula consisting mainly of vitamins and minerals, without omega fatty acids, in the treatment of ADHD in adults.MethodThis double-blind randomised controlled trial assigned 80 adults with ADHD in a 1:1 ratio to either micronutrients (n = 42) or placebo (n = 38) for 8 weeks (trial registered with the Australian New Zealand Clinical Trials Registry: ACTRN12609000308291).ResultsIntent-to-treat analyses showed significant between-group differences favouring active treatment on self- and observer- but not clinician-ADHD rating scales. However, clinicians rated those receiving micronutrients as more improved than those on placebo both globally and on ADHD symptoms. Post hoc analyses showed that for those with moderate/severe depression at baseline, there was a greater change in mood favouring active treatment over placebo. There were no group differences in adverse events.ConclusionsThis study provides preliminary evidence of efficacy for micronutrients in the treatment of ADHD symptoms in adults, with a reassuring safety profile.

Download Full-text

Efficacy of Individualized Homeopathic Medicines in Plantar Fasciitis: Double-blind, Randomized, Placebo-Controlled Clinical Trial

Homeopathy ◽

10.1055/s-0041-1731383 ◽

2021 ◽

Author(s):

Sana Shahid ◽

Shubhamoy Ghosh ◽

Ardhendu Shekhar Chakraborty ◽

Shukdeb Maiti ◽

Satarupa Sadhukhan ◽

...

Keyword(s):

Plantar Fasciitis ◽

Controlled Trial ◽

Plantar Fascia ◽

Convincing Evidence ◽

Mean Difference ◽

Attrition Rate ◽

Effect Sizes ◽

Controlled Clinical Trial ◽

Serious Adverse Events ◽

Double Blind

Abstract Introduction Plantar fasciitis (PF) is a chronic degenerative condition causing marked thickening and fibrosis of the plantar fascia, and collagen necrosis, chondroid metaplasia and calcification. There is little convincing evidence in support of various approaches, including homeopathy, for treating PF. This study was undertaken to examine the efficacy of individualized homeopathic medicines (IHMs) compared with placebo in the treatment of PF. Methods A double-blind, randomized, placebo-controlled trial was conducted at the outpatient departments of Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, West Bengal, India. Patients were randomized to receive either IHMs or identical-looking placebo in the mutual context of conservative non-medicinal management. The Foot Function Index (FFI) questionnaire, as an outcome measure, was administered at baseline, and every month, up to 3 months. Group differences (unpaired t-tests) and effect sizes (Cohen's d) were calculated on an intention-to-treat sample. The sample was analyzed statistically after adjusting for baseline differences. Results The target sample size was 128; however, only 75 could be enrolled (IHMs: 37; Placebo: 38). Attrition rate was 9.3% (IHMs: 4, Placebo: 3). Differences between groups in total FFI% score favored IHMs against placebo at all the time points, with large effect sizes: month 1 (mean difference, −10.0; 95% confidence interval [CI], −15.7 to −4.2; p = 0.001; d = 0.8); month 2 (mean difference, −14.3; 95% CI, −20.4 to −8.2; p <0.001; d = 1.1); and month 3 (mean difference, −23.3; 95% CI, −30.5 to −16.2; p <0.001; d = 1.5). Similar significant results were also observed on three FFI sub-scales (pain%, disability%, and activity limitation%). Natrum muriaticum (n = 14; 18.7%) and Rhus toxicodendron and Ruta graveolens (n = 11 each; 14.7%) were the most frequently prescribed medicines. No harms, serious adverse events, or intercurrent illnesses were recorded in either of the groups. Conclusion IHMs acted significantly better than placebo in the treatment of PF; however, the trial being underpowered, the results should be interpreted as preliminary only. Independent replications are warranted. Trial registration: CTRI/2018/10/016014.

Download Full-text

A randomized, double-blind, placebo-controlled trial of anti-IgE for chronic rhinosinusitis

Rhinology Journal ◽

10.4193/rhino09.144 ◽

2010 ◽

Vol 48 (3) ◽

pp. 318-324

Author(s):

J.M. Pinto ◽

N. Mehta ◽

M. DiTineo ◽

J. Wang ◽

F.M. Baroody ◽

...

Keyword(s):

Chronic Rhinosinusitis ◽

Controlled Trial ◽

Mucosal Inflammation ◽

Secondary Outcome ◽

Control Group ◽

Controlled Clinical Trial ◽

Double Blind ◽

Double Blind Placebo ◽

Cellular Inflammation ◽

Olfactory Testing

Evidence suggests IgE may play a role in chronic rhinosinusitis (CRS). We sought to determine if treatment with a monoclonal antibody against IgE (omalizumab) is effective in reducing CRS inflammation. We performed a randomized, double blind, placebo controlled clinical trial in subjects with CRS despite treatment (including surgery). Subjects were randomized to receive omalizumab or placebo for 6 months. The primary outcome was quantitative measurement of sinus inflammation on imaging. Secondary outcome measures included quality of life, symptoms, and cellular inflammation, nasal airflow (NPIF) and olfactory testing (UPSIT). Subjects on omalizumab showed reduced inflammation on imaging after treatment, whereas those on placebo showed no change. The net difference, however, was not different between treatments. Treatment with omalizumab was associated with improvement in the Sino-Nasal Outcome Test (SNOT-20) at 3, 5, and 6 months compared to baseline with no significant changes in the control group. Remaining measures showed no significant differences across treatments. We conclude that IgE plays, at most, a small role in the mucosal inflammation of CRS and the symptoms. Placebo controlled, blinded studies with larger enrollment are needed to determine the clinical significance of any potential change.

Download Full-text

Predischarge home visits after hip fracture: a randomized controlled trial

Clinical Rehabilitation ◽

10.1177/0269215518823256 ◽

2019 ◽

Vol 33 (4) ◽

pp. 681-692 ◽

Cited By ~ 5

Author(s):

Kylee J Lockwood ◽

Katherine E Harding ◽

Jude N Boyd ◽

Nicholas F Taylor

Keyword(s):

Randomized Controlled Trial ◽

Hip Fracture ◽

Hospital Discharge ◽

Controlled Trial ◽

Hospital Readmissions ◽

Intervention Group ◽

Functional Independence ◽

Secondary Outcome ◽

Group Differences ◽

Randomized Controlled

Objective: The objective of this study is to investigate whether home assessment visits prior to hospital discharge for patients recovering from hip fracture reduce falls and prevent hospital readmissions, within the first 30 days and six months after discharge home. Design: A randomized controlled trial was conducted. Setting: The study setting included hospital wards and the community. Participants: The study included adults 50 years and over recovering from hip fracture ( n = 77). Intervention: Both groups received inpatient rehabilitation and hospital-based discharge planning. In addition, the intervention group received a home assessment visit by an occupational therapist prior to discharge from hospital. Main measures: Primary outcomes were falls and hospital readmissions. Secondary outcome measures included Functional Independence Measure, Functional Autonomy Measurement Scale, Nottingham Extended Activities of Daily Living Scale, EuroQol five dimension scale questionnaire and Falls Efficacy Scale-International. Results: The intervention group had fewer hospital readmissions in the first 30 days compared to the control group (intervention n = 1, control n = 10; odds ratio (OR) 12.9, 95% confidence interval (CI) 1.5 to 99.2). The intervention group was observed to have fewer falls than controls in the 30 days after discharge (intervention n = 6, control n = 14; incidence rate ratio (IRR) = 0.41, 95% CI 0.15 to 1.11). Between-group differences favoured the intervention group for functional independence at six months (11.2 units, 95% CI 4.2 to 18.2). There were no other between-group differences. Conclusion: Home assessment visits by occupational therapists prior to hospital discharge for patients recovering from hip fracture reduced the number of readmissions to hospital, increased functional independence at six months and may have reduced the risk of falls in the first 30 days after discharge.

Download Full-text

Effect of tart cherry juice on risk of gout attacks: protocol for a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2019-035108 ◽

2020 ◽

Vol 10 (3) ◽

pp. e035108

Author(s):

Kirstie Louise Lamb ◽

Anthony Lynn ◽

Jean Russell ◽

Margo E Barker

Keyword(s):

Research Ethics ◽

Outcome Measures ◽

Controlled Trial ◽

Intervention Group ◽

Serum Urate ◽

Secondary Outcome ◽

Primary Study ◽

Tart Cherry ◽

Double Blind ◽

Cherry Juice

IntroductionGout is a painful form of inflammatory arthritis associated with several comorbidities, particularly cardiovascular disease. Cherries, which are rich in anti-inflammatory and antioxidative bioactive compounds, are proposed to be efficacious in preventing and treating gout, but recommendations to patients are conflicting. Cherry consumption has been demonstrated to lower serum urate levels and inflammation in several small studies. One observational case cross-over study reported that cherry consumption was associated with reduced risk of recurrent gout attacks. This preliminary evidence requires substantiation. The proposed randomised clinical trial aims to test the effect of consumption of tart cherry juice on risk of gout attacks.Methods and analysisThis 12-month, parallel, double-blind, randomised, placebo-controlled trial will recruit 120 individuals (aged 18–80 years) with a clinical diagnosis of gout who have self-reported a gout flare in the previous year. Participants will be randomly assigned to an intervention group, which will receive Montmorency tart cherry juice daily for a 12-month period, or a corresponding placebo group, which will receive a cherry-flavoured placebo drink. The primary study outcome is change in frequency of self-reported gout attacks. Secondary outcome measures include attack intensity, serum urate concentration, fractional excretion of uric acid, biomarkers of inflammation, blood lipids and other markers of cardiovascular risk. Other secondary outcome measures will be changes in physical activity and functional status. Statistical analysis will be conducted on an intention-to-treat basis.Ethics and disseminationThis study has been granted ethical approval by the National Research Ethics Service, Yorkshire and The Humber—Leeds West Research Ethics Committee (ref: 18/SW/0262). Results of the trial will be submitted for publication in a peer-reviewed journal.Trial registration numberNCT03621215.

Download Full-text

The Effect of Protein Supplementation versus Carbohydrate Supplementation on Muscle Damage Markers and Soreness Following a 15-km Road Race: A Double-Blind Randomized Controlled Trial

Nutrients ◽

10.3390/nu13030858 ◽

2021 ◽

Vol 13 (3) ◽

pp. 858

Author(s):

Dominique S. M. ten Haaf ◽

Martin A. Flipsen ◽

Astrid M. H. Horstman ◽

Hans Timmerman ◽

Monique A. H. Steegers ◽

...

Keyword(s):

Placebo Group ◽

Protein Intake ◽

Muscle Soreness ◽

Controlled Trial ◽

Protein Supplementation ◽

Group Differences ◽

Double Blind ◽

Carbohydrate Supplementation ◽

Protein Group ◽

Road Race

We assessed whether a protein supplementation protocol could attenuate running-induced muscle soreness and other muscle damage markers compared to iso-caloric placebo supplementation. A double-blind randomized controlled trial was performed among 323 recreational runners (age 44 ± 11 years, 56% men) participating in a 15-km road race. Participants received milk protein or carbohydrate supplementation, for three consecutive days post-race. Habitual protein intake was assessed using 24 h recalls. Race characteristics were determined and muscle soreness was assessed with the Brief Pain Inventory at baseline and 1–3 days post-race. In a subgroup (n = 149) muscle soreness was measured with a strain gauge algometer and creatine kinase (CK) and lactate dehydrogenase (LDH) concentrations were measured. At baseline, no group-differences were observed for habitual protein intake (protein group: 79.9 ± 26.5 g/d versus placebo group: 82.0 ± 26.8 g/d, p = 0.49) and muscle soreness (protein: 0.45 ± 1.08 versus placebo: 0.44 ± 1.14, p = 0.96). Subjects completed the race with a running speed of 12 ± 2 km/h. With the Intention-to-Treat analysis no between-group differences were observed in reported muscle soreness. With the per-protocol analysis, however, the protein group reported higher muscle soreness 24 h post-race compared to the placebo group (2.96 ± 2.27 versus 2.46 ± 2.38, p = 0.039) and a lower pressure muscle pain threshold in the protein group compared to the placebo group (71.8 ± 30.0 N versus 83.9 ± 27.9 N, p = 0.019). No differences were found in concentrations of CK and LDH post-race between groups. Post-exercise protein supplementation is not more preferable than carbohydrate supplementation to reduce muscle soreness or other damage markers in recreational athletes with mostly a sufficient baseline protein intake running a 15-km road race.

Download Full-text

A Short Mindfulness Retreat for Students to Reduce Stress and Promote Self-Compassion: Pilot Randomised Controlled Trial Exploring Both an Indoor and a Natural Outdoor Retreat Setting

Healthcare ◽

10.3390/healthcare9070910 ◽

2021 ◽

Vol 9 (7) ◽

pp. 910

Author(s):

Dorthe Djernis ◽

Mia S. O’Toole ◽

Lone O. Fjorback ◽

Helle Svenningsen ◽

Mimi Y. Mehlsen ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Effect Sizes ◽

Medium Effect ◽

Control Group ◽

Post Intervention ◽

Pilot Randomised Controlled Trial ◽

Self Compassion ◽

Randomised Controlled

Here, we developed and examined a new way of disseminating mindfulness in nature to people without meditation experience, based on the finding that mindfulness conducted in natural settings may have added benefits. We evaluated a 5-day residential programme aiming to reduce stress and improve mental health outcomes. We compared an indoor and an outdoor version of the programme to a control group in a pilot randomised controlled trial (RCT). Sixty Danish university students experiencing moderate to high levels of stress were randomised into a residential mindfulness programme indoors (n = 20), in nature (n = 22), or a control group (n = 18). Participants completed the Perceived Stress Scale and the Self-Compassion Scale (primary outcomes) along with additional secondary outcome measures at the start and end of the program and 3 months after. Stress was decreased with small to medium effect sizes post-intervention, although not statistically significant. Self-compassion increased post-intervention, but effect sizes were small and not significant. At follow-up, changes in stress were not significant, however self-compassion increased for both interventions with medium-sized effects. For the intervention groups, medium- to large-sized positive effects on trait mindfulness after a behavioural task were found post-intervention, and small- to medium-sized effects in self-reported mindfulness were seen at follow-up. Connectedness to Nature was the only outcome measure with an incremental effect in nature, exceeding the control with a medium-sized effect at follow-up. All participants in the nature arm completed the intervention, and so did 97% of the participants in all three arms. Overall, the results encourage the conduct of a larger-scale RCT, but only after adjusting some elements of the programme to better fit and take advantage of the potential benefits of the natural environment.

Download Full-text