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Study to Investigate the Efficacy and Safety of Cannabis Oil for the Treatment of Subjects With Hidradenitis Suppurativa Hidradenitis Suppurativa (HS), is a chronic skin disease, manifested as Complementary and Alternative Medicine Use in Patients With Hidradenitis Suppurativa Accepted for Publication: November 29, 2019. Corresponding Author: Vivian Y. Shi, MD, Dermatology

Study to Investigate the Efficacy and Safety of Cannabis Oil for the Treatment of Subjects With Hidradenitis Suppurativa

Hidradenitis Suppurativa (HS), is a chronic skin disease, manifested as inflamed areas of hair follicles around apocrine sweat glands found in areas most commonly the axillae, inguinal and anogenital regions. Patients experience great deal of physical pain as well as profound psychological problems. HS patients may also be prone to health complications and diseases. Treatment to date is limited and consist mainly of antibiotic administration and novel biological drug with up to 40% efficiency. Recently it was shown that cannabinoids reduces the folliculo pilosebaceous activity, most likely due to activating arachnoiditis, lipostat , anti-proliferative and anti-inflammatory agents and reduce inflammation inducing cytokines.

Condition or disease Intervention/treatment Phase
Hidradenitis Suppurativa Drug: Cannabis oil Drug: Placebo Phase 2

Forty participants will be recruited over two years. After determine eligibility by examining the study criteria for inclusion and exclusion, the patient will be asked to sign the informed consent form.

The YAKAR form of medical cannabis license application and a confidentiality waiver form will be sent to the YAKAR. The physician will explain to the patients that his/her participation in the trial can be terminated at any time and will explain the medical license conditions: It is absolutely forbidden to:

  • Use cannabis in the presence of minors or in public
  • Drive under the influence of cannabis
  • The participant shall take measures to prevent the theft of cannabis and inform the Investigator and the YAKAR of an attempt to steal or lose of cannabis.

When the patient license arrives, the patient will be scheduled an appointment for the first visit of the trial at the hospital. Tikun-Olam will be informed and asked to supply the patient product on the visit day. The copy of the patient’s license will be included into the trial source documents.

The participants will be randomly assigned in a 1:1 ratio to receive Avidekel oil or placebo oil. Patients will receive the oils as drops applied under the tongue 3 times a day.

The duration of study participation for each subject is expected to be 12 weeks (84 days), about 4 weeks from visit 0 until receiving the license and 8 weeks trial,of which, six weeks of dose titration. Over the course of twelve weeks, four visits will be conducted and there will be 3 telephone evaluations. During first visit screening and enrolment will be conducted. The second visit will take place four weeks later where patients will receive the oils and start the trial, followed by a phone call evaluation at day 5-7 after starting the treatment and at week 2±2 days. Than a visit approximately four weeks later, following another phone call evaluation at week 5±2 days from treatment beginning, F Last visit will be conducted at week 8±3 days. In each visit, the relevant variables will be collected (Please refer to Table 3. Schedule of events). At the end of the eight-week experiment, patients from the treatment and control groups will be given the option to use the Avidekel oil for a period of one year. First, all the patients will use the drug in the open label phase for 8 weeks, during this period 3 phone calls and 2 visits in the hospital will be conducted, using PI-NRS and HS-PGA score to evaluate treatment success. Patients who will have at least 1 point reduction on the HS-PGA score will be permitted to continue to the 1 year follow-up. During that period 2 visits, six months and one year, will be conducted and the relevant variables will be collected (see Table 3). All visits will take place at the hospital.

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Complementary and Alternative Medicine Use in Patients With Hidradenitis Suppurativa

Accepted for Publication: November 29, 2019.

Corresponding Author: Vivian Y. Shi, MD, Dermatology Division, Department of Medicine, University of Arizona, 7165 N Pima Canyon Dr, Tucson, AZ 85718 ([email protected]).

Published Online: January 29, 2020. doi:10.1001/jamadermatol.2019.4595

Author Contributions: Ms Price and Dr Shi had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Thompson, Rizvi, Hendricks, Alavi, Hsiao, Shi.

Acquisition, analysis, or interpretation of data: Price, Rizvi, Hendricks, Hsiao, Shi.

Drafting of the manuscript: Price, Rizvi, Alavi, Shi.

Critical revision of the manuscript for important intellectual content: Thompson, Rizvi, Hendricks, Hsiao, Shi.

Statistical analysis: Price, Rizvi.

Administrative, technical, or material support: Price, Alavi.

Supervision: Thompson, Hsiao, Shi.

Conflict of Interest Disclosures: Dr Alavi received honoraria as a consultant, speaker, or advisory board participant from AbbVie, Galderma, Janssen, Leo, Novartis, Sanofi, and Valeant; received grants from AbbVie; and was a research investigator with AbbVie, Aristea, Asana, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Eli Lilly, Genetech, Glenmark, Incyte, InflaRx, Janssen, Kyowa, Leo, Novartis, Pfizer, Regeneron, and UCB. Dr Shi is a stock shareholder of Learn Health and has been an advisory board member, investigator, and/or research funding recipient with Sanofi Genzyme, Regeneron, AbbVie, Eli Lilly, Novartis, Sun Pharma, Leo Pharma, Pfizer, Menlo Therapeutics, Burt’s Bees, GpSkin, the National Eczema Association, Global Parents for Eczema Research, the Foundation for Atopic Dermatitis, and Skin Actives Scientific. No other disclosures were reported.

Additional Contributions: We are grateful for the patients with hidradenitis suppurativa and support group leaders for their dedicated time and assistance on these projects. We are also grateful to Catherine Ludwig, BA, University of Illinois College of Medicine, Chicago, and Jennifer Fernandez, BS, RD University of Arizona College of Medicine, Tucson, for their assistance in collecting responses. The named individuals were not compensated for their contributions.

This survey study examines the use and perceptions of complementary and alternative medicine by individuals with hidradenitis suppurativa who completed an anonymous survey.

Hidradenitis suppurativa (HS) is a debilitating disease characterized by recurrent painful nodules, abscesses, and sinus tracts in intertriginous areas. Available treatments have variable and limited efficacy. 1,2 Complementary and alternative medicine (CAM) is widely used in other chronic dermatoses; however, there is a dearth of investigations into CAM in HS. The goal of this study is to explore patterns of conventional and CAM therapies used by patients with HS.

Methods

An anonymous, multiple-choice, 25-item questionnaire with free-text answer options was distributed in HS specialty clinics (University of Arizona–Tucson, University of California–Los Angeles, and York Dermatology Clinic and Research Center in Richmond Hill, Ontario, Canada) and through international social media support groups (Hope For HS, International Association of HS Network, and HS Warriors). The study was granted exemption from the University of Arizona institutional review board. Informed consent was unnecessary due to the use of anonymous data.

Data were collected between June 2019 and August 2019. Excel version 16.31 (Microsoft) and SAS version 9.4 (SAS Institute) were used for data analysis. A χ 2 test of variance was used to determine significant differences between groups, with a threshold P value of .05.

Results

A total of 303 respondents participated (mean [SD] age, 38.0 [10.9] years; 268 female participants [88.4%], 34 male participants [11.2%], and 1 nonbinary participant [0.3%]). Additional demographic data are summarized in the Table . Nearly all respondents (296 [97.7%]) reported using conventional therapies ( Figure , A). Surgical excisions (73 of 126 respondents [57.9%]), prescription pain medications (79 of 148 respondents [53.4%]), and intralesional steroids (71 of 133 respondents [53.4%]) were perceived to be most helpful. Half of respondents using biologics (56 of 112 respondents [50.0%]) perceived them as helpful, and less than one-third of respondents perceived oral (75 of 267 respondents [28.1%]) and topical (76 of 235 respondents [32.3%]) antibiotics as helpful. Nearly half of respondents (147 of 296 [49.7%]) perceived conventional therapy as not very successful ( Figure , B).

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Table.

Patient Characteristic No. (%)
Age, y
Mean (SD) 38.0 (10.9)
Median (range) 37.0 (17-78)
17-24 31 (10.2)
25-34 88 (29.0)
35-44 104 (34.3)
45-54 57 (18.8)
55-64 19 (6.3)
≥64 4 (1.3)
Sex
Male 34 (11.2)
Female 268 (88.4)
Other 1 (0.3)
Race/ethnicity
White 236 (73.5)
Black/African American 36 (11.2)
Hispanic 24 (7.5)
Native American 8 (2.5)
South Asian 7 (2.2)
Other 4 (1.2)
East Asian 3 (0.9)
Middle Eastern 3 (0.9)
Pacific Islander
Highest education level
12 (4.0)
High school graduate 62 (20.5)
Occupational skills training 33 (10.9)
College 147 (48.5)
Graduate school 49 (16.2)
Country of residence
United States 220 (72.6)
Canada 43 (14.2)
United Kingdom 10 (3.3)
Sweden 8 (2.6)
Ireland 6 (2.0)
Australia 5 (1.7)
New Zealand 2 (0.7)
Albania 1 (0.3)
Denmark 1 (0.3)
Germany 1 (0.3)
Greece 1 (0.3)
India 1 (0.3)
Lebanon 1 (0.3)
Malaysia 1 (0.3)
The Netherlands 1 (0.3)
South Africa 1 (0.3)
Location type
Metropolitan 192 (63.6)
Rural 110 (36.4)
Height, cm
Mean (SD) 166.6 (7.6)
Median (range) 167.6 (142.2-195.6)
Weight, kg
Mean (SD) 96.1 (26.8)
Median (range) 93.4 (43.5-302.1)
BMI
Mean (SD) 34.5 (9.9)
Median (range) 33.5 (18.6-33.5)
Normal (18.5-24.9) 29 (11.0)
Overweight (25.0-29.9) 55 (20.8)
Obesity (≥30) 180 (68.2)
Hurley stage
1 26 (8.58)
2 145 (47.85)
3 132 (43.56)
Hidradenitis suppurativa duration, y
8 (2.64)
1-5 30 (9.90)
6-10 57 (18.81)
11-19 78 (25.74)
20-29 78 (25.74)
30-39 39 (12.87)
40-49 11 (3.63)
>50 2 (0.66)
How were you first introduced to the use of alternative medicine?
Internet or personal research 76 (25.1)
Social media 46 (15.2)
Friend or coworker 40 (13.2)
Family member 39 (12.9)
Other 13 (4.3)
Other media (radio, television, advertisement) 4 (1.3)
Do any of your family members use alternative medicine?, No./total No. (%)
No 146/303 (48.2)
Respondents using CAM 119/146 (81.5)
Yes 77/303 (25.4)
Respondents using CAM 72/77 (93.5)
Unsure/do not know 80/303 (26.4)
Respondents using CAM 66/80 (82.5)

Abbreviations: BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); CAM, complementary and alternative medicine.

A, Respondent-perceived effects of conventional therapies on hidradenitis suppurativa (HS); B, Overall respondent-perceived success of conventional medicine compared with complementary and alternative medicine (CAM); C, Reasons for using CAM; D, Respondent-perceived effects of CAM. CBD indicates cannabidiol.

While 255 respondents (84.2%) reported using CAM, only 177 of these (69.4%) disclosed their CAM use to a health care professional (HCP). There were no significant differences in CAM use based on demographics or disease characteristics. The most common reasons for CAM use were “frustration with conventional treatment” (163 respondents [63.9%]) and desire to try “new” (130 respondents [51.0%]) or “more ‘natural’” (113 respondents [44.3%]) treatments ( Figure , C).

The most commonly used CAM products were turmeric/curcumin (152 of 255 respondents [59.6%]), magnesium sulfate salt bath (151 of 255 [59.2%]), and zinc (140 of 255 [54.9%]) ( Figure , D). The respondents perceived marijuana (59 of 103 respondents [57.3%]), magnesium sulfate bath (72 of 151 [47.7%]), and topical cannabidiol (CBD) oil (30 of 67 [44.8%]) as most helpful. The most common lifestyle practices for HS were dietary changes (230 of 255 respondents [90.2%]), tobacco cessation (86 of 255 [33.7%]), and yoga or Pilates (58 of 255 [22.7%]) ( Figure , D). Of 230 respondents, 106 (46.1%) reported that dietary changes were beneficial for HS. Most respondents who used CAM (166 of 255 [65.1%]) perceived having at least mild success with CAM ( Figure , B). Most respondents (183 of 255 respondents [71.8%]) would recommend CAM to others.

Discussion

The use of CAM among this cohort of patients with HS (84.2%) is more common than in patients with psoriasis (46.7%) and atopic dermatitis (50.4%). 3,4 Despite pervasive use of conventional treatments (296 [97.7%]), only half of these respondents perceived conventional medicine at least mildly successful, compared with two-thirds of those who used CAM. These differences were consistent with the reported frustration with conventional medicine among respondents who used CAM. Dietary changes were the CAM modality most commonly implemented (230 respondents [90.2%]) and were deemed helpful in nearly half of implementers. Marijuana, topical CBD, and oral CBD oil were also relatively successful. Other commonly used CAM methods included turmeric and magnesium sulfate baths.

To our knowledge, this study is the largest and most comprehensive survey to date that explores CAM use in patients with HS. Previously, a 9-question CAM HS survey was distributed to patients in a clinic in Ireland. 5 Only 20% of their 107 participants reported CAM use, compared with the 84.2% reported by the more diverse respondents in this study.

Only 69.4% reported having informed an HCP about CAM use. Previous investigations have shown that patients are less likely to report CAM use when not asked or do not believe HCPs need to know about CAM use. 6 For clinicians, inquiring about CAM use can promote shared decision-making and establishing trust and transparency in HS management.

This study is limited by self-reported HS disease severity. The proportion of respondents who completed the questionnaire from online vs in clinic is unknown. Additionally, patients’ perceived views of treatment success may differ from clinical determinants of success.

Conclusions

Respondents with HS reported inadequate response to conventional therapy, which may lead to frustration and lower treatment adherence. The efficacy and safety of CAM modalities, as well as the role of CAM as adjunctive therapy in HS treatment, warrant further investigation.

References

1. Alikhan A, Sayed C, Alavi A, et al.. North American clinical management guidelines for hidradenitis suppurativa: a publication from the United States and Canadian Hidradenitis Suppurativa Foundations, part I: diagnosis, evaluation, and the use of complementary and procedural management . J Am Acad Dermatol . 2019; 81 ( 1 ):76-90. doi: 10.1016/j.jaad.2019.02.067 [PMC free article] [PubMed] [CrossRef] [Google Scholar]

2. Alikhan A, Sayed C, Alavi A, et al.. North American clinical management guidelines for hidradenitis suppurativa: a publication from the United States and Canadian Hidradenitis Suppurativa Foundations, part II: topical, intralesional, and systemic medical management . J Am Acad Dermatol . 2019; 81 ( 1 ):91-101. doi: 10.1016/j.jaad.2019.02.068 [PMC free article] [PubMed] [CrossRef] [Google Scholar]

3. Damevska K, Neloska L, Nikolovska S, Gocev G, Duma S. Complementary and alternative medicine use among patients with psoriasis . Dermatol Ther . 2014; 27 ( 5 ):281-283. doi: 10.1111/dth.12139 [PubMed] [CrossRef] [Google Scholar]

4. Simpson EL, Basco M, Hanifin J. A cross-sectional survey of complementary and alternative medicine use in patients with atopic dermatitis . Am J Contact Dermat . 2003; 14 ( 3 ):144-147. doi: 10.2310/6620.2003.6156 [PubMed] [CrossRef] [Google Scholar]

5. Kearney N, Byrne N, Kirby B, Hughes R. Complementary and alternative medicine use in hidradenitis suppurativa . Br J Dermatol . 2019. doi: 10.1111/bjd.18426 [PubMed] [CrossRef] [Google Scholar]

6. Jou J, Johnson PJ. Nondisclosure of complementary and alternative medicine use to primary care physicians: findings from the 2012 National Health Interview Survey . JAMA Intern Med . 2016; 176 ( 4 ):545-546. doi: 10.1001/jamainternmed.2015.8593 [PubMed] [CrossRef] [Google Scholar]

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