Nigeria researchers from Nnamdi Azikiwe University Awka, Anambra State, have demonstrated the efficacy and safety of Syferol-IHP (blend of virgin coconut oil and Ocimum sanctum/scent leaf oil) as adjunct to conventional triple therapy for the treatment of peptic ulcer disease (PUD).
The study titled “Efficacy and safety of Syferol-IHP for the treatment of peptic ulcer disease: a pilot, double blind randomized trial” was published 2019 in the journal Clinical and Experimental Gastroenterology.
The researchers conducted a pilot double-blind randomised trial in patients with confirmed diagnosis (endoscopy-guided biopsy) of PUD. Eligible patients were randomized to Pylorest (a three-in-one tablet containing rabeprazole 20 mg, amoxicillin 1 g, and clarithromycin 500 mg) and Syferol-IHP for two weeks, followed by rabeprazole and Syferol-IHP for two weeks or Pylorest and placebo for two weeks, followed by rabeprazole and placebo for two weeks.
Repeat endoscopy-guided biopsy and histology were done four weeks post therapy. Primary outcome measures were the healing of ulcer and eradication of Helicobacter pylori. Secondary outcome measures were the disappearance of epigastric pain, gastritis, and duodenitis. Analysis was by intention-to-treat.
The results showed that of the 63 patients enrolled, 60 patients had complete evaluation, with 37 patients receiving Pylorest and Syferol-IHP and 23 patients receiving Pylorest and Placebo.
According to the study, healing of the PUD in favour of Pylorest and Syferol-IHP was significantly higher for gastric ulcer but not for duodenal ulcer. H. pylori eradication was 100 per cent with Syferol-IHP vs 50 per cent with placebo.
Epigastric pain (reduction to 16.2 per cent vs 43.5 per cent; P=0.021), gastritis (reduction to 13.5 per cent vs 39.1 per cent; P = 0.024), and duodenitis (reduction to 0 per cent vs 8.7 per cent; P=0.327) were observed in the Syferol-IHP and Pylorest vs placebo and Pylorest groups, respectively.
Adverse events and laboratory parameters were not significantly different pre- and post therapies for both groups.
The researchers concluded: “Although both treatment arms were equally safe, co-administration of Syferol-IHP and triple therapy is more efficacious than triple therapy alone for treating PUD.”
Syferol-IHP, produced by Bioresource Development Group, Abuja, is a special blend of virgin coconut oil (VCO) and cold-pressed Ocimum sanctum oil, which reportedly have been shown to be very effective in the treatment of PUD.
VCO (Cocos nucifera L. Arecaceae) works by exhibiting antibacterial property on H. pylori, thereby helping in the amelioration of the symptoms of PUD.
Studies have shown that O. sanctum oil, which is basil oil, has antibacterial and antiulcerogenic activities. Therefore, Syferol-IHP is a combination of natural product therapy.
According to the researchers, the potential antibacterial property of Syferol-IHP is made possible based on the fact that the coconut oil is made up of saturated fatty acids of the medium chain variety mostly lauric acid. Lauric acid has been demonstrated to be bactericidal in its activity without exerting undue adverse side effect as humans easily metabolize it. Also, the medium chain fatty acids of VCO are easily digestible.
Anecdotal reports have shown that there is strong improvement in PUD symptoms following the ingestion of triple therapy in combination with Syferol-IHP. This lends support to the hypothesis that triple therapy for PUD in combination with Syferol-IHP might be needed to achieve maximum and optimum clinical benefits.
“To our knowledge, this is the first randomized study reporting the efficacy and safety of this combined Syferol-IHP and triple therapy schedule. We therefore designed this pilot randomized double-blind trial to compare the efficacy and safety of Syferol-IHP on adult patients with PUD when used as adjuncts with conventional triple therapy.”
The study was carried out at the Nnamdi Azikiwe University Teaching Hospital (NAUTH), Nnewi, and Chukwuemeka Odumegwu Ojukwu University Teaching Hospital (COOUTH), Amaku, Awka, being government-owned hospitals in the South-East of Nigeria. They are public tertiary institutions. All the endoscopic procedures were done by CDE at Eldorado Multi-Specialist Hospital, Awka, and a hospital that is accredited for the management of adults with PUD.
The results of the study will be presented on Tuesday October 8, 2019 at HerbFest 2019 in Owerri, Imo State, by the team of researchers. Dr. George Eleje and Dr. Chiemelu Emegoakor of the Department of Obstetrics and Gynecology, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Anambra State will present the lead paper, “Report of a Double-Blind Randomized Clinical Trial on the Effectiveness and Safety of Syferol – IHP for treatment of Peptic Ulcer Disease in Nigeria,” on Wednesday October 9, 2019.
The theme of the programme is, “Food as Medicine: advances in treatment of gastrointestinal diseases – The Syferol report, natural products for HIV and immune health, natural medicine as effective cancer therapy, management of metabolic diseases, and herbs/spices in export market.”
The sub themes include: Advances in the treatment of gastrointestinal diseases – The Syferol report and Natural products for HIV and immune health.
The keynote lecture on “The Health and Wealth in Our Forests: Our Herbs” will be delivered by the Vice Chancellor, Nnamdi Azikiwe University, Awka, Prof. Charles Esimone.
The event will be followed on Thursday October 10, 2019 by a high level dialogue on phytotherapy in collaboration with the Nigerian Medical Association (NMA) Imo State Chapter. “The high level dialogue is indeed unique to enable doctors and orthodox health care professionals to interrogate possible use of herbal medicine in mainstream clinical care.”
Meanwhile, PUD is increasingly recognised as a major gastrointestinal disease affecting the stomach and duodenum. It arises from the deleterious effects of certain ulcerogenic agents such as the bacterium Helicobacter pylori, Non Steroidal Anti Inflammatory Drugs (NSAIDs), and alcohol.
To date, the management of PUD has become more challenging than ever because of the menace of increasing global antimicrobial resistance. In addition, PUD not associated with H. pylori infection or the use of NSAIDs is now also imposing substantial diagnostic and therapeutic challenges.
Conventionally available and accepted therapies for the management of PUD are associated with a vast array of noxious side effects, and the cost of treatment with these agents could be enormous. One recent meta-analysis on PUD therapy revealed that standard triple therapy consisting of proton pump inhibitors, such as amoxicillin and clarithromycin, were suboptimal.
Also, in a recent Cochrane review aimed at assessing the proportion of peptic ulcers healed and the proportion that remained free from relapse with eradication therapy against placebo or other pharmacological therapies in PUD, it was concluded that there is no evidence at present that H. pylori eradication therapy is an effective treatment in people with PUD compared to ulcer healing drug alone.
PUD can recur and becomes a chronic problem or can lead to a number of serious complications including gut perforation and upper gastrointestinal bleeding. Therefore, there is need for more alternative or adjunctive therapy for PUD.
Meanwhile, the participants comprised both male and female adult patients with the endoscopy diagnosis of PUD and who had given their written informed consent before recruitment. The patients were recruited at the outpatient clinics or referred for the treatment of their dyspeptic symptoms.
Both male and female individuals aged between 18 and 60 years with the confirmed diagnosis of PUD and with normal liver and renal function markers and hematological profiles were included.
Pregnant women and those with complications arising from PUD such as bleeding and perforation were excluded.
From January 2017 until August 2017, 77 patients at two hospitals were screened for eligibility. The patients eligible for the study were randomized into two groups using a simple (nonblock) randomisation table created by a computer software programme by a person not involved in the study and available at www.researchrandomizer.org. Allocation sequences and codes were concealed from the person allocating the participants to the intervention arms using numbered containers containing drugs.
Syferol-IHP and the placebo consisting of liquid preparations (containing mixture of carboxymethyl cellulose, tartrazine yellow, and orange- and banana-flavored purified water) were packed in identical opaque bottles. Participants could not distinguish from one preparation (Syferol-IHP and conventional triple therapy) to the other (conventional triple therapy and placebo for Syferol-IHP). Both personnel and outcome assessors were also blinded.
Patients with a clinical diagnosis of PUD presenting in Medical Outpatient Clinic of the hospitals for symptoms such as abdominal or epigastric pain, abdominal discomfort, vomiting, and other symptoms relating to PUD were screened consecutively. All patients also underwent routine medical examination including pulse rate, body weight, blood pressure determination, and abdominal examination to ascertain the presence and severity of abdominal or epigastric tenderness. All consenting patients were diagnosed to have either PUD or not after undergoing upper gastrointestinal tract endoscopy.
Eligible patients were sequentially allocated using an opaque sealed envelope to receive either Syferol-IHP and conventional triple therapy or the placebo for Syferol-IHP and conventional triple therapy in a double-blinded pattern. Therapies were given for four weeks.
Standard doses of 20 mL of Syferol-IHP were administered in conjunction with Pylorest (Saga Laboratories, Ahmedabad, India) tablets (a three-in-one tablet containing rabeprazole 20 mg, amoxicillin 1 g, and clarithromycin 500 mg) two times a day (breakfast and dinner) for two weeks and then followed by Rabefast (Pulse Pharmaceuticals Pvt Ltd, Uttarakhand, India) tablet containing 20 mg of rabeprazole, administered twice daily for another two weeks.
Standard doses of 20 mL of placebo for Syferol-IHP were administered in conjunction with Pylorest tablets (a three-in-one tablet containing rabeprazole 20 mg, amoxicillin 1 g, and clarithromycin 500 mg) two times a day (breakfast and dinner) for two weeks and followed by 20 mg of rabeprazole administered twice daily for another two weeks.
During each follow-up weekly visit, patients were encouraged and/or reminded to avoid smoking, aspirin, and other NSAIDs. Patients were contacted through phone on daily basis to assess the level of compliance. The patients were also encouraged to record any side effects or adverse events in a paper that was reviewed at each follow-up visit, and they were explicitly asked about such events during each interview. The drug compliance was checked before the follow-up test. Any patient found to be developing complications such as perforation and bleeding were discontinued from the study and were given appropriate treatment.
Repeat upper gastrointestinal endoscopy was done four weeks post treatment in all the participants to confirm the success of treatment (ulcer healing) and the absence of adverse effects. All the pre- and post- (repeat) upper gastrointestinal endoscopies were carried out by CDE.
Primary endpoints were the healing of ulcer and the eradication of H. pylori. Secondary endpoints were the disappearance of epigastric pain, gastritis, and duodenitis and the presence of adverse events. Other secondary outcome measures included renal function tests (serum electrolyte, urea, and creatinine), liver function tests, and lipid profile parameters and were repeated four weeks post treatment.
The intention-to-treat efficacy analyses were based on all the patients who received the study medication and had completed the follow-up visit. The number needed to treat (NNT) analysis (the number of patients who need to be treated for one of them to benefit compared with a control in a clinical trial) was also done. Patients with no observed outcome were considered as treatment failures. A univariate analysis was employed. When possible, subgroup analysis was also planned.
The study adheres to CONSORT guidelines. The study protocol was approved by the ethics committee of NAUTH, Nnewi (NAUTH/CS/66/VOL.9/93; approval date: November 7, 2016), and the ethics committee of COOUTH, Amaku, Awka, (COOUTH/AA/vol.1.016; approval date: August 1, 2016). The study was also registered with the Pan African Clinical trial registry: PACTR201606001665364 at www.pactr.org. The trial was registered on June 1, 2016. The procedures followed were in accordance with the guidelines of the World Medical Association’s Declaration of Helsinki (1964) and its later amendments.
The characteristics of all randomised patients at baseline are shown. The groups were balanced with respect to baseline characteristics (age, gender, H. pylori-positive lesions, and full blood count parameters). Seventy-seven participants at two hospitals were screened for eligibility.
Of these patients, 63 patients were included in the study and 14 patients did not fulfill the criteria for randomization and were excluded. The reasons for exclusion were not agreeing to participate in the study (n=four) and no positive findings at endoscopy (n=seven) and bleeding ulcer (n=three). All patients included in the study were adults and were non-treatment naive.
Of the 63 patients, 39 patients received Syferol-IHP with conventional triple therapy and 24 patients received placebo and conventional triple therapy. Of the 60 patients who completed their follow-up visits, 43 patients had endoscopy-guided biopsy of the lesion. Six (16.2 per cent) of the 37 patients in the Syferol group and four (17.4 per cent) of the placebo group were H. pylori positive, whereas 12 (32.4 per cent) and five (21.7 per cent) had unknown H. pylori status.
Although none of the patients withdrew consent after randomisation, one was lost to follow-up in the triple therapy–Syferol-IHP group and one was lost to follow-up in the triple therapy–placebo group. A total of 37 patients from the triple therapy–Syferol-IHP group and 23 in the triple therapy–placebo group completed the study with follow-up data of four weeks after enrollment. The study was stopped after completing the follow-up of 60 participants due to costs.
The effects on healing of the ulcer in favour of Syferol-IHP were statistically significantly different for gastric ulcer but not for duodenal ulcer.
CREDIT: GUARDIAN
